Patient Information Leaflet

Atrovent® 250 UDVs® ,2 ml

(ipratropium bromide)

What You Should Know About Your Medicine

Please read this leaflet carefully before you start to take your medicine. It contains a summary of the information available on your medicine. The information in this leaflet applies to ATROVENT 250 UDVs, 2 ml only. If after reading this you have any questions, ask your doctor, pharmacist or practice nurse.

The name of your medicine is ATROVENT 250 UDVs, 2 ml. ATROVENT 250 UDVs, 2 ml contains a solution for nebulisation. Each single dose unit contains 250 micrograms of the active ingredient ipratropium bromide as ipratropium bromide monohydrate in 2 ml of solution. The solution also contains sodium chloride, purified water and hydrochloric acid.

Ipratropium bromide belongs to a group of medicines called bronchodilators which help to improve your breathing by opening up your airways.

ATROVENT 250 UDVs, 2 ml are available in cartons containing 20 and 60 single dose units.

The Product Licence for ATROVENT 250 UDVs, 2 ml is held by: Boehringer Ingelheim Limited,

Ellesfield Avenue,

Bracknell, Berkshire,

RG12 8YS, United Kingdom.

PACKAGING COPY PRODUCT: Atrovent 250 UDVs, 2 ml

ATROVENT 250 UDVs, 2ml are manufactured by

Laboratoire Unither,

Espace Industriel Nord,

151 rue de Andre Durouchez — CS 28028

80084 Amiens Cedex 2

France.

How Your Medicine Helps You

ATROVENT 250 UDVs, 2 ml help patients who have breathing difficulties, such as asthma or chronic obstructive pulmonary disease, to breathe more easily.

ATROVENT 250 UDVs, 2 ml can be taken at the same time as beta₂-agonist bronchodilators, for example salbutamol.

Before Using Your Medicine

Tell your doctor or pharmacist if:

•    You are pregnant, planning to become pregnant or if you are breast feeding

•    You are allergic to the active ingredient ipratropium bromide or similar drugs, e.g. atropine, or any other ingredient in this product

•    You suffer from glaucoma or you have been told that you are likely to develop glaucoma

•    You suffer from cystic fibrosis

•    You are a man who suffers from prostate problems

•    You have difficulty passing urine

■ You are taking any other medicines, particularly beta-adrenergics (e.g. salbutamol) or xanthine preparations (e.g. theophylline, aminophylline)

If in doubt, ask your doctor or pharmacist.

PRODUCT: Atrovent 250 UDVs, 2 ml

How To Use Your Medicine

Follow your doctor's instructions about when and how to use your medicine and always read the label.

The usual recommended dose is as follows:

Children 6-12 years:    250 micrograms (1 vial) up to a total daily dose of 1 mg. The time

between doses should be decided by your doctor.

Children 0-5 years    125 - 250 micrograms (1/2 to 1 vial) up to a total daily dose of 1

for treatment of acute    mg. The time between doses should not be less than 6 hours.

asthma only:

Use in children should be supervised by a responsible adult.

ATROVENT 250 UDVs, 2 ml should only be used in a nebuliser approved by your doctor and

should not be swallowed or injected.

Do not use your nebuliser to take ATROVENT 250 UDVs, 2 ml and disodium cromoglycate

inhalation solution at the same time.

1.    Get your nebuliser ready by following the manufacturer's instructions and the advice of your doctor.

2.    Carefully separate a new dose unit from the strip. Never use one which has been opened already. (picture 1)

3.    Open by simply twisting off the top, always taking care to hold it in an upright position. (picture 2)

4.    Unless otherwise instructed by your doctor, squeeze all the contents into the nebuliser chamber. If you have also been prescribed a short-acting beta2-agonist nebuliser solution, the solutions can be combined in the same nebuliser chamber. If dilution is necessary this should be carried out using only sterile sodium chloride 0.9% solution and as instructed by your doctor. (picture 3)

5.    Use your nebuliser as directed by your doctor.

6.    After you have finished, throw away any leftover solution or partially used vials. Follow the manufacturer's instructions for cleaning your nebuliser. It is important that your nebuliser is kept clean.

Do not let the mist from the nebuliser get into your eyes, as it may cause harm. Use a mouthpiece or

a tight fitting face mask.

Do not use more than the doctor has prescribed.

In the event of overdosage consult a doctor immediately.

If you forget a dose do not worry, inhale a dose when you remember but if it is near to the time for the next dose, wait until this is due. Do not take a double dose. Then go on as before.

If you feel at any time that your medicine is not working as well as it should, or you need to use your nebuliser more often than your doctor has recommended, then you should call your doctor and explain the situation.

PRODUCT: Atrovent 250 UDVs, 2 ml

If after inhaling ATROVENT you feel more wheezy or experience any other difficulties in breathing, do not take any more doses (unless you have been instructed to), and consult your doctor immediately

After Using Your Medicine

All medicines can sometimes cause side-effects. The side effects described below have been experienced by people taking ATROVENT and they are listed as either common, uncommon or rare.

Common side effects - experienced by between 1 in 10 and 1 in 100 people

•    Headache, dizziness

•    Dry mouth, nausea (feeling sick), stomach upset or discomfort

•    Cough and local irritation immediately after inhaling ATROVENT.

Uncommon side effects - experienced by between 1 in 100 and 1 in 1000 people

•    Allergic reactions such as swelling of the mouth and face, sudden difficulties in breathing and reduction of the blood pressure. Tightening of the throat

•    Unexpected tightness of the chest, swelling of the throat, dry throat

•    If any of the solution or mist accidentally gets into the eye, eye problems such as increased pressure in the eye, blurred vision, stinging, dilated pupils, painful, stinging, red or swelling of the eyes, see colours or lights

•    Itching, skin rash

•    Palpitations or quickening of the heart rate

•    Difficulty in passing urine (especially if you already have problems passing urine)

•    Glaucoma

•    Mouth or lip sores

•    Diarrhoea, constipation or being sick

Rare side effects - experienced by between 1 in 1000 and 1 in 10000 people

•    Urticaria (nettle rash)

•    Difficulty focusing.

•    Increased heart rate or irregular heart rhythm e.g. atrial fibrillation.

If you experience any problems with your eyes contact your doctor immediately. If affected by dizziness, or have difficulty in focusing, or blurred vision while taking ATROVENT do not drive or operate machinery.

If you have a severe allergic reaction, do not take any further doses of ATROVENT and contact your doctor immediately.

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.

PRODUCT: Atrovent 250 UDVs, 2 ml

How To Store Your Medicine

Do not use this medicine after the expiry date which is printed on the packaging.

Do not store your medicine above 25°C. Keep vials in the outer carton in order to protect from light. Keep out of the sight and reach of children.

This leaflet was revised in June 2014.

Remember this medicine is for you. Only a doctor can prescribe it for you. Never give it to others as it may harm them even if their symptoms are the same as yours.

^@Boehringer Ingelheim Limited 2014