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Benylin Dry Coughs 7.5mg/5ml Syrup

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Dry Coughs

7.5mg/5ml Syrup dextromethorphan

■    This medicine is used to help relieve dry, irritating coughs.

■    This medicine is for use by adults and children aged 12 years and over.

   Do not use this medicine:

There are some people who should not use this medicine. To find out if you are one of them see section 2 C If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6 C

   Speak to your doctor:

If you suffer from any of the conditions mentioned in section 2. See section 2 C

If you are taking any other medicines. See section 2 C

   Follow the dosage instructions carefully. These are shown in the table. See section 3 C

Now read this whole leaflet carefully before you use this medicine. Keep the leaflet: you might need it again.

1    What the medicine is and what it is used for

Benylin Dry Coughs 7.5mg/5ml Syrup is a medicine which is used to help relieve dry, irritating coughs. The liquid contains dextromethorphan hydrobromide which is an antitussive to help stop persistent coughing.

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

2    What you need to know before taking this medicine

This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist.

Do not use this medicine...

■    If you have ever had a bad reaction (e.g. rashswelling of the face and throat, difficulty breathing) to dextromethorphan or any of the other ingredients.

■    If you suffer from lung disease.

■    If you are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs).

■    If you are taking selective serotonin re-uptake inhibitors (used to treat depression and anxiety).

■    For children under 12 years old.

If any of these apply to you, get advice from a doctor or pharmacist without using Benylin Dry Coughs 7.5mg/5ml Syrup.

Talk to your doctor or pharmacist.

■    If you suffer from liver or kidney problems.

■    If you have a persistent cough such as occurs with asthma or produces a lot of mucus (phlegm).

■    If you have alcohol dependence.

■    If you have an intolerance to some sugars.

■    If you are taking any other cough and cold medicines.

■    If your child is susceptible to developing certain allergic reactions (e.g. atopic reactions).

■    If you are taking any other medicines, including:

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

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

If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist.

If any of these bullet points apply to you now or in the past, talk to a doctor or pharmacist.

If you are pregnant or breast-feeding

■    If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

^k Some of the ingredients can cause problems

■    This medicine contains sucrose, sorbitol and liquid glucose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product. Contains 2.38 g glucose per 5 ml. Contains 1.6 g sucrose. This should be taken into account in patients with diabetes mellitus.

■    This medicinal product contains 6 vol% ethanol (alcohol), i.e. up to 240 mg per 5 ml, equivalent to 6 ml beer, 2.5 ml wine per 5 ml. This can be harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Driving and using machines

■    This medicine can affect your ability to drive.

Do not drive whilst taking this medicine until you know how this medicine affects you.

It may be an offence to drive when taking this medicine if your ability to drive safely is affected. Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

There is further information for patients who are intending to drive in the UK - go to https://www. gov.uk/drug-driving-law.

3 How to take this medicine

Check the table below to see how much medicine to take.

■    For oral use only.

■    Do not take more than the stated dose shown below.

o Children under 12 years

Do not give to children under 12 years old.

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3 How to take this medicine continued

Adults and children aged 12 years and over

Age

Dose

Adults and

Take two 5 ml spoonfuls

children aged 12 years and over

four times a day.

■ Do not take more

than 4 doses in 24 hours.

■ If symptoms persist, talk to your doctor or pharmacist.

If anyone has too much

If anyone has too much contact a doctor or your nearest Accident and Emergency Department (Casualty) taking this leaflet and pack 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.

4 Possible side-effects

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

If you experience any of the following stop using the medicine and seek immediate medical help:

■    Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.

■    Fits

If you experience any of the following stop using the medicine and talk to your doctor

■    Itching, rash, hives.

Other effects which may occur include:

■    Dizziness, drowsiness.

■    Nausea, vomiting, diarrhoea.

■    Upset stomach or stomach pain.

■    Difficulty sleeping or feeling restless or confused.

■    Shallow breathing.

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.

The following details are applicable for Malta:

ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira

Website: www.medicinesauthority.gov.mt email: postlicensing.medicinesauthority@gov.mt By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store this medicine

Do not store above 30°C.

Keep out of the sight and reach of children.

Do not use your medicine after the date shown as an expiry date on the packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Contents of the pack and other further information

What’s in this medicine?

The active ingredient in 5 ml of Benylin Dry Coughs 7.5mg/5ml Syrup is: 7.5 mg

Dextromethorphan hydrobromide.

Other ingredients are: Sorbitol solution, glycerol, sucrose, liquid glucose, citric acid monohydrate, sodium benzoate (E2II), caramel, saccharin sodium, imitation peach flavour, levomenthol, ethanol, carbomer and purified water.

What the medicine looks like

Benylin Dry Coughs 7.5mg/5ml Syrup is a pale brown coloured, peach flavoured syrup, available in I50 ml glass bottles.

Product Licence holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Manufacturer: Famar Orleans, 5 avenue de Concyr, 45071 Orleans, Cedex 2, France.

This leaflet was revised January 2016.

Benylin is a registered trade mark.

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Component code: F310405 15-0067, Version: V6.3 Dimensions: 160 x 210 mm Date: 06/01/2016


F3I0405

15-0067


06/01/16


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