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EBUFAC TABLETS 400MG

Active substance(s): IBUPROFEN

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PROPOSED
PATIENT INFORMATION LEAFLET

MIGRAFEN 400
Ibuprofen 400 mg

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MIGRAFEN 400
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.
How does Ibuprofen work?
Ibuprofen is a member of a group of medicines known as Non Steroidal Anti Inflammatory Drugs (NSAID’s). These change the
body’s response to pain, swelling and fever.
The product license holder of ‘Migrafen 400’ tablets is:
Chelonia Healthcare Ltd, 11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus.
The manufacturer of ‘Migrafen 400’ tablets is:
Dr. Reddy’s Laboratories (UK) Limited, 208-214 York Road, Battersea, London SW11 3SD, United Kingdom.
What are ‘Migrafen 400’ tablets used for?
‘Migrafen 400’ is used for mild to moderate pain, including muscular pain, neuralgia, backache, migraine, headache, dental pain,
period pains, cold and ‘flu. Ibuprofen also lowers body temperature in feverish conditions.
Check before you take these tablets
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.
Do not take ‘Migrafen 400’
 If you are taking aspirin or any other NSAID
 If you suffer from stomach ulcers or any other stomach disorders, or have ever done so.
 If you are allergic to Ibuprofen or Aspirin or any other NSAID or any other pain-killer.
 If you are allergic to any of the ingredients of ‘Migrafen 400’ listed above.
 If you suffer from asthma unless instructed to do so by your doctor.
 If you are elderly unless instructed to do so by your doctor.
 If you have a heart problem or high blood pressure unless instructed to do so by your doctor.
 If you are also taking Furosemide, Thiazides, Lithium or Methotrexate. If you are unsure ask your doctor or pharmacist for
advice.
Do not give to children under 12 years of age.
Use in pregnancy and breast feeding
Ask your doctor’s advice before taking ‘Migrafen 400’ if you are pregnant, breast-feeding or intend to become pregnant.
When and how to take these tablets
Adults and children over 12 years of age: 1 tablet to be taken preferably after food or a milk drink. A subsequent tablet may be
taken every 4 to 6 hours. Do not take more than 3 tablets in 24 hours.
If in adolescents (between 12 and 18 years) this medicinal product is required for more than 3 days, or if symptoms worsen a
doctor should be consulted.
Do not exceed the stated dose. If your symptoms persist, do not continue to use these tablets for longer than 48 hours without
consulting your doctor or pharmacist.
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PROPOSED

Can ‘Migrafen 400’ tablets cause problems?
Medicines such as Ibuprofen Tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or
stroke. There is a risk of renal impairment in dehydrated children and adolescents.
Possible undesirable effects include dizziness, hearing disturbances, headache, stomach upset, bleeding from the stomach or
‘tarry’ stools, impaired liver or kidney function and impaired vision.
If you experience these effects or any of the following, stop taking the medicine immediately and tell your doctor: Unexplained
wheezing, shortness of breath, skin rash, itching, bruising, or facial swelling, high blood pressure, irregular heartbeat and chest
pains.
Undesirable effects may be minimised by taking the lowest dose for the shortest possible time.
If you take too many tablets
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.
Storing your medicine
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.
Do not use after the date shown on the pack.
The information in this leaflet applies only to ‘Migrafen 400’ Ibuprofen tablets 400mg.
Product Licence No. PL 33414/0050

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This leaflet was revised in December 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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