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ATROVENT 250 UDVS 1ML

Active substance(s): IPRATROPIUM BROMIDE

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3.

ATROVENT® 250 UDVS®, 1ML
(Ipratropium bromide)
PATIENT INFORMATION LEAFLET

How many dose units
Adults (including the elderly) and children over 12 years

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
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HOW TO USE ATROVENT 250 UDVs

Always use Atrovent 250 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.





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




this leaflet:
What Atrovent 250 UDVs are and what they are used for
Before you use Atrovent 250 UDVs
How to use Atrovent 250 UDVs
Possible side effects
How to store Atrovent 250 UDVs
Further information

1 single dose unit (250 micrograms) up to a total daily dose of 4 single dose units (1mg)
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
(1mg)
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.

WHAT ATROVENT 250 UDVs ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Atrovent 250 UDVs, 1ml (called Atrovent 250 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.

Do not use your nebuliser to take Atrovent 250 UDVs and ‘disodium cromoglycate inhalation
solutions’ which have the preservative ‘benzalkonium chloride’ at the same time.

Atrovent 250 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).

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.

Atrovent 250 UDVs can be taken at the same time as medicines called ‘beta2-agonist
bronchodilators’ such as salbutamol.

How to use your nebuliser

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

Atrovent 250 UDVs work by opening up your airways.

2.

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

BEFORE YOU USE ATROVENT 250 UDVs

Do not use Atrovent 250 UDVs if:




Do not use more than your doctor has told you

You are allergic (hypersensitive) to ipratropium bromide or any of the other ingredients in
Atrovent 250 UDVs. (listed in Section 6 below)
You are allergic (hypersensitive) to medicines that are similar to Atrovent 250 UDVs, such as
atropine

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.

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 250 UDVs.

Take special care with Atrovent 250 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 250 UDVs.

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 ‘shortacting 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.

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 250 UDVs can affect the way some other medicines work. Also some other
medicines can affect the way Atrovent 250 UDVs work.
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 250 UDVs.




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 250
UDVs. If this happens do not drive or use any tools or machines.

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.

Page 1 of 2

If you use more Atrovent 250 UDVs than you should

Manufacturer

If you forget to use Atrovent 250 UDVs

Procured from within EU and repackaged by: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.

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.




4.

Atrovent 250 UDVs are manufactured by: Laboratoire Unither, ZI de Longpre,
10 rue Andre Durouchez, 80084 Amiens Cedex 2, France.

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.

Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland,
NE42 6PX.

POSSIBLE SIDE EFFECTS

PL No: 21828/0654

Like all medicines, Atrovent 250 UDVs can cause side effects, although not everybody gets
them.

Leaflet issue and revision date (Ref): 19.10.15

Stop using Atrovent 250 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 250 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)

Atrovent® and UDVs® are registered trademarks of
Boehringer Ingelheim Pharma GmbH & Co., KG.

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 250 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.

POM

HOW TO STORE ATROVENT 250 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.
Keep the vials in the outer carton to protect from light.
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 shows any 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 250 UDVs contain

Atrovent 250 UDVs contain a nebuliser solution.
Each single dose unit contains 250 micrograms ipratropium bromide (as monohydrate) in 1ml of
solution.
The other ingredients are: sodium chloride, hydrochloric acid and purified water.

What Atrovent 250 UDVs look like and contents of the pack

Atrovent 250 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.

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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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