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BOOTS PARACETAMOL EXTRA SOLUBLE TABLETS

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PATIENT INFORMATION LEAFLET PARACETAMOL & CAFFEINE 500/65 mg SOLUBLE TABLETS (paracetamol and caffeine)
The name of this medicine is Paracetamol & Caffeine 500/65 mg Soluble Tablets, which will be referred to as Paracetamol & Caffeine Tablets throughout this leaflet. Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Paracetamol & Caffeine Tablets carefully to get the best results from them. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In 1. 2. 3. 4. 5. 6. this leaflet: What Paracetamol & Caffeine Tablets are and what they are used for Before you take Paracetamol & Caffeine Tablets How to take Paracetamol & Caffeine Tablets Possible side effects How to store Paracetamol & Caffeine Tablets Further Information

Take special care with Paracetamol & Caffeine Tablets Before you take Paracetamol & Caffeine Tablets you should tell your doctor or pharmacist if you: have severe kidney disease have severe liver disease, including alcoholic liver disease have persistent headaches. Taking other medicines Talk to your doctor or pharmacist before taking this medicine if you are taking any prescribed medicine, in particular: metoclopramide or domperidone - for nausea (feeling sick) or vomiting (being sick) cholestyramine - used to treat high cholesterol. If you take blood thinning medicines (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.
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1. WHAT PARACETAMOL & CAFFEINE TABLETS ARE AND WHAT THEY ARE USED FOR
The active ingredients in your tablets are paracetamol and caffeine. Paracetamol is an analgesic and an antipyretic; it works by relieving pain and reducing body temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol. Paracetamol & Caffeine Tablets are used to treat headache, migraine, backache, rheumatic and muscle pain, toothache and period pain. They also relieve discomfort in colds, influenza, sore throats and help reduce temperature.

Ask your doctor or pharmacist for advice before taking any medicine.
Item Code : HC01 C Artist : Atul

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Pharmacode/2D Code: 3864_std

2. BEFORE YOU TAKE PARACETAMOL & CAFFEINE TABLETS
Do not take Paracetamol & Caffeine Tablets if you: are allergic (hypersensitive) to paracetamol, caffeine, or to any of the other ingredients (these are listed in section 6, Further Information) are taking any other paracetamol-containing products are under 12 years of age.
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This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.
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Important information about some of the ingredients of Paracetamol & Caffeine Tablets Each of these tablets contains 409 mg of sodium. This may interfere if you are on a low sodium diet.

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Driving and using machines It is unlikely that Paracetamol & Caffeine Tablets will affect your ability to drive or operate machines.

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AXP063FUA

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Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you might be pregnant, are planning to become pregnant or are breast feeding.

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You should avoid drinking too much coffee or tea when taking these tablets.

Glossmeter reading (for white surface): NOT LESS THAN 80 %

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Date : 20-09-12 (03-12-12)

Taking your medicine with food and drink Paracetamol & Caffeine Tablets should be dissolved in a glass of water and can be taken with or without a meal.

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You may still be able to take Paracetamol & Caffeine Tablets but your doctor or pharmacist will be able to advise you.

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3. HOW TO TAKE PARACETAMOL & CAFFEINE TABLETS
Dosage Adults and children aged 12 years and over 2 tablets dissolved in a glass of water every 4 hours as required. Do not take more frequently than every 4 hours. Do not take more than 8 tablets in 24 hours. Do not take more than the recommended dose. Not recommended for children under 12 years of age. Method of administration For oral administration only. These tablets should be dissolved in a glass of water before taking them. These tablets are meant to be dissolved first so dont try to swallow them whole. If you take more Paracetamol & Caffeine Tablets than you should: If you have accidentally taken more than the recommended dose, contact your nearest hospital casualty emergency department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. 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. An overdose of paracetamol can cause serious liver damage, which may not show any signs for a day or two, by which time treatment may not be successful. If you have any further questions on the use of this product, ask your doctor or pharmacist.

5. HOW TO STORE PARACETAMOL & CAFFEINE TABLETS
Keep out of the reach and sight of children. Do not take this medicine after the expiry date (EXP) stated. The expiry date refers to the last day of that month. Store in the original package and protect from moisture. 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 to protect the environment.

6. FURTHER INFORMATION
What Paracetamol & Caffeine Tablets contain: The active ingredients are paracetamol and caffeine. Each tablet contains 500 mg of paracetamol and 65 mg of caffeine. Other ingredients are: citric acid (anhydrous) (E330), povidone, saccharin sodium, sodium hydrogen carbonate (E500), sodium carbonate anhydrous, simeticone (E900), Polysorbate 80 (E433) and aspartame (E951). What Paracetamol & Caffeine Tablets look like and contents of the pack: Paracetamol & Caffeine Tablets are white to off-white coloured circular flat bevelled tablets plain on both sides. Your medicine is available in packs of 24 tablets. Marketing Authorisation Holder: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK. Manufacturer responsible for batch release: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK. This information is available in alternative formats upon request.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Paracetamol and Caffeine Tablets can cause side effects although not everybody gets them. If you get any of the following symptoms after taking these tablets you should contact you doctor or pharmacist immediately: any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat skin rash Very rarely effects on the blood have been reported, resulting in: an increased tendency to bruise or bleed easily an increased susceptibility to infection. If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet was last approved in: November 2012.

AXP063FUA

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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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