Informations for option: Salipraneb 0.5mg / 2.5mg Per 2.5 Ml Nebuliser Solution, show other option

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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.

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 longstanding breathing difficulties.

2.    BEFORE YOU USE SALIPRANEB NEBULISER SOLUTION Do not use Salipraneb Nebuliser Solution:

-    If you are allergic (hypersensitive) to ipratropium bromide, salbutamol sulphate, 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 breast-feeding

-    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

Salipraneb UK - PL Text - V0

-    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 non-sparing 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.

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. HOW TO USE 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.

Contact your doctor immediately if:

•    You are not getting relief from your current dose

•    Your breathing is getting worse

•    Your chest feels tight

These are signs that your condition is not being controlled and you may need different or additional treatment.

If you use more Salipraneb Nebuliser Solution than you should you may flush, feel shaky, restless and/or dizzy, have chest pains and feel that your heart is beating faster than usual. Call your doctor immediately or go to the nearest hospital casualty department. If you feel shaky you should not drive. Take this leaflet or an ampoule of your medicine with you so that the hospital will know what you have taken.

If you forget to take your Salipraneb Nebuliser Solution take the next dose when it is due or before you become wheezy. Do not take a double dose to make up for the one you missed.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Salipraneb Nebuliser Solution can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Rarely, inhaled drugs such as Salipraneb Nebuliser Solution can cause acute wheezing and/or shortness of breath. If this occurs, stop using your medicine immediately and seek medical advice.

The following side effects have been reported:

Common side effects (probably affecting up to 1 in 10 people taking this medicine):

• Headaches	•	Dry mouth	•	Difficulty in speaking or hoarseness of the
				voice
• Palpitations (heart	•	Feeling sick (nausea)	•	Difficulty focussing
flutter)				your eyes
• Faster heartbeat	•	Cough
Uncommon side effects (probably affecting fewer than 1 in 100 people taking this
medicine): • Dizziness	•	Being sick (vomiting)	•	Difficulty passing
				urine
• Increases in blood	•	Trembling or shaking	•	Nervousness
pressure
Rare side effects (probably affecting fewer than 1 in every 1000 people taking this
medicine): • Sweating	•	Constipation	•	Weakness and muscle pain/cramps
• Reduction in blood	•	Allergic reactions (see	•	Restlessness
pressure and circulatory problems		above)
• Irritation of the mouth	•	Breathing difficulties	•	Memory problems
and throat		(see above)
• Anxiety and	•	Hyperactivity in	•	Eye problems
depression		children		including eye pain

and glaucoma (increased pressure in the eye).

If any of the solution or mist accidentally gets into your eyes, you may experience eye pain and/or inflammation, blurred vision and spots in front of your eyes. It is therefore important to be careful when using your medicine and to protect your eyes.

Sometimes this medicine can cause a lowering of potassium levels in the blood which can make you feel generally unwell. If you feel unwell, tell your doctor as they may wish to give you a blood test.

Although it is not known exactly how often this happens, some people may occasionally experience chest pain (due to heart problems such as angina). Tell your doctor/midwife if you develop these symptoms whilst receiving treatment with salbutamol, but do not stop using this medicine unless told to do so.

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.

5.    HOW TO STORE SALIPRANEB NEBULISER SOLUTION

Keep out of the reach and sight of children.

Do not store above 25°C. Store the ampoules in the foil sachet in their original carton in order to protect them from light. Do not freeze.

Do not use Salipraneb Nebuliser Solution after the expiry date which is stated on the carton, foil sachet or ampoule after EXP:. The expiry date refers to the last date of that month.

Do not use if the product appears to have deteriorated e.g. the pack is damaged or the solution is not clear.

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.

6.    FURTHER INFORMATION

What Salipraneb Nebuliser Solution contains:

•    The active substances are Ipratropium bromide (0.5mg/2.5ml) and Salbutamol (as sulphate) (2.5mg/2.5ml)

•    The other ingredients are sodium chloride, hydrochloric acid and water for injections.

Each 2.5ml ampoule of Salipraneb Nebuliser Solution contains 0.5mg of Ipratropium bromide and 2.5mg of Salbutamol (as sulphate)

What Salipraneb Nebuliser Solution looks like and contents of the pack

Salipraneb is a nebuliser solution.

Your medicine comes in the form of plastic ampoules containing 2.5ml of a clear colourless solution to be nebulised (made into a fine mist for inhalation). The ampoules are packed in strips inside a foil sachet which is then packed into a carton.

The cartons are available in pack sizes containing 10, 20, 40, 60, 80, 100 or 120 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder: Breath Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, U.K.

Manufacturer:

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

This leaflet was last approved in 12/2013

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