Ibufen

Company name: Memphis co. for pharm. & chem. Ind.

Trade name: Ibufen tablets

Generic name: Ibuprofen

Composition:
Each tablet contains:

Ibuprofen  400 mg
Microcrystalline cellulose (Avicel pH 102) 162 mg
Croscarmellose sodium (Ac-di-sol) 10 mg
Polysorbate 80 (Tween 80) 0.8 mg
Polyvinyl pyrrolidone K 90 10 mg
Talc  7.2 mg
Colloidal silicone dioxide (Aerosil) 30 mg

Pharmaceutical form: Tablet

Pharmacological actions:
Ibufen is a non-steroidal anti-inflammatory drug, which possesses analgesic, antipyretic and anti-inflammatory activities.
Ibufen also inhibits platelet function for a short duration.
The drug acts by inhibition of prostaglandin synthesis.

Pharmacokinetics:
Absorption of ibuprofen is delayed when taken with food.
Ibuprofen binds to plasma proteins, it is found in synovial fluid.
Ibuprofen is metabolized to inactive forms, and is excreted mainly through urine.

Indications:
Ibufen is indicated for symptomatic treatment of:
• Long duration of:
- Chronic rheumatic inflammation (especially polyarthritis).
- Spondylarthritis ankylosis.

• Short duration of:
- Scapulohumeral periarthritis, tendinitis, bursitis.
- Arthrosis.
- Lumbago.
- Dysmenorrhoea.
- Radiculalgia.
- Fever.
- Mild to moderate pain.
- Acute post-trauma attack.

Dosage & administration:
- Ibufen is better taken between meals.
- Adults (more than 15 years old).

Rheumatic attack:
2 tablets (800 mg) three times daily.
Maintenance dose: One tablet (400 mg) three to four times daily.

Dysmenorrhoea:
One tablet (400 mg) once daily, to be repeated if necessary without exceeding 4 tablets (1600 mg) daily.

Pain or fever:
One tablet (400 mg) once daily, to be repeated if necessary without exceeding 3 tablets (1200 mg) daily.

Contraindication:
Ibufen is contraindicated:
- In allergy, asthma, gastroduodenal ulcer, disseminated lupus erythematosus.
- In severe hepatic, renal or cardiac insufficiency.
- From the 6th month of pregnancy.
- In patients who have hypersensitivity to any of the components of the product.
 
Side effects:
Some of the following side effects may occur in some cases:
Nausea, vomiting, dyspepsia, rash, pruritus, vertigo, oliguria, agranulocytosis, haemolaytic anemia, visual troubles.

Drug interactions:
- Coadministration of Ibufen with aspirin, other non-steroidal anti-inflammatory drugs increases risk of bleeding and gastric ulcer, while with clopidogrel, heparin or ticlopidine there is increased risk of hemorrhage.

- There is a risk of hyperkalemia when Ibufen is coadministered with diuretics, potassium salts, NSAIDs, heparin, trimethoprim, cyclosporine.

- Ibufen decreases renal clearance of lithium & methotrexate and so there is increased risk of lithaemia and hematologic toxicity of methotrexate.

- Reduction in antihypertensive effects is reported when ß-blockers are administered with Ibufen.

- Risk of nephrotoxic effects is reported especially in old patients when cyclosporine is administered with Ibufen.

Pregnancy:
Ibufen should not be used during the first 5 months of pregnancy unless clearly needed and is contraindicated from the 6th month.

Lactation:
Use of Ibufen should be avoided during lactation.

Precautions & warnings:
- Patients suffering from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis, possess risk of allergic manifestations after intake of Ibufen.

- Gastrointestinal haemorrage or ulcer/perforation may happen during treatment with Ibufen especially in old, debilitated patients or patients on anticoagulant therapy, in this case, Ibufen should be immediately discontinued.

- In case of visual troubles manifestations during treatment with Ibufen, a complete ophthalmology test must be done.

Overdosage:
Treatment:
- patient should be transfered immediately to the hospital.
- Gastric lavage.
- Administration of activated charcoal.
- Symptomatic treatment.

Therapeutic category: Analgesic, antipyretic, anti-inflammatory.

Legal category: OTC.

Package:

Storage:

 

THIS IS A MEDICAMENT
Medicament is a product, which affects your health and its consumption contrary to instructions is dangerous for you. Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are the experts in medicines, their benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed.
- Do not repeat the same prescription without consulting your doctor.
- Keep all medicaments out of reach of children.

Council of Arab Health Ministers, Union of Arab Pharmacists.