Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Ipratropium bromide monohydrate; SALBUTAMOL SULFATE
Neutec Inhaler Ireland Limited
R03AL02
Ipratropium bromide monohydrate; SALBUTAMOL SULFATE
Nebuliser solution
salbutamol and ipratropium bromide
Not marketed
2023-09-30
1 PACKAGE LEAFLET: INFORMATION FOR THE USER IPRATROPIUM BROMIDE/SALBUTAMOL NEUTEC 0.5 MG/2.5 MG PER 2.5 ML NEBULISER SOLUTION ipratropium bromide/salbutamol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ipratropium bromide/salbutamol Neutec is and what it is used for 2. What you need to know before you use Ipratropium bromide/salbutamol Neutec 3. How to use Ipratropium bromide/salbutamol Neutec 4. Possible side effects 5. How to store Ipratropium bromide/salbutamol Neutec 6. Contents of the pack and other information 1. WHAT IPRATROPIUM BROMIDE/SALBUTAMOL NEUTEC IS AND WHAT IT IS USED FOR Ipratropium bromide/salbutamol Neutec contains the active substances ipratropium bromide and salbutamol. Both belong to a group of medicines called bronchodilators, which help to improve your breathing by opening up your airways. This is achieved by preventing the contraction of the smooth muscles surrounding the airways, therefore allowing the airways to remain open. Ipratropium bromide/salbutamol Neutec is used in adults, and adolescents aged 12 years and above to treat long-term breathing problems in an illness called ‘chronic obstructive pulmonary disease’ or COPD. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE IPRATROPIUM BROMIDE/SALBUTAMOL NEUTEC DO NOT USE IPRATROPIUM BROMIDE/SALBUTAMOL NEUTEC, IF YOU: • are allergic to salbutamol, ipratropium bromide, atropine (including medicines similar to atropine) or any of the other ingredients of this medicine (listed in section 6). • have a heart Read the complete document
Health Products Regulatory Authority 02 October 2023 CRN00C287 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ipratropium bromide/salbutamol Neutec 0.5/2.5 mg per 2.5 ml nebuliser solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2.5 mL single-dose container contains 0.5 mg ipratropium bromide (as ipratropium bromide monohydrate) and 2.5 mg salbutamol (as salbutamol sulphate), which is equivalent to 0.2 mg ipratropium bromide and 1 mg of salbutamol per 1 mL. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. A clear, colourless or almost colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ipratropium bromide/salbutamol Neutec is indicated for the symptomatic treatment of bronchospasm in adults and adolescents over 12 years of age with chronic obstructive pulmonary disease who require treatment with both ipratropium bromide and salbutamol. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose for adults (including elderly patients) and adolescents over 12 years: 1 single-dose container inhaled via nebuliser three or four times daily. _Special patient groups_ _Patients with hepatic or renal impairment_ Ipratropium bromide/salbutamol has not been studied in patients with hepatic or renal insufficiency and must therefore be administered with caution in these patient groups. _Paediatric population_ The safety and efficacy of ipratropium bromide/salbutamol in children under 12 years of age has not been established, therefore Ipratropium bromide/salbutamol Neutec is not intended for use in this group of patients. _ _ If higher doses than those recommended are required to achieve a good effect, the patient's overall treatment must be reviewed by a doctor. _ _ Method of administration Inhalation use. The use of Ipratropium bromide/salbutamol Neutec follows five simple steps, which are outlined below: 1. The nebuliser is prepared for use according to the manufacturer's instructions. 2. The pouch is opened a Read the complete document