Mucosolv Capsules 375 mg Capsules
PDF Leaflet Revision Date: 11/11/2022
Clinical Summary
Quick overview from the medicine insert
Indication
Adjunctive therapy in respiratory tract disorders with excessive viscous mucus.
Dosage (summary)
Adults: 2 capsules three times daily, reduce to 1 capsule four times daily as needed.
Special Populations
- Peptic ulcer history
Pregnancy & Breastfeeding
Safety in pregnancy and lactation not established.
Contraindications
- Hypersensitivity to ingredients
- Active peptic ulceration
Common side effects
- Nausea
- Diarrhoea
- Gastric discomfort
- Headache
Counselling Points
- Take with plenty of fluids
- Report any allergic reactions
Serious warnings
- Caution in peptic ulcer or duodenal disease
Important Disclaimer
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Clinical Particulars
Section 4 of the official insert — extracted exactly as issued, no alterations
4.1 Therapeutic indications
MUCOSOLV CAPSULES is indicated as adjunctive therapy in respiratory tract disorders characterised by excessive viscous mucous in the absence of infection.
4.2 Posology and method of administration
Posology
Adults: Take two (2) capsules three (3) times daily, reducing to one (1) capsule four (4) times daily when a satisfactory response has been obtained.
Method of administration
MUCOSOLV CAPSULES are for oral use only.
4.3 Contraindications
Hypersensitivity to any of the ingredients, including excipients listed in section 6.1. Use in patients with active peptic ulceration.
4.4 Special warnings and precautions for use
MUCOSOLV CAPSULES must be used with caution in patients with a history of peptic ulcer or duodenal disease because of the risk that mucolytics may disrupt the gastric mucosal barrier.
4.5 Interaction with other medicines and other forms of interaction
No known interactions.
4.6 Fertility, pregnancy and lactation
Safety in pregnancy and lactation has not been established.
4.7 Effects on ability to drive and use machines
MUCOSOLV CAPSULES have no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Immune system disorders
Frequency unknown: Anaphylactic reactions, allergic skin eruption and fixed drug eruption
Gastrointestinal disorders
Frequent: Nausea, diarrhoea, gastric discomfort
Less frequent: Gastro-intestinal bleeding
Frequency unknown: vomiting
Skin and subcutaneous tissue disorders
Less frequent: Skin rashes
Frequency unknown: allergic skin eruptions. Isolated cases of dermatitis bullous such as Stevens-Johnson syndrome and erythema multiforme have also been reported.
General disorders and administrative site conditions
Less frequent: Headache
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 and to Cipla Medpro (Pty) Ltd at [email protected] or telephone 080 222 6662 (toll free).
4.9 Overdose
Gastrointestinal disturbance is the most likely symptom of MUCOSOLV CAPSULES overdosage.
