SULVORID Tablet Ref.[51045] Active ingredients: Levosulpiride

• In randomized clinical trials versus placebo performed in a population of patients with dementia treated with some atypical antipsychotics, an increase of about three times of the cerebrovascular events risk was observed. The mechanism for this increased risk is not known. An increased risk for other antipsychotics or other patient populations can not be ruled out. Sulvorid should be used with caution in patients with risk factors for stroke.
• A complex symptoms disorder, potentially fatal, called Neuroleptic Malignant Syndrome has been reported in the course of treatment with antipsychotic drugs. Clinical manifestations of this syndrome are hyperpyrexia, muscle rigidity, akinesia, vegetative disorders (irregular pulse or blood pressure, sweating, tachycardia, arrhythmias), altered state of consciousness that may progress to stupor and coma. The treatment of Neuroleptic Malignant Syndrome consists of immediate discontinuation of the antipsychotic medicines and other not essential medicines and setting of an intensive symptomatic treatment (care must be taken in reducing hyperthermia and in correcting dehydration). In case the resumption of the treatment with antipsychotics is held to be essential, the patient should be carefully monitored. Concomitant therapy with other neuroleptics must be avoided.
• Levosulpiride should not be used when the stimulation of gastrointestinal motility can be detrimental, for example in the presence of gastrointestinal bleeding, mechanical obstructions or perforations.
• Levosulpiride should be used with caution in patients with cardiovascular disease or with a family history of QT prolongation.
• There have been reports of venous thromboembolism (VTE) with antipsychotic medicines use. Since patients treated with antipsychotics often present with acquired risk factors for VTE, these factors need to be identified before and during treatment with Sulvorid, in order to take appropriate preventive measures.
• Simultaneous intake of alcohol must be avoided.

Sulvorid contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The association with other medicines requires special caution and vigilance from the physician, in order to avoid unexpected effects from unwanted interaction.

• Concomitant administration of neuroleptics with medicines that prolong the QT interval, increases the risk of cardiac arrhythmias.
• Levosulpiride should not be administered concomitantly with medicines that cause electrolyte disturbances.

Pregnancy

Do not use in pregnancy, possible pregnancy and during the breastfeeding period. Neonates exposed to conventional or atypical antipsychotics included Product name during the third trimester of pregnancy are at risk for side effects including extrapyramidal symptoms or withdrawal symptoms that may vary by severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder. Therefore, newborns should be carefully monitored.

Sulvorid has major influence on the ability to drive and use machines.

Patients under treatment may experience numbness, dizziness and dyskinesia, therefore they should be advised to avoid driving and operations requiring supervision.

According to MedDRA system, organ classification, frequency categories are defined as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).

Immune system disorders

Very rare: allergic reactions

Endocrine disorders

Not known: some disorders such as amenorrhea, gynecomastia, galactorrhea, hyperprolactinemia and changes in libido, observed in special cases, are due to a reversible effect of levosulpiride on the functionality of the hypothalamic-pituitary-gonadal axis, similar to that known for many neuroleptics.

Metabolism and nutrition disorders

Not known: cases of weight gain have been reported after prolonged treatment.

Nervous system disorders

Very rare: psychomotor agitation, neurovegetative disorders and allergic reactions and extrapyramidal effects such as tremors, parkinsonism and dystonia. All these effects are modest in magnitude and reversible.

The following side effects have been observed with other medicines of the same class:

Cardiac disorders

Rare: cases of QT prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation and cardiac arrest.

Very rare: cases of sudden death.

Vascular disorders

Not known: there have been reports of venous thromboembolism (VTE), including cases of pulmonary embolism (PE) and deep venous thrombosis (VTE).

Pregnancy, puerperium and perinatal conditions

Not known: neonatal withdrawal syndrome, extrapyramidal symptoms (see section 4.6).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.

There are no known data.