LEMSIP COUGH MAX FOR MUCUS COUGH & COLD 500 MG / 100 MG / 6.1 MG CAPSULES, LEMSIP MAX ALL IN ONE COLD & FLU CAPSULES - Patient leaflet, side effects, dosage

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

Capsules for oral use.

This Medicine is a combination of active ingredients which are effective in relieving the symptoms

Lassociated'with -cotds_ andfTu, _including_ reMefofaches and pains,_ sore throats/headache; nas_at" “ congestion, lowering of temperature and chesty cough.

EG Paracetamol is a well known painkiller (analgesic). It is effective against aches and pains including headache and can also reduce a fever (antipyretic). Guaifenesin (expectorant) allows you to cough up

■U™ phlegm when suffering from a chesty cough. Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing pressure which ------1 may-cause- a headache.---------------------------------------------------------

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

Do not take this medicine if:

• You are allergic to paracetamol, guaifenesin, phenylephrine hydrochloride or any of the other ingredients listed in section 6.
• You have a serious heart condition, or an overactive thyroid.
• You have a high blood pressure (hypertension).
• You are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), usually to treat depression.
• You have an enlarged prostate
• You are taking other decongestant medications.
• You have phaeochromocytoma

Warnings and precautions

Talk to your doctor or pharmacist before taking Lemsip Cough Max for Mucus Cough and Cold 500mg/100mg/6.1mg Capsules if:

• You suffer from liver or kidney problems or heart disease.
• You suffer from Raynaud’s syndrome (poor blood circulation which makes the fingers or toes pale and numb), or diabetes mellitus.
• " ,„Tou"have“hon-cirrhotic (liver -disease that isnotassociated with-changes"to_the structure“ ofthe liver)" liver disease.
• You have glaucoma.
• You are suffering from porphyria (a rare blood disease).

This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially “sodium free”.

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Other Medicines and Lemsip Cough Max for Mucus Cough and Cold 500mg/100mg/6.1mg Capsules:

• Do not take with any other paracetamol – containing products.
• Do not take with any other product used for relief of cold, flu or congestion.

If you are taking any of the following medicines, talk to your doctor or pharmacist before taking ------Lemsip -Cough-Max for-Mucus Cough & Cold-500mg/100mg/6.1mg -Capsules:------------------

• 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 anti-depressants (a specific class of drugs used to treat depression); other decongestants, or barbiturates (used to treat sleep problems or epilepsy).
• You are taking other medicines some drugs may affect the way paracetamol works, including those

1 used to treat blood cholesterol (cholestyramine) and nausea and vomiting metoclopramide and domperidone). Some drugs may affect the way in which phenylephrine works (digoxin and cardiac glycoside).

• The effect of blood thinning drugs (warfarin and other coumarins) may be increased by paracetamol.

3. How to take this Medicine

The capsule should be swallowed whole with water. Do not chew.

It is important to drink plenty of liquid when suffering from colds and flu.

Adults, the elderly and children 16 years and over: Take two capsules every 4–6 hours as required.

Do not take more than 8 capsules (4 doses) in 24 hours.

Do not give to children under 16 years of age.

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If symptoms persist for more than three days, or worsen, consult your doctor.

If you take more of this medicine 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 or high blood pressure with headache if you take too much of this medicine

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If you forget to take this medicine:

This product should only be used when necessary.

Do not take a double dosage to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects.

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

• 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), leucopoenia, pancytopenia(re­duction in white and red blood cells), neutropenia and agranulocytosis (reduction in white blood cells which make infection more likely).
• Very rare cases of serious skin reactions have been reported.

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• Nausea and Vomiting.
• Abdominal discomfort
• Difficulty in passing urine (especially in males).

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

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at : or search for MHRAYellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store this medicine

Do not store above 25°C.

Keep out of the sight and reach of children.

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The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect environment.

6. Contents of the pack and other information

What this medicine contains:

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• The active ingredients per capsule are: paracetamol 500mg, guaifenesin 100mg and phenylephrine hydrochloride 6­.1mg.

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The product is a hard gelatin capsule with a green body and a red cap with Lemsip printed on the cap.

UK: The product is available in carton of 8 and 16 capsules.

NZ: The product is available in carton of 16 capsules

Marketing Authorisation Holder/Manufac­turer:

Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS, UK. (PL 00063/0551)

Marketing Authorisation Holder:

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Reckitt Benckiser Healthcare, Auckland, New Zealand 0508 731234

Manufacturer:

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

Leaflet was last approved in October 2021

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

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1.3.1 Package Leaflet CMax Clean

eCTD Lemsip All in One Capsules 0211405 National