800 mg prolonged-release tablet is 
ibuprofen

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Brufen Retard is and what it is used for 
2. What you need to know before taking Brufen Retard 
3. How to take Brufen Retard 
4. Possible side effects 
5. How to store Brufen Retard 
6. Contents of the packaging and other information 

1. What Brufen Retard is and what it is used for

Brufen Retard contains the active substance ibuprofen and belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Brufen Retard is analgesic, antipyretic, and anti-inflammatory.

Brufen Retard is used in the symptomatic treatment of pain and inflammation in rheumatism ( rheumatoid arthritis ) and in joint wear and tear ( osteoarthritis ) in adults and adolescents (12-18 years, from 40 kg).

2. What you need to know before you take Brufen Retard

Do not take Brufen Retard

  • if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)
  • if you have a stomach ulcer or duodenal ulcer or have had recurrent ulcers or bleeding in the stomach or intestines
  • if you have severe liver or kidney disease
  • if you have severe heart failure
  • if you have any disease with an increased tendency to bleed
  • if you have previously had bleeding or perforation (holes) in your stomach or intestines during treatment with Brufen Retard or similar medicines (other NSAIDs )
  • during the last three months of pregnancy
  • if you have had allergic symptoms (eg difficulty breathing, nasal congestion, rash) when taking acetylsalicylic acid or similar medicines for inflammation (other NSAIDs ).

Do not take Brufen Retard if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.

Warnings and cautions

Talk to your doctor or pharmacist before taking Brufen Retard:

  • if you have asthma, chronic rhinitis (chronic stuffy and runny nose), or allergic diseases as Brufen Retard may cause breathing difficulties, rash, or a severe allergic reaction when you have any of these conditions
  • if you have certain disorders of the immune system (various connective tissue disorders, systemic lupus erythematosus ( SLE ), conditions in which the immune system affects the connective tissue resulting in joint pain, skin changes, and disorders of other organs) as it may increase the risk of non-bacterial meningitis
  • if you have impaired kidney or liver function
  • 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 or feet due to narrow or blocked blood vessels), or any kind of stroke (including “mini-” stroke “or transient ischemic attack ( TIA ))
  • if you have high blood pressure, diabetes, high cholesterol, a history of heart disease or stroke in the family, or if you are a smoker
  • if you have inflammatory bowel disease, have previously had stomach ulcers, or other tendencies to increase bleeding.
  • if you are dehydrated, as there is a risk of impaired kidney function, especially in dehydrated adolescents and the elderly.
  • if you have an infection – see the heading “Infections” below.

Talk to your doctor or pharmacist before taking Brufen Retard if any of the above apply to you.

Do not take Brufen Retard if you are planning to become pregnant. First, consult a doctor, see also the section “Pregnancy, breast-feeding and fertility”.

This drug belongs to a group of drugs ( NSAIDs ) that can reduce fertility in women. This effect is temporary and will stop if the medication is stopped, see also the section “Pregnancy, breast-feeding and fertility”.

Lowest effective dose

The lowest possible dose and the shortest possible treatment time should always be sought to reduce the risk of side effects. In general, higher doses than recommended can lead to risks. This also means that the combination of several NSAIDs at the same dose should be avoided.

If you use painkillers for a long time, this can cause headaches which should not be treated with more painkillers. If you think this is true for you, talk to a doctor or pharmacist

Heart attack and stroke

Anti-inflammatory/analgesic drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when using high doses. Do not exceed the recommended dose or treatment time.

Bleeding, wounds, or perforation (holes) in the gastrointestinal tract

Patients who have previously had gastrointestinal problems, especially elderly patients, should consult a physician in case of abdominal symptoms (especially gastrointestinal bleeding), especially if the symptoms occur at the beginning of treatment.

Treatment must be stopped and a doctor consulted if bleeding or ulcers in the gastrointestinal tract occur during treatment with Brufen Retard.

Skin reactions

Serious skin reactions have been reported with Brufen Retard. You should immediately stop taking Brufen Retard and seek medical attention if you develop any rash, mucosal ulcers, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Infection is

Brufen Retard can hide signs of infection such as fever and pain. Therefore, Brufen Retard may delay the appropriate treatment of infection and increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections associated with chickenpox. If you take this medicine while you have an infection and the symptoms of infection persist or worsen, you should contact a doctor immediately.

For chickenpox, this medicine should not be used.

Older

Elderly patients should be aware of their increased risk of side effects, especially bleeding and perforation (holes) in the gastrointestinal tract, which can be life-threatening

Children and young people

Brufen Retard should not be used in children under 12 years of age. There is a risk of impaired kidney function in adolescents who are dehydrated.

Other medicines and Brufen Retard

Do not use different types of painkillers at the same time without a doctor’s prescription.

Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.

Brufen Retard may affect or be affected by treatment with certain medicines, including those used to treat / prevent:

  • tumors and disorders of the immune system (methotrexate)
  • manic depressive illness (lithium)
  • irregular heartbeat ( digoxin )
  • pain ( acetylsalicylic acid )
  • blood clots (blood thinners, eg acetylsalicylic acid, dicumarol, warfarin, ticlopidine)
  • depression (so-called SSRIs – selective serotonin reuptake inhibitors)
  • high blood pressure (eg ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan )
  • rejection reactions in organ transplant patients (drugs that inhibit the immune system such as ciclosporin or tacrolimus)
  • inflammation ( corticosteroids are)
  • bacterial infections (certain antibiotics including aminoglycosides )
  • fungal infections (eg voriconazole and fluconazole )
  • diabetes (sulphonylureas)
  • high cholesterol (cholestyramine)
  • HIV – infection (zidovudine).

Some other medicines may also affect or be affected by treatment with Brufen Retard. You should therefore always consult your doctor or pharmacist before using Brufen Retard with other medicines.

Brufen Retard with food, drink, and alcohol

Brufen Retard can be taken with food and drink. If Brufen Retard is taken with alcohol, the side effects may increase.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women should not use Brufen Retard during the last three months of pregnancy.

Taking Brufen Retard should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.

Ibuprofen passes into breast milk but is unlikely to affect the breast-feeding baby when used for short-term treatment. Consult a physician if you need more than temporary use of Brufen Retard during breast-feeding.

Treatment with ibuprofen may affect the ability to conceive. Ibuprofen is not recommended for women who want to become pregnant or undergo infertility tests.

Driving and using machines

Brufen Retard may impair the ability of some people to react, e.g. due to side effects such as blurred vision, dizziness, or drowsiness. This should be borne in mind at times when sharper attention is required, for example when driving a car, and applies to a greater extent in combination with alcohol.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to take Brufen Retard

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The lowest effective dose should be used for the shortest possible time to relieve symptoms. Contact a doctor immediately if you have an infection and the symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents over 12 years (from 40 kg):

The recommended dose is 2 tablets every night (possibly 1 tablet in the morning and 2 tablets in the evening). The maximum daily dose is 3 tablets (2400 mg). To avoid a transient burning sensation in the throat or mouth, the tablets should be swallowed whole and rinsed with at least half a glass of water.

Take Brufen Retard with food if you have a sensitive stomach.

If you have severe liver or kidney disease or are older, your doctor will determine the appropriate minimum dose.

Use for children

Brufen Retard should not be given to children under 12 years of age.

Symptoms may include nausea, stomach pain, vomiting (may be mixed with blood), headache, ear noise, confusion, and visual disturbances. At high doses, drowsiness, chest pain, palpitations, unconsciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, frostbite, and difficulty breathing have been reported.

If you forget to take Brufen Retard

Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Brufen Retard and contact a doctor immediately if you get any of the following symptoms:

  • Angioedema (a less common side effect ) with symptoms such as:
    • swelling of the face, tongue, or throat
    • difficulty swallowing
    • hives and difficulty breathing.
  • An infection with symptoms such as fever and severe general malaise, or fever with local infectious symptoms such as sore throat/pharynx/mouth or difficulty urinating. Brufen Retard may cause a decrease in the number of white blood cells( agranulocytosis ) with decreased resistance to infection as a result (a less common side effect ). It is important that you inform your doctor about your medicines.
  • Severe changes in the skin and mucous membranes such as epidermal necrolysis and/or erythema multiforme have been reported (a very rare side effect ). In addition, a severe skin reaction called DRESS syndrome may occur. Symptoms of DRESS include rash, fever, swelling of lymph nodes, and an increase in eosinophils(a type of white blood cell ). Stop taking Brufen Retard and consult a doctor you get a rash or sores in the mucous membranes. The severe rashes can include blisters on the skin, especially on the legs, arms, hands, and feet, and can also involve the face and lips. This can also become even more serious as the blisters can become larger and spread and parts of the skin can fall off ( toxic epidermal necrolysis ). There can also be serious infection with destruction ( necrosis ) of the skin, subcutaneous tissue, and muscles.
  • Widespread red, scaly rash with bumps under the skin and blisters mainly in the folds of the skin, on the torso and arms together with fever at the beginning of treatment ( acute generalized exanthematous pustulosis ) ( side effect has been reported, occurs in an unknown number of users). See also section 2.

Other side effects that may occur:

Common (may affect up to 1 in 10 people):

  • Headache, dizziness
  • Gastrointestinal side effects (indigestion, diarrhea, nausea, vomiting, abdominal pain, flatulence, constipation, black stools, bleeding from the stomach and intestines, bloody vomiting)
  • Fatigue
  • Rash.

Uncommon (may affect up to 1 in 100 people):

  • Allergic rhinitis
  • Hypersensitivity
  • Insomnia, slight anxiety
  • Visual disturbances, hearing damage
  • Tracheal spasm, asthma
  • Ulcers in the oral mucosa
  • Gastric ulcer, intestinal ulcer, ruptured gastric ulcer, inflammation of the gastric mucosa
  • Inflammation of the liver, jaundice, abnormal liver function
  • Itching, slight bleeding in the skin and mucous membranes
  • Photosensitivity
  • Impaired renal function
  • Blood count changes
  • Anemia (a decrease in the number of red blood cells or hemoglobin which may make the skin pale and may lead to weakness)
  • Drowsiness
  • Ant crawls
  • Hearing loss.

Rare (may affect up to 1 in 1,000 people):

  • Non-bacterial meningitis
  • Allergic reaction
  • Depression, confusion
  • Visual impairment, tinnitus (ringing in the ears), dizziness
  • Liver damage and fluid retention in the body.

Very rare (may affect up to 1 in 10,000 users) :

  • Inflammation of the pancreas, impaired liver function.

Has been reported (occurs in an unknown number of users):

  • Exacerbation of colon ulcer ( colitis ) and Crohn’s disease (intestinal disease)
  • Heart failure, heart attack, high blood pressure.

Note that Brufen Retard may prolong bleeding time.

In rare cases, serious side effects occur in connection with chickenpox.

When NSAIDs are used, an infection-related inflammation of the skin may develop or worsen (for example, a condition such as necrotizing fasciitis may develop which is characterized by intense pain, high fever, swollen and hot skin, blistering, tissue death). If signs of an infection occur or get worse while using ibuprofen, it is recommended that you see your doctor immediately.

Medicines such as Brufen Retard may cause a small increased risk of heart attack or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. How to store Brufen Retard

Keep this medicine out of the sight and reach of children.

Pressure packaging: Do not store above 25 ºC in the original packaging (moisture sensitive).

Plastic bottle: Do not store above 25 ° C. Close the jar tightly (moisture sensitive).

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified 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. Contents of the packaging and other information

Content declaration

  • The active substance is ibuprofen. One prolonged-release tablet contains 800 mg of ibuprofen.
  • The other ingredients are xanthan gum, povidone, stearic acid, anhydrous colloidal silica, talc, hypromellose, titanium dioxide (dye E171).

What the medicine looks like and the contents of the pack

White, oval, film-coated prolonged-release tablets.

30 tablets (pressure pack)

100 tablets (plastic jar)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

BGP Products AB

Box 23033,

104 35 Stockholm

Manufacturer :

FAMAR AVE Anthoussa Plant,

Anthoussa Avenue 7,

Anthoussa Attiki,

153 49 Greece

FAMAR AVE Avlon Plant (49 th  km),

49th km National Road Athens-Lamia,

Avlona Attiki,

190 11

Greece

This medicinal product is authorized under the European Economic Area under the names:

Country Product name
Bulgaria Brufen Retard 800mg prolonged-release tablets
Estonia Brufen, 800 mg toimeaine prolongeeritult vabastavad tabletid
Hungary Brufen 800 mg retard tablet
Latvia Brufen 800 mg ilgstošās darbības tablets
Lithuania Brufen 800 mg pailginto atpalaidavimo tablets
Poland Brufen Retard , 800 mg, tablets or prescription uwalnianiu
Romania Brufen Retard 800 mg compresses to eliminate elongation
Slovenia Brufen retard 800 mg tablet s podaljšanim sproščanjem

Muhammad Nadeem

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