Dexamethasone 2mg Tablets
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DS artwork - Paginated for PRINT
4pp Folded: 148mm wide x 225mm high Flat: 297mm wide x 225mm high
A/W - pdf proof v1 - 01.10.2013 A/W - pdf proof v2 - 01.10.2013 A/W - pdf proof v3 - 07.10.2013 A/W - pdf proof v4 - 25.02.2014 A/W - pdf proof v5 - 03.03.2014
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Product |
Dexamethasone 0.5 mg & 2 mg Tablets |
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Strength |
0.5 mg & 2 mg |
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Pack Size(s) | |
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Artwork |
Package leaflet |
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PIL Code |
A1000097/1 |
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Supersedes (PIL Code) |
Not applicable |
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Author | |
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Date |
03.03.2014 |
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Artwork Reference / Version | |
Notes
Colour Specifications
Pantone
Process
Black
Scaling 1:1
D Auden Mckenzie (Pharma Division) Ltd, Mckenzie House, Bury Street, Ruislip, Middlesex HA4 7TL. Tel: 01895 627 420 info@audenmckenzie.com
Steroids including Dexamethasone 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 Dexamethasone.
• 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.
If you notice any of these problems talk to a doctor straight away.
Other side effects can include:
• brittle bones (osteoporosis), spontaneous fractures, tendon rupture, muscle wasting
• diabetes, reduced carbohydrate tolerance -increased insulin need
• mental disturbances such as excitability (euphoria), delusions (paranoia), psychological dependence, depression (risk of suicide in patients with a history of mental disorder), being unable to sleep (insomnia), Feeling, seeing or hearing things that do not exist. Having strange and frightening thoughts, changing how you act or having feelings of being alone, fits or epilepsy may become worse, schizophrenia may become worse.
• stomach ulcers which may perforate or bleed, indigestion, having more of an appetite than usual, diarrhoea, feeling or being sick, thrush (candidiasis)
• irregular or absent monthly periods, weight gain, increased appetite
• moon face, excess body hair (hirsutism), flushing, increased bruising and skin discolouration, acne
• stunted growth (infants, children, teenagers)
• increased liability to infection and severity of infection
• delayed wound healing, skin thinning, dilated capillaries, heart muscle rupture subsequent to recent heart attack, changes in fluid levels and the levels of certain chemicals in your blood called electrolytes, increased concentration of white blood cells, allergic reactions (including anaphylaxis), nausea, malaise, hiccups, increased sweating, increased likelihood of blood clots
• increased pressure within brain
• increased severity of eye infections
• increased pressure in the eye (glaucoma)
• changes in vision including cataract
• headache, vertigo
• congestive heart failure
• rash (urticaria) or red/purple spots (petechiae)
You are more likely to have side effects if you are on a higher dose.
Your doctor will want to see you now and then to lookout for these
effects. If you notice any of these, or if you get any other unusual
feelings or symptoms, keep taking Dexamethasone but contact your
doctor or pharmacist as soon as you can.
See also Section 2, What you need to know before you take Dexamethasone Tablets, above.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
PATIENT INFORMATION LEAFLET
5. How to store Dexamethasone Tablets
• Keep this medicine out of the sight and reach of children.
• Keep the tablets in the original container in order to protect from light.
• Do not use Dexamethasone tablets after the expiry date which is stated on the carton, blister and bottle after Exp:. The expiry date refers to the last day of that month.
• Medicines should not be disposed via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
The name of your medicine is Dexamethasone 0.5 mg or 2 mg Tablets. As well as containing 0.5 mg or 2 mg of dexamethasone, each tablet contains lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), colloidal hydrated silica and magnesium stearate (E470b).
Dexamethasone 0.5 mg Tablets are round, white tablets marked DX 0.5 on one side.
Dexamethasone 2 mg Tablets are round, white tablets marked DX 2 on one side.
The 0.5 mg tablets are supplied in blister packs of 28, 50 and 100 tablets.
The 2 mg tablets are supplied in blister packs of 50 and 100 tablets, and a plastic bottle of 500 tablets (hospital dispensing pack).
Marketing Authorisation holder:
Auden Mckenzie (Pharma Division) Ltd., Mckenzie House,
Bury Street. Ruislip, Middlesex, HA4 7TL, UK.
Manufacturer:
TioFarma BV, Benjamin Franklinstraat 9, Oud-Beijerland,
The Netherlands.
For information in large print, on tape, on CD or in Braille, phone 01895 627 420.
Leaflet updated March 2014.
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DEXAMETHASONE 0.5 mg and 2 mg TABLETS
This leaflet contains important information about Dexamethasone 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• Dexamethasone is 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
• Dexamethasone 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 medicine, 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 below)
• If you take it for more than 3 weeks, you will get a blue ‘steroid card': always keep it with you and show 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 Dexamethasone Tablets are and what they are used for
2. What you need to know before you take Dexamethasone Tablets
3. How to take Dexamethasone Tablets
4. Possible side effects
5. How to store Dexamethasone Tablets
6. Contents of the pack and other information
1. What Dexamethasone Tablets are and what they are used for
Dexamethasone Tablets belong 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 dexamethasone) is an effective way to treat various illnesses involving inflammation in the body.
Dexamethasone 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.
Ask your doctor to explain why you have been given Dexamethasone tablets if you are unsure.
2. What you need to know before you take Dexamethasone Tablets
• have an infection.
• are going to have any vaccinations - you must tell your doctor or nurse that you have been prescribed dexamethasone.
If you are not sure talk to your doctor or pharmacist before taking
Dexamethasone.
Take special care with Dexamethasone 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 Dexamethasone.
• any of your close family has had these illnesses.
If either of these applies to you, talk to a doctor before taking
Dexamethasone.
Check with your doctor before taking your medicine if:
• you have recently had a heart attack
• you have tuberculosis (TB) or X-ray changes, or have had it in the past
• you have a stomach ulcer or other digestive problem
Do not take Dexamethasone Tablets If you:
• are allergic (hypersensitive) to dexamethasone or any of the other ingredients of Dexamethasone Tablets.
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A1000097/1
DS artwork - Paginated for PRINT
Size: 4pp Folded: 148mm wide x 225mm high
Flat:297mm widex225mm high
|
A/W - pdf proof A/W - pdf proof A/W - pdf proof A/W - pdf proof A/W - pdf proof |
v1 -01.10.2013 v2-01.10.2013 v3-07.10.2013 v4-25.02.2014 v5-03.03.2014 |
|
Product |
Dexamethasone 0.5 mg & 2 mg Tablets |
|
Strength |
0.5 mg & 2 mg |
|
Pack Size(s) | |
|
Artwork |
Package leaflet |
|
PIL Code |
A1000097/1 |
|
Supersedes (PIL Code) |
Not applicable |
|
Author | |
|
Date |
03.03.2014 |
|
Artwork Reference / Version | |
Notes
• you have chickenpox, shingles, measles or any other infection including an eye infection
• you had muscle weakness after taking steroids in the past
• you have bowel problems such as ulcerative colitis
• you have epilepsy
Also, check with your doctor if any of the following problems run in your family, or if you have anyofthem:
• 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 the tablets.
Important
If you are taking or have recently (within the last 3 months) been taking Dexamethasone and you become ill, suffer stress, get injured or are about to have surgery, tell your doctor or other healthcare professional.
If you have been on Dexamethasone for longer than 3 weeks and wish to stop taking it, do not stop suddenly.
Taking Dexamethasone for a long time increases your chance of getting infections and these might be worse than normal. Also, dexamethasone treatment can hide the usual symptoms of infection. Amoebic dysentery and an infestation of a gut worm (strongyloidiasis) may be activated or become worse, as may fungal and viral infections of the eye.
It is particularly important to avoid contact with people who have chicken pox, shingles or measles especially if you have not already had these illnesses or are not sure if you have had them. Go to your doctor immediately if you come in contact with measles. Dexamethasone increases the risk of a severe bout of chicken pox.
You should still take your Dexamethasone, but the dose may need adjusting. If you are about to take dexamethasone, or are already taking it, and you get a rash or other symptoms of an infection, tell your doctor immediately.
Mental Problems while taking Dexamethasone Tablets
Mental problems can happen while taking steroids like Dexamethasone (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.
Colour Specifications
Pantone
Process
Black
Scaling 1:1
© Auden Mckenzie (Pharma Division) Ltd, Mckenzie House, Bury Street, Ruislip, Middlesex HA4 7TL. Tel: 01895 627 420 info@audenmckenzie.com
Talk to a doctor if you (or someone taking this medicine), show 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.
Pay attention when using Dexamethasone:
Dexamethasone should not be used routinely in preterm neonates with respiratory problems.
Taking other medicines
Please 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 Dexamethasone can affect the way some medicines work. Also, some other medicines can affect the way Dexamethasone works.
In particular do not take this medicine and tell your doctor or pharmacist if you are taking any of the following:
• some medicines for fungal infections such as casofungin, amphotericin and ketoconazole
• cough and cold medicines that contain a decongestant called ephedrine
• Antiviral drugs such as indinavir, lopinavir, saquinavir, ritonavir
• Aprepitant, a drug used to treat sickness and feeling sick
• Aspirin
• medicines for fits (epilepsy) such as phenytoin, phenobarbital, carbamazepine and primidone
• medicines used for TB (tuberculosis) called rifabutin or rifampicin
• medicines used to thin the blood such as warfarin
• water tablets (diuretics)
• 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
• Carbenoxolone, an ulcer-healing drug
• Anti-cancer drugs (cytotoxics)
• Mifepristone, a drug used to assist in the medical termination of pregnancy
• 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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Dexamethasone.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast feeding. Dexamethasone can reach your baby and may slow its growth.
Small amounts of dexamethasone may get into breast milk; tell your doctor if you 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.
Important information about some of the ingredients of Dexamethasone Tablets
Dexamethasone tablets contains lactose monohydrate: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Dexamethasone Tablets
Remember always to carry a Steroid Treatment Card. Make sure your doctor or pharmacist gives you this and has filled out the details including the dose and how long you will have treatment.
If you have surgery, an accident or become unwell while taking this medicine, tell whoever is treating you that you are taking Dexamethasone tablets.
Taking this medicine
The dose is chosen by your doctor and usually depends on how serious your condition is. Always follow your doctor’s instructions and read the pharmacy label. If you are unsure, ask your doctor or pharmacist.
Swallow the tablets whole with some water. Do not chew them. Adults:
Your doctor will probably ask you to take a total DAILY dose of between 2 mg and 10 mg. Up to 20 mg daily may be given for treating swelling on the brain. Usually, you will take your day’s dose of Dexamethasone Tablets as a single dose in the morning.
Children:
• Your child’s doctor will decide what dose should be given to your child, depending on the condition that is being treated and the size of your child.
• Children will be prescribed the lowest possible dose.
• The doctor will keep an eye on their growth and development.
Sometimes, you may need blood or urine tests to work out how much you should take.
Do not stop taking Dexamethasone Tablets suddenly. When you no longer need them, your daily dose should be reduced gradually. However, you should speak to your doctor or pharmacist about the best way to safely reduce your daily dose.
If you take more Dexamethasone Tablets than you should
Taking too many tablets will cause much larger effects and you may get any of the side effects described in this leaflet. Tell your doctor who will treat your symptoms and may slowly reduce your dexamethasone dose. Do not stop taking your Dexamethasone Tablets suddenly.
If you forget to take Dexamethasone Tablets
• If you forget to take your dose, take it as soon as you remember, then continue to take your medicine as before.
If you are thinking about stopping or have recently been told to stop Dexamethasone Tablets
Do not stop taking Dexamethasone Tablets just because you feel better. If you stop too soon or too suddenly you may get withdrawal symptoms which can be severe. Refer to your Steroid Treatment Card and always discuss your treatment with your doctor who will tell you if treatment can be stopped and how to reduce the dose gradually.
Sudden withdrawal (after 3 weeks or more of treatment) can cause such a severe drop in blood pressure it may kill you.
Less severe symptoms of withdrawal can include: Fever, muscle pain, joint pain, runny nose (rhinitis), sticky eyes (conjunctivitis), painful itchy skin lumps and weight loss.
Your doctor or pharmacist will give you advice on how to reduce the dose that 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, Dexamethasone 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.
Serious effects: tell a doctor straight away
• Any kind of skin rash or itching of the skin
• Difficulty in breathing or collapse.
These are signs of an allergic reaction and you may need to stop taking the medicine.
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