Atrovent 250 UDVs 250 micrograms/ 1ml Nebuliser Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ipratropium bromide

Available from:

Boehringer Ingelheim Limited

ATC code:

R03BB; R03BB01

INN (International Name):

Ipratropium bromide

Dosage:

250 microgram(s)/millilitre

Pharmaceutical form:

Nebuliser solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Anticholinergics; ipratropium bromide

Authorization status:

Marketed

Authorization date:

1996-06-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
USING THIS MEDICINE
• 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 250 UDVs, 1 ml are and
what they are used for
2. Before you use ATROVENT 250 UDVs, 1ml
3. How to use ATROVENT 250 UDVs, 1 ml
4. Possible side effects
5. How to store ATROVENT 250 UDVs, 1 ml
6. Further information
1. WHAT ATROVENT 250 UDVS, 1 ML ARE AND WHAT THEY ARE USED FOR
The name of your medicine is ATROVENT 250
UDVs, 250 micrograms/1 ml Nebuliser Solution
(called ATROVENT in the rest of this leaflet). You
use it with a device called a ‘nebuliser’. This
changes your medicine into a mist for you to
breathe in.
ATROVENT 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 can be taken at the same
time as medicines called ‘beta
2
-agonist
bronchodilators’ such as salbutamol.
ATROVENT works by opening up your airways.
2. BEFORE YOU USE ATROVENT 250 UDVS, 1 ML
DO NOT USE ATROVENT IF:
• You are allergic (hypersensitive) to ipratropium
bromide or any of the other ingredients in
ATROVENT (listed in Section 6 below)
• You are allergic (hypersensitive) to medicines
that are similar to ATROVENT, such as
atropine
Do not use this medicine 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 you

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atrovent 250 UDVs 250 micrograms/ 1ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose unit contains 250 micrograms ipratropium bromide (as
ipratropium bromide monohydrate) in 1 ml of
solution (0.025% w/v)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser Solution (nebuliser liquid)
A clear, colourless aqueous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Atrovent 250 UDVs, 1ml are indicated for maintenance treatment of
bronchospasm associated with chronic obstructive
pulmonary disease and, when used concomitantly with inhaled beta
2
-agonists, for treatment of acute and chronic
asthma and acute bronchospasm associated with chronic obstructive
pulmonary disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage should be adapted to the individual needs of the patient.
The following doses are recommended:
Adults (including the elderly) and adolescents > 12 years of age:
500 micrograms 3 to 4 times daily.
For treatment of acute bronchospasm, 500 micrograms.
Repeated doses can be administered until the patient is stable.
The time interval between the doses may be determined
by the physician.
It is advisable not to exceed the recommended daily dose during either
acute or maintenance treatment.
Daily doses
exceeding 2 mg in adults and adolescents > 12 years of age should only
be given under medical supervision.
Children < 12 years of age:
250 micrograms up to a total daily dose of 1mg.
The time interval between doses may be determined by the physician.
For acute bronchospasm, repeated doses may be administered until the
patient is stable.
The time interval between
doses may be determined by the physician.
It is advisable not to exceed the recommended daily dose.
Daily doses exceeding 1mg in this age group should be
given under medical supervision.
There is limited information for children < 6 years of age, therefore
the recommended dose should only be given under
medical supe