INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
IMODIUM® syrup

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

IMODIUM^® syrup

COMPOSITION
Each mL contains 0,2 mg loperamide hydrochloride. Methylparaben 0,072% m/v and propylparaben 0,008% m/v as preservatives.

PHARMACOLOGICAL CLASSIFICATION
A.11.9 Medicines acting on gastro-intestinal tract. Anti-diarrhoeals.

PHARMACOLOGICAL ACTION
IMODIUM 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).
IMODIUM normalizes the stool in both acute and chronic diarrhoea.
IMODIUM is incompletely absorbed from the gut, and it is almost completely metabolized in the liver where it is conjugated and excreted via the bile. IMODIUM is mainly eliminated via the faeces.

INDICATIONS
Adults and children 6 years and older: IMODIUM is indicated for the control and symptomatic relief of acute and chronic nonspecific diarrhoea and inhibits peristalsis and slows intestinal transit time in patients with ileostomies, colostomies and other intestinal resections.
Children below 6 years of age: IMODIUM is indicated for inhibition of peristalsis and slowing intestinal transit time.

CONTRA-INDICATIONS
IMODIUM is contra-indicated in patients with a known hypersensitivity to the medicine.
IMODIUM is contra-indicated in infants under 24 months of age.
Since treatment of diarrhoea with IMODIUM is only symptomatic, diarrhoea should be treated causally, whenever causal treatment is available. IMODIUM should not be used as the primary therapy in acute dysentery, which is characterised by blood in stools and high fever.
IMODIUM must not be used in patients with acute ulcerative colitis or pseudomembranous colitis associated with broad-spectrum antibiotics. In general, IMODIUM should not be used when inhibition of peristalsis is to be avoided and must be discontinued promptly if constipation, abdominal distension or symptoms and signs suggestive of ileus 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
IMODIUM should not be used in infants under 2 years.
Acute non-specific diarrhoea:
One medicine measure (5 mL) per 12,5 kg body mass followed by ½ medicine measure (2,5 mL) per 12,5 kg after each subsequent loose stool.
Daily dosage should not exceed three medicine measures (15 mL) per 12,5 kg body mass.

Weight in Kilograms (kg)	Initial Dose (mL)	On Subsequent Loose Stools	Maximum Daily Dose
10-14,9	5 mL	2,5 mL	15 mL
15-19,9	7,5 mL	3,7 mL*	20 mL
20	10 mL	5 mL	30 mL
40	15 mL	7,5 mL	60 mL
70	20 mL	10 mL	80 mL

* 3,7 mL is equal to ¾ of a medicine measure.
Important: As soon as diarrhoea is under control, stop dosage.
In acute diarrhoea, if clinical improvement is not observed within 48 hours, the administration of IMODIUM should be discontinued and patients should be advised to consult their doctor.
Chronic non-specific diarrhoea(consult your doctor)
With individually adjusted dosage it is usually possible to obtain a virtually normal bowel movement.
The starting dose is 1 medicine measure (5 mL) per 12,5 kg body mass a day for children.
The daily dose should be adjusted until 1 –2 solid stools per day are obtained. This is usually achieved on a maintenance dose of ½ –2 medicine measures (2,5 mL –10 mL) daily.
If constipation occurs, the dosage should be decreased.
Instructions for use:
The bottle comes with a child-proof cap, and should be opened as follows:

1.	push the plastic screw cap down,
2.	while pressing down, turn the cap counter clockwise.

{illustrated}

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Reversible paralytic ileus may occur.
Constipation and or abdominal distension, dry mouth, abdominal pain or discomfort and other gastro-intestinal disturbances (e.g. nausea and vomiting), drowsiness or dizziness and fatigue may occur. Urinary retention has been reported less frequently.
Hypersensitivity reactions such as skin rash and urticaria and less frequently 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, especially in infants, 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 should not be given to children less than 6 years of age without medical prescription and supervision.
IMODIUM is not recommended for routine use in acute or chronic diarrhoea in children under the age of 6 years.
Patients with hepatic dysfunction should be monitored closely for signs of central nervous system toxicity because of the high first-pass metabolism.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage (including relative overdosage due to hepatic dysfunction), may lead to constipation, urinary retention, ileus and depression of the central nervous system (e.g. stupor, coordination abnormality, somnolence, miosis, muscular hypertonia, respiratory depression). 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
Clear, red coloured, slightly viscous solution with a fruity flavour.

PRESENTATION
50 mL and 500 mL amber glass bottles.

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

REGISTRATION NUMBER
J/11.9/166

NAME AND BUSINESS ADDRESS OF THE APPLICANT
JANSSEN-CILAG
Janssen Pharmaceutica (Pty) Ltd.
(Reg. No. 1980/011122/07)
15th Road, Halfway House 1685.
Website: www.janssencilag.co.za
© JANSSEN PHARMACEUTICA (Pty) Ltd. SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
19 July 2002.

® TRADEMARK
                        Code No.: 024222
                        2002I
                        Britepak

Updated on this site: October 2003
Source: Pharmaceutical Industry
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