24 mm

PACKAGE LEAFLET: INFORMATION FOR USER

Dextromethorphan Hydrobromide 10 mg/5 ml _Oral Solution_

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 is and what it is used for

2.    What you need to know before you Dextromethorphan

3.    How to take Dextromethorphan

4.    Possible side effects

5.    How to store Dextromethorphan

6.    Contents of the pack and other information

The name of your medicine is Dextromethorphan Hydrobromide 10 mg/5 ml Oral Solution, but is referred as 'Dextromethorphan' throughout the leaflet.

1. What Dextromethorphan 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 of persistent dry irritant coughs. Dry coughs do not produce phlegm or mucus on the chest.

The medicine is for use in adults and children aged 12 years and over.

2. What you need to know before you take Dextromethorphan

Do not take this medicine

•    If you are allergic to this medicine or any of the other ingredient (these are listed in Section 6)

•    If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), used to treat depression or have taken this medicine in the last 14 days.

•    If 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.

•    If you are currently taking any other medication for depression, psychiatric, or emotional conditions, or Parkinson's disease

•    If you suffer from lung disease (including asthma or any other lung or breathing problems);

•    For children under 12 years old.

If any of these apply to you, get advice from a doctor or

pharmacist without using dextromethorphan.

Warnings and Precautions

Talk to your doctor or pharmacist:

•    If you suffer from liver or kidney problems.

•    If you have a persistent cough (if your cough lasts more than 7 days) such as occurs with smoking, asthma or produces a lot of mucus (phlegm).

•    If you are taking alcohol.

Other medicines and Dextromethorphan

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines.

•    Antipsychotics (haloperidol, thioridazine drugs used to treat mood disorders);

•    Amiodarone, propafenone and quinidine (used to treat an irregular heart beat).

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 your doctor or pharmacist for advice before taking this medicine.

Dextromethorphan with food drink and alcohol

You should not drink alcohol whilst you are on this medicine.

Driving and using machines

Dextromethorphan can affect your ability to drive or operate machinery 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.

This medicine contains Maltitol and Naphthol red

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Naphthol red may cause allergic reactions.

SAME SIZE ARTWORK 240 x 120 mm Front

3. How to take Dextromethorphan

Always take this medicine exactly as described in this leaflet or as your doctor pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

For oral use only.

Do not take more than the stated dose shown below.

The recommended dose is:

Adults and children over 12 years old

Children under 12 years

Do not give to children under 12 years old.

If you take more Dextromethorphan than you should

If anyone has too much, contact your nearest Hospital Casualty/Accident and Emergency Department take this medication in its original packaging with you..

If you forget to take the medicine

You should only take this medicine as required following the dosage instructions above carefully.

If you forget to take a dose, take the next dose when needed. Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Mild effects that may occur include:

•    Dizziness.

•    Nausea or vomiting.

•    Upset stomach.

Reporting of side effects

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

•    Keep this medicine out of the sight and reach of children

•    Do not store above 25°C. 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 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's in this medicine?

•    The active substance in Dextromethorphan is Dextromethorphan Hydrobromide.

•    Each 5ml of Dextromethorphan contains 10 mg 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), Naphthol red.

What this medicine looks like

Dextromethorphan Hydrobromide 10 mg/5 ml oral solution is a limpid red solution for oral administration, 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 and Manufacturer

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

Email:    info@bristol-labs.co.uk

Dextromethorphan Hydrobromide 10 mg/5 ml Oral Solution; PL 17907/0314

This leaflet was last revised in July 2016

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.

V7 05-07-2016 DO

SAME SIZE ARTWORK

240 x 120 mm

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