Atrovent 500 UDVs, 500 mcg/2ml Nebuliser Solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

IPRATROPIUM BROMIDE

Available from:

Boehringer Ingelheim Limited

ATC code:

R03BB01

INN (International Name):

IPRATROPIUM BROMIDE

Pharmaceutical form:

NEBULISER SOLUTION

Composition:

IPRATROPIUM BROMIDE 500 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Authorised

Authorization date:

2006-11-27

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 500 UDVs, 2 ml are and what
they are used for
2. Before you use ATROVENT 500 UDVs, 2 ml
3. How to use ATROVENT 500 UDVs, 2 ml
4. Possible side effects
5. How to store ATROVENT 500 UDVs, 2 ml
6. Further information
1. WHAT ATROVENT 500 UDVS, 2 ML ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is ATROVENT 500
UDVs, 500 micrograms/2 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 500 UDVS, 2 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 yo

Summary of Product characteristics

NAME OF THE MEDICINAL PRODUCT
Atrovent
®
500 UDVs
®
, 500 micrograms/2ml Nebuliser Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single unit dose vial contains 500 micrograms ipratropium bromide
(as ipratropium
bromide monohydrate) in 2 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 UDVs, 2ml 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 supervision.
ATROVENT UDVs can