PACKAGE LEAFLET: INFORMATION FOR THE USER

Ipratropium Bromide Inhalation Solution

(Ipratropium Bromide 250mcg/1ml and 500mcg/2ml)

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 serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ipratropium Bromide Inhalation Solution is and what it is used for

2.    Before you use Ipratropium Bromide Inhalation Solution

3.    How to use Ipratropium Bromide Inhalation Solution

4.    Possible side effects

5.    How to store Ipratropium Bromide Inhalation Solution

6.    Further information

1. WHAT IPRATROPIUM BROMIDE INHALATION SOLUTION IS AND WHAT IT IS USED FOR

The active substance in Ipratropium Bromide Inhalation Solution is called ipratropium bromide. Ipratropium bromide belongs to a group of medicines known as bronchodilators. It is used to treat breathing difficulties associated with wheezing, chest tightness or shortness of breath. It works by opening up the air passages in your lungs so that you can breathe more easily.

2. BEFORE YOU USE IPRATROPIUM BROMIDE INHALATION SOLUTION Do not use Ipratropium Bromide Inhalation Solution

-    if you are allergic (hypersensitive) to ipratropium bromide, atropine or any of the other ingredients of Ipratropium Bromide Inhalation Solution

Talk to your doctor before using this product if this applies to you.

Take special care with Ipratropium Bromide Inhalation Solution

-    if you are pregnant

-    if there is a chance you might become pregnant

-    if you are breast-feeding

-    if you are already taking another type of medicine by nebuliser

-    if you suffer from an eye disorder called glaucoma

-    if you suffer from an enlarged prostate

If any of the above apply to you, it is important that you tell your doctor or pharmacist before using Ipratropium Bromide Inhalation Solution and they will decide what to do. It may still be safe for you to use Ipratropium Bromide Inhalation Solution.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Ipratropium Bromide Inhalation Solution with food and drink

Food and drink have no known influence.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before using Ipratropium Bromide Inhalation Solution, or any other medicine, during pregnancy or while breast-feeding.

Driving and using machines

Ipratropium Bromide Inhalation Solution may cause dizziness and blurred vision. Do not drive or use machines until you know how it affects you.

3. HOW TO USE IPRATROPIUM BROMIDE INHALATION SOLUTION

Always use Ipratropium Bromide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

First use of Ipratropium Bromide

The first time you use Ipratropium Bromide should be under close medical supervision.

The usual dose for adults and the elderly is 0.4-2.0ml up to 4 times daily. For children aged 314 years the usual dose is 0.4-2.0ml up to 3 times daily.

Ipratropium Bromide must only be administered by inhalation from a suitable nebuliser. (This product should not be swallowed). A nebuliser is a machine which turns the nebuliser solution into a fine spray which you can then inhale, usually through a mask.

Preparing the nebuliser and Ipratropium Bromide Inhalation Solution:

1.    Ensure that you are fully familiar with the operation of your nebuliser. Your doctor will instruct you in how to correctly use the nebuliser and Ipratropium Bromide Inhalation Solution. You should also carefully read the instructions provided with the nebuliser.

2.    Prepare the nebuliser for use.

3.    Separate a Steripoule from the strip by carefully pulling and twisting (Figure 1). Never use one that is already open.

4.    Hold the Steripoule upright and twist off the tab (Figure 2). Use the contents of the Steripoule immediately after opening.

5.    Squeeze the appropriate amount of the Steripoule contents (usually all contents) into the nebuliser reservoir (Figure 3). If dilution is necessary, this should be carried out using only sterile normal saline solution as instructed by your doctor.

6.    Assemble the nebuliser and use it as instructed by your doctor. Care should be taken to ensure that the nebuliser mist (or the solution) does not enter your eyes. Eye protection is recommended for people with a history of glaucoma.

7.    After nebulisation throw away any remaining solution and clean the nebuliser as instructed.

If your treatment is less effective than usual

If your treatment is less effective than usual or the effect does not last as long as usual, do not attempt to exceed your prescribed dose. You should contact your doctor immediately to discuss the situation.

If you use more Ipratropium Bromide Inhalation Solution than you should

If you have taken a slightly larger dose than recommended, you may develop an increased heart rate and feel palpitations (your heart beat). This usually wears off after a few hours. However, if you have taken a much larger dose than normal, you should contact either your doctor or your nearest casualty department immediately for further advice. Take this leaflet and any remaining medicine with you.

If you forget to use Ipratropium Bromide Inhalation Solution

If you forget an inhalation, take it when you remember. Do not take a double dose to make up for a forgotten dose.

The next dose following this should be after your normal interval between doses (normally 6 hours).

If you stop using Ipratropium Bromide Inhalation Solution

Your doctor will advise you when to stop using Ipratropium Bromide Inhalation Solution.

Follow your doctor’s instructions.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ipratropium Bromide Inhalation Solution can cause side effects, although not

everybody gets them.

There are rare, serious side effects and if you experience these you must stop using Ipratropium

Bromide Inhalation Solution immediately and contact your doctor. If you notice any of the

following side effects you may need urgent medical treatment.

-    You have difficulty breathing or become wheezy

-    Allergic reactions- signs may include skin rash, itching and nettle rash. In severe cases the lips, mouth, face and tongue can swell along with sudden breathing difficulty and reduced blood pressure. Tightening of your throat.

-    Palpitations (conscious awareness of your heartbeat), quickening of the heart rate or irregular heart rhythm.

-    Increased heart rate

Stop using this medicine and see your doctor immediately if you have any of the above side effects.

Other side effects include:

Common (affects less than 1 in 10 people)

-    Headache, dizziness

-    Unexpected tightness of the chest, cough and local irritation when you have just used Ipratropium Bromide Inhalation Solution

-    Dry mouth, diarrhoea, constipation, feeling or being sick

Uncommon (affects less than 1 in 100 people)

-    Skin rash, itching of skin, nettle rash (urticaria)

-    Blurred vision or difficulty focusing

-    Increased pressure in your eyes (glaucoma)

Rare (affects less than 1 in 1000 people)

-    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, blurred vision or dilated pupils. You may also see colours or lights. If this happens or you experience any of these side effects, talk to your doctor for advice. If affected do not drive or use any tools or machinery. If you get any problems with your eyes at any other time, talk to your doctor for advice.

If any of the side effects above gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE IPRATROPIUM BROMIDE INHALATION SOLUTION

Keep out of the reach and sight of children.

Do not use Ipratropium Bromide Inhalation Solution after the expiry date, which is stated on the carton, foil bag and plastic ampoules. The expiry date refers to the last day of that month.

Store the product below 25^oC. Keep the Steripoules in the foil bag within the carton in order to protect the product from light and moisture.

Do not use Ipratropium Bromide Inhalation Solution if you notice that the packaging or any of the plastic ampoules are damaged, or if the solution in the plastic ampoules is no longer clear and colourless.

Do not keep or use a Steripoule which has been opened previously - throw it away.

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

What Ipratropium Bromide Inhalation Solution contains

The active substance is called ipratropium bromide. Each Steripoule contains either 250 micrograms of ipratropium bromide in 1ml (250mcg/1ml) or 500 micrograms of ipratropium bromide in 2ml (500mcg/2ml).

The other ingredients in the Steripoules are: dilute sulphuric acid, sodium hydroxide solution, sodium chloride and water for injections.

What Ipratropium Bromide Inhalation Solution looks like and the contents of the pack Each carton of Ipratropium Bromide contains either 20 or 60 plastic ampoules (Steripoules) packed in strips of 10 Steripoules. Each strip is individually wrapped in a foil bag. Each Steripoule contains 1ml or 2ml of a clear, colourless solution for use only through a nebuliser.

Marketing Authorisation Holder

Focus Pharmaceuticals Ltd Unit 5, Faraday Court First Avenue, Centrum 100 Burton upon Trent Staffordshire DE14 2WX, UK

Manufacturer

Almac Pharma Services Limited

Almac House

20 Seagoe Industrial Estate

Craigavon

BT63 5QD

UK

This leaflet was last revised in April 2011.