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Paracetamol & Caffeine 500 Mg / 65 Mg Effervescent Tablets

PATIENT INFORMATION LEAFLET PARACETAMOL & CAFFEINE 500 mg / 65 mg EFFERVESCENT TABLETS (paracetamol and caffeine)

The name of this medicine is Paracetamol & Caffeine 500 mg / 65 mg Effervescent 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 this leaflet:

1.    What Paracetamol & Caffeine Tablets are and what they are used for

2.    Before you take Paracetamol & Caffeine Tablets

3.    How to take Paracetamol & Caffeine Tablets

4.    Possible side effects

5.    How to store Paracetamol & Caffeine Tablets

6.    Further Information


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.


2. BEFORE YOU TAKE PARACETAMOL & CAFFEINE TABLETS


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.

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

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.

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

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.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

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.

This product also contains aspartame (a source of phenylalanine), which should not be given to anyone with phenylketonuria.


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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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3. HOW TO TAKE PARACETAMOL & CAFFEINE TABLETS


5. HOW TO STORE 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 don’t 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.

Talk to a doctor at once if you take too much of this medicine even if you feel well.

This is because too much paracetamol can cause delayed, serious liver damage.

If you have any further questions on the use of this product, ask your doctor or pharmacist.


Keep out of the sight and reach 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


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.

Reporting of side effects

If you get any side effects, talk to your doctor, 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.

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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:

Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom. Manufacturer:

Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom

This leaflet is available in formats suitable for the blind and partially-sighted upon request.

This leaflet was last revised in June 2014.


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