Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

DICLOFENAC NATRIUM

Verfügbar ab:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-Code:

M01AB05

INN (Internationale Bezeichnung):

DICLOFENAC SODIUM

Darreichungsform:

Maagsapresistente tablet

Zusammensetzung:

CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; DIMETICON (E 900) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; SILICA, HYDRATE FORM UNKNOWN (E 551) ; SILICIUMDIOXIDE (E 551) ; SIMETICON EMULSIE ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; DIMETICON (E 900) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; SILICA, HYDRATE FORM UNKNOWN (E 551) ; SILICIUMDIOXIDE (E 551) ; SIMETICON EMULSIE ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Verabreichungsweg:

Oraal gebruik

Therapiebereich:

Diclofenac

Produktbesonderheiten:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1); DIMETICON (E 900); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 8000; MACROGOLGLYCEROLHYDROXYSTEARAAT; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201); SILICA, HYDRATE FORM UNKNOWN (E 551); SILICIUMDIOXIDE (E 551); SIMETICON EMULSIE; TALK (E 553 B); TITAANDIOXIDE (E 171);

Berechtigungsdatum:

1999-03-15

Gebrauchsinformation

Sandoz B.V.
Page 1/9
Diclofenacnatrium Sandoz
®
50, maagsapresistente
tabletten 50 mg; RVG 23243
1313-V34
1.3.1.3 Bijsluiter
December 2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[NATIONALLY COMPLETED NAME] 50 MG GASTRO-RESISTANT TABLETS
diclofenac sodium
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
Diclofenac sodium, the active substance in [nationally completed name]
belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which
are used to treat pain and
inflammation.
Diclofenac relieves symptoms of inflammation, such as swelling and
pain, and also reduces fever. It
has no effect on the causes of inflammation or fever.
[nationally completed name] can be used to treat the following
conditions:
•
rheumatism, including inflammatory joint pain (arthritis) and juvenile
rheumatoid arthritis joint
degeneration (arthrosis) and certain types of back pain (vertebral
joint disease)
•
painful, inflamed so called frozen shoulder
•
painful inflammation and swelling e.g. after dental or orthopaedic
surgery
•
severely painful menstrual periods
•
infectious diseases that are accompanied with fever, especially for
s

Fachinformation

Sandoz B.V.
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Diclofenacnatrium Sandoz 50, maagsapresistente
tabletten 50 mg; RVG 23243
1313-V25a
1.3.1.1 Samenvatting van de Productkenmerken
December 2022
1.
NAAM VAN HET GENEESMIDDEL
Diclofenacnatrium Sandoz 50, maagsapresistente tabletten 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 50 mg of diclofenac sodium.
Excipients with known effect:
Each gastro-resistant tablet contains 23.8 mg of lactose (as
monohydrate) and 0.22 mg of polyoxyl
hydrogenated castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Light brown, round, slightly biconvex.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of:
-
Inflammatory and degenerative forms of rheumatism such as rheumatoid
arthritis, juvenile
rheumatoid arthritis, osteoarthritis including spondylarthritis
-
Periarthritis humeroscapularis
-
Painful postoperative and post-traumatic inflammation, and swelling,
e.g. following dental or
orthopaedic surgery
-
Primary dysmenorrhoea
-
Diseases accompanied by fever, especially for short term use as
adjuvant in chemotherapy in
inflammatory infections
-
Fever as such is not an indication
Since the formulation of this medicinal product is a delayed-release
formulation, the product is not
indicated when a quick onset of efficacy (relief of pain) is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sandoz B.V.
Page 2/17
Diclofenacnatrium Sandoz 50, maagsapresistente
tabletten 50 mg; RVG 23243
1313-V25a
1.3.1.1 Samenvatting van de Productkenmerken
December 2022
General information
The dose should be individually adjusted. Undesirable effects may be
minimised by using the lowest
effective dose for the shortest duration necessary to control symptoms
(see section 4.4).
Posology
_ADULTS _
There is no general dose information for adults. For the dose regimen
in adults we refer to the
paragraphs containing specific information per indication.
_Rheumatoid arthritis _
The initial dose for adults is 150 mg daily