Paracetamol Adult 500mg/5ml oral suspension

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Paracetamol

可用日期:

Rosemont Pharmaceuticals Ltd

ATC代码:

N02BE; N02BE01

INN（国际名称）:

Paracetamol

剂量:

500 mg/5ml

药物剂型:

Oral suspension

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Anilides; paracetamol

授权状态:

Marketed

授权日期:

2012-04-05

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JOB INFORMATION
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Name:
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Univers Roman
UNIVERS BOLD
500mg/5ml
BLACK
PANTONE
PANTONE
KEYLINE
UKL412
419
210 x 300mm
N/A
30 x 150mm
1
1 of 2
10pt
NO
150ml
150ml
N/A
G2AD1RBJ1
P0765
N/A
927222
Paracetamol 500mg/5ml Oral Suspension
12/09/18
-
NH
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3
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TELL YOUR DOCTOR IF YOU GET ANY OF THESE SIDE EFFECTS:
n
skin rash
If paracetamol is taken for a long time, it may lead to liver and
kidney problems.
If any of the side effects gets serious, or if you notice any side
effects not mentioned in this
leaflet, please tell your doctor or pharmacist.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in
this leaflet. You can also report side effects
directly (see details below). By reporting side
effects you can help provide more information
on the safety of this medicine.
UNITED KINGDOM
Yellow Card Scheme:
www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google Play
or Apple App Store.
5. HOW TO STORE PARACETAMOL ORAL SUSPENSION
n
Keep out of the sight and reach of children.
n
Do not store above 25°C. Do not refrigerate or freeze. Store in the
original package.
n
Do not use 1 month after you first open it. Take it back to the
pharmacy.
n
Do not use after the expiry date (month, year) on the label. The
expiry date refers to the last
day of that month.
n
If it is out of date or you no longer want it, take it back to the
pharmacy

产品特点

Health Products Regulatory Authority
08 November 2018
CRN008L8Z
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Adult 500mg/5ml oral suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 500mg Paracetamol
Excipients:
Methyl parahydroxybenzoate – 6mg/5ml
Propyl parahydroxybenzoate – 1.5mg/5ml
Liquid maltitol – 2.05g/5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
An opaque pink/brown suspension
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of mild to moderate pain in patients who are unable
to receive
other paracetamol formulations such as lower strength liquid
preparations,
effervescent tablets or tablets.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and adolescents over 16 years: 500mg (5ml) or 1000mg (10ml) up
to three to
four times a day, as required. Maximum daily dose should not exceed 4g
(40ml).
The dose should not be repeated more frequently than every four hours,
and not
more than four doses should be taken in any 24 hour period.
Special Populations
Renal impairment:
_When a 500 mg administration is possible:_
Health Products Regulatory Authority
08 November 2018
CRN008L8Z
Page 2 of 9
It is recommended, when giving paracetamol to patients with renal
impairment, to
reduce the dose and to increase the minimum interval between each
administration
to at least 6 hours unless directed otherwise by a physician. See
Table below:
Adults:
Glomerular filtration rate
Dose
10-50 ml/min
500mg every 6 hours
<10ml/min
500mg every 8 hours
_ _
Hepatic impairment:
In patients with hepatic impairment or Gilbert's Syndrome, the dose
should be
reduced or the dosing interval prolonged.
The daily dose should not exceed 2g/day unless directed by a
physician.
The elderly:
Experience has indicated that normal adult dosage is usually
appropriate. However in
frail, immobile,elderly subjects or in elderly patients with renal or
hepatic impairment,
a reduction in the amount or frequency of dos