Brufen Retard 800 mg 20 tablets

Brufen Retard 800 mg 20 tablets

Composition

Active ingredient: Ibuprofen 800 mg per tablet

Description

Brufen Retard is a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic, and antipyretic properties. It is used primarily for the treatment of rheumatoid arthritis, osteoarthritis, and various pain-related conditions.

Indications for Use

-Inflammatory Rheumatism: Rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, seronegative arthropathies.

-Degenerative Rheumatism: Osteoarthritis, degenerative joint disease (knee and hip), polyarthritis, spondylosis.

-Extra-articular Rheumatism: Myalgia, periarthritis, bursitis, tendinitis, tendovaginitis, low back pain, neuralgia.

-Traumatology: Soft tissue injuries (sprains, strains), post-operative pain, toothache, pain after dental procedures.

-Other Uses: Dysmenorrhea and as an adjunct therapy in infections with inflammation or fever.

Dosage and Administration

-Adults: 1 tablet (800 mg) twice daily, preferably in the evening after food with plenty of water.

-Severe Cases: Additional ibuprofen (200-600 mg, not prolonged release) may be taken in the morning.

-Paediatric Population: Not suitable for children under 12 years.

-Tablets should be swallowed whole, not chewed, broken, or crushed.

Contraindications

-Hypersensitivity to ibuprofen or NSAIDs.

-History of bronchospasm, urticaria, or allergic reactions to NSAIDs.

-Third trimester of pregnancy.

-Active or recurrent gastric/peptic ulcers, gastrointestinal bleeding.

-Inflammatory bowel disease (Crohn’s disease, ulcerative colitis).

-Severe liver impairment, renal impairment (creatinine clearance <30 ml/min).

-Severe heart failure (NYHA III-IV).

-Post-operative pain management after coronary bypass surgery.

Precautions

-Gastrointestinal Risks: Risk of ulcers, bleeding, and perforation; use with caution in elderly patients and those with a history of ulcers.

-Cardiovascular Risks: Possible increased risk of thrombotic events, myocardial infarction, and stroke, especially at high doses (>2400 mg/day).

-Renal Effects: Risk of renal impairment, especially in dehydrated patients, elderly, or those with pre-existing renal conditions.

-Liver Function: Use with caution in patients with hepatic impairment.

-Interactions: Increased risk of bleeding with anticoagulants, corticosteroids, and selective serotonin reuptake inhibitors.

-Alcohol Use: Increases risk of gastrointestinal and central nervous system side effects.

-Skin Reactions: Rare severe reactions like Stevens-Johnson syndrome; discontinue at first sign of skin rash or hypersensitivity.

-Infections: May mask symptoms of infection, potentially delaying diagnosis and treatment.

Pregnancy and Lactation

-First and Second Trimester: Use only if necessary and at the lowest effective dose.

-Third Trimester: Contraindicated due to risks of fetal cardiopulmonary toxicity, renal impairment, and prolonged labor.

-Lactation: Not recommended; ibuprofen is excreted in breast milk.

Side Effects

Common: Nausea, dyspepsia, abdominal pain, diarrhea, headache, dizziness.

Serious: Gastrointestinal bleeding, ulceration, heart failure, renal impairment, liver dysfunction, anaphylaxis, severe skin reactions.

Neurological: Rare cases of aseptic meningitis, particularly in patients with autoimmune diseases.

Storage Conditions

Store at a temperature below 25°C.

Keep in original packaging to protect from moisture and light.

Keep out of reach of children.

Packaging

A carton box contains 2 blisters of 10 film-coated tablets (total: 20 tablets) and a package insert.