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COMBIVENT UDVS

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

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Combivent® UDVs®

ABCD

(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
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 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 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.

Pregnancy and breast-feeding
Do not use COMBIVENT if you are pregnant,
likely to get pregnant or are breast-feeding.

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.

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.

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.

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.

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
Your doctor may need to check how well
your medicine is working.
In some cases your doctor may need to
change your medicine.

Mandatory in

File information

TD

Printfile

Issue date of TD:

27/AUGUST/2014

Yes

Yes

PPM SKU:

P014293

No

Yes

PPM SKU version: 

004

No

Yes

Issue date of artwork:

01/SEPTEMBER/2014

No

Yes

Print colors:

PAN Black

No

Yes

No

Yes

Mat. No. Pack. Site:

65NOT1070/D

Min. font size:

8.6

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

Technical information
a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors
BI-Diecut-Legendcase

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.

65NOT1070/D

direction of travel
Package leaflet: Information for the user

Free area

Gluepoints

MESSAGE TO OUR SUPPLIER :
Page 1 is always the front side. The text direction can be in landscape or portrait.

Additional information
Bottle pack :

4010/3-8-9-11

Dimension :

280 x 200 mm

Dimension of the leaflet after folding :

35 x 200 mm

direction of travel
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 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.

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 month.
Store below 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.
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 solution.
The other ingredients are: sodium chloride,
(1N) hydrochloric acid and purified water.
What COMBIVENT looks like and contents of
the pack
Your medicine comes with a nebuliser. This
changes COMBIVENT into a mist for you to
breathe in. COMBIVENT UDVs are available in
packs of 60 units.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation for
COMBIVENT UDVs is held by:



Boehringer Ingelheim Limited,
Ellesfield Avenue,
Bracknell, Berks.,
RG12 8YS, United Kingdom.
COMBIVENT UDVs are manufactured by:
Laboratoire Unither
Espace Industriel Nord
151 rue André Durouchez - CS 28028
80084 Amiens Cedex 2
France
This leaflet was revised in September 2014.
© Boehringer Ingelheim Ltd 2014

65NOT1070/D

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

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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