Panadol Extra film-coated Tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

PARACETAMOL, CAFFEINE

Tilgjengelig fra:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC-kode:

N02BE01

INN (International Name):

PARACETAMOL 500 mg CAFFEINE 65 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

PARACETAMOL 500 mg CAFFEINE 65 mg

Resept typen:

OTC

Terapeutisk område:

ANALGESICS

Autorisasjon status:

Authorised

Autorisasjon dato:

2006-04-18

Informasjon til brukeren

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 Extra tablets carefully to get the 
best results from them.
•  Keep this leaflet, you may need to read it 
again.
•  Ask your pharmacist if you need more 
information or advice.
•  You must contact a doctor if your 
symptoms worsen or do not improve.
•  If any of the side effects get serious, or 
you notice any side effects not listed in 
this leaflet, please tell your doctor or 
pharmacist.
IN THIS LEAFLET:
1.  What Panadol Extra tablets do
2.  Check before you take Panadol Extra 
  tablets
3.  How to take Panadol Extra tablets
4.  Possible side effects
5.  How to store Panadol Extra tablets
6.  Further information
1. WHAT PANADOL EXTRA TABLETS DO
PANADOL EXTRA TABLETS ARE USED FOR THE 
RELIEF OF HEADACHE, MIGRAINE, BACKACHE, 
RHEUMATIC PAIN, MUSCLE PAIN, NEURALGIA, 
TOOTHACHE AND PERIOD PAIN. They also 
relieve discomfort in colds, flu, and sore 
throat and help reduce temperature.
The tablets contain two active ingredients. 
Paracetamol is a painkiller and reduces your 
temperature when you have a fever. 
Caffeine acts to further help the 
effectiveness of paracetamol. 
2. CHECK BEFORE YOU TAKE PANADOL 
   EXTRA TABLETS
DO NOT TAKE PANADOL EXTRA TABLETS:
•  IF YOU HAVE EVER HAD AN ALLERGIC 
REACTION to paracetamol, caffeine or to 
any of the other ingredients (listed in 
Section 6).
•  if you are TAKING OTHER MEDICINES 
CONTAINING PARACETAMOL.
•  If you are UNDER 12 YEARS.
ASK YOUR DOCTOR BEFORE YOU TAKE 
THIS MEDICINE:
•  if you have SEVERE LIVER or KIDNEY 
DISEASE, including ALCOHOLIC LIVER 
DISEASE.
IF YOU ARE TAKING OTHER 
MEDICINES
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 VOMI

Preparatomtale

Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Panadol Extra Film-Coated tablets
Paracetamol 500mg
Caffeine 65mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg and Caffeine 65 mg.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet. (tablet)
White, capsule shaped film-coated tablet with 'Panadol Extra' embossed
on one side of the tablet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The tablets are recommended for use as an analgesic in the relief of
mild to moderate pain such as is
associated with rheumatism, neuralgia, musculoskeletal disorders,
headache and of discomfort
associated with influenza, feverishness and feverish colds, toothache
and dysmenorrhoea.
Page 2 of 8
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults (including the elderly)
2 tablets up to four times daily. Do not exceed 8 tablets in 24 hours.
Children
Not recommended for children under 12 years of age.
Minimum dosing interval: 4 hours.
Should not be used with other paracetamol-containing products.
4.3 CONTRAINDICATIONS
Known hypersensitivity to paracetamol, caffeine or any of the other
ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients who have been diagnosed with liver or kidney impairment must
seek medical advice before
taking this medication.
Excessive intake of caffeine (e.g. coffee and some canned drinks)
should be avoided while taking this
product.
Prolonged use except under medical supervision may be harmful.
Do not exceed the stated dose.
Take only when necessary.
If symptoms persist, consult your doctor.
Keep out of reach and sight of children.
Page 3 of 8
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Paracetamol may increase the elimination half-life of chloramphenicol.
The absorption of paracetamol
may be increased by metaclopramide and decreased by cholestyramine.
Oral contraceptives may
increase the rate of clearance of paracetamol.
The anticoagu