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Paracetamol Capsules 500mg

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Document: leaflet MAH GENERIC_PL 39484-0037 change

180 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500mg CAPSULES

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 500mg capsules 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 effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Paracetamol 500mg Capsules are and what they are used for

2.    Before you take Paracetamol 500mg capsules

3.    How to take Paracetamol 500mg capsules

4.    Possible side effects

5.    How to store Paracetamol 500mg capsules

6.    Further information


1. WHAT PARACETAMOL 500mg CAPSULES ARE AND WHAT THEY ARE USED FOR

Paracetamol 500mg capsules contain the active ingredient paracetamol and are used for the relief of mild to moderate pain, including:

•    rheumatic and muscular    pain

•    backache, toothache

•    neuralgia (severe nerve    pain), period pain

•    migraine, headache

•    fevers, colds and flu.

BEFORE YOU TAKE PARACETAMOL 500mg CAPSULES

DO NOT take paracetamol 500mg Capsules If you are:

•    allergic (hypersensitive) to paracetamol, other pain relievers or any of the other ingredients in the product (see Section 6 on ‘What Paracetamol 500mg Capsules contain’)

•    taking any other paracetamol-containing medicines, i.e. over-the-counter cold remedies.

This medicine is NOT recommended for children under 12 years of age.

Take special care with Paracetamol 500mg Capsules

Consult your doctor before taking these capsules if you:

•    have kidney or liver problems.

•    are an alcoholic

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly:

•    other products containing paracetamol (see ’DO NOT take Paracetamol 500mg Capsules’)

•    warfarin and other drug which thin the blood

•    cholestyramine (reduces blood cholesterol levels)

•    metoclopramide and domperidone (used to treat nausea, vomiting or other stomach problems).

Taking Paracetamol 500mg Capsules with food and drink

Avoid alcoholic drinks whilst taking these capsules.

Pregnancy and Breast Feeding

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant, planning to become pregnant or breast-feeding.

Driving and using machines

Paracetamol 500mg capsules are not expected to affect your ability to drive or operate machinery

HOW TO TAKE PARACETAMOL 500mg CAPSULES

Always take Paracetamol 500mg Capsules exactly as your doctor has told you. Swallow each capsule with a drink of water.

WARNING: DO NOT EXCEED THE STATED DOSE

Contains paracetamol. Do not take with other paracetamol containing

products.


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.


Adults:

Take one or two capsules every 4 to 6 hours, up to a maximum of 8 capsules in any 24 hour period. You should not take Paracetamol 500mg Capsules for longer than 3 days.

This medicine is not recommended for children under 12 years of age.

If symptoms persist consult your doctor. Do not use for more than 3 days without consulting your doctor.

If you take more Paracetamol 500mg Capsules than you should

It is extremely important to follow the dosage instructions that have been given to you. DO not change your dose without discussing it with your doctor first. Symptoms of overdose include pallor (Paleness of skin), nausea, vomiting, anorexia and stomach pain. If you accidentally take more than recommended dose, or know someone who has, contact your doctor or nearest hospital casualty immediately. Take any remaining medicine and this leaflet with you if possible.

If you forget to take Paracetamol 500mg capsules If you miss a dose, take it as soon as you remember.

NEVER take a double dose to make up for the dose you have forgotten.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Paracetamol 500mg Capsules can cause side effects, although not everbody gets them.

Like all medicines, Paracetamol 500mg Capsules can cause side effects, although not everbody gets them. You may suffer an allergic reaction, symptoms of which Include skin rashes and Itching. If this happens to you, stop taking the capsules Immediately and seek urgent medical help.

The following have also been reported.

•    hives

•    blood abnormalities, but these were not necessarily due to paracetamol treatment.

•    drowsiness and impaired mental function severe liver poisoning in alcoholics.

Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www. mhra. gov.uk/yellowcard alternatively you can call Freephone 0808 100 3352 (available between 10 am - 2 pm Monday - Friday) or fill in a paper form available from your local pharmacy.

HOW TO STORE PARACETAMOL 500mg CAPSULES

Keep out of reach and sight of children

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

Do not use Paracetamol 500mg Capsules after the expiry date shown on the package.

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.

FURTHER INFORMATION

What Paracetamol 500mg Capsule contain The active substance is paracetamol 500mg.

The other ingredients are starch 1500, magnesium stearate, sodium lauryl sulphate. The capsule shell is opaque red/white gelatin 100mg, containing as colours erythrosine (E127), patent blue V (E131), titanium dioxide (E171) and quinoline yellow (E104).

What Paracetamol 500mg Capsules look like and contents of the pack

Paracetamol 500mg Capsules are clean, oblong shaped red and white capsules.

They are supplied in:

cartons containing blister strips of 8,12,16,24,32,50,60,84,96 and 100 capsules bottles of 16, 25, 50, 60 and 100 capsules tamper-evident plastic tubs of 250, 500 and 1000 capsules.

Marketing Authorisation Holder:

Fourrts (UK) Pharmacare Ltd, First floor, 2 Victoria Road,

Harpenden, Hertfordshire, A15 4EA, UK.

Manufacturer: Strandhaven Ltd t/a Somex Pharma, Seven Kings,

Ilford, Essex IG3 8RA, UK.

This leaflet was last revised in 08/2013

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