Paracetamol Hot Drink 500 Mg Powder For Oral Solution In Sachet
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GlaxoSmithKline Consumer Healthcare
1.3.1 Leaflet
1.3.1 Proposed Package Leaflet Paracetamol Hot Drink
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. What Paracetamol Hot Drink does.
2. Check before you take Paracetamol Hot Drink.
3. How to take Paracetamol Hot Drink.
4. Possible side effects.
5. How to store Paracetamol Hot Drink.
6. 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.
-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:
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 30°C.
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
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
m1-3-1 Proposed Package Leaflet Paracetamol Hot Drink - 120229ds Page 5 of 5