Paracetamol 500 mg Tablets PL43461/0006

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 other information

• if you are allergic to paracetamol or any of the other ingredients (listed in Section 6).
• if you are taking any other prescription or non-prescription medicines that contain Paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.

Ask your doctor before you take this medicine:

• if you suffer from mild arthritis and need to take painkillers every day.
• have liver or kidney problems
• are underweight or malnourished
• regularly drink alcohol
• have a severe infection as this may increase the risk of metabolic acidosis.

Signs of metabolic acidosis include:

• deep, rapid, difficult breathing
• feeling sick (nausea), being sick (vomiting)
• loss of appetite

Contact a doctor immediately if you get a combination of these symptoms. You may need to avoid using this product altogether or limit the amount of paracetamol that you take.

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, particularly:

• Anticoagulant to thin your blood e.g. Warfarin and you need to take a pain reliever on a daily basis, talk to your doctor because of the risk of bleeding. But you can still take occasional doses of Paracetamol Tablets at the same time as anticoagulants.
• Medicines to control nausea and vomiting e.g. Metoclopramide or domperidone
• Medicines to lower blood cholesterol 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 are advised NOT to drink alcohol whilst taking Paracetamol tablets. Taking alcohol with Paracetamol can increase your chances of getting side effects.

Talk to your healthcare professional before taking Paracetamol Tablets if you are pregnant. You can take this product whilst breast feeding.

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

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Adults and children aged 16 years and over:

Swallow 1-2 tablets every 4 to 6 hours as needed.

Do not take more than 8 tablets in 24 hours.

Children aged 10-15 years:

Give 1 tablet every 4 to 6 hours as needed.

Do not give more than 4 tablets in 24 hours.

Do not give for more than 3 days at a time unless your doctor tells you to.

Dosage instruction:

• Do not take more frequently than every 4 hours.
• Do not take more than the recommended dose.
• Do not give to children under 10 years.

• Talk to your doctor once if you take too much of this medicine even if you feel well, because too much paracetamol can cause delayed, serious liver damage.
• If your symptoms continue or your headache becomes persistent, see your doctor.

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.

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 or search for MHRA Yellow Card in Google Play Store 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 break line on one side and plain on other.

Paracetamol Tablets are available in blister packs of 4, 6, 12 and 16 Tablets.