Hydrocortone 10mg Tablets
Package Leaflet: Information for the User
Hydrocortone® 10mg Tablets
(hydrocortisone)
This leaflet contains important information about Hydrocortone 10mg Tablets.
Read this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The name of this medicine is Hydrocortone 10mg Tablets but it will be referred to as Hydrocortone Tablets throughout the remainder of this leaflet.
• Hydrocortone Tablets are also available in other strengths.
• Hydrocortone Tablets are a steroid medicine, prescribed for many different conditions, including serious illnesses
• You need to take it regularly to get the maximum benefit
• Don’t stop taking this medicine without talking to your doctor - you may need to reduce the dose gradually
• Hydrocortone Tablets can cause side effects in some people (read ‘Possible side effects' section below). Some problems such as mood changes (feeling depressed, or ‘high'), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read ‘Possible side effects' section for more information)
• If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you
• Keep away from people who have chicken pox or shingles, if you
have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.
In this leaflet
1. What Hydrocortone Tablets are and what are they used for
2. Before taking Hydrocortone Tablets
3. How to take Hydrocortone Tablets
4. Possible side effects
5. How to store Hydrocortone Tablets
6. Further information
1. What Hydrocortone Tablets are and what are they used for
Hydrocortone Tablets contain a medicine called hydrocortisone. This belongs to a group of medicines called ‘steroids'. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Hydrocortone Tablets) is an effective way to treat various illnesses involving inflammation in the body.
Hydrocortone Tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.
Hydrocortone Tablets are used for:
• adding hydrocortisone usually made naturally in the body because part of the adrenal gland is not working properly
• adding hydrocortisone after injuries, surgery or other stressful events
• some other types of illness.
Ask your doctor to explain why you have been given Hydrocortone Tablets if you are unsure.
2. Before taking Hydrocortone Tablets
Before you take Hydrocortone Tablets
Check with your doctor first if
• You have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like Hydrocortone Tablets.
• any of your close family has had these illnesses.
If either of these apply to you, talk to a doctor before taking Hydrocortone Tablets.
Do not take Hydrocortone Tablets if you:
• are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hydrocortone Tablets
• have thrush, candida or any other fungal infection.
If you are not sure talk to your doctor or pharmacist before taking Hydrocortone Tablets.
Take special care with Hydrocortone Tablets
Check with your doctor before taking your medicine if:
• you have recently had a heart attack
• you have a heart condition called congestive heart disease
• you have septicaemia, tuberculosis (TB) or have had it in the past
• you have a stomach ulcer or other digestive problem
• you have chicken pox or shingles
• you come in contact with people who have chicken pox or shingles, especially if you have not already had these illnesses or are not sure if you have had them
• you have a herpes infection in the eye called ocular herpes simplex
• you had muscle weakness after taking steroids in the past
• you have recently visited a tropical country
• you have bowel problems such as ulcerative colitis
• you have epilepsy
• you have thrombophlebitis (swelling and redness along a vein which is extremely tender when touched)
• you have exanthematous disease (disease affecting the skin, rash)
• you have metastatic carcinoma (cancer that has spread from one part of the body to another)
• you are taking Hydrocortone Tablets for a long time increases your chance of getting infections
• you have amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse.
Also, check with your doctor if any of the following problems run in your family, or if you have any of them:
• diabetes
• heart problems
• high blood pressure
• an eye condition called ‘glaucoma'
• kidney or liver problems
• a type of muscle weakening problem called ‘myasthenia gravis'
• thinning of the bones (osteoporosis)
• low thyroid levels (hypothyroidism).
If you are not sure if any of the above run in your family, or you have them, talk to your doctor or pharmacist before taking a tablet.
Mental Problems while taking Hydrocortone Tablets
Mental problems can happen while taking steroids like Hydrocortone Tablets (see also section 4 Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped.
• However, if problems do happen they might need treatment.
Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription.
This includes herbal medicines. This is because Hydrocortone Tablets can affect the way some medicines work.
Also, some other medicines can affect the way Hydrocortone Tablets work.
In particular do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:
• aspirin
• medicines for fits (epilepsy) such as phenytoin, phenobarbital, carbamazepine and primidone
• cough and cold medicines that contain a decongestant called ephedrine
• medicines used for TB (tuberculosis) called rifabutin or rifampicin
• medicines used to thin the blood such as warfarin
• water tablets (diuretics)
• some medicines for fungal infections such as amphotericin and ketoconazole
• a medicine for cancer called aminoglutethimide
• some medicines for heart failure such as digoxin, furosemide or bumetanide
• a medicine used for some infections called erythromycin
• oral contraceptive pills and hormone replacement therapy (HRT)
• a type of growth hormone called somatropin
• some medicines for high blood pressure
• some medicines for heart disease such as guanethidine, isosorbide mononitrate, isosorbide dinitrate and theophylline
• medicines sometimes used for asthma, low blood pressure or in cough and cold remedies called sympathomimetics
• calcium supplements
• medicines for pain and inflammation called NSAIDs such as ibuprofen, diclofenac or naproxen
• a medicine for urea cycle disorder called sodium phenylbutyrate (usually started by a specialist doctor or consultant)
• medicines for diabetes
• ritonavir (a medicine used in the treatment of HIV infections)
• methotrexate (a medicine used to treat rheumatoid arthritis)
• ciclosporin (a medicine used for psoriasis or in patients who have organ transplants)
• minoxidil & hydralazine (used for antihypertensive)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hydrocortone Tablets.
Hydrocortone Tablets and infections
Infections are easier to get and harder to spot while you are taking Hydrocortone Tablets.
Stay away from anyone you know with:
• chicken pox • shingles
• measles.
See your doctor if you think you may have picked up an infection. Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.
Driving and using machines
Steroids may cause a feeling of movement, even while you are still and this can cause you to feel dizzy (vertigo). Changes in your eyesight or muscle weakness may also happen. If you are affected you should not drive or operate machinery.
Taking Hydrocortone Tablets with food and drink
Hydrocortone Tablets can be taken with or without food.
Having vaccines or tests while you are taking Hydrocortone Tablets
Tell your doctor that you are taking Hydrocortone Tablets if you are to receive any vaccinations or have any diagnostic or laboratory tests. This is because steroids can affect the results of some tests.
Information you should carry while you are taking Hydrocortone Tablets
If you are taking Hydrocortone Tablets, get a steroid card from your pharmacist, and carry it with you. It shows what you are taking and who your doctor is in case of an emergency.
If you have an accident, fall ill or see a different doctor while taking Hydrocortone Tablets, show them your steroid card or, tell whoever treats you that you are taking Hydrocortone Tablets, because your dose may need to be changed.
Important information about some of the ingredients of Hydrocortone Tablets
Hydrocortone Tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
3. How to take Hydrocortone Tablets
Always take Hydrocortone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
You should take this medicine by mouth. The amount you take each day will depend on your illness. The number of tablets to be taken will be on the label of your medicine. If you are unsure about the dose you should take, you must talk to your doctor or pharmacist. The usual doses of Hydrocortone Tablets are:
Adults
• 20 to 30 mg a day.
• Sometimes it is taken with 4 to 6 g of salt (sodium chloride) or 50 to 300 micrograms of fludrocortisone.
Children
• 0.4 to 0.8 mg a day, for every kilogram of your child's weight in two or three separate doses.
• Children will be prescribed the lowest possible dose.
• The doctor will keep an eye on their growth and development.
If you take more Hydrocortone Tablets than you should
If you take too many tablets by mistake, contact your doctor as soon as possible.
If you forget to take Hydrocortone Tablets
• If you forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgotten dose.
If you are thinking about stopping or have recently been told to stop Hydrocortone Tablets
It is dangerous to reduce your dose of Hydrocortone Tablets too quickly. Stopping Hydrocortone Tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as:
• pains in muscles or joints • fever
• general discomfort.
Your doctor or pharmacist will give you advice on how to reduce the number of tablets you take if you need to do this.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Hydrocortone Tablets can cause side effects, although not everybody gets them. People taking steroids to replace similar naturally occurring hormones, should be less likely to get side effects than, people taking steroids for other illnesses. Your doctor will want to see you now and then to look out for these effects.
Tell your doctor straight away if you notice any of these problems, or if you think you are at increased risk of infection (e.g. you have been in contact with someone who has an infection):
• An allergic reaction such as skin rash, swelling of the face or wheezing.
• Irregular or very fast or slow pulse, faintness.
• Muscle cramps or spasms.
• Pseudotumourcerebri in children (raised pressure within the skull, indicated by headaches with vomiting, listlessness and drowsiness); this usually occurs after treatment is stopped.
• Nausea, vomiting.
• Burst or bleeding ulcers (indicated by stomach pain especially if it seems to spread to your back, bleeding from the back passage, black stools or vomiting with blood in the vomit).
• Acute pancreatitis (abdominal pain, possibly accompanied by shock,
i.e. low blood pressure with decreased output of urine and often loss of consciousness).
• A worsening of sight.
• Thrombosis (a blood clot in a vein in your leg, symptoms of which are a swollen, red, hot, tender muscle).
• Thromboembolism (a blood clot which may go to the lung, symptoms of which are sudden chest pain and coughing up blood).
• Heart failure - problems with the pumping of your heart indicated by swollen ankles, chest pain, difficulty in breathing and palpitations or irregular beating of the heart, irregular or very fast or slow pulse; hypertension (high blood pressure, indicated by headaches, or generally feeling unwell).
Steroids including Hydrocortone Tablets can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Hydrocortone Tablets.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
Effects on your digestive system
• Swollen abdomen.
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloating.
• Hiccups.
Effects on your muscles and bones
• Muscle weakness or wasting.
• Osteoporosis (brittle bones - bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood (pain in the hip).
• Aseptic necrosis (joint inflammation in the knee and groin).
• Torn muscle tendons (pain and/or swelling).
Effects on your body water and salts
• Cramps and spasms due to the loss of the potassium salts from your body. In rare cases, loss of potassium can lead to palpitations (an uneven beating of your heart that you become aware of).
Effects on your hormones and metabolic system
• Suppression of normal growth in children.
• Irregular or no periods in women.
• Increased hair on the body and face in women.
• Round or moon-shaped face.
• Increased appetite and weight gain.
• Increase in blood sugar levels, breakdown of body protein stores (loss of weight and muscle loss in arms or legs), loss of calcium and nitrogen.
Effects on your skin
• thin or delicate skin, bruising, red or purple spots
• slow healing of cuts or wounds
• acne, sweating, redness
• stretch marks
Effects on your eyes
• changes in vision as a result of cataracts or glaucoma (increased pressure inside the eye)
• thinning of the surface of the eye
• eye infections may get worse
• bulging eyes.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Hydrocortone Tablets
• Keep out of the sight and reach of children.
• Do not store above 25oC.
• Store in original package in order to protect from light.
• Do not use Hydrocortone Tablets after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any signs of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Hydrocortone Tablets contain
Each tablet contains 10mg hydrocortisone.
Other ingredients: Lactose monohydrate, magnesium stearate and maize starch.
What Hydrocortone Tablets look like and contents of the pack
Hydrocortone Tablets are white, oval-shaped tablets quarter-scored on one side and imprinted with ‘HYD10' on the other side.
The tablets are scored so that they can easily be broken into halves or quarters. This can allow you to take lower dose of half of a tablet (5mg) or quarter of a tablet (2.5mg).
Hydrocortone Tablets come in blister packs of 30 tablets.
Manufactured by
Tiofarma, Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijerland, Netherlands.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
Further information about your condition may be available from The Pituitary Foundation, P.O. Box 1944, Bristol, BS99 2UB Telephone: 0845 450 0375.
(The Pituitary Foundation is an independent organisation, it is not associated with Auden Mckenzie (Pharma Division) Ltd. or MPT Pharma Ltd.).
PL: 33532/0688
POM |
Leaflet dated 19th August 2016 Leaflet coded xxxxxxxxxxxx
Hydrocortone® is a registered trademark of Auden McKenzie (Pharma Division) Ltd.
This leaflet contains important information about Hydrocortisone 10mg Tablets.
Read this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The name of this medicine is Hydrocortisone 10mg Tablets but it will be referred to as Hydrocortisone Tablets throughout the remainder of this leaflet.
• Hydrocortisone Tablets are also available in other strengths.
• Hydrocortisone Tablets are a steroid medicine, prescribed for many different conditions, including serious illnesses
• You need to take it regularly to get the maximum benefit
• Don’t stop taking this medicine without talking to your doctor - you may need to reduce the dose gradually
• Hydrocortisone Tablets can cause side effects in some people (read ‘Possible side effects' section below). Some problems such as mood changes (feeling depressed, or ‘high'), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read ‘Possible side effects' section for more information)
• If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you
• Keep away from people who have chicken pox or shingles, if you
have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.
In this leaflet
1. What Hydrocortisone Tablets are and what are they used for
2. Before taking Hydrocortisone Tablets
3. How to take Hydrocortisone Tablets
4. Possible side effects
5. How to store Hydrocortisone Tablets
6. Further information
1. What Hydrocortisone Tablets are and what are they used for
Hydrocortisone Tablets contain a medicine called hydrocortisone. This belongs to a group of medicines called ‘steroids'. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Hydrocortisone Tablets) is an effective way to treat various illnesses involving inflammation in the body.
Hydrocortisone Tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.
Hydrocortisone Tablets are used for:
• adding hydrocortisone usually made naturally in the body because part of the adrenal gland is not working properly
• adding hydrocortisone after injuries, surgery or other stressful events
• some other types of illness.
Ask your doctor to explain why you have been given Hydrocortisone Tablets if you are unsure.
2. Before taking Hydrocortisone Tablets
Before you take Hydrocortisone Tablets
Check with your doctor first if
• You have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like Hydrocortisone Tablets.
• any of your close family has had these illnesses.
If either of these apply to you, talk to a doctor before taking Hydrocortisone Tablets.
Do not take Hydrocortisone Tablets if you:
• are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hydrocortisone Tablets
• have thrush, candida or any other fungal infection.
If you are not sure talk to your doctor or pharmacist before taking Hydrocortisone Tablets.
Take special care with Hydrocortisone Tablets
Check with your doctor before taking your medicine if:
• you have recently had a heart attack
• you have a heart condition called congestive heart disease
• you have septicaemia, tuberculosis (TB) or have had it in the past
• you have a stomach ulcer or other digestive problem
• you have chicken pox or shingles
• you come in contact with people who have chicken pox or shingles, especially if you have not already had these illnesses or are not sure if you have had them
• you have a herpes infection in the eye called ocular herpes simplex
• you had muscle weakness after taking steroids in the past
• you have recently visited a tropical country
• you have bowel problems such as ulcerative colitis
• you have epilepsy
• you have thrombophlebitis (swelling and redness along a vein which is extremely tender when touched)
• you have exanthematous disease (disease affecting the skin, rash)
• you have metastatic carcinoma (cancer that has spread from one part of the body to another)
• you are taking Hydrocortisone Tablets for a long time increases your chance of getting infections
• you have amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse.
Also, check with your doctor if any of the following problems run in your family, or if you have any of them:
• diabetes
• heart problems
• high blood pressure
• an eye condition called ‘glaucoma'
• kidney or liver problems
• a type of muscle weakening problem called ‘myasthenia gravis'
• thinning of the bones (osteoporosis)
• low thyroid levels (hypothyroidism).
If you are not sure if any of the above run in your family, or you have them, talk to your doctor or pharmacist before taking a tablet.
Mental Problems while taking Hydrocortisone Tablets
Mental problems can happen while taking steroids like Hydrocortisone Tablets (see also section 4 Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped.
• However, if problems do happen they might need treatment.
Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription.
This includes herbal medicines. This is because Hydrocortisone Tablets can affect the way some medicines work.
Also, some other medicines can affect the way Hydrocortisone Tablets work.
In particular do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:
• aspirin
• medicines for fits (epilepsy) such as phenytoin, phenobarbital, carbamazepine and primidone
• cough and cold medicines that contain a decongestant called ephedrine
• medicines used for TB (tuberculosis) called rifabutin or rifampicin
• medicines used to thin the blood such as warfarin
• water tablets (diuretics)
• some medicines for fungal infections such as amphotericin and ketoconazole
• a medicine for cancer called aminoglutethimide
• some medicines for heart failure such as digoxin, furosemide or bumetanide
• a medicine used for some infections called erythromycin
• oral contraceptive pills and hormone replacement therapy (HRT)
• a type of growth hormone called somatropin
• some medicines for high blood pressure
• some medicines for heart disease such as guanethidine, isosorbide mononitrate, isosorbide dinitrate and theophylline
• medicines sometimes used for asthma, low blood pressure or in cough and cold remedies called sympathomimetics
• calcium supplements
• medicines for pain and inflammation called NSAIDs such as ibuprofen, diclofenac or naproxen
• a medicine for urea cycle disorder called sodium phenylbutyrate (usually started by a specialist doctor or consultant)
• medicines for diabetes
• ritonavir (a medicine used in the treatment of HIV infections)
• methotrexate (a medicine used to treat rheumatoid arthritis)
• ciclosporin (a medicine used for psoriasis or in patients who have organ transplants)
• minoxidil & hydralazine (used for antihypertensive)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hydrocortisone Tablets.
Hydrocortisone Tablets and infections
Infections are easier to get and harder to spot while you are taking Hydrocortisone Tablets.
Stay away from anyone you know with:
• chicken pox • shingles
• measles.
See your doctor if you think you may have picked up an infection. Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.
Driving and using machines
Steroids may cause a feeling of movement, even while you are still and this can cause you to feel dizzy (vertigo). Changes in your eyesight or muscle weakness may also happen. If you are affected you should not drive or operate machinery.
Taking Hydrocortisone Tablets with food and drink
Hydrocortisone Tablets can be taken with or without food.
Having vaccines or tests while you are taking Hydrocortisone Tablets
Tell your doctor that you are taking Hydrocortisone Tablets if you are to receive any vaccinations or have any diagnostic or laboratory tests. This is because steroids can affect the results of some tests.
Information you should carry while you are taking Hydrocortisone Tablets
If you are taking Hydrocortisone Tablets, get a steroid card from your pharmacist, and carry it with you. It shows what you are taking and who your doctor is in case of an emergency.
If you have an accident, fall ill or see a different doctor while taking Hydrocortisone Tablets, show them your steroid card or, tell whoever treats you that you are taking Hydrocortisone Tablets, because your dose may need to be changed.
Important information about some of the ingredients of Hydrocortisone Tablets
Hydrocortisone Tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
3. How to take Hydrocortisone Tablets
Always take Hydrocortisone Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
You should take this medicine by mouth. The amount you take each day will depend on your illness. The number of tablets to be taken will be on the label of your medicine. If you are unsure about the dose you should take, you must talk to your doctor or pharmacist. The usual doses of Hydrocortisone Tablets are:
Adults
• 20 to 30 mg a day.
• Sometimes it is taken with 4 to 6 g of salt (sodium chloride) or 50 to 300 micrograms of fludrocortisone.
Children
• 0.4 to 0.8 mg a day, for every kilogram of your child's weight in two or three separate doses.
• Children will be prescribed the lowest possible dose.
• The doctor will keep an eye on their growth and development.
If you take more Hydrocortisone Tablets than you should
If you take too many tablets by mistake, contact your doctor as soon as possible.
If you forget to take Hydrocortisone Tablets
• If you forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgotten dose.
If you are thinking about stopping or have recently been told to stop Hydrocortisone Tablets
It is dangerous to reduce your dose of Hydrocortisone Tablets too quickly. Stopping Hydrocortisone Tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as:
• pains in muscles or joints • fever
• general discomfort.
Your doctor or pharmacist will give you advice on how to reduce the number of tablets you take if you need to do this.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Hydrocortisone Tablets can cause side effects, although not everybody gets them. People taking steroids to replace similar naturally occurring hormones, should be less likely to get side effects than, people taking steroids for other illnesses. Your doctor will want to see you now and then to look out for these effects.
Tell your doctor straight away if you notice any of these problems, or if you think you are at increased risk of infection (e.g. you have been in contact with someone who has an infection):
• An allergic reaction such as skin rash, swelling of the face or wheezing.
• Irregular or very fast or slow pulse, faintness.
• Muscle cramps or spasms.
• Pseudotumourcerebri in children (raised pressure within the skull, indicated by headaches with vomiting, listlessness and drowsiness); this usually occurs after treatment is stopped.
• Nausea, vomiting.
• Burst or bleeding ulcers (indicated by stomach pain especially if it seems to spread to your back, bleeding from the back passage, black stools or vomiting with blood in the vomit).
• Acute pancreatitis (abdominal pain, possibly accompanied by shock,
i.e. low blood pressure with decreased output of urine and often loss of consciousness).
• A worsening of sight.
• Thrombosis (a blood clot in a vein in your leg, symptoms of which are a swollen, red, hot, tender muscle).
• Thromboembolism (a blood clot which may go to the lung, symptoms of which are sudden chest pain and coughing up blood).
• Heart failure - problems with the pumping of your heart indicated by swollen ankles, chest pain, difficulty in breathing and palpitations or irregular beating of the heart, irregular or very fast or slow pulse; hypertension (high blood pressure, indicated by headaches, or generally feeling unwell).
Steroids including Hydrocortisone Tablets can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Hydrocortisone Tablets.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
Effects on your digestive system
• Swollen abdomen.
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloating.
• Hiccups.
Effects on your muscles and bones
• Muscle weakness or wasting.
• Osteoporosis (brittle bones - bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood (pain in the hip).
• Aseptic necrosis (joint inflammation in the knee and groin).
• Torn muscle tendons (pain and/or swelling).
Effects on your body water and salts
• Cramps and spasms due to the loss of the potassium salts from your body. In rare cases, loss of potassium can lead to palpitations (an uneven beating of your heart that you become aware of).
Effects on your hormones and metabolic system
• Suppression of normal growth in children.
• Irregular or no periods in women.
• Increased hair on the body and face in women.
• Round or moon-shaped face.
• Increased appetite and weight gain.
• Increase in blood sugar levels, breakdown of body protein stores (loss of weight and muscle loss in arms or legs), loss of calcium and nitrogen.
Effects on your skin
• thin or delicate skin, bruising, red or purple spots
• slow healing of cuts or wounds
• acne, sweating, redness
• stretch marks
Effects on your eyes
• changes in vision as a result of cataracts or glaucoma (increased pressure inside the eye)
• thinning of the surface of the eye
• eye infections may get worse
• bulging eyes.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Hydrocortisone Tablets
• Keep out of the sight and reach of children.
• Do not store above 25oC.
• Store in original package in order to protect from light.
• Do not use Hydrocortisone Tablets after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any signs of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Hydrocortisone Tablets contain
Each tablet contains 10mg hydrocortisone.
Other ingredients: Lactose monohydrate, magnesium stearate and maize starch.
What Hydrocortisone Tablets look like and contents of the pack
Hydrocortisone Tablets are white, oval-shaped tablets quarter-scored on one side and imprinted with ‘HYD10' on the other side.
The tablets are scored so that they can easily be broken into halves or quarters. This can allow you to take lower dose of half of a tablet (5mg) or quarter of a tablet (2.5mg).
Hydrocortisone Tablets come in blister packs of 30 tablets.
Manufactured by
Tiofarma, Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijerland, Netherlands.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
Further information about your condition may be available from The Pituitary Foundation, P.O. Box 1944, Bristol, BS99 2UB Telephone: 0845 450 0375.
(The Pituitary Foundation is an independent organisation, it is not associated with Auden Mckenzie (Pharma Division) Ltd. or MPT Pharma Ltd.).
PL: 33532/0688
Leaflet dated 19th August 2016 Leaflet coded xxxxxxxxxxxx
|POM |
This leaflet contains important information about Hydrocortisone Auden 10mg Tablets.
Read this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The name of this medicine is Hydrocortisone Auden 10mg Tablets but it will be referred to as Hydrocortisone Auden Tablets throughout the remainder of this leaflet.
• Hydrocortisone Auden Tablets are also available in other strengths.
• Hydrocortisone Auden Tablets are a steroid medicine, prescribed for many different conditions, including serious illnesses
• You need to take it regularly to get the maximum benefit
• Don’t stop taking this medicine without talking to your doctor - you may need to reduce the dose gradually
• Hydrocortisone Auden Tablets can cause side effects in some people (read ‘Possible side effects' section below). Some problems such as mood changes (feeling depressed, or ‘high'), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read ‘Possible side effects' section for more information)
• If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you
• Keep away from people who have chicken pox or shingles, if you
have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.
In this leaflet
1. What Hydrocortisone Auden Tablets are and what are they used for
2. Before taking Hydrocortisone Auden Tablets
3. How to take Hydrocortisone Auden Tablets
4. Possible side effects
5. How to store Hydrocortisone Auden Tablets
6. Further information
1. What Hydrocortisone Auden Tablets are and what are they used for
Hydrocortisone Auden Tablets contain a medicine called hydrocortisone. This belongs to a group of medicines called ‘steroids'. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Hydrocortisone Auden Tablets) is an effective way to treat various illnesses involving inflammation in the body.
Hydrocortisone Auden Tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.
Hydrocortisone Auden Tablets are used for:
• adding hydrocortisone usually made naturally in the body because part of the adrenal gland is not working properly
• adding hydrocortisone after injuries, surgery or other stressful events
• some other types of illness.
Ask your doctor to explain why you have been given Hydrocortisone Auden Tablets if you are unsure.
2. Before taking Hydrocortisone Auden Tablets
Before you take Hydrocortisone Auden Tablets
Check with your doctor first if
• You have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like Hydrocortisone Auden Tablets.
• any of your close family has had these illnesses.
If either of these apply to you, talk to a doctor before taking Hydrocortisone Auden Tablets.
Do not take Hydrocortisone Auden Tablets if you:
• are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hydrocortisone Auden Tablets
• have thrush, candida or any other fungal infection.
If you are not sure talk to your doctor or pharmacist before taking Hydrocortisone Auden Tablets.
Take special care with Hydrocortisone Auden Tablets
Check with your doctor before taking your medicine if:
• you have recently had a heart attack
• you have a heart condition called congestive heart disease
• you have septicaemia, tuberculosis (TB) or have had it in the past
• you have a stomach ulcer or other digestive problem
• you have chicken pox or shingles
• you come in contact with people who have chicken pox or shingles, especially if you have not already had these illnesses or are not sure if you have had them
• you have a herpes infection in the eye called ocular herpes simplex
• you had muscle weakness after taking steroids in the past
• you have recently visited a tropical country
• you have bowel problems such as ulcerative colitis
• you have epilepsy
• you have thrombophlebitis (swelling and redness along a vein which is extremely tender when touched)
• you have exanthematous disease (disease affecting the skin, rash)
• you have metastatic carcinoma (cancer that has spread from one part of the body to another)
• you are taking Hydrocortisone Auden Tablets for a long time increases your chance of getting infections
• you have amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse.
Also, check with your doctor if any of the following problems run in your family, or if you have any of them:
• diabetes
• heart problems
• high blood pressure
• an eye condition called ‘glaucoma'
• kidney or liver problems
• a type of muscle weakening problem called ‘myasthenia gravis'
• thinning of the bones (osteoporosis)
• low thyroid levels (hypothyroidism).
If you are not sure if any of the above run in your family, or you have them, talk to your doctor or pharmacist before taking a tablet.
Mental Problems while taking Hydrocortisone Auden Tablets
Mental problems can happen while taking steroids like Hydrocortisone Auden Tablets (see also section 4 Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped.
• However, if problems do happen they might need treatment.
Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription.
This includes herbal medicines. This is because Hydrocortisone Auden Tablets can affect the way some medicines work.
Also, some other medicines can affect the way Hydrocortisone Auden Tablets work.
In particular do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:
• aspirin
• medicines for fits (epilepsy) such as phenytoin, phenobarbital, carbamazepine and primidone
• cough and cold medicines that contain a decongestant called ephedrine
• medicines used for TB (tuberculosis) called rifabutin or rifampicin
• medicines used to thin the blood such as warfarin
• water tablets (diuretics)
• some medicines for fungal infections such as amphotericin and ketoconazole
• a medicine for cancer called aminoglutethimide
• some medicines for heart failure such as digoxin, furosemide or bumetanide
• a medicine used for some infections called erythromycin
• oral contraceptive pills and hormone replacement therapy (HRT)
• a type of growth hormone called somatropin
• some medicines for high blood pressure
• some medicines for heart disease such as guanethidine, isosorbide mononitrate, isosorbide dinitrate and theophylline
• medicines sometimes used for asthma, low blood pressure or in cough and cold remedies called sympathomimetics
• calcium supplements
• medicines for pain and inflammation called NSAIDs such as ibuprofen, diclofenac or naproxen
• a medicine for urea cycle disorder called sodium phenylbutyrate (usually started by a specialist doctor or consultant)
• medicines for diabetes
• ritonavir (a medicine used in the treatment of HIV infections)
• methotrexate (a medicine used to treat rheumatoid arthritis)
• ciclosporin (a medicine used for psoriasis or in patients who have organ transplants)
• minoxidil & hydralazine (used for antihypertensive)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hydrocortisone Auden Tablets.
Hydrocortisone Auden Tablets and infections
Infections are easier to get and harder to spot while you are taking Hydrocortisone Auden Tablets.
Stay away from anyone you know with:
• chicken pox • shingles
• measles.
See your doctor if you think you may have picked up an infection. Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.
Driving and using machines
Steroids may cause a feeling of movement, even while you are still and this can cause you to feel dizzy (vertigo). Changes in your eyesight or muscle weakness may also happen. If you are affected you should not drive or operate machinery.
Taking Hydrocortisone Auden Tablets with food and drink
Hydrocortisone Auden Tablets can be taken with or without food.
Having vaccines or tests while you are taking Hydrocortisone Auden Tablets
Tell your doctor that you are taking Hydrocortisone Auden Tablets if you are to receive any vaccinations or have any diagnostic or laboratory tests. This is because steroids can affect the results of some tests.
Having surgery while you are taking Hydrocortisone Auden Tablets
If you are having surgery requiring an anaesthetic tell your doctor you are taking Hydrocortisone Auden Tablets.
Information you should carry while you are taking Hydrocortisone Auden Tablets
If you are taking Hydrocortisone Auden Tablets, get a steroid card from your pharmacist, and carry it with you. It shows what you are taking and who your doctor is in case of an emergency.
If you have an accident, fall ill or see a different doctor while taking Hydrocortisone Auden Tablets, show them your steroid card or, tell whoever treats you that you are taking Hydrocortisone Auden Tablets, because your dose may need to be changed.
Important information about some of the ingredients of Hydrocortisone Auden Tablets
Hydrocortisone Auden Tablets contain lactose, which is a type of sugar.
If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
3. How to take Hydrocortisone Auden Tablets
Always take Hydrocortisone Auden Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
You should take this medicine by mouth. The amount you take each day will depend on your illness. The number of tablets to be taken will be on the label of your medicine. If you are unsure about the dose you should take, you must talk to your doctor or pharmacist. The usual doses of Hydrocortisone Auden Tablets are:
Adults
• 20 to 30 mg a day.
• Sometimes it is taken with 4 to 6 g of salt (sodium chloride) or 50 to 300 micrograms of fludrocortisone.
Children
• 0.4 to 0.8 mg a day, for every kilogram of your child's weight in two or three separate doses.
• Children will be prescribed the lowest possible dose.
• The doctor will keep an eye on their growth and development.
If you take more Hydrocortisone Auden Tablets than you should
If you take too many tablets by mistake, contact your doctor as soon as possible.
If you forget to take Hydrocortisone Auden Tablets
• If you forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgotten dose.
If you are thinking about stopping or have recently been told to stop Hydrocortisone Auden Tablets
It is dangerous to reduce your dose of Hydrocortisone Auden Tablets too quickly. Stopping Hydrocortisone Auden Tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as:
• pains in muscles or joints • fever
• general discomfort.
Your doctor or pharmacist will give you advice on how to reduce the number of tablets you take if you need to do this.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Hydrocortisone Auden Tablets can cause side effects, although not everybody gets them. People taking steroids to replace similar naturally occurring hormones, should be less likely to get side effects than, people taking steroids for other illnesses. Your doctor will want to see you now and then to look out for these effects.
Tell your doctor straight away if you notice any of these problems, or if you think you are at increased risk of infection (e.g. you have been in contact with someone who has an infection):
• An allergic reaction such as skin rash, swelling of the face or wheezing.
• Irregular or very fast or slow pulse, faintness.
• Muscle cramps or spasms.
• Pseudotumourcerebri in children (raised pressure within the skull, indicated by headaches with vomiting, listlessness and drowsiness); this usually occurs after treatment is stopped.
• Nausea, vomiting.
• Burst or bleeding ulcers (indicated by stomach pain especially if it seems to spread to your back, bleeding from the back passage, black stools or vomiting with blood in the vomit).
• Acute pancreatitis (abdominal pain, possibly accompanied by shock, i.e. low blood pressure with decreased output of urine and often loss of consciousness).
• A worsening of sight.
• Thrombosis (a blood clot in a vein in your leg, symptoms of which are a swollen, red, hot, tender muscle).
• Thromboembolism (a blood clot which may go to the lung, symptoms of which are sudden chest pain and coughing up blood).
• Heart failure - problems with the pumping of your heart indicated by swollen ankles, chest pain, difficulty in breathing and palpitations or irregular beating of the heart, irregular or very fast or slow pulse; hypertension (high blood pressure, indicated by headaches, or generally feeling unwell).
Steroids including Hydrocortisone Auden Tablets can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Hydrocortisone Auden Tablets.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
Effects on your digestive system
• Swollen abdomen.
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloating.
• Hiccups.
Effects on your muscles and bones
• Muscle weakness or wasting.
• Osteoporosis (brittle bones - bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood (pain in the hip).
• Aseptic necrosis (joint inflammation in the knee and groin).
• Torn muscle tendons (pain and/or swelling).
Effects on your body water and salts
• Cramps and spasms due to the loss of the potassium salts from your body. In rare cases, loss of potassium can lead to palpitations (an uneven beating of your heart that you become aware of).
Effects on your hormones and metabolic system
• Suppression of normal growth in children.
• Irregular or no periods in women.
• Increased hair on the body and face in women.
• Round or moon-shaped face.
• Increased appetite and weight gain.
• Increase in blood sugar levels, breakdown of body protein stores (loss of weight and muscle loss in arms or legs), loss of calcium and nitrogen.
Effects on your skin
• thin or delicate skin, bruising, red or purple spots
• slow healing of cuts or wounds
• acne, sweating, redness
• stretch marks
Effects on your eyes
• changes in vision as a result of cataracts or glaucoma (increased pressure inside the eye)
• thinning of the surface of the eye
• eye infections may get worse
• bulging eyes.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Hydrocortisone Auden Tablets
• Keep out of the sight and reach of children.
• Do not store above 25oC.
• Store in original package in order to protect from light.
• Do not use Hydrocortisone Auden Tablets after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any signs of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Hydrocortisone Auden Tablets contain
Each tablet contains 10mg hydrocortisone.
Other ingredients: Lactose monohydrate, magnesium stearate and maize starch.
What Hydrocortisone Auden Tablets look like and contents of the pack
Hydrocortisone Auden Tablets are white, oval-shaped tablets quarter-scored on one side and imprinted with ‘HYD10' on the other side.
The tablets are scored so that they can easily be broken into halves or quarters. This can allow you to take lower dose of half of a tablet (5mg) or quarter of a tablet (2.5mg).
Hydrocortisone Auden Tablets come in blister packs of 30 tablets. Manufactured by
Tiofarma, Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijerland, Netherlands.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
Further information about your condition may be available from The Pituitary Foundation, P.O. Box 1944, Bristol, BS99 2UB Telephone: 0845 450 0375.
(The Pituitary Foundation is an independent organisation, it is not associated with Auden Mckenzie (Pharma Division) Ltd. or MPT Pharma Ltd.).
PL: 33532/0688
POM |
Leaflet dated 19th August 2016 Leaflet coded xxxxxxxxxxxx
Package Leaflet: Information for the User
Hitoden® 10mg Tablets
(hydrocortisone)
This leaflet contains important information about Hitoden 10mg Tablets.
Read this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The name of this medicine is Hitoden 10mg Tablets but it will be referred to as Hitoden Tablets throughout the remainder of this leaflet.
• Hitoden Tablets are also available in other strengths.
• Hitoden Tablets are a steroid medicine, prescribed for many different conditions, including serious illnesses
• You need to take it regularly to get the maximum benefit
• Don’t stop taking this medicine without talking to your doctor - you may need to reduce the dose gradually
• Hitoden Tablets can cause side effects in some people (read ‘Possible side effects' section below). Some problems such as mood changes (feeling depressed, or ‘high'), or stomach problems can happen straight away. If you feel unwell in any way, keep taking your tablets, but see your doctor straight away
• Some side effects only happen after weeks or months. These include weakness of arms and legs, or developing a rounder face (read ‘Possible side effects' section for more information)
• If you take it for more than 3 weeks, you will get a blue ‘steroid card’: always keep it with you and show it to any doctor or nurse treating you
• Keep away from people who have chicken pox or shingles, if you
have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, see your doctor straight away.
Now read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important for you.
In this leaflet
1. What Hitoden Tablets are and what are they used for
2. Before taking Hitoden Tablets
3. How to take Hitoden Tablets
4. Possible side effects
5. How to store Hitoden Tablets
6. Further information
1. What Hitoden Tablets are and what are they used for
Hitoden Tablets contain a medicine called hydrocortisone. This belongs to a group of medicines called ‘steroids'. Their full name is corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid (such as Hitoden Tablets) is an effective way to treat various illnesses involving inflammation in the body.
Hitoden Tablets reduce this inflammation, which could otherwise go on making your condition worse. You must take this medicine regularly to get maximum benefit from it.
Hitoden Tablets are used for:
• adding hydrocortisone usually made naturally in the body because part of the adrenal gland is not working properly
• adding hydrocortisone after injuries, surgery or other stressful events
• some other types of illness.
Ask your doctor to explain why you have been given Hitoden Tablets if you are unsure.
2. Before taking Hitoden Tablets
Before you take Hitoden Tablets
Check with your doctor first if
• You have ever had severe depression or manic depression (bipolar disorder). This includes having had depression before or while taking steroid medicines like Hitoden Tablets.
• any of your close family has had these illnesses.
If either of these apply to you, talk to a doctor before taking Hitoden Tablets.
Do not take Hitoden Tablets if you:
• are allergic (hypersensitive) to hydrocortisone or any of the other ingredients of Hitoden Tablets
• have thrush, candida or any other fungal infection.
If you are not sure talk to your doctor or pharmacist before taking Hitoden Tablets.
Take special care with Hitoden Tablets
Check with your doctor before taking your medicine if:
• you have recently had a heart attack
• you have a heart condition called congestive heart disease
• you have septicaemia, tuberculosis (TB) or have had it in the past
• you have a stomach ulcer or other digestive problem
• you have chicken pox or shingles
• you come in contact with people who have chicken pox or shingles, especially if you have not already had these illnesses or are not sure if you have had them
• you have a herpes infection in the eye called ocular herpes simplex
• you had muscle weakness after taking steroids in the past
• you have recently visited a tropical country
• you have bowel problems such as ulcerative colitis
• you have epilepsy
• you have thrombophlebitis (swelling and redness along a vein which is extremely tender when touched)
• you have exanthematous disease (disease affecting the skin, rash)
• you have metastatic carcinoma (cancer that has spread from one part of the body to another)
• you are taking Hitoden Tablets for a long time increases your chance of getting infections
• you have amoebic dysentery and an infestation of a gut worm (strongyloidiasis), it may be activated or become worse.
Also, check with your doctor if any of the following problems run in your family, or if you have any of them:
• diabetes
• heart problems
• high blood pressure
• an eye condition called ‘glaucoma'
• kidney or liver problems
• a type of muscle weakening problem called ‘myasthenia gravis'
• thinning of the bones (osteoporosis)
• low thyroid levels (hypothyroidism).
If you are not sure if any of the above run in your family, or you have them, talk to your doctor or pharmacist before taking a tablet.
Mental Problems while taking Hitoden Tablets
Mental problems can happen while taking steroids like Hitoden Tablets (see also section 4 Possible Side Effects).
• These illnesses can be serious.
• Usually they start within a few days or weeks of starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is lowered or the medicine is stopped.
• However, if problems do happen they might need treatment.
Talk to a doctor if you (or someone taking this medicine), shows any signs of mental problems. This is particularly important if you are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including those obtained without a prescription.
This includes herbal medicines. This is because Hitoden Tablets can affect the way some medicines work.
Also, some other medicines can affect the way Hitoden Tablets work.
In particular do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:
• aspirin
• medicines for fits (epilepsy) such as phenytoin, phenobarbital, carbamazepine and primidone
• cough and cold medicines that contain a decongestant called ephedrine
• medicines used for TB (tuberculosis) called rifabutin or rifampicin
• medicines used to thin the blood such as warfarin
• water tablets (diuretics)
• some medicines for fungal infections such as amphotericin and ketoconazole
• a medicine for cancer called aminoglutethimide
• some medicines for heart failure such as digoxin, furosemide or bumetanide
• a medicine used for some infections called erythromycin
• oral contraceptive pills and hormone replacement therapy (HRT)
• a type of growth hormone called somatropin
• some medicines for high blood pressure
• some medicines for heart disease such as guanethidine, isosorbide mononitrate, isosorbide dinitrate and theophylline
• medicines sometimes used for asthma, low blood pressure or in cough and cold remedies called sympathomimetics
• calcium supplements
• medicines for pain and inflammation called NSAIDs such as ibuprofen, diclofenac or naproxen
• a medicine for urea cycle disorder called sodium phenylbutyrate (usually started by a specialist doctor or consultant)
• medicines for diabetes
• ritonavir (a medicine used in the treatment of HIV infections)
• methotrexate (a medicine used to treat rheumatoid arthritis)
• ciclosporin (a medicine used for psoriasis or in patients who have organ transplants)
• minoxidil & hydralazine (used for antihypertensive)
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Hitoden Tablets.
Hitoden Tablets and infections
Infections are easier to get and harder to spot while you are taking Hitoden Tablets.
Stay away from anyone you know with:
• chicken pox • shingles
• measles.
See your doctor if you think you may have picked up an infection. Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.
Driving and using machines
Steroids may cause a feeling of movement, even while you are still and this can cause you to feel dizzy (vertigo). Changes in your eyesight or muscle weakness may also happen. If you are affected you should not drive or operate machinery.
Taking Hitoden Tablets with food and drink
Hitoden Tablets can be taken with or without food.
Having vaccines or tests while you are taking Hitoden Tablets
Tell your doctor that you are taking Hitoden Tablets if you are to receive any vaccinations or have any diagnostic or laboratory tests. This is because steroids can affect the results of some tests.
Information you should carry while you are taking Hitoden Tablets
If you are taking Hitoden Tablets, get a steroid card from your pharmacist, and carry it with you. It shows what you are taking and who your doctor is in case of an emergency.
If you have an accident, fall ill or see a different doctor while taking Hitoden Tablets, show them your steroid card or, tell whoever treats you that you are taking Hitoden Tablets, because your dose may need to be changed.
Important information about some of the ingredients of Hitoden Tablets
Hitoden Tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
3. How to take Hitoden Tablets
Always take Hitoden Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
You should take this medicine by mouth. The amount you take each day will depend on your illness. The number of tablets to be taken will be on the label of your medicine. If you are unsure about the dose you should take, you must talk to your doctor or pharmacist. The usual doses of Hitoden Tablets are:
Adults
• 20 to 30 mg a day.
• Sometimes it is taken with 4 to 6 g of salt (sodium chloride) or 50 to 300 micrograms of fludrocortisone.
Children
• 0.4 to 0.8 mg a day, for every kilogram of your child's weight in two or three separate doses.
• Children will be prescribed the lowest possible dose.
• The doctor will keep an eye on their growth and development.
If you take more Hitoden Tablets than you should
If you take too many tablets by mistake, contact your doctor as soon as possible.
If you forget to take Hitoden Tablets
• If you forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgotten dose.
If you are thinking about stopping or have recently been told to stop Hitoden Tablets
It is dangerous to reduce your dose of Hitoden Tablets too quickly. Stopping Hitoden Tablets may leave you without enough steroid hormones in your body. This may cause withdrawal symptoms such as:
• pains in muscles or joints • fever
• general discomfort.
Your doctor or pharmacist will give you advice on how to reduce the number of tablets you take if you need to do this.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Hitoden Tablets can cause side effects, although not everybody gets them. People taking steroids to replace similar naturally occurring hormones, should be less likely to get side effects than, people taking steroids for other illnesses. Your doctor will want to see you now and then to look out for these effects.
Tell your doctor straight away if you notice any of these problems, or if you think you are at increased risk of infection (e.g. you have been in contact with someone who has an infection):
• An allergic reaction such as skin rash, swelling of the face or wheezing.
• Irregular or very fast or slow pulse, faintness.
• Muscle cramps or spasms.
• Pseudotumourcerebri in children (raised pressure within the skull, indicated by headaches with vomiting, listlessness and drowsiness); this usually occurs after treatment is stopped.
• Nausea, vomiting.
• Burst or bleeding ulcers (indicated by stomach pain especially if it seems to spread to your back, bleeding from the back passage, black stools or vomiting with blood in the vomit).
• Acute pancreatitis (abdominal pain, possibly accompanied by shock, i.e. low blood pressure with decreased output of urine and often loss of consciousness).
• A worsening of sight.
• Thrombosis (a blood clot in a vein in your leg, symptoms of which are a swollen, red, hot, tender muscle).
• Thromboembolism (a blood clot which may go to the lung, symptoms of which are sudden chest pain and coughing up blood).
• Heart failure - problems with the pumping of your heart indicated by swollen ankles, chest pain, difficulty in breathing and palpitations or irregular beating of the heart, irregular or very fast or slow pulse; hypertension (high blood pressure, indicated by headaches, or generally feeling unwell).
Steroids including Hitoden Tablets can cause serious mental health problems. These are common in both adults and children. They can affect about 5 in every 100 people taking medicines like Hitoden Tablets.
• Feeling depressed, including thinking about suicide.
• Feeling high (mania) or moods that go up and down.
• Feeling anxious, having problems sleeping, difficulty in thinking or being confused and losing your memory.
• Feeling, seeing or hearing things which do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone.
Effects on your digestive system
• Swollen abdomen.
• Ulcers or thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloating.
• Hiccups.
Effects on your muscles and bones
• Muscle weakness or wasting.
• Osteoporosis (brittle bones - bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood (pain in the hip).
• Aseptic necrosis (joint inflammation in the knee and groin).
• Torn muscle tendons (pain and/or swelling).
Effects on your body water and salts
• Cramps and spasms due to the loss of the potassium salts from your body. In rare cases, loss of potassium can lead to palpitations (an uneven beating of your heart that you become aware of).
Effects on your hormones and metabolic system
• Suppression of normal growth in children.
• Irregular or no periods in women.
• Increased hair on the body and face in women.
• Round or moon-shaped face.
• Increased appetite and weight gain.
• Increase in blood sugar levels, breakdown of body protein stores (loss of weight and muscle loss in arms or legs), loss of calcium and nitrogen.
Effects on your skin
• thin or delicate skin, bruising, red or purple spots
• slow healing of cuts or wounds
• acne, sweating, redness
• stretch marks
Effects on your eyes
• changes in vision as a result of cataracts or glaucoma (increased pressure inside the eye)
• thinning of the surface of the eye
• eye infections may get worse
• bulging eyes.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Hitoden Tablets
• Keep out of the sight and reach of children.
• Do not store above 25oC.
• Store in original package in order to protect from light.
• Do not use Hitoden Tablets after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any signs of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Hitoden Tablets contain
Each tablet contains 10mg hydrocortisone.
Other ingredients: Lactose monohydrate, magnesium stearate and maize starch.
What Hitoden Tablets look like and contents of the pack
Hitoden Tablets are white, oval-shaped tablets quarter-scored on one side and imprinted with ‘HYD10' on the other side.
The tablets are scored so that they can easily be broken into halves or quarters. This can allow you to take lower dose of half of a tablet (5mg) or quarter of a tablet (2.5mg).
Hitoden Tablets come in blister packs of 30 tablets.
Manufactured by
Tiofarma, Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijerland, Netherlands.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
Further information about your condition may be available from The Pituitary Foundation, P.O. Box 1944, Bristol, BS99 2UB Telephone: 0845 450 0375.
(The Pituitary Foundation is an independent organisation, it is not associated with Auden Mckenzie (Pharma Division) Ltd. or MPT Pharma Ltd.).
PL: 33532/0688
POM |
Leaflet dated 19th August 2016 Leaflet coded xxxxxxxxxxxx
Hitoden® is a registered trademark of Auden McKenzie (Pharma Division) Ltd.