Country: Israel
Language: English
Source: Ministry of Health
IPRATROPIUM BROMIDE
BOEHRINGER INGELHEIM ISRAEL LTD.
R03BB01
INHALER
IPRATROPIUM BROMIDE 0.02 MG
INHALATION
Required
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE
For the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema.
2024-01-31
Atrovent Proposed patient information Metered dose inhaler November 2020 Boehringer Ingelheim Israel 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only ATROVENT ® INHALER EACH PUFF RELEASES: 0.02 MILLIGRAM IPRATROPIUM BROMIDE Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Relieving symptoms of reversible bronchospam in cases of asthma, chronic bronchitis, and emphysema. THERAPEUTIC GROUP: anticholinergic. ATROVENT is an inhaler that dilates the airways in cases of bronchospasm (constriction of the bronchial walls), so that you can breathe freely more easily. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient ipratropium bromide, to atropine or atropine derivatives (anticholinergic substances with similar structure) or to any of the other ingredients in this medicine (listed in section 6). • You are pregnant (particularly during the first three months) or are breastfeeding, unless your doctor has recommended this treatment after weighing the risks and benefit. SPECIAL WARNINGS ABOUT USING THIS MEDICINE • Talk to your doctor or pharmacist before using this medicine. • Make sure that the solution or medicine mist does not get in your eyes. • Use ATROVENT with caution if you have a tendency to narrow-angle glaucoma. If the medicine accidentally gets in your eyes during use, mild and reversible eye complications may occu Read the complete document
Atrovent Proposed prescribing information Boehringer Ingelheim November 2020 Boehringer Ingelheim Israel 2 ATROVENT IPRATROPIUM BROMIDE 0.02 MG Metered Dose Inhaler 1. NAME OF THE MEDICINAL PRODUCT Atrovent ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each actuation delivers 0.02 mg Ipratropium bromide. Excipient with known effect: Ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Metered dose inhaler 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Atrovent is indicated for the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be adapted to the individual requirements of the patient; patients should also be kept under medical supervision during treatment. It is advisable not to greatly exceed the recommended daily dose during both acute and maintenance treatment. If therapy does not produce a significant improvement or if the patient's condition worsens, medical advice must be sought in order to determine a new regimen of therapy. In the case of acute or rapidly worsening dyspnea, a doctor should be consulted immediately. The recommended dosage is as follows: _Adults _ Usually 1 or 2 puffs four times daily, although some patients may need up to 4 puffs at a time to obtain maximum benefit during early treatment. However, the total number of inhalations should not exceed 12 in 24 hours. _Children _ 6-12 years: Usually 1 or 2 puffs three times daily. In order to ensure that the inhaler is used correctly, administration should be supervised by an adult. The dose recommendations are the same for children < 6 years of age. As there is insufficient ex- perience in this age group, inhalation of the product should be medically supervised. Atrovent Proposed prescribing information Boehringer Ingelheim November 2020 Boehringer Ingelheim Israel 2 4.3 CONTRAINDICATIONS Atrovent is contraindicated in patients with hypersensitivity to the active substance, to atropine o Read the complete document