Panadol Extra tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

paracetamol, caffeine

Available from:

GlaxoSmithKline Dungarvan Limited

ATC code:

N02BE71

INN (International Name):

paracetamol, caffeine

Dosage:

500mg+ 65mg

Pharmaceutical form:

tablets film-coated

Units in package:

(12/1x12/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2017-05-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panadol
®
Extra
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg and Caffeine 65.0 mg.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF MILD TO MODERATE PAIN AND RELIEF OF FEVER INCLUDING:
Headache
Migraine
Muscle ache
Dysmennorhoea
Sore throat
Musculoskeletal pain
Fever and pain after vaccination
Pain after dental procedures/ tooth extraction
Toothache
Pain of osteoarthritis
_For Colds and Flu:_
For the relief of symptoms of the common cold and influenza for
example headache, fever,
sore throat, muscular aches and pains reduced alertness and
drowsiness.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only.
Adults (including the elderly) and children aged 12 years and over:
1-2 tablets every 4 to 6 hours as required. Do not exceed 8 tablets in
24 hours. Minimum
dosing interval: 4 hours. The lowest dose necessary to achieve
efficacy should be used.
Children:
not recommended for children under the age of 12 years.
Do not exceed the stated dose.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol, caffeine or excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
CONTAINES 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 with liver or kidney impairment must seek
medical advice
before taking this medication.
Cases of hepatic dysfunction/failure has been reported in patients
with depleted glutathione
levels, such as those who are severely malnourished, anorexic, have
low body mass index or
are chronic heavy users of alcohol.
CHECK WITH YOUR DOCTOR BEFORE USE IF YOU:

have liver or kidney problems.

are underweight or malno