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Active substance(s): IPRATROPIUM BROMIDE / IPRATROPIUM BROMIDE MONOHYDRATE / SALBUTAMOL / SALBUTAMOL SULPHATE
(ipratropium bromide and salbutamol sulfate)
Read all of this leaflet carefully before you start
taking this medicine
• Keep this leaflet. You may need to read it
• If you have any further questions, ask your
doctor, pharmacist or practice nurse.
• 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 gets troublesome
or serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or
In this leaflet:
1. What COMBIVENT UDVs is and what it is
2. Before you use COMBIVENT UDVs
3. How to use COMBIVENT UDVs
4. Possible side effects
5. How to store COMBIVENT UDVs
6. Further information
1. WHAT COMBIVENT UDVs IS AND WHAT IT IS
The name of your medicine is COMBIVENT
UDVs. 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 sulfate
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 UDVs
Do not use COMBIVENT if:
• You are allergic (hypersensitive) to ipratropium
or salbutamol or any of the other ingredients
in COMBIVENT. (Listed in section 6: Further
• You are allergic to similar medicines which
contain atropine or medicines like atropine
• You have a heart problem called ‘hypertrophic
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
• You are pregnant, likely to get pregnant or are
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
A condition known as lactic acidosis has been
reported in association with high therapeutic
doses of salbutamol, mainly in patients being
treated for an acute bronchospasm (see Section
3 and 4). Increase in lactate levels 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.
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
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
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
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
• Medicines called ‘beta mimetics’ such as
fenoterol for breathing problems
• Digoxin - used for a fast heart beat or heart
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
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.
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
How to use your nebuliser
Read through numbers 1 to 6 first, before
starting to use your nebuliser.
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.
Pregnancy and breast-feeding
Do not use COMBIVENT if you are pregnant,
likely to get pregnant or are breast-feeding.
1. Get your nebuliser ready by following the
manufacturer’s instructions. Ask your doctor
if you are not sure how to use it.
If you forget to take COMBIVENT
• If you forget a dose, take it as soon as you
• However, if it is time for the next dose, skip
the missed dose
• Do not take a double dose to make up for a
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 UDVs
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.
How many dose units
The usual dose is the contents of 1 single dose
unit, three or four times a day for:
Adults (including the elderly) and children over
COMBIVENT is not recommended for
children under 12 years.
Do not swallow or give this medicine by
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.
In some cases your doctor may need to change
2. • O
pen 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
3. • Twist off the top
• Always hold it upright while
you do this
4. • S
queeze all the contents of the
dose unit into the nebuliser
• 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.
fter you have finished, dispose of any
6. • A
leftover medicine carefully
• Follow the manufacturer’s instructions
on how to clean your nebuliser
• It is important to keep your nebuliser
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 have any further questions, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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
• 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
See your doctor straight away if you have any of
these side effects.
The following side effect can also happen but
the frequency of this is not known:
• A condition known as lactic acidosis which
may cause stomach pain, hyperventilation,
shortness of breath even though there may be
improvement in your wheezing, cold feet and
hands, irregular heartbeat or thirst.
The side effects described below have been
experienced by people taking COMBIVENT.
Uncommon (affects less than 1 in 100 people)
• Feeling nervous, shaky or dizzy
• Dry mouth
• Cough, headache
• Feeling sick (nausea)
• Throat irritation
• Increase in blood pressure
• Increased heart rate or uneven heart beats
• Voice problems (‘dysphonia’)
• Skin reactions
5. HOW TO STORE COMBIVENT UDVs
Do not use this medicine after the expiry date
which is stated on the carton and the vial label.
The expiry date refers to the last day of the
Rare (affects less than 1 in 1,000 people)
• Irregular heart beat
• Regular but abnormally fast heart rate
• 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
Store below 25°C. Do not freeze. Do not use if
the liquid is discoloured.
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.
Marketing Authorisation Holder and
The Marketing Authorisation for
COMBIVENT UDVs is held by:
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.
Boehringer Ingelheim Limited,
RG12 8YS, United Kingdom.
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.
Keep vials in the outer carton in order to protect
Keep out of the sight and reach of children.
6. FURTHER INFORMATION
What COMBIVENT contains
COMBIVENT UDVs contain a nebuliser solution.
Each single dose unit contains ipratropium
bromide 500 micrograms and salbutamol
2.5 mg (as sulfate) in 2.5 ml of aqueous
The other ingredients are: sodium chloride, (1N)
hydrochloric acid and purified water.
What COMBIVENT looks like and contents of
Your medicine should be used with a nebuliser.
This changes COMBIVENT into a mist for you to
breathe in. COMBIVENT UDVs are available in
packs of 60 units.
COMBIVENT UDVs are manufactured by:
Espace Industriel Nord
151 rue André Durouchez - CS 28028
80084 Amiens Cedex 2
This leaflet was revised in January 2018.
© Boehringer Ingelheim Ltd 2018
Package leaflet: Information for the user
direction of travel
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.