Lemsip Cough Max for Mucus Cough & Cold Oral Solution

Patient Information Leaflet

In this leaflet:    1. What this medicine is for

2.    Before you take the medicine

3.    How to take the medicine

4.    Possible side effects

5.    Storing the medicine

6.    Further information

1.    What this medicine is for

This medicine provides short term relief of cold and flu symptoms, including aches and pains, headache, feverishness, blocked nose, tickly sore throat and chesty coughs. Paracetamol is an analgesic (relieves pain) and antipyretic (reduces fever). Phenylephrine Hydrochloride is a nasal decongestant; it reduces swelling of the blood vessels in the nasal passages, helping you to breathe more easily. Guaifenesin is an expectorant which loosens phlegm so will relieve chesty coughs. Cetylpyridinium Chloride is an antiseptic and anti-infective which will ease tickly sore throats.

2.    Before you take the medicine

Do not take Lemsip Cough Max for Mucus Cough & Cold Oral Solution if you:

•    are allergic to any active substances or any of the other ingredients listed in section 6

•    are pregnant or breast-feeding

•    have a serious heart condition

•    have high blood pressure (hypertension) or an overactive thyroid

•    are taking or have taken within the last 14 days a medicine called a monoamine oxidase inhibitor (MAOI), usually used to treat depression.

Do not give to children under 16 years of age

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)

•    have diabetes mellitus

•    have closed angle glaucoma or prostatic enlargement

•    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)

•    are taking tricyclic antidepressants (a specific class of drugs used to treat depression)

•    are taking other decongestants or barbiturates (used to treat sleep problems or epilepsy)

•    have a problem with your liver or kidneys

•    have non-cirrhotic liver disease (liver disease that is not associated with changes in the structure of the liver).

Other medicines and Lemsip Cough Max for Mucus Cough & Cold Oral Solution

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Some drug may affect the way in which paracetamol works; including:

•    those used to treat blood cholesterol (cholestyramine)

•    those used to treat nausea and vomiting (metoclopramide and domperidone).

•    blood thinning medicines (warfarin and coumarins) as their blood thinning effect may be increased.

Digoxin and cardiac glycosides may affect the way in which phenylephrine works.

You must not take this medicine if you are taking:

•    any other paracetamol-containing products

•    any other products for the relief of colds, flu or congestion.

Pregnancy and breast feeding

Do not take this medicine if you are pregnant or breast feeding.

Driving and using machines

The amount of alcohol in this medicinal product may impair your ability to drive or use machines.

Important information about some of the ingredients

Each dose contains 2g Liquid Maltitol and approximately 3g of sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This product may have a mild laxative effect. Calorific value 2.6 kcal/g sorbitol.

WARNING: This product contains 19% (v/v) ethanol. Each 20 ml dose contains up to 3g of ethanol (alcohol), equivalent to 32ml of wine or 76ml of beer. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.

The amount of alcohol in this medicinal product may alter the effects of other medicines.

3. How to take this medicine

Shake the bottle for 10 seconds before use.

For oral use only.

Do not take this medicine with any other paracetamol-containing product.

As with all medicines, if your child is taking any medicine, consult a doctor or pharmacist before giving this product.

Adults and children 16 years and older

Never give more medicine than shown in the dosage table on page 2.

Always use the measuring cup supplied in the pack.

Do not overfill the measuring cup.

Leave at least 4 hours between doses.

Do not take more than 4 doses in any 24 hour period.

You must contact a doctor if symptoms worsen or do not improve.

Do not give this medicine to a child for more than 3 days without speaking to a doctor or pharmacist.

If you forget to take this medicine:

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

If you take too much medicine:

Talk to the doctor straight away, or go to your nearest hospital casualty department. Take the carton and this leaflet with you. 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. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

4.    Possible side effects

Most people take Lemsip Cough Max for Mucus Cough & Cold Oral Solution without any problems but, like all medicines, it can cause side effects.

If you experience any of the following symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking it and talk to your pharmacist or doctor:

•    skin rashes or other allergic reactions

•    rarely blood disorders (these may be seen as unusual bleeding or unexplained bruises, sore throat, ulcers in your mouth or throat, fever, unusual tiredness or weakness)

•    changes in the number of blood cells, such as thrombocytopenia (reduction in blood platelets which might mean that you bleed or bruise more easily), leucopoenia, pancytopenia, neutropenia and agranulocytosis (reduction in white blood cells which make infections more likely).

•    rarely dizziness, palpitations and high blood pressure

•    upset stomach or diarrhoea

•    headache

•    nausea and vomiting

•    difficulty in passing urine (in men only)

•    acute pancreatitis causing severe abdominal pain (after ingestion of above normal amounts)

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:

www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

5.    Storing the medicine

Do not use after the expiry date printed on the label and carton.

Do not use if any solids can be seen in the solution.

Do not store above 25°C. In order to protect from light, keep the container in the outer carton. Keep the container tightly closed.

Store safely out of the sight and reach of children.

6.    Further information What is in this medicine:

The active ingredients are: Paracetamol lOOOmg, Phenylephrine Hydrochloride 12.18mg, Guaifenesin 200mg and Cetylpyridinium Chloride 3.0mg in each 20ml dose.

The other ingredients are: Liquid Maltitol, Sorbitol (E420), Ethanol, Propylene Glycol, Glycerol (E422), Saccharin Sodium, Sodium Cyclamate, Acesulfame Potassium, Sodium Citrate, Anhydrous Citric Acid (E330), Xanthan Gum (E415), Levomenthol, Eucalyptus Oil, colours Quinoline Yellow (E104), Patent Blue V (E131) and Purified Water.

What this medicine looks like and contents of the pack

Lemsip Cough Max for Mucus Cough & Cold Oral Solution is a green solution. This medicine is available in bottles containing 160ml of liquid (8 doses).

Marketing Authorisation Number: PL 00063/0712

Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull HU8 7DS

Manufacturer: Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull HU8 7DS.

Q ( 0086

The CE mark only covers the measure cup.

Manufacturer of the measure cup: United Closures & Plastics Ltd (UCP), Salhouse Road, Norwich, NR7 9AL,UK.

Date of revision: March 2015

0124994