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PACKAGE LEAFLET: INFORMATION FOR THE USER Superdrug Maximum Strength Cold & Flu Relief Powder

Paracetamol and Phenylephrine hydrochloride

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 Superdrug Maximum Strength Cold & Flu Relief Powder carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again while you are receiving your treatment.

-    If you have any further questions, please ask your pharmacist.

-    You must contact a doctor if your symptoms worsen or do not improve after 3 days.

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

The name of your medicine is Superdrug Maximum Strength Cold & Flu Relief Powder. In the rest of this leaflet it is called Maximum Strength Cold & Flu Relief Powder

In this leaflet:

1.    What Maximum Strength Cold & Flu Relief Powder is and what it is used for

2.    Before you take Maximum Strength Cold & Flu Relief Powder

3.    How to take Maximum Strength Cold & Flu Relief Powder

4.    Possible side effects

5.    How to store Maximum Strength Cold & Flu Relief Powder

6.    Further information

1. What Maximum Strength Cold & Flu Relief Powder is and what it is used for

The name of your medicine is Maximum Strength Cold & Flu Relief Powder. This powder contains a combination of paracetamol (a painkiller) and phenylephrine hydrochloride (a decongestant).

Maximum Strength Cold & Flu Relief Powder is used to relieve the symptoms of the common cold and flu; including, headaches, sore throat and nasal congestion (blocked nose and sinus)

2. Before you take Maximum Strength Cold & Flu Relief Powder

You should not take Maximum Strength Cold & Flu Relief Powder if you:

•    are allergic (hypersensitive) to paracetamol, phenylephrine hydrochloride or any of the other ingredients in Maximum Strength Cold & Flu Relief Powder (see section 6, Further information)

•    have a severely overactive thyroid

•    have swelling of blood vessels (aneurysms) or narrowing of blood vessels

•    have very high blood pressure

•    suffer from a tumour called a phaeochromocytoma

•    suffer from an enlarged prostate

•    suffer from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency

•    are taking antidepressants called monoamine oxidase inhibitors (MAOIs).

Talk to your doctor or pharmacist before taking Maximum Strength Cold & Flu Relief Powder if you:

•    are elderly

•    suffer from kidney disease or liver disease, particularly if caused by alcohol

•    suffer from alcoholism

•    suffer from asthma, particularly if your asthma is worsened by aspirin

•    suffer from heart disease including high blood pressure

•    suffer from phenylketonuria (a hereditary enzyme disorder).

Caution should be exercised when taking paracetamol products prior to (less than 72 hours before) or at the same time as intravenous busulfan.

This medicine contains paracetamol; do not take with any other paracetamol-containing products at the same time.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The following medicines can affect or be affected by Maximum Strength Cold & Flu Relief Powder:

•    general anaesthetics such as halothane and cyclopropane

•    medicines used to treat bacterial infections (e.g. isoniazid used to treat tuberculosis)

•    medicines used to treat epilepsy (fits) (e.g. carbamazepine, phenobarbital, phenytoin, primodone)

•    medicines used to treat depression (e.g. fluvoxamine, tricyclic antidepressants such as imipramine and monoamine oxidase inhibitors (MAOIs) such as moclobemide)

•    metoclopramide and domperidone (used to treat sickness and nausea)

•    oral contraceptives (“The Pill”, mini-pill), hormonal implants and HRT

•    warfarin and other coumarin medicines (used to thin the blood due to increased risk of bleeding)

•    probenecid (used to treat gout)

•    diflunisal (an anti-inflammatory painkiller)

•    colestyramine (used to treat high cholesterol and in diseases of the intestine and liver)

•    alpha-blockers (used in high blood pressure and problems associated with enlarged prostate)

•    atropine (used in anaesthesia or to increase the heart rate)

•    ergot alkaloids (used in the treatment of migraines)

•    oxytocin (used to induce childbirth)

•    sympathomimetics (used to maintain blood pressure in critically ill patients)

•    intravenous busulfan (used in chemotherapy to treat cancer).

Pregnancy and breast-feeding

If you are pregnant or are breast-feeding you should only take this medicine if your doctor has specifically recommended it.

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Driving and using machinery

It is possible that Maximum Strength Cold & Flu Relief Powder may cause dizziness. Do not drive or operate machinery if affected.

Important Information about some of the ingredients in Maximum Strength Cold & Flu Relief Powder

This medicine contains phenylalanine. It may be harmful for people with phenylketonuria. It also contains 1.77mmol of sodium per dose. This should be taken into account by patients on a sodium controlled diet.

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.

3. How to take Maximum Strength Cold & Flu Relief Powder

Always follow the instructions on the label. If you are not sure then ask your doctor or pharmacist for advice.

Adults and children over 12 years

•    1 sachet dissolved in hot water every 4 hours as required

•    do not take more than 4 sachets in 24 hours

•    do not exceed the recommended dose

•    if symptoms persist see your doctor

•    do not take for more than 3 days unless you have been told to do so by your doctor.

Children under 12 years

•    do not give to children under 12 years unless your doctor tells you to.

If you take more Maximum Strength Cold & Flu Relief Powder than you should

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. Always take the container and this leaflet with you.

If you forget to take Maximum Strength Cold & Flu Relief Powder

If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.

4. Possible side effects

Like all medicines, Maximum Strength Cold & Flu Relief Powder can cause side effects, although not everybody gets them.

As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:

•    rash, itching, swelling of your lips, face, throat or tongue and/or difficulty breathing.

Side effects that have been reported with Maximum Strength Cold & Flu Relief Powder are:

•    changes in blood cells    • rash    • worsening of asthma

•    kidney disease    •    high blood pressure    •    headache

•    vomiting    •    dizziness    •    slow heart beat

•    difficulty or inability to pass water    •    palpitations    •    allergic reaction

•    narrowing of blood vessels    •    muscle weakness    •    tremor.

•    acidosis (increased acid    •    piloerection (bristling of hairs

concentration in the blood)    on the skin)

The use of this medicine over a long time can cause kidney problems. If you experience any serious side effects or feel that the medicine is affecting you badly tell your doctor or pharmacist immediately.

5. How to store Maximum Strength Cold & Flu Relief Powder

•    Maximum Strength Cold & Flu Relief Powder should be stored in a dry place below 25°C

•    Store in the original container to protect from light; do not transfer to another container

•    Maximum Strength Cold & Flu Relief Powder should not be taken after the expiry date on the label; the expiry date refers to the last day of the month.

6. Further information

Maximum Strength Cold & Flu Relief Powder contains

The active ingredients are: paracetamol 1000mg and phenylephrine hydrochloride 10mg.

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

Maximum Strength Cold & Flu Relief Powder looks like and the contents of the pack Maximum Strength Cold & Flu Relief Powder is a powder for oral solution.

Maximum Strength Cold & Flu Relief Powder is available on general sale in pack sizes of 5 or 10 sachets. Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

WOCKHARDT

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