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MIGRAFEN TABLETS

Active substance(s): IBUPROFEN

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Proposed
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:
 If you are taking aspirin or any other non-steroidal anti-inflammatory drug (NSAID).
 If you suffer from stomach ulcers or other stomach disorders, or have ever done so.
 If you are allergic to Ibuprofen or aspirin, or any other non- Steroidal anti-Inflammatory drug, or any other pain killers.
 If you are allergic to any of the ingredients of Ibuprofen tablets listed above.
 If you have experienced severe liver, kidney or heart failure.
 If you are in the late stages of pregnancy.
Special warnings and precautions
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.
You should also seek your doctor's advice before taking these tablets if you:
 have any kidney, heart or liver problems
There is a risk of renal impairment in dehydrated children and adolescents.
 have a history of gastrointestinal diseases
 have or have suffered from bronchial asthma
 have systemic lupus erythematosus or mixed connective tissue disease
Tell your doctor if you are taking the following medicines before taking Migrafen:
 any heart stimulating tablets or antihypertensives
 anticoagulants, such as warfarin
 corticosteroids
 diuretics, such as furosemide
 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.
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.
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When and how to take these tablets
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 accidentally take too many tablets, call your doctor straight away or go to the nearest hospital casualty department and show
them your pack of tablets.
The general symptoms of overdose are: Drowsiness, headache, nausea, upper abdominal pain, vomiting, diarrhoea and a drop in
blood pressure. Other more severe symptoms may occur with more serious poisoning.
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:
 Unexplained wheezing, shortness of breath, skin rash, itching, bruising, or facial swelling.
 In patients suffering from or with a previous history of bronchial asthma or allergic disease, Ibuprofen may trigger wheezing or
breathing difficulties.
 Kidney damage with blood in the urine and leading to kidney failure may occur.
 Jaundice, inflammation of the liver with, occasionally, liver failure, abnormal liver function tests.
 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:
 Pass blood in your faeces (stools/motions)
 Pass black tarry stools
 Vomit any blood or dark particles that look like coffee grounds
STOP TAKING the medicine and tell your doctor if you experience:
 Indigestion or heartburn
 Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
Other side effects: Headache, dizziness, hearing disturbances such as ringing in the ears, sensitivity to light, assorted skin
disorders including various rashes, gain in weight and swelling of feet, ankles and legs due to fluid retention, eye symptoms such
as blurred vision, diminished vision or changes in colour vision, nasal inflammation and runny nose, inflammation of the pancreas,
high blood pressure, irregular heartbeat and chest pains.
WARNING:
DO NOT EXCEED THE MAXIMUM DOSE KEEP OUT OF THE REACH OF CHILDREN
Store in a dry place below 25 °C.
Do not use after the expiry date shown on the carton.
The Manufacturer is:
Dr. Reddy’s Laboratories (UK) Limited, 208-214, York Road, Battersea, London, SW11 3SD, United Kingdom.
The Product Licence Holder is:
Chelonia Healthcare Ltd, 11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus.
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PL 33414/0051
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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