Paracetamol, also known as Acetaminophen, is an analgesic (painkiller) It is a medication for the relief of mild pain and fever associated with headaches, sore throats, migraines, toothache, period pains, neuralgia, colds and flu. Paracetamol may also help relieve mild pain associated with Rheumatism and Arthritis.

It is important that you read and fully understand the Patient Information Leaflet before purchasing this item.

Before you take this medicine

This medicine can be taken by adults and children aged 6 years and over. However, some
people should not take this medicine or should seek the advice of their pharmacist or doctor
first. Please view the section on Ingredients and Precautions.

Usage
Check the foil is not broken before use. If it is, do not take that tablet.

Adults and children of 12 years and over: one or two tablets up to four times a day, if you need to. Don’t take more than 8 tablets in any 24 hours.

Children of 6 to 11 years: half to one tablet up four times a day, if you need to. Don’t take more than 4 tablets in any 24 hours.

Don’t take more often than every 4 hours.
Swallow each tablet with water.
Do not give to children under 6 years, unless your doctor tells you to.

Paracetamol 500mg PIL galpharm caplets 16 GSL

Ingredients

Paracetamol 500 mg, is the active ingredient. As well as the active ingredient, the tablets also contain pregelatinised maize starch, sodium metabisulphite (E223), magnesium stearate.

Precautions

• Do not take with any other paracetamol containing products.
• Immediate medical advice should be sought in the event of an overdose, even if you feel well.
• Do not exceed the stated dose.
• Do not take this medicine for more than 3 days, unless your doctor tells you to.
• This is a medicine. Consult your doctor or pharmacist if you have an underlying medical condition, are taking any other medication or complementary therapy, or if symptoms persist.
• Seek advice before using if you are breast feeding, pregnant, planning to become pregnant, or suffer from allergies.
• Do not use the tablets after the end of the expiry month shown on the product packaging.
• Do not take this medication if you have ever had an allergic reaction to paracetamol or any of the ingredients in the tablet. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• If you (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
• If you forget to take a tablet take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.
• Check with your doctor before taking this medication if you have been an alcoholic or suffer from severe kidney or severe liver disease.
• Keep the tablets stored below 25°C in a dry place, protected from light.
• If symptoms persist or worsen after 3 days, you should consult your doctor for further advice.
  Talk to your doctor or pharmacist before you take this medicine if you:
• Are suffering from liver problems including liver problems due to excessive alcohol
  consumption
• Have 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 hemolytic anemia (abnormal breakdown of red blood cells).

The following medicines can affect Paracetamol:

• blood thinning drugs (anti-coagulants e.g. warfarin). The effect of anti-coagulants may be
  increased by prolonged regular use of paracetamol with an increased risk of bleeding,
  however occasional doses have no significant effect.
• colestyramine to lower blood cholesterol
• metoclopramide and domperidone (to treat nausea and vomiting)
• 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 Caplets with food and drink
This medicine may be taken with or without food.

Possible Side effects when taking Paracetamol 500mg tablets.

Like all medicines, paracetamol 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

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 here 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 product.

Other Information

If you need more advice consult your doctor or pharmacist.

Keep all medicines out of the sight and reach of children.