SOSFEVER FORT

COMPOSITION: Each soft capsule contains

Ibuprofen............................................. 400 mg

Excipients: Polyethylene glycol, potassium acetate, Povidone, Glycerin, Gelatin, Sorbitol, Methylparaben, Propylparaben, Ethyl vanillin, Brilliant blue, Tartrazine, Purified water.

INDICATIONS

SOSFEVER/ SOSFEVER FORT is also indicated for For the relief of mild to moderate pain including rheumatic and muscular pain, migraine (with or without aura), backache, headache, dental pain, dysmenorrhoea, feverishness and for the relief of symptoms of cold and influenza. 

DOSAGE AND ADMINISTRATION For oral administration and short-term use only.

For all indications: Adults, older people and children and adolescents between 12-18 years of age:

• If in children or adolescents between 12 -18 years of age, this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
• For adults aged 18 years or older, the lowest effective dose should be used for the shortest duration necessary to relieve symptoms and minimise undesirable effects. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

One capsule 200 mg SOSFEVER or 400 mg (SOSFEVER FORT)  up to three times per day as required. The respective dosing interval should be chosen in line with the observed symptoms and the maximum recommended daily dose. Doses should be given approximately every 6-8 hours, with a minimum interval of 4 hours between each dose. A total dose of 1200 mg of ibuprofen (3 capsules) should not be exceeded in any 24 hour period. The capsules should be taken with water.

Not to be used for children under 12 years of age.

SOSFEVER should be swallowed whole and not chewed or crushed.

Contraindications

• Hypersensitivity to ibuprofen or any of the other ingredients.
• Use in patients hypersensitive to aspirin or with bronchospasm, asthma, rhinitis, angioedema or urticaria associated with non-steroidal anti-inflammatory drugs (NSAIDs).
• Ibuprofen should not be given to patients with active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
• History of gastrointestinal bleeding or perforation related to previous NSAID therapy.
• Cerebrovascular bleeding, other active bleeding, or haematological disease.
• Severe hepatic failure, severe renal failure or severe heart failure (NYHA Class IV).
• Last trimester of pregnancy

Special warnings and precautions for use

Older people have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation.

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease and ibuprofen should not be used where other NSAIDs have produced reactions.

Caution is required in patients with renal, cardiac or hepatic impairment since renal function may deteriorate. The dose should be as low as possible and renal function should be monitored.

There is a risk of renal impairment in dehydrated children or adolescents between 12 - 18 years of age.

Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.

Clinical studies suggest that use of ibuprofen, particularly at high doses (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 1200 mg/day) is associated with an increased risk of arterial thrombotic events.

Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated.

GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors (SSRIs) or anti-platelet agents such as aspirin.

When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.

Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

There is limited evidence that drugs which inhibit cyclo-oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Ingredients:

• SOSFEVER FORT contains sorbitol. Patients with rare hereditary problems ò fructose intolerance should not take this medecine.
• SOSFEVER FORT contains methylparaben, propylparaben, brilliant blue, tartrazine may cause allergic reactions.

Pregnancy:

There are no adequate and controlled studies in pregnant women. Only use ibuprofen for pregnant women when necessary. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy..

Lactation:

In limited studies, ibuprofen appears in breast milk in very low concentrations. Based upon the low level detected (0.0008% of maternal dose), it is unlikely to affect the breast-fed infant adversely.

Effects on ability to drive and use machines

Undesirable effects of ibuprofen such as Headache (Uncommon), dizziness, tinnitus and trouble of vision (Very rare). Therefore, patients should avoid driving or using machinery unless they have established their own response to the effects of the drug, as well as they can perform such activities safely.

PRESENTATION

• Aluminium – PVC - Aluminium blister of 10 soft Box of 1, 3 and 10 blisters
• Aluminium – PVC blister of 10 soft capsules, 1 blister/ aluminium pouch/ box, 3 blisters/ aluminium pouch/ box and 10 blisters/ aluminium pouch/ box.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Manufactured and Distributed by: AMPHARCO U.S.A PJSC

Nhon Trach 3 Industrial Park, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province.

Tel: 02513 566 202    -     Fax: 02513 566 203