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PACKAGE LEAFLET: INFORMATION FOR THE USER Hot Lemon Cold Relief Powders

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 Hot Lemon Cold Relief Powders

carefully to get the best results from them.

-    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.

In this leaflet:

1.    What Hot Lemon Cold Relief Powder is and what it is used for

2.    Before you take Hot Lemon Cold Relief Powder

3.    How to take Hot Lemon Cold Relief Powder

4.    Possible side effects

5.    How to store Hot Lemon Cold Relief Powder

6.    Further information

1. What Hot Lemon Cold Relief Powder is and what it is used for

The name of your medicine is Hot Lemon Cold Relief Powder. This powder

contains a combination of paracetamol (a painkiller) and phenylephrine hydrochloride (a decongestant).

Hot Lemon Cold Relief Powder is used to relieve the symptoms of the common

cold and flu; including, headaches, sore throat nasal congestion (blocked nose and sinus) and

feverishness.

2. Before you take Hot Lemon Cold Relief Powder

You should not take Hot Lemon Cold Relief Powder if you:

•    are allergic (hypersensitive) to paracetamol, phenylephrine hydrochloride or any of the other ingredients in Hot Lemon Cold Relief Powder (see section 6, Further

information)

•    have a severely overactive thyroid

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

•    have 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) such as moclobemide.

Talk to your doctor or pharmacist before taking Hot Lemon Cold Relief Powder if you:

•    suffer from severe kidney and 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 such as prinzmetal angina (chest pain) or thromboembolic disorders following myocardial infarction(reduced blood supply in veins or arteries following a heart attack) or a history of ischemic heart disease

•    suffer from diabetes

•    suffer from an overactive thyroid

•    suffer from phenylketonuria (a hereditary enzyme disorder).

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 Hot Lemon Cold Relief Powder:

•    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 and lamotrigine)

•    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) as there is an 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).

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.

Driving and using machinery

It is possible that Hot Lemon Cold Relief Powder may cause dizziness. Do not drive or operate machinery if affected.

Important Information about some of the ingredients in Hot Lemon Cold 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 Hot Lemon Cold 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 Hot Lemon Cold Relief Powder than you should

If you (or anybody else, including a child) takes more Hot Lemon Cold Relief Powder than you should, immediate medical advice should

be sought even if you feel well, because of the risk of delayed, serious liver damage. You should contact your nearest hospital casualty department or your doctor immediately. Always take the container and this leaflet with you.

If you forget to take Hot Lemon Cold 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, Hot Lemon Cold 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 and/or difficulty breathing.

with Hot Lemon Cold Relief Powder are:

•    rash    • worsening of asthma

•    high blood pressure    • headache

• dizziness    • slow heart beat

• palpitations    • allergic reaction.

5. How to store Hot Lemon Cold Relief Powder

Keep out of the reach and sight of children.

•    Hot Lemon Cold 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

•    Hot Lemon Cold Relief Powder should not be taken after the expiry date on the label; the expiry date refers to the last day of the month.

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

6. Further information

What Hot Lemon Cold Relief Powder contains

The active ingredients are: paracetamol 650mg 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

What Hot Lemon Cold Relief Powder looks like and the contents of the pack

Hot Lemon Cold Relief Powder is a powder for oral solutions.

Hot Lemon Cold Relief Powder is available on general sale in laminated sachets with pack sizes of 5 or 10 sachets.

Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd, 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).

Please be ready to give the following information:

Product name	Reference number
Hot Lemon Cold Relief Powder	29831/0168