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ATROVENT UDVS 250 MICROGRAMS/1ML NEBULISER SOLUTION

Active substance(s): IPRATROPIUM BROMIDE

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6. FURTHER INFORMATION
What Atrovent contains
Atrovent contains 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 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 are available in cartons containing 20 and
60 single dose units.
Manufacturer and Licence Holder
This medicine is manufactured by Laboratoire
Unither, Espace Industriel Nord, 151 rue Andre
Durouchez - CS 28028, 80084 Amiens Cedex 2,
France and is procured from within the EU.
Product Licence Holder LTT Pharma Limited, B98
0RE and repackaged by Lexon (UK) Limited Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 33723/0116

Atrovent is a registered trademark of Boehringer
Ingelheim Pharma GmbH & Co. KG.
Revision date: 19/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited,
Tel: 01527 505414
for help.

PATIENT INFORMATION LEAFLET

Ref: LTT116/190116/1/F

Atrovent ® UDVs
250 micrograms / 1ml Nebuliser Solution
(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.

2. BEFORE YOU USE ATROVENT

Your medicine is called Atrovent UDVs 250
micrograms / 1ml Nebuliser Solution throughout
the remainder of this leaflet it will be referred to as
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

In this leaflet:
1, What Atrovent are and what they are used for
2, Before you use Atrovent
3, How to use Atrovent
4, Possible side effects
5, How to store Atrovent
6, Further information
1. WHAT ATROVENT ARE AND WHAT THEY
ARE USED FOR
You use Atrovent 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.

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.

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

Atrovent works by opening up your airways.
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
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 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.

2.





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 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.





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

Rare (affects less than 1 in 1000 people)
• Difficulty focusing
• Nettle rash (urticaria)

4. POSSIBLE SIDE EFFECTS
1. Get your nebuliser ready by following the
manufacturer's instructions. Ask your doctor if
you are not sure how to use it.

How many dose units

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

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.





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.

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.

Diarrhoea, constipation or being sick
Mouth or lip sores
Problems passing water (urine), especially if
you already have problems passing urine

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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide
more information on the safety of this medicine.

5. HOW TO STORE ATROVENT










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.
Do not open the foil pouch and remove the vials
until you are ready to start using them. Once
the foil pouch has been opened the vial should
be used within three months. Any unused vial
left after three month should be discarded.
Keep out of the sight and reach of children.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.

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 colour
or lights
Ref: LTT116/190116/1/B

6. FURTHER INFORMATION
What Ipratropium Bromide contains
Ipratropium Bromide contains 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 Ipratropium Bromide looks like and
contents of the pack
Your medicine comes with a nebuliser. This
changes Ipratropium Bromide into a mist for you to
breathe in. Ipratropium Bromide are available in
cartons containing 20 and 60 single dose units.
This medicine is manufactured by Laboratoire
Unither, Espace Industriel Nord, 151 rue Andre
Durouchez - CS 28028, 80084 Amiens Cedex 2,
France and is procured from within the EU.
Product Licence Holder LTT Pharma Limited, B98
0RE and repackaged by Lexon (UK) Limited Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.

POM

PL 33723/0116

Revision date: 19/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone LTT Pharma Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Ref: LTT116/190116/2/F

Ipratropium Bromide
250 micrograms/1ml Nebuliser Solution
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.
Your medicine is called Ipratropium Bromide 250
micrograms / 1ml Nebuliser Solution throughout
the remainder of this leaflet it will be referred to as
Ipratropium Bromide.
In this leaflet:
1, What Ipratropium Bromide are and what they
are used for
2, Before you use Ipratropium Bromide
3, How to use Ipratropium Bromide
4, Possible side effects
5, How to store Ipratropium Bromide
6, Further information
1. WHAT IPRATROPIUM BROMIDE ARE AND
WHAT THEY ARE USED FOR
You use Ipratropium Bromide with a device called
a 'nebuliser'. This changes your medicine into a
mist for you to breathe in.
Ipratropium Bromide 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).
Ipratropium Bromide can be taken at the same
time as medicines called 'beta2-agonist
bronchodilators' such as salbutamol.
Ipratropium Bromide works by opening up your
airways.

2. BEFORE YOU USE IPRATROPIUM BROMIDE
Do not use Ipratropium Bromide if:
• You are allergic (hypersensitive) to ipratropium
bromide or any of the other ingredients in
Ipratropium Bromide (listed in Section 6 below)
• You are allergic (hypersensitive) to medicines
that are similar to Ipratropium Bromide, 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 Ipratropium Bromide.
Take special care with Ipratropium Bromide
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
Ipratropium Bromide.
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
Ipratropium Bromide can affect the way some
other medicines work. Also some other medicines
can affect the way Ipratropium Bromide 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
Ipratropium Bromide.

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 Ipratropium Bromide.
If this happens do not drive or use any tools or
machines.
3. HOW TO USE IPRATROPIUM BROMIDE
Always use Ipratropium Bromide 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 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.



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








4.



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.



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 Ipratropium
Bromide and ‘disodium cromoglycate inhalation
solutions’ which have the preservative
‘benzalkonium chloride’ at the same time.

3.

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.

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 Ipratropium Bromide 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 Ipratropium Bromide
• 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, Ipratropium Bromide can cause
side effects, although not everybody gets them.
Stop using Ipratropium Bromide 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 Ipratropium Bromide 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, 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 Ipratropium Bromide





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.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide
more information on the safety of this medicine.

5. HOW TO STORE IPRATROPIUM BROMIDE










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.
Do not open the foil pouch and remove the vials
until you are ready to start using them. Once
the foil pouch has been opened the vial should
be used within three months. Any unused vial
left after three month should be discarded.
Keep out of the sight and reach of children.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Medicines should not be disposed of via waste
water or household waste. Ask your pharmacist
how to dispose of medicines no longer required.
These measures will help to protect the
environment.

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
Ref: LTT116/190116/2/B

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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