Impilo Diarrhoea Mixture 5 ml Suspension
PDF Leaflet Revision Date: 25 January 2023
Clinical Summary
Quick overview from the medicine insert
Indication
Symptomatic treatment of mild to moderately acute diarrhoea.
Dosage (summary)
Adults: 30-60 ml (6-12 measures) 3-4 times daily; Not for children under 3 years.
Special Populations
- Children
- Elderly
Pregnancy & Breastfeeding
Safety in pregnancy and lactation not established.
Key Drug Interactions
- Anticholinergics
- Digoxin
- Clindamycin
- Lincomycin
Contraindications
- Hypersensitivity
- Intestinal obstruction
- Chronic gastrointestinal ulceration
- Colostomy
- Children under 3 years
Common side effects
- Constipation
Counselling Points
- Shake before use
- Maintain hydration
- Administer 2-3 hours apart from other medications
Serious warnings
- Risk of dehydration
- Consult doctor if symptoms worsen after 48 hours
Important Disclaimer
The Impilo Diarrhoea Mixture 5 ml Suspension professional information leaflet below is the property of Avid Brands SA and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
IMPILO DIARRHOEA MIXTURE, as adjunct to rest, fluids and appropriate diet, is indicated in the symptomatic treatment of mild to moderately acute diarrhoea.
4.2 Posology and method of administration
Posology
SHAKE BOTTLE BEFORE USE
The dose should be taken in water 3 to 4 times daily
Children:
3 to under 6 years: 1,5 to 3 medicine measures (7,5 to 15 ml)
6 to under 12 years: 3 to 6 medicine measures (15 to 30 ml)
12 years and over: 6 medicine measures (30 ml)
Adults and adolescents: 6 to 12 medicine measures (30 to 60 ml)
NOT FOR USE IN CHILDREN UNDER THREE YEARS OF AGE.
As a consequence of diarrhoea, the patient may become dehydrated. If the symptoms persist for more than 48 hours, or the condition of the patient deteriorates, use of the product must be discontinued and a doctor must be consulted. Hydration may be maintained by the administration of adequate fluids and or electrolytes. Do not exceed the recommended dosage unless on the advice and under the supervision of a doctor.
Method of administration
For oral use only.
4.3 Contraindications
- Hypersensitivity to any of the ingredients,
- intestinal obstruction,
- patients with chronic ulceration of the gastrointestinal tract or who have undergone colostomies.
- IMPILO DIARRHOEA MIXTURE should not be given to children under the age of 3 years (see Section 4.2).
4.4 Special warnings and precautions for use
Caution is recommended when using IMPILO DIARRHOEA MIXTURE by children and the elderly. Due to the risk of electrolyte and fluid loss, adequate hydration should be ensured. The absorption of other medicines, notably digoxin, from the gastrointestinal tract may be reduced if taken concomitantly. Other medicines should therefore not be taken at the same time as IMPILO DIARRHOEA MIXTURE (see Section 4.5). A doctor should be consulted if the symptoms worsen or do not improve after 48 hours.
4.5 Interaction with other medicines and other forms of interaction
Concurrent use of IMPILO DIARRHOEA MIXTURE with anticholinergics or medicines with anticholinergic activity, antidyskinetics, digoxin, clindamycin and lincomycin, loxapine, phenothiazines or thioxanthenes may impair absorption of these medicines when administered orally which can result in decreased therapeutic efficacy. Coadministration of Dolutegravir with IMPILO DIARRHOEA MIXTURE may decrease the bioavailability of dolutegravir. It is recommended that IMPILO DIARRHOEA MIXTURE is administered at least 2 to 3 hours before or after other oral medicines.
4.6 Fertility, pregnancy and lactation
The safety of this preparation in pregnancy and lactation has not been established. No fertility data available.
4.7 Effects on ability to drive and use machines
No effect is expected on the ability to drive and use machines.
4.8 Undesirable effects
The following side effects may occur: Gastrointestinal disorders
Frequency unknown: Constipation. This side effect may be mild and transient but may lead to faecal impaction.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRAvia the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8
4.9 Overdose
In overdose, side effects can be precipitated and/or be of increased severity (see section 4.8). Treatment is supportive and symptomatic.
