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ATROVENT 500 MICROGRAMS/2ML UDVS

Active substance(s): IPRATROPIUM BROMIDE

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P18317

Children under 12 years

ATROVENT® 500 MICROGRAMS/2ML UDVS®
(Ipratropium bromide)

Not recommended for use.
When children are using this medicine they must be supervised by a responsible adult.
Do not swallow or give this medicine by injection.

PATIENT INFORMATION LEAFLET

Do not use your nebuliser to take Atrovent 500 UDVs and ‘disodium cromoglycate inhalation solutions’
which have the preservative ‘benzalkonium chloride’ at the same time.

Your medicine is available as Atrovent 500 micrograms/2ml UDVs, but will be referred to as Atrovent
500 UDVs throughout this leaflet.

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.

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
1.
2.
3.
4.
5.
6.
1.

How to use your nebuliser

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

this leaflet:
What Atrovent 500 UDVs are and what they are used for
Before you use Atrovent 500 UDVs
How to use Atrovent 500 UDVs
Possible side effects
How to store Atrovent 500 UDVs
Further information

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.

WHAT ATROVENT 500 UDVS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Atrovent 500 micrograms/2ml UDVS (called Atrovent 500 UDVs 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 500 UDVs contain 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 500 UDVs can be taken at the same time as medicines called ‘beta2-agonist bronchodilators’
such as salbutamol.
Atrovent 500 UDVs work by opening up your airways.

2.

BEFORE YOU USE ATROVENT 500 UDVS

Do not use Atrovent 500 UDVs if:

You are allergic (hypersensitive) to ipratropium bromide or any of the other ingredients in Atrovent
500 UDVs. (listed in Section 6 below)

You are allergic (hypersensitive) to medicines that are similar to Atrovent 500 UDVs, 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 500 UDVs.





5.

Use your nebuliser as directed by your doctor.

6.





Take special care with Atrovent 500 UDVs

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 500 UDVs.

Using other medicines

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 500 UDVs 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.

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 500
UDVs can affect the way some other medicines work. Also some other medicines can affect the way
Atrovent 500 UDVs 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 500 UDVs.

Pregnancy and breast-feeding

Talk to your doctor before using this medicine if you are pregnant, likely to get pregnant or are breastfeeding.

Driving and using machines

You may feel dizzy, or have difficulty in focusing, or blurred vision while taking Atrovent 500 UDVs. If
this happens do not drive or use any tools or machines.

3.

HOW TO USE ATROVENT 500 UDVS

Always use Atrovent 500 UDVs 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





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.

If you forget to use Atrovent 500 UDVs




4.

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.

POSSIBLE SIDE EFFECTS

Like all medicines, Atrovent 500 UDVs can cause side effects, although not everybody gets them.
Stop using Atrovent 500 UDVs 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 500 UDVs 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)




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

Page 1 of 2

Headache, dizziness
Dry mouth, feeling sick (nausea), stomach upset or discomfort
Cough and throat irritation when you have just used Atrovent 500 UDVs.

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.

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.












6.

HOW TO STORE ATROVENT 500 UDVS

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.
Protect from light.
Keep vials in the outer carton.
The solution should be used immediately after opening the vial.
Discard any unused solution.
Keep out of the sight and reach of children.
If your solution appears to be discoloured or shows any other signs of deterioration, please return
to your pharmacist who will advise you.
If your doctor tells you to stop using the solution, please take it back to the pharmacist for safe
disposal. Only keep the solution if your doctor tells you to.
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

FURTHER INFORMATION

What Atrovent 500 UDVs contain

Atrovent 500 UDVs contain a nebuliser solution.
Each single dose unit contains 500 micrograms Ipratropium bromide as Ipratropium bromide
monohydrate in 2ml of isotonic solution.
The other ingredients are: sodium chloride, hydrochloric acid and purified water.

What Atrovent 500 UDVs look like and contents of the pack

Atrovent 500 UDVs is a clear, colourless, aqueous solution in a single use polyethylene vial with a
twist-off top.
Your medicine is available in packs of 20 or 60 vials.

Manufacturer

Atrovent 500 UDVs are manufactured by: Laboratoire Unither, ZI de Longpre, 10 rue Andre Durouchez,
80084 Amiens Cedex 2, France.
OR
Laboratoire Unither, Espace Industriel Nord, 151 rue Andre Durouchez – CS 28028,
80084 Amiens Cedex 2, France.
Procured from within EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0435

POM

Leaflet issue and revision date (Ref): 07.07.15
Atrovent® and UDVs® are registered trademarks of Boehringer Ingelheim Pharma GmbH & Co., KG.
P18317

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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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