Panadol Tablet, film coated 500mg

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

PARACETAMOL

Disponível em:

GlaxoSmithKline Consumer Health-care UK Trading Limited

Código ATC:

N02BE01

DCI (Denominação Comum Internacional):

PARACETAMOL

Forma farmacêutica:

FILM-COATED TABLET

Composição:

PARACETAMOL 500 mg

Tipo de prescrição:

OTC

Área terapêutica:

ANALGESICS

Status de autorização:

Authorised

Folheto informativo - Bula

PATIENT INFORMATION LEAFLET
PANADOL 500MG FILM-COATED TABLETS
PARACETAMOL
PATIENT INFORMATION LEAFLET
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS
MEDICINE.
This medicine is available without prescription, but you still need to
use Panadol 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 Panadol tablets are and what they are used for
2. Check before you take Panadol tablets
3. How to take Panadol tablets
4. Possible side effects
5. How to store and dispose of Panadol tablets
6. Further information
1. WHAT PANADOL TABLETS ARE AND WHAT THEY ARE USED FOR
PANADOL TABLETS ARE USED FOR FAST AND EFFECTIVE RELIEF OF HEADACHES,
TOOTHACHE, BACKACHE,
RHEUMATIC AND MUSCLE PAINS AND PERIOD PAIN. It also relieves sore
throat and the
feverishness, aches and pains of colds and flu. Panadol tablets also
provide relief from the
pain associated with osteoarthritis as diagnosed by a doctor.
The active ingredient is paracetamol which is a painkiller and also
reduces your temperature
when you have a fever.
2. CHECK BEFORE YOU TAKE PANADOL TABLETS
DO NOT TAKE PANADOL 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 any OTHER MEDICINES CONTAINING PARACETAMOL
• if you are UNDER 6 YEARS
CHECK WITH YOUR DOCTOR BEFORE USE IF YOU:
• have liver or kidney problems, including alcoholic liver disease
•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 or limit the amount of
paracetamol that you take.
Please see your doctor if your symptoms do n

Características técnicas

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Panadol 500mg Film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500mg.
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Film coated tablet.
White capsule shaped film coated tablet with a triangular logo
embossed on one face and
scored with a breakline on the other face.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Panadol is a mild analgesic and antipyretic. The tablets are
recommended for use in the short-
term management of headaches, musculoskeletal disorders, menstrual
pains, toothache and for
symptoms of common colds and flu. Panadol may also be used in the
symptomatic relief of
mild to moderate pain associated with osteoarthritis as diagnosed by a
doctor.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Panadol is for oral administration.
Adults (including the elderly)
2 tablets repeated if necessary 3- 4 times a day to a maximum of 8
tablets in any 24 hour
period.
Children 6-12 years:
½ - 1 tablet repeated if necessary 3- 4 times a day to a maximum of 4
tablets in any 24 hour
period.
Panadol tablets are not suitable for children under 6 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.
The lowest dose necessary to achieve efficacy should be used.
Maximum duration of continued use without medical advice: 3 days.
4.3.
CONTRAINDICATIONS
Page 2 of 5
Hypersensitivity to paracetamol or any of the other constituents.
Use in children under 6 years of age.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains paracetamol. Do not use with any other paracetamol-containing
products. The
concomitant use with other products containing paracetamol may lead to
an overdose.
Paracetamol overdose may cause liver failure which can lead to liver
transplant or death.
Underlying liver disease increases the risk of paracetamol related
liver damage. Patients
who have been diagnosed wit