ATROVENT UDVS 1ML

Active substance: IPRATROPIUM BROMIDE MONOHYDRATE

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Atrovent®
250 UDVs®, 1 ml

ABCD

(
­ ipratropium bromide)

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 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.

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

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.

When children are using this medicine they
must be supervised by a responsible adult.

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.

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 swallow or give this medicine by
injection.

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.

65NOT1014/B

Package leaflet: Information for the user

2. • 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
3. • Twist off the top
• Always hold it upright
while you do this
4. • 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

Other side effects include:

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.

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

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.

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

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.

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.

65NOT1014/B

1. ­­
Get your nebuliser ready by following
the manufacturer’s instructions. Ask your
doctor if you are not sure how to use it.

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.

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 and 60
single dose units.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation for ATROVENT
250 UDVs, 1 ml is held by:
Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell, Berks.,
RG12 8YS, United Kingdom.
ATROVENT 250 UDVs, 1 ml are manufactured
by:
Laboratoire Unither
Zl de Longpré,
10 rue Andre Durouchez
80084 Amiens Cedex 2
France
This leaflet was revised in October 2010.
© Boehringer Ingelheim Ltd 2010

Store below 25°C.
Keep vials in the outer carton in order to
protect from light.
Keep out of the sight and reach of children.

20100518

How to use your nebuliser
Read through numbers 1 to 6 first, before
starting to use your nebuliser.

Expand view ⇕

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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