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Benylin Mucus Cough Night

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Document: leaflet MAH BRAND 2_PL 15513-0050 change

MUCUS COUGH

NIGHT

diphenhydramine, guaifenesin, levomenthol

■    This medicine is used to help provide night time relief of cough, related congestive symptoms and aid restful sleep.

■    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. 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 for

Benylin Mucus Cough Night is a medicine which is used to help provide night time relief of coughing and related congestive symptoms and aid restful sleep. The liquid contains diphenhydramine which is an antihistamine that helps relieve coughing, dry secretions in the nose and chest, and helps you sleep, guaifenesin (an expectorant) to help loosen mucus (phlegm) from the lungs and make it easier to cough up, and levomenthol which helps you breathe more easily by relieving congestion.

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

2 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 to any of the ingredients.

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

■    For a child under 12 years of age.

If any of these apply to you, get advice from a doctor or pharmacist without using Benylin Mucus Cough Night.

^^Talk to your doctor or pharmacist.

■    If you suffer from liver or kidney problems.

■    If you have prostate problems (difficulty with passing water or needing to pass water often).

■    If you have narrow-angle glaucoma (increased pressure in the eye).

■    If you have had a cough for a few weeks that may be caused by asthma, or a cough which brings up a lot of mucus (phlegm).

■    If you are taking alcohol.

■    If you are taking any other medicines containing:

■    anticholinergic drugs e.g.

■    antihistamines (drugs used to treat allergies).

■    antidepressants (drugs to treat mood disorders).

■    atropine (used to treat some eye conditions and occasionally bowel conditions).

■    minor tranquillisers (drugs used to relax muscles or decrease anxiety).

■    barbiturates (a kind of sleeping tablet).

■    codeine (sometimes used as a painkiller).

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

you are pregnant or breast-feeding

■    Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding.

I

Special warnings about this medicine

■ This medicine may cause drowsiness. If affected, do not drive or operate machinery. Avoid alcoholic drink.

ilksome of the ingredients can cause problems

This medicine contains sucrose 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 1 g sucrose and 3.5 g glucose per 5 ml. This should be taken into account in patients with diabetes mellitus.

This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200 mg per 5 ml, equivalent to 5 ml beer, 2 ml wine per 5 ml. This can be harmful for those suffering from alcoholism. The ethanol content should be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

Ponceau 4R (E124) may cause allergic reactions. This medicinal product contains 16.42 mg sodium per 5 ml. This should be taken into account by patients on a controlled sodium diet.

3 How to take this medicine

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

■    For oral use only.

■    Do not use more than the stated dose shown overleaf.

O Children under 12 years

Do not use in children under 12 years.

turn over c

Adults and children aged 12 years and over

Age    Dose

Adults and children Take two 5 ml spoonfuls aged 12 years and at bedtime followed by over.    two 5 ml spoonfuls every

6 hours, as required.

OR

Take two 5 ml spoonfuls

four times a day.

■    Do not take more than 4 doses (1 dose = two 5 ml spoonfuls) 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) immediately, taking this leaflet and pack with you.

A If you forget to take the medicine

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

4    Possible side-effects

Benylin Mucus Cough Night can have side-effects, like all medicines, although these don’t affect everyone and are usually mild.

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

■    Swelling of the face, lips and/or tongue.

■    Allergic reactions including skin rashes (which may be severe and include blistering or peeling of the skin) and itching.

■    Fits or numbness (paraesthesia).

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

■    An increased awareness of your heartbeat (palpitations).

■    Shakiness (tremor).

■    Difficulty passing water.

Other effects which may occur include:

■    Drowsiness, dizziness, blurred vision.

■    Dry mouth, nose and throat.

■    Upset stomach, nausea or vomiting.

If you experience any side-effects not included in this leaflet or are not sure about anything, talk to your doctor or pharmacist.

5    Storing this medicine

Do not store this product above 30°C.

Do not keep in the fridge or freeze.

Keep the product out of the reach and sight of children. Do not leave your child unattended when using this medicine.

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 Further information

What’s in this medicine?

The active ingredients in 5 ml of Benylin Mucus Cough Night are: 14 mg Diphenhydramine hydrochloride, 100 mg Guaifenesin and 1.1 mg Levomenthol.

Other ingredients are: Liquid glucose, sucrose, ethanol, glycerol, sodium citrate, saccharin sodium, citric acid monohydrate, sodium benzoate (E2II), caramel (EI50), raspberry essence, natural sweetness enhancer, carbomer, Ponceau 4R (EI24) and water.

What the medicine looks like

Benylin Mucus Cough Night is a clear red syrup, available in I50 ml glass bottles.

Marketing Authorisation 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 October 2011.

Benylin is a registered trade mark.

McNeil^    F308547

11-0169

F308547 - Leaflet BENYLIN Mucus Cough Night 150 ml UKV3.2.indd 2 25/10/11 13:35