Paracetamol 500mg Soluble Tablets
B. PACKAGE LEAFLET
Patient Information Leaflet
KEEP THIS LEAFLET AND READ IT BEFORE YOU TAKE YOUR MEDICINE Paracetamol 500 mg Soluble Tablets
Read this entire leaflet carefully because it contains important information for you.
This medicine is available without prescnption, for you to treat a mild illness without a doctor's help. Nevertheless, you still need to use Paracetamol 500 mg Soluble Tablets carefully to get the best results from it
• Keep this leaflet Y ou may need to read this again.
• Ask your pharmacist if you need more information or advice
• You must see a doctor if your symptoms worsen or do not improve after 3 days
THE LEAFLET CONTAINS INFORMATION ON:
• What are Paracetamol 500 mg Soluble Tablets and what are they used for?
• Information to read before taking Paracetamol 500 mg Soluble Tablets?
• How to take your tablets?
• Can your tablets have any side effects?
• Storing your tablets
The name of your medicine is Paracetamol 500 mg Soluble Tablets.
These are white, biplane tablets with facets on both sides. Each tablet contains Paracetamol 500 mg. Other ingredients are citric acid anhydrous, sodium sulphate anhydrous, lactose monohydrate, sodium hydrogen carbonate, povidone K25, simethicone, saccharin sodium, lemon flavour H & R 213 841 (containing citral, citrtc acid, ethyl alcohol, lemon oil, lime oil, alpha-tocopherol, triacetin, maltodextrin, gum arabic and sucrose) and macrogol 6000.
The marketing authorisation holder:
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
PC. 1060 Nicosia.
Cyprus
The tablets are manufactured by:
Medreich PLC 9 Royal Parade Kew Gardens,
Surrey TW9 3QD England
WHAT ARE PARACETAMOL 500 MG SOLUBLE TABLETS AND WHAT ARE THEY USED FOR?
What are Paracetamol 500 mg Soluble Tablets?
These tablets contain paracetamol which is an analgesic (pain-killer) and antipyretic (brings down the body temperature in case of fever) Paracetamol 500 mg Soluble Tablets are available in the tube pack of 32 tablets (2x16 tablets).
What are they used for?
Paracetamol Soluble Tablets are used for headache, migraine, tension headaches, toothache, neuralgia, rheumatic and musde pain, period pain, sore throat and for relieving the fever, aches and pains of cold and flu.
INFORMATION TO READ BEFORE USING PARACETAMOL 500 MG SOLUBLE TABLETS
Do not take Paracetamol 500 mg Soluble Tablets:
• If you are allergic or sensitive to paracetamol
• If you are allergic or sensitive to any other ingredient of this product
Take special care with Paracetamol 500 mg Soluble Tablets:
• If you suffer from severe liver disease
• If you suffer from severe kidney disease
Please consult your doctor if any of the above statements are applicable to you.
WARNING:
1 PLEASE DO NOT TAKE WITH ANY OTHER PARACETAMOL-CONTAINING PRODUCTS.
2 IF SYMPTOMS PERSIST, CONSULT YOU DOCTOR
Immediate medical advice should be sought in the event of an overdose even if you feel well.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Pregnancy:
Please consult your doctor for advice before taking these tablets.
Breast-feeding
You can take Paracetamol 500 mg Soluble Tablets whilst breast-feeding Effect on the ability to drive and use machines:
Your tablets are unlikely to have any effect on your ability to drive and use machines
Important information about some of the ingredients of Paracetamol 500 mg Soluble Tablets:
Each tablet contains 392 mg of sodium. THESE TABLETS MAY BE HARMFUL FOR PEOPLE ON LOW SODIUM DIET
Taking Paracetamol 500 mg Soluble Tablets with other medication
Please see your doctor before taking your tablets if you are taking:
• Metoclopramide or domperidone - used for nausea and vomiting
• Cholestyramine - used for high blood cholesterol
• Anti-coagulants (blood-thinning drugs) like warfarin and you need to take Paracetamol 500 mg Soluble tablets regularly. However, occasional doses can be taken
HOW TO TAKE YOUR TABLETS?
Please dissolve your tablet(s) in a glass of water before taking. The recommended doses are as follows:
Adults (including elderly)
1-2 tablets every four to six hours as required. Do not take more than 8 tablets in 24 hours Children aged 12 - 15 years:
1 tablet every four to six hours, as required, up to a maximum of 4 tablets in any 24 hours. Children aged under 12 years:
This medicine is NOT recommended for children of this age.
DO NOT EXCEED THE STATED DOSE Consult your doctor if symptoms persist If you take too many tablets
Immediate medical advise should be sought in the event of an overdose even if you feel well, because of the risk of delayed, serious liver damage.
CAN YOUR TABLETS HAVE ANY SIDE EFFECTS?
Like all other medicines, Paracetamol 500mg Soluble Tablets can have side effects.
Side effects are usually mild and may indude skin rashes and other allergic reactions occasionally. Very rarely there have been reports of blood disorders but these were not necessarily caused by paracetamol.
These effects should go away once you stop taking your tablets.
In case you are concerned about these effects or you notice any side effects not mentioned in this leaflet, please consult your doctor or pharmacist.
STORING YOUR TABLETS.
Keep all medicines away from the reach and sight of children
Do not store above 25°C. Store in original container. Keep the container tightly dosed.
On the label you will find a date after which the medicine is no longer fit for use. Do not use this
medicine after this date
Store away from heat and direct sunlight
Do not store in bathroom, near the kitchen sink, or in damp places. Heat or moisture may cause the medicine to break down
Date of preparation: September 2016
PL 28444/0096
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