Pacimol

국가: 뉴질랜드

언어: 영어

출처: Medsafe (Medicines Safety Authority)

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Download 제품 특성 요약 (SPC)
01-02-2022

유효 성분:

Paracetamol 500mg;  

제공처:

Ipca Pharma (NZ) Pty Limited

복용량:

500 mg

약제 형태:

Tablet

구성:

Active: Paracetamol 500mg   Excipient: Magnesium stearate Sodium metabisulfite Starch

처방전 유형:

Prescription

치료 징후:

For the temporary relief of pain and discomfort in headaches, colds and flu symptoms, rheumatic muscular and neuralgic conditions and dental pain. Assist in reducing fever.

제품 요약:

Package - Contents - Shelf Life: Blister pack, Al foil/PVC coating - 1000 tablets - 60 months from date of manufacture stored at or below 25°C protect from light and moisture. Protect from Heat

승인 날짜:

2019-02-28

제품 특성 요약

                                NEW ZEALAND DATA SHEET
Page 1 of 7
1.
PRODUCT NAME
Pacimol, paracetamol 500 mg, uncoated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient :
Paracetamol (BP) 500 mg/tablet
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, capsule shaped, biconvex uncoated tablet with break line on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary relief of pain & discomfort, in headaches, colds and
flu symptoms, rheumatic.
muscular and neuralgic conditions and dental pain. Assist in reducing
fever.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adults and children aged 12 years and over: 1 to 2 tablets every four
to six hours as required.
Maximum of 8 tablets in 24 hours. Maximum daily dose: 4000 mg.
Children 7 to 11 years: ½ to
1 tablet every four to six hours as required. Maximum of 4 tablets in
24 hours. Do not exceed
the stated dose. Adults: Do not take this medicine for longer than a
few days at a time unless
advised by a doctor. Children and Adolescence: Do not take this
medicine for longer than 48
hours at a time unless advised by a doctor.
Not suitable for children under seven years of age. Take orally with
water or other fluid. The
lowest dose necessary to achieve efficacy should be used for the
shortest duration of
treatment. Should not be used with other paracetamol‐containing
products.
Minimum dosing interval: 4 hours.
4.3
CONTRAINDICATIONS
These products are contraindicated in patients with a previous history
of hypersensitivity to
paracetamol or any of the excipients.
NEW ZEALAND DATA SHEET
Page 2 of 7
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 may require liver
transplant or lead to
death.
Paracetamol should be used with caution in patients with:

Impaired liver function: Underlying liver
                                
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