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PACKAGE LEAFLET: INFORMATION FOR THE USER

PARACETAMOL 500mg CAPSULES

Read all of this leaflet carefully 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 or pharmacist.

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

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

What is in this leaflet

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

2.    What you need to know before you take Paracetamol Capsules

3.    How to take Paracetamol Capsules

4.    Possible side effects

5.    How to Store Paracetamol Capsules

6.    Contents of the pack and other information

1. What Paracetamol Capsules are and _what they are used for_

Paracetamol is an analgesic and an antipyretic which means it relieves pain and lowers temperature. These capsules are used for the relief of:

•    Fever, pain, headache, migraine, sharp nerve pain (neuralgia), toothache, sore throat, period pains, aches and pain.

•    symptomatic relief of rheumatic aches and pains, influenza symptoms, feverishness and feverish colds.

2. What you need to know before you take Paracetamol Capsules Do not take these capsules if you:

•    are allergic to paracetamol or any other ingredients (listed in section 6).

•    are taking any other products containing paracetamol Warnings and precautions

Take special care and talk to your doctor or pharmacist before taking Paracetamol Capsules if you:

•    are suffering from liver problems including liver problems due to excessive alcohol consumption

•    are suffering from Gilbert's syndrome (mild jaundice)

•    are suffering from kidney problems

•    are suffering from dehydration and chronic malnutrition

•    suffer from asthma and are sensitive to aspirin

•    are taking any other paracetamol containing medicines

•    have a fever that does not improve after taking this medicine

•    have glucose-6-phosphatedehydrogenase deficiency (enzyme deficiency)

•    have haemolytic anemia (abnormal breakdown of red blood cells).

Other medicines and Paracetamol Capsules Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not obtained without a prescription.

The following medicines can affect Paracetamol:

•    Drugs to thin the blood (anti-coagulant drugs e.g. Warfarin, other coumarins)

•    Medicines used to relieve sickness (e.g. Metoclopramide, Domperidone)

•    Medicines used to treat high cholesterol (Cholestyramine)

•    Probenecid (Medicine used to treat high levels of uric acid in the blood stream (gout))

•    Medicine to treat fever or mild pain (Aspirin, Salicylamide)

•    Barbiturates and tricyclic antidepressants (to treat depression)

•    Medicines used to treat epilepsy (Lamotrigine)

•    Medicines to treat tuberculosis (Isoniazid)

Effects of paracetamol on laboratory tests

Uric acid and blood sugar tests may be affected.

Paracetamol capsules with food and drink

This medicine may be taken with or without food.

Pregnancy and breast-feeding

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

If you are pregnant see your doctor before you take Paracetamol.

Small amounts of paracetamol may pass into breast milk. This medicine may be taken, as instructed (see section 3), by mothers who are breast-feeding.

Driving and using machines

Paracetamol has no influence on the ability to drive and use machines.

Paracetamol Capsules contain Parahydroxybenzoates

•    The capsule shell contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed) and exceptionally bronchospasm.

3. How to take Paracetamol Capsules

•    Always take this medicine exactly as advised by your doctor. Check with your doctor or pharmacist if you are not sure.

•    Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor.

•    The capsules should be swallowed whole with a drink of water.

Adults, the elderly and children of 16 years and over:

Take two capsules not more than every 4 hours as required, to a maximum of 8 capsules in a day.

Children aged 12 - 15 years:

Take one capsule every 4-6 hours when necessary to a maximum of 4 capsules in a day.    s

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Children under 12 years:

Do not give to children under 12 years.

If you take more Paracetamol capsules than you should

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 (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain or liver damage.

If you forget to take the Paracetamol Capsules

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

4. Possible side effects

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

Very rare cases of serious skin reactions have been reported.

•    accumulation of fluid in the larynx including an itchy rash, throat swelling (severe allergic reaction),

•    swelling on the face, mouth, hands (angioedema)

You should stop taking this medicine and see your doctor immediately if you experience symptoms like:

•    serious skin disease causing rash, skin peeling and sores.

•    severe blistering and peeling of the skin.

The frequency using the following convention:

Rare (may affect up to 1 in 1,000 people):

Oedema (abnormal accumulation of fluid under the skin), abnormal vision, simple skin rash or urticaria (dark red rash on the skin), haemorrhage (bleeding), abdominal pain, diarrhoea, nausea, vomiting, dizziness, fever, reduction of irritability or agitation (sedation), platelet disorders (clotting disorders), stem cell disorders (disorders of the blood forming cell in the bone marrow), abnormal liver function,liver failure,

hepatic necrosis (death of liver cells), jaundice, overdose and poisoning,tremor, headache, depression, confusion, hallucinations, sweating, pruritus (itching), feeling lousy (malaise).

Very rare (may affect up to 1 in 10,000 people):

hepatotoxicity (damage caused to the liver), thrombocytopenia (reduction in blood platelets, which increases the risk of bleeding or bruising), leucopenia (frequent infections due to poorly functioning white blood cells or decrease in white blood cells), neutropenia (reduced neutrophil count in blood), agranulocytosis (severe decrease in white blood cells which may lead to severe infections), hemolytic anemia (abnormal breakdown of red blood cells, which may cause weakness or pale skin), hypoglycemia (low levels of glucose in the blood), cloudy urine and kidney disorders.

Other adverse reactions of paracetamol whose frequency cannot be estimated from available data are: anaemia (decrease in red blood cells), problems with the way your kidneys work (kidney alteration), problems with the way your liver works (liver alteration), haematuria (blood in urine), anuresis (inability to urinate), gastrointestinal effects, vertigo. There have been cases of difficulty breathing, wheezing, coughing, and shortness of breath with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs such as ibuprofen.

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 Capsules

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25⁰C. Store in the original package.

•    Do not use the capsules after the expiry date printed on the

carton after (EXP.). The expiry date refers to the last day of that month.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Paracetamol capsules contain

•    The active substance is Paracetamol.

•    The other ingredients are: pregelatinised maize starch, magnesium stearate and sodium laurylsulfate.

•    The capsule shell contains: titanium dioxide (E171), erythrosine (E127), quinolone yellow (E104), patent blue (E131), gelatin, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

What Paracetamol capsules look like and contents of the pack

•    They are red and white hard gelatine capsules, containing white free flowing powder.

•    They are available in cartons containing 100 capsules.

Marketing Authorisation Holder and Manufacturer Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

E-mail:    info@bristol-labs.co.uk

Paracetamol 500mg Capsules; PL 17907/0245 This leaflet was last revised in August 2016

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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