INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo IMODIUM Plus™

                © J-C 2000

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

IMODIUM Plus
chewable tablets.

COMPOSITION
Each chewable tablet contains 2 mg
loperamide hydrochloride and 125 mg simethicone.

PHARMACOLOGICAL CLASSIFICATION
A.11.9 2 Medicines acting on gastro-intestinal tract. Other.

PHARMACOLOGICAL ACTION
Loperamide hydrochloride inhibits hypermotility by direct action on the bowel wall. Its inhibition of peristalsis is the result of decreasing the activity of both the longitudinal muscles (preparatory and reflex phases) and the circular muscles (reflex phase).
Loperamide hydrochloride normalises the stool in acute diarrhoea.
Loperamide hydrochloride is incompletely absorbed from the gut, and it is almost completely metabolised in the liver where it is conjugated and excreted via the bile. Loperamide hydrochloride is mainly eliminated via the faeces.
Simethicone is a nonabsorbable inert surface acting agent with antifoaming properties.

INDICATIONS
Adults and children 12 years and older
IMODIUM Plus is indicated for the control and symptomatic relief of acute and chronic non-specific diarrhoea and its commonly associated symptoms: discomfort, bloating, cramping and flatulence. It also inhibits peristalsis and slow intestinal transit time in patients with ileostomies, colostomies and other intestinal resections.

CONTRA-INDICATIONS
IMODIUM Plus is contra-indicated in patients with a known hypersensitivity to any component of this medicine.
IMODIUM Plus should not be used in children under 12 years of age.
Since treatment of diarrhoea with loperamide and simethicone is only symptomatic, diarrhoea should be treated causally, whenever causal treatment is available.
IMODIUM Plus should not be used as the primary therapy, in acute dysentery, which is characterised by blood in stools and high fever. IMODIUM Plus should not be used in patients with acute ulcerative colitis or pseudomembranous colitis associated with broad-spectrum antibiotics.
In general, IMODIUM Plus should not be used when inhibition of peristalsis is to be avoided and must be discontinued promptly if constipation, abdominal distension or subileus develop.
Loperamide administration may precipitate toxic megacolon in patients with inflammatory bowel disease.
The safety of use during pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE
Adults and children over 12 years:
Chew two tablets initially, followed by 1 tablet after each subsequent loose stool. Not more than 4 tablets should be taken in a day, limited to no more than 2 days.
If clinical improvement is not observed within 48 hours, the administration of IMODIUM Plus should be discontinued and patients should be advised to consult their doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Reversible paralytic ileus may occur at a high dose level.
Constipation and or abdominal distension, dry mouth, abdominal pain or discomfort and other gastro-intestinal disturbances (eg. nausea and vomiting), drowsiness or dizziness and fatigue may occur.
Hypersensitivity reactions such as skin rash and urticaria and less frequent cases of anaphylactic shock and bullous eruption including Toxic Epidermal Necrolysis. Other medications may have caused or contributed to some of these cases.
Precautions:
In patients with diarrhoea, fluid and electrolyte depletion may occur. In such cases administration of appropriate fluid and electrolyte replacement (oral rehydration therapy {ORT}) is the most important measure.
IMODIUM Plus should not be given to children less than 12 years of age without medical prescription and supervision. IMODIUM Plus is not recommended for routine use in acute or chronic diarrhoea in children under the age of 12 years.
Patients with hepatic dysfunction should be monitored closely for signs of central nervous system toxicity because of the reduced first-pass metabolism.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage may, lead to constipation and depression of the central nervous system. Children may be more sensitive to central nervous system effects of loperamide than adults. Convulsions have been reported in children under the age of 2 years.
Excessive inhibition of peristalsis with nausea and dryness of the mouth.
Treatment is symptomatic and supportive. Naloxone can be given as an antidote. Since the duration of action of IMODIUM is longer than that of naloxone (1 to 3 hours) repeated treatment with naloxone may be indicated. Therefore, the patient should be monitored closely for at least 48 hours in order to detect possible central nervous system depression.

IDENTIFICATION
White, round flat faced tablet with "IMO" imprint on one side, and a vanilla mint odour.

PRESENTATION
Cartons containing blister strips of 2, 4, 5 or 6 tablets.

STORAGE DIRECTIONS
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
31/11.9.2/0402

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN PHARMACEUTICA (PTY) LTD
(Reg. No. 80/11122/07)
15th Road
HALFWAY HOUSE
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT
26 February 1999

JANSSEN-CILAG logo

Zaf.- 3000005 V

Updated on this site: March 2001

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