KRISMOTIL Tablet Ref.[115609] Active ingredients: Loperamide

Source: Registered Drug Product Database (NG)  Publisher: Krishat Pharma Industries Limited, KM 15, Lagos-Ibadan Expressway, Ibadan, Oyo State, NIGERIA., Email: info@krishatpharma.com, Company contacts details: operations@krishatpharma.com

4.1. Therapeutic indications

For the symptomatic treatment of acute diarrhoea in adults and children aged 12 years and over.

For the symptomatic treatment of acute episodes of diarrhoea associated with Trritable Bowel Syndrome in adult aged 18 years and over following initial diagnosis by a doctor.

4.2. Posology and method of administration

Acute diarrhoea

Adults, the elderly, and children 12 years and over

Two tablets (4 mg) initially followed by 1 tablet (2 mg) after every loose stool. The maximum daily dose should not exceed 6 tablets (12 mg). Symptomatic treatment of acute episodes of diarrhoea associated with irritable bowel syndrome.

Adults aged 18 years and over

Two tablets (4 mg) initially, followed by 1 tablet (2 mg) after every loose stool, or as previously advised by your doctor. The maximum daily dose should not exceed 6 tablets (12 mg).

Elderly

No dose adjustment is required for the elderly.

Renal impairment

No dose adjustment is required for patients with renal impairment.

Hepatic impairment

Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide tablets should be used with caution in such patients because of reduced first pass metabolism.

Method of administration

Oral use.

4.9. Overdose

Symptoms

In case of overdose (including relative overdose due to hepatic dysfunction), CNS depression (stupor, coordination abnormality, somnolence, miosis, muscular hypertonia and respiratory depression), constipation, urinary retention and ileus may occur. Children, and patients with hepatic dysfunction, may be more sensitive to CNS effects.

Treatment

If symptoms of overdose occur, naloxone can be given as an antidote. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone might be indicated. Therefore, the patient should be monitored closely for at least 48 hours in order to detect possible CNS depression.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Store in a temperature below 30°C, protect from light and moisture.

Protect from light and moisture.

6.5. Nature and contents of container

Product is packed in 20x5x10 Tablets strip pack in a printed carton along with insert.

6.6. Special precautions for disposal and other handling

No special requirements.

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