DICLOFENACO 100 mg TABLETA DE LIBERACION PROLONGADA

Land: Peru

Sprache: Spanisch

Quelle: DIGEMID (Dirección General de Medicamentos, Insumos y Drogas)

Wirkstoff:

DICLOFENACO DE SODIO;

Verfügbar ab:

INSTITUTO QUIMIOTERAPICO S.A.

ATC-Code:

M01AB05

INN (Internationale Bezeichnung):

DICLOFENAC SODIUM;

Darreichungsform:

TABLETA DE LIBERACION PROLONGADA

Zusammensetzung:

POR TABLETA

Verabreichungsweg:

ORAL

Einheiten im Paket:

Caja de cartón dúplex x 2, 5, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 100, 200, 500 y 1000 Tabletas de Liberación Prolongada en

Verschreibungstyp:

Con receta médica

Hergestellt von:

INSTITUTO QUIMIOTERAPICO S.A.; PERU

Therapiegruppe:

DICLOFENACO

Produktbesonderheiten:

Presentación: Caja de cartón dúplex x 2, 5, 10, 14, 15, 20, 21, 28, 30, 40, 50, 60, 100, 200, 500 y 1000 Tabletas de Liberación Prolongada en envase blíster de PVC/PVDC ámbar -Aluminio y envase blíster de PVC/PVDC incoloro-Aluminio .

Berechtigungsstatus:

VIGENTE

Berechtigungsdatum:

2026-07-04

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dicloflex Retard 100 mg
Fenactol Retard 100mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Diclofenac sodium 100 mg
Excipients(s) with known effect
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prolonged-release tablet.
Pink, round, biconvex tablet, marked "DICL100" on one face.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS AND ELDERLY
Relief of all grades of pain and inflammation in a wide range of
conditions,
including:
(i)
arthritic
conditions:
rheumatoid
arthritis,
osteoarthritis,
ankylosing
spondylitis, acute gout,
(ii)
acute musculo-skeletal disorders such as periarthritis (for example
frozen
shoulder), tendinitis, tenosynovitis, bursitis,
(iii)
other painful conditions resulting from trauma, including fracture,
low
back pain, sprains, strains, dislocations, orthopaedic, dental and
other
minor surgery.
CHILDREN
Diclofenac
Sodium
100mg
prolonged-release
tablets
are
not
suitable
for
children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
000014
000047
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4).
_ADULTS:_ One 100 mg diclofenac sodium prolonged-release tablet daily.
If necessary,
the daily dosage can be increased to 150 mg by supplementation with
the
conventional dosage forms containing diclofenac sodium 25 mg or 50 mg.
The recommended maximum daily dose of diclofenac sodium is 150mg.
_SPECIAL POPULATIONS _
_ELDERLY:_ Although the pharmacokinetics of Diclofenac sodium are not
impaired to
any clinically relevant extent in elderly patients, nonsteroidal
anti-inflammatory drugs
should be used with particular caution in such patients who generally
are more prone
to adverse reactions. In particular it is recommended that the lowest
effective dosage
be used in frail elderly patients or those with a low body weight (see
also precautions)
and the patient should be monitored for GI bleeding during NSAID
therapy.