TUSSMUCO Effervescent tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
TUSSMUCO 200 mg effervescent tablets.
2. Qualitative and quantitative composition
Each effervescent tablet of TUSSMUCO contains 200 mg N-acetylcysteine.
Contains sugar:
Glucose liquid 113 mg and mannitol 190 mg.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Effervescent tablets.
TUSSMUCO is a round, white to off white, mottled, flat tablet plain on one side and a break line on the other side.
4.1. Therapeutic indications
TUSSMUCO effervescent tablets are used as a mucolytic, of non-infective secretions in cystic fibrosis and in respiratory conditions.
4.2. Posology and method of administration
Posology
Adults and adolescents from 14 years of age
1 effervescent tablet 2 to 3 times daily (equivalent to 400 to 600 mg N-acetylcysteine/day).
Paediatric population
Children from 6 to 14 years o...
4.3. Contraindications
TUSSMUCO is contraindicated in:
Patients with hypersensitivity to N-acetylcysteine or to any excipients in TUSSMUCO (see section 6.1).
In children below 2 years of age.
Safety in pregnancy has not ...
4.4. Special warnings and precautions for use
TUSSMUCO should be used with caution in asthmatic patients (see section 4.8).
Since mucolytics, such as TUSSMUCO may disrupt the gastric mucosal barrier, TUSSMUCO should be used with caution in pat...
4.5. Interaction with other medicinal products and other forms of interaction
Tetracycline hydrochloride (with the exception of doxycycline) and other oral antibiotics such as cephalosporin cause a degree of antibiotic inactivation and must be administered separately from TU...
4.6. Fertility, pregnancy and lactation
Pregnancy
Safety and efficacy has not been established (see section 4.3).
Breastfeeding
Safety has not been established. There is insufficient information on the excretion of N-acetylcysteine in hu...
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive or use machines have been performed. TUSSMUCO has no known effect on the ability to drive and use machines.
Patients should not drive, use machiner...
4.8. Undesirable effects
a) Tabulated list of adverse reactions
System organ class
Frequent
Less frequent
Frequency
unknown
(cannot be
estimated from the
available data)
Immune system disorders
Anaphylactic reactions up
...
4.9. Overdose
Symptoms
Small children are at risk of hypersecretion (see section 4.8).
An acute overdose of N-acetylcysteine can cause gastrointestinal symptoms such as nausea, vomiting and diarrhoea.
Treatment
...
5.1. Pharmacodynamic properties
A 10.3 Medicines acting on the respiratory system – other
Pharmacotherapeutic group:
Mucolytics
ATC code:
R05CB01
Mechanism of action
N-acetyl-L-cysteine (NAC) exerts an intense mucolytic fluid...
5.2. Pharmacokinetic properties
Absorption
Following oral administration, N-acetylcysteine is rapidly and almost completely absorbed and metabolised in the liver to cysteine (the pharmacologically active metabolite), diN-acetylcy...
6.1. List of excipients
Ascorbic acid, citric acid anhydrous, glucose liquid, lemon flavour, mannitol, sodium benzoate, sodium bicarbonate, sodium citrate, tartaric acid.
Lemon flavour consists of: acacia gum 414, ascorbi...
6.2. Incompatibilities
In the absence of compatibility studies, this medicine must not be mixed with other medicines.
6.3. Shelf life
24 months.
6.4. Special precautions for storage
Store at or below 25°C.
6.5. Nature and contents of container
15 or 20 or 25 or 40 (2 x 20's) tablets are packed into a polypropylene tube with a white LDPE cap with a tamper seal and desiccant. The tube is packed into a cardboard carton.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
8. Marketing authorization number(s)
54/10.3/0854
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 17 November 2020
10. Date of revision of the text
10 June 2022
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