Sodium Oxybate 500mg/ml oral solution

LETAFEN 200 MG: Tablets

LETAFEN 400 MG: Tablets

LETAFEN SUSPENSION: Liquid for oral administration

COMPOSITION:

• 200 mg Tablet: Each film coated tablet contains Ibuprofen 200 mg.
• 400 mg Tablet: Each film coated tablet contains Ibuprofen 400 mg.
• Pediatric Suspension (100 mg/5 ml): Each 5 ml of suspension contains 100 mg Ibuprofen.

PHARMACOLOGICAL CLASSIFICATION

Antirheumatics (anti-inflammatory agents).

PHARMACOLOGICAL ACTION

Chemically, ibuprofen is described as 2-(4-isobutylphenyl) propionic acid and is a non-steroidal compound, which exhibits anti-inflammatory, analgesic and antipyretic activities.

Letafen is well absorbed on oral administration. An oral dose taken on an empty stomach by human volunteers produced peak serum levels after three quarters of an hour. Absorption was slower and peak serum levels lower after food.

INDICATIONS

Letafen is indicated for its analgesic and anti-inflammatory effect in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or disease), ankylosing spondylitis and osteo- arthritis, and acute gouty arthritis. Letafen is indicated in the treatment of non-articular rheumatism including fibrositis. Letafen is indicated in peri-articular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low-back pain. Letafen can also be used in soft- tissue injuries such as sprains and strains. Letafen is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhea, dental, post-episiotomy pain and post- partum pain. Letafen may also be used as an antipyretic.

CONTRA-INDICATIONS

Letafen should not be given to patients with peptic ulceration. The safety of Letafen in pregnancy has not been established.

Hypersensitivity to Ibuprofen, aspirin or any other non-steroidal anti-inflammatory agent. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.

DOSAGE AND DIRECTIONS FOR USE

Adults: The recommended dosage of Letafen is one (1) tablet 2-3 times daily. If the acute symptoms do not resolve within three days, consult a doctor.

Children:

In Juvenile Rheumatoid Arthritis, the total daily dosage of Letafen is 20 mg/kg of body mass given in divided doses. Safety in children under one year of age has not been proven:

• 1-2 years: 2.5 ml 3 to 4 times daily.
• 3-7 years: 5.0 ml 3 to 4 times daily.
• 8-12 years: 10 ml 3-4 times daily.
• Do not give to children less than 7 kg or 1 year of age, except on the advice of your doctor.

SIDE EFFECTS AND SPECIAL PRECAUTIONS

The most frequent side effects occurring with Ibuprofen are gastro-intestinal disturbances; reactions range from abdominal discomfort, nausea and vomiting, and abdominal pain to serious gastro- intestinal bleeding or activation of peptic ulcer. CNS-related side effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness, and insomnia.

Precautions: Letafen should be given with care to the elderly, to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease, a history of peptic ulceration, and in liver or renal failure. Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency require local synthesis of vasodilating prostaglandins to maintain renal perfusion, and therefore these patients are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT 

The most likely symptoms of over dosage are epigastric pain and nausea. If recently taken, gastric lavage will remove any unabsorbed ibuprofen. Electrolytes may be corrected by intravenous infusions, if necessary. There is no specific antidote to Letafen.

PREGNANCY AND LACTATION

No adverse effects have been observed in breast feeding infants whose mothers were receiving ibuprofen. However, ask your doctor or pharmacist for advice before taking this medicine.

INTERACTION WITH FOOD AND DRUGS

Use of Ibuprofen with azapropazone and phenylbutazone may result in an increase in plasma concentrations of lithium, methotrexate, and cardiac glycosides. The risk of nephrotoxicity may be increased if given with ACE inhibitors, ciclosporin, tacrolimus, or diuretics. Effects on renal function may lead to reduced excretion of some drugs. The risk of gastrointestinal bleeding and ulceration associated with NSAIDs is increased when used with corticosteroids, the antiplatelets clopidogrel, and ticlopidine, or, possibly, alcohol, bisphosphonates, or pentoxifylline.

PRESENTATION 

LETAFEN 200 mg: 500 tablets plastic jar and 100 x 10 Tablets Blisters.

LETAFEN 400 mg: BLISTER PACK containing 50x 10 tablets.

LETAFEN SUSPENSION (100 mg/5 mL): 100 ml amber glass bottles.

STORAGE INSTRUCTIONS 

• Tablets: Store below 30°C. 
• Suspensions: Store below 30°C. Protect against light. Shake well before use.

KEEP OUT OF REACH OF CHILDREN

Inactive ingredients:

Tablets: Micro cellulose, Cab-o-Sil, Magnesium Stearate, Nipagin & Nipa sol blend, Sodium Lauryl Sulphate. Starch, Sodium Starch glycolate and Kolli don CL. Suspension: Sugar, Glycerin, Sorbitol, Xanthan Gum, Tween 80, Sodium Edetate, Sodium Saccharin, Citric Acid, Sunset Yellow, Nipagin & Nipa sol blend, Sodium benzoate, Microcrystalline cellulose and flavor.

Date of Publication: January 2014.

Letap Pharmaceuticals Limited, P. O. Box 3346, Plot 107, Graphic Road, Accra, Ghana.

0596422356