Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IPRATROPIUM BROMIDE
Boehringer Ingelheim Limited
R03BB01
IPRATROPIUM BROMIDE
20 Mcg/Dose
Pressurised Inhalation Soln
Product subject to prescription which may be renewed (B)
ipratropium bromide
Marketed
2004-05-14
PACKAGE LEAFLET: INFORMATION FOR THE USER ATROVENT ® INHALER CFC-FREE 20 MICROGRAMS PER METERED DOSE PRESSURISED INHALATION, SOLUTION (ipratropium bromide) • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets troublesome or serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What ATROVENT Inhaler CFC-FREE is and what it is used for 2. Before you use ATROVENT Inhaler CFC-FREE 3. How to use ATROVENT Inhaler CFC-FREE 4. Possible side effects 5. How to store ATROVENT Inhaler CFC-FREE 6. Further information 1. WHAT ATROVENT INHALER CFC-FREE IS AND WHAT IT IS USED FOR The name of your medicine is ATROVENT Inhaler CFC-FREE. This is an inhaler and contains a medicine called ipratropium bromide. This belongs to a group of medicines called bronchodilators. It is used to make breathing easier for people who have breathing difficulties, such as in chronic asthma or chronic obstructive pulmonary disease (COPD). ATROVENT works by opening up your airways. 2. BEFORE YOU USE ATROVENT INHALER CFC-FREE DO NOT USE ATROVENT IF: • You are allergic (hypersensitive) to ipratropium or any of the other ingredients in ATROVENT. (Listed in section 6: Further information) • You are allergic to similar medicines which contain atropine or medicines like atropine Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using ATROVENT. TAKE SPECIAL CARE WITH ATROVENT Check with your doctor or pharmacist before using this medicine if: • You are pregnant, likely to get pregnant or are breast- feeding • You have glaucoma, or have been told that you may develop it • You have problems passing water (urine) • You are a man who has prostate problems • You have cystic fi Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atrovent Inhaler CFC-Free 20 micrograms per metered dose pressurised inhalation solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One metered dose (ex-valve) contains 20 micrograms ipratropium bromide (as the monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, solution. A clear, colourless liquid, free from suspended particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ATROVENT Inhaler CFC-Free is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (including chronic bronchitis and emphysema) and asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including the elderly): Usually 1 or 2 puffs three or four times daily, although some patients may need up to 4 puffs at a time to obtain maximum benefit during early treatment. CHILDREN: 6-12 years: Usually 1 or 2 puffs three times daily. < 6 years: Usually 1 puff three times daily. In order to ensure that the inhaler is used correctly, administration should be supervised by an adult. The recommended dose should not be exceeded. If therapy does not produce a significant improvement or if the patient’s condition gets worse, medical advice must be sought. The patient should be instructed that in the case of acute or rapidly worsening dyspnoea a physician should be consulted immediately. ADMINISTRATION The canister should be pressed twice to release two metered doses into the air before the inhaler is used for the first time, or when the inhaler has not been used for 3 days or more, to ensure that the inhaler is working properly and that it is ready for use. Before each occasion on which the inhaler is used the following should be observed: 1. Remove the dustcap from the mouthpiece. 2. Holding the inhaler upright, breathe out gently and then immediately… 3. …place the mouthpiece in the mouth and close the lips around it. After starting to breathe in slowl Read the complete document