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COMBIVENT UDVS NEBULISER SOLUTION

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

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S1588 LEAFLET Combivent 20150615

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

®

COMBIVENT UDVs NEBULISER SOLUTION
(ipratropium bromide and salbutamol sulphate)
The name of your medicine is Combivent UDV Nebuliser Solution
but will be referred to as Combivent throughout the following leaflet.
Read all of this leaflet carefully before you start taking this
medicine

In particular, tell your doctor or pharmacist if you are taking any of
the following medicines:


Steroid medicines such as prednisolone



Water tablets (also called ‘diuretics’)



Medicines for depression



Medicines to help your breathing



Medicines called ‘anti-cholinergics’. These can be used to treat
colic pain, Parkinson’s Disease, problems passing water or lack
of control of your bladder or bowels



Medicines called ‘beta blockers’ such as propanolol. These can
be used to treat heart problems, high blood pressure, anxiety or
migraine



Keep this leaflet. You may need to read it again.





If you have any further questions, ask your doctor, pharmacist
or practice nurse.

Medicines called ‘beta mimetics’ such as fenoterol for breathing
problems



Digoxin - used for a fast heart beat or heart failure



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 you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before using Combivent.



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

Operations

In this leaflet:

Some gases used in operations (anaesthetic gases) may affect how
your medicine works. If you are about to have surgery, make sure
you mention that you are taking Combivent to the doctor, dentist or
anaesthetist.

1. What Combivent is and what it is used for
2. Before you use Combivent

Tests

3. How to use Combivent

If you have to provide an urine sample as part of a routine sport
drug test, tell the person giving the test that you are taking this
medicine. This is because Combivent contains salbutamol and this
may lead to a positive result.

4. Possible side effects
5. How to store Combivent
6. Further information

Pregnancy and breast-feeding
1. WHAT COMBIVENT IS AND WHAT IT IS USED FOR
The name of your medicine is Combivent. You use it with a device
called a ‘nebuliser’. This changes your medicine into a mist for you
to breathe in. Combivent contains two different medicines called:


Ipratropium bromide and



Salbutamol sulphate

Both belong to a group of medicines called bronchodilators. They
are used to make breathing easier in an illness called ‘chronic
obstructive pulmonary disease’ or COPD. They work by opening up
your airways.
2. BEFORE YOU USE COMBIVENT
Do not use Combivent if:

Do not use Combivent if you are pregnant, likely to get pregnant or
are breast-feeding.
Driving and using machines
You may feel dizzy, or have difficulty in focusing, or blurred vision
whilst taking Combivent. If this happens do not drive or use tools or
machines.
3. HOW TO USE COMBIVENT
Always use Combivent exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Follow these instructions to get the best results. If anything is
unclear after reading this leaflet, ask your doctor, pharmacist or
practice nurse.



You are allergic (hypersensitive) to ipratropium or salbutamol or
any of the other ingredients in Combivent. (Listed in section 6:
Further information.)



You are allergic to similar medicines which contain atropine or
medicines like atropine

The usual dose is the contents of 1 single dose unit, three or four
times a day for:



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

Adults (including the elderly) and children over 12 years.



You have a very fast heart beat (called ‘tachyarrythmia’)



You are pregnant, likely to get pregnant or are breast-feeding

Do not use if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist before using Combivent.
Take special care with Combivent
Check with your doctor or pharmacist before using this medicine if:

How many dose units

Combivent is not recommended for children under 12 years.
Do not swallow or give this medicine by injection.
Do not use more than your doctor has told you
See your doctor straight away if:


You feel that your medicine is not working as well as usual



You need to use the nebuliser more than your doctor has
recommended

Your doctor may need to check how well your medicine is working.



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

How to use your nebuliser



You have an over-active thyroid gland



You have problems passing water (urine)

Read through numbers 1 to 6 first, before starting to use your
nebuliser.



You are a man who has prostate problems



You have cystic fibrosis



You have ever had something called ‘pheochromocytoma’. This
is a rare tumour which is not malignant. Using your inhaler can
make the symptoms of this worse

If you are not sure if any of these apply to you, talk to your doctor or
pharmacist before using Combivent.
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. This includes herbal medicines. This is
because Combivent can affect the way some other medicines work.
Also some other medicines can affect the way Combivent works.

In some cases your doctor may need to change your medicine.

1. Get your nebuliser ready by following the manufacturer’s
instructions. Ask your doctor if you are not
sure how to use it.
2. •

Open the pouch and remove the strip of
unit dose vials



Carefully separate a new dose unit from
the strip



Do not use if it is already open or if the
liquid inside is discoloured

3. •


Twist off the top
Always hold it upright while you do this

4.



Squeeze all the contents of the dose unit
into the nebuliser chamber



Your doctor will tell you if you need to
use a different amount



If your doctor has told you that your
medicine needs to be diluted, you will be
given ‘sterile sodium chloride 0.9%’
solution. Your doctor will tell you how to do this
5. Use your nebuliser as directed by your doctor.
6. • After you have finished, dispose of any leftover medicine
carefully


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 use more Combivent than you should
If you use more of this medicine than you should, talk to a doctor or
go to a hospital straight away.
If you forget to take Combivent


If you forget a dose, take it as soon as you remember it



However, if it is time for the next dose, skip the missed dose



Do not take a double dose to make up for a forgotten dose

You may also get unusually low levels of potassium in your blood
(called ‘hypokalemia’). If this happens, your doctor will keep
checking your potassium levels.
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.
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 COMBIVENT


Keep out of the sight and reach of children.



Do not store above 25°C.



Keep vials in the outer carton in order to protect from light.



Do not refrigerate or freeze.



Do not use Combivent if solution becomes discoloured or
shows any other signs of deterioration.



Do not use Combivent after the expiry date which is stated on
the carton and pouch. The expiry date refers to the last day of
that month.



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.

If you have any further questions, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

Like all medicines, Combivent 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 may need urgent medical treatment:

What Combivent contains





If after taking Combivent you are wheezy or have other
difficulties in breathing, do not take any more (unless you have
been told to by your doctor)
Allergic 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 and a fall
in your blood pressure that may cause dizziness.

See your doctor straight away if you have any of these side effects.



Each single dose unit of 2.5 ml solution contains 0.52 mg
ipratropium bromide monohydrate (equivalent to 0.50 mg
ipratropium bromide anhydrous) and 3.01 mg of salbutamol
sulphate (equivalent to 2.5 mg salbutamol base).



The other ingredients are: sodium chloride, hydrochloric acid,
purified water.

What Combivent looks like and contents of the pack
Combivent comes in strips of 10 polyethylene vials containing
colourless solution for inhalation.
Combivent are available in packs of 60 vials (6 strips of 10 vials).

The side effects described below have been experienced by people
taking Combivent.
Uncommon (affects less than 1 in 100 people)

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.



Feeling nervous, shaky or dizzy



Dry mouth



Cough, headache



Manufacturer

Feeling sick (nausea)



This product is manufactured by

Throat irritation





Increase in blood pressure

Boehringer Ingelheim B.V., Comeniusstraat 6, Alkmaar,
NL-1817 MS, The Netherlands. or



Increased heart rate or uneven heart beats (palpitations)





Voice problems (‘dysphonia’)

Laboratoire UNITHER, 10 Rue Andre Durouchez, 80084
AMIENS, France.



Skin reactions
POM

PL: 19488/1588

Rare (affects less than 1 in 1,000 people)


Irregular heart beat



Regular but abnormally fast heart rate (supraventricular
tachycardia)



Chest pain (due to heart problems such as angina). Tell your
doctor or pharmacist if this occurs but do not stop taking this
medicine unless told to do so



Blurred vision, dilated pupils, glaucoma, painful, stinging, or red
eyes, swelling of the eyes, see colours or lights



Increased sweating



Unexpected tightening of the chest immediately after inhaling
the medicine



Dry throat, swelling of the throat



Difficulty in breathing or speaking due to a brief spasm of your
vocal muscles



Diarrhoea, constipation, being sick (vomiting) or other problems
with your digestive system



Inflammation of the mouth



Muscle cramps, muscle weakness and pain



Difficulty in passing water (urine)



Feeling weak



Fall in blood pressure



Mood changes

Leaflet revision date: 15 June 2015
Combivent and UDVs are registered trademarks of Boehringer
Ingelheim Ltd.
S1588 LEAFLET Combivent 20150615

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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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