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PARACETAMOL HOT DRINK 500 MG POWDER FOR ORAL SOLUTION IN SACHET

Active substance(s): PARACETAMOL

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1.3.1 Leaflet

Paracetamol Hot Drink
GlaxoSmithKline Consumer Healthcare

1.3.1 Proposed Package Leaflet Paracetamol Hot Drink

m1-3-1 Proposed Package Leaflet Paracetamol Hot Drink

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Paracetamol Hot Drink
GlaxoSmithKline Consumer Healthcare

1.3.1 Leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Paracetamol Hot Drink 500 mg, powder for oral solution in sachet
(contains Paracetamol)

Please read right through this leaflet before you start using this medicine.
This medicine is available without prescription, but you still need to use
Paracetamol Hot Drink carefully to get the best results from them.
Keep this leaflet, you may need to read it again.
If you have any questions or if there is anything you do not understand ask
your pharmacist.
In this leaflet:
1.
2.
3.
4.
5.
6.

What Paracetamol Hot Drink does.
Check before you take Paracetamol Hot Drink.
How to take Paracetamol Hot Drink.
Possible side effects.
How to store Paracetamol Hot Drink.
Further information.

1.
What Paracetamol Hot Drink does
Paracetamol Hot Drink is used for the relief cold and flu symptoms including fever,
sore throat, headache, aches and muscle pains.
The powders contain one active ingredient. Paracetamol is a painkiller (analgesic) and
helps reduce reduces your temperature when you have a fever.
2.

Check before you take Paracetamol Hot Drink

Do not take Paracetamol Hot Drink
-if you have ever had an allergic reaction to paracetamol or to any of the other
ingredients including azo dyes sunset yellow (E110), carmoisine (E122) and brilliant
black (E151) contained in each powder (listed in Section 6). This product may cause
allergic reactions, or may rarely cause severe hypersensitivity reactions and
bronchospasm.
-if you are taking other medicines containing paracetamol.
-if you are under 12 years.

m1-3-1 Proposed Package Leaflet Paracetamol Hot Drink

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Paracetamol Hot Drink
GlaxoSmithKline Consumer Healthcare

1.3.1 Leaflet

-if you suffer from rare hereditary problems of fructose intolerance, glucose galactose
malabsorption or sucrase-isomaltase insufficiency.

Important information about some of the ingredients of Paracetamol Hot Drink
Ask your doctor before you take this medicine:
-if you have liver or kidney disease, including alcoholic liver disease.
-Each sachet contains 118 mg of sodium. To be taken into consideration by people on
a controlled sodium diet.
-If you suffer from phenylketonuria, use this product with caution because each
powder sachet contains aspartame (E951) which is a source of phenylalanine.
If you are taking other medicines
Talk to your doctor or pharmacist before taking these sachets if you are taking any
prescribed medicines; particularly metoclopramide or domperidone (for nausea
(feeling sick) or vomiting (being sick)) or colestyramine (for lowering blood
cholesterol). If you take blood thinning drugs (anticoagulants e.g. warfarin) and you
need to take a pain reliever on a daily basis, talk to your doctor because of the risk of
bleeding. But you can still take occasional doses of Paracetamol Hot Drink at the
same time as anticoagulants.
Pregnancy and breast feeding
Paracetamol Hot Drink are not recommended for use during pregnancy or if breast
feeding and you should only take them at the request and instructions of your doctor.
3.

How to take Paracetamol Hot Drink

For oral use. Dissolve the contents of sachets in a cup or mug of hot water, but not
boiling water, and stir well.
Adults (including the elderly and children aged 16 years and over):
One to two sachets to be taken every 4 to 6 hours as required. The dose should not be
repeated more frequently than every 4 hours. Do not exceed 8 sachets in 24 hours.
Children aged 12-15 years:
One to two sachets to be taken every 4 to 6 hours as required. The dose should not be
repeated more frequently than every 4 hours. Do not exceed 6 sachets in 24 hours.
Children:

m1-3-1 Proposed Package Leaflet Paracetamol Hot Drink

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Paracetamol Hot Drink
GlaxoSmithKline Consumer Healthcare

1.3.1 Leaflet

Not recommended for children under 12 years, except on medical advice.
Do not exceed the stated dose.
If your symptoms persist or worsen, you must see a doctor or pharmacist.
If you take too many sachets
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. Go to your nearest
hospital casualty department. Take your medicine and this leaflet with you.
4.

Possible side effects

Like all medicines, Paracetamol Hot Drink can have side effects, but not everybody
gets them.
The following side-effects may occur but are rare, if you get them stop taking this
medicine and tell your doctor.
-Allergic reactions such as skin rash, or peeling, itching or mouth ulcers, swelling of
the lips, tongue, throat or face.
-If you have previously experienced breathing problems with aspirin or other
painkillers like Ibuprofen and have experienced a similar reaction with this product.
-You get unexplained bruising or bleeding.
-Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.
If you do get any side effects even those not mentioned in this leaflet, tell your doctor
or pharmacist.
5.

How to store Paracetamol Hot Drink

Keep out of the reach and sight of children.
Do not use this medicine after the ‘EXP’ date shown on the pack.
Do not store above 30ºC.
Do not use the product if the sachet has been opened before or tampered in any way.
Store in original package.
6.

Further information

Active ingredients: Each sachet contains Paracetamol 500mg

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1.3.1 Leaflet

Paracetamol Hot Drink
GlaxoSmithKline Consumer Healthcare

Other ingredients: Sucrose, aspartame (E951), tartaric acid, trisodium citrate
(anhydrous), blackcurrant flavour, menthol flavour, red colorant (Rojo Conacert
M659).
Blackcurrant flavour contains sulphites.
Red colorant (Rojo Conacert M659) contains carmoisine (E122), sunset yellow
(E110) and brilliant black (E151).
Packs of Paracetamol Hot Drink contain 5, 6 or 10 sachets.

The marketing authorisation holder is GlaxoSmithkline Consumer Healthcare,
Brentford, TW8 9GS, UK. All enquiries should be sent to this address.
The manufacturer is SmithKline Beecham S.A. Ctra. De Ajalvir, KM 2,500, Alcala
De Henares, Madrid 28806, Spain.
This leaflet was last revised in February 2012.
PL00079/0673
Beechams is registered trade mark of the GlaxoSmithKline group of companies

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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