Migrafen 400
PROPOSED
PATIENT INFORMATION LEAFLET
EBUFAC Tablets 400 mg
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE What is in your medicine?
Each tablet contains 400 mg of Ibuprofen as the active ingredient. The other (non-active) ingredients of the tablets are pregelatinised maize starch, talc, crospovidone, colloidal silicon dioxide, magnesium stearate, stearic acid, shellac, povidone 25, povidone, sucrose, E127, E104, E211, titanium dioxide (E171), sucrose, beeswax, carnuba wax.
Why does your doctor want you to take this medicine?
Your doctor has prescribed this medicine for you because he has done some tests which show that you have one of the following conditions:
• Rheumatoid arthritis
• Still's disease
• Osteoarthritis
• Ankylosing spondylitis
• Seronegative (non-rheumatoid) arthropathy
• Bursitis (inflammation of the joint membrane)
• Tenosynovitis (inflammation of the tendon membrane)
• Tendinitis (inflammation of the tendon)
• Capsulitis (frozen shoulder)
'Ebufac'can have a beneficial effect on these conditions.
‘Ebufac’ is also effective in the treatment of soft tissue injuries, particularly strains and low back pain.
‘Ebufac’also provides relief from migraine, headaches, rheumatic pain, muscular pain, backache, period pain, dental pain, neuralgia, colds and 'flu, as well as lowering body temperature in feverish conditions.
The product license holder of 'Ebufac' tablets 400 mg is:
Chelonia Healthcare Ltd, 11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus.
The manufacturer of 'Ebufac' tablet 400 mg is:
Dr. Reddy's Laboratories (UK) Limited, 208-214 York Road, Battersea, London SW11 3SD, United Kingdom Before you take your medicine
Medicines such as Ibuprofen Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
There is a risk of renal impairment in dehydrated children and adolescents (between 12 and 18 years).
You should only take these tablets if your doctor has advised you to. Some people should not take them.
Tell your doctor or pharmacist if you are hypersensitive - allergic reactions including asthma, rhinitis (runny nose) or urticaria (skin rash) - to any of the ingredients or to aspirin or other anti-inflammatory drugs. Also tell your doctor if you suffer, or if you have suffered from stomach ulcers or severe heart failure.
It is recommended that 'Ebufac' is not used during pregnancy.
It is important to tell the doctor or pharmacist if you have any of the above conditions, because this may not be the correct medicine for you.
Can you take ‘Ebufac’ tablets with other medicines?
You can take these tablets with other medicines but there are some medicines which can interfere with 'Ebufac' tablets. It is important to tell your doctor or pharmacist about all the medicines which you are taking, even those bought without a prescription.
'Ebufac' tablets may interact with the following medicines: Furosemide and thiazide diuretics (drugs used to increase the passage of urine), drugs for high blood pressure, lithium, methotrexate, aspirin or other anti-inflammatory pain killers and drugs to dilute the blood such as warfarin or dicoumarin. Tell your doctor if you are taking any of the above.
When and how to take your medicine
Follow your doctor's instructions about when and how to take 'Ebufac' tablets. Your pharmacist can also help if you are not sure. You should take these tablets exactly as your doctor has directed.
The adult and elderly dose is 1 to 3 tablets daily increased in severe conditions up to 4 tablets daily.
Children will be given a dose according to the child's body-weight (your doctor will tell you the exact dose to give your child).
Do not take more medicine than your doctor has prescribed.
Do not stop the treatment without talking to your doctor first. You may feel well, but the tablets are helping to prevent another attack of your illness.
If you forget to take your medicine, just carry on with the next dose as normal. Do not take an extra dose to make up for the missed dose. If you are not sure, ask your doctor or pharmacist for advice.
After you have taken your medicine
If you accidentally take too many of your tablets, either call your doctor straight away, or go to the nearest hospital casualty department. Always keep any remaining tablets in the container in which they were given to you, and also the label so that the medicine can be identified by the doctor or pharmacist in the hospital.
Can ‘Ebufac’ tablets cause problems?
Medicines such as Ibuprofen Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Like many medicines, 'Ebufac' tablets can sometimes cause problems.
The most usual reactions are a feeling of sickness (nausea), indigestion (dyspepsia), stomach pain, headache, dizziness and hearing disturbances. Yellowing of the whites of the eye and the skin (jaundice) may rarely occur. Rarely kidney failure may occur.
If you develop any of these or symptoms of stomach ulcer such as heart-burn, stomach pain or bleeding; or any eye symptoms such as blurred vision, diminished vision or changes in colour vision you should report this immediately to your doctor.
If you experience unexplained wheezing, shortness of breath, skin rash, itching, bruising, or facial swelling, stop taking the medicine immediately and tell your doctor.
If you have asthma be sure to tell your doctor immediately you notice any unusual symptoms. If you suffer from a heart condition, or increased blood pressure, you should be aware that 'Ebufac' may cause swelling of your ankles and feet due to fluid retention (oedema). If you pass blood with your urine tell your doctor straight away.
Storing your medicine
PROPOSED
You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.
Keep your medicine in a dry place below 25°C. Keep the tablets in the container in which they were given to you.
If your doctor tells you to stop the treatment, return the remaining tablets to the pharmacist, or flush them down the toilet. Only keep the medicine if the doctor tells you to.
On the label you will find the letters 'EXP' or 'EXPIRY DATE' followed by some numbers. These numbers are the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who has access to additional information.
The information in this leaflet applies only to ‘Ebufac’ tablets 400 mg.
Product Licence No. PL 33414/0050 [POM]
This leaflet was revised in December 2015
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