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0015 PL 00063/0536 RTQ Section 4 SmPC Update with

CCDS

UmsTiTMin Min Oik Wiragary ft Hof Prangs

Fonder for oral solution

(paracetamol, guaifenesin and phenylephrine hydrochloride)

Please read this leaflet carefully before you take this medicine. If you are not sure of anything ask your pharmacist or doctor.

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

Lemsip Max All in One Wild Berry & Hot Orange Powder for Oral Solution contains a combination of ingredients which are effective in relieving the symptoms associated with colds and flu, including relief ofaches and pains, sore throats, headache, nasal congestion and lowering of temperature, and chesty coughs.

paracetamol is a war-known painkiller (anftlgfsjc) It is effective against aches and pains, including a headache, andean also reduce a fever (antipyretic). Guaifenesin (expectorant) allows you to cough up phlegm when suffering from a chesty cough. 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 e drink large quantities of alcohol.

As with all medicines Lemsip Max All in One Wild Berry & Hot Orange Powder for Oral Solution may hot be suitable for some people.

Do not take this medicine if:

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

• You have a serious heart condition ¹ • You have high blood pressure (hypertension) or an overactive thyroid ‘ I" YarareialdfigorlKve taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), usually used to treat depression.

You should ask the pharmaefat before taking Lemsip Max All in One Wild Berry & Hot Orange Powder for Oral Solution if

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

■ You are taking bcta-blockcre 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 ycrur liver or kidneys

•    You have non-cirrhotic liver disease (Kver disease that is not associated with changes in

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i • 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 domperidonc). The effect of blood thinning drugs (warfarin and other coumarins) maybe increased by paracetamol.

Some drugs may affect the way in which phenylephrine works (digoxin and cardiac glycosides).

Information about some of the Ingredients In your medldne

Contains aspartame, a source of phaiylalanine. May be harmful for people with phenylketonuria (an

Pregnancy and bresst-feedbe-

iThis product should not be used in women wife a history of pre-eclampsia.

jAsk ycrur doctor or pharmacist for advice before taking this product if you are pregnant or breast-feeding.

3. Howto take this medicine

[To be made into a hot drink. Dissolve one sachet in a mug of hot hut not boiling water.

Stir until dissolved. If preferred sweeten to taste with sugar, honey or your usual sweetener, lit is important to drink plenty of fluids when suffering from colds and flu.

Adults and children 12 yean of age and oven

Dose may be repeated in 4 to 6 hours. Do not take more than four sachets in a total of 24 hours. iDo not give to children under 12 years of age.

'If foe symptoms of your cold or flu persist for more than three days, or worsen, consult ycrur pharmacist iTalk to a doctor at once if you take too much of this medicine, even if you feet welL This is because too much paracetamol can came delayed, serious liver damage. You may experience symptoms of idizrineM, palpitations (irregular or forceful heartbeat), stomach pain or high blood pressure with headache if you take too much of this medicine.

'A. Po» [Do not use after the end of the month of fee expiry date (RXP month/year) shown on the pack. Do not store above 25^<,C(77°F). Store m the original package.

Contains the active ingredients paracetamol lOOOmg, guaifenesin 200mg and phenylephrine hydrochloride 12.2mg. The other ingredients are ascorbic acid (Vitamin Cj, citric acid, sucrose, aspartame, sodium citrate, saccharin sodium, enocyanin anid wild beny and hot orange flavour, w iHe product is available in cartons of8 or 10 sachets. Not all pack sizes may be marketed.

< Alternative format patient information for the visually impaired is available on request from the K Marketing Authorisation Holder/Mamifacturer ^ Reckitt Benckiser Healthcare (UK) Ltd, Hull, HUS 7DS.

S Marketing Authorisation Number: PL00063/0536

1.3.2 Mock-up

Max All in One Wildberry & Hot Orange National Powder