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Health Essentials Max Strength Cold & Flu Relief Blackcurrant Flavour Powder For Oral Solution

Paracetamol, Phenylephrine

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

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

his medicine contains:

•    paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever

,• phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily.

These sachets are used for the relief of the symptoms of colds and flu, including headache, aches and pains, sore throat, nasal congestion |(blocked nose) and feverishness (high temperature).

2.    Is this medicine suitable for you?

Do not take this medicine if you:

•    are allergic to paracetamol, phenylephrine or any of the other ingredients

|» have a serious heart condition

•    have glaucoma

•    have an over active thyroid gland |» have an enlarged prostate

•    have diabetes

•    have phaeochromocytoma

|» have high blood pressure (hypertension)

Please see your doctor or pharmacist before taking this medicine if you:

!• are pregnant or breastfeeding

•    suffer from kidney or liver problems, including

L alcoholic liver disease _ _ _ _

•    have circulatory disorders such as a condition called Raynaud's Phenomenon, which results from poor circulation in the fingers and toes

•    have an intolerance to some sugars

•    suffer with phenylketonuria, a rare, inherited metabolic disorder.

If you are taking any of the following medicines please see your doctor:

•    medicines to treat high cholesterol levels whichl reduce the amount of fat in the blood such as colestyramine

•    medicines to control feeling sick or being sick such as metoclopramide or domperidone

•    medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins - you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis

•    barbiturates (for epilepsy or to help you sleep), such as phenobarbitones

•    tricyclic antidepressants such as imipramine, amitriptyline

•    antidepressant drugs called monoamine oxidase inhibitors (MAOI's) or have taken them within the last 14 days - these are medicines such as phenelzine and isocarboxacid

•    medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers (for example atenolol), vasodilators (for example hydralazine) or cardiac glycosides (for example digoxin)

•    other decongestant drugs such as ephedrine or xylometazoline.

Contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Other important information:

Do not drink alcohol (beer, wine, spirits etc) while taking this product.

Please turn over

Information about some of the ingredients in this medicine:

Contains 2.4 g of sucrose (sugar) per sachet.

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 should be taken into account in patients with diabetes. Contains aspartame (E951), a source of phenylalanine equivalent to 30 mg per sachet. May be harmful for people with phenylketonuria. Each sachet contains 118 mg sodium.

[To be taken into consideration by patients on a controlled sodium diet.

3.    How to take this medicine

Pour the contents of 1 sachet into a standard mug. .Fill the mug to below the brim with approximately |250 ml (8 fluid oz) of hot, but not boiling, water. Stir until dissolved, and allow to cool to a drinkable temperature.

Adults, the elderly and children 12 years and over: 1 sachet every 4 hours as required. Do not [take more than 4 sachets (4 doses) in any 24 hour period. Leave at least 4 to 6 hours between doses. Do not give to children under 12 years.

Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor Do not take for longer than 7 days, unless your doctor agrees.

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. Go to your [nearest hospital casualty department. Take your medicine and this leaflet with you.

4.    Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience (any of the following side effects, or anything else unusual happens, stop taking the medicine .immediately, and see your doctor or pharmacist. Rare side effects are:

• allergic reactions such as skin rash p_ raised blood pressure _

•    changes inTieart rale

•    difficulty sleeping (insomnia)

•    restlessness

•    tremor

•    anxiety

•    problems passing water

•    hallucinations.

More rarely, the following side effects can happen:

•    you may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.

Very rare cases of serious skin reactions have been reported.

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.aov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store your medicine

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date printed on the pack. Do not store above 25°C.

6.    What is in this medicine?

Each 5 g sachet of purple powder, taken as a hot blackcurrant drink, contains the active ingredients paracetamol 1000 mg and phenylephrine hydrochloride 12.2 mg.

The other ingredients are: sucrose, sodium citrate, citric acid, ascorbic acid (Vitamin C), acesulfame potassium (E950), aspartame (E951), blackcurrant flavour, carmoisine (E122) and brilliant blue (E133). This product is available in pack sizes of 5 or 10 sachets, although not all may be marketed.

7.    Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

Text revised: March 2016.

PL 12063/0070    _ _ _ SA02