Document: leaflet MAH BRAND_PL 00063-0143 change

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• leaflet MAH BRAND_PL 00063-0143
• leaflet MAH BRAND_PL 00063-0529

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Reckitt Benckiser

i    i    Lemsip Max Day &~Niglft~fcbId' & Flu Relief Capsules    ■" "

|    |    (paracejtamol, caffeine and phenylephrine hydrochloride)    ]

i Patient Information Leaflet i

[Please read this leaflet carefully before y[ou take this medicine. If you are not sure ([>f anything ask your pharmacist or doctor.

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

iLemsip Max Day <St Night Cold & Flu Relief Capsules contain a combination of ingredients which are elective in [relieving the symptoms associated with <j:olds and flu, including relief of aches and[pains, sore throats, headache, nasal congestion and lowering of temperature, i

(Paracetamol is a well-known painkiller ^analgesic). It is effective against aches and pains, including a headache, and can ^lso reduce a fever (antipyretic). Caffeinp (a mild stimulant), helps relieve fatigue ^nd drowsiness through the day (it is only used in the Dajy capsule). 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. [    [

^lso, you should njot drink large quantities of alcohol, whilst taking this medicine}.    [

(As with all medicines Lemsip Max Day & Night Cold & Flu Relief Capsules may not be suitable for some people. iDo not take this medicine if:    !    !    !    !

[•    You are allergic fo any ingredient (see[ section 6 for further [information)    [    [

i*    You have a serious heart condition    ■    ■    ■    ■

[• You have high bfood pressure (hypertension) or an overactijve thyroid    [    [

You are taking of have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), usually i    used to treat depression    i    i    i    i

[*    You are taking other sympathomimetip decongestants    [    [    [

[You should ask thp pharmacist before faking Lemsip Max pay & Night Cold & flu Relief Capsules 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 usetj to treat high blood pressure, leg pain i    due to vascular problems or Raynaud’s syndrome)    i    i    i

|*    You are taking trjicyclic antidepressanfs    [    [    [

' (a specific class of drugs used to treat depression), other decongestants, or barbiturates (used to treat sleep problems or

[    epilepsy)    I    [    I    [    [

*• You have a problem with your liver of kidneys or a history of stomach ulcer ¹

!• You have non-cirrhotic liver disease (liver disease that is not associated with changes in the structure of the liver)

[*    You have closed [angle glaucoma or pfostatic enlargement [    [    [

i* You are taking other medicines. Some drugs may affect the way in which paracetamol works, including those used to [ treat blood cholesterol (cholestyraminjs) and nausea and vofniting (metoclopramfde and domperidone). The effect of i blood thinning drugs (warfarin and other coumarins) may be increased by paracetamol. Some drugs may affect the way ! in which phenylephrine works (digoxrn and cardiac glycosides). The speed at wlaich caffeine is disposed of by the body [ can be slowed dcfwn by cimetidine (u^ed to reduce stomaclf acid), disulfiram (usjsd to treat alcoholism) or oral i contraceptives, i Pregnancy and breast-feeding-

[This product should not be used in wom^n with a history of pfe-eclampsia.    [    [

[ i---“| rr>---Ask your doctor or pharmacist for advice before taking this product if you are

I    ! j JJll pregnant or breast-feeding.    !    !

i    i . did d , i    i    i    i

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3.How to take thismedidne

fhe capsules should be swallowed whol^ with water. Do not fhew.

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

	Dose	i i
	Daytime	Night time]
Adults and children over 12	Two red and yellow cajpsules every 4-6 houfs. Maximum daytime dosage: 6 capsules ;	Two blue and red capsules to be] taken at bed time. Maximum'night time dosage: 2 capsules
	Do not exceed 8 capsules in total in any 24 hours 1 1

Do not give to children under 12 years.    ¹¹

if the symptoms of your cold and flu persist for more than 3 days, or worsen consult your pharmacist. !

[Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because to<f much paracetamol can cause delayed, serious liver damage. You may experience symptoms of dimness, palpitations (irregular} or forceful heartbeat), stomach pain or high blood pressure jvith headache if you[take too much of thip medicine.

A. Possible side-effects    !    !    !    !    [

[• Allergic reactions (such as skin rashesQ    !    !    !    ¹

i* Very rare cases of serious skin reactions have been reported.    i    '    [

[• Blood disorders, such as thrombocytopenia (reduction in bl[ood platelets which might mean that you tjleed or bruise    ¹

¹ more easily), pancytopenia (reduction¹ in white and red blood cells), agranulocytosis, leucopenia or neutropenia    !

i (reduction in white blood cells which makes infections more likely)    i    i

[* Nausea or vomiting    !    !    !    !    ¹

i* Stomach discomfort.    i    i    i    i    [

[• Difficulty in sleeping, restlessness, nefvousness or mental confusion. If you are Effected by any of thejse symptoms, do ■ ¹ not drive or use machines    ^{1    1    1    1}    [

!• Caffeine, if taken close to bedtime, may interfere with sleep    !    !

[• Difficulty in passing urine (especially [in males)    !    !    !    ¹

Reporting of side effects    i    i    i    i    [

[If you get any side Effects, talk to your doctor, pharmacist or i)urse. This includes a[ny possible side effects not listed in this i 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 informatlion on the safety of this Medicine.    [

5. How to store    i    i    i    i    [

JCeep all medicines out of the sight and rjeach of children. [    [    [

Do not use after the end of the month of the expiry date (EXP'month/year) shown on pack.    ¹    [

[Do not store above [25°C (77°F). Store in the original package.    !    !

6. Further information    i    '    '    '

[Red and yellow Day capsules contain the!active ingredients paracetamol 500mg, caffeine 25mg and phenylephrine hydrochloride 6.1 mg. The other ingredients are starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, sterilised talc, gelatin, titanium dioxide (Iil71), patent blue V (&131), erythrosine (El27) shellac and quinoline yellow (E104). [Red and blue Night capsules contain the [active ingredients paracetamol 500mg an4 phenylephrine hydrOchloride 6.1 mg. iThe other ingredients are starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, sterilised talc, gelatin, titanium dioxide (E[171), quinoline yelloV (El 04), patent blu^ V (El31) and erythrjDsine (E127) shellac. [

The product is available in cartons of 8 and 16 capsules.    ^{1    1    1}

[Marketing Authorisation Number: PL00()63/0143    [    [    [

[Marketing Authorisation Holder/Manuf^cturer: Reckitt Benckiser Healthcare (UK) Ltd, Hull, HU8_7DS[

[Leaflet last revised April 2016    [    [    [ [    [ [

iLemsip, Lemsip Max and ( T ) are trade marks    !    ! !    ! !    , .

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