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Paracetamol 500mg Capsules

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Document: leaflet MAH GENERIC_PL 20395-0089 change

Artw rl<

Creative* Dee ions

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Artwork No.

280113/5

Colours Used

Customer

Relon Chem

Balck

Description

Paracetamol 500mg Caps Pi 1

Keyline (not to print)

Market

UK

Language

English

Size

1 20 x 260 mm

■JP

Min. Font Size

9 pt

Page No.

1 of 1

e-mail : prasad.pdp@gmail.com Ph : +91-9845609386

Version No.

10

Date

04-11-16

Software

Illustrator 1 0

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

RelonGhem

PARACETAMOL 500mg CAPSULES


PACKAGE LEAFLET: INFORMATION FORTHE USER


Warning: Do nottake more medicine than the label tells you to. Ifyou do not get better, talk to your doctor.


Talk to a doctor at once ifyou take too much of this medicine even if you feel well, this is because too much Paracetamol can cause delayed, serious liver damage.


Read all of this leaflet carefully before

you start taking this medicine because

It contains Important Information for

you.

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

•    If you have any further questions, ask your doctor, pharmacist or nurse.

•    If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

What is in this leaflet:

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

2.    What you need to know 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.    Contents of the pack and other information

1. WHAT PARACETAMOL 500mg CAPSULES ARE AND WHAT THEY ARE USEDFOR

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.

2. WHAT YOU NEED TO KNOW 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') Signs ofan allergic reaction including a rash and breathing problems, there can also be swelling of the legs, arms, face, throat or tongue

This medicine is NOT recommended in children

Warnings and precautions:

Talk to your doctor or pharmacist or nurse before taking Paracetamol 500mg Capsules if you:

•    have kidney or liver problems.

•    are an alcoholic.

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

Other medicines and Paracetamol 500mg Capsules

Tell your doctor or Pharmacist ifyou are taking, have recently taken or might take any other medicines.

This includes medicines obtained without prescription, including herbal medicines.

This is because paracetamol can affect the way some other medicines work. Also some other medicines can affect the way paracetamol works.

While taking paracetamol you should not take any other medicines which contain paracetamol.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

•    Anything else containing paracetamol (see 'DO NOT take paracetamol 500mg capsules')

•    Warfarin and other drugs which thin blood

•    Cholestyramine (reduces blood cholesterol level)

•    Metoclopramide and dompiridone (used to treat nausea, vomiting or other stomach problems).

Taking Paracetamol 500mg Capsules with alcohol

You should not drink whilst taking these tablets. Taking alcohol with paracetamol can increase your chances of getting side effects.

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.

3. 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.

Adults:

Take one or two capsules every 4to6 hours, up to a maximum of8capsules in any 24 hour period. You should not take Paracetamol 500mg Capsules for longer than 3 days.

Ifyou need to use this medicines for more than three days at a time, see your doctor.

This medicine is NOT recommended in children

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.

Ifyou accidentally take more than the 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

Ifyou miss a dose, take it as soon as you remember. NEVER take a double dose to make up for the dose you have forgotten. Ifyou have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

You may suffer an allergic reaction, symptoms of which include skin rashes, itching, rapid swelling of the face, mouth, tongue and throat. Very rare cases of serious skin reactions have been reported. Symptoms could include skin reddening, blisters or rash. If these happen to you, stop taking the capsules immediately and seek urgent medical help.

The following have also been reported:

• Blood does not clot well, which may result in easy bruising or bleeding. A severe reduction in the number of white blood cells, which makes infections more likely.

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.

5. HOW TO STORE PARACETAMOL 500mg CAPSULES

Keep out of the sight and reach 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Paracetamol 500mg Capsules 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 48,60,96 and 100 Capsules.

*    Not all pack sizes may be marketed.

Marketing Authorisation Holder

Relonchem Limited,

Cheshire House, Gorseylane,

Widnes, WA8 0RP. United Kingdom.

Tel: 0207 419 5043 Fax: 0207 419 5024 Email: lnfo@relonchem.com

PL 20395/0089 | POM |

Date Leaflet last revised: November 2016