Paracetamol 500mg Capsules (GSL)

This medicine is available without prescription for you to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a pharmacist or doctor if your symptoms worsen or do not improve after 3 days.

• If you are allergic to any of the ingredients.
• If you have severe liver disease.

Talk to your pharmacist or doctor:

• If you have kidney problems.
• If you have other liver problems (including a disease caused by drinking alcohol).

• 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).

If necessary, this medicine 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.

This medicine contains paracetamol.

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

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Domperidone or metoclopramide, for feeling sick or being sick (may increase the pain relief effect of paracetamol).
• Colestyramine, for lowering blood lipid levels (may reduce the pain relief effect of paracetamol).
• Warfarin or other coumarins (for thinning the blood) – if you take warfarin you can take occasional doses of this medicine, but talk to your doctor first before you take it on a regular basis.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see 'Warnings and precautions').

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicines you have bought yourself, including herbal and homeopathic remedies.

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. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

• Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions).
• Very rare cases of serious skin reactions have been reported.

Frequency “Not known” (frequency cannot be estimated from the available data):

• A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see 'Warnings and precautions').

These other effects are less serious, if they bother you talk to a pharmacist:

• Other allergic reactions.
• Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in the blood.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

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.

PL 31308/0004