Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: ALTURiX Ltd, 287 Upper Fourth Street, Milton Keynes, MK9 1EH UK
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 only.
1 effervescent tablet of 600 mg once daily.
The safety and efficacy is not established in children aged 2 years and older and adolescents.
The use of NACSYS 600 mg effervescent tablets is contraindicated in children under 2 years of age (see section 4.3).
For patients with a reduced cough reflex (elderly and weakened patients) are advised to take the effervescent tablet in the mornings.
Dissolve NACSYS 600 mg effervescent tablets in half a glass of water. This produces a solution that may be consumed immediately.
NACSYS 600 mg effervescent tablets are contraindicated in children under 2 years of age (see section 4.3). Other forms and strengths of Acetylcysteine are more suitable for are more suitable for children >2 and adolescents.
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 any serious undesirable effects being observed.
Oral doses of up to 500 mg acetylcysteine per kg body weight are tolerated without any signs of poisoning.
Overdoses may lead to gastrointestinal effects such as nausea, vomiting and diarrhoea.
Symptomatic treatment in the event of an overdose.
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.
Store in the original package to protect against moisture.
For storage conditions after first opening of the medicinal product, see section 6.3.
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 cap and a desiccant.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
