LEMSIP MAX DAYTIME COLD AND FLU RELIEF - patient leaflet, side effects, dosage

Reckitt Benckiser

। - if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects 1

• ______1 = YoiLmustJalk_to-a_doctar_if you doaiot feel better_ar jf you feel worse. a Iler A days__________­____

• 1 What is in this leaflet

• 11. What this medicine is and what it is used for

• 12. What you need to know before you take this medicine

• 13. How to take this medicine

• 14. Possible side effects

• । Lemsip Max Daytime Cold & Flu Relief contain a combination of ingredients which are effective in [ [ relieving the symptoms associated with colds and flu. including relief of aches and pains, sore throats. । 1 headache, nasal congestion and lowering of temperature. ।

→ paracetamol Is- a well-known painkiller {analgesic-).-It Is-effecti-v-e-against aches and -pains- including a J -headache, and can also reduce a fever (antipyretic). Caffeine (a mild stimulant), helps relieve fatigue 1

' । and drowsiness through the day. Phenylephrine hydrochloride (nasal decongestant) reduces swelling ।

[As with all medicines Lemsip Max Daytime Cold & Flu Relief may not be suitable for some people. [

• 1 You are allergic to paracetamol, caffeine or phenylephrine hydrochloride or any of the other ।

• । ingredients of this medicine (listed in section 6)

• । You have an enlarged prostate
• । You have phaeochromocytoma

• । Talk to your doctor or pharmacist before taking this medicine if:

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

। Children and adolescents:

। Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

• 1 Concomitant use of other cough and cold medicines could lead to overdose and should therefore be । । avoided.

• 1 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)

• [ Tricyclic antidepressants (a specific class of drugs used to treat depression), other decongestants, or1
• । Other medicines. Some drugs may affect the way in which paracetamol works, including those

used to treat blood cholesterol (cholestyramine) and nausea and vomiting (metoclopramide and 1

• 1 domperidone). The effect of blood thinning drugs (warfarin and other coumarins) may be increased ।

• । by paracetamol. Some drugs may affect 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 by1

[3. How to take this medicine

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

– (t-isimpertant-te-drink-plenty-of Thirds-when suffering-frem-eolds-and-flu.---------------------

Adults, the elderly and children aged 16 years and over : Take two capsules every 4–6 hours as Required to a maximum of four doses in any 24 hours, or up to a maximum of three doses in any 24 hours if a night-time paracetamol-containing product is taken before bedtime. Do not take more than 8 capsules (4 doses) in any 24 hours.

[Do not give to children under 16 years of age.

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

pharmacist.

[If you take more capsules than you should: Talk to a doctor at once if you take too much of this medicine, even if you feel 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, high blood pressure with headache, unhealthy pale appearance (pallor), feeling sick (nausea), vomiting or loss of appetite if you take too much of this medicine.

4. Possible sitle-ellecls i

[Like all medicines, this medicine can cause side effects, although not everybody gets them.

[Very rare (fewer than 1 in 10.000 patients treated)

i* Cases of serious skin reactions have been reported ।

[Frequency not known

• [ Allergic reactions (such as skin rashes) 1
• ! Blood disorders, such as thrombocytopenia (reduction in blood platelets which might mean that voui

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bleed or bruise more easily), pancytopenia (reduction in white and red blood cells), agranulocytosis, leucopenia or neutropenia (reduction in white blood cells which makes infections more likely)

• ! Stomach and gut disorder, such as feeling sick, being sick or abdominal discomfort
• [ Difficulty in sleeping, restlessness, nervousness or mental confusion. If you are affected by any of

[ these symptoms, do not drive or use machines

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

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[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 can also report side effects directly via the Yellow Card Scheme [at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

. [By_repotting_side. effects. _youxan Jielp. provide-more-informatioiuan-tiie.safety of this, medicine______

[5. How to store this medicine

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 the pack. Do not store above 25°C (77°F). Store in the original package. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

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[What this medicine contains:

• ' The active ingredients are: paracetamol 500mg. caffeine 25mg and phenylephrine hydrochloride

। 6.1mg.

• [ The other ingredients are starch, croscarmellose sodium, sodium lauril sulfate, magnesium stearate.

1 sterilised talc, gelatin, titanium dioxide (E171). patent blue V (E131). erythrosine (E127) shellac

i and quinoline yellow (E104).

- [Whatthis^ medicine looks4ike-andcontents-of-the-packr The product are-red/yellow-hard gelatine – -tapsules. The product is available in cartons of 4. 6. 8 and 16 capsules. Not all pack sizes may be marketed.

[Marketing Authorisation Holder/Manufac­turer:

[Reckitt Benckiser Healthcare (UK) Limited. Hull. HU8 7DS. UK. PL 00063/0148

Manufacturer:

[RB NL Brands B.V. WTC Schiphol Airport. Schiphol Boulevard 207. 1118 BH Schiphol. Netherlands

—

Leaflet last revised November 2021

[Lemsip and the Lemsip logo are trade marks of the RB group of companies

1.3.1 Package Leaflet Clean

Lemsip Max Cold and Flu Daytime Capsules EU National eCTD

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