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Lemsip Max Day & Night Cold & Flu Relief Capsules.

Document: leaflet MAH BRAND 2_PL 00063-0529 change

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i    i    Lemsip iviai Cord"& TIu Plus Day &NightReliei'Capsules    i    ]

]    ]    (paracejamol, caffeine and phenylephrine hydrochloride)    ]    i

'    '    ' Patient Information Leaflet '    '

I    I    I    I    I    I

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

[doctor.    I    I    I    !    I    1

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

lemsip Max Cold j& Flu Plus Day & Njght Relief Capsules [contain a comhinatioin of ingredients whifh are effective in i 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 wfell-known painkiller (analgesic). It is effective against aches apd pains, including a [headache, and can i also reduce a feveri (antipyretic). Caffeine (a mild stimulant)) helps relieve fatigue and drowsiness through the day (it is [ [only used in the D4y capsule). Phenylephrine hydrochloride [(nasal decongestant)! reduces swelling in (he passages of the i nose, relieving nasal congestion and reducing the pressure which may cause a headache.    |    [

'l. Before taking tins medicine !    !    !    !    [

po not take this n)edicine with any otper paracetamol-containing products. [    [

'Also, you should not drink large quantities of alcohol, whilst taking this medicine.    '

[As with all medicines Lemsip Max Colijl & Flu Plus Day & Night Relief Capsules may not be suitably for some people. 1 Do not take this medicine if:    1    1    1    1    [

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

[ • You have a seriops heart condition [    [    [    [    1

s

tf)


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

[ • You are taking or have taken within tfe last 14 days a medicine called a monoamine oxidase inhihitjor (MAOI),

1 usually used to treat depression 1    1    1    1    [

!• You are pregnant or breast feeding !    !    !    !

[You should ask thf pharmacist beforf taking Lemsip Max [Cold & Flu Plus DaJ & Night Relief Capsules if: i • You have Raynaud’s syndrome (pooriblood circulation which makes the fingers or toes pale and numb), or diabetes [ mellitus    !!!!!'

1 • 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 Raynaudi’s syndrome) [    [    [

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

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

I • 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 prostatic enlargement!    [    [

[ • You are taking other medicines. Some 'drugs may affect the [way in which paracetamol works, including those used to treat! I blood cholesterol (cholestyramine) and nausea and vomiting (metoclopramide and domperidone). The effect of blood [ thinning drugs (vfarfarm and other copmarins) may he increased by paracetamol. [Some drugs may affdct the way in which ' phenylephrine works (digoxin and cardiac glycosides). The speed at which caffeine is disposed of by the body can be    [

[ slowed down by fimetidme (used to rejduce stomach acid), (Jisulfiram (used to trejat alcoholism) or oral contraceptives.    '

3- How to take thi|s medicine    !    [

'The capsules should be swallowed whole with water. Do not chew.

[It is important to djink plenty of fluids (vhen suffering from folds and flu.


Pharmacode Reads This Way

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Last Bar


First Bar


150


Dose

Daytime

Night time [

Adults and

Two red and yellow} capsules every 4-6 flours.

Two blue ar}d red capsules to be [taken at bed time.

children over 12

Maximum daytime dosage: 6 capsules

Maximum night time dosage: 2 capsules

Do not exceed 8 capsules in total in any 24 hours


Do not give to children under 12 years.

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

Immediate medical advice should be sought in the event of overdose, even if you feel well because of the risk of delayed, serious liver damage.

[4. Possible side-effects    !

Allergic reactions (such as skin rashes)

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 bl()od cells), agranulocytosis, leucopenia or Neutropenia (reduction in white blood cells which makes infections more likely)

Nausea or vomiting    !    |

Stomach ulcers 1    1    1

Acute pancreatitis (after ingestion of above normal amounts)

High blood pressure with headache ]    [

Central Nervousi System effects suchias difficulty in sleeping, restlessness/nervousness or mental confusion often accompanied by[hallucinations (seeing and hearing things! that are not there)

Palpitations (irregular or forceful heartbeats)    1

Caffeine, if taken close to bedtime, may interfere with sleep Difficulty in passing urine (in men oifly)    [

Tell your doctor oripharmacist if you have any side-effects after taking this medicine, including any not listed in this [leaflet.    !

5.    How to store

Keep all medicines out of the sight and reach of children, i    i

po not use after thp end of the month of the expiry date (EXp month/year) showi) on pack.

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

6.    Further information    !    I    !

[Red and yellow Da[y capsules contain tl)e active ingredients paracetamol 500mg, [caffeine 25mg and ppenylephrine hydrochloride 6.1mg. The other ingredients are starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, [sterilised talc, gelatin, titanium dioxide (E171), patent blue V (E131), erythrosinei (E127) shellac and 4uinoline yellow (E104).

Red and blue Night capsules contain the active ingredients paracetamol 500mg and phenylephrine hydrochloride 6. lmg. [The other ingredients are starch, croscafmellose sodium, sodium laurilsulfate, ma[gnesium stearate, sterilised talc, gelatin, titanium dioxide (E171), quinoline yellow (E104), patent blue V (E131) and erythrosine (E127) shellac.

[The product is available in a carton of 2[4 capsules.    [    [    [

Marketing Authorisation Number: PL 00063/0529

Marketing Authorisation Holder/Manufacturer:Reckitt Benckiser Healthcare (Uf*) Ltd, Hull, HU8 7pS [Leaflet last revised] October 2015.


Lemsip, Lemsip Max and (J) are trade marks


. RH.05Q261


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i    i    Lemsip iviai Cord"& TIu Plus Day &NightReliei'Capsules    i    ]

]    ]    (paracetamol, caffeine and pfienylephrine hydrochloride)    ]    i

'    '    ' Patient Information Leaflet '    '

I    I    I    I    I    I

Please read this leaiflet carefully before you take this medicine. If you are not sure of anything ask your pharmacist or ] [doctor.    I    I    I    !    I    1

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

lemsip Max Cold j& Flu Plus Day & Njght Relief Capsules [contain a combinatioin of ingredients whifh are effective in i 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 wfell-known painkiller (analgesic). It is effejctive against aches agd pains, including a [headache, and can i also reduce a feveri (antipyretic). Caffeine (a mild stimulant)) helps relieve fatigue and drowsiness through the day (it is [ [only used in the D4y capsule). Phenylephrine hydrochloride [(nasal decongestant)! reduces swelling in jhe passages of the i nose, relieving nasal congestion and reducing the pressure which may cause a headache.    |    [

'l. Before taking tins medicine !    !    !    !    [

po not take this n)edicine 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 Colijl & Flu Plus Day & Night Relief Capsules may not be suitable for some people. 1 Do not take this medicine if:    1    1    1    1    [

1 • You are allergic to any ingredient (see section 6 for further information)    1    1    [

[ • You have a seriops heart condition [    [    [    [    1

1 • You have high blood pressure (hypertension) or an overactive thyroid    1    1    [

[ • You are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhihitjor (MAOI),

1 usually used to treat depression 1    1    1    1    [

!• You are pregnant or breast feeding !    !    !    !

[You should ask thf pharmacist beforf taking Lemsip Max [Cold & Flu Plus DaJ & Night Relief Capsules if:

1 • You have Raynaud’s syndrome (pooriblood circulation which makes the fingers or toes pale and numb), or diabetes [ mellitus    !!!!!'

1 • 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 Raynaudi’s syndrome) [    [    [

[ • You are taking tricyclic antidepressants (a specific class of drugs used to treat (Repression), other decongestants, or 1 1 barbiturates (used to treat sleep problems or epilepsy) 1    1    1    [

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

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 prostatic enlargement!    [    [

[ • You are taking other medicines. Some 'drugs may affect the [way in which paracetamol works, including those used to treat! I blood cholesterol (cholestyramine) and nausea and vomiting (metoclopramide and domperidone). The effect of blood [ thinning drugs (vfarfarm and other copmarins) may he increased by paracetamol. [Some drugs may affdct the way in which 1 phenylephrine works (digoxin and cardiac glycosides). The speed at which caffeine is disposed of by the body can be    [

[ slowed down by fimetidme (used to rejduce stomach acid), (Jisulfiram (used to trejat alcoholism) or oral contraceptives.    '

3. How to take thi|s medicine    !    [

'The capsules should be swallowed whole with water. Do not chew.

[It is important to djink plenty of fluids )vhen suffering from folds and flu.


Pharmacode Reads This


<-

Last Bar


Way


First Bar


Dose

Daytime

Night time [

Adults and

Two red and yellow} capsules every 4-6 flours.

Two blue ar}d red capsules to be [taken at bed time.

children over 12

Maximum daytime dosage: 6 capsules

Maximum night time dosage: 2 capsules

Do not exceed 8 capsules in total in any 24 hours


Do not give to children under 12 years.

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

Immediate medical advice should be sought in the event of overdose, even if you feel well because of the risk of delayed, serious liver damage.

Possible side-effects    |

Allergic reactions (such as skin rashes)

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 bl()od cells), agranulocytosis, leucopenia or Neutropenia (reduction in white blood cells which makes infections more likely)

Nausea or vomiting    !    |

Stomach ulcers 1    1    1

Acute pancreatitis (after ingestion of above normal amounts)

High blood pressure with headache ]    [

Central Nervousi System effects suchias difficulty in sleeping, restlessness/nervousness or mental confusion often accompanied by[hallucinations (seeing and hearing things! that are not there)

Palpitations (irregular or forceful heartbeats)    1

Caffeine, if taken close to bedtime, may interfere with sleep Difficulty in passing urine (in men oifly)    [

Tell your doctor oripharmacist if you have any side-effects after taking this medicine, including any not listed in this [leaflet.    ]

5. How to store

Keep all medicines out of the sight and reach of children, i    i

po not use after th£ end of the month of the expiry date (EXp month/year) showi) on pack.

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

6. Further information    i    i    i    i

[Red and yellow Da[y capsules contain tl)e active ingredients paracetamol 500mg, [caffeine 25mg and ppenylephrine hydrochloride 6.1mg. The other ingredients are starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, [sterilised talc, gelatin, titanium dioxide (E171), patent blue V (E131), erythrosinei (E127) shellac and 4uinoline yellow


(E104).    1    [    |    [

Red and blue Night capsules contain the active ingredients paracetamol 500mg and phenylephrine hydrochloride 6. lmg. [The other ingredients are starch, croscafmellose sodium, socfium laurilsulfate, ma[gnesium stearate, sterilised talc, gelatin, titanium dioxide (E171), quinoline yellow (E104), patent blue V (E131) and erythrosine (E127) shellac.

[The product is available in a carton of 2[4 capsules.    [    [    [

Marketing Authorisation Number: PL 00063/0529

Marketing Authorisation Holder/Manufacturer:Reckitt Benckiser Healthcare (UK!) Ltd, Hull, HU8 7pS [Leaflet last revised] October 2015.    [ Lemsip, Lemsip Max and (J) are trade marks

RH05Q2d