NACSYS Effervescent tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

NACSYS 600 mg effervescent tablets.

2. Qualitative and quantitative composition

Each effervescent tablet contains 600 mg of acetylcysteine. Excipient(s) with known effect: contains sodium hydrogen bicarbonate (E500) (equivalent to 115 mg of sodium). For the full list of excipients, ...

3. Pharmaceutical form

Effervescent tablet. Round, flat, white to yellowish effervescent tablet (1500 mg/tablet; ~ 17 4.25mm).

4.1. Therapeutic indications

Acetylcysteine is indicated for use as a mucolytic in respiratory disorders such as in bronchitis, emphysema, mucoviscidoses and bronchiectasis. NACSYS 600 mg effervescent tablets is indicated in adults ...

4.2. Posology and method of administration

Posology Adults 1 effervescent tablet of 600 mg once daily. Paediatric population Children older than 2 years of age and adolescents The safety and efficacy is not established in children aged 2 years ...

4.3. Contraindications

Hypersensitivity to acetylcysteine or to any of the excipients listed in section 6.1. The tablets should not be used by children under 2 years of age.

4.4. Special warnings and precautions for use

Bronchospasms may occur with the use of acetylcysteine. If bronchospasm occur, the medicinal product should be discontinued immediately. Caution is advised in patients with a history of peptic ulcer, especially ...

4.5. Interaction with other medicinal products and other forms of interaction

Interaction with other medicinal products Simultaneous solution of NACSYS 600 mg effervescent tablets with other medicinal products is not recommended. To date, the inactivation of antibiotics by acetylcysteine ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are limited data about the use of acetylcysteine in pregnant women. Animal studies do not indicate reproductive toxicity (see section 5.3). Acetylcysteine crosses the placenta. Available ...

4.7. Effects on ability to drive and use machines

There are no data on the effect of acetylcysteine on the ability to drive. An effect is, however, not likely.

4.8. Undesirable effects

The table below lists the undesirable effects recorded after systemic use of oral acetylcysteine according to system/organ class. System/organ class Undesirable effect Uncommon (≥1/1,000 to <1/100) ...

4.9. Overdose

To date no toxic overdose has been observed for the oral pharmaceutical forms of acetylcysteine. Voluntary study subjects were treated for three months with a dose of 11.6 acetylcysteine per day without ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Mucolytics ATC-code: R05CB01 Mechanism of action / Pharmacodynamic effects Acetylcysteine is a mucolytic. The mucolytic action is mediated by a reduction in the ...

5.2. Pharmacokinetic properties

Absorption / Distribution Acetylcysteine is rapidly absorbed after oral administration and distributed throughout the organism. The highest tissue concentrations are reached in the liver, kidneys and lungs. ...

5.3. Preclinical safety data

Preclinical data of acetylcysteine based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction do not indicate a risk ...

6.1. List of excipients

Sodium hydrogen carbonate (E500) Citric acid (E330) Sucralose (E955) Orange flavour (contains Orange Essential Oil, Orange Essential Oil Terpenless, Gum Arabic (E414), butylhydroxyanisole (E320), Citric ...

6.2. Incompatibilities

Acetylcysteine can react with rubber and metal (e.g. iron, nickel, copper). Use of glass and/or plastic delivery systems is recommended when administering via nasogastric or nasointestinal tube. Do not ...

6.3. Shelf life

3 years. Shelf life after first opening: the product may be stored for a maximum of 10 days in tube with 10 effervescent tablets or 20 days in tube with 20 effervescent tablets.

6.4. Special precautions for storage

Store in the original package to protect against moisture. For storage conditions after first opening of the medicinal product, see section 6.3.

6.5. Nature and contents of container

The tablet container(s) are packaged in cardboard boxes. The box contains 6, 2x6, 10, 2x10, 20 or 3x10 effervescent tablets. The effervescent tablets are packaged in a propylene tube with a polyethylene ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

ALTURiX Ltd, 287 Upper Fourth Street, Milton Keynes, MK9 1EH UK

8. Marketing authorization number(s)

PL 44490/0006

9. Date of first authorization / renewal of the authorization

11/05/2017

10. Date of revision of the text

02/10/2020

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