SPEDIFEN

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

IBUPROFEN

Disponible depuis:

TUNGGAL IDAMAN ABDI - Indonesia

DCI (Dénomination commune internationale):

IBUPROFEN

Dosage:

400 MG

forme pharmaceutique:

TABLET SALUT SELAPUT

Unités en paquet:

DUS,5 BLISTER @ 6 TABLET SALUT SELAPUT

Fabriqué par:

ZAMBON S.P.A. - Italy

Date de l'autorisation:

2021-10-29

Résumé des caractéristiques du produit

PIL_Eng _SDF400_11_20
SPEDIFEN
®
IBUPROFEN
FILM-COATED TABLET
CARDIOVASCULAR RISK
-
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with
duration of use. Patients with cardiovascular disease or risk factors
for cardiovascular
disease may be at greater risk
-
NSAIDs is contraindicated for the treatment of perioperative pain in
the setting of
coronaryartery bypass graft (CABG) surgery
GASTROINTESTINAL RISK
-
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
bleeding, ulceration, and perforation of the stomatch or intestines,
which can be fatal.
These events can occur at any time during use and without warning
symptoms. Elderly
patients are at greater risk for serious gastrointestinal events.
COMPOSITIONS
SPEDIFEN 400 mg film-coated tablet, each tablet contains 400 mg
Ibuprofen as L-arginine
salt.
SPEDIFEN 400 mg film-coated tablet also contains : Sodium hydrogen
carbonat, cropovidone,
magnesium stearate, Hypermellose, sucrose, Titanium dioxide and
Macrogol 4000.
THERAPEUTIC INDICATIONS :
SPEDIFEN is indicated for relieving pain of various etiology:
headache, pain after tooth
extraction and postoperative pain, as well as for the treatment of
primary dysmenorrhea.
SPEDIFEN is also indicated for the relief of signs and symptoms of
rheumatoid arthritis and
_osteoarthritis_, as well as for the musculoskeletal and traumatic
alterations implying pain and
inflammation
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES:
GENERAL PROPERTIES
_Pharmacotherapeutic _
_group_:
Antiinflammatory and anti-rheumatic
products,
non-steroids,
Propionic acid derivatives.
ATC code: M01AE01.
Ibuprofen is a synthetic analgesic-antiinflammatory drug with a marked
antipyretic action.
_Mechanism of action _
Ibuprofen is the first phenylpropionic acid derivative. It is a
prostaglandin synthetase inhibitor
with analgesic, antipyretic and anti-inflammatory properties.
It possesses a non-narcotic analge