Read all of this leaflet carefully before you start taking this medicine
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your pharmacist.
This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.
WHAT SALIPRA IS AND WHAT IT IS USED FOR:
SALIPRA contains two different medicines called: ipratropium bromide and salbutamol, both are bronchodilators. This means it helps to keep the air-passages open and thereby make breathing easier. It is used for patients with bronchitis, emphysema and other lung disorders that fall under a condition called ‘chronic obstructive pulmonary disease’ or COPD.
SALIPRA is used with a device called a ‘nebuliser’. This changes your medicine into a mist for you to breathe in.
WHAT YOU NEED TO KNOW BEFORE YOU USE SALIPRA
The use of SALIPRA is not recommended for children under the age of 12 years.
Do not use SALIPRA if:
- You are hypersensitive (allergic) to ipratropium bromide or salbutamol sulphate or any other ingredients listed in section 6 below.
- You are allergic to similar medicines which contain atropine or medicines like atropine
- You have a heart problem called ‘hypertrophic obstructive cardiomyopathy’. This is where the wall between the two sides of the heart gets bigger and blocks the blood flow
- You have a very fast heart beat (called ‘Tachydysrhythmia’).
- Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using SALIPRA.
Warnings and precautions
Do not exceed the recommended maximum doses.
A condition known as lactic acidosis has been reported with high doses of salbutamol, mainly in patients being treated for an acute bronchospasm (see Sections 3 and 4). This results in an increase in lactate levels and may lead to shortness of breath and hyperventilation even though there may be improvement in your wheezing.
If you feel that your medicine is not working as well as usual and you need to use the nebuliser more than your doctor has recommended, immediately talk to a doctor.
Take special care with SALIPRA if you have severe hypertension.
The use of SALIPRA may lead to positive results with regards to salbutamol in tests for substance abuse e.g. in the context of athletic performance enhancement (doping).
Check with your doctor or pharmacist before using this medicine if:
- You have glaucoma, or have been told that you may develop it
- You have heart or circulation problems, or have had a recent heart attack
- You have diabetes
- You have an over-active thyroid gland
- You have problems passing water (urine)
- You are a man who has prostate problems
- You have cystic fibrosis.
- You have ever had something called ‘pheochromocytoma’. This is a rare tumour of the adrenal gland which is not malignant. Using your inhaler can make the symptoms of this worse.
Other medicines and SALIPRA
When you are taking SALIPRA, it is especially important to tell your doctor or healthcare professional if you are taking any of the following medicines:
- Steroid medicines such as prednisone.
- Theophylline or any other medicine to help your breathing.
- Diuretics (water tablets)
- Medicines for depression
- Digoxin (used for your heart)
- Medicines called ‘beta-blockers’ e.g. propranolol which is used to treat blood pressure.
- Some anaesthetic gasses may affect SALIPRA and therefore if you are having an operation, inform your doctor, dentist and nurse that you are taking SALIPRA .
Pregnancy, breastfeeding and fertility
Safety of this medicine in pregnancy and breast-feeding has not been established. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.
Driving and using machines
If you experience any side effects such as dizziness, blurred vision, dilated pupil then you should avoid driving or operating machinery.
HOW TO USE SALIPRA
Always use SALIPRA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
The usual dose for adults and children over 12 years:
Treatment of acute attacks: One ampoule is sufficient for prompt symptom relief in most cases. If in very severe cases, two ampoules are required for symptom relief, these should be administered under medical supervision.
Maintenance treatment: One 2,5 ml vial 3 to 4 times per day .
DO NOT EXCEED THE RECOMMENDED DOSE.
Direction on how to use SALIPRA
Prepare your nebulizer, according to the instructions given by the manufacturer or your doctor.
Use your nebuliser as directed by your doctor or the manufacturer’s instructions.
After you have finished, any leftover medicine should be carefully disposed of.
Follow the manufacturer’s instructions on how to clean your nebulizer. It is important to keep your nebulizer clean.
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.
If you take more SALIPRA than you should:
Too much SALIPRA can cause side effects. to occur. If you experience any signs and symptoms that are untoward, talk to your doctor or healthcare professional or go to a hospital straight away.
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
If you forget to take SALIPRA
- If you forget a dose, take it as soon as you remember it.
- Do not take a double dose to make up for a forgotten dose.
SALIPRA can have side effects.
Not all side effects reported for SALIPRA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SALIPRA, please consult your health care provider for advice.
Check with your doctor immediately or go to your nearest hospital if any of the following side effects occur:
- Your difficulty in breathing increases.
- You get angioedema (swelling of face, lips or eyelids), skin rash, urticaria (hives).
- Chest discomfort or pain.
- Changes in the way your heart beats, for example, if you notice it beating faster.
- Changes in blood pressure.
- You have blurred vision or other changes in vision, burning eyes, eye pain (signs of glaucoma).
- Hypokalaemia (low potassium levels), hyperglycaemia (high blood glucose levels).
These are all serious side effects. You may need urgent medical attention.
Tell your doctor if you notice any of the following side effects:
Frequent side effects:
- fine tremor of muscles (particularly the hands),
- dry mouth,
Less frequent side effects:
- nausea (feeling sick) or vomiting
- throat irritation
- hoarse, rough, raspy, weak voice
- dry and sore throat
- headache or dizziness
- change in sense of taste
- urinary retention or constipation
- nasal dryness
- sleep disturbances
- muscle cramp or pain
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SALIPRA.
HOW TO STORE SALIPRA
Store at or below 30˚C. Store this medicine in a cool place away from light and moisture. Do not refrigerate or freeze this medicine.
Do not remove from outer carton until required for use. Discard unused solution from respules after opening.
Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy.
Store all medicines out of reach and sight of children.
CONTENTS OF THE PACK AND OTHER INFORMATION
SALIPRA contains the active substance ipratropium bromide 0,5 mg and salbutamol sulphate 2,5 mg. Other ingredients are sodium chloride and sulphuric acid.
What SALIPRA looks like and contents of the pack
SALIPRA is a clear colourless solution contained in a transparent 2,5 ml fill form seal; low density polyethylene (plastic) vial.
2,5 ml vials are packed in cartons of either 10, 20, 35, 60 and 100 unit dose vials.
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Medivision (Pty) Ltd
100 Northern Parkway Rd Crownwood Office Park Ormonde
This Leaflet was Last Revised In:
Access to corresponding Professional Information
The packaged carton contains the package insert as well.