24 mm

PACKAGE LEAFLET: INFORMATION FOR USER

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.

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.

SAME SIZE ARTWORK 240 x 120 mm Front

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.

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

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 alpha-tocopherol), 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 Berkhamsted, Hertfordshire, United Kingdom, HP4 1EG Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Road,

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 do

SAME SIZE ARTWORK

240 x 120 mm

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