Imoflora 20 tablets

Imoflora 20 tablets

Composition:
Each tablet contains:
Active ingredients:
Loperamide Hydrochloride - 2 mg
Simethicone - 125 mg.
Inactive ingredients:
Calcium phosphate dibasic anhydrous, Maltodextrin, Propylene glycol, Microcrystalline cellulose, Sodium starch glycolate, Stearic acid.
Description:
A combined antidiarrheal product used for the symptomatic treatment of acute diarrhea associated with gas-related abdominal discomfort, including bloating, cramps and flatulence.
Loperamide reduces intestinal motility, while simethicone relieves gas symptoms.
Indications for Use:
Symptomatic treatment of acute diarrhea in adults and adolescents over 12 years when accompanied by gas-related abdominal discomfort (bloating, cramps, flatulence).
Dosage and Method of Administration:
Tablets should be taken with liquid.
Adults (over 18 years):
Initial dose: 2 tablets.
Then: 1 tablet after each loose stool.
Maximum: 4 tablets per day, not longer than 2 days
Adolescents (12-18 years): 
Initial dose: 1 tablet.
Then: 1 tablet after each loose stool.
Maximum: 4 tablets per day, not longer than 2 days
Hepatic impairment:
Use with caution due to reduced first-pass metabolism.
Contraindications:
- Children under 12 years
- Hypersensitivity to loperamide, simethicone, or excipients
- Acute dysentery (bloody stools, high fever)
- Acute ulcerative colitis
- Pseudomembranous colitis associated with antibiotics
- Diarrhea caused by invasive pathogens
- Conditions where inhibition of peristalsis must be avoided (ileus, megacolon, toxic megacolon)
- Discontinue if constipation or abdominal distension develops.
Precautions:
- Not for use in children
- Not recommended in high fever accompanied by diarrhea
- Treatment is symptomatic; underlying cause should be treated when known
- Fluid and electrolyte replacement is essential in severe diarrhea
- Stop treatment if no improvement within 48 hours
- AIDS patients should discontinue at the first sign of abdominal distension
- Use cautiously in hepatic impairment due to possible CNS toxicity.
Side Effects:
Common:
Dysgeusia, Nausea
Uncommon:
Somnolence, Dizziness, Abdominal pain, Abdominal distension, Constipation, Flatulence, Dry mouth, Rash, Asthenia
Rare:
Hypersensitivity and anaphylaxis, Loss of consciousness, Ileus, megacolon, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Urticaria, Angioedema, Pruritus, Urinary retention, Fatigue.
Pregnancy and Lactation:
Pregnancy:
Should not be used unless absolutely necessary; avoid during the first trimester.
Lactation:
Loperamide may pass into breast milk.
Not recommended while breastfeeding.
Storage Conditions:
Store below 30°C in a dry place.
Keep out of reach of children.
Packaging:
Carton box containing 2 strips of 10 tablets with an insert.