PACKAGE LEAFLET: INFORMATION FOR THE USER
Brufen 200 mg film-coated tablets
Brufen 400 film-coated mg tablets
Brufen 600 film-coated mg tablets
Ibuprofen
Read all of this leaflet carefully before you start taking this medicine.
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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.
What Brufen is and what it is used for
Before you take Brufen
How to take Brufen
Possible side effects
How to store Brufen
Further information
1.
WHAT BRUFEN IS AND WHAT IT IS USED FOR
Brufen belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory
drugs). Brufen reduces fever, relieves pain and has an anti-inflammatory effect.
Brufen is used for pain of mild to moderate intensity, fever, rheumatic conditions (rheumatic
arthritis, arthrosis) and menstrual pain, by adults and adolescents (12-18 years old),
Children 6-12 years can be treated with Brufen 200 mg tablets during acute painful conditions
and fever associated with common cold.
The effect of Brufen is achieved usually within 30 minutes.
2.
BEFORE YOU TAKE BRUFEN
Do not take Brufen:
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if you are allergic (hypersensitive) to ibuprofen or other ingredients
if you are in the last three months of pregnancy
if you have an increased tendency to bleed
if you have severe liver and kidney disease
if you have severe heart failure
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if you have a stomach ulcer, duodenal ulcer, or if you have had a stomach ulcer or
duodenal ulcer previously when treated with Brufen or a similar product.
if you have experienced allergic reactions (e.g. breathing difficulties, nasal obstruction,
rash) to acetylsalicylic acid or other anti-inflammatory drugs.
Take special care with Brufen:
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Always aim for the lowest possible dose and shortest possible treatment time to reduce the risk
of side effects. It is generally the case that higher than recommended doses can entail risks. This
also means that the combination of several NSAID products at the same administration time
should be avoided.
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People who have or have had the following illnesses or symptoms should consult a
doctor before starting treatment with Brufen: systemic lupus erythematosus (connective
tissue disease), impaired kidney or liver function, mild to moderate heart failure,
asthma, inflammatory bowel diseases, previous stomach ulcer or other increased
tendency to bleed.
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Like other anti-inflammatory drugs, Brufen can mask signs of infection.
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This product belongs to a group of medicines (NSAIDs) which may impair the fertility in
women. This effect is reversible on stopping the medicine.
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Patients who have previously had gastrointestinal tract problems, especially elderly
patients, should contact a doctor in the event of abdominal symptoms, particularly at the
start of treatment.
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Serious skin reactions have been reported in very rare cases when using a NSAID. Stop taking
Brufen and contact a doctor if you develop a rash or mucous membrane lesions.
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In patients with Systemic lupus erythematosus and mixed connective tissue disorders there may
be an increased risk of aseptic meningitis.
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Stop taking Brufen and contact a doctor immediately if you develop any of the following
symptoms (angioedema)
• swelling of the face, tongue or throat,
• difficulties swallowing,
• hives and difficulties breathing.
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Medicines like Brufen may entail a slightly increased risk of heart attack or stroke. This
increased risk is more likely when using high doses and in long-term treatment. Do not exceed
the recommended dose or treatment time.
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Consult a doctor or pharmacist about your treatment if you have heart problems, if you
previously have had a stroke or if you think that you have an increased risk for these
conditions (for example, if you have high blood pressure, diabetes, high cholesterol
levels or if you smoke).
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Do not take Brufen if you are planning a pregnancy. Consult your doctor first.
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During varicella it is advisable to avoid use of this drug.
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Brufen may cause a reduction in the number of white blood cells and your resistance to
infection may be decreased. If you experience an infection with symptoms such as fever and
serious deterioration of your general condition, or fever with local infection symptoms such as
sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A
blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is
important to inform your doctor about your medicine.
Taking other medicines:
Do not use different types of pain-relieving medicines at the same time unless directed by a
doctor.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Brufen can affect or be affected by treatment with certain medicines, including those to treat:
- tumours and immune system disorders (methotrexate),
- manic depressive illness (lithium),
- irregular heart beat (digoxin),
- pain (acetylsalicylic acid),
- blood clots (e.g. dicumarol, warfarin, ticlopidine),
- depression (medicines called SSRIs),
- high blood pressure (e.g beta blockers, diuretics, ACE inhibitors, angiotensin II
inhibitors),
- inflammation (corticosteroids).
- fungal infections (antifungals particularly voriconazole or fluconazole)
- diabetes mellitus (sulphonylureas)
- human immunodeficiency virus (HIV) infection (zidovudine)
For this reason, the doctor treating you needs to know about all the medicines you are taking.
Using Brufen with food and drink
Brufen could be used together with food and drinks. Brufen can be given on an empty
stomach for faster relief.
Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before use of any medicinal product.
Pregnant women should not use Brufen during the three final months of the pregnancy.
Use of Brufen should be avoided by women who are planning a pregnancy or are pregnant.
Treatment at any time in pregnancy should only take place as directed by a doctor.
Ibuprofen passes into breast milk. The use of ibuprofen is therefore not recommended while
breastfeeding. However, consult a doctor if using Brufen more than occasionally while
breastfeeding is required.
The use of ibuprofen may affect fertility. The use of ibuprofen is not recommended while
attempting to conceive or during investigation of infertility.
Driving and using machines
Brufen may impair reactions in some people. This should be taken into consideration on
occasions when high alertness is required, e.g. driving.
You alone are responsible to decide if you are in fit condition to drive a motor vehicle or
perform other tasks that demand increased concentration. Because of their effects or
undesirable effects, one of the factors that can reduce your ability to do these things safely is
your use of medicines. Descriptions of these effects can be found in other sections. Read all
the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if
you are unsure about anything.
Important information about some of the ingredients of Brufen
Brufen tablets contain lactose monohydrate. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3.
HOW TO TAKE BRUFEN
Always take Brufen exactly as your doctor has told you. You should check with your doctor
or pharmacist if you are not sure.
The usual dose for adults and adolescents (12-18 years old)
Rheumatic conditions: one 400 mg tablet 3 times daily or one 600 mg tablet 3 times daily.
Allow 4-6 hours between doses. For faster relief of stiffness in the morning, the first dose can
be given on an empty stomach.
Maximum daily dose: 2400 mg.
Menstrual pain: one 400 mg tablet 1-3 times daily when needed. Allow 4-6 hours between
doses.
Start treatment at the first signs of menstrual pain.
Pain of mild to moderate intensity: one 200 mg tablet or one 400 mg tablet as a single dose or
3-4 times daily. Allow 4-6 hours between doses. Single doses exceeding 400 mg have not
been shown to have any additional analgesic effect.
Fever in adults and adolescents: one 200 mg tablet or one 400 mg tablet 1-3 times daily, as
required.
Acute pain and fever associated with cold, children 6-12 years: one 200 mg tablet 1-3 times
daily. Allow 4-6 hours between doses.
To help prevent a passing feeling of a burning sensation in the throat or mouth, the tablets
should be swallowed whole with at least half a glass of water.
If you have severe liver and kidney disease or are elderly your doctor will tell you the correct
dose to take which will be the lowest dose possible.
If you take more Brufen than you should
If you have taken more Brufen than you should, or if children have been taken medicine by
accident always contact a doctor, hospital or Giftinformationscentralen (tel. 112) 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, loss of
consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold
body feeling, and breathing problems have been reported.
If you forget to use Brufen
Do not use a double dose to make up for a forgotten dose
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Brufen can cause side effects, although not everybody gets them.
Common (affects 1 to 10 users in 100):
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Headache, lightheadedness
Gastrointestinal side effects (indigestion, diarrhoea, nausea, vomiting, abdominal pain,
flatulence, constipation, black stools, bleeding in stomach and intestine, vomiting
blood).
Rash.
Tiredness.
Uncommon (affects 1 to10 users in 1,000): Rhinitis, insomnia, anxiety, visual disturbances,
hearing impairment. Difficulty breathing, bronchial spasm, asthma. Mouth ulceration.
Stomach ulcer, ruptured stomach ulcer, inflammation of mucous membrane of stomach.
Hepatitis. Jaundice. Abnormal liver function. Hives, itching, small bruises in skin and mucous
membranes, angioedema (for symptoms see section 2 Take special care with Brufen),
photosensitivity. Impaired kidney function. Changes in blood count including
agranulocytosis. Drowsiness. Tingling sensation.
Rare ((affects 1 to 10 users in 10,000:)
Non-bacterial meningitis, allergic reaction, depression, confusion, impaired vision, tinnitus
(ringing in ears), liver damage and fluid retention in body.
Very rare (affects less than 1 user in 10,000):
Inflammation of the pancreas, liver failure, skin and mucous membrane changes (sometimes
severe) such as epidermal necrolysis and/or erythema multiforme.
Not known:
Colitis and Crohn’s Disease.
Please note that Brufen can prolong bleeding time.
There have been reports of high blood pressure and heart failure as well as worsening of
ulcers in the large intestine and Crohn’s disease (bowel disease) in treatment with painrelieving medicines (NSAIDs).
Exceptional serious infections of the skin in case of varicella.
Medicines like Brufen may entail a slightly increased risk of heart attack or stroke.
If any of these side effects becomes serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5.
HOW TO STORE BRUFEN
Keep out of the reach and sight of children.
Do not store above 25C.
Do not use Brufen after the expiry date stated on the bottle, blister or carton. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.
6.
FURTHER INFORMATION
What Brufen contains
One tablet contains 200 mg ibuprofen
One tablet contains 400 mg ibuprofen
One tablet contains 600 mg ibuprofen
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The active substance is ibuprofen.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose
monohydrate, colloidal anhydrous silica, sodium lauryl sulphate, magnesium stearate,
hypromellose, talc, colouring agent (titanium dioxide E 171) .
What Brufen looks like and contents of the pack
Film-coated tablet: white oval tablets.
Brufen 200 mg: 30 tablets (blister), 100 tablets (HDPE bottle in the carton)
Brufen 400 mg: 20, 30 and 60 tablets (blister), 100 tablets (HDPE bottle in the carton)
Brufen 600 mg: 30 tablets (blister), 100 tablets (HDPE bottle in the carton)
Not all pack sizes may be marketed.
Marketing Authorisation holder:
Abbott Scandinavia AB
Box 1498
171 29 Solna
Manufacturer:
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
FAMAR S.A, 7 Anthoussas Ave., 153 44 Anthousa Attiki, Greece.
This medicinal product is authorised in the Member States of the EEA under the
following names:
Strength
200 mg
400 mg
600 mg
Country
Estonia
Greece
Latvia
Lithuania
Malta
Poland
Portugal
Slovenia
Sweden
Switzerland
UK
Austria
Belgium
Cyprus
Czech republic
Denmark
Estonia
France
Greece
Ireland
Italy
Latvia
Lithuania
Luxembourg
Malta
Poland
Portugal
Romania
Slovak Republic
Slovenia
Spain
Sweden
Switzerland
UK
Austria
Belgium
Cyprus
Denmark
Product name
Brufen
Brufen ®
Brufen 200 mg apvalkotās tabletes
Brufen 200mg plėvele dengtos tabletės
Brufen Tablets 200m
Brufen®
Brufen 200 mg comprimidos resestidos
por pelicula
Brufen 200 mg filmsko obložene tablete
Brufen
Ibuprofenum
Brufen Tablets 200m
Brufen ® 400mg – Flimtabletten
Brufen 400
Brufen®
Brufen 400
Brufen
Brufen
Brufen 400 mg, comprime pellicule
Brufen®
Brufen Tablets 400 mg
BRUFENÒ 400 mg Compresse rivestite
Brufen 400 mg apvalkotās tabletes
Brufen 400mg plėvele dengtos tabletės
BRUFEN 400
Brufen Tablets 400mg
Brufen®
Brufen 400 mg comprimidos resestidos
por pelicula
Brufen 400 mg, comprimate filmate
BRUFEN 400
Brufen 400 mg filmsko obložene tablete
Neobrufen 400 mg comprimidos
Brufen
Ibuprofenum
Brufen Tablets 400mg
Brufen ® 600mg – Flimtabletten
BRUFEN FORTE 600
Brufen®
Brufen
France
Greece
Ireland
Italy
Luxembourg
Malta
Poland
Portugal
Slovenia
Spain
Sweden
Switzerland
UK
Brufen 600 mg, comprime pellicule
Brufen®
Brufen 600 mg Tablets
BRUFENÒ 600 mg Granulato per
sospensione orale
BRUFEN FORTE 600
Brufen 600mg Tablets
Brufen®
Brufen 600 mg comprimidos resestidos
por pelicula
Brufen 600 mg filmsko obložene tablete
Neobrufen 600 mg comprimidos
Brufen
Ibuprofenum
Brufen 600mg Tablets
This leaflet was last approved in 3 April 2013
Detailed information on this medicine is available on the web site of the Swedish Medical
Products Agency.