Atrovent 250micrograms/1ml nebuliser liquid UDVs

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ipratropium bromide

Available from:

Boehringer Ingelheim Ltd

ATC code:

R03BB01

INN (International Name):

Ipratropium bromide

Dosage:

250microgram/1ml

Pharmaceutical form:

Nebuliser liquid

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010200; GTIN: 5012816012202 5012816012103

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, 1 ml
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, 1 ml (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 anticholinergics which act
as 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 your m

Summary of Product characteristics

OBJECT 1
ATROVENT 250 UDVS, 1 ML
Summary of Product Characteristics Updated 01-Mar-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Atrovent
®
250 UDVs
®
, 1 ml
Atrovent
®
UDVs
®
, 2 ml
2. Qualitative and quantitative composition
Each single dose unit contains 0.025 % w/v ipratropium bromide i.e.
250 micrograms in 1 ml and 500
micrograms in 2 ml.
For excipients, see 6.1.
3. Pharmaceutical form
Nebuliser solution.
4. Clinical particulars
4.1 Therapeutic indications
ATROVENT UDVs are indicated for treatment of reversible bronchospasm
associated with chronic
obstructive pulmonary disease (COPD).
ATROVENT UDVs are indicated, when used concomitantly with inhaled beta
2
-agonists, for treatment of
reversible airways obstruction as in acute and chronic asthma.
4.2 Posology and method of administration
The dosage should be adapted to the individual needs of the patient.
In children aged 12 years and under,
only ATROVENT 250 UDVs, 1 ml should be used. The following doses are
recommended:
Adults (including the elderly) and adolescents > 12 years of age:
250 - 500 micrograms (i.e. one vial of 250 micrograms in 1 ml or 1
vial of 500 micrograms in 2 ml) 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 6 - 12 years of age:
250 micrograms (i.e. one vial of 250 micrograms in 1ml) up to a total
daily dose of 1mg (4 vials).
The time interval between doses may be determined by the physician.
Children 0 – 5 years of age (for treatment of acute asthma only):
125 – 250 micrograms (i.e. half to one vial of 250 micrograms in 1
ml) up to a total daily dose of 1 mg (4
vials).
Ipratropium bromide should be administered no more f