PACKAGE LEAFLET: INFORMATION FOR THE USER

Salipraneb 0.5mg / 2.5mg per 2.5ml Nebuliser Solution

(Ipratropium bromide/Salbutamol)

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

In this leaflet:

1.    What Salipraneb Nebuliser Solution is and what it is used for

2.    Before you use Salipraneb Nebuliser Solution

3.    How to use Salipraneb Nebuliser Solution

4.    Possible side effects

5.    How to store Salipraneb Nebuliser Solution

6.    Further information

1. WHAT SALIPRANEB NEBULISER SOLUTION IS AND WHAT IT IS USED FOR

Salipraneb Nebuliser Solution belongs to a group of medicines called "bronchodilators” which help to open up the air passages in your lungs so that you can breathe more easily.

Salipraneb Nebuliser Solution helps to make breathing easier in patients who have long-standing breathing difficulties.

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

Pregnancy and breast-feeding

If you are pregnant, think you are pregnant or are breast-feeding you should not use Salipraneb Nebuliser Solution unless your doctor tells you to. If you become pregnant whilst taking this medicine you should tell your doctor as soon as possible.

Driving and using machines

Salipraneb Nebuliser Solution has no known effects on the ability to drive and use machines.

3. HOWTO USE SALIPRANEB NEBULISER SOLUTION

2. BEFORE YOU USE SALIPRANEB NEBULISER SOLUTION

Do not use Salipraneb Nebuliser Solution:

•    If you are allergic (hypersensitive) to ipratropium bromide, salbutamol sulfate, atropine or any of the other ingredients of Salipraneb Nebuliser Solution (see section 6)

•    If you have a heart condition called cardiomyopathy (this is when your heart does not work properly due to inflammation of the heart muscles)

•    If you have a fast and irregular heartbeat (known as tachyarrhythmia)

Take special care with Salipraneb Nebuliser Solution

Talk to your doctor if any of the following apply to you:

•    If you are pregnant, thinking of becoming pregnant or if you are breastfeeding

•    If you have diabetes

•    If you have a heart condition, a history of heart disease or have recently had a heart attack

•    If you have high blood pressure, an irregular heart rhythm or angina

•    If you have an overactive thyroid gland

•    If you suffer from cystic fibrosis

•    If you have a condition which makes passing urine difficult

•    If you suffer from glaucoma (excessive pressure inside your eyes) or you are at risk of suffering from it

•    If you have or have had problems with your liver or kidneys

•    If you have ever been told that you suffer from pheochromocytoma.

This is a rare tumour which produces chemicals that can cause restlessness, high blood pressure and your heart to beat faster.

Taking other medicines

Tell your doctor if you are taking any of the following medicines as they

may interact with Salipraneb:

•    Steroids including prednisolone

•    Medicines called xanthines such as theophylline

•    Medicines called beta-blockers such as propranolol or timolol, as these can reduce the effectiveness of your medicine

•    Diuretic medicines (commonly known as 'water tablets') including nonsparing potassium diuretics such as furosemide or indapamide

•    Digoxin, which is used in the treatment of heart failure

•    Other medicines which can help you breathe such as terbutaline

•    Anticholinergic medicines (which can be used to treat asthma, irritable bowel syndrome, Parkinson's disease and incontinence)

•    Certain medicines to treat depression (known as 'monoamine oxidase inhibitors' and 'tricyclic antidepressants').

Some anaesthetic gases may interact with your medicine. If you are to

undergo any surgery, you should tell the anaesthetist or doctor that you

are taking Salipraneb Nebuliser Solution.

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

Your doctor will probably tell you to use your nebuliser at regular times each day and you should always follow your doctor's instructions.

The usual dose for adults (including the elderly) and adolescents over 12 years of age is the contents of one ampoule which should be taken three or four times a day.

Salipraneb Nebuliser Solution is not to be used in children under 12 years of age.

General Instructions:

Open each foil sachet one at a time and use all the ampoules inside before opening the next foil sachet. Always return any remaining ampoules to the foil sachet and place the sachet back in the carton after use. Since the ampoules do not contain a preservative, it is important to use them as soon as they are opened.

Instructions for use:

1.    Prepare your nebuliser following the manufacturer's instructions and/or the dosing instructions given by your doctor

2.    Take a strip of ampoules from the foil sachet. Remove one ampoule and put the rest back in the foil sachet and replace the foil sachet in the carton (see diagram 1). Never use an ampoule that has been opened already or if the solution is discoloured

3.    Hold the ampoule upright and open it by twisting off the top (see diagram 2)

4.    Unless otherwise instructed by your doctor, squeeze all of the liquid from the plastic ampoule into the nebuliser chamber

5.    Throw away the empty plastic ampoule

6.    Turn on the nebuliser and breathe in the "mist” calmly and deeply using the face mask or mouthpiece. If you are using a face mask make sure that it is fitted correctly. Protect your eyes from the mist produced as it can cause pain or discomfort if it gets into your eyes. This is especially important if you suffer from glaucoma.

7.    The length of time it takes your nebuliser to turn your medicine into a mist will depend on the type of equipment you use. You will know when your treatment is complete because the fine mist will stop coming out of your mask or mouthpiece

8.    You must wash your nebuliser, face mask and/or mouthpiece in warm soapy water and rinse well after each use.

Salipraneb Nebuliser Solution should only be used in a nebuliser approved by your doctor and should not be mixed with other medicines in the same nebuliser.

4. POSSIBLE SIDE EFFECTS

5. HOWTO STORE SALIPRANEB NEBULISER SOLUTION

6. FURTHER INFORMATION

Manufacturer:

Laboratoire Unither, Espace lndustriel Nord, 151 rue Andre Durouchez- CS 28028, 80084 AMIENS Cedex 2, France.

This leaflet was last revised in January 2016