Document: leaflet MAH BRAND 2_PL 00063-0104 change

• leaflet MAH BRAND 2_PL 00063-0104
• leaflet MAH BRAND_PL 00063-0104

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i    i    T^ehislp Max Cold ^FluTlus Capsules    i”“

|    ]    (paracetpmol, caffeine and phenylephrine hydrochloride)    ]

i    i    i Patient Information Leaflet '    '

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jPlease read this leaflet carefully befoi]e you take this medicine. If you are not| sure of anything asjc your pharmacist or doctor.    '    '    '

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jl. What is this medicine and what ifc it used for?    |    |    |

'Lemsip Max Cold & Flu Plus Capsules contain a combination of ingredients which are effective'in relieving the symptoms associated with colds and ilu, including relief of aches and pains, sore throats, headache, nasal Congestion and lowering of temperatujre.    |    |    |

[Paracetamol is a well-known painkiller (analgesic). It is elffective against aches and pains, including a headache, {and can also reduce a fever (antipyretic). Caffeine (a mile) stimulant), helps relieve fatigue and drowsiness through the day. Phenylephrine hydrochloridei (nasal decongestant) reduces swelling in the passages of the nose, relieving [nasal congestion £|nd reducing the pressure which may cajuse a headache.

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2. Before taking this medicine i    i    i    i

[Do not take this (nedicine with any {other paracetamol-containing products.    [

jAlso, you should |not drink large quantities of alcohol, Whilst taking this medicine.    |

|As with all medicines Lemsip Max Cpld & Flu Plus Capsjules may not be suitable for some people.

[Do not take this medicine if:    [    !

{• You are allergic to any ingredientj (see section 6 for farther information) i® You have a serious heart condition    i

You have higlji blood pressure (hypertension) or an oyeractive 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 pregnant or breast feeding    ]

[You should ask the pharmacist before taking Lemsip Max Cold & Flu Plus Capsules if:    [

You have Raypaud’s syndrome (poor blood circulation which makes the {fingers or toes pale pnd numb), or diabetes mellitus    i    '    i

You are taking beta-blockers for high blood pressure,[ or vasodilators (drpgs used to treat high blood pressure, leg pain due to vascular problems' or Raynaud’s syndrome)    ^1    1

You are taking tricyclic antidepressants (a specific class of drugs used to [treat depression), oiher decongestants^ or barbiturates (uspd to treat sleep problems or epilepsy)    ]    ]

You have a problem with your liver or kidneys or a history of stomach ulcer    i

You have nonl-cirrhotic liver disease (liver disease thpt is not associated ptith changes in the Structure of the liver)    i    i    i    i    i

You have closed angle glaucoma or prostatic enlargement    [    [

You are taking other medicines. Slome 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 ofplood thinning drug$ (warfarin and othe]r coumarins) may bp increased by paracetamol.

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

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[The capsules should be swallowed whole with water. Do fiot chew.    j    ]

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

The dosage for adults and children [12 years and over is 2 capsules to be t&ken every four to six hours.

|Do not take more than 8 capsules in 24 hours.

fro not give to children under 12 years.    !    !    !

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

immediate medical advice should be sought in the event of an overdose, even if you feel wel) because of the risk of delayed, serious liver damage.

]4. Possible side-effects    !    !    !    !

|*    Allergic reactions (such as skin rajshes)    ]    j

i* 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, l^ucopenia or ' neutropenia (reduction in white blood cells which makes infections more'likely)    '

]• Nausea ]    ]    ]    ]    ]

]• Stomach ulcers

i* Acute pancreatitis (after ingestion of above normal amounts)    i    i

]•    High blood pressure with headache    ]    ]    ]

f Central Nervous System effects such as difficulty in sleeping, restlessness/nervousness or mental confusion ] often accompanied by hallucinations (seeing and heading things that are i)ot there)    ]

Vomiting ^{1    1    1    1    1}

!• Palpitations (irregular or forceful heartbeats)    !    I    !

[• Caffeine, if ta|ren close to bedtim^, may interfere witl) sleep    ]    ]

i*    Difficulty in passing urine (in men only)    i    i    i

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[Tell your doctor of pharmacist if you have any side-effecfs after taking this nfedicine, including ^ny not listed in this leaflet. i    i    i    i    i

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[5. How to store ]    ]    ]    ]    ]

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

po not use after d)e end of the month ]of the expiry date (pXP month/year) st|own on the pack. ]

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

6. Further information    ]    ]    ]    ]

Lemsip Max Cold & Flu Plus Capsules contain the active ingredients paracetamol 500mg, caffeine 25mg and phenylephrine hydrochloride 6.1mg. The other ingredient]s are starch, croscaqmellose sodium, sodium laurilsulfate, magnesium stearate, sterilised talc, gelatin, titanium dioxide (El[71), patent blue V (E131), erythrosine (E1271) shellac and quinoline yellow (E104). !    I    1

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The product is available in cartons of ]8 and 16 capsules. ]

Marketing Authorisation Number: PL]00063/0104    ]    I    ]

[Marketing Authorisation Holder/Manjufacturer: Reckitt B]enckiser Healthcare] (UK) Ltd, Hull, HTJJ8 7DS

Leaflet last revised October 2015. Lemsip, Lemsip Max and ( T ) are trade marks.    !

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CUSTOMER INFO: Minimum Point Size = 9.00pt