■    This medicine is used to relieve the symptoms of colds, flu and allergies including aches, pains, fever, nasal and sinus congestion.

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

■    Do not take this medicine:

There are some people who should not take 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. These are shown in the table.

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

Non-Drowsy Sinutab relieves the symptoms of colds, flu and allergies including aches, pains, fever, nasal and sinus congestion.

The tablets contain paracetamol, an analgesic and antipyretic to relieve pain and fever, and pseudoephedrine, a decongestant to clear nasal congestion and blocked sinuses.

This 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 (e.g. rash, swelling of the face and throat, difficulty breathing) to any of the ingredients.

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

■    If you are taking any other medicines containing paracetamol.

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

■    For children under 12 years old.

If any of these apply to you, get advice from a

doctor or pharmacist without using

Non-Drowsy Sinutab.

Talk to your doctor or pharmacist...

■    If you have liver or kidney problems.

■    If you have alcohol dependence.

■    If you have high blood pressure or heart disease.

■    If you have diabetes.

■    If you have an overactive thyroid gland.

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

■    If you have prostate problems (difficulty with

passing water or needing to pass water often).

■    If you are taking any other medicines, including:

Antihypertensives (drugs to treat high blood pressure such as guanethidine, methyldopa, alpha and beta blockers, debrisoquine, bretylium and betanidine).

Sympathomimetic drugs (stimulants or appetite suppressants and drugs used to treat congestion and asthma).

Tricyclic antidepressants (used to treat mood disorders).

Colestyramine (to lower blood cholesterol).

Metociopramide and domperidone (to treat nausea and vomiting).

Anticoagulants (to thin the blood such as warfarin).

Barbiturates (used to treat anxiety or help you sleep).

Oral contraceptives ("the pill"). Anticonvulsants (drugs used to treat epilepsy). 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:

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

3 How to take this medicine

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

■ For oral use only.

turn over^

■    Do not take more than the stated dose shown.

■    Take with a glass of water.

3 How to take this medicine

(continued)

o Children under 12 years

Do not give to children under 12 years old.

O Adults and children aged 12 years and over

Dose

Adnlts and children 2 tablets every 4 - 6 hours, aged 16 years and over up to 4 times a day Children aged 12 years 1 tablet every 4 - 6 hours, to 15 years    up to 4 times a day

■    Leave at least 4 hours between doses.

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

■    If symptoms persist talk to your doctor.

klf anyone has too much

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver

Aklf 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

Non-Drowsy Sinutab 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 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 men, especially those with prostate problems, may have trouble passing water.

■    There have been rare reports of blood disorders in people taking paracetamol, the symptoms of which include unusual tiredness, unexpected bruising or bleeding and getting more infections (such as colds) than normal.

Long-term use

■    People who use medicine containing paracetamol every day for a long time (several months or more) could get certain side-effects including liver and kidney damage. People taking paracetamol in the usual way for shorter periods have not had these problems.

Other effects which may occur include:

■    Restlessness, having trouble getting to sleep or

Reporting of side effects

If you experiences 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.

Store in the original packaging.

Keep 1he product out of the sight and reach of children. Do not use your medicine 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.

6    Further information

What's in this medicine?

The active ingredients in Non-Drowsy Sinutab are:

500 mg Paracetamol and

30 mg Pseudoephedrine hydrochloride per tablet. Other ingredients are: Pregelatinised maize starch, crospovidone, povidone K30, stearic acid, microcrystalline cellulose, sodium starch glycollate, magnesium stearate.

What the medicine looks like

Non-Drowsy Sinutab tablets are white round tablets, available in packs of 15 tablets.

Product Licence holder:

McNeil Products Ltd, Maidenhead, Berkshire,

SL6 3UG, UK.

Manufacturer: Janssen-Cilag, Domaine de Maigremont, 27100 Val de Reuil, France.

This leaflet was revised October 2016.

Sinutab is a registered trade mark.

MCNetT)    16-0540

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