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LEMSIP COLD & FLU LEMON - patient leaflet, side effects, dosage

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Patient leaflet - LEMSIP COLD & FLU LEMON

1. what this medicine is andwhatitis used for?

Lemsip Cold & Flu Lemon contains 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). Itis effective against aches and pains, including a headache, and can also reduce a fever (antipyretic). Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache.

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

As with all medicines Lemsip Cold & Flu Lemon may not be suitable for some people.

Do not take this medicine if:

  • You are allergic to any ingredient (see section 6 for further information)
  • 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 inhibitor (MAOI), usually used to treat depression.
  • 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
  • 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
  • You have phenylketonuria

  • Do not take with other paracetamol-containing products

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 anti-depressants (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 i treat blood cholesterol (cholestyramine) and nausea and vomiting (metoclopramide and domperidone).

[ The effect ofblood thinning drugs (warfarin and other coumarins) may be increased by paracetamol.

। Some drugs may affect the way in which phenylephrine works (digoxin and cardiac glycoside).

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

Pregnancy and breast-feeding: This product should not be used in women with a history of pre-eclampsia. Ask your doctor or pharmacist for advice before taking this product if you are pregnant or breast-feeding.

This medicine contains:

  • Aspartame, 45mg in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
  • Lactose and sucrose (2.62 g of sucrose per sachet. This should be taken into account in patients with diabetes mellitus.). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
  • Sodium (120.74mg per sachet), main component of cooking/table salt. This is equivalent to 6% of the recommended maximum daily dietary intake of sodium for an adult. The maximum

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recommended daily dose of this medicinal product contains 482.96 mg sodium (found in table salt). This is equivalent to 24.1 % of the adult recommended maximum daily dietary intake for sodium.

Talk to your pharmacist or doctor if you need this medicine on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.

Total sugars 2.6g

3. how to take this medicine

To be made into a hot drink. Dissolve one sachet in amug of hot but not boiling water. Stir until dissolved.

If preferred sweeten to taste with sugar, honey or your usual sweetener.

Itis important to drink plenty of fluids when suffering from colds and flu.

Adults, the elderly and children 16 years and over: One sachet every 4–6 hours as required. Do not take more than 4 sachets in 24 hours.

Do not give to children under 16 years.

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

If you take more Lemsip Cold and Flu Lemon 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) or vomiting if you take too much of this medicine.

If you forget to take this medicine Do not take a double dose to make up for a forgotten dose. If you forget a dose, take it as soon as you remember it an then take the next dose at least 4 hours later.

  • 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 vomiting, nausea or 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 at : or search forMHRAYellowCardin 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

Keep all medicines out of the sight and reach of children. Do not use after the end of the month of the expiry date (EXPmonth/year) shown on the pack. Do not store above 25°C (77°F). Store in the original package.

6. contents of the pack and other information

What this medicine contains:

  • The active substances per sachet are: paracetamol 650mg and phenylephrine hydrochloride 10mg.
  • The other ingredients are: ascorbic acid (Vitamin C), citric acid, sucrose, aspartame, sodium citrate, saccharin sodium, caster sugar, curcumin (contains curcumin E100, lactose, polysorbate 80 E433 and silica E551) and lemon flavour.

Contents of the pack

This product is available in cartons of5 and 10 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder/Manufac­turer:

Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS, UK. PL 00063/0034

Manufacturer:

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


Leaflet last revised October 2021

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

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130 mm


1.3.1 Package Leaflet Clean

eCTD Lemsip Cold and Flu Lemon EU National 650mg 10mg


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