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BUTAMIRATE 7.5MG/5ML SYRUP

Active substance(s): BUTAMIRATE CITRATE

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Package leaflet: Information for the patient
Butamiratе 7.5mg/5ml Syrup
butamirate citrate

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse after 4 to 5 days.
The full name of this medicine is Butamiratе 7.5mg/5ml Syrup but within the leaflet it will be
referred to as Butamiratе Syrup.
What is in this leaflet
1.
2.
3.
4.
5.
6.

1.

What Butamiratе Syrup is and what it is used for
What you need to know before you take Butamiratе Syrup
How to take Butamiratе Syrup
Possible side effects
How to store Butamiratе Syrup
Contents of the pack and other information
What Butamiratе Syrup is and what it is used for

Butamiratе Syrup contains the active ingredient butamirate citrate, which belongs to a group of
medicines called antitussives.
Butamiratе Syrup is used for the symptomatic treatment of non-productive (dry) cough.

2.

What you need to know before you take Butamiratе Syrup

Do not take Butamiratе Syrup if you are allergic to butamirate citrate or any of the other ingredients
of this medicine (listed in section 6).
Butamiratе Syrup must not be used in children or adolescents under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Butamiratе Syrup.
Before you begin using this cough medicine, consult your doctor or pharmacist so that they can decide
whether this medicine is suitable for you.
If your cough persists after taking this medicine at the recommended dose, consult your doctor or
pharmacist.
This cough medicine should not be used for prolonged periods of time.
Do not use this cough medicine for longer than your doctor or pharmacist has told you to.

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This medicinal product suppresses the coughing reflex. You should avoid taking it at the same time as
some other cough medicines called ‘expectorants’ since this could lead to the build-up of mucus in
your lungs, possibly causing breathing difficulty and/or lung infection.
Other medicines and Butamiratе Syrup
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
It is not known whether Butamiratе Syrup affects the way other medicines work, or whether
Butamiratе Syrup is affected by other medicines.
You should not take Butexio if you are taking medicines known as ‘strong enzyme inhibitors’ or
medicines known to have ‘a narrow therapeutic index’. Your doctor or pharmacist will be able to
confirm whether this applies to you.
Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
You should not take Butamiratе Syrup during the first trimester of pregnancy.
You shoud only take Butamiratе Syrup during the second or third trimester of pregnancy if your
doctor has advised you to do so.
You should not take Butamiratе Syrup if you are breastfeeding.
Driving and using machines
Butamiratе Syrup may cause drowsiness and dizziness. Butamiratе Syrup should be used with caution
if you drive or use machines.
Butamiratе Syrup contains sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
May have a mild laxative effect.

3.

How to take Butamiratе Syrup

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults: 15 ml up to 4 times daily
Use the enclosed measuring cup for proper dosing. Clean and dry the measuring cup after use.
You should stop taking this medicine when symptoms disappear.
Talk to a doctor if your cough lasts longer than 4 to 5 days or if you develop a fever, shortness of
breath or chest pain.
If you have kidney or liver problems, talk to your doctor or pharmacist before taking this medicine
because you may be more likely to get side effects.
If you take more Butamiratе Syrup than you should
If you have taken more Butamiratе Syrup than you should, talk to your doctor immediately.
If you forget to take Butamiratе Syrup
Do not take a double dose to make up for a forgotten dose.
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If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur in rare cases (they may affect 1 to 10 patients in 10,000):
 drowsiness
 dizziness
 nausea
 diarrhoea
 itchy skin rash
Allergic reactions have also been reported (frequency not known).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: 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 Butamiratе Syrup

Do not store above 25°C.
Shelf life after first opening the bottle: 6 months.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Butamiratе Syrup contains
The active substance is butamirate citrate. 1ml of syrup contains 1.5mg butamirate citrate.
5ml of syrup contains 7.5mg butamirate citrate.
The other ingredients are: sorbitol (E420), glycerol, sucralose (E955), sodium benzoate (E211),
citric acid monohydrate, caramel flavour 12788 (containing: flavouring substances, flavouring
preparations, natural flavouring substances, propylene glycol (E1520)), mix chocolate 70244
(containing: flavouring preparations, flavouring substances, natural flavouring substances,
smoke flavourings, propylene glycol (E1520), water, quinine hydrochloride, dextrose, quassin),
purified water.
What Butamiratе Syrup looks like and contents of the pack
Butamiratе Syrup is a colourless or pale yellow liquid.

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Butamiratе Syrup is supplied in a 100ml or 200ml glass or plastic bottle with a child-resistant plastic
screw cap. Each pack contains a plastic measuring cup with graduations for dosing.
Marketing Authorisation Holder and
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Balkanpharma Troyan AD
1, Krayrechna Str., Troyan 5600
Bulgaria

This leaflet was last revised in April 2015.

If you would like a
leaflet with larger text,
please contact
01271 385257.

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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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