Reckitt Benckiser

0020 PL 00063/0529 CCDS RTQ2

i    i    LemsipMax Day    & Flu Relief C apsules    i    ]

|    |    (paracetamol, caffeine and phenylephrine hydrochloride)    |    i

'    '    ' Patient Information Leaflet '    >    |

iPlease read this leaflet carefully before you take this medicine. If you are not sure of anything ask your pharmacist or ] jdoctor.    ill!!¹

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

[Lemsip Max Day 4 Night Cold & Flu Relief Capsules cousin a combination of ingredients which ar^ 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.    !    !    I

[Paracetamol is a well-known painkiller (analgesic). It is effective against aches ahd pains, including a [headache, and can! also reduce a feveri(antipyretic). Caffeine (a mild stimulant)* helps relieve fatigue and drowsiness through the day (it is [ pnly used in the D4y capsule). Phenylephrine hydrochloride |(nasal decongestant)) reduces swelling in the passages of the i nose, relieving nasal congestion and reducing the pressure which may cause a headache.    [    !

[2. Before taking tfris medicine !    !    !    !

Do not take this medicine with any other paracetamol-containing products. '    '    !

|41so, you should pot drink large quantities of alcohol, whilst taking this medicitie.    !

As with all medicines Lemsip Max Day] & Night Cold & Fli} Relief Capsules may not be suitable for some people. ! Do not take this medicine if:    i    i    i    i

| * You are allergic Jo any ingredient (see section 6 for further information)    [    [    i

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

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

¹ * You are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), ! i usually used to treat depression i    i    i    i

[ * You are taking o]ther sympathomimetic decongestants    !    !    !    ¹

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

! * You have Raynajid’s syndrome (poor!blood circulation wljich makes the finger's or toes pale and numb), or diabetes ■ ¹ mellitus    '''''!

! • 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 Raynaud’s syndrome)    '    j    j

i • 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 your liver or kidneys or a history of stomach ulcer ■    j    !

! * You have non-cirrhotic liver disease (liver disease that is pot associated with changes in the structure of the liver) ¹ [ * You have closed'angle glaucoma or pjrostatic enlargement]

i * You are taking other medicines. Someidrugs may affect the way in which paracetamol works, including those used to treat] | blood cholesterol) (cholestyramine) and nausea and vomiting (metoclopramide anjd domperidone). The )effect of blood    i

i thinning drugs (warfarin and other coumarins) may be increased by paracetamol. 'Some drugs may affect the way in which) ) phenylephrine w(>rks (digoxin and cardiac glycosides). The [speed at which caffeine is disposed of by the body can be    ¹

¹ slowed down by Cimetidme (used to reduce stomach acid), disulfiram (used to treat alcoholism) or oral contraceptives.    )

'Pregnancy and breast-feeding- This product should not be 'used in women with¹ a history of pre-eclampsia. Ask your [ tioctor or pharmacist for advice before taking this product if !you are pregnant or hreast-feeding. !

3. How to take this medicine

iThe capsules shoulid be swallowed whole with water. Do not chew.    !    !

-It fs important to drink [plenty of fluids wheiji suffering from coldjs and flu.

RB98992

Adults and children over 12

Dose

Daytime

Two red and yellow) capsules every 4-6 hours. Maximum daytime dosage: 6 capsules

Do not exceed 8 cai

Night time)

Two blue arid red capsules to be Jaken at bed time. Maximum night time dosage: 2 capsules

in total in any 24 hours

Do not give to children under 12 year^.

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

[Talk to a doctor aj once if you take top much of this medicine, even if you feejl well. This is because too much paracetamol can cause delayed, serious liver damage. You may experience symptoms of dizziness, palpitations (irregular or forceful heartbeat), stomach pain or high b(ood pressure with headache if you take too much of this medicine. ^1    1

4.    Possible side-effects    i    '    '    '    )

! * Allergic reactions (such as skin rashes)    !    !    !

' • Very rare cases Of serious skin reactions have been reported.    '    '    !

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 bipod cells), agranulocytosis, leucopenia or peutropenia i (reduction in white blood cells which makes infections more likely)    '    '    [

) • Nausea or vomitjing    !    !    !    !    ¹

¹ • Stomach discomfort.    ^{1    1    1    1}    !

! • Difficulty in sleeping, restlessness, nervousness or mental! confusion. If you are affected by any of these symptoms, do¹ ) not drive or use inachines

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

) * Difficulty in passing urine (especially in males)    !    !    !    ¹

[Reporting of side Effects    !    !    !    !

If you get any side 'effects, talk to your doctor, pharmacist or nurse. This includes' any possible side effects not listed in ) [this leaflet. You cap also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uJf/yellowcard [By reporting side effects, you can help provide more information on the safety of this Medicine. [    !

5.    How to store !!!!![

[Keep all medicines! out of the sight and [reach of children. [    [    [

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

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

6.    Further information    !    !    !    !    ¹

'Red and yellow Day capsules contain the active ingredients paracetamol 500mg, caffeine 25mg and phenylephrine ! hydrochloride 6.1 nag. The other ingredients are starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate,) Sterilised talc, gelatin, titanium dioxide (E171), patent blue y (E131), erythrosinej (E127) shellac and quinoline yellow i (E104).    i    i    i    i    i    [

[Red and blue Nigh); capsules contain thp active ingredients pjaracetamol 500mg ahd phenylephrine hydrochloride 6.1mg.' The other ingredients are starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate, sterilised talc, [ gelatin, titanium dioxide (E171), quinoline yellow (E104), patent blue V (E131) and erythrosine (E12i7) shellac.

The product is available in a carton of 24 capsules.

Marketing Authorisation Number: PL 00063/0529    i    i    i

[Marketing Authorisation Holder/Manuf^cturer:Reckitt Bencjriser Healthcare (UR)) Ltd, Hull, HU8 7DjS [Leaflet last revised] April 2016. Lerhsip, Lemsip Max anti (J) ^are hade marks)    [ [

RB98992

Pharmacode Reads This Way

<-

Last Bar    First Bar

1.3.1 Package Leaflet - Clean

Lemsip Max Cold And Flu Day And Night Cold And Flu Relief Capsules EU National

Page 1