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DEXTROMETHORPHAN HYDROBROMIDE 10MG / 5ML SYRUP

Active substance: DEXTROMETHORPHAN HYDROBROMIDE

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Dextromethorphan hydrobromide, 10mg/5ml syrup
Dextromethorphan hydrobromide monohydrate
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, pharmacist or
nurse 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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
- You must talk to a doctor if you do not feel better or if you feel worse after 3-5 days.
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your your doctor or pharmacist
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1. What Dextromethorphan hydrobromide 10mg/5ml syrup is and what it is used for
2. Before you take Dextromethorphan hydrobromide 10mg/5ml syrup
3. How to take Dextromethorphan hydrobromide 10mg/5ml syrup
4. Possible side effects
5. How to store Dextromethorphan hydrobromide 10mg/5ml syrup
6. Contents of the pack and further information
1. What Dextromethorphan hydrobromide 10mg/5ml syrup is and what it is used for
Pharmacotherapeutic group: Cough and cold preparations
Dextromethorphan hydrobromide 10mg/5ml syrup is used to help relieve dry, irritating coughs.
It contains the active ingredient dextromethorphan hydrobromide which belongs to a group of
medicines called cough suppressants that help provide relief from dry coughs.
The medicine is for use in adults and children aged
12 years and over.
2. What you need to know before you take Dextromethorphan hydrobromide 10mg/5ml
syrup
Do not take Dextromethorphan hydrobromide 10mg/5ml syrup
 if you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed
in section 6)
 if you have a long-term cough or acute symptoms from respiratory conditions such as asthma,
Chronic obstructive pulmonary disease (COPD), pneumonia.
 if you are less than 12 years old

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 if you are taking or have taken in the last two weeks medicines for depression known as
Monoamine Oxidase inhibitors (MAO’Is). If you are uncertain as to whether you are
taking such medication, talk to your doctor or pharmacist
Warning and precautions
Talk to your doctor, pharmacist or nurse before taking Dextromethorphan hydrobromide
-

Dextromethorphan hydrobromide may cause dependency when used over longer
periods of time or by people with a tendency towards abuse

If you suffer from liver problems
If you have persistent cough or cough associated with considerable mucus production
(phlegm)
If you are intolerant to some sugars

Children
Dextromethorphan hydrobromide should not be used in children under 12 years of age
Other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, especially amiodarone, quinidine, fluoxetine, haloperidol, paroxetine, propafenon,
thioridazine, cimetidine and ritonavir or mucolytics (medicines which loosen phlegm).
Dextromethorphan hydrobromide with alcohol
Some side effects can be more likely when alcohol is consumed along with
Dextromethorphan hydrobromide .
Pregnancy and breast–feeding
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.
Driving and using machines
This medicine may make you feel drowsy or dizzy. If you are affected do not drive or use
machines. The risk of these effects is increased with alcohol and some other medicines.
Dextromethorphan hydrobromide contains:
Malititol 89(kcal/g)
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
Calorific value 2.3kcal/g maltitol
2.8 mg of propylene glycol
Methylhydroxybenzoate (E219)
May cause allergic reactions (possibly delayed)
3. How to take Dextromethorphan hydrobromide 10mg/5ml syrup

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Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and children aged 12 years and over.
15 ml of syrup up to 3 times daily, every 6 - 8 h as required.
Do not exceed the maximum total daily dose of 45 ml of syrup (3 intakes).
Use the measuring device included in the package.
When self-medicating, do not use for more than 3-5 days.
The syrup does not contain sugar (sucrose) and thus may be taken by diabetics.
If you take more Dextromethorphan hydrobromide 10mg/5ml syrup than you should
If you take too much of this medicine, consult your doctor or hospital immediately.
Bring any remaining medicine to show the doctor.
If you forget to take Dextromethorphan hydrobromide 10mg/5ml syrup do not take a
double dose to make up for a forgotten dose.
Take the next dose when needed.
4. Possible side effects
Like all medicines, Dextromethorphan hydrobromide 10mg/5ml syrup can cause side
effects, although not everybody gets them.

Allergic reactions
 Symptoms could include itchy skin or rashes, difficulty breathing, faster heart rate,
swelling of the face or the throat.
 If you get any of these symptoms, stop using the medicine and get medical help at
once.
Other possible side effects
 Common (affects less than 1 in 10 people)
o dizziness, vomiting, upset stomach, nausea, exhaustion
 Very rare (affects less than 1 in 10,000 people)
o hallucinations, addiction, sleepiness
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects
not listed in this leaflet.
5. How to store Dextromethorphan hydrobromide 10mg/5ml syrup
Store in the original packaging in order to protect from light.

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Keep this medicine out of the sight and reach of children.
Do not use Dextromethorphan hydrobromide 10mg/5ml syrup this medicine after the expiry
date which is stated on the label carton and bottle. The expiry date refers to the last date of the
month.
After first opening: 12 months
Do not use this medicine if you notice any signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer use. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Dextromethorphan hydrobromide 10mg/5ml syrup contains
-The active substance is dextromethorphan hydrobromide monohydrate.
-The other excipients are:
Saccharin sodium
Maltitol liquid (E965)
Propylene glycol
Apricot flavour
Vanilla flavour
Methyl parahydroxybenzoat (E218)
Purified water
What Dextromethorphan hydrobromide 10mg/5ml syrup looks like and contents of the
pack
5 ml contains 10 mg of dextromethorphan hydrobromide monohydrate (equivalent to 7.35mg of
dextromethorphan).
Dextromethorphan hydrobromide 10mg/5ml syrup is a clear, colourless to slightly yellow syrup
available in a type III amber glass bottle and plastic cap.
Pack-sizes:
1 x 190ml bottle and 1 measuring device
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

Manufacturer
DELPHARM REIMS
10 rue Colonel Charbonneaux, 51100 REIMS
France
This medicines product is authorised in the Member States of the EEA under the
following names:
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Czech Republic:
Estonia:
Poland:
Slovak Republic:

MUGOTUSSOL 10mg/5ml
Mugotussol
Mucotussin
Mugotussol

This leaflet was last approved in 02/2014

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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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