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Teva Max Strength Cold & Flu Day & Night Capsules Hard

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Document: leaflet MCNEIL PRODUCTS_PL 12063-0073 change

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SVDAFED

MUCUS RELIEF

DAY & NIGHT Capsules

Paracetamol, Caffeine & Phenylephrine

■    This medicine is used for the relief of symptoms associated with colds and flu, including stuffy nose, headache, fever, sore throat, aches ana pains.

■    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

■    If you have ever had a bad reaction to any of the ingredients. For the list of ingredients see section 6

■    Speak to your doctor:

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

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

   Follow the dosage instructions carefully. There are different capsules for day and night time doses. See section 3

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

Sudafed Mucus Relief Day & Night Capsules are used for the relief of symptoms associated with colds and flu, including stuffy nose, headache, fever, sore throat, aches and pains. The Day Capsules can also relieve tiredness and drowsiness. The Night Capsules contain paracetamol, an analgesic and antipyretic which helps to relieve pain and fever and phenylephrine hydrochloride, which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily.

The Day Capsules contain paracetamol and phenylephrine hydrochloride (as above) but also contain caffeine, which provides relief from fatigue (tiredness) associated with colds and flu. Caffeine can also increase pain relief from paracetamol.

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

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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.

■    Ifyou have severe heart disease or cardiovascular disorder(s).

■    Ifyou have high blood pressure.

■    Ifyou have an overactive thyroid gland.

■    Ifyou have a history of stomach ulcers.

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

If any of these apply to you, get advice from a doctor or pharmacist without using Sudafed Mucus Relief Day &

Night Capsules.

A Talk to your doctor or pharmacist...

■    Ifyou have liver or kidney problems.

■    Ifyou are taking alcohol.

■    Ifyou have a blood circulation problem (including Raynaud's Phenomenon).

■    Ifyou suffer from diabetes.

■    Ifyou are taking any other medicines, including:

tricyclic antidepressants (drugs used to treat mood disorders).

barbiturates (a kind of sleeping tablet). sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

antihypertensives (drugs used to treat high blood pressure such as beta blockers or vasodilators). colestyramine (used to lower blood cholesterol). metoclopramide or domperidone (used to treat nausea and vomiting).

anticoagulants (drugs used to thin the blood, such as warfarin).

Ifyou 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

A past, talk to a doctor or pharmacist.

Ifyou are pregnant or breast-feeding:

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

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A CONTAINS PARACETAMOL

■ Do not take anything else containing paracetamol while taking this medicine.

3 How to take this medicine

Check the table that follows to see how much medicine to take.

■    For oral use only.

■    Swallow the capsules whole with water. Do not chew.

■    Do not take more medicine than the label tells you to.

O Children under 12 years old

Do not give to children under 12 years old.

U Adults and children aged 12 years and over Age    Dosage

Adults and    Daytime: 2 red/yellow Day Capsules

children aged eveiy 4 - 6 hours, up to 3 times a day. 12years    Night time: 2 dark blue/light blue Night

and over    Capsules to be taken at night.

■    Leave at least 4 hours between doses.

■    Do not take more than 6 Day Capsules and 2 Night Capsules in 24 hours.

■    If you do not get better, talk to your doctor.

The Day time capsules contain caffeine and so may disrupt sleep if taken at night._

If anyone has too much

Talk to a doctor at once ifyou take too much of this medicine even ifyou feel well. This is because too much

A paracetamol can cause delayed, serious liver damage. Ifyou forget to take the medicine Ifyou 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

Sudafed Mucus Relief Day & Night Capsules can have side-effects, like all medicines, although these don't affect everyone and are usually mild.

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

■ Allergic reactions such as skin rash.

■ Raised blood pressure with headache, vomiting and palpitations.

■ An increase or decrease in heart rate.

■ You may become more prone to bleeding, bruising, fever and infections, sucn as sore throat and ulcers, due to changes in your blood.

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Other effects which may occur include:

■    Nausea.

■    Difficulty sleeping.

■    Tingling and coolness of the skin.

Very rare cases of serious skin reactions have been reported.

Reporting of side-effects

Ifyou 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 above 25°C.

Keep the product out of the sight and reach of children.

Do not use after the end of the month shown as an expiry date on the packaging.

6    Further information

What's in this medicine?

The active ingredients in Sudafed Mucus Relief Day & Night Capsules are: Day Capsule: Paracetamol 500 mg, caffeine 25 mg and phenylephrine hydrochloride 6.1 mg per capsule.

Night Capsule: Paracetamol 500 mg and phenylephrine hydrochloride 6.1 mg per capsule.

Other ingredients are: Day Capsules: Maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talc The capsule shell is made of gelatin and contains the colours quinoline yellow (E104), titanium dioxide (E171), patent blue V (E131) and erythrosine (E127).

Night Capsules: Maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate and talcThe capsule shell is made of gelatin and contains the colours titanium dioxide (E171), erythrosine (E127) and indigo carmine (E132).

What the medicine Looks like

Sudafed Mucus Relief Day & Night Capsules are red /yellow capsules (Day) and dark blue / light blue capsules (Night) and are available in packs containing 12 Day Capsules and 4 Night Capsules.

Marketing Authorisation holder and manufacturer:

Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

Distributor: McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

Sudafed is a registered trade mark.

This leaflet was revised June 2015.

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