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Package leaflet: Information for the user Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
Combivent® UDVs®
ABCD
medicines, including medicines obtained without
a prescription. This includes herbal medicines.
500 micrograms / This is because COMBIVENT can affect the way
some other medicines work. Also some other
2.5 mg per 2.5 ml
Driving and using machines
You may feel dizzy, have difficulty in focusing,
dilated pupils or blurred vision whilst taking
COMBIVENT. If this happens do not drive or use
tools or machines.
3. HOW TO USE COMBIVENT UDVs

65NOT1071/D
medicines can affect the way COMBIVENT works. Always use COMBIVENT exactly as your doctor
has told you. You should check with your doctor
Nebuliser solution In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
or pharmacist if you are not sure. Follow these
instructions to get the best results. If anything is
(ipratropium bromide and salbutamol) • Steroid medicines such as prednisolone unclear after reading this leaflet, ask your doctor,
• Water tablets (also called ‘diuretics’) pharmacist or practice nurse.
• Medicines for depression
Read all of this leaflet carefully before you start 2. BEFORE YOU USE COMBIVENT UDVs • Medicines to help your breathing How many dose units
taking this medicine Do not use COMBIVENT if: • Medicines called ‘anti-cholinergics’. These can The usual dose is the contents of 1 single dose
• Keep this leaflet. You may need to read it again. • You are allergic (hypersensitive) to ipratropium be used to treat colic pain, Parkinson’s Disease, unit, three or four times a day for:
• If you have any further questions, ask your or salbutamol or any of the other ingredients in problems passing water or lack of control of Adults (including the elderly).
doctor, pharmacist or practice nurse. COMBIVENT. (Listed in section 6: Further your bladder or bowels
• This medicine has been prescribed for you. Do information) • Medicines called ‘beta blockers’ such as COMBIVENT is not recommended for children.
not pass it on to others. It may harm them, even • You are allergic to similar medicines which propanolol. These can be used to treat heart
if their symptoms are the same as yours. contain atropine or medicines like atropine problems, high blood pressure, anxiety or Do not swallow or give this medicine by injection.
• If any of the side effects gets troublesome or • You have a heart problem called ‘hypertrophic migraine
serious, or if you notice any side effects not obstructive cardiomyopathy’. This is where the • Medicines called ‘beta mimetics’ such as Do not use more than your doctor has told you
listed in this leaflet, please tell your doctor or wall between the two sides of the heart gets fenoterol for breathing problems See your doctor straight away if:
pharmacist. bigger and blocks the blood flow • Digoxin - used for a fast heart beat or heart • You feel that your medicine is not working as
• You have a very fast heart beat (called failure well as usual
In this leaflet: ‘tachyarrythmia’) If you are not sure if any of the above apply to • You need to use the nebuliser more than your
1. What COMBIVENT UDVs is and what it is used • You are pregnant, likely to get pregnant or are you, talk to your doctor or pharmacist before doctor has recommended
for breast-feeding using COMBIVENT.
2. Before you use COMBIVENT UDVs Do not use if any of the above apply to you. Your doctor may need to check how well your
3. How to use COMBIVENT UDVs If you are not sure, talk to your doctor or Operations medicine is working.
4. Possible side effects pharmacist before using COMBIVENT. Some gases used in operations (anaesthetic
5. How to store COMBIVENT UDVs gases) may affect how your medicine works. If In some cases your doctor may need to change
6. Further information Take special care with COMBIVENT you are about to have surgery, make sure you your medicine.
Check with your doctor or pharmacist before mention that you are taking COMBIVENT to the
1. WHAT COMBIVENT UDVs IS AND WHAT IT IS using this medicine if: doctor, dentist or anaesthetist.
USED FOR • You have glaucoma, or have been told that you
The name of your medicine is COMBIVENT UDVs. may develop it Tests
You use it with a device called a ‘nebuliser’. This • You have heart or circulation problems, or have If you have to provide an urine sample as part of
changes your medicine into a mist for you to had a recent heart attack a routine sport drug test, tell the person giving the
breathe in. COMBIVENT contains two different • You have diabetes test that you are taking this medicine. This is
medicines called: • You have an over-active thyroid gland because COMBIVENT contains salbutamol and
• Ipratropium bromide and • You have problems passing water (urine) this may lead to a positive result.
• Salbutamol sulphate • You are a man who has prostate problems
• You have cystic fibrosis Pregnancy and breast-feeding
Both belong to a group of medicines called • You have ever had something called Do not use COMBIVENT if you are pregnant, likely
bronchodilators. They are used to make breathing ‘pheochromocytoma’. This is a rare tumour to get pregnant or are breast-feeding.
easier in an illness called ‘chronic obstructive which is not malignant. Using your inhaler can
pulmonary disease’ or COPD. They work by make the symptoms of this worse
opening up your airways. If you are not sure if any of these apply to you,
talk to your doctor or pharmacist before using
COMBIVENT.

Mandatory in
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How to use your nebuliser 4. POSSIBLE SIDE EFFECTS • Difficulty in breathing or speaking due to a brief 6. FURTHER INFORMATION
Read through numbers 1 to 6 first, before starting Like all medicines, COMBIVENT can cause side spasm of your vocal muscles What COMBIVENT contains
to use your nebuliser. effects, although not everybody gets them. • Diarrhoea, constipation, being sick (vomiting or COMBIVENT UDVs contain a nebuliser solution.
other problems with your digestive system Each single dose unit contains 500 micrograms
1. Get your nebuliser ready by following the Tell your doctor straight away if you notice any of (gastrointestinal motility disorder) ipratropium bromide (as the monohydrate) and
manufacturer’s instructions. Ask your doctor if the following serious side effects - you may need • Inflammation of the mouth 2.5 mg salbutamol (as the sulphate) in 2.5 ml of
you are not sure how to use it. urgent medical treatment: • Muscle cramps, muscle weakness and pain aqueous solution.

65NOT1071/D
• If after taking COMBIVENT you are wheezy or • Difficulty in passing water (urine)
2. • Carefully separate a new dose have other difficulties in breathing, do not take • Feeling weak The other ingredients are: sodium chloride,
unit from the strip any more (unless you have been told to) • Fall in blood pressure hydrochloric acid and purified water.
• Do not use it if it is already • Allergic reactions - the signs may include skin
open rash, itching and nettle rash. In severe cases the You may also get unusually low levels of What COMBIVENT looks like and contents of the
signs include swelling of your tongue, lips and potassium in your blood (called ‘hypokalemia’).If pack
3. • Twist off the top face, sudden difficulties in breathing and this happens, your doctor will keep checking your Your medicine is a clear, colourless or almost
• Always hold it upright while reduction of your blood pressure potassium levels. colourless solution for use with a nebuliser. This
you do this See your doctor straight away if you have any of changes COMBIVENT into a mist for you to
these side effects. If any of the liquid or mist accidentally gets into breathe in. COMBIVENT UDVs are available in
your eyes you may get painful, stinging or red packs of 20 or 60 units.
4. • Squeeze all the contents of the The side effects described below have been eyes, dilated pupils, blurred vision, see colours or
dose unit into the nebuliser experienced by people taking COMBIVENT. lights. If this happens, talk to your doctor for Marketing Authorisation Holder and
chamber advice. If you get problems with your eyes at any Manufacturer
• Your doctor will tell you if you Uncommon (affects less than 1 in 100 people) other time, talk to your doctor for advice. The Marketing Authorisation for
need to use a different amount • Dry mouth COMBIVENT UDVs is held by:
• If your doctor has told you that • Feeling nervous, shaky or dizzy Reporting of side effects
your medicine needs to be diluted, • Mood changes If you get any side effects, talk to your doctor, Boehringer Ingelheim Limited,
you will be given ‘sterile sodium • Cough, headache pharmacist or nurse. This includes any possible Ellesfield Avenue,
chloride 0.9%’ solution. Your • Feeling sick (nausea) side effects not listed in this leaflet. You can also Bracknell, Berks.,
doctor will tell you how to use this • Throat irritation report side effects directly via RG12 8YS, United Kingdom.
• Increase in blood pressure
5. Use your nebuliser as directed by your doctor. • Increased heart rate or uneven heart beats HPRA Pharmacovigilance COMBIVENT UDVs are manufactured by:
(palpitations) Earlsfort Terrace Laboratoire Unither
6. • After you have finished, dispose of any
leftover medicine carefully • Voice problems (‘dysphonia’) IRL – Dublin 2 Espace Industriel Nord
• Follow the manufacturer’s instructions on • Skin reactions Tel: +353 1 6764971 151 rue André Durouchez - CS 28028
how to clean your nebuliser Fax: +353 1 6762517 80084 Amiens Cedex 2
• It is important to keep your nebuliser clean Rare (affects less than 1 in 1,000 people) Website: www.hpra.ie France
• Serious allergic reactions causing swelling of e-mail: medsafety@hpra.ie
If any of the liquid or mist accidentally gets into the throat or face, or difficulty in breathing or
your eyes you may get painful, stinging or red dizziness By reporting side effects you can help provide This leaflet was revised in March 2015.
eyes, dilated pupils, blurred vision, see colours or • Irregular heart rhythm more information on the safety of this medicine.
lights. If this happens, talk to your doctor for • Regular but abnormally fast heart rate © Boehringer Ingelheim Ltd 2015
advice. If you get problems with your eyes at any (supraventricular tachycardia) 5. HOW TO STORE COMBIVENT UDVs
other time, talk to your doctor for advice. • Some people may occasionally experience chest Do not use this medicine after the expiry date
pain (due to heart problems such as angina). which is stated on the carton and the vial label.
If you use more COMBIVENT than you should Tell your doctor/midwife if you develop these The expiry date refers to the last day of the
If you use more of this medicine than you should, symptoms whilst receiving treatment with month.
talk to a doctor or go to a hospital straight away. salbutamol, but do not stop using this medicine
unless told to do so Do not store above 25°C. Do not freeze. Keep the
If you forget to take COMBIVENT • Blurred vision, dilated pupils, glaucoma, painful, UDVs in the outer carton.
• If you forget a dose, take it as soon as you stinging or red eyes, or swelling of the eyes, see
remember it colours or lights Keep out of the sight and reach of children.
• However, if it is time for the next dose, skip • Rash, itching or nettle rash
the missed dose • Increased sweating
• Do not take a double dose to make up for a • Unexpected tightening of the chest immediately
forgotten dose after inhaling the medicine
• Dry throat, swelling of the throat
If you have any further questions, ask your doctor
or pharmacist.