SUDAFED

PRESSURE & PAIN Tablets

Pseudoephedrine hydrochloride & Ibuprofen

■    This medicine is used for the treatment of nasal and sinus congestion, headache, pain, inflammation, fever and other symptoms of colds and flu.

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

■    One of the active ingredients in this medicine is ibuprofen which is a non-steroidal anti-inflammatory (NSAID) painkiller.

■    Speak to your doctor:

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

If you are over 65.

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

■    Follow the dosage instructions carefully. See section 3 ►

■    Do not use this product and speak to your doctor If you are trying to get pregnant, suspect you are pregnant, are pregnant or are breast-feeding. See section 2 ►

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 Sinus Pressure & Pain Tablets is a medicine which is used to provide relief from the symptoms of nasal and sinus congestion, headache, pain, inflammation, fever and other symptoms of colds and flu.The tablets contain pseudoephedrine hydrochloride, which is a decongestant that relieves nasal and sinus congestion, and ibuprofen, which is a non-steroidal anti-inflammatory (NSAID) painkiller that relieves pain and headaches, reduces temperature and inflammation.

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. asthma, runny nose, swelling of face and throat, rash) after taking ibuprofen, any of the other ingredients (see section 6), aspirin or non-steroidal anti-inflammatory (NSAID) painkillers.

■    If you are taking any other painkillers (such as other nonsteroidal anti-inflammatory (NSAID) painkillers).

■    If you are currently taking aspirin at doses of above 75 mg a day.

■    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 decongestants.

■    If you are taking tricyclic antidepressants (used to treat depression).

□    If you are in the last 3 months of pregnancy.

■    If you have or have previously had:

heart, kidney or liver failure, a stomach ulcer, perforation or bleeding, closed angle glaucoma (increased pressure in the eye), high blood pressure, circulatory problems, a phaeochromocytoma (a rare tumour which affects your heart rate and blood pressure) or diabetes.

If any of these apply to you, get advice from a doctor or pharmacist without using Sudafed Sinus Pressure & Pain Tablets.

Talk to your doctor or pharmacist...

■    If you have any conditions which may put you

at risk of heart problems or stroke e.g. you suffer from diabetes, have high cholesterol or you smoke.

■    If you have or have previously had:

asthma or allergic diseases of the lungs, liver, kidney, stomach or bowel problems (e.g. ulcerative colitis or Crohn's Disease), heart disease, a stroke, a thyroid disorder or prostate problems (difficulty in passing water or needing to pass water often).

□    If you suffer from lupus (SLE, an allergic condition which causes joint pain, skin rashes and fever) or a similar disease.

■    If you have an intolerance to some sugars.

■    If you are in the first 6 months of pregnancy.

I

■    If you are over 65, as you may be more Likely to experience the side-effects of the medicine.

■    If you are taking any other medicines, including:

low dose aspirin, up to 75 mg a day.

anticoagulants (drugs that thin the blood, such as warfarin). diuretics (drugs to help you pass water). furazolidone (an anti-bacterial agent), medicines to treat heart problems (e.g. digoxin, quinidine).

antihypertensives (drugs used to treat high blood pressure such as guanethidine, reserpine, methyldopa). corticosteroids (a type of anti-inflammatory drug e.g. hydrocortisone).

lithium (used to treat mood disorders). methotrexate (used to treat arthritis). zidovudine (used to treat HIV).

sympathomimetic drugs (used to treat congestion and asthma). cyclosporin (used to suppress the body's immune system e.g. following a transplant). mifepristone (used in pregnancy termination). quinolone antibiotics (used to treat a wide range of infections).

SSRIantidepressants (e.g. fluoxetine). antiplatelet drugs (e.g. clopidogrel). tacrolimus (a transplant drug).

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 tiying to become pregnant, suspect you are pregnant, are pregnant or breast-feeding

■    Ibuprofen belongs to a group of medicines which may impair fertility in women.The effect is reversible on stopping the medicine. If you are having problems becoming pregnant talk to your doctor before using this product.

■    You should only take this product on doctors advice during the first 6 months of pregnancy.

■    Do NOT take ibuprofen if you are in the last

3 months of pregnancy due to potential harm to the unborn child.

■    You should speak to your doctor for advice before breastfeeding whilst taking this product.

turn over ►

Distance between cutted line/middel of the spot = 83.6 mm

Barcodes placed at 14 mm Hightfor bars : 10 mm

pharmacode 770 reading way

Some of the ingredients can cause problems

■    Methyl and propyl hydroxybenzoate may cause allergic reactions such as skin rash; this may occur after a few days.

■    This medicine contains sucrose. 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

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

■    For oral use only.

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

□ The medicine should be used for the shortest time possible and at the lowest dose to relieve your symptoms.

■    Take with a glass of water.

Q Children under 12 years

Do not give to children under the age of 12.

O Adults and children aged 12 years and over

Age    Dosage

Adults and children    One or two tablets

aged 12 years and over    every 4-6 hours.

■    Leave at least 4-6 hours between doses.

■    Do not take more than 6 tablets in 24 hours.

■    If symptoms persist or worsen, or if the medicine is needed for more than 10 days, talk to your doctor or pharmacist.

If anyone has too much

If anyone has taken too many tablets contact a doctor or your nearest Accident and Emergency Department (Casualty) 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 provided that the last dose was taken at least 4 hours ago. Do not take a double dose.

4 Possible side-effects

Sudafed Sinus Pressure & Pain Tablets 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 medical help:

■    Blood in your faeces (stools / motions).

■    Black tarry stools.

□    Vomiting any blood or dark particles that look like ground coffee.

■    Chest pains.

■    Unexplained wheezing, shortness of breath, skin rash (which may be severe and include blistering or peeling of the skin), mouth ulcers, swelling of the face, tongue or throat, itching or bruising, light-headed ness, racing heart or fluid retention, e.g. swollen ankles.

□    Stiff neck with headache, nausea, vomiting, fever, disorientation or sensitivity to bright light.

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

□    Unexplained stomach pain, indigestion, heartburn, feeling sick and / or vomiting.

■    Yellowing of the eyes and/or skin, which may be a sign of liver problems.

■    Severe sore throat with high fever.

■    Unexplained bruising, bleeding or tiredness or getting more infections (such as colds) than usual.

■    Difficulties passing water.

■    Fast irregular heart beat.

■    Muscle weakness.

■    Hallucinations.

Other effects which occur are listed below:

Uncommon:

■    Headache.

□    Difficulty sleeping, excitability, anxiety, tremor.

■    Dry mouth, thirst and loss of appetite.

Rare:

■    Diarrhoea, wind or constipation. If any of these become troublesome or last more than a few days, tell your doctor.

Very rare:

□    Worsening of colitis and Crohn's disease.

Other effects reported include:

■    High blood pressure.

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

Store below 30°C.

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

Do not use your medicine after the date shown as an expiiy 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 Sudafed Sinus Pressure & Pain Tablets are: Ibuprofen 200 mg and Pseudoephedrine hydrochloride 30 mg per tablet.

Other ingredients are: Maize starch, pregelatinised maize starch, croscarmellose sodium, colloidal silicon dioxide, sodium lauryl sulfate, stearic acid, sucrose, microcrystalline cellulose, camauba wax, shellac, iron oxide (El72), povidone, acetylated monoglyceride, titanium dioxide (El71), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216) and sodium hydroxide.

What the medicine looks like

Sudafed Sinus Pressure & Pain Tablets are light brown, sugar-coated tablets.They are available in packs of 12 or 24 tablets.

Marketing Authorisation holder:

McNeil Products Ltd, Maidenhead, Berkshire, SL6 3UG, UK.

Manufacturer: Janssen-Cilag, Domaine de Maigremont,

27100Val de Reuil, France.

This leaflet was revised September 2013.

Sudafed is a registered trade mark.

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364897E

CT5

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Job Bag No: 13-0078 Dimension: 145 x 210mm Version Number: 1 Date: 27/09/2013