20 mm

PACKAGE LEAFLET: INFORMATION FOR THE

_USER_

PRIMACARE MAXIMUM FLU STRENGTH HOT LEMON POWDER FOR ORAL SOLUTION

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

This medicine is available without prescription. However, you still need to take it carefully to get the best results from it.

•    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 if your symptoms worsen or do not improve after 3 days.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you take this medicine

3.    How to take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Further information_

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

The two active substances in this medicine are Paracetamol and Phenylephrine hydrochloride. Paracetamol relieves pain and lowers temperature. Phenylephrine hydrochloride is a decongestant which helps clear a blocked nose and sinuses to help you breathe more easily.

This medicine is used for the relief of sinus pain,

congestion and the symptoms of cold and influenza, including fever, shivers, aches, pains, sore throat and

headache._

|    2. Before you take this medicines l

Do not take this medicine if you:

•    are allergic to paracetamol, phenylephrine hydrochloride, or any of the other ingredients (these are listed in section 6, Further Information)

•    are taking any other paracetamol-containing products or other decongestants

•    suffer from high blood pressure or any heart conditions

•    suffer from an overactive thyroid

•    are diabetic

•    suffer from an eye condition called glaucoma

•    Phaeochromocytoma (tumour of the adrenal gland) Take special care with this medicine if you:

•    suffer from any kidney or liver problems (especially if severe)

•    suffer from phenylketonuria (this product contains aspartame a source of phenylalanine which may lead to severe mental retardation)

•    use with caution if you suffer from blood circulatory diseases.

•    suffer from alcohol liver disease Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not prescribed, for example, herbal remedies and health supplements from a pharmacy, supermarket or health food shop, as they may interact with this medicine.

•    Should not be given to patients being treated for depression and taking drugs such as, monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants or within 14 days of stopping treatment.

The following medicines can affect this medicine:

•    barbiturates or medicines for angina, high blood pressure or other heart problems (including beta blockers)

•    moclobemide (used to treat depression and social anxiety)

•    ergot alkaloids (used to treat migraine) e.g. ergotamine & methysergide.

•    oxytocin (used to induce labour and increase milk production)

•    appetite suppressants and amphetamine-like psychostimulants (substances that reduces the appetite)

•    cardiac glycosides (used to treat congestive heart failure and irregular heart rate) e.g. digoxin

•    antihypertensives (drugs used to treat high blood pressure) e.g. atenolol

•    warfarin (to thin the blood). The other effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with an increased risk of bleeding, however occasional doses have no significant effect.

•    cholestyramine (to lower blood cholesterol)

•    metoclopramide and domperidone (to treat nausea and vomiting)

•    anticonvulsants (used to treat epilepsy)

•    oral contraceptives (the “pill”)

•    chloramphenicol (antibiotic to treat infections)

Taking this medicine with alcohol

•    You are advised NOT to consume a large quantity of alcohol whilst on this medicine.

Pregnancy and breast-feeding

•    Do NOT take this medicine if you are pregnant, think

you have become pregnant or intend to become > pregnant whilst taking this medicine or are breast- | feeding.    ²

120m,m

Prima care hot lemon    210 mm

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SAME SIZE ARTWORK

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•    Always ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of this medicine

•    This medicine contains SUCROSE.

•    If you have been told by your doctor that you have intolerance to some sugars (such as sucrose), check with your doctor before taking this medicine.

_3. How to take this medicine_

You should check with your doctor or pharmacist if you are not sure. The usual dose is:

Adults, elderly and children over 12 years:

•    One sachet, dissolved in a tumbler of hot (not boiling) water, every 4 hours.

DO NOT GIVE TO CHILDREN UNDER 12 YEARS OF AGE.

The dose should not be taken more frequently than eveiy four hours and not more than four times in any 24 hours period.

DO NOT EXCEED THE STATED DOSE.

If symptoms persist consult your doctor.

If you take more of this medicine than you should

If you accidentally take more than you should, tell your doctor immediately or go to the nearest hospital A & E (casualty) department even if you feel well because of the risk of delayed serious liver damage. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily. Children (aged 12 years and under)

Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage.

If you forget to take this medicine

If necessary, take the missed dose when you remember and then leave at least 4 hours before taking the next dose.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE

_4. Possible side effects_

Like all medicines this medicine can cause unwanted effects, although not everybody gets them.

STOP TAKING and contact your doctor at once if any signs of an allergic reaction occur such as:

•    swelling of the face, lips, tongue or throat

•    breathing difficulties or swallowing

•    itchy skin rash, change in skin colour

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

•    nausea (feeling sick) and vomiting

•    fast heart rate and palpitation

•    unusual headaches and high blood pressure

•    unusual bruising, or infections such as sore throat this may be a sign of very rare changes in the blood

•    stomach problems

•    unable to pass urine

•    inability to sleep

•    hallucinations

•    anxiety

•    restlessness

•    irritability

_5. How to store this medicine_

•    Keep out of the reach and sight of children.

•    Do not store above 25°C. Store in the original package in order to protect from moisture.

•    Do not use these sachets after the expiry date printed on the carton.

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

_6. Further information_

What this medicine contains

•    The active substance is Paracetamol 1000mg and Phenylephrine hydrochloride 10mg.

•    The other ingredients are: sucrose, sodium citrate, tartaric acid, citric acid, maize starch, lemon juice, ascorbic acid, aspartame (E951), natural colour (E100) and lemon flavour.

•    The sodium content is 122mg per sachet.

What this medicine looks like and contents of the pack

•    Each sachet contains a creamy yellow-white granule powder.

•    They are available in packs of 5 and 10 sachets.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0)1442 200 922

Fax:    0044 (0)1442 873717

E-mail:    info@bristol-labs.co.uk

Prima Care Maximum Flu strength Hot Lemon Powder for Oral Solution; PL 17907/0164 This leaflet was last approved in August 2010 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

120 mm

SAME SIZE ARTWORK

210x 120mm

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210 mm