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Paracetamol 500mg Tablet

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PROPOSED

PROPOSED

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Paracetamol carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact your doctor if your symptoms worsen or do not improve after 3 days of treatment.

-    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.


PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500 mg TABLETS

THIS LEAFLET CONTAINS

1.    What Paracetamol is for

2.    Before you take Paracetamol

3.    How to take Paracetamol

4.    Possible side effects

5.    How to store Paracetamol

6.    Further information

1. WHAT PARACETAMOL IS FOR

Paracetamol belongs to groups of medicines known as analgesics and antipyretics. It works by relieving pain and reducing body temperature in cases of fever.

Paracetamol Tablets are used to relieve mild to moderate pain including headache, migraine, toothache, backache, period pain and muscle and rheumatic pain.

They can also be used to relieve the symptoms of colds and flu (sore throat, fever, aches and pains), as well as relieve the pain due to mild arthritis.

2. BEFORE YOU TAKE PARACETAMOL

Do not take this medicine if you:

•    are allergic to paracetamol or any of the other ingredients in the tablets (see section 6 of this leaflet)

•    are taking other paracetamol-containing products

Do not take this medicine if any of the above apply to you. If you are not sure, check with your pharmacist or doctor before taking Paracetamol.

•    have liver problems, particularly those due to drinking too much alcohol

•    suffer from mild arthritis and need to take painkillers everyday

Taking other medicines

Consult your pharmacist or doctor if you are taking or have recently taken any other medicines, including medicines bought without a prescription. This is because Paracetamol can affect the way some medicines work. Also some medicines can affect the way Paracetamol works.

In particular, tell your pharmacist or doctor if you are taking any of the following:

•    medicines to treat epilepsy such as phenobarbital

•    doxorubicin, used in the treatment of cancer

•    aspirin, used to treat pain, inflammation or fever

•    metoclopramide or domperidone, for nausea (feeling sick) and vomiting (being sick)

•    cholestyramine, to reduce blood cholesterol levels

•    warfarin and other coumarins, used to thin the blood and prevent clots from forming

If you are not sure if any of the above apply to you, talk to your pharmacist or doctor before taking Paracetamol.

Taking Paracetamol with food and drink

Avoid alcohol whilst taking Paracetamol, as it can increase the risk of the side effects.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor or pharmacist before taking any medicines.

Driving and using machines

This medicine should not affect your ability to drive or operate machines.

3. HOW TO TAKE PARACETAMOL

Follow the instructions provided in this leaflet. You should check with your pharmacist or doctor if you are not sure.

Taking this medicine

•    Do not exceed the recommended dose

•    Do not take with other paracetamol-containing products

•    If your symptoms persist for more than three days, you should consult your doctor

•    Swallow the tablets with a drink of water

Dosage:

Adults (including the elderly) and children over 12 years:

Take 2 tablets, up to 4 times a day as required. Wait at least 4 hours between doses. Do not take more than 8 tablets in any 24 hour period.

Take special care with Paracetamol

Consult your doctor before you take this medicine if you: • have kidney problems

Children under 12 years:

A liquid form of this medicine may be more suitable for use in children under 12 years of age.

If you take more Paracetamol than you should

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the delayed risk of serious liver damage. Symptoms of an overdose may include paleness, nausea, vomiting, loss of appetite and abdominal pains. Consult a doctor or go to the nearest hospital casualty department straight away. Take this leaflet and the medicine pack with you, so the doctor knows what has been taken.

If you forget to take Paracetamol

Take the next dose when needed. Do not take a double dose (two doses at the same time) to make up for the forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol can cause side effects, although not everybody gets them.

STOP TAKING this medicine and see a doctor or go to a hospital straight away if you notice any of the following side effects:

•    an allergic reaction. The symptoms of which may include skin rash, itching, blistering or peeling of the skin, swelling of the face, lips, tongue or throat, difficulty in breathing or swallowing, sudden wheezing or collapse.

If you get any of the following side effects, stop taking this medicine and talk to your doctor as soon as possible:

•    unexplained bruising or bleeding, red-purple spots of discolouration on the skin, sore throats or infections. These may be signs of changes to your blood cells.

•    loss of appetite, abdominal discomfort, dark urine, or yellowing of the eyes and skin. These may be signs of changes to your liver.

If you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.

6. FURTHER INFORMATION

What Paracetamol tablets contain

The active ingredient in the tablets (the ingredient which makes this medicine work) is paracetamol. Each tablet contains 500 mg of paracetamol.

The tablets also contain povidone, starch, magnesium stearate and stearic acid.

What Paracetamol tablets look like and contents of the pack

Paracetamol tablets are white capsule-shaped tablets, scored on one side, which come in containers or blister packs of 2, 4, 8, 12 and 16 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited Boumpoulinas 11, 3rd Floor,

Nicosia, P.C. 1060, Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 04/2012

CL0076/G/PIL/G1

5. HOW TO STORE PARACETAMOL

Keep out of the reach and sight of children.

Do not store above 25 ° C. Store in the original package.

Do not use the tablets after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.

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.