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Benylin Mucus Cough Menthol Flavour 100 Mg/5 Ml Oral Solution

Informations for option: Benylin Mucus Cough Menthol Flavour 100 Mg/5 Ml Oral Solution, show other option

100 mg/5 ml Oral Solution

Guaifenesin

■    Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use it carefully to get the best results from it.

■    Keep this leaflet. You may need to read it again.

■    Ask your pharmacist if you need more information or advice.

■    Contact a doctor if your symptoms worsen or do not improve within 7 days.

■    If any of the side-effects gets serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What the medicine is and what it is used for.

2.    Before you take this medicine.

3.    How to take this medicine.

4.    Possible side effects.

5.    How to store this medicine.

6.    Further information.

1 What the medicine is and what it is used for

Benylin Mucus Cough Menthol flavour 100 mg/5 ml oral solution contains guaifenesin which is a type of medicine called an expectorant. It helps to relieve chesty (productive) coughs by loosening phlegm (mucus), making it easier to cough up and the cough more productive.

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

2 Before you take this medicine

□ Do NOT take this medicine if you

■    are allergic (hypersensitive) to guaifenesin or any of the other ingredients (see Section 6 and Section 2).

^^Take special care with this medicine

Talk with your doctor or pharmacist before taking this medicine if you:

■    have had a cough for more than 7 days or your cough recurs or is accompanied by a fever, rash or persistent headache.

■    have a persistent cough that may be caused by asthma.

■    have a cough which brings up a lot of mucus (phlegm).

■    suffer from liver or kidney problems.

■    are taking alcohol.

^^Interference with laboratory tests

If you are undergoing urine tests it is important to tell the doctor or nurse you are taking, or have recently taken, this medicine as it can affect some results.

Taking other medicines

Always tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine, including medicines obtained without a prescription.

■    It is not recommended that you take this medicine with other cough medicines intended to stop you from coughing (antitussives or cough suppressants) as they may interfere with the action of this medicine.

^^Taking with food or drink

You can take this medicine with or without food or drink.

^^Pregnancy and breast-feeding

■    If you are pregnant or think you may be pregnant, tell your doctor or pharmacist. This medicine

i

should not be used during pregnancy unless advised by a doctor.

■    Do not take this medicine if you are breastfeeding until you speak with a doctor or pharmacist.

Driving and using machines

Benylin Mucus Cough Menthol flavour 100 mg/

5 ml oral solution is not expected to affect your ability to drive or operate machinery. However, if you do feel unwell, do not drive or use machinery.

^^Important information on some of the other ingredients in this medicine

■    4.7 vol % ethanol (alcohol), i.e. up to

400 mg per dose, equivalent to approximately 10 ml beer, 4 ml wine per 10 ml dose. 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 or kidney disease or epilepsy.

   Ponceau 4R (EI24) - red colouring - may cause allergic reactions.

■    17.6 mg sodium per 10 ml dose. This should be taken into consideration by those on a controlled sodium diet.

   Glucose and fructose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3 How to take this medicine

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

■    This solution is for oral use only.

   Do not use more than the stated dose

shown.

turn over c

3 How to take this medicine (continued)

Age

Dose

Adults and

Take two 5 ml spoonfuls

adolescents over

(total of I0 ml) 4 times

12 years

a day

Elderly

As for adults

Children under 12 years

Do not give

Patients with liver

Speak to a doctor or

or kidney problems

pharmacist

■    Do NOT take more than 4 doses (40 ml) in 24 hours.

■    Contact a doctor if your symptoms worsen or do not improve within 7 days.

^^If you take too much of this medicine

If anyone has too much, contact a doctor or your nearest Accident and Emergency Department taking this leaflet and pack with you.

If you take too much of this medicine you may develop kidney stones.

Symptoms may include:

■ Upset stomach, nausea and drowsiness.

^^If you forget to take this medicine

You should only take this medicine as required following the dosage instructions 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. Do not take more than 4 doses (40 ml) in 24 hours.

4    Possible side-effects

Like all medicines, Benylin Mucus Cough Menthol flavour 100 mg/5 ml oral solution can cause side-effects, although not everybody gets them.

If you experience any of the following STOP using the medicine and seek medical help immediately:

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

Mild effects that may occur include:

■    Nausea or vomiting.

■    Stomach pain and diarrhoea.

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 this medicine

■    Keep this medicine out of the reach and sight of children.

■    Do not store this medicine above 25°C.

■    Keep the product in the original packaging (bottle in a carton) to protect from light.

Do not use if bottle seal is broken when purchased.

■    Do not use this medicine after the expiry date which is stated on the bottle and outer carton after ‘EXP’. The expiry date refers to the last day of that month.

■    Use within 4 weeks of opening.

■    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 Benylin Mucus Cough Menthol flavour 100 mg/5 ml oral solution contains:

The active substance is guaifenesin. Each ml of oral solution contains 20 mg of guaifenesin. Each 10 ml of oral solution contains 200 mg of guaifenesin.

Other ingredients: Xanthan gum, sodium chloride, saccharin sodium, ammonium glycyrrhizate, citric acid, sodium citrate, macrogol glycerol hydroxystearate 40, levomenthol, raspberry flavour (includes ethanol, glucose and fructose), glycerol, macrogol 1500, propylene glycol, ethanol, purified water, sodium benzoate (E2II), Ponceau 4R (EI24), caramel (EI50)(includes glucose).

(for further information on some of the ingredients see Section 2).

What Benylin Mucus Cough Menthol flavour 100 mg/5 ml oral solution looks like and contents of the pack

Benylin Mucus Cough Menthol flavour I00 mg/

5 ml oral solution is a clear to slightly opalescent red solution for oral use only. It is available in a 150 ml brown glass bottle fitted with a plastic child resistant cap. A plastic dosing cup marked with a I0 ml graduation may be provided in the pack.

Marketing authorisation holder: McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

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

This package leaflet was prepared January 2014. Benylin is a registered trade mark.

McNeil^

^ Products Ltd.

F30967I

13/0039