Paracetamol Banner 500 mg soft capsules

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Paracetamol

थमां उपलब्ध:

Banner Pharmacaps Europe B.V.

ए.टी.सी कोड:

N02BE; N02BE01

INN (इंटरनेशनल नाम):

Paracetamol

डोज़:

500 milligram(s)

फार्मास्यूटिकल फॉर्म:

Capsule, soft

चिकित्सीय क्षेत्र:

Anilides; paracetamol

प्राधिकरण का दर्जा:

Not marketed

प्राधिकरण की तारीख:

2019-08-19

सूचना पत्रक

1
IE - version 5.0; Date 09-2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETAMOL BANNER 500 MG SOFT CAPSULES
Paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1.
What Paracetamol Banner is and what it is used for
2.
What you need to know before you take Paracetamol Banner
3.
How to take Paracetamol Banner
4.
Possible side effects
5.
How to store Paracetamol Banner
6.
Contents of the pack and other information
1.
WHAT PARACETAMOL BANNER IS AND WHAT IT IS USED FOR
Paracetamol Banner contains 500 mg of paracetamol which belongs to a
group of medicines named
analgesics (painkillers).
Paracetamol Banner is used for symptomatic treatment of mild to
moderate pain and/or fever.
Paracetamol Banner is indicated in adults and children weighing more
than 30 kg (approximately
above 9 years of age).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL BANNER
DO NOT TAKE PARACETAMOL BANNER IF YOU:
-
have ever had an allergic reaction to paracetamol or to any of the
other ingredients of this
medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Paracetamol Banner:
-
liver or kidney disorder
-
moderate to severe renal insufficiency (unsatisfactory activity of
kidneys)
-
mild to severe hepatic insufficiency (unsatisfactory activity of the
liver)
-
Gilbert’s syndrome
-
glucose-6-phosphate dehydrogenase deficiency
-
haemolytic anaemia
-
dehydration
-
chronic nutritional problems (malnutrition)
-
asthmatic patien

उत्पाद विशेषताएं

Health Products Regulatory Authority
02 November 2022
CRN00D5WQ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Banner 500 mg soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 500 mg paracetamol.
Excipients with known effect
Every capsule contains 58.2 mg of sorbitol and 6.0 mg of propylene
glycol.
The capsules may contain trace amounts of soya lecithin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, soft.
White, oblong soft gelatin capsule
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatmentof mild to moderate pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population_
_ _
_Children weighing less than 30 kg (approximately below 9 years old):_

Paracetamol Banner should not be used in children weighing less than
30 kg (approximately below the age of 9
years). For those children other formulations and dosage strengths are
available which may be more appropriate.
_Children weighing between 31 and 55 kg (aged approximately 9 to 15
years):_

For children weighing 31 to 40 kg (approximately 9 to 12 years), take
1 capsule (500 mg) at a time, without
exceeding 4 capsules (2000 mg) per day.

For children weighing 41 to 55 kg (approximately 12 to 15 years), take
1 capsule (500 mg) at a time, without
exceeding 6 capsules per day.
The lower frequency of administration is intended for the youngest
children in the relevant age group.
For children weighing less than 50 kg (approximately below 12 years of
age) the daily dose should not be higher than 60
mg/kg body weight.
_ _
_For adults and children weighing more than 55 kg (from about 15 years
old):_
The usual dosage is 1 to 2 capsules (500-1,000 mg) at a time, with a
maximum of 6 capsules (3,000 mg) every 24 hours.
_ _
_Instructions for use:_

The administration interval must be at least 4 hours.

Do not use in combination with other paracetamol-containing products.
Health Products Regulatory Auth