Paracetalgin 1000 mg, tabletten

Страна: Нидерланды

Язык: голландский

Источник: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активный ингредиент:

PARACETAMOL 1000 mg/stuk

ИНН (Международная Имя):

PARACETAMOL 1000 mg/stuk

Фармацевтическая форма:

Tablet

состав:

ALGINEZUUR (E 400) ; CALCIUMCARBONAAT (E 170) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551), ALGINEZUUR ; CALCIUMCARBONAAT (E 170) ; CROSPOVIDON (E 1202) ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551)

Администрация маршрут:

Oraal gebruik

Дата Авторизация:

2022-04-22

тонкая брошюра

Paracetamol, DE/H/6508/002, 03.03.22
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PARACETALGIN 1000 MG, TABLETTEN
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
The active ingredient is paracetamol which is a painkiller and also
reduces your temperature when you
have a fever.
is used for symptomatic treatment of mild to moderate
pain and/or fever.
is indicated in adults and adolescents aged 16 years
and over.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE:
-
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
To avoid overdose tell your doctor if you are taking other paracetamol
containing products. Your
doctor will adjust the dosage, in order to avoid the risk of overdose.
Do not take any other paracetamol-containing products.
Talk to your doctor or pharmacist before using if you:
-
have liver or kidney problems
-
are underweight or malnourished
-
regularly drink alcohol
-
are suffering from impaired liver function (liver inflammation,

Характеристики продукта

Paracetamol
,
DE/H/6508/001, 03.03.22
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Paracetalgin 1000 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1000 mg paracetamol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, oval shaped biconvex tablet, breakline on both
sides of the tablet. The tablet is
approximately 9.2 x 22.0 mm in size with a height of approximately
7.0-8.5 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.
is indicated in adults and adolescents aged 16 years
and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage is in accordance with the information in the following table.
Dose depends on age and body weight, generally 10 to 15 mg/kg body
weight as a single dose, up to a
maximum of 60 mg/kg body weight as the total daily dose.
In each case, the dosing interval depends on the symptoms and maximum
total daily dose. It should
be no less than 4 hours.
If symptoms persist beyond 3 days, a doctor should be consulted.
BODY WEIGHT (AGE)
SINGLE DOSE (EQUIVALENT
PARACETAMOL DOSE)
(NUMBER OF TABLETS)
MAX. DAILY DOSE (24 H)
(EQUIVALENT PARACETAMOL
DOSE) (NUMBER OF
TABLETS/DOSES)
MINIMUM
INTERVAL
BETWEEN DOSES
> 55 kg (adults and
adolescents from 16
years of age)
500 mg – 1,000 mg
(
1
/
2
-1 tablet)
3,000 mg
(maximum of 3 tablets/ 3-6
doses)
4 – 6 hours
The maximum daily dose (24 hours) stated in the table must not be
exceeded under any circumstances.
2
The lowest dose necessary to achieve efficacy should be used.
Maximum duration of continued use without medical advice: 3 days.
Elderly patients
Dose adjustment is not required in the elderly. However, it should be
taken into account that renal
and/or hepatic insufficiency is more common in the elderly (see
section 4.4).
Renal impairment
Paracetamol should be used with caution in the presence of renal
insufficiency and