PARACETAMOL 500 Milligram Tablets

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

PARACETAMOL

Предлага се от:

Millmount Healthcare Limited

INN (Международно Name):

PARACETAMOL

дозиране:

500 Milligram

Лекарствена форма:

Tablets

Вид предписание :

Product not subject to medical prescription

Статус Оторизация:

Withdrawn

Дата Оторизация:

2013-09-04

Листовка

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START  
TAKING THIS MEDICINE. 
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your  
doctor or pharmacist.
•
This medicine has been prescribed for you. Do
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or  
pharmacist.
In this leaflet:
1.  What paracetamol is and what it is used for
2.  Before you take paracetamol
3.  How to take paracetamol
4.  Possible side effects
5.  How to store paracetamol
6.  Further information 
1. WHAT PARACETAMOL IS AND WHAT IT IS     
    USED FOR 
Paracetamol is a pain relieving, fever reducing  
medicinal product (analgesic and antipyretic).
Paracetamol is used for symptomatic treatment of
mild to moderate pain and/or fever.
2. BEFORE YOU TAKE PARACETAMOL 
Do not take paracetamol  
•
if you are allergic (hypersensitive) to  
paracetamol or any of the other ingredients  
of paracetamol.
Take special care with paracetamol 
•
if you have kidney or liver disease;
•
if you have impaired nutritional state e.g. caused
by alcohol abuse.
•
If you are taking any other paracetamol  
containing products.
•
If you have severe haemolytic anaemia  
(abnormal breakdown of red blood cells)
You should not use paracetamol frequently for a long
period of time, as prolonged use may cause liver
problems. Discuss with your doctor or pharmacist
if you intend taking paracetamol for a longer period
of time.
In children treated with 60mg/kg daily of  
paracetamol, the combination with another  
antipyretic is not justified except in the case of  
ineffectiveness.
Caution is advised in the administration of  
paracetamol to patients with Severe renal  
insufficiency or mild to moderate hepatocellular
insufficiency
Paracetamol should be used with caution in patients
with mild to moderate hepato

Данни за продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg paracetamol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, caplet-shaped tablet, debossed with '500' on one side and plain on other side.
(17.5 mm long x 7.3mm wide x 5.7 mm thick)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Doses depend on body weight and age; a single dose ranges from 10 to 15 mg/kg body weight to a maximum of 60
mg/kg for total daily dose.
The specific dose interval depends on the symptoms and the maximum daily dose. It should, however, not fall below 4
hours.
The maximum daily dose of paracetamol must not exceed 3000mg
Don`t use Paracetamollonger than three days without medical advice
Special groups of patients
Elderly population
There is no need for dosage reduction in the elderly.
Impaired liver or kidney function
BODY WEIGHT (AGE)
SINGLE DOSE
(EQUIVALENT
PARACETAMOL DOSE)
MAX. DAILY DOSE (24 H)
(EQUIVALENT PARACETAMOL DOSE)
33 kg - 43 kg
(children 11 - 12 years)
500 mg
2,000 mg
44 kg – 65 kg
(adults and adolescents
from 12 years of age)
500 mg
3,000 mg
>65 kg
500 – 1,000 mg
3,000 mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/03/2013_
_CRN 2126787_
_page number: 1_
In patients with impaired hepatic or renal function or Gilbert’s syndrome, the dose must be reduced or the dosing
interval prolonged.
Patients with impaired renal function
_Impaired kidney function_
In patients with renal insufficiency, the dose should be reduced:
Children and adolescents�