ATROVENT UDVS 2 ML

Active substance: IPRATROPIUM BROMIDE MONOHYDRATE

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Add/amend 4 - To update the quantity on the leaflet.
Package Leaflet: Information for the User
Assessed against UK PIL dated October 2010.
A Chohan. 25 February 2014
®
®

Atrovent 250 UDVs , 1ml /
Ipratopium bromide 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.
• Atrovent is available in other strengths.
In this leaflet:
1. What Atrovent 250 UDVs, 1ml are and what they are used for
2. Before you use Atrovent 250 UDVs, 1ml
3. How to use Atrovent 250 UDVs, 1ml
4. Possible side effects
5. How to store Atrovent 250 UDVs, 1ml
6. Further information
1. What Atrovent 250 UDVs, 1ml are and what they are used for
The name of your medicine is Atrovent 250 UDVs, 1ml OR Ipratopium
bromide 250 micrograms/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 ‘beta2agonist bronchodilators’ such as salbutamol.
Atrovent works by opening up your airways.

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, 1ml
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

2. Before you use Atrovent 250 UDVs, 1ml
When children are using this medicine they must be supervised by a
responsible adult.
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.

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.
• 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

• 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.
4.

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

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, 1ml
• 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 vials
should be used within three months. Any unused vials left after three
months should be discarded.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• Keep out of the sight and reach of children.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information
What Atrovent 250 UDVs, 1ml contain
Atrovent 250 UDVs, 1ml contain a nebuliser solution.
The active ingredient is ipratropium bromide.
Each single dose vial contains 250 micrograms of ipratropium bromide as
ipratropium bromide monohydrate Ph. Eur. in 1 ml of solution.
The other ingredients are:
Sodium chloride, hydrochloric acid (for pH adjustment) and purified
water.

4. Possible side effects
Like all medicines, Atrovent can cause side effects, although not
everybody gets them.

What Atrovent 250 UDVs, 1ml looks like and contents of the pack
Clear colourless nebuliser solution free of suspended particles in a clear,
colourless plastic vial with twist-off top.
Atrovent 250 UDVs, 1ml come in packs of 20 and 60 vials.

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.

Product Licence Holder
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by xxxxxxxxxxx
Manufacturer: Laboratoire Unither, ZI de Longpre, 10 rue Andre
Durouchez, 80084 Amiens Cedex 2, France
®

®

Atrovent 250 UDVs , 1ml / Ipratopium bromide 250 micrograms/1ml
Nebuliser Solution
PLPI: 33532/0391
Leaflet dated: 20 February 2014
®

Leaflet code xxxxxx

Atrovent is a trademark of
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
®
UDVs is a trademark of
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.

POM

Package Leaflet: Information for the User
®

®

Atrovent UDVs , 2ml / Ipratopium bromide 500 micrograms/2ml 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.
• Atrovent is available in other strengths.
In this leaflet:
1. What Atrovent UDVs, 2ml are and what they are used for
2. Before you use Atrovent UDVs, 2ml
3. How to use Atrovent UDVs, 2ml
4. Possible side effects
5. How to store Atrovent UDVs, 2ml
6. Further information
1. What Atrovent UDVs, 2ml are and what they are used for
The name of your medicine is Atrovent UDVs, 2ml OR Ipratopium
bromide 500 micrograms/2ml 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.

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 UDVs, 2ml
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 ½ to 1 single dose unit (250-500
micrograms), three to four times a day
• For acute attacks of breathlessness use 1 single dose unit (500
micrograms)
• If breathlessness does not go away or gets worse consult your doctor
Children under 12 years
• Not recommended for use

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).

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

Atrovent can be taken at the same time as medicines called
‘beta2-agonist bronchodilators’ such as salbutamol.

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.

Atrovent works by opening up your airways.
2. Before you use Atrovent UDVs, 2ml
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

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.
• 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

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.

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 UDVs, 2ml
• 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 vials
should be used within three months. Any unused vials left after three
months should be discarded.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• Keep out of the sight and reach of children.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information
What Atrovent UDVs, 2ml contain
Atrovent UDVs, 2ml contain a nebuliser solution.
The active ingredient is ipratropium bromide.
Each single dose vial contains 500 micrograms of ipratropium bromide as
ipratropium bromide monohydrate Ph. Eur. in 2 ml of solution.
The other ingredients are:
Sodium chloride, hydrochloric acid (for pH adjustment) and purified
water.
What Atrovent UDVs, 2ml looks like and contents of the pack
Clear colourless nebuliser solution free of suspended particles in a clear,
colourless plastic vial with twist-off top.
Atrovent UDVs, 2ml come in packs of 20 and 60 vials.
Product Licence Holder
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by xxxxxxxxxxx
Manufacturer: Laboratoire Unither, ZI de Longpre, 10 rue Andre
Durouchez, 80084 Amiens Cedex 2, France
®

®

Atrovent UDVs , 2ml / Ipratopium bromide 500 micrograms/2ml
Nebuliser Solution
PLPI: 33532/0391
Leaflet dated: 23 April 2013
®

Leaflet code xxxxxx

Atrovent is a trademark of
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.
®
UDVs is a trademark of
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.

POM

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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