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SALIPRANEB 0.5MG / 2.5MG PER 2.5 ML NEBULISER SOLUTION

Active substance(s): IPRATROPIUM BROMIDE MONOHYDRATE / SALBUTAMOL SULPHATE

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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.
Please tell your doctor or pharmacist if you are taking or have recently
In this leaflet:
taken any other medicines, including medicines obtained without a
1. What Salipraneb Nebuliser Solution is and what it is used for
prescription.
2. Before you use Salipraneb Nebuliser Solution
3. How to use Salipraneb Nebuliser Solution
Pregnancy and breast-feeding
4. Possible side effects
If you are pregnant, think you are pregnant or are breast-feeding you
5. How to store Salipraneb Nebuliser Solution
should not use Salipraneb Nebuliser Solution unless your doctor tells you
6. Further information
to. If you become pregnant whilst taking this medicine you should tell
your doctor as soon as possible.
1. WHAT SALIPRANEB NEBULISER SOLUTION IS AND WHAT IT
Driving and using machines
IS USED FOR
Salipraneb Nebuliser Solution has no known effects on the ability to drive
and use machines.
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.
3. HOW TO USE SALIPRANEB NEBULISER SOLUTION
Salipraneb Nebuliser Solution helps to make breathing easier in patients
who have long-standing breathing difficulties.
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 1 DETACH
HERE
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
2
chamber
5. Throw away the empty plastic ampoule
TWIST
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.

Ipratropium/Salbutamol 0.5mg/2.5mg per 2.5ml ampule leaflet - UK

colours/plates:
1. Black

item no:

AAAI2012

dimensions:

print proof no:

7

pharmacode:

origination date: 12.08.15
approved for print/date

min pt size:

200 x 280

2.
3.
4.

9

5.
6.

originated by:

jh

revision date:

18.01.16

Technical Approval

revised by:

MB

date sent:

supplier:

Unither

technically app. date: 12.10.15

12.08.15

Non Printing Colours
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Contact your doctor immediately if:

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.

• 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.

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.
5. HOW TO STORE SALIPRANEB NEBULISER SOLUTION

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.

Keep out of the sight and reach of children.

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

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor straight away if you notice any of the following
serious side effects – you many need urgent medicial attention:
• If after taking Salipraneb you are wheezy or have other
difficulties breathing, do not take any more (unless you have
been told to, by your doctor)
•A
 llergic reactions - the signs may include skin rash, itching and
nettle rash. In severe cases the signs include swelling of your
tongue, lips and face, sudden difficulties in breathing
•P
 alpatations (heart flutter), increased heart rate, reduction in
blood pressure and circulatory problems.
See your doctor straight away if you have any of these side
effects.
The following side effects have been reported:
Common side effects (probably affecting up to 1 in 10 people taking this
medicine):
•H
 eadaches

• F eeling sick (nausea)

•D
 ry mouth
•D
 ifficulty in speaking or
hoarseness of the voice

•D
 ifficulty focussing your eyes
• C ough

Uncommon side effects (probably affecting fewer than 1 in 100 people
taking this medicine):
•D
 izziness
• B eing sick (vomiting)
•D
 ifficulty passing urine

• Increases in blood pressure
• T rembling or shaking
•N
 ervousness

Rare side effects (probably affecting fewer than 1 in every 1000 people
taking this medicine):
• S weating
• C onstipation
•W
 eakness and muscle pain/
cramps
•A
 llergic reactions (see above)
• R estlessness

• Irritation of the mouth and throat
•M
 emory problems
•A
 nxiety and depression
•H
 yperactivity in children
• E ye problems including eye pain
and glaucoma (increased pressure
in the eye).

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:
• T he active substances are Ipratropium bromide (0.5mg/2.5ml) and
Salbutamol (as sulfate) (2.5mg/2.5ml)
• T he 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 sulfate)
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, Whiddon Valley, Barnstaple, North Devon,
EX32 8NS, United Kingdom.
Manufacturer:
Laboratoire Unither, Espace lndustriel Nord, 151 rue André Durouchez- CS
28028, 80084 AMIENS Cedex 2, France.
This leaflet was last revised in January 2016

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.
AAAI2012

Ipratropium/Salbutamol 0.5mg/2.5mg per 2.5ml ampule leaflet - UK

colours/plates:
1. Black

item no:

AAAI2012

dimensions:

print proof no:

7

pharmacode:

origination date: 12.08.15
approved for print/date

min pt size:

200 x 280

2.
3.
4.

9

5.
6.

originated by:

jh

revision date:

18.01.16

Technical Approval

revised by:

MB

date sent:

supplier:

Unither

technically app. date: 12.10.15

12.08.15

Non Printing Colours
1.
2.
3.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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