Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg

Kraj: Holandia

Język: niderlandzki

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

Składnik aktywny:

DICLOFENAC NATRIUM

Dostępny od:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kod ATC:

M01AB05

INN (International Nazwa):

DICLOFENAC SODIUM

Forma farmaceutyczna:

Maagsapresistente tablet

Skład:

CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1) ; DIMETICON (E 900) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (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) ; 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),

Droga podania:

Oraal gebruik

Dziedzina terapeutyczna:

Diclofenac

Podsumowanie produktu:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHYLMETHACRYLAAT (2:1); DIMETICON (E 900); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (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);

Data autoryzacji:

1999-03-15

Ulotka dla pacjenta

Sandoz B.V.
Page 1/9
Diclofenacnatrium Sandoz
®
25/50, maagsapresistente
tabletten 25/50 mg; RVG 23242-3
V30
1.3.1.3 Bijsluiter
April 2020
BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
DICLOFENACNATRIUM SANDOZ
® 25, MAAGSAPRESISTENTE TABLETTEN 25 MG
DICLOFENACNATRIUM SANDOZ
® 50, MAAGSAPRESISTENTE TABLETTEN 50 MG
diclofenacnatrium
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
•

Charakterystyka produktu

Sandoz B.V.
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Diclofenacnatrium Sandoz 25, maagsapresistente tabletten
25 mg; RVG 23242
V19
1.3.1.1 Samenvatting van de Productkenmerken
April 2020
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Diclofenacnatrium Sandoz 25, maagsapresistente tabletten 25 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 25 mg diclofenac sodium.
Excipients with known effect:

Each gastro-resistant tablet contains 15.2 mg of lactose (as lactose
monohydrate).

Each gastro-resistant tablet contains 0.13 mg of polyoxyl hydrogenated
castor oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant tablet.
Yellow, round, slightly biconvex, with bevelled edges
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.
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Diclofenacnatrium Sandoz 25, maagsapresistente tabletten
25 mg; RVG 23242
V19
1.3.1.1 Samenvatting van de Productkenmerken
April 2020
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 dosage information for adults. For the dose
regimen in adults we refer to the
paragraphs containing specific information