Lessmusec 375 mg Capsules
PDF Leaflet Revision Date: 30 March 2023
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, then 1 capsule four times daily after response.
Special Populations
- Elderly
- History of gastroduodenal ulcers
Pregnancy & Breastfeeding
Not recommended during pregnancy or breastfeeding due to lack of data.
Key Drug Interactions
- Incompatible with pholcodine linctus
Contraindications
- Hypersensitivity to carbocisteine
- Active peptic ulcer
Common side effects
- Dizziness
- Headache
- Nausea
- Gastrointestinal bleeding
Counselling Points
- Take with caution until effects are known
- Report any allergic reactions
Serious warnings
- Caution in elderly and those with gastrointestinal bleeding risk
Important Disclaimer
The Lessmusec 375 mg Capsules professional information leaflet below is the property of Brunel Laboratoria 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
Adjunctive therapy in respiratory tract disorders characterised by excessive viscous mucus in the absence of infection.
4.2 Posology and method of administration
Posology
Adults: Two capsules three times daily, reducing to one capsule four times daily after satisfactory response has been obtained.
Paediatric population
No data available.
Method of administration
LESSMUSEC is for oral use only.
4.3 Contraindications
- Hypersensitivity to carbocisteine or any of the excipients of LESSMUSEC listed in section 6.1.
- Use in patients with an active peptic ulcer.
4.4 Special warnings and precautions for use
LESSMUSEC should be used with caution in elderly patients, those with a history of gastroduodenal ulcers, or those taking concomitant medicines known to cause gastrointestinal bleeding due to the risk of disruption of the gastric mucosal barrier. If gastrointestinal bleeding occurs, LESSMUSEC therapy should be discontinued. Transient hypothyroidism may develop in patients with compromised thyroid function.
Excipient warnings
LESSMUSEC contains Sunset Yellow FCF (E110), ponceau 4R (E124) and carmoisine (E122) which may cause allergic reactions.
4.5 Interaction with other medicines and other forms of interaction
Incompatible with pholcodine linctus.
4.6 Fertility, pregnancy and lactation
Safety and efficacy during pregnancy and lactation have not been established.
Pregnancy
There are no available data on carbocisteine use in pregnant women. The use of carbocisteine in pregnant women is not recommended.
Breastfeeding
There are no available data on the presence of carbocisteine in human milk, milk production, or the effects on the breastfed infant. The use of carbocisteine in breastfeeding women is not recommended.
Fertility
No fertility data are available.
4.7 Effects on ability to drive and use machines
LESSMUSEC is not likely to affect the ability to drive a vehicle or operate machinery. However, patients must take care until they know how they will react to LESSMUSEC.
4.8 Undesirable effects
Immune system disorders
Frequency unknown: Anaphylactic reactions, allergic skin eruption and fixed medicine eruption.
Nervous system disorders
Frequency unknown: Dizziness, headache.
Cardiac disorders
Frequency unknown: Palpitations.
Gastrointestinal disorders
Frequency unknown: Nausea, heartburn, diarrhoea, epigastric discomfort, gastrointestinal bleeding, vomiting.
Skin and subcutaneous tissue disorders
Frequency unknown: Skin rash, bullous dermatitis, Stevens-Johnson syndrome, erythema multiforme.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of LESSMUSEC is important. It allows continued monitoring of the benefit/risk balance of LESSMUSEC. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the 6.04 Adverse Drug Reactions Reporting Form, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8
4.9 Overdose
See sections 4.4 and 4.8. Gastrointestinal disturbance is the most likely symptom of LESSMUSEC overdosage. Treatment is symptomatic and supportive.
