Martapan 2mg/5ml Oral Solution
Out of date information, search anotherPACKAGE LEAFLET: INFORMATION FORTHE USER D02434
Marta pan 2 mg/5 ml Oral Solution
Dexamethasone
(as Dexamethasone Sodium Phosphate)
The name of the product is Martapan 2mg/5ml Oral Solution but will be referred to as Martapan in this leaflet
Read all of this leaflet carefully before you start taking Martapan. It contains important information.
• Keep this leaflet. You may need to read it again
• If you have any further questions, please ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Martapan is and what it is used for
2. Before you take Martapan
3. How to take Martapan
4. Possible side effects
5. How to store Martapan
6. Further information
This leaflet contains a summary of the information available for this medicine. You should askyour doctor or nurse ifyou are unsure about any aspect of this leaflet.
1. What Martapan is and what it is used for
Martapan belongs to a group of medicines called corticosteroids. These corticosteroids occur naturally in the body, and help to maintain health and well-being. Boosting your body with extra corticosteroid, such as Martapan, is an effective way to treat various illnesses involving inflammation in the body.
Martapan reduces this inflammation, which could otherwise continue to make your condition worse. You must take this medicine regularly to get the maximum benefit from it.
Martapan can be used to:
• Reduce inflammation
• Treat a number of different diseases of the immune system
2. Before you take Martapan
Do not take Martapan ifyou:
• are allergic (hypersensitive) to dexamethasone or to any of the other ingredients in this medicine, listed in section 6 of this leaflet
• have an infection that affects the whole body
• had vaccination with live vaccines, e.g. chickenpox
Do not take this medicine if any of the above apply to you, talk to your doctor or pharmacist before taking Martapan.
Take special care with Martapan.
Tell your doctor before taking Martapan if:
• you have kidney or liver problems
• you have high blood pressure, heart disease or you have recently had a heart attack
• you suffer from diabetes or there is a family history of diabetes
• you have osteoporosis (thinning of the bones), particularly ifyou are a female who has been through the menopause
• you have suffered from muscle weakness with this or other steroids in the past
• you have glaucoma (raised eye pressure) or there is a family history of glaucoma
• you have a bowel disorder or a stomach (peptic) ulcer
• you have psychiatric problems or you have had a psychiatric illness which was made worse by this type of medicine
• you have epilepsy
• you have had an allergy or unusual reaction to corticosteroids
• you have an underactive thyroid gland
• you have a parasitic infection
• you have spent time in the tropics
• you have unexplained diarrhoea
• you have tuberculosis, septicaemia or a viral or fungal infection in the eye
• you have herpes (cold sores or genital herpes)
• you have asthma
• you or any of your close family have ever had severe depression or manic depression (bipolar disorder).This includes having had depression before while taking steroid medicines like Martapan.
Mental health problems can happen while taking steroids like Martapan (see 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 stopped. However, if problems do happen, they might need treatment.
Talkto a doctor ifyou (or someone taking this medicine), show any signs of mental problems. This is particularly important ifyou are depressed, or might be thinking about suicide. In a few cases, mental problems have happened when doses are being lowered or stopped.
It is important that whilst you are taking this medicine you avoid contact with anybody who is suffering from chickenpox/shingles or measles as you may need specialist treatment. Ifyou think you may have had exposure to any of these diseases, you should consult your doctor immediately. You should also inform your doctor ifyou have ever had infectious diseases such as measles or chickenpox and of any vaccinations.
Ifyou have an accident, are ill, or require any surgery (even at the dentists) or you require a vaccination (particularly with 'live virus' vaccines) whilst taking or when you have finished taking this medicine, you should inform the person treating you that you are taking or have taken steroids.
You should always carry a'Steroid treatment'card which gives clear guidance on the special care to be taken when you are taking this medicine. Show this to any doctor, dentist or person who may be giving you treatment. Even after your treatment has finished you must tell anyone who is giving you treatment that you have taken steroids.
Ifyou develop an infection whilst on this medicine you should talk to your doctor.
Ifyou have suppression tests or tests for infection you should inform the person performing the test that you are taking Martapan as it may interfere with the results.
If your child is taking this medicine, it is important that the doctor monitors their growth and development at frequent intervals.
Dexamethasone should not be used routinely in preterm neonates with respiratory problems.
You may also find that your doctor will reduce the amount of salt in your diet and give you a potassium supplement whilst you are taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Ifyou are taking any of the following medicines, you should consult your doctor before taking Martapan:
• medicines which thin the blood (anticoagulants) such as warfarin
• aspirin or similar medicines (non-steroidal anti-inflammatories) such as indometacin
• medicines used to treat diabetes such as insulin, sulfonylureas and metformin
• medicines used to treat high blood pressure
• medicines that make you pass more urine (diuretics)
• medicines used to treat fungal infections such as amphotericin B and ketoconazole
• medicines used to treat epilepsy such as phenytoin, carbamazepineand primidone
• medicines used to treat tuberculosis (TB) such as rifabutin, rifampicin and isoniazid
• medicines used to treat excess stomach acid (antacids) -particularly those containing magnesium trisilicate
• medicines used to aid sleep and relieve anxiety (barbiturates)
• aminoglutethimide, a medicine used to treat cancer
• carbenoxolone, a medicine used to treat stomach ulcers
• ephedrine, a medicine used to treat nasal congestion
• acetazolamide, a medicine used to treat glaucoma and epilepsy
• antiviral drugs such as ritonavir and saquinovir, used to treat HIV
• medicines used to treat myasthenia gravis such as neostigmine
• estrogen hormones including the contraceptive pill (birth control)
• Methotrexate used for cancer or inflammatory problems Pregnancy and breast-feeding
You must not use Martapan during pregnancy or breast-feeding unless clearly indicated by your doctor.
Ifyou are pregnant, think you may be pregnant or you are breast-feeding, you should consult your doctor before taking the medicine.
Driving and using machines
Martapan may cause side effects that may affect your ability to drive or use machines (see also section 4. Possible side effects). If you are affected you should not attempt to drive or use machines. Important information about some of the ingredients of Martapan
• This medicine also contains up to 3g sorbitol and 7g liquid maltitol per dose. Ifyou have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product. May have a mild laxative effect. Calorific value 2.6kcal/g sorbitol and 2.3 kcal/g maltitol.
Continued overleaf
100mm Measurement Verification Bar
3. How to take Martapan
This medicine is only to be taken by mouth. Take this medicine exactly as directed by the doctor. These instructions will have been added to the dispensing label by your pharmacist.
Do not exceed or take less than the stated dose.
Do not take it more or less often than prescribed.
The usual dose is:
Adults: The usual dose is 0.5mg to lOmg each day As you get better your doctor may reduce your dose
Children: The usual dose is 0.01 to 0.1 milligrams per kilogram of body weight
Ifyou forget to take Martapan
Ifyou have missed a dose take it as soon as you remember unless it is almost time for the next one then carry on as before. Never take two doses together.
Ifyou take too much Martapan
Ifyou take too much of your medicine you should contact your doctor or your nearest hospital casualty department immediately. Ifyou stop taking Martapan
It can be dangerous to stop taking this medicine abruptly. If your treatment is to be stopped you should follow your doctor's advice. They may tell you to reduce the amount of medicine you are taking gradually until you stop taking it altogether. The symptoms that have been reported when treatment has been stopped too quickly have included low blood pressure and in some cases, relapse of the disease for which the treatment was given.
A'withdrawal syndrome'may also occur, the symptoms of which include fever, muscle and joint pain, inflammation of the nose lining (rhinitis), weight loss, itchy skin and inflammation of the eye (conjunctivitis). Your doctor should gradually reduce the dose.
Ifyou have any further questions on the use of this product, ask your doctor, nurse or pharmacist.
4. Possible side effects
Like all medicines Martapan can cause side effects, although not everybody gets them.
Some side effects that have been reported following treatment with Martapan are listed below.
Serious side effects
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 Martapan. If any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately:
• 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 that do not exist
• having strange and frightening thoughts, changing how you act or having feelings of being alone
It is also possible to experience a severe allergic reaction to medicines like Martapan. If any of the following symptoms occur, contact your doctor or nearest accident and emergency department immediately.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
• collapse
Other side effects that may occur include:
• feeling or being sick
• hiccups or indigestion
• increased appetite
• stomach discomfort and swollen abdomen
• inflammation and ulcers in your throat
• stomach ulcers that may split and bleed
• inflamed pancreas (which may show as pain in the back and abdomen)
• tearing of the bowel particularly ifyou have inflammatory bowel disease
• unusual fat deposits
• water retention
• salt imbalances, potassium loss due to low carbon dioxide levels (hypokalaemic alkalosis), loss of protein and calcium balance
• congestive heart failure in people who are prone to heart problems
• high blood pressure
• thinning of the bone with an increased risk of fractures and other bone disease
• ruptured tendons, muscle wasting and muscle weakness
• thrush
• an increased riskof getting an infection
• recurrence of tuberculosis (TB) ifyou have already had this infection
• blood disorder caused by infection
• skin problems including slow wound healing, thinned delicate skin, unusual marks on the skin, bruising, redness and inflammation of the skin, stretch marks, visible swollen capillaries, acne, increased sweating, impaired reaction to skin tests, skin rash, swelling or thinning of the hair
• eye problems including cataracts, increased pressure in the eye, swelling of the eye, thinning of the eye membranes, worsening of existing eye infections or protrusion of the eyeballs
• blood clots
• irregular and absence of menstrual cycles (periods) and impairment of the body's regulation of hormones
• stunted growth in children and teenagers
• swelling and weight gain of the body and face -'Cushingoid state'
• development of excess body hair (particularly in women),
• weight gain and increased requirement for diabetic medication
• change in effectiveness of the medicine following stress and trauma, surgery or illness.
• fits and worsening of epilepsy
• mental health problems including extreme mood swings, worsening of schizophrenia, depression, inability to sleep, hallucinations (seeing or hearing things that don't exist), delusions (believing things that are not true), feeling restless or worried, confusion, memory loss, suicidal thoughts, or dependence on Martapan.
If any of the side effects get serious, or ifyou notice any side effects not listed in this leaflet, please tell your doctor immediately.
5. Storing Martapan
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original container, in order to protect from light.
Use within 28 days of opening.
Do not use Martapan after the expiry date which is stated on the carton and bottle label after (EXP). The expiry date refers to the last day of that month.
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.
Always keep the medicine in the bottle in which it was originally given to you.
Ifyou notice any defects, or any signs of deterioration in the medicine you should consult your pharmacist.
6. Further Information
What Martapan contains:
The active substance is Dexamethasone Sodium Phosphate.
This medicine contains Dexamethasone Sodium Phosphate which is equivalent to 2mg Dexamethasone per 5 ml.
The other ingredients are benzoic acid (E210), propylene glycol (El 520), citric acid monohydrate, sodium citrate, liquid sorbitol (non-crystallising), liquid maltitol, garden mint flavour (contains propylene glycol El 520), citric acid 10% solution (pH adjustment) and purified water.
What Martapan looks like and contents of the pack:
Martapan is a colourless to faint yellow solution with an odour of mint. Each bottle contains 150 ml of solution.
Marketing Authorisation Holder:
Martindale Pharma
Bampton Road, Harold Hill, Romford, Essex RM3 8UG
United Kingdom
Manufacturer:
Martindale Pharmaceuticals
Bampton Road, Harold Hill, Romford, Essex RM3 8UG
United Kingdom
Marketing Authorisation number: PL 00156/0125 Leaflet revision date: 01/2013
Ifyou would like any more information, or would like the leaflet in a different format, please contact medical information at the above address
MARTINDALE PHARMA
Bampton Road, Harold Hill, Romford, RM3 8UG, UK
ro
^1-
CN
O
O
2434-A