Tala Health & Wellness MUCOBOOST 600
Professional Information

1. Name of medicine

Tala Health & Wellness MUCOBOOST 600 Effervescent Tablets

2. Qualitative and Quantitative Composition 
Each effervescent tablet contains 600 mg N-acetyl cysteine (NAC).
Contains sweetener: sucralose 25 mg 

3. Pharmaceutical form
White round effervescent tablets. When dissolved in a glass of water it forms a clear colourless solution.
 
4.   Clinical Particulars 
4.1 Therapeutic Indications 
N-acetyl cysteine has a mucolytic action in acute respiratory conditions.

4.2 Posology and method of administration 
Adults and children over 14 years: Take one (1) effervescent tablet dissolved in a glass of water once daily.

Elderly populations
No studies have been performed in elderly populations, but no dose adjustment is expected to be required. 
 
Duration of treatment 
Tala Health & Wellness MUCOBOOST 600 should not be taken for more than 14 days without medical advice.

Paediatric populations: 
Not recommended for use in children and adolescents under the age of 14 years. Do not use in infants. 

4.3 Contraindications: 
Do not take TALA Health & Wellness MUCOBOOST 600 if you are allergic to the active substance, N-acetyl cystine or other ingredients (listed in Section 6).

Contraindicated in cases of active peptic ulcers. 

4.4 Special warnings and precautions for use
TALA Health & Wellness MUCOBOOST 600 should be used with caution in asthmatic patients. Stop taking TALA Health & Wellness MUCOBOOST 600 if bronchospasm occurs. Immediately start appropriate treatment.

TALA Health & Wellness MUCOBOOST 600 should be used with caution in people with a history of stomach ulcer, taking N-acetyl cysteine may cause nausea and vomiting thereby increasing the chances of unwanted effects. 

4.5 Interactions with other medicines and other forms of interaction

Taking TALA Health & Wellness MUCOBOOST 600 with antitussives may cause secretory congestion due to the reduced cough reflex. 

4.6 Fertility, pregnancy, and lactation 
Safety of TALA Health & Wellness MUCOBOOST 600 in pregnancy and lactation has not been established. 
Fertility: Data concerning effects of N-acetyl cysteine on human fertility are not available.
Pregnancy: There are no adequate clinical data from the use of N-acetyl cysteine in pregnant women. TALA Health & Wellness MUCOBOOST 600 should not be used during pregnancy.
Breastfeeding: No information is available regarding excretion of acetyl cysteine or its metabolites into breast milk. The use of TALA Health & Wellness MUCOBOOST 600 while breast feeding is not recommended.

4.7. Effects on ability to drive and use machines

TALA Health & Wellness MUCOBOOST 600  has no known effect on the ability to drive and use machines.

4.8 Undesirable effects   
Most side effects are caused by hypersensitivity to the active ingredient,
N-acetyl cysteine. These include headache, blurred vision, tinnitus, and tachycardia. Dyspnoea, bronchospasm may occur in patients with hyperactive reactive bronchial system in association with bronchial asthma.

Other side effects include nausea, vomiting, diarrhoea, abdominal pain, stomatitis. These side effects are uncommon (occurring in 1 to 10 in 1000 patients treated). 

4.9 Overdose
Large doses of TALA Health & Wellness MUCOBOOST 600  may lead to gastrointestinal symptoms such as nausea, vomiting and diarrhoea. 

5. Pharmacological properties 

5.1 Mechanism of action
N-acetyl cysteine causes the breaking of disulfide bonds in mucoprotein complexes which reduces the viscosity of mucous secretion, thereby improving mucociliary clearance.

5.2 Pharmacokinetic properties
N-acetyl cysteine is almost completely absorbed after oral dosing with a mean tmax of 0.65 – 0.73 h. N-acetyl cysteine is rapidly metabolised giving a elimination half life of 2.27h. 

6. Pharmaceutical properties 
List of excipients 
Citric acid, sodium bicarbonate, isomalt, microcrystalline cellulose, flavouring, silicone dioxide, colourant (E104).

Incompatibilities
In the absence of studies TALA Health & Wellness MUCOBOOST 600 should not be given with other medicines. 

Shelf Life
24 months.

Special precautions for storage
Keep out of reach of children. 
Store at or below 25 ˚C.

Presentation
Polypropylene tube containing 10 white effervescent tablets. 

7. Applicant
Tala Health & Wellness
454 Koedoesnek Street
Waterkloof Ridge
012 347 8497

8. Date of revision of the text
October 2023