Four in One Flu Relief - PL 16028/0077 20/01/2016

GALPHARM FOUR IN ONE FLU RELIEF Patient Information Leaflet

Read this leaflet carefully because it contains important information for you.

■    Keep this leaflet. You may need to read it again.

■    Ask your pharmacist if you need more information or advice.

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

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 and sinuses, tickly sore throat and chesty coughs.

Paracetamol is an analgesic (relieves pain) and antipyretic (reduces fever). Phenylephrine Hydrochloride is a nasal decongestant, it reduces the blood vessels in the nose and sinuses which opens the nasal airways helping you to breathe more easily. Guaifenesin is an expectorant which loosens phlegm so will relieve chesty coughs. Cetylpyridium Chloride is an antiseptic and anti-infective which will ease tickly sore throats.

2.    Before you take the medicine

Do not take Galpharm Four In One Flu Relief if you:

■    are allergic to Paracetamol, Phenylephrine Hydrochloride,

Guaifenesin, Cetylpyridinium Chloride or any of the other ingredients listed in section 6.

■    are pregnant.

Do not give to children under 12 years of age.

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

■    suffer from liver or kidney problems, heart disease, diabetes, glaucoma, high blood pressure, prostate trouble or if you have an over active thyroid gland.

■    are breastfeeding.

■    are receiving any other medication especially any of the following drugs: Colestyramine, drugs used to prevent blood clotting (e.g. warfarin), drugs for high blood pressure (anti-hypertensive drugs e.g. betablocker, propranolol), drugs for heart trouble (e.g. cardiac glycosides, digoxin), anti-depressants (including monoamine-oxidase inhibitors or MAOIs), Metoclopramide, Domperidone (both used to control nausea and vomiting)

If you are taking other medicines

You must not take this medicine if you are taking:

■    any other paracetamol-containing products.

■    any other product for the relief of colds, flu or congestion.

Pregnancy and Breast feeding

Do not take this medicine if you are pregnant.

Important information about some of the ingredients

Each dose contains 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 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, epilepsy. The amount of alcohol in this medicinal product may alter the effects of other medicines.

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

3. How to take the medicine

Shake well before each use. To be taken by mouth.

Age	Dose and how often to take
Adults, the elderly and children aged 12 years and over.	Fill the measure cup to the 20ml mark and take one 20ml dose (four 5ml spoonfuls). Wipe the neck of the bottle clean and replace the cap securely, without over-tightening it. Leave at least 4 hours between doses, and do not take more than 4 doses in any 24 hours.
For short term use only. If symptoms do not go away talk to your doctor. Do not exceed the stated dose.
Do not give to children under 12 years of age.

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 a doctor straight away, or go to your nearest hospital casualty department. Take the carton and this leaflet with you. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.    Possible side effects

Most people take Galpharm Four In One Flu Relief without any problems, but they can have side effects like all medicines.

If you experience any of the following symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking 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)

■    Rarely dizziness, palpitations and high blood pressure

■    upset stomach or diarrhoea

■    headache

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 1000mg, 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, Acesulphame 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

Galpharm Four In One Flu Relief is a green solution. This medicine is available in

bottles containing 160ml of liquid (8 doses).

Marketing Authorisation Holder: Galpharm Healthcare Ltd, Wrafton Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturer: Pinewood Healthcare, Ballymacarbry, Clonmel, County Tipperary, Ireland.