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IPRATROPIUM BROMIDE 500 MICROGRAMS/SALBUTAMOL SULPHATE 2.5MG PER 2.5ML NEBULISER SOLUTION

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

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PATIENT INFORMATION LEAFLET

5. HOW TO STORE COMBIVENT UDVs

POM
• 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
month.
• Do not store above 25°C.
• Do not freeze.
• Do not use if the liquid is discoloured.
• Keep vials in the outer carton in order to protect
from light.
• Keep out of the sight and reach of children.
• 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 Combivent contains
Combivent UDVs contain a nebuliser solution.
Each single dose unit contains ipratropium
bromide 500 micrograms and salbutemol 2.5mg
(as sulphate) in 2.5 ml of aqueous solution.
The other ingredients are: sodium chloride,
hydrochloric acid and purified water.
What Combivent looks like and contents
of the pack
Combivent UDVs come in LDPE (low density
polyethylene) vials containing 2.5ml clear,
colourless solution formed into strips of 10 vials in
sealed pouches and then packed into a carton
containing 60 vials.
Manufacturer and Licence Holder
This medicine is manufactured by Laboratoire
Unither, Espace Industriel Nord, 151 rue André
Durouchez - CS 28028, 80084 Amiens Cedex 2,
France and is procured from within the EU.
Product Licence Holder: LTT Phama Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE. Repackaged by Lexon
(UK) Limited, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

PL 33723/0109

Combivent is registered trademarks of the
Boehringer Ingelheim Limited.
Leaflet revision date: 28/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: LTT0109/280116/1/F

®

Combivent UDVs
(ipratropium bromide and salbutamol sulphate)
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 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
pharmacist.
In this leaflet:
1. What Combivent UDVs is and what it is used
for
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 USED FOR
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 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 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
information.)
• 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
‘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:
• 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
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 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

• Medicines called ‘beta mimetics’ such as
fenoterol for breathing problems
• Digoxin - used for a fast heart beat or heart
failure
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
COMBIVENT.
Operations
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.
Tests
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.
Pregnancy and breast-feeding
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 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.

Your doctor may need to check how well your
medicine is working.
In some cases your doctor may need to change
your medicine.
How to use your nebuliser
Read through numbers 1 to 6 first, before starting
to use your nebuliser.
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.

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 12 years.
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

6. • After you have finished, dispose of any leftover
medicine carefully
• Follow the manufacturer’s instructions on how
to clean your nebuliser
• It is important to keep your nebuliser 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.
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 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.
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
(palpitations)
• Voice problems (‘dysphonia’)
• Skin reactions
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
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.

Ref: LTT0109/280116/1/B

5. HOW TO STORE IPRATROPIUM BROMIDE /
SALBUTAMOL SULPHATE
• 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
month.
• Do not store above 25°C.
• Do not freeze.
• Do not use if the liquid is discoloured.
• Keep vials in the outer carton in order to protect
from light.
• Keep out of the sight and reach of children.
• 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 Ipratropium Bromide / Salbutamol
Sulphate contains
Ipratropium Bromide / Salbutamol Sulphate
contain a nebuliser solution. Each single dose unit
contains ipratropium bromide 500 micrograms and
salbutemol 2.5mg (as sulphate) in 2.5 ml of
aqueous solution.
The other ingredients are: sodium chloride,
hydrochloric acid and purified water.
What Ipratropium Bromide / Salbutamol
Sulphate looks like and contents of the pack
Ipratropium Bromide / Salbutamol Sulphate
come in LDPE (low density polyethylene) vials
containing 2.5ml clear, colourless solution formed
into strips of 10 vials in sealed pouches and then
packed into a carton containing 60 vials.
Manufacturer and Licence Holder
This medicine is manufactured by Laboratoire
Unither, Espace Industriel Nord, 151 rue André
Durouchez - CS 28028, 80084 Amiens Cedex 2,
France and is procured from within the EU.
Product Licence Holder: LTT Phama Limited, Unit
18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE. Repackaged by Lexon
(UK) Limited, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

PATIENT INFORMATION LEAFLET
POM

PL 33723/0109

Leaflet revision date: 28/01/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: LTT109/280116/2/F

Ipratropium Bromide 500 micrograms / Salbutamol Sulphate
2.5mg per 2.5ml
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 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
pharmacist.
In this leaflet:
1. What Ipratropium Bromide / Salbutamol
Sulphate is and what it is used for
2. Before you use Ipratropium Bromide /
Salbutamol Sulphate
3. How to use Ipratropium Bromide / Salbutamol
Sulphate
4. Possible side effects
5. How to store Ipratropium Bromide / Salbutamol
Sulphate
6. Further information
1. WHAT IPRATROPIUM BROMIDE /
SALBUTAMOL SULPHATE IS AND WHAT IT
IS USED FOR
The name of your medicine is Ipratropium
Bromide / Salbutamol Sulphate. You use it with a
device called a ‘nebuliser’. This changes your
medicine into a mist for you to breathe in.
Ipratropium Bromide / Salbutamol Sulphate
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 IPRATROPIUM BROMIDE
/ SALBUTAMOL SULPHATE
Do not use Ipratropium Bromide / Salbutamol
Sulphate if:
• You are allergic (hypersensitive) to ipratropium or
salbutamol or any of the other ingredients in
Ipratropium Bromide / Salbutamol Sulphate.
(Listed in section 6: Further information.)
• 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
‘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 Ipratropium Bromide / Salbutamol
Sulphate.
Take special care with Ipratropium Bromide /
Salbutamol Sulphate
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
Ipratropium Bromide / Salbutamol Sulphate.
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 Ipratropium Bromide / Salbutamol
Sulphate can affect the way some other medicines
work. Also some other medicines can affect the
way Ipratropium Bromide / Salbutamol Sulphate
works.
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
• Medicines called ‘beta mimetics’ such as
fenoterol for breathing problems
• Digoxin - used for a fast heart beat or heart
failure
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before using
Ipratropium Bromide / Salbutamol Sulphate
Operations
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 Ipratropium Bromide /
Salbutamol Sulphate to the doctor, dentist or
anaesthetist.

Ipratropium Bromide / Salbutamol Sulphate 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.
In some cases your doctor may need to change
your medicine.
How to use your nebuliser
Read through numbers 1 to 6 first, before starting
to use your nebuliser.
1. Get your nebuliser ready by following the
manufacturer’s instructions. Ask your doctor if
you are not sure how to use it.

Tests
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 Ipratropium Bromide / Salbutamol
Sulphate contains salbutamol and this may lead to
a positive result.

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

Pregnancy and breast-feeding
Do not use Ipratropium Bromide / Salbutamol
Sulphate if you are pregnant, likely to get pregnant
or are breast-feeding.

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

Driving and using machines
You may feel dizzy, or have difficulty in focusing,
or blurred vision whilst taking Ipratropium Bromide
/ Salbutamol Sulphate. If this happens do not drive
or use tools or machines.
3. HOW TO USE IPRATROPIUM BROMIDE /
SALBUTAMOL SULPHATE
Always use Ipratropium Bromide / Salbutamol
Sulphate 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 12 years.

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 nebuliser
• It is important to keep your nebuliser 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 Ipratropium Bromide /
Salbutamol Sulphate 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 takeIpratropium Bromide /
Salbutamol Sulphate
• 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
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ipratropium Bromide /
Salbutamol Sulphate 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 Ipratropium Bromide / Salbutamol
Sulphate 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.
The side effects described below have been
experienced by people taking Ipratropium Bromide
/ Salbutamol Sulphate.
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
(palpitations)

• Voice problems (‘dysphonia’)
• Skin reactions
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
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.

Ref: LTT109/280116/2/B

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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