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Paracetamol 500mg Capsules

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Document: leaflet MAH GENERIC_PL 20395-0081 change

PARACETAMOL 500mg CAPSULES


RelonGhem


PACKAGE LEAFLET: INFORMATION FOR THE USER


Read all of this leaflet carefully before you start taking this medicine because It contains important information foryou.

Always take this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you.

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

• Askyourpharmacist ifyou need more information or advice.

•    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.

• You must talk to a doctor ifyou do not feel better or ifyou feel worse after 3 days

•    This medicine has been prescribed foryou. 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.    Whatyou 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 USED FOR


paracetamol suumg uapsuies belong to a group of medicines called Analgesics and Antipyretics.

They work by relieving pain and reducing high temperature and fever.

Paracetamol 500mg Capsules are used for the relief of mild to moderate pain including headache, migraine, tension headaches, neuralgia (severe pain in nerves), backache, toothache, sore throat, period pain, symptomatic relief of sprains, strains, rheumatic pain, sciatica (low back pain and leg pain), lumbago (low back pain), fibrositis (muscle and connective tissue pain), muscular aches and pains, joint swelling and stiffness, influenza.feverishness and feverish colds. They may also be used for symptomatic relief of pain due to nonserious arthritis.


2. WHATYOUNEEDTOKNOWBEFORE 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 Sectionon '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:

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.:

(see 'DO NOT take Paracetamol 500mg Capsules')

blood

cholesterol levels)

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.


WARNING: Do not take anything else containing paracetamol while taking this medicine.


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.


Pregnancy and Breast-Feeding

Ask your doctor or pharmacist for advice before taking any medicine ifyou 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. HOWTOTAKEPARACETAMOL 500mg CAPSULES

Always take Paracetamol 500mg Capsules exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist ifyou are not sure.

Adults:

Take one or two capsules every 4to6 hours, up to a maximum of 8 capsules in any 24 hourperiod.

This medicine is NOT recommended in children

The dose should not be repeated more frequentlythan 4 hourly intervals.

Do not take more medicine than the label tells you to. Ifyou do not get better, talk to 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 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 some one who has, contact your doctor or nearest hospital casuality 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. POSSIBLESIDEEFFECTS

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

Ifyou experience any of the following serious effects STOP taking this medicine immediately and contact your doctor or pharmacist:

Severe allergic reactions include:

•    difficulty in breathing

•    skin rash and itching

•    swelling of the face and throat

•    runny nose

•    Very rare cases of serious skin reactions have been reported. Symptoms could include skin reddening, blisters or rash.

Other possible side effects

•    Blooddoesnotclotwell.whichmay result in easy bruising or bleeding

•    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: "http://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 ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTSOFTHEPACKAND 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 of8,16 and 32 Capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer:

Relonchem Limited,

Cheshire House,

Gorsey Lane, Widnes,

Cheshire, WA8 ORP, UK.

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

PL 20395/0081    [p]

This leaflet was last revised in November 2016.