Paracetamol 500mg tablets

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Paracetamol

Доступна с:

Milpharm Ltd

код АТС:

N02BE01

ИНН (Международная Имя):

Paracetamol

дозировка:

500mg

Фармацевтическая форма:

Oral tablet

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 04070100; GTIN: 8901175043118

тонкая брошюра

Black
PACKAGE LEAFLET:
INFORMATION FOR THE
PATIENT
PARACETAMOL 500 MG
TABLETS
Paracetamol
Version: 11
Dater & Time: 05.07.2021 & 5.00 PM
Submission Code: N00599
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 effect, 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 is and what is it
used for
2. What you need to know before you
take Paracetamol
3. How to take Paracetamol
4. Possible side effects
5. How to store Paracetamol
6. Contents of the pack and other
information
1. WHAT PARACETAMOL IS AND WHAT IT IS
USED FOR
Paracetamol contains active substance
Paracetamol which belongs to a group of
medicines called analgesics (painkillers).
Paracetamol is used to relieve pain and
help reduce fever. The tablets can treat
mild to moderate pain and/or fever [e.g.
headache and toothache].
Paracetamol tablets may be used in adults
and adolescents but is not suitable for use
in children below 10 years.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE PARACETAMOL
DO NOT TAKE PARACETAMOL
•
If you are allergic to Paracetamol or
any of the other ingredients of this
medicine (listed in section6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Paracetamol
•
if you have kidney or liver disease
(including Gilbert’s syndrome or acute
hepatitis)
•
if you have a deficiency of a certain
enzyme called glucose-6-phosphatase
•
if you have hemolytic anemia
(abnormal breakdown of red blood
cells).
•
if you regularly take large amounts of
alcohol. Never take more than
2000 mg a day.
•
if you a

Характеристики 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 the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White to off-white, uncoated, round shaped tablets debossed with
‘A’ and ‘8’
separated with break line on one side and plain on other side. The
size is 12
mm. The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of mild to moderate pain and/or fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology: _
For oral use only.
_ _
Adults, the elderly and children 16 years and over (above 55 kg body
weight):
Take 500 mg to 1000 mg at a time, up to 3000 mg per 24 hours.
The maximum daily dose of Paracetamol must not exceed 3000 mg.
Children 10 to 15 years of age (40-55 kg body weight)
Take 500 mg at a time, up to 2000 mg per 24 hours.
The daily dose must not exceed 2000 mg.
Not recommended for children under 10 years of age.
The dose should not be repeated more frequently than every 4 hours and
not
more than 4 doses should be taken in any 24-hour period
Direction for use:
•
Paracetamol tablet is not suitable for children below 10 years.
•
The dosing interval should be at least 4 hours.
•
The indicated dose should not be exceeded due to risk of serious
damage to the liver (see section 4.4 and 4.9).
•
If pain for more than 5 days or fever for more than 3 days exists or
get
worse, or if any other symptom occur, treatment should be
discontinued and a physician should be consulted.
•
The ingestion of Paracetamol with food and drink does not affect the
efficacy of the medicinal product.
_Special Populations: _
•
In case of renal insufficiency (renal failure), the dose should be
reduced:
Glomerular
filtration rate
Dose
10 – 50 ml/min
500 mg every
6 hours
< 10 ml/min
500 mg every
8 hours
•
In patients with impaired hepatic or Gilberts syndrome, the dose must
be reduced or the dosing inter