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Reckitt Benckiser

0018 PL-00063-0069 CCDS RTQ Section 4

i    XemsipMax Cold &Tlu Lemon

i    (paracetamol and phenylephrine hydrochloride)

Patent Information Leaflet

Please read this leaflet carefully before you take this medicine. If you are not sure of anything

ask your pharmacist or doctor.

il. What is this medicine and what is it used for?

[Lemsip Max Cold & Flu Lemon contains a combination of ingredients which are effective in relieving the symptoms associated with colds and flu, including relief of aches and pains,

[sore throats, headache, nasal congestion and lowering of temperature.

Paracetamol is a well-known painkiller (analgesic). It is effective against aches and pains, including a headache, and can also reduce a fever (antipyretic). Phenylephrine hydrochloride |(nasal decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache.

2. Before taking this medicine

[Do not take this medicine with any other paracetamol-containing products. Also, you should not drink large quantities of alcohol, whilst taking this medicine.

[As with all medicines Lemsip Max Cold & Flu Lemon may not be suitable for some people. iDo not take this medicine if:

You are allergic to any ingredient (see section 6 for further information)

You have a serious heart condition

You have high blood pressure (hypertension) or an overactive thyroid You are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), usually used to treat depression.

You are taking other sympathomimetic decongestants [You should ask the pharmacist before taking Lemsip Max Cold & Flu Lemon if:

You have Raynaud’s syndrome (poor blood circulation which makes the fingers or toes pale and numb), or diabetes mellitus

You are taking beta-blockers for high blood pressure, or vasodilators (drugs used to treat high blood pressure, leg pain due to vascular problems or Raynaud’s syndrome)

You are taking tricyclic antidepressants (a specific class of drugs used to treat depression), other decongestants, or barbiturates (used to treat sleep problems or epilepsy)

You have a problem with your liver or kidneys

You have non-cinhotic liver disease (liver disease that is not associated with changes in tiie structure of the liver)

You have closed angle glaucoma or prostatic enlargement

You are taking other medicines. Some drugs may affect the way in which paracetamol works, including those used to treat blood cholesterol (cholestyramine) and nausea and vomiting (metoclopramide and domperidone). The effect of blood thinning drugs (warfarin and other coumarins) may be increased by paracetamol. Some drugs may affect the way in which phenylephrine works (digoxin and cardiac glycosides). [Informatioii about some of the ingredients in your medicine 'If you have phenylketonuria (an inherited genetic disorder) please note that this product contains aspartame, a source of phenylalanine. This medicine also contains sucrose and [lactose, therefore if you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

[Total sugars 2.2g. This product also contains 840mg sucrose per sachet dose.

This product contains 59.56 mg (2.59 mmol) sodium per dose - to be taken into consideration for patients on a controlled sodium diet.

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Pregnancy and breast-feeding

This product should not be used in women with a history of pre-eclampsia.

Ask your doctor or pharmacist for advice before taking this product if you are pregnant or

3. How to take this medicine

[To be made into a hot drink. Dissolve one sachet in a mug of hot but not boiling water. Stir until dissolved. If preferred sweeten to taste with sugar, honey or your usual sweetener.

[It is important to drink plenty of fluids when suffering from colds and flu.

[Adults and children 12 years and over:

Dose may be repeated in 4 to 6 hours. Do not take more than four sachets in a total of 24 hours.

[Do not give to children under 12 years.

[If the symptoms of your cold or flu persist for more than three days, or worsen, consult your

Talk to a doctor at once if you take too much of this medicine, even if you feel welL This js because too much paracetamol can cause delayed, serious liver damage. You may experience symptoms of dizziness, palpitations (irregular or forceful heartbeat), stomach pain or high blood pressure with headache if you take too much of this medicine.

[4. Possible side-effects

i • Allergic reactions (such as skin rashes)

[ • Very rare cases of serious skin reactions have been reported

¹ * Blood disorders, such as thrombocytopenia (reduction in blood platelets which might mean that you bleed or bruise more easily), pancytopenia (reduction in white and red blood cells), agranulocytosis, leucopenia or neutropenia (reduction in white blood cells which makes infections more likely)

[ • Vomiting and Nausea

i * Abdominal discomfort

| • Difficulty in passing urine (especially in males).

[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. How to store

Keep all medicines out of the sight and reach of children.

Do not use after the end of the month of the expiry date (EXP month/year) shown on the pack. [Do not store above 25°C (77°F). Store in the original package.

6. Further information

Contains the active ingredients paracetamol lOOOmg and phenylephrine hydrochloride 12.2mg. The other ingredients are ascorbic acid (Vitamin C), citric acid, sucrose, aspartame, sodium citrate, saccharin sodium, curcumin (contains curcumin El00, lactose, polysorbate 80 E433 and silica E551) and lemon flavour.

The product is available in cartons of 5,7,9 and 10 sachets.

Marketing Authorisation Number: PL00063/0069

Marketing Authorisation Holder/Manufacturer: Reckitt Benckiser Healthcare (UK) Ltd, Hull, HU87DS

Leaflet last revised Feb 2016. Lemsip, Lemsip Max and {    1 are trade marks.

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Lemsip Max Cold & Flu Lemon EU National 1000mg 12.2mg

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