Panadol tablets film-coated

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

제품 특성 요약 제품 특성 요약 (SPC)
21-03-2023

유효 성분:

paracetamol

제공처:

GlaxoSmithKline Dungarvan Limited

ATC 코드:

N02BE01

INN (International Name):

paracetamol

복용량:

500mg

약제 형태:

tablets film-coated

패키지 단위:

(12/1x12/) in blister

처방전 유형:

OTC

승인 상태:

Registered

승인 날짜:

2023-03-21

제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Panadol
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg
3.
PHARMACEUTICAL FORM
Film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short-term relief of pain and antipyretic including:

Headache

Musculoskeletal pain.

Dysmennorhoea

Toothache.

Cold and flu symptoms
It can also be used for symptomatic relief of pain from mild to
moderate intensity in
osteoarthritis diagnosed by a doctor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration only.
Adults (including the elderly) and children aged 16 years and
over: 1-2 tablets up to 4 times daily as required.
Children 10 - 15 years: 1 tablet up to 4 times daily as required.
Maximum duration of
continued use without medical advice: 3 days.
Minimum dosing interval: 4 hours. No more than four doses in any 24
hour period.
Children: Not recommended for children under the age of 10 years.
Patients with renal / hepatic impairment: Patients with severe hepatic
or severe renal
insufficiency are not recommended to use the drug. Patients who have
been diagnosed with
kidney/liver impairment must seek medical advice before taking this
medication.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used.
_ _
_ _
4.3
CONTRAINDICATIONS
Previous history of hypersensitivity to paracetamol or any of the
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 deplete
                                
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