देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
Acetylcysteine
Alpex Pharma (Irl) Limited
R05CB; R05CB01
Acetylcysteine
600 milligram(s)
Effervescent tablet
Product subject to prescription which may not be renewed (A)
Mucolytics; acetylcysteine
Not marketed
2017-06-02
PACKAGE LEAFLET: INFORMATION FOR THE USER NACSYS 600 MG EFFERVESCENT TABLETS. acetylcysteine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What NACSYS 600 mg effervescent tablets are_ _and what they are_ _used for 2. What you need to know before you take_ _NACSYS 600 mg effervescent tablets 3. How to take_ _NACSYS 600 mg effervescent tablets 4. Possible side effects 5. How to store NACSYS 600 mg effervescent tablets 6. Other information 1. WHAT NACSYS 600 MG EFFERVESCENT TABLETS ARE_ _AND WHAT THEY ARE_ _ USED FOR Acetylcysteine breaks down and loosens thick phlegm, making it runny and easy to cough up. Acetylcysteine is used in the treatment of airway diseases such as bronchitis (inflammation of the mucous membranes in the airways), emphysema, mucoviscidosis (cystic fibrosis) and bronchiectasis (chronic widening of an airway passage). NACSYS 600 mg Effervescent tablets are only_ _indicated for adults. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ _NACSYS 600 MG EFFERVESCENT TABLETS DO NOT TAKE_ _NACSYS 600 MG EFFERVESCENT TABLETS If you are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6). Children under 2 years of age must_ _not take_ _this medicine. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking NACSYS 600 mg effervescent tablets: Acetylcysteine can cause shortness of breath due to muscle cramping of the airways (bronchospasms) especially in patients with asthma. If this occurs, immediately stop the treatment and c पूरा दस्तावेज़ पढ़ें
Health Products Regulatory Authority 06 September 2023 CRN00DT7Q Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 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, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablet. Round, flat, white to yellowish effervescent tablet (1500 mg/tablet; ~ 17 x 4.25mm). 4 CLINICAL PARTICULARS 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 _ONLY_. 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 and older and adolescents. Children under 2 years of age: The use of NACSYS 600 mg effervescent tablets is contraindicated in children under 2 years of age (see section 4.3). Method of administration _ _ _Precautions to be taken before handling or administering the medicinal product._ 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. 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. Health Products Re पूरा दस्तावेज़ पढ़ें