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ATROVENT 250 UDVS 1ML NEBULISER SOLUTION

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Package leaflet: Information for the user

Atrovent®
250 UDVs®, 1ml Nebuliser Solution
(ipratropium bromide)
The name of your medicine is Atrovent 250 UDVs, 1ml Nebuliser solution but will be referred
to as Atrovent 250 UDVs, 1ml throughout the remainder of the leaflet.
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, 1ml
4. Possible side effects
5. How to store ATROVENT 250 UDVs, 1
ml
6. Further information
1. WHAT ATROVENT 250 UDVs, 1ml
ARE AND WHAT THEY ARE USED
FOR
You use this medicine 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 ‘beta2-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 medicine if:
 You have cystic fibrosis
 You have glaucoma or have been told
that you may develop it
 You are a man who has prostate
problems
 You have problems passing water
(urine)
 You are pregnant, likely to get pregnant
or if you are breast-feeding
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before using ATROVENT.

Using other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines
obtained without a prescription and herbal
medicines.
This is because ATROVENT can affect the
way some other medicines work. Also some
other medicines can affect the way
ATROVENT works.
In particular, tell your doctor or pharmacist if
you are taking any of the following:
 Medicines for breathing problems called
‘beta-agonists’ such as salbutamol
 Medicines for breathing problems called
‘xanthine preparations’ such as
theophylline or aminophylline
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before using ATROVENT.
Pregnancy and breast-feeding
Talk to your doctor before using this
medicine if you are pregnant, likely to get
pregnant or are breast-feeding.
Driving and using machines
You may feel dizzy, or have difficulty in
focusing, or blurred vision while taking
ATROVENT. If this happens do not drive or
use any tools or machines.
3. HOW TO USE ATROVENT 250 UDVs,
1 ml
Always use ATROVENT exactly as your
doctor has told you. You should check with
your doctor or pharmacist if you are not
sure. Follow these instructions to get the
best results. If anything is unclear after
reading this leaflet, ask your doctor or
pharmacist.
How many dose units
Adults (including the elderly) and
children over 12 years
 The usual dose is the contents of 1 to 2
single dose units (250-500 micrograms),
three to four times a day




For acute attacks of breathlessness use
2 single dose units (500 micrograms)
If breathlessness does not go away or
gets worse consult your doctor

Children 6-12 yrs
 1 single dose unit (250 micrograms) up
to a total daily dose of 4 single dose
units (1 mg)
 The time between doses should be
decided by your doctor
Children 0-5 years for treatment of acute
asthma only
 ½ to 1 single dose unit (125-250
micrograms) up to a total daily dose of 4
single dose units (1 mg)
 The time between doses should be not
be less than 6 hours
When children are using this medicine they
must be supervised by a responsible adult.
Do not swallow or give this medicine by
injection.
Do not use your nebuliser to take
ATROVENT and ‘disodium cromoglycate
inhalation solutions’ which have the
preservative ‘benzalkonium chloride’ at the
same time.
Do not use more than your doctor has
told you
See your doctor straight away if:
 You feel that your medicine is not
working as well as usual
 You need to use the nebuliser more
than your doctor has recommended
Your doctor may need to check how well
your medicine is working. In some cases
your doctor may need to change your
medicine.

How to use your nebuliser
Read through numbers 1 to 6 first, before
starting to use your nebuliser.
1. Get your nebuliser ready by following
the manufacturer’s instructions. Ask
your doctor if you are not sure how to
use it.
2. 


3. 



4. 






Open the pouch and
remove the strip of unit
dose vials. Carefully
separate a new dose unit
from the strip
Do not use it if it is already
open
Twist off the top
Always hold it upright while
you do this
Squeeze all the contents of
the dose unit into the
nebuliser chamber
Your doctor will tell you if
you need to use a different
amount
If you have also been
prescribed a medicine called
a ‘short-acting beta2-agonist
nebuliser solution’ such as
salbutamol the liquids can
be mixed in the same
nebuliser chamber
If your doctor has told you
that your medicine needs to
be diluted, you will be given
‘sterile sodium chloride
0.9%’ solution. Your doctor
will tell you how to do this

5. Use your nebuliser as directed by your
doctor.
6. 



After you have finished, dispose of
any leftover medicine carefully
Follow the manufacturer’s
instructions on how to clean your
nebuliser
It is important to keep your nebuliser
clean

Use a mouthpiece or a tight fitting mask. If
any of the liquid or mist accidentally gets
into your eyes you may get painful, stinging
or red eyes, dilated pupils, blurred vision,
see colours or lights. If this happens, talk to
your doctor for advice. If you get problems
with your eyes at any other time, talk to
your doctor for advice.
If you use more ATROVENT than you
should
If you use more of this medicine than you
should, talk to a doctor or go to a hospital
straight away. Take the medicine pack with
you.
If you forget to use ATROVENT
 If you forget a dose, use it as soon as
you remember
 However, if it is nearly time for the next
dose, skip the missed dose
 Do not use a double dose to make up
for a forgotten dose
4. POSSIBLE SIDE EFFECTS
Like all medicines, ATROVENT can cause
side effects, although not everybody gets
them.
Stop using ATROVENT and see a doctor
straight away, if you notice any of the
following serious side effects - you may
need urgent medical treatment:
 If after using ATROVENT you are
wheezy or have other difficulties in
breathing, do not use any more (unless
you have been told to by your doctor).
 Allergic reactions – the signs may
include skin rash and itching (affects
less than 1 in 100 people). In severe
cases the signs include swelling of your
mouth and face, sudden difficulties in
breathing and reduction of your blood
pressure. Tightening of your throat
(affects less than 1 in 100 people)
 Palpitations (fast or uneven heart beats)
or quickening of the heart rate (affects
less than 1 in 100 people)
 Increased heart rate or irregular heart
rhythm such as atrial fibrillation (affects
less than 1 in 1000 people)

Stop using this medicine and see your
doctor straight away if you have any of
these side effects.
Other side effects include:
Common (affects less than 1 in 10
people)
 Headache, dizziness
 Dry mouth, feeling sick (nausea),
stomach upset or discomfort
 Cough and throat irritation when you
have just used ATROVENT
Uncommon (affects less than 1 in 100
people)
 Itching, skin rash
 Unexpected tightness of the chest,
swelling of the throat, dry throat
 Blurred vision, dilated pupils, glaucoma,
painful, stinging, red or swelling of the
eyes, see colours or lights
 Diarrhoea, constipation or being sick
 Mouth or lip sores
 Problems passing water (urine),
especially if you already have problems
passing urine
Rare (affects less than 1 in 1000 people)
 Difficulty focusing
 Nettle rash (urticaria)
If any of the liquid or mist accidentally gets
into your eyes you may get painful, stinging
or red eyes, dilated pupils, blurred vision,
see colours or lights. If this happens, talk to
your doctor for advice. If affected, do not
drive or use any tools or machines. If you
get problems with your eyes at any other
time, talk to your doctor for advice.
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.
5. HOW TO STORE ATROVENT 250
UDVs, 1 ml
Do not use this medicine after the expiry
date which is stated on the carton and the

vial label. The expiry date refers to the last
day of the month.
Do not store above 25°C.
Keep vials in the outer carton in order to
protect from light.
Keep out of the sight and reach of children.
6. FURTHER INFORMATION
What ATROVENT 250 UDVs, 1 ml contain
ATROVENT 250 UDVs, 1 ml contain a
nebuliser solution. Each single dose unit
contains 250 micrograms of the active
ingredient ipratropium bromide as
Ipratropium Bromide monohydrate Ph. Eur.
in 1 ml of solution.
The other ingredients are: sodium chloride,
hydrochloric acid and purified water.
What ATROVENT 250 UDVs, 1 ml looks
like and contents of the pack
Your medicine comes with a nebuliser. This
changes ATROVENT into a mist for you to
breathe in. ATROVENT 250 UDVs, 1 ml are
available in cartons containing 20 single
dose units.
Product Licence Holder and
Manufacturer
This product is procured from within the EU
by the Product Licence Holder: IMED
Healthcare Ltd, New Road, Buncrana, Co.
Donegal, Ireland.
Atrovent UDV’s 1ml are manufactured by:
Laboratoire Unither
Zl de Longpré
10 rue Andre Durouchez
80084 Amiens Cedex 2
France
PL 40854/0034

POM

This leaflet was revised in 21/06/2013.
© Boehringer Ingelheim Ltd 2010

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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