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DEXTROMETHORPHAN HYDROBROMIDE 10MG/5ML ORAL SOLUTION

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24 mm

Dextromethorphan Hydrobromide
10mg/5ml Oral Solution
Dextromethorphan Hydrobromide
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
- 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.
- You must talk to a doctor if you do not feel better or if you
feel worse.
What is in this leaflet:
1. What Dextromethorphan Hydrobromide 10mg/5ml Oral
Solution is and what it is used for
2. What you need to know before you take Dextromethorphan
10mg/5ml oral solution
3. How to take Dextromethorphan Hydrobromide
10mg/5ml Oral Solution
4. Possible side effects
5. How to store Dextromethorphan Hydrobromide
10mg/5ml Oral Solution
6. Contents of the pack and other information

1. What Dextromethorphan Hydrobromide 10mg/5ml
Oral Solution is and what it is used for
Dextromethorphan Hydrobromide acts as a cough suppressant
which acts to reduce coughing.
It can be used to relieve dry and tickly coughs. Dry coughs
do not produce phlegm or mucus on the chest.

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2.What you need to know before you take
Dextromethorphan 10mg/5ml oral solution
Do not take this medicine if you:
• are allergic to this medicine or any of the other ingredient
(these are listed in Section 6, Further Information)
• You are currently taking a prescription monoamine oxidase
inhibitor (MAOI), used to treat depression and Parkinson’s
disease or have taken this medicine in the last 14 days.
- You are currently taking a selective serotonin reuptake
inhibitor (SSRI), used to treat depression and anxiety or
have taken this medicine in the last 14 days.
- You are currently taking any other medication for
depression, psychiatric, or emotional conditions, or
Parkinson’s disease or have done so in the last 14
days.
Warnings and Precautions
- You have had a cough for a long time or if you have asthma
or suffer from serious asthma attacks, or if your cough is
accompanied by a fever, rash, or persistent headache.
- You have liver problems.
Other Medicines and Dextromethorphan hydrobromide
10mg/5ml oral solution
Talk to your doctor or pharmacist before taking
Dextromethorphan hydrobromide 10mg/5ml oral
solution
Do not take if you are taking any of the following medicines, or
have done so in the last 14 days:
- A prescription monoamine oxidase inhibitor (MAOI), used
to treat depression and Parkinson’s disease.
- A selective serotonin reuptake inhibitor (SSRI), used to
treat depression and anxiety.
- Any other medication for depression, psychiatric, or
emotional conditions, or Parkinson’s disease.

If you are not sure if your prescription medicine contains one
of these drugs, ask a doctor or
pharmacist before taking this product.
Talk to your doctor or pharmacist if you are:
- Taking Quinidine or Amiodarone, which are both used to
treat some heart conditions.
Pregnancy, Breast-feeding and Fertility
• If you are pregnant or breast feeding, think you may be
pregnant or are planning to have a baby, ask you doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Dextromethorphan hydrobromide can affect your ability to
drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how
it affects you.
• It is an offence to drive if this medicine affects your ability
to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or
dental problem and
- You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether
it is safe for you to drive while taking this medicine.
If you feel that your reactions are affected, do not operate
machinery.
Taking this medicine with alcohol
Do not drink alcohol whilst taking this medicine. Alcohol
increases the risk of side effects occurring and may make
you feel more drowsy.
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PACKAGE LEAFLET: INFORMATION FOR USER

3. How to take Dextromethorphan Hydrobromide
10mg/5ml Oral Solution
You should check with your doctor or pharmacist if you are
not sure.
The usual doses are as follows:
Adults and children over 12: Take 10-20mg every 4-6 hours
(1-2 spoonful of 5ml), up to a maximum of 80mg/day.
Do not exceed the 4 daily intakes.
Do not give to Children under 12 years of age.
If you take more medicine than you should
If you accidently take too much Dextromethorphan
Hydrobromide 10mg/5ml oral solution, tell your doctor
immediately or contact your nearest Hospital Casualty/Accident
and Emergency Department even if there are no signs of
discomfort.
Take this medication in its original packaging with you in order
to enable the doctor to identify your medication easily.
If you forget to take the medicine
If you forget to take a dose, take it as soon as you remember.
Then carry on as before, but do not take double dose to make
up for forgotten dose.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. Side effects with

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dextromethorphan hydrobromide are rare. However,
susceptible individuals may experience unwanted side effects.
If any of the side effects gets serious or you experience any
other side effects, STOP taking this medicine immediately and
consult your doctor:
- Allergic reactions. Symptoms could include itchy skin or
rashes, difficulty breathing, faster heart rate, swelling of the
face or the throat.
- Stomach upset.
- Dizziness.
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 Dextromethorphan Hydrobromide
10mg/5ml Oral Solution
• Keep this medicine out of the sight and reach of children
• Do not store above 250C. Store in the original container.
Keep the container tightly closed.
• Do not use this medicine after the expiry date printed on the
pack. The expiry date refers to the last day of that month.
• Do not use this medicine if you notice any visible signs of
deterioration.
• 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 Dextromethorphan Hydrobromide 10mg/5ml Oral
Solution contains

• The active substance in Dextromethorphan Hydrobromide
10mg/5ml Oral Solution is Dextromethorphan Hydrobromide.
• Each 5ml of Dextromethorphan Hydrobromide 10mg/5ml
Oral Solution contains 10mg of Dextromethorphan
Hydrobromide.
Other ingredients are Sodium Benzoate, Anhydrous citric acid,
Liquid maltitol, Saccharin sodium, Propylene glycol,
Strawberry flavour (containing propylene glycol and alphatocopherol), Contramarum flavouring (containing propylene
glycol and benzyl alcohol), (Amaranth) E123.
What Dextromethorphan Hydrobromide 10mg/5ml Oral
Solution looks like and contents of the pack
• A limpid red solution for oral administration.
• Dextromethorphan Hydrobromide 10mg/5ml oral solution
is packed into amber coloured polyethylene terephthalate
(PET) bottle, closed by a high density polyethylene (HDPE)
white coloured closure. 1.25, 2.5 and 5 ml polypropylene
doubled spoon with EC mark are provided as administration
device.
Marketing Authorisation Holder
Name and Address: Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,
Berkhamsted, Hertfordshire,
United Kingdom, HP4 1EG
Telephone:
0044 (0)1442 200922
Fax:
0044 (0)1442 873717
info@bristol-labs.co.uk
Email:
Dextromethorphan Hydrobromide 10mg/5ml Oral
Solution: PL 17907/0314
This leaflet was last revised in July 2014
To request a copy of this leaflet in Braille, large print or audio
format, please contact the licence holder at the address
(or telephone, fax, email) above.
V3 11-07-2014 D0
IXXXXX

Dextromethorphan hydrobromide 10mg/5ml oral
solution contains Maltitol
If you have been previously told by your doctor you have
fructose intolerance, contact your doctor before taking this
medicine.
Dextromethorphan hydrobromide 10mg/5ml oral
solution contains Amaranth (E123)
It may cause allergic reactions.

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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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