Paracetamol 500 mg Film-Coated Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Paracetamol

Verfügbar ab:

Chefaro Ireland DAC

ATC-Code:

N02BE; N02BE01

INN (Internationale Bezeichnung):

Paracetamol

Dosierung:

500 milligram(s)

Darreichungsform:

Film-coated tablet

Verschreibungstyp:

Product not subject to medical prescription

Therapiebereich:

Anilides; paracetamol

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1992-08-20

Gebrauchsinformation

PATIENT INFORMATION LEAFLET
PARACETAMOL 500MG FILM-COATED TABLETS
PARACETAMOL
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use paracetamol tablets
carefully to get the best results from them.
• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
IN THIS LEAFLET:
1. What paracetamol tablets are and what they are used for
2. Check before you take paracetamol tablets
3. How to take paracetamol tablets
4. Possible side effects
5. How to store and dispose of paracetamol tablets
6. Further information
1. WHAT PARACETAMOL TABLETS ARE AND WHAT THEY ARE USED FOR
PARACETAMOL TABLETS ARE USED FOR RELIEF OF HEADACHES, INCLUDING
MIGRAINE AND TENSION HEADACHES,
TOOTHACHE, BACKACHE, RHEUMATIC AND MUSCLE PAINS, NEURALGIA AND PERIOD
PAIN. It also relieves sore
throat and the feverishness, aches and pains of colds and flu. The
active ingredient is paracetamol
which is a painkiller and also reduces your temperature when you have
a fever.
2. CHECK BEFORE YOU TAKE PARACETAMOL TABLETS
☒
DO NOT TAKE PARACETAMOL TABLETS:
• IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol or to any
of the other ingredients (listed
in Section 6).
• if you are TAKING OTHER MEDICINES CONTAINING PARACETAMOL.
• if you are UNDER 6 YEARS unless your doctor tells you to.
! ASK YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE:
• if you have SEVERE LIVER or KIDNEY DISEASE, including ALCOHOLIC
LIVER DISEASE.
! OTHER MEDICINES AND PARACETAMOL 500MG TABLETS
Talk to your doctor or pharmacist before taking these tablets if you
are taking any prescribed
medicines; particularly METOCLOPRAMIDE or DOMPERIDONE (for NAUSEA
[feeling sick] or VOMITING
[being sick]); COLESTYRAMINE (to lower BLOOD CHOLESTEROL); PROBENECID
(gout), flucloxacillin
(antibiotic), due to a serious risk of blood and fluid abnormality
(high anion gap metabolic acidosis)
that must have urgent treatment and which may occur particularl

Fachinformation

Health Products Regulatory Authority
09 June 2022
CRN00CYCJ
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White film coated capsule-shaped tablet with flat edges and a break
line on one side. The break line is only to facilitate
breaking for ease of swallowing and do not divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Paracetamol tablets are a mild analgesic and antipyretic. The tablets
are recommended for use in the short term management
of headaches, including migraine and tension headaches, backache,
rheumatic and muscle pain, period pains, nerve pains,
toothache and for relieving of fever, aches and pains of colds and
flu.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only.
AGE
HOW MUCH
HOW OFTEN
Adults and children over 16years
1 or 2 tablets
Every 4-6 hours, as required. Don't take more than 8 tablets (4 doses)
in
any 24 hours.
Children 12-15 years
1 to 1½ tablets
Every 4-6 hours, as required. Don't take more than 6 tablets (4 doses)
in
any 24 hours.
Children 10-12 years
1 tablet
Every 4-6 hours, as required. Don't take more than 4 tablets (4 doses)
in
any 24 hours.
Children 6-10 years
½ tablet
Every 4-6 hours, as required. Don't take more than 2 tablets (4 doses)
in
any 24 hours.
Paracetamol tablets are not suitable for children under 10 years of
age.
These doses should not be repeated more frequently than every 4 hours
and not more than 4 doses should be given in any 24
hour period.
Maximum duration of continued use without medical advice: 3 days.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1. Use in children under 10 years of age.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Hepatic impairment
Health Products Regulatory Authority
09 June 2022
CRN00CYCJ