Tramadol HCl/Paracetamol Sandoz 75/650 mg, tabletten

Страна: Нідерланди

мова: голландська

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

Активний інгредієнт:

PARACETAMOL ; TRAMADOLHYDROCHLORIDE SAMENSTELLING overeenkomend met ; TRAMADOL

Доступна з:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Код атс:

N02AJ13

ІПН (Міжнародна Ім'я):

PARACETAMOL ; TRAMADOLHYDROCHLORIDE COMPOSITION corresponding to ; TRAMADOL

Фармацевтична форма:

Tablet

Склад:

MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551), MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551),

Адміністрація маршрут:

Oraal gebruik

Терапевтична области:

Tramadol and paracetamol

Огляд продуктів:

Hulpstoffen: MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551);

Дата Авторизація:

2017-08-22

інформаційний буклет

Sandoz B.V.
Page 1/8
Tramadol HCl/Paracetamol Sandoz 75/650 mg, tabletten
RVG 117332
v6
1.3.1.3 Bijsluiter
Juni 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRAMADOL HCL/PARACETAMOL SANDOZ® 75/650 MG, TABLETTEN
tramadol hydrochloride/paracetamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
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.
WHAT IS IN THIS LEAFLET
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] is a combination of two analgesics (pain
killers), tramadol and
paracetamol, which act together to relieve pain.
[nationally completed name] is indicated for the treatment of moderate
to severe pain when your
doctor recommends that a combination of tramadol and paracetamol is
needed.
[nationally completed name] should only be taken by adults and
adolescents 12 years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
•
if you are allergic to tramadol, paracetamol or any of the other
ingredients of this medicine
(listed in section 6)
•
in acute poisoning with alcohol, sleeping pills, pain relievers or
other psychotropic medicines
(medicines that affect mood and emotions)
•
if you are taking medicines called monoamine oxidase (MAO) inhibitors
(certain medicine

Характеристики продукта

Sandoz B.V.
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Tramadol HCl/Paracetamol Sandoz 75/650 mg, tabletten
RVG 117332
1311-v6
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tramadol HCl/Paracetamol Sandoz 75/650 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg of tramadol hydrochloride and 650 mg of
paracetamol.
Each tablet contains 0.42 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, elongated, scored tablets.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[nationally completed name] tablets are indicated for the symptomatic
treatment of moderate to severe
pain.
The use of [nationally completed name] should be restricted to
patients whose moderate to severe pain
is considered to require a combination of tramadol and paracetamol
(see also section 5.1.).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR THIS TABLET STRENGTH WITH 75 MG/650 MG TRAMADOL
HYDROCHLORIDE/PARACETAMOL, A MAXIMUM
DOSE OF 4 TABLETS PER DAY MUST NOT BE EXCEEDED (SEE BELOW).
The use of [nationally completed name] should be restricted to
patients whose moderate to severe pain
is considered to require a combination of tramadol and paracetamol.
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual patient.
The lowest effective dose for analgesia should generally be selected.
_Adults and adolescents (12 years and older)_
An initial dose of one tablet of [nationally completed name] 75 mg/650
mg is recommended.
Additional doses can be taken as needed, not exceeding 4 tablets
(equivalent to 300 mg of tramadol
hydrochloride and 2600 mg of paracetamol) per day.
The dosing interval should not be less than 6 hours.
Sandoz B.V.
Page 2/14
Tramadol HCl/Paracetamol Sandoz 75/650 mg, tabletten
RVG 117332
1311-v6
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2019
Tramadol/paracetamol should under no circumstances be administered for
l