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Multi-Action ACTIFED® Dry Coughs

pseudoephedrine, triprolidine, dextromethorphan

■    This medicine is used to help relieve symptoms of cold and flu including irritating dry cough and related congestion symptoms.

■    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 n 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 for

Multi-Action Actifed Dry Coughs is a medicine which is used to help relieve dry coughs and related congestion symptoms. The liquid contains triprolidine hydrochloride which is an antihistamine that helps stop sneezing, runny nose and watery eyes, pseudoephedrine hydrochloride which is a decongestant that unblocks stuffy noses and dextromethorphan hydrobromide which is an antitussive to help stop coughing.

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...

n If you have ever had a bad reaction to any of the ingredients.

■    If you have very high blood pressure or severe heart disease.

n 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 furazolidone (an antibacterial agent).

n If you have had a cough for a few weeks, or a cough which brings up any blood or a lot of mucus that may be caused by asthma or other serious breathing difficulties. n If you are taking any other cough and cold medicine.

■    For children under 12 years old.

If any of these apply to you, get advice from a doctor or pharmacist without using MultiAction Actifed Dry Coughs.

^. Talk to your doctor or pharmacist.

n If you suffer from liver or kidney problems. n If you have high blood pressure or heart disease.

■    If you have diabetes or have been told by your doctor that you have an intolerance to some sugars.

n If you have glaucoma (increased pressure in the eye).

n If you have an overactive thyroid gland.

n If you have prostate problems (difficulty with passing water or needing to pass water often). n If you are taking alcohol.

■    If you are taking any other medicines, including:

Sedatives (drugs used to treat anxiety and tension).

n Tricyclic antidepressants (used to treat mood disorders).

n Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma). n Antihypertensives (drugs used to treat high blood pressure such as guanethidine, methyldopa, alpha and beta blockers, debrisoquine, bretylium and betanidine).

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.

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If you are pregnant or breast-feeding

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

Special warnings about this medicine

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

n This medicine can affect your ability to drive as it may make you sleepy or dizzy.

■    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.

■    However, you would not be committing an offence if:

n The medicine has been taken to treat a medical or dental problem and

You have taken it according to the information provided with the medicine and n 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.

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law

Some of the ingredients can cause problems

■    Each 5 ml of this medicine contains 2.8 g of sucrose. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

■    This medicine contains 5% v/v ethanol (alcohol), which is up to 190 mg per 5 ml, equal to 5 ml beer or 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 and epilepsy.

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■    Methyl hydroxybenzoate (E2I8) may cause allergic reactions such as skin rash; this may happen after a few days.

■    The colouring in this medicine may cause allergic reactions.

3 How to take this medicine

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

■    For oral use only.

■    Always shake the bottle thoroughly before use.

■    Do not take more than the stated dose shown in the table.

■    Do not overfill the spoon.

There is a double-ended spoon in the pack.

O Children under 12 years old

Do not give this medicine to children under I2 years old.

O Adults and Children aged 12 years and over

Age    Dosage

Adults and    Take two large 5 ml

children aged 12 spoonfuls every 4 - 6 years and over    hours, up to 4 times a day.

■    Do not take more than 4 doses in 24 hours.

■    Leave at least 4 hours between doses.

■    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

If you forget to take a dose, take the next dose when needed provided that the last dose was taken at least 4 hours ago. Do not take a double dose.

4    Possible side-effects

Multi-Action Actifed Dry Coughs 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 taking this medicine and talk to your doctor:

■    A few people have had hallucinations, but this is rare.

■    Occasionally people get skin rashes that are sometimes itchy.

■    A few people may find their heartbeat increased.

■    A few men, especially those with prostate problems, may have trouble passing water.

■    Nausea, vomiting and upset stomach.

Other effects which may occur include:

■    Restlessness, having trouble getting to sleep or bad dreams.

■    Drowsiness.

■ Dry mouth, nose or throat.

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    Storing this medicine

Do not store this product above 25°C.

Keep the bottle in the outer carton and away from light. Keep the product out of the reach and sight of children. Do not use after the end of the month 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.

CRR: 318150 Ref: F310xxx 15/0148 v10

Dimension:160 x 210mm Date: 04/05/2015

6 Further Information

What’s in this medicine?

The active ingredients in 5 ml of Multi-Action Actifed Dry Coughs are:

Triprolidine hydrochloride I.25 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide I0 mg.

Other ingredients are: Sorbitol, sucrose, sodium benzoate (E2II), methyl hydroxybenzoate (E2I8), ponceau 4R (EI24), alcohol, blackberry flavour, levomenthol, vanillin and purified water.

What the medicine looks like

Multi-Action Actifed Dry Coughs is a clear red liquid available in I00 ml bottles.

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

The Manufacturer: Famar Orleans,

5 avenue de Concyr, 4507I Orleans, Cedex 2, France This leaflet was revised May 2015.

Actifed is a registered trade mark.

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04/05/15