UMTHUTHUZELI is used for winds, gripes, colic and upset stomach associated with excess acid in infants.
1. What UMTHUTHUZELI is and what it is used for
2. What you need to know before you give UMTHUTHUZELI
Do not administer UMTHUTHUZELI:
- If your infant has:
- blood pH higher than normal,
- low calcium levels,
- low stomach acid.
- if your infant is hypersensitive (allergic) to sodium bicarbonate or any of the ingredients of UMTHUTHUZELI (listed in section 6).
Warnings and precautions
Take special care with UMTHUTHUZELI:
- If your infant has heart failure, high blood pressure, reduced kidney function, swelling, or high levels of aldosterone (steroid hormone) extreme caution is advised.
- Avoid excessive use in infants.
- UMTHUTHUZELI contains a high percentage of alcohol.
- Special care must be taken when administering UMTHUTHUZELI with other medicines, and in particular with salicylates, tetracyclines, barbiturates and lithium.
Other medicines and UMTHUTHUZELI
Always tell your health care provider if you are administering any other medicine. (This includes all complementary or traditional medicines.) UMTHUTHUZELI may interact with a number of medicines.
3. How to administer UMTHUTHUZELI
Do not share medicines prescribed for your infant with any other person. Always give UMTHUTHUZELI exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Shake the bottle well before use. The usual dose for infants is one medicine measure (5 ml) given after meals or as required. The mixture should not be given for longer than a few days without medical advice.
4. Possible side effects
UMTHUTHUZELI can have side effects. Not all side effects reported for UMTHUTHUZELI are included in this leaflet. Should your infant’s general health worsen or if your infant experiences any untoward effects while taking UMTHUTHUZELI, please consult your health provider for advice.
The following side effects may occur:
Frequency unknown: Stomach cramps, burping, flatulence (gassiness).
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of UMTHUTHUZELI.
5. How to store UMTHUTHUZELI
- Store at or below 25 °C.
- Keep the bottle tightly closed and protect from light.
- Keep bottle in unit carton until prior to use.
- Do not use after the expiry date stated on the label.
- Store all medicines out of reach of children.
- Return all unused medicine to your pharmacist.
- Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).