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DEXTROMETHORPHAN HYDROBROMIDE 10MG / 5ML SYRUP

Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE / DEXTROMETHORPHAN HYDROBROMIDE / 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 an y side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
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 h ydrobromide 10m g/5ml syrup is used to help relieve dry, irritating
coughs.
It c ontains t he a ctive i ngredient de xtromethorphan hydrobromide w hich be longs t o 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.

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2. What you need to know before you take Dextromethorphan
10mg/5ml syrup

hydrobromide

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
− 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 (i.e. exceeding the recommended treatment period) or by people
with a tendency towards abuse
If you are taking or have recently been taking certain medicines e.g. for
depression, such as SSRI or tricyclic antidepressives
If you suffer from liver or renal problems
If you have persistent cough or cough associated with considerable mucus
production (phlegm), (e.g. patients with conditions such as bronchiectasis and
cystic fibrosis) or in patients with neurological illness associated with a markedly
reduced cough reflex (such as stroke, Parkinson’s disease and dementia)
If you are intolerant to some sugars
If you are diagnosed to have mastocytosis

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 m edicines, especially
amiodarone, quinidine, f luoxetine, ha loperidol,
paroxetine, pr opafenon, t hioridazine, c imetidine, r itonavir, be rberine, bupr opion,
cinacalcet, flecainide and terbinafine or mucolytics (medicines which loosen phlegm
or serotonergic medicines. Serotonergic medicines are e.g certain antidepressives such
as MAO-inhibitors, s elective s erotonin r euptake i nhibitors ( SSRI) ( e.g. f luoxetine,
paroxetine) or t ricyclic antidepressives. D extromethorphan m ay i ncrease t he r isk of
serotonin s yndrome. S ymptoms of s erotonin s yndrome i nclude a gitation, i ncreased
heart an d b reath r ate, r estlessness, m uscle s pasms a nd t witching, hi gh bod y
temperature, excessive sweating, shivering, and tremor.

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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 ar e p regnant o r b reast-feeding, t hink you may b e pregnant or are planning t o
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 g of propylene glycol
Methylhydroxybenzoate (E219)
May cause allergic reactions (possibly delayed)

3. How to take Dextromethorphan hydrobromide 10mg/5ml syrup
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told y
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.
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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 a ll me dicines, D extromethorphan h ydrobromide 10mg/5ml syrup can cau se
side effects, although not everybody gets them.
Allergic reactions
 which may be serious include the following symptoms: difficulty in breathing
or dizziness, swelling of the face or the throat, severe itching or hives
(urticaria), skin rash, redness of the skin (erythema), fixed drug eruption
 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
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 national
reporting system listed in Appendix V*.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dextromethorphan hydrobromide 10mg/5ml syrup
Store in the original packaging in order to protect from light.
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 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.

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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 m l c ontains 10 m g of de xtromethorphan h ydrobromide m onohydrate ( equivalent t o
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 100 ml bottle and 1 measuring device.
1 x 190 ml bottle and 1 measuring device
Not all pack-sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
United Kingdom
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
DELPHARM REIMS
10 rue Colonel Charbonneaux, 51100 REIMS
France
the following names:>

This leaflet was last approved in August 2017
D2/UK/MAT/PIL/1

Expand Transcript

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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