Brufen Retard prolonged-release tablet ENG.doc

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					                    PACKAGE LEAFLET: INFORMATION FOR THE USER

                           Brufen Retard 800 mg prolonged-release tablets


                                                Ibuprofen

Read all of this leaflet carefully before you start taking this medicine.
    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.     What Brufen Retard is and what it is used for
2.     Before you take Brufen Retard
3.     How to take Brufen Retard
4.     Possible side effects
5.     How to store Brufen Retard
6.     Further information


1.    WHAT BRUFEN RETARD IS AND WHAT IT IS USED FOR

Brufen Retard belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory
drugs). Brufen Retard relieves pain, reduces fever and has an anti-inflammatory effect.

Brufen Retard is used for symptomatic treatment of pain and inflammation in rheumatic conditions
(rheumatoid arthritis and osteoarthritis) by adults.


2.    BEFORE YOU TAKE BRUFEN RETARD

Do not take Brufen Retard:

     if you are allergic (hypersensitive) to ibuprofen or other ingredients of Brufen Retard.
     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
     if you have a stomach ulcer, duodenal ulcer, or if you have had a stomach ulcer or duodenal
      ulcer previously when treated with Brufen Retard 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 Retard:

     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.
     People who have or have had the following illnesses or symptoms should consult a doctor
      before starting treatment with Brufen Retard: SLE (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.

     Brufen Retard is not suitable for children under the age of 12 years

     Like other anti-inflammatory drugs, Brufen Retard can mask signs of infection.

     Brufen Retard belongs to a group of medicines (NSAIDs) which may impair the fertility in
      women. This effect is reversible on stopping the medicine.

     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.

     Serious skin reactions have been reported in very rare cases when using a NSAID. Stop taking
      Brufen Retard and contact a doctor if you develop a rash or mucous membrane lesions.

     In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders
      there may be an increased risk of aseptic meningitis.

     Stop taking Brufen Retard 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.

     Medicines like Brufen Retard 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.

     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).

     Do not take Brufen Retard if you are planning a pregnancy. Consult your doctor first.

     During varicella it is advisable to avoid use of Brufen Retard.

     Brufen Retard 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 Retard 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 – selective serotonin reuptake inhibitors)
   - high blood pressure (e.g. beta blockers, diuretics, ACE inhibitors, angiotensin II inhibitors)
   - inflammation (corticosteroids)
   - fungal infections (e.g. 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 Retard with food and drink
Brufen Retard could be used together with food and drinks.

Pregnancy and breast-feeding
Please ask your doctor or pharmacist for advice before use of any medicinal product.

Pregnant women should not use Brufen Retard during the three final months of the pregnancy. Use of
Brufen Retard 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 Retard 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 Retard may impair reactions in some people, for example due to side effects such as visual
disturbances, dizziness or drowsiness. This should be taken into consideration on occasions when high
alertness is required, e.g. driving.


3.    HOW TO TAKE BRUFEN RETARD

Always take Brufen Retard exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

The recommended dose for adults and adolescents over 12 years: 2 tablets every evening (possibly 1
tablet in the morning and 2 tablets in the evening). The maximum daily dose is 2400 mg. 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.

Brufen Retard is not suitable for children under the age of 12 years
If you take more Brufen Retard than you should
If you have taken more Brufen Retard than you should, or if a child has taken the 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, 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 Retard
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 Retard can cause side effects, although not everybody gets them.

Common (affects 1 to 10 users in 100):
   - Headache, lightheadedness
   - Gastrointestinal side effects (indigestion, diarrhoea, nausea, vomiting, abdominal pain,
     flatulence, constipation, black stools, bleeding in stomach and intestine, vomiting blood)
   - Tiredness
   - Rash

Uncommon (affects 1 to 10 users in 1,000):
Rhinitis, insomnia, anxiety, visual disturbances, hearing impairment. Difficulty breathing, bronchial
spasm, asthma. Mouth ulcerations. 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
Retard), photosensitivity, impaired kidney function. Changes in blood count including
agranulocytosis. Drowsiness. Tingling sensation.


Rare (affects 1 to 10 users in 10,000):
Non-bacterial meninigitis, 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 Retard 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 pain-relieving medicines
(NSAIDs).
Exceptional serious infections of the skin in case of varicella.

Medicines like Brufen Retard 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 RETARD

Keep out of the reach and sight of children.

Blister: Do not store above 25C. Store in the original package, in order to protect from moisture.
Plastic bottle: Do not store above 25C. Keep the bottle tightly closed, in order to protect from
moisture.

Do not use after the expiry date stated on the package. 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 Retard contains

         The active substance is ibuprofen.
         The other ingredients are xanthan gum, povidone, stearic acid, silica colloidal anhydrous, talc,
          hypromellose, titanium dioxide (E 171).

What Brufen Retard looks like and contents of the pack

White oval, film-coated prolonged-release tablets.

30 tablets (blister)
100 tablets (plastic bottle)

Not all pack sizes may be marketed.


Marketing Authorisation holder and Manufacturer:

Marketing Authorisation holder:
To be completed nationally

Manufacturer:
Abbot GmbH & Co. KG, Ludwigshafen, Germany
FAMAR S.A, Anthousa Attiki, Greece
This medicinal product is authorised in the Member States of the EEA under the
following names:



          Country                                    Product Name

Bulgaria                  Brufen Retard 800mg prolonged release tablets

Estonia                   Brufen, 800 mg toimeainet prolongeeritult vabastavad tabletid

Hungary                   Brufen 800 mg retard tabletta

Latvia                    Brufen 800 mg ilgstošās darbības tabletes

Lithuania                 Brufen 800 mg pailginto atpalaidavimo tabletės

Poland                    Brufen Retard, 800 mg, tabletki o przedłużonym uwalnianiu

Romania                   Brufen Retard 800 mg comprimate cu eliberare prelungită

Slovenia                  Brufen retard 800 mg tablete s podaljšanim sproščanjem

Sweden                    Brufen Retard 800 mg depottabletter


This leaflet was last approved in 2011-12-20

				
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