COMPOSITION AND EXIPIENTS
Each orange enteric coated tablet contains:
Active Ingredient:
Bromelain equivalent 100.000 Rorer Units.
Excipients:
Dibasic Calcium Phosphate, Maize Starch, Magnesium Stearate, Methacrylic Acid Copolymer, Talc, Poly Ethylene Glycol, Lake Sunset Yellow.
PROPERTIES
Bromelain, derived from the pineapple plant, is one of a group of Proteolytic enzymes (enzymes capable of digesting protein). Bromelain is effectiveness in protein break down that leads to its anti-inflammatory properties. Bromelain breaks down fibrin, a blood protein that is involved in clotting and inflammation.
Bromelain also stops the production of kinins, inflammatory hormone compounds.
INDICATIONS
Bromelain is an anti- inflammatory agent and for this reason is helpful in healing minor injuries, particularly sprains and strains, muscle injuries, and the pain, swelling, and tenderness that accompany sports injuries.
Probably due to its anti- inflammatory action, Bromelain was helpful to patients with rheumatoid arthritis.
Bromelain is a natural blood thinner because it prevents excessive blood platelet stickiness.
This may explain, in part, the positive reports in a few clinical trials of Bromelain to decrease symptoms of angina and thrombophiebitis.
DRUG INTERACTIONS
Because Bromelain acts as a blood thinner and little is known about how Bromelain interacts with blood-thinning drugs, people should avoid combining such drugs with Bromelain in order to reduce the theoretical risk of excessive bleeding.
DOSAGE AND ADMINISTRATION
One enteric coated tablet : 3 – 4 times daily.
WARNINGS
Safety of use of this product during pregnancy has not been established.
Due to limited clinical experience, the use of this drug in children 12 years of age and under is not recommended.
PRECAUTIONS
Bromelain Forte issa should be used with caution in patients with abnormalities of the blood clotting mechanism, such as hemophilia, or with severe hepatic or renal disease. Patients on anticoagulant therapy should be observed carefully because of possible potentiating of the anticoagulant effect.
ADVERSE REACTIONS
While seldom observed, sensitivity manifested by urticaria or skin rash has occurred, there has been no report of anaphylactoid reactions. One case of hypofibrinogenemia and several cases of menorrhagia and metrorrhgia possibly related to the drug have been reported.
Rare, cases of nausea, vomiting or diarrhea has been reported.
Adverse reactions are usually reversible upon discontinuation of the drug.
STORAGE CONDITIONS
Store at room temperature 15° – 25°C. Keep out of the reach of children.
PACKAGING
Bromelain Forte issa is supplied as blister strips (Aluminum – P.V.C), each strip contains 10 enteric coated tablets and each pack contains 2 or 3 strips with enclosed leaflet (20 or 30 enteric coated tablets per pack).