SOSDOL FORT

COMPOSITION: Each soft capsule contains:

• Diclofenac potassium ............................................................. 50 mg.
• Excipients: Polyethylene glycol, Citric acid, Povidone K30, Glycerin, Gelatin, Sorbitol, Methylparaben, Propylparaben, Ethyl vanillin, Titanium dioxide, Quinoline yellow, Sunset yellow, Purified water s. one soft capsule

INDICATIONS

Short-term treatment of post traumatic pain, post operative pain, inflammation and swelling following dental or orthopedic surgery, painful and inflammation conditions such as primary dysmenorrhoea, rheumatism, rheumatoid arthritis, osteoarthritis...

DOSAGE AND ADMINISTRATION

-     Adults: recommended initial daily dosage: 100 – 150 mg; divided into 2-3 doses.

-     For children from 14 – 18 years old and for patients with mild symptoms: daily dosage should be 75 - 100 mg; divided into 2-3 doses.

-     SOSDOL FORT should be swallowed whole with a glass of water, preferably before meals.

CONTRAINDICATIONS

-     Hypersensitivity to any component(s) of drug.

-     Bronchospasm caused by aspirin.

-     Gastric and duodenal ulcer.

-     Hemophilia.

-     Patients with cardiovascular diseases, severe liver or renal failure.

-     Patients with collagen disease.

-     Patients who wear soft contact lenses.

-     Pregnancy.

PRECAUTIONS

-     Gastro-intestinal bleeding or ulceration / perforation can occur at any time during treatment, with or without warning symptoms or a previous history.

-     As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions can occur in rare cases without earlier exposure to the drug.

-     Like other NSAIDs, diclofenac may mask the symptoms of infections due to its pharmacodynamic properties.

-     Caution is called for when using diclofenac in patients with porphyrin since drug may trigger an attack.

PREGNANCY AND LACTATING WOMAN

-     Diclofenac should be used in pregnancy only when it is judged absolutely necessary. It is not recommended in the last trimester of pregnancy (risk of inhibition uterine contractions and premature closing of ductus arteriosus).

-     Diclofenac passes into the breast milk but in very low quantity. There is no experience of the effects on the infant. Diclofenac may be prescribed for breast feeding mothers if a non steroidal anti-inflammatory agent is required while nursing.

PRESENTATION

• Blisters of 10 soft capsules; 3 blisters/ aluminium pouch.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

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