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Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have
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 effect, 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 if you feel worse after 3 days.
Warning: Ingestion of higher doses than the recommended involves risk of serious liver damage. The
maximal daily dose of paracetamol must therefore not be exceeded. Care should also be taken for
concurrent use of other medicinal products also containing paracetamol. See also section 3 “If you
take more Paracetamol than you should”.
In case of high fever or signs of infection after more than 3 days of treatment or if pain persists after
more than 5 days of treatment, you should contact your doctor.
Paracetamol can affect how some laboratory tests work, such as tests for uric acid and blood sugar.
Dosage
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told
you. Check with your doctor or pharmacist if you are not sure.
Do not exceed the stated dose. Please observe that higher doses than those recommended may result
in a risk of very serious liver damage.
Paediatric dosage should be based on body weight and suitable dosage form used. Information on the
age of children within each weight group given below is for guidance only.
Paracetamol 500 mg is not intended for children weighing less than 26 kg.
In case of high fever or signs of infection after more than 3 days of treatment or if pain persists
after more than 5 days of treatment, you should contact your doctor.
Elderly patients
Dose adjustment is not required in the elderly.
If you experience difficulty in breathing, swelling of the face, lips, neck, tongue or throat (severe
allergic reactions) stop taking this medicine and seek immediate medical advice.
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 HPRA
Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; E-mail: [email protected].
By reporting side effects you can help provide more information on the safety of this medicine.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
Pack sizes:
Blister packs: 10, 12, 20, 24 and 30 tablets
Manufacturer
Balkanpharma – Dupnitsa AD
3, Samokovsko Shosse Str., 2600 Dupnitsa
Bulgaria
Or
Orifice Medical AB
Aktergatan 2, 4 och 5
271 55 Ystad
Sweden