Paracetamol 500mg Tablets (PL 43461/0003)

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

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or you feel worse after 3 days.

1. What Paracetamol Tablets is and what it is used for
2. What you need to know before you take Paracetamol Tablets
3. How to take Paracetamol Tablets
4. Possible side effects
5. How to store Paracetamol Tablets
6. Contents of the pack and further information

• if you are allergic to paracetamol or any of the other ingredients (listed in Section 6).
• If you are taking any other medicines that contain Paracetamol

• if you have severe kidney or liver problems including non-cirrhotic alcoholic liver disease
• if you have non-serious arthritis and need to take painkillers everyday

During treatment with Paracetamol, tell your doctor straight away if:

If you have severe illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin.

Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription.

• Chloramphenicol (an antibiotic): paracetamol may increase the levels of chloramphenicol in the blood
• Anticoagulant to thin your blood such e.g. warfarin
• Medicines to control nausea and vomiting e.g. Metoclopramide or domperidone
• Medicines to control high lipid levels e.g. Colestyramine

Please inform your doctor or pharmacist if you are taking :

flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

You should not drink alcohol whilst taking Paracetamol Tablets. Taking alcohol with paracetamol can increase your chances of getting side-effects

If necessary, Paracetamol 500 mg Tablets can be used during pregnancy. You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible.

Contact your doctor if the pain and/or fever are not reduced or if you need to take the medicine more often.

Tell your doctor if you are pregnant or planning to become pregnant, or are breast-feeding.

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

Paracetamol Tablets contain sodium metabisulphite which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).

For Adults (16 years and over):

Take one to two 500mg tablets every dose.

Do not take more than 8 tablets in 24 hours.

For Children:

• Ages 6 to 8 years:
  Give half a 500mg tablet every 4 to 6 hours if needed.
  Do not give more than 4 doses in 24 hours.
• Ages 8 to 10 years:
  Give half a 500mg tablet every 4 to 6 hours if needed.
  Maximum of 4 doses in 24 hours.
• Ages 10 to 12 years:
  Give one 500mg tablet every 4 to 6 hours if needed.
  Do not give more than 4 doses in 24 hours.
• Ages 12 to 15 years:
  Give one to one and a half 500mg tablets every 4 to 6 hours if needed.
  Maximum of 4 doses in 24 hours

Paracetamol Tablets should not be given to children under 6 years of age.

• Talk to your doctor even if you feel well because of the risk of delayed, serious liver damage
• Always take any tablets left over with you, also the box and leaflet as this will allow easier identification of the tablets

If you forget to take a dose, take it as soon as you remember. However, do not take a double dose to make up for a forgotten dose.

Remember to leave at least 4 hours between doses.

• difficulty in breathing
• skin rash and itching
• swelling of the face and throat
• runny nose

Rare cases of serious skin reactions have been reported with symptoms like skin reddening, blisters or rash.

Frequency not known: Metabolic acidosis -A serious condition that can make blood more acidic, in patients with severe illness using paracetamol (see section 2)

If any of the following side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist:

• Occasionally the blood does not clot well, which may result in easy bruising or bleeding.
• Rarely, a severe reduction in the number of white blood cells, which makes infections more likely.
• Nausea, sudden weight loss, loss of appetite, abdominal pain and swelling, dark colored urine or stools and yellowing of skin and eyes.

If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA yellow card in Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

These tablets contain 500 mg of Paracetamol as the active ingredient.

They also contain pregelatinised starch, magnesium stearate (E572), stearic acid (E570) and sodium metabisulphite (E223).

Paracetamol Tablets are white to off white, circular flat bevelled edge tablet with a breakline on one side and plain on the other.

The tablet can be divided into equal doses.

Paracetamol Tablets are available in blister packs of 100 tablets.