Paracetamol 500mg Caplets BP (PL 43461/0078)

• 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.

1. What Paracetamol Tablets are and what they are 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 to any other of the other ingredients of this medicine (listed in section 6).

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

Talk to your doctor or pharmacist before taking Paracetamol Tablets

• If you suffer from any liver or kidney problems
• If you suffer from alcoholic liver disease
• If you suffer from mild arthritis and need to take painkillers every day
• If you are pregnant or breastfeeding

During treatment with this tablets 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).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This means medicines you have bought yourself as well as those you have on prescription from doctor.

Paracetamol Tablets and other medicines you may be taking may affect how each other work.

Make sure your doctor knows if you are taking/using any of the following:

• Anticoagulants to thin the blood (e.g. warfarin)
• Colestyramine (used to lower the amount of fats in your blood). Should not be taken at least one hour before and after taking paracetamol
• Metoclopramide or domperidone (used to nausea and vomiting)
• Chloramphenicol (used to treat conjunctivitis)
• Imatinib (used to treat leukaemia and some stomach tumours).

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).

If necessary, Paracetamol 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.

If you are suffering from a headache and it becomes persistent, consult your doctor.

The tablets contain sodium metabisulphite (E223) which may rarely cause severe hypersensitivity reactions and bronchospasm (breathing difficulties).

Paracetamol Tablets should not affect your ability to drive or operate machinery.

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 miss a dose don't worry. Do not take a double dose to make up for the forgotten dose, just carry on with the normal routine.

• Swelling of the face, lips or throat, difficulty in breathing or dizziness. These may be signs of a serious allergic reaction
• Allergic skin reactions including rash, blistering of the skin, mouth, eyes and genitals
• Breathing problems or wheezing. These effects are more likely if you have asthma and have experienced them before when taking aspirin or other medicines called NSAIDs e.g. ibuprofen
• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin
• Very rare cases of serious skin reactions have been reported.
• Changes in blood which may lead to bruising or bleeding gums. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor
• Not known Frequency - Metabolic acidosis: A serious condition that can make blood more acidic, in patients with severe illness using paracetamol (see section 2).

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.

The tablets are white and capsule shaped with a break line on one side. The tablets are available in blister packs as below:

Blister packs: 8, 12, 16 tablets. Not all the pack sizes may be available.

Product licence number

PL 43461/0078