PIZOGRAN Film-coated tablet Ref.[28048] Active ingredients:

Hepatic injury has been reported, ranging from transaminase elevations to severe hepatitis. Pizotifen treatment should be discontinued if there is any clinical evidence of hepatic dysfunction during treatment and until the cause of the liver abnormality is determined.

In view of the long half-life in the body and excretion in the urine, this drug should be used with caution in patients with renal dysfunction. The dosage interval may need to be prolonged.

In view of the slight anticholinergic effect of pizotifen, caution is required in patients with narrow-angle glaucoma (except those successfully treated by surgery) or urinary retention (e.g. in prostatic enlargement).

Seizures as undesirable effects have been observed more frequently in patients with epilepsy.

Pizogran should be used with caution in patients with epilepsy and in patients receiving monoamine oxidase inhibitors.

Withdrawal symptoms like depression, tremor, nausea, anxiety, malaise, dizziness, sleep disorder and weight decreased have been reported following abrupt cessation of pizotifen (see section 4.8 Undesirable effects), therefore gradual withdrawal is recommended.

This product contains lactose.

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

The following drugs may exhibit drug interactions with pizotifen upon concomitant administration.

Anticipated drug interactions to be considered

Pizotifen is extensively metabolized in the liver, primarily by N-glucuronidation. Increased plasma concentration of pizotifen upon concomitant administration of drugs which exclusively undergo glucuronidation can not be excluded.

Cisapride

Concomitant administration of pizotifen with cisapride may lead to reduced efficacy of cisapride.

Central nervous system agents

Central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by pizotifen.

Pizogran antagonises the hypotensive effect of adrenergic neurone blockers.

Pregnancy

Pregnancy should be avoided whilst taking this drug.

Breast-feeding

Use in nursing mothers is not recommended.

Pizotifen may cause sedation, somnolence, dizziness and other CNS effects. Therefore, caution should be exercised when driving or using machines.

Patients being treated with Pizogran and presenting with sedation and/or somnolence episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk.

The most common side effects are appetite stimulating effect, increase in body weight and sedation (including somnolence and fatigue).

Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000), including isolated reports.

Table 1:

Adverse drug reactions from post-marketing spontaneous reports

The following additional adverse drug reactions have been identified with pizotifen based on post-marketing spontaneous reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Hepatobiliary disorders

Unknown: Hepatic enzyme increased, jaundice, hepatitis

Musculoskeletal and connective tissue disorders

Unknown: Muscle cramps

Withdrawal symptoms

Acute withdrawal reactions have been reported following abrupt cessation of Pizogran therefore gradual withdrawal is recommended (see section 4.4 special warnings and precautions for use). Withdrawal symptoms may include: depression, anxiety, tremors, sleep disorder, nausea, malaise, dizziness and weight decreased.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization 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 via the national reporting system.

Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475, Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.

Not applicable.