Document: leaflet MAH BRAND 2_PL 00063-0143 change

• leaflet MAH BRAND 2_PL 00063-0143
• leaflet MAH BRAND 2_PL 00063-0529
• leaflet MAH BRAND_PL 00063-0143
• leaflet MAH BRAND_PL 00063-0529

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i    Lemsip Max^-Cold'S FIuFlus Day S Night RelierCapsuIes    r~

]    (paracet4mol, caffeine and phenylephrine hydrochloride)    ]

i    ' Patient Information Leaflet '    '

I    I    I    I    I

please read this leaflet carefully befoi]e you take this medicine. If you are not| sure of anything asjc your pharmacist or doctor.    ¹¹¹

II    I    I    I    I

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

Lemsip Max Cold & Flu Plus Day & Night Relief Capsules contain a combination of ingredients which are effective in relieving the symptoms associated with colds land flu, including relief of aches and pains, sore throats, headache, nasal congestion and lowering of temperature, j    j    j

paracetamol is a ^ell-known painkiller (analgesic). It is effective against achps and pains, including a headache, and can also reduce a fever (antipyretic). Caffeine (a mila stimulant), helps relieve fatigue and drowsiness through (he day (it is only psed in the Day capsule). Phenylephrinp hydrochloride (na^al decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache.

|2. Before taking (his medicine I    I    I    I

Do not take this medicine with any other paracetamohcontaining products.    ¹

Also, you should Inot drink large quantities of alcohol, whilst taking this medicine.

[As with all medicares Lemsip Max Col]d & Flu Plus Day & [Night Relief Capsules may not be suitable for some people. Do not take this medicine if:

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

You have a seripus heart condition j    [    [    [

You have high blood pressure (hypertension) or an overactive thyroid i

You are taking pr have taken withni the last 14 days a rjiedicine called a monoamine oxidase inhibitor (MAOI), usually used to treat depression ^{1    1    1    1}

You are pregnant or breast feeding III!

I    I    I    I

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

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

You are taking beta-blockers for high blood pressure, or vasodilators (drugs used to treat high blood pressure, leg pain due to Vascular problems qr Raynaud’s syndro(ne)    |    |

You are taking tricyclic antidepressants    ^{1    1    1}

(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 or a history of stomach ulcer

You have non-c)rrhotic liver diseasp (liver disease that i|s not associated with changes in the stricture of the liver) You have closed angle glaucoma or prostatic enlargement    ¹

You are taking other medicines. Some drugs may affect the way in which paracetamol works, including those used to treat bipod cholesterol (cholestyramine) and nafisea and vomiting (jmetoclopramide anp domperidone). The effect of blood thinning drugs (warfarin and other coumarins) may be mcreased by paracetamol. Some drugs may affect the way in which phenylephrine workjs (digoxin and cardiac glycosides). Thp speed at which caffeine is disposed of by the body can be slowed down by cimetidine (used to reduce stomach acid), disulfiram (used to treat alcoholism) or oral contraceptives. |

3. How to take this medicine

the capsules should be swallowed whole with water. Do not chew.

If is important to driifk plenty of fluids When suffering from [colds and flu.

. -RB0&Q21!

Pharmacode Reads This Way

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Last Bar    First Bar

-c:-

i    Lemsip Max^-Cold'S FIuFlus Day S Night RelierCapsuIes    r~

]    (paracet4mol, caffeine and phenylephrine hydrochloride)    ]

i    ' Patient Information Leaflet '    '

I    I    I    I    I

please read this leaflet carefully befoi]e you take this medicine. If you are not| sure of anything asjc your pharmacist or doctor.    ¹¹¹

II    I    I    I    I

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

Lemsip Max Cold & Flu Plus Day & Night Relief Capsules contain a combination of ingredients which are effective in relieving the symptoms associated with colds land flu, including relief of aches and pains, sore throats, headache, nasal congestion and lowering of temperature, j    j    j

paracetamol is a ^ell-known painkiller (analgesic). It is effective against achps and pains, including a headache, and can also reduce a fever (antipyretic). Caffeine (a mila stimulant), helps relieve fatigue and drowsiness through (he day (it is only psed in the Day capsule). Phenylephrinp hydrochloride (na^al decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache.

|2. Before taking (his medicine I    I    I    I

Do not take this medicine with any other paracetamohcontaining products.    ¹

Also, you should Inot drink large quantities of alcohol, whilst taking this medicine.

[As with all medicares Lemsip Max Col]d & Flu Plus Day & [Night Relief Capsules may not be suitable for some people. Do not take this medicine if:

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

You have a seripus heart condition j    [    [    [

You have high blood pressure (hypertension) or an overactive thyroid i

You are taking pr have taken withni the last 14 days a rjiedicine called a monoamine oxidase inhibitor (MAOI), usually used to treat depression ^{1    1    1    1}

You are pregnant or breast feeding III!

I    I    I    I

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

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

You are taking beta-blockers for high blood pressure, or vasodilators (drugs used to treat high blood pressure, leg pain due to Vascular problems qr Raynaud’s syndro(ne)    |    |

You are taking tricyclic antidepressants    ^{1    1    1}

(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 or a history of stomach ulcer

You have non-c)rrhotic liver diseasp (liver disease that i|s not associated with changes in the stricture of the liver) You have closed angle glaucoma or prostatic enlargement    ¹

You are taking other medicines. Some drugs may affect the way in which paracetamol works, including those used to treat bipod cholesterol (cholestyramine) and nafisea and vomiting (jmetoclopramide anp domperidone). The effect of blood thinning drugs (warfarin and other coumarins) may be mcreased by paracetamol. Some drugs may affect the way in which phenylephrine workjs (digoxin and cardiac glycosides). Thp speed at which caffeine is disposed of by the body can be slowed down by cimetidine (used to reduce stomach acid), disulfiram (used to treat alcoholism) or oral contraceptives. |

3. How to take this medicine

the capsules should be swallowed whole with water. Do not chew.

If is important to driifk plenty of fluids When suffering from [colds and flu.

. -RB0&Q21!

'Do not give to children under 12 years.

if the symptoms olf your cold and flu persist for more than 3 days, or worsen consult your pharmacist, immediate medical advice should b{e sought in the evefit of overdose, evefi if you feel well because of the risk of delayed, serious liver damage, i

4. Possible side-effects    !    !    !    !

'• Allergic reactions (such as skin rashes)    '    '    i

!• Blood disorders, such as thrombocytopenia (reduction jn blood platelets which might mean that you bleed or

| bruise more easily), pancytopenia (reduction in white and red blood cells),^agranulocytosis, leucopenia or

I    neutropenia (reduction in white blood cells which makes infections more likely)    !

|* Nausea or vomiting    !    !    !    !

i* Stomach ulcers i    i    i    i    i

|* Acute pancreatitis (after ingestion c)f above normal amounts)    |    |

'• High blood pressure with headache¹

!• Central Nervous System effects such as difficulty in sleeping, restlessness/riervousness or mental confusion often ] accompanied b^ hallucinations (seejing and hearing things that are not ther£) i* Palpitations (irregular or forceful heartbeats)

]• Caffeine, if tak^n close to bedtime, |may interfere with £leep » Difficulty in passing urine (in men only)

Pell your doctor of pharmacist if you have any side-effecljs after taking this medicine, including any not listed in [this leaflet. ]    ]    ]    j    ]

|5. How to store !    !    !    I    !

Keep all medicinejs out of the sight an|d reach of children'    j    j

Do not use after the end of the month iof the expiry date (EXP month/year) shown on pack, po not store abovf 25°C (77°F). Stor£ in the original package.    |    |

6. Further information

ped and yellow Dhy capsules contain|the active ingredients paracetamol 500(ng, caffeine 25mg hnd phenylephrine 'hydrochloride 6.1mg. The other ingredients are starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, sterilised!talc, gelatin, titanium dioxide (E171), patent blue V (E13l), erythrosine (E127!) shellac and buinoline yellow (El04).    '    ]    |    ]

Red and blue Night capsules contain the active ingredients paracetamol 500mg and phenylephrine hydrochloride ]6.1mg. The other fngredients are starcjh, croscarmellose sodium, sodium laurflsulfate, magnesiunf stearate, sterilised talc, gelatin, titanium dioxide (E171), quinoline¹ yellow (E104), patent blue V (E131) and erythrosine (E127) shellac. !    !    !    !

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

Marketing Authorisation Number: PL00063/0143 i

Marketing Authorisation Holder/Manfifacturer:Reckitt B^nckiser Healthcare ](UK) Ltd, Hull, HU[8 7DS

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peaflet last revised October 2015.    |    |

Pemsip, Lemsip hllax and (^) are trlade marks