Imotil Plus 2mg + 125mg Tablet 1 Strip

✔️ Dosage & Administration

Adults & Adolescents (12 years & older):

• Take 2 tablets initially after the first loose stool.
• Follow with 1 tablet after each subsequent loose stool (maximum 4 tablets per day for no more than 2 days).

Children (6-11 years):

• Not recommended unless advised by a doctor.
• Ages 9-11 years: Start with 1 tablet, then ½ tablet after each loose stool (maximum 3 tablets/day).
• Ages 6-8 years: Start with 1 tablet, then ½ tablet after each loose stool (maximum 2 tablets/day).
• Use with caution in children under 12 due to variable responses and swallowing difficulties.

Elderly (65+ years):

• No dosage adjustments are required.

Patients with Renal Impairment:

• No dosage modification is necessary.

Patients with Hepatic Impairment:

• Use with caution due to the potential for increased drug levels and CNS effects.

✔️ Possible Side Effects

Common side effects (≥1%):

• Altered taste (2.6%)
• Nausea (1.6%)

✔️ Administration:

• Oral use only – tablets should be taken with a full glass (250 mL) of water.
• Chewable tablets should be fully chewed before swallowing.
• Take on an empty stomach (1 hour before or 2 hours after meals).
• Drink plenty of fluids to prevent dehydration during diarrhea episodes.

✔️ Drug Interactions

• P-glycoprotein inhibitors (quinidine, ritonavir) increase loperamide levels 2-3 times.
• CYP3A4 inhibitors (itraconazole, ketoconazole) and CYP2C8 inhibitors (gemfibrozil) raise plasma concentrations of loperamide 3-5 times.
• A combination of itraconazole & gemfibrozil results in a 13-fold increase in total plasma exposure.
• Desmopressin levels may rise 3-fold due to slower gut motility.
• Drugs that accelerate GI transit may reduce effectiveness, while those that slow peristalsis may enhance effects.
• Simethicone has no known drug interactions due to lack of absorption.

✔️ Do not use if:

• You are allergic to any component of this medication.
• You have bloody stools, fever, or acute dysentery.
• You suffer from bacterial enterocolitis (e.g., Salmonella, Shigella, Campylobacter infections).
• You have ulcerative colitis or pseudomembranous colitis caused by antibiotics.
• You experience abdominal bloating or distension, which may indicate a serious condition like toxic megacolon.
• Children under 2 years old should not take this medication.

✔️ Use During Pregnancy & Breastfeeding

• Pregnancy: Use only if clinically justified, especially during the first trimester. Animal studies do not indicate harmful effects.
• Breastfeeding: Not recommended, as small amounts of loperamide may pass into breast milk.

✔️ Precautions & Warnings

• This medication treats symptoms but does not cure underlying causes. If diarrhea persists beyond 48 hours, discontinue use and consult a doctor.
• Hepatic impairment may lead to CNS toxicity—use with caution in severe liver dysfunction.
• Cardiac risks (QT prolongation, QRS widening) have been reported in cases of overdose.

✔️ Storage Instructions

• Store below 30°C, away from light and moisture.
• Keep out of reach of children.