LEMSIP MAX DAY & NIGHT COLD & FLU RELIEF CAPSULES, LEMSIP MAX PLUS DAY & NIGHT COLD & FLU RELIEF CAPSULES - patient leaflet, side effects, dosage

1. what this medicine is and what it is used for

Lemsip Max Day & Night Cold & Flu Relief Capsules 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, headache, nasal congestion and lowering of temperature.

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

2. what you need to know before you take this medicine

------As with all medicines Lemsip Max Day & Night Cold & Flu Relief Capsules may not be suitable for some people.

Do not take this medicine if:

• You are allergic to paracetamol, caffeine or phenylephrine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• You have a serious heart condition
• You have high blood pressure (hypertension) or an overactive thyroid
• You are taking or have taken within the last 14 days a medicine called a monoamine oxidase ------! – – inhibiiar-(MAOI),.usually used-to -treat depression.-----------------------------------1
• You are taking other sympathomimetic decongestants
• You have an enlarged prostate
• You have phaeochromocytoma

Warnings and precautions: Talk to your doctor or pharmacist before taking this medicine if:

• You have Raynaud’s syndrome (poor blood circulation which makes the fingers or toes pale and numb), or diabetes mellitus
• You have a problem with your liver or kidneys or a history of stomach ulcer
• 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

Children and adolescents: Do not give this medicine to children under 16 years of age.

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

• Do not take with other paracetamol-containing products
• Do not take if you are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), a medicine used to treat depression.
• Concomitant use of other cough and cold medicines could lead to overdose and should therefore be avoided.

Talk to your doctor or pharmacist if 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)
• Tricyclic antidepressants (a specific class of drugs used to treat depression), other decongestants, or barbiturates (used to treat sleep problems or epilepsy)
• 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 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 by cimetidine (used to reduce stomach acid), disulfiram (used to treat alcoholism) or oral contraceptives

Pregnancy and breast-feeding : If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. This product should not be used in women with a history of pre-eclampsia.

Driving and using machines: This medicine can cause difficulty in sleeping, restlessness, nervousness or mental confusion. Do not drive or use machines if you are affected by any of these

3. How to take this medicine

The capsules should be swallowed whole with water. Do It is important to drink plenty of fluids when suffering fr If the symptoms of your cold and flu persist for more tha Adults, the elderly and children aged 16 years and ov

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Daytime

Night time

Take two red and yellow capsules every 4–6 hours during the day to a maximum of 3 doses when necessary. Do not take more than 6 red and yellow capsules in any 24 hours.

Take two blue and red capsules at night if needed.

Do not take more than 8 capsules (4 doses) in any 24 hours. Do not give to children under

16 years of age.

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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 side-effects

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

Very rare (fewer than 1 in 10,000 patients treated)

• Cases of serious skin reactions have been reported

Frequency not known

• 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 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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• Difficulty in passing urine (especially in men)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmaci effects not listed in this leaflet. You can also report side at : or search for MHRA Store.

By reporting side effects, you can help provide more inf

5. How to store this medicine

Keep all medicines out o Do not use after the end of the month of the expiry date Do not store above 25°C (77°F). Store in the original pac Do not throw away any medicines via wastewater or hou throw away medicines you no longer use. These measure

st or nurse. This includes any possible side effects directly via the Yellow Card Scheme Yellow Card in the Google Play or Apple App

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ormation on the safety of this medicine.

f the sight and reach of children.

EXP month/year) shown on pack.

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sehold waste. Ask your pharmacist how to s will help protect the environment

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What this medicine contains: Red and yellow Day capsules contain:

• 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, sterilised talc, gelatin, titanium dioxide (E171), patent blue V (E131), erythrosine E127) shellac and quinoline yellow (E104).

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Red and blue Night capsules contain:

• The active ingredients are: paracetamol 500mg and phenylephrine hydrochloride 6­.1mg.
• The other ingredients are: starch, croscarmellose sodium, sodium lauril sulfate, magnesium stearate, sterilised talc, gelatin, titanium dioxide (E171), patent blue V (E131) and erythrosine E127) shellac.

What this medicine looks like and contents of the pack:

Day-time capsules are red/yellow hard gelatin capsules, Night-time capsules are red/blue hard gelatin capsules. The product is available in

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cartons of 24 capsules.

Marketing Authorisation Holder/Manufac­turer:

Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS, UK. PL 00063/0529

Manufacturer:

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

Leaflet last revised November 2021

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

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Lemsip Max Cold and Flu Day and Night Relief Capsules EU National eCTD

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