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S1588 LEAFLET Combivent 20180222



(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

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

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

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.


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

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


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
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.
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
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

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

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


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

Follow the manufacturer’s instructions on how to clean your

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.

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 or search for MHRA Yellow Card in
the Google Play or Apple App Store.
By reporting side effects you can help provide more information on
the safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 25°C.

If you use more Combivent than you should

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

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

Do not refrigerate or freeze.

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

If you forget to take Combivent

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 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

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

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.

What Combivent contains

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

Feeling sick (nausea)


Throat irritation

Increase in blood pressure

This product is manufactured by Laboratoire Unither, Espace
Industriel Nord, 151 rue Andre Durouchez – CS 28028, 80084
AMIENS Cedex 2, France.

Increased heart rate or uneven heart beats (palpitations)

Voice problems (‘dysphonia’)

Skin reactions


PL: 19488/1588

Leaflet revision date: 22 February 2018
Rare (affects less than 1 in 1,000 people)

Irregular heart beat

Regular but abnormally fast heart rate (supraventricular

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

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Combivent® and UDVs® are registered trademarks of Boehringer
Ingelheim Pharma GmbH & Co. KG, Germany.
S1588 LEAFLET Combivent 20180222

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.