Composition:-
Each tablet contains:
- Active ingredient:
pencreatin special grade 200 mg contains:
- Lipase ------------------------------ 800 (USNF units)
- Amylase ---------------------------- 5000 (USNF units)
- Protease ---------------------------- 5000 (USNF units)
- Pepsin (1 :10.000) ---------------- 100 mg.
- Hemicellulase (5000 IU/g.) ---- 40 mg.
- Ox bile extract -------------------- 20 mg.
- Dimethylpolysiloxane ----------- 20 mg.
- Vitamin B1 ------------------------- 25 mg.
- Inactive ingredients: Magnesium stearate, talc purified powder, aerosil, avicel (PH 102), lactose monohydrate, mannitol, PVP K 25, eudragit L 30 D, Isopropyl alcohol, shellac.
- Film coat: sunset yellow, vanillin, talc, aerosil, PEG 6000.
Pharmaceutical Forms:-
Film coated tablets.
Pharmacological Action:-
•Digestive enzymes are of definite value in clinical management of various dyspepsias. Enzymes included in Zymogen Forte are combined in order to replace deficient secretions in the gastro-intestinal tract, zymogen forte tablets are prepared in the form of two layers.
•The outer layer contains pepsin, dimethylpolysiloxane and vitamin B1.
•Pepsin is a proteolytic enzyme which is active in acidic media. It controls the degradation of proteins into proteases and peptones. Dimethylpolysiloxane exerts a defoaming effect, it is used in the treatment of flatulence for the elimination of gas or foam from the gastro-intestinal tract. Vitamin B1 improves appetite and gastro-intestinal motility.
•The inner layer is enteric coated to protect the pancreatic enzymes against inactivation by gastric juice.
•The enteric coat disintegrates in the intestine where the enzymes liberated exercise their action on the digestion of fats proteins and carbohydrates.
•Ox bile extract promotes the enzymatic splitting of fats by emulsifying the neutral fats and activating the lipase. It stimulates intestinal peristalsis in chronic constipation.
•Hemicellulase brings about an early breakdown of cellulose, thus reducing the amount of substrate available for bacterial fermentative gas formation.
Pharmacokinetics:-
The product acts locally in the gastrointestinal tract and excreted in faeces.
Indications:-
- Dyspepsias due to gastric, pancreatic, biliary and intestinal dysfunction.
- Relief of abdominal distension.
Dosage and Administration:-
One tablet three times daily during or after meals.
Contra Indications:-
Biliary tract obstruction and severe hepatitis.
Side Effects:-
Blurred vision and difficult urination.
Drug Interactions:-
None.
Pregnancy and Lactation:-
- No clinical data on exposed pregnancies or breast feeding women are available.
- Caution should be exercised when prescribing the product to pregnant or breast feeding women.
Precautions and Warning:-
Administer with caution to patients with urinary bladder neck obstruction as in prostatic hypertrophy.
Package and Storage:-
- Carton boxe contains 2 strips each of 10 film coated tablets + Pamphlet.
- Store at temperature below 25 C.
Instructions to Patients:-
- Don't increase the dose without consulting your physician.
Reference: Product leaflet