)‫בטיחות‬
)‫מידע בטיחות‬
‫החמרה (( מידע‬
‫על החמרה‬
‫הודעה על‬
‫הודעה‬
12/07/2012:‫תאריך‬
ARTHROTEC 50, ARTHROTEC 75 TABLETS
:‫שם תכשיר באנגלית‬
ARTHROTEC 50: 139 73 28553 00 :‫מספר רישום‬
ARTHROTEC 75: 130 98 29104 00
‫ פייזר פרמצבטיקה ישראל בע"מ‬:‫שם בעל הרישום‬
‫השינויים בעלון מסומנים על רקע צהוב‬
‫רופא‬
‫בעלון ללרופא‬
‫בעלון‬
‫ים‬/‫ים המבוקש‬/‫פרטים על השינוי‬
‫טקסט חדש‬
‫טקסט נוכחי‬
‫פרק בעלון‬
Fertility
Based on the mechanism of action, the use of
NSAIDs, including diclofenac/misoprostol may
delay or prevent rupture of ovarian follicles, which
has been associated with reversible infertility in
some women. In women who have difficulties
conceiving or who are undergoing investigation of
infertility, withdrawal of NSAIDs, including
diclofenac/misoprostal should be considered.
Pregnancy
Diclofenac/misoprostol is contraindicated in
women who are pregnant because misoprostol
induces uterine contractions and is associated with
abortion, premature birth, and fetal death. Use of
misoprostol has been associated with birth defects
(See sections 4.3 CONTRAINDICATIONS and 4.8
UNDESIRABLE EFFECTS).
Diclofenac may
cause premature closure of the ductus arteriosus.
Women of childbearing potential should not be
started on diclofenac/misoprostol until pregnancy
is excluded, and should be fully counseled on the
importance of adequate contraception while
undergoing treatment. If pregnancy is suspected,
use of the product should be discontinued.
4.6. FERTILITY,
PREGNANCY AND
LACTATION
Pregnancy
Diclofenac/misoprostol is contraindicated in
women who are pregnant because misoprostol
induces uterine contractions and is associated
with abortion, premature birth, and fetal death.
Use of misoprostol has been associated with birth
defects (See sections 4.3 CONTRAINDICATIONS
and 4.8 UNDESIRABLE EFFECTS). Diclofenac
may cause premature closure of the ductus
arteriosus.
...
Inhibition of prostaglandin synthesis might
adversely
affect
pregnancy.
Data
from
epidemiological studies suggest an increased risk
of spontaneous abortion after use of prostaglandin
synthesis inhibitors in early pregnancy.
In
animals, administration of prostaglandin synthesis
inhibitors has been shown to result in increased
pre- and post-implantation loss.
Women of childbearing potential should not be
started on diclofenac/misoprostol until pregnancy
is excluded, and should be fully counseled on the
importance of adequate contraception while
undergoing treatment. If pregnancy is suspected,
use of the product should be discontinued.
...
Postmarketing Surveillance:
Blood and lymphatic system disorders:
thrombocytopenia , platelet aggregation inhibition
Postmarketing Surveillance:
Blood and lymphatic system disorders:
thrombocytopenia
Immune system disorders: allergic reactions
(including anaphylaxis and angioedema)
Immune system disorders: allergic reactions
(including anaphylaxis and angioedema)
Metabolism and nutrition disorders: fluid retention
Psychiatric disorders: changes in mood,
nightmares
Psychiatric disorders: changes in mood,
nightmares
Nervous system disorders: aseptic meningitis ,
4.8.
Undesirable
effects
stroke
Nervous system disorders: aseptic meningitis ,
stroke
Eye disorders: blurred vision
Eye disorders: blurred vision
Cardiac disorders: myocardial infarction
Cardiac disorders: myocardial infarction
Vascular disorders: vasculitis, hypertension
Respiratory, thoracic and mediastinal disorders:
dyspnea
Gastrointestinal disorders: pancreatitis, stomatitis,
gastrointestinal inflammation, gastrointestinal
bleeding, gastrointestinal ulceration,
gastrointestinal perforation
Hepatobiliary disorders: hepatic failure, hepatitis,
jaundice
Skin and subcutaneous tissue disorders:
cutaneous reactions (including rash and
bullous eruption), dermatitis exfoliative, erythema
multiforme, urticaria, mucocutaneous reactions,
Stevens-Johnson syndrome, toxic epidermal
necrolysis
Renal and urinary disorders: interstitial nephritis,
renal failure interstitial nephritis,
glomerulonephritis, renal papillary necrosis,
nephrotic syndrome, renal impairment
Pregnancy, puerperium and perinatal conditions:
abnormal uterine contractions, uterine
rupture/perforation, retained placenta , amniotic
fluid embolism,incomplete abortion, premature
birth, fetal death
Reproductive system and breast disorders: uterine
hemorrhage, female fertility decreased
Congenital, familial and genetic disorders: birth
defects
General disorders and administration site
conditions: chills, fever , edema
Respiratory, thoracic and mediastinal disorders:
dyspnea
Gastrointestinal disorders: pancreatitis, stomatitis,
Hepatobiliary disorders: hepatic failure, hepatitis,
jaundice
Skin and subcutaneous tissue disorders:
cutaneous reactions (including rash and
bullous eruption), dermatitis exfoliative, erythema
multiforme, urticaria, mucocutaneous reactions,
Renal and urinary disorders: interstitial nephritis,
renal failure
Pregnancy, puerperium and perinatal conditions:
abnormal uterine contractions, uterine
rupture/perforation, retained placenta , amniotic
fluid embolism,incomplete abortion, premature
birth, fetal death
Reproductive system and breast disorders: uterine
hemorrhage
Congenital, familial and genetic disorders: birth
defects
General disorders and administration site
conditions: chills, fever