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COMBIVENT UDVS 500 MICROGRAMS / 2.5MG PER 2.5ML NEBULISER SOLUTION
Active substance(s): IPRATROPIUM BROMIDE / SALBUTAMOL / IPRATROPIUM BROMIDE / SALBUTAMOL / IPRATROPIUM BROMIDE / SALBUTAMOL
Combivent ® UDVs®
500micrograms/2.5mg per 2.5ml
(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
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
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 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
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
You have a very fast heart beat (called
You are pregnant, likely to get pregnant or
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
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.
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 migraine
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
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
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
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
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
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
3.• Twist off the top
• Always hold it upright while
you do this
4.• Squeeze all the contents of
the dose unit into the
• Your doctor will tell you if
you need to use a
• 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
6. 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
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
However, if it is time for the next dose, skip
the missed dose
Do not take a double dose to make up for a
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
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
Feeling sick (nausea)
Increase in blood pressure
Increased heart rate or uneven heart beats
Voice problems (‘dysphonia’)
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
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
Inflammation of the mouth
Muscle cramps, muscle weakness and pain
Difficulty in passing water (urine)
Fall in blood pressure
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
By reporting side effects you can help provide
more information on the safety of this medicine.
After you have finished, dispose of any leftover
medicine carefully. Follow the manufacturers
instructions on how to clean your nebulisers. It
is important to keep your nebuliser clean.
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
Do not store above 25°C. Do not freeze. Do not
use if the liquid is discoloured.
What Combivent UDVs looks like
and contents of the pack
Polyethylene unit dose vials
containing a clear, colourless or
almost colourless solution. Combivent
UDVs are supplied in a pack size of 60
Combivent UDVs are manufactured by:
Espace Industriel Nord,
151 rue Andre Durouchez - CS 28028
80084 Amiens Cedex 2
Procured from within the EU by the product
Mr R J Mills and Mrs J Mills t/a Millsdale
Pharmaceuticals, The Warehouse, John Street,
Warrington, Cheshire, WA2 7UB. UK.
Keep vials in the outer carton in order to protect
Keep out of the sight and reach of children.
This leaflet was prepared
18th October 2016
Medicines should 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 notice any signs of deterioration of any
medicine, tell your pharmacist immediately.
6. FURTHER INFORMATION
What Combivent UDVs contains Combivent
UDVs contain a nebuliser solution. Each single
dose unit contains ipratropium bromide
500micrograms (as monohydrate) and
(as sulphate) in 2.5 ml of aqueous
The other ingredients are: sodium
chloride, hydrochloric acid and purified
Combivent® and UDVs® are registered
trademarks of Boehringer Ingelheim Pharma
GmbH & Co., KG..
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.