La sertraline ne doit être utilisée chez la femme allaitante que si votre médecin considère que les bénéfices l'emportent sur les risques éventuels pour le nourrisson.Des études chez lanimal ont montré que certains médicaments tels que la sertraline peuvent réduire la qualité du sperme. The following adverse reactions were reported from controlled trials (n=281 patients treated with sertraline):Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.
After one week, the dose should be increased to 50 mg once daily. When stopping treatment with sertraline the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (see sections 4.4 and 4.8). Impact on human fertility has not been observed so far.Clinical pharmacology studies have shown that sertraline has no effect on psychomotor performance. SSRIs or SNRIs including sertraline have however been associated with cases of clinically significant hyponatraemia in elderly patients, who may be at greater risk for this adverse event (see Hyponatraemia in section 4.4). Patients not responding to a 50 mg dose may benefit from dose increases. The administration of sertraline with grapefruit juice is not recommended (see section 4.5).False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline. Only your physician can make this decision.The drug passes into breast milk.
However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD.
Insulin and/or oral hypoglycaemic dosage may need to be adjusted.There are no clinical studies establishing the risks or benefits of the combined use of ECT and sertraline.
In addition, on Postnatal Days 21 to 56, dehydration, chromorhinorrhea, and reduced average body weight gain was also observed. * these adverse reactions also occurred in postmarketing experience ** the denominator uses the number of patients in that sex group-combined: sertraline (1118 males, 1424 females) placebo (926 males, 1219 females) For OCD, short term, 1-12 week studies only *** Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 4.4).
Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo. The clinical significance of these changes is unknown. The following symptoms may occur in the neonate after maternal sertraline use in later stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor, jitteriness, irritability, lethargy, constant crying, somnolence and difficulty in sleeping. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma, especially in patients pre-disposed.
Use of sertraline during pregnancy has been reported to cause symptoms, compatible with withdrawal reactions, in some neonates, whose mothers had been on sertraline. Sertraline must not be initiated for at least 14 days after discontinuation of treatment with an irreversible MAOI. Cardiac (e.g.