Patient leaflet - MIGRAFEN TABLETS
PATIENT INFORMATION LEAFLET
MIGRAFEN
Ibuprofen 200 mg Tablets
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION
What is in your medicine?
This pack contains pink sugar-coated tablets, each containing 200 mg Ibuprofen BP as the active ingredient.
The tablets also contain the following inactive ingredients to make up the bulk of the tablet: maize starch, talc, crospovidone, colloidal silicon dioxide, magnesium stearate, stearic acid, shellac, povidone, sucrose, titanium dioxide E171, quinoline yellow E104, erythrosine E127, sodium benzoate E211, beeswax and carnauba wax.
How does Ibuprofen work?
Ibuprofen is a member of a group of medicines known as the non- steroidal anti-inflammatory drug (NSAID's). These change the body's chemical response to pain, swelling and increased temperature.
What is Ibuprofen used for?
Ibuprofen is used for mild to moderate pain, including muscular pain, neuralgia, backache, migraine, headache, dental pain, period pains, colds and 'flu. Ibuprofen also reduces inflammation and lowers body temperature in feverish conditions.
Before taking your medicines
Do not take Ibuprofen:
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■ If you are taking aspirin or any other non-steroidal anti-inflammatory drug (NSAID).
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■ If you suffer from stomach ulcers or other stomach disorders, or have ever done so.
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■ If you are allergic to Ibuprofen or aspirin, or any other non- Steroidal anti-Inflammatory drug, or any other pain killers.
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■ If you are allergic to any of the ingredients of Ibuprofen tablets listed above.
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■ If you have experienced severe liver, kidney or heart failure.
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■ If you are in the late stages of pregnancy.
Special warnings and precautions
Take special care with Migrafen. The elderly should use the minimum dose and for the shortest possible time to reduce the possibility of side effects.
If you are taking medicines which increase the amount of urine you produce, or medicines that reduce your blood pressure, or medicines which reduce clotting of the blood, then you should seek your doctor's advice before taking these tablets.
Anti-inflammatory/pain-killer medicines like Migrafen Tablets may be associated with a small increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Migrafen if you:
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– have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to narrow or blocked arteries), or any kind of stroke (including ‘ministroke’ or transient ischaemic attack “TIA”).
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– have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker. – have an infection – please see heading “Infections” below.
Infections
Migrafen may hide signs of infections such as fever and pain. It is therefore possible that Migrafen may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.
Skin reactions
Serious skin reactions have been reported in association with Migrafen treatment. You should stop taking Migrafen and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section Other side effects.
You should also seek your doctor's advice before taking these tablets if you:
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■ have any kidney, heart or liver problems
There is a risk of renal impairment in dehydrated children and adolescents.
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■ have a history of gastrointestinal diseases
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■ have or have suffered from bronchial asthma
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■ have systemic lupus erythematosus or mixed connective tissue disease
Other medicines and Migrafen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Migrafen as it may affect or be affected by some other medicines. For example:
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■ medicines that are anti-coagulants (used to thin blood or prevent clotting such as aspirin or acetylsalicylic acid, warfarin, ticlopidine)
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■ medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
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■ any heart stimulating tablets or antihypertensives
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■ corticosteroids
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■ diuretics, such as furosemide
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■ any other NSAID's, as side effects are more likely to occur and may be increased.
Do not take Migrafen if you are taking aspirin at doses of above 75mg daily. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Migrafen tablets.
Some other medicines may also affect or be affected by the treatment of Migrafen. You should therefore always seek the advice of your doctor or pharmacist before you use Migrafen with other medicines.
Use in pregnancy and breast feeding
Ask your doctor's advice before taking Ibuprofen if you are pregnant, breast-feeding, or intend to become pregnant.
Ibuprofen belongs to a group of medicines, which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that ibuprofen, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.
When and how to take these tablets
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
Adults, including the elderly and Adolescents (children over 12 years old to 18 years old): This product is intended for short-term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms.
If in adolescents, this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Adults, including the elderly: You should not take Migrafen tablets for longer than 10 days. If symptoms persist or worsen consult your doctor, who may instruct you to continue taking the medicine.
To start, take one or two tablets, preferably after food or a milk drink. Then, if necessary, take one or two tablets every 4 or 6 hours. Do not take more than 6 tablets in any 24 hour period.
If your symptoms persist, do not continue to use these tablets for longer than 48 hours without consulting your doctor or pharmacist.
Overdose
If you have taken more Migrafen Tablets than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.
The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.
Side Effects
Like most medicines, Ibuprofen may cause some unwanted effects in some people. The side effects may be minimized by using the lowest effective dose for the shortest possible time.
If you experience any of the following, stop taking the medicine immediately and tell your doctor:
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■ Unexplained wheezing, shortness of breath, skin rash, itching, bruising, or facial swelling.
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■ In patients suffering from or with a previous history of bronchial asthma or allergic disease, Ibuprofen may trigger wheezing or breathing difficulties.
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■ Kidney damage with blood in the urine and leading to kidney failure may occur.
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■ Jaundice, inflammation of the liver with, occasionally, liver failure, abnormal liver function tests.
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■ Abdominal discomfort, nausea, constipation and diarrhoea, bleeding in the stomach and ulceration may occasionally occur.
If you suffer from any of the following at any time during your treatment STOP TAKING the medicine and seek immediate medical help:
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■ Pass blood in your faeces (stools/motions)
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■ Pass black tarry stools
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■ Vomit any blood or dark particles that look like coffee grounds
STOP TAKING the medicine and tell your doctor if you experience:
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■ Indigestion or heartburn
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■ Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.