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Hot Lemon Cold Relief Powders

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Document: leaflet MAH BRAND_PL 29831-0168 change

Package Leaflet: Information for the user Hot Lemon Cold Relief Powders

Paracetamol and Phenylephrine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you.

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

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

-    If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse after 3 days.

The name of your medicine is Hot Lemon Cold Relief Powders. In the rest of this leaflet, it is called Hot Lemon Cold Relief Powder.

What is in this leaflet:

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

2.    What you need to know 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.    Contents of the pack and other 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. What you need to know before you take Hot Lemon Cold Relief Powder

Do not take Hot Lemon Cold Relief Powder if you:

   have ever had an allergic reaction to paracetamol, phenylephrine hydrochloride, ascorbic acid or to any of the other ingredients (listed in section 6)

•    have kidney or liver problems, overactive thyroid, diabetes, high blood pressure or heart or circular disease

•    have phaeochromocytoma or glaucoma

•    are taking tricyclic anti-depressants (e.g. imipramine or amitriptyline) or if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) prescribed for depression.

•    are taking beta blockers

Warnings and precautions

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

•    have a blood vessel disease such as Raynaud's Phenomenon

•    have an enlarged prostate

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

Do not take with any other flu, cold or decongestant product.

Other medicines and Hot Lemon Cold Relief Powder

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. The following medicines can affect or be affected by Hot Lemon Cold Relief Powder:

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

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

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

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

•    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)

•    ergot alkaloids (used in the treatment of migraines)

•    oxytocin (used to induce childbirth)

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

•    medicine used to treat heart disease (digoxin)

•    beta-blockers and other antihypertensives used in the treatment of hypertension and other cardiovascular side effects.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Hot Lemon Cold Relief Powder contains Phenylalanine, sodium

This medicine contains phenylalanine. May be harmful for people with phenylketonuria.

This medicinal product contains 5.3mmol sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Hot Lemon Cold Relief Powder contains sucrose

If you have diabetes mellitus or if you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

3. How to take Hot Lemon Cold Relief Powder

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist or nurse if you are not sure.

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. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. A small number of people have had side effects.

Stop taking this medicine and tell your doctor immediately if you experience

   Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath

•    skin rash or peeling or mouth ulcers

   Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen or aspirin

•    Unexplained bruising or bleeding

•    Reoccuring fevers or infections

•    Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin

•    Visual disturbances. This is rare but is more likely in those with glaucoma

•    Unusually fast pulse rate or a sensation of an unusually fast or irregular heartbeat.

   Difficulty passing water. This is more likely to occur in men with an enlarged prostate gland.

The following side effects may occur. Tell your doctor if you get them:

•    Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness or sickness.

•    Irritability, restlessness, and excitability Reporting of side effects

If you get any side effects, talk to your doctor or 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. How to store Hot Lemon Cold Relief Powder

Keep this medicine out of the sight and reach 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

•    Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Content of the pack and other information What Hot Lemon Cold Relief Powder contains

The active substances 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 contents of the pack

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

Hot Lemon Cold Relief Powders 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 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).

Please be ready to give the following information:

Product name

Reference number

Hot Lemon Cold Relief Powder

29831/0168


This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in November 2016

GSL