Atrovent Inhaler CFC-Free 20 micrograms per metered dose pressurised inhalation solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ipratropium bromide

Available from:

Boehringer Ingelheim International GmbH

ATC code:

R03BB; R03BB01

INN (International Name):

Ipratropium bromide

Dosage:

20 microgram(s)/dose

Pharmaceutical form:

Pressurised inhalation, solution

Therapeutic area:

Anticholinergics; ipratropium bromide

Authorization status:

Marketed

Authorization date:

2004-05-14

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
13 April 2021
CRN00C945
Page 1 of 7
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).
Excipient(s) with known effect
This medicine contains about 8 mg of alcohol (ethanol) in each
actuation.
For the 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