Prest 500 mg, orodispergeerbare tabletten

Kraj: Holandia

Język: niderlandzki

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

Składnik aktywny:

PARACETAMOL

Dostępny od:

Olvos Science S.A.

Kod ATC:

N02BE01

INN (International Nazwa):

PARACETAMOL

Forma farmaceutyczna:

Orodispergeerbare tablet

Skład:

AARDBEIENSMAAKSTOF ; ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; ETHYLCELLULOSE (E 462) ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421),

Droga podania:

Oraal gebruik

Dziedzina terapeutyczna:

Paracetamol

Podsumowanie produktu:

Hulpstoffen: AARDBEIENSMAAKSTOF; ARABISCHE GOM (E 414); ASPARTAAM (E 951); CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); ETHYLCELLULOSE (E 462); MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421);

Data autoryzacji:

2013-04-10

Ulotka dla pacjenta

Page 1 of 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREST 500 MG ORODISPERGEERBARE 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 has 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 Prest is and what it is used for
2.
What you need to know before you take Prest
3.
How to take Prest
4.
Possible side effects
5.
How to store Prest
6.
Contents of the pack and other information
1.
WHAT PREST IS AND WHAT IT IS USED FOR
Prest contains the active substance paracetamol which belongs to a
group of medicines called analgesics
(painkillers).
Prest is used for symptomatic treatment of mild to moderate pain
and/or fever.
Prest 500 mg orodispergeerbare tabletten may be used in adults and
adolescents.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREST
DO NOT TAKE PREST
-
if you are allergic to paracetamol or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Prest:
-
if you are taking other paracetamol containing medicines, as it may
severely damage the liver.
-
if you have liver problems (including Gilbert’s syndrome or acute
hepatitis).
-
if you have impaired kidney function.
-
if you have a deficiency of a certain enzyme called
glucose-6-phosphatase.
-
if you have haemolytic anaemia (abnormal breakdown of red blood
cells).
-
if you drink alcohol.
-
if you have a poor nutritional status, for example as a result of
alcohol abuse, loss of appetite
(anorexia), or malnutrition. You may have to take a lower dose,

Charakterystyka produktu

Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prest 500 mg, orodispergeerbare tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 500 mg paracetamol.
Excipient with known effect
Each tablet contains 22.4 mg aspartame (E951).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet
White to off-white round, flat face radius edge tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prest 500 mg orodispersible tablet is indicated in adults and
adolescents only.
Symptomatic treatment of mild to moderate pain and/or fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Doses depend on body weight and age; a single dose ranges from 10 to
15 mg/kg body weight (= b.w.) to a
maximum of 60 mg/kg b.w. for total daily dose (see also section 4.4).
Adolescents:
500 mg, max 3000 mg per 24 hours.
Adults:
500-1000 mg, max 3000 mg per 24 hours.
Prest 500 mg orodispersible tablet is not recommended in children
below 12 years of age (43 kg).
_Direction for use: _
-
The specific dose interval depends on the symptoms and the maximum
daily dose. Depending on the
reoccurrence of symptoms (fever and/or pain), repeated administration
is allowed. It should,
however, preferably never fall below 6 hours and in no case fall below
4 hours.
-
Not to be used in combination with other paracetamol-containing
products.
Page 2 of 10
-
The indicated dose must not be exceeded due to risk of serious damage
to the liver (see section 4.4
and 4.9).
-
If the patient does not feel better or he/she feels worse after 3 days
or if other symptoms 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.
_Renal impairment _
In case of renal insufficiency (renal failure), the dose should be
reduced.
For adults:
Glomerular filtration rate
Dose
10 – 50 ml/min,
500 mg every 6 hours
< 10 ml/min,
500 mg every 8 hours
_H