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EBUFAC TABLETS 400 MG, MIGRAFEN 400 - patient leaflet, side effects, dosage

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Patient leaflet - EBUFAC TABLETS 400 MG, MIGRAFEN 400



Ibuprofen 400 mg


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 pre-gelatinised 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.

Warnings and precautions

Take special care with Migrafen 400.

Anti-inflammatory/pain-killer medicines like ibuprofen 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:

  • – 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”).

  • – 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.


Migrafen 400 may hide signs of infections such as fever and pain. It is therefore possible that Migrafen 400 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 400 treatment. You should stop taking Migrafen 400 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 Can ‘Migrafen 400’ tablets cause problems?

Do not give to children under 12 years of age.

Other medicines and Migrafen 400 Tablets

Tell your doctor if you are taking, have recently taken or might taken any other the following medicines. Migrafen 400 Tablets may affect or be affected by some other medicines. For example:

  • – medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetyl­salicylic acid, warfarin, ticlopidine)

  • – medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)

Some other medicines may also affect or be affected by the treatment of Migrafen 400 Tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Migrafen 400 Tablets with other medicines.

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.

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).

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.

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.

Not known

A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).

Skin becomes sensitive to light.

Stop using Migrafen 400 if you develop these symptoms and seek medical attention immediately. See also section Check before you take these tablets.

A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

If you take too many tablets

If you have taken more Migrafen 400 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. 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.

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.

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 [P]

This leaflet was revised in February 2021

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