Package leaflet

STEMETIL 5 mg film-coated tablets, 10 mg suppositories

prochlorperazine
PHARMACOTHERAPEUTIC CATEGORY
Antiemetic and anti-nausea.
THERAPEUTIC INDICATIONS
Treatment and prevention of vomiting and nausea of any kind.
CONTRAINDICATIONS

hypersensitivity to prochlorperazine or other phenothiazines and/or to any of the excipients;
comatose states;
central nervous system (CNS) depression, particularly that induced by substances with CNS depressant activity (alcohol, barbiturates, narcotics, etc.);
bone marrow depression;
pheochromocytoma;
severe impairment of hepatic and renal function;
not to be used under two years of age and in pediatric age;
period prior to surgical intervention;
first trimester of pregnancy.

PRECAUTIONS FOR USE
Special attention is required when administering in elderly and children, as the risk of extrapyramidal reactions is higher.
Stemetil, like other phenothiazines, should be used with caution in patients with hepatic or renal insufficiency, heart disease, severe myasthenia, severe respiratory diseases, prostatic hypertrophy, urinary retention, intestinal obstruction, and closed-angle glaucoma.
Caution is advised in patients with epilepsy, as phenothiazines may lower the seizure threshold. Prudence is also recommended in patients with Parkinson's disease, as the condition may worsen.
As with other phenothiazines, caution is advised in patients with leukopenia and/or neutropenia, in those taking drugs known to cause neutropenia, and in patients with a history of myelodepression due to concomitant illness, radiotherapy, or chemotherapy. Periodic blood counts should be performed, and promptly requested in case of unexplained infection or fever.
Elderly patients are more prone to adverse effects of phenothiazines due to the risk of orthostatic hypotension. Periodic monitoring of blood pressure is recommended in patients over 65 years of age.
INTERACTIONS
Potential interactions concerning prochlorperazine:
The CNS-depressant effect of phenothiazines may be enhanced by alcohol, anesthetics, narcotics, sedatives, etc., possibly resulting in respiratory depression. The anticholinergic effect of phenothiazines may be potentiated by other anticholinergic agents, causing constipation, urinary retention, heat stroke, etc.
Reduced bioavailability: antacids, drugs for Parkinson's disease, and lithium may interfere with the absorption of antipsychotics.
Increased risk of ventricular arrhythmias may occur when prochlorperazine is used concomitantly with drugs that prolong the QT interval, such as antiarrhythmics, antidepressants, and other antipsychotics.
Increased risk of agranulocytosis may occur when phenothiazines are used together with drugs having potential myelosuppressive effects, such as carbamazepine, sulfonamides, or cytotoxic agents.
When used with lithium, there is an increased risk of extrapyramidal effects and neurotoxicity.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
SPECIAL WARNINGS
Extrapyramidal symptoms (parkinsonian symptoms, dystonia, and dyskinesias) depend partly on dose, duration of treatment, and individual sensitivity. Parkinsonian symptoms usually resolve upon discontinuation of the drug.
Phenothiazines may alter the regulation of body temperature; therefore, caution is advised during very hot (risk of hyperthermia) or very cold (risk of hypothermia) seasons.
Neuroleptic Malignant Syndrome (NMS): a potentially fatal condition associated with treatment with prochlorperazine or other neuroleptics used for antipsychotic purposes. Clinical manifestations of NMS include hyperpyrexia, muscular rigidity, autonomic nervous system dysfunction (irregular pulse or blood pressure, sweating, tachycardia, arrhythmias), and altered mental status, which may progress to stupor and coma. In such cases, drug therapy must be discontinued immediately.
Patients undergoing treatment with phenothiazines should avoid excessive exposure to sunlight, using protective creams if necessary.
The antiemetic action of phenothiazines may mask signs of overdose of other drugs or make diagnosis of concomitant conditions difficult, especially gastrointestinal or CNS disorders such as intestinal obstruction, brain tumors, or Reye's syndrome.
For this reason, these substances should be used cautiously in combination with chemotherapeutic agents with antineoplastic activity that may cause vomiting at toxic doses.
The drug may induce depression of the cough center, thereby increasing the risk of aspiration of vomit.
Prolonged use may lead to increased serum prolactin levels, with possible effects on target organs.
As with other neuroleptics, very rare cases of QT interval prolongation have been reported. Caution is particularly advised during the initial phase of treatment in patients with predisposing factors for ventricular arrhythmias, such as significant heart disease, metabolic disturbances (e.g., hypokalemia, hypomagnesemia), or concomitant use of drugs that prolong the QT interval. Monitoring of electrolyte levels and ECG may be useful, especially during the initial phase of treatment.
Pregnancy and lactation
Pregnancy: Do not administer during the first trimester of pregnancy. In later stages, the drug may be used only if considered essential and always under direct medical supervision. Use of the drug as an antiemetic during pregnancy is not recommended.
Prolongation of labor has been reported; therefore, avoid administration until the cervix has dilated to 3–4 cm. Adverse effects on the fetus include lethargy, paradoxical hyperexcitability, tremor, and low Apgar score.
Consult your doctor or pharmacist before taking any medicine.
Lactation: Since phenothiazines may be excreted in breast milk, breastfeeding should be discontinued during treatment.
Effects on ability to drive and use machines
Since phenothiazines may cause sedation and drowsiness, patients should avoid driving vehicles or operating machinery while taking Stemetil.
If you are known to have an intolerance to certain sugars, consult your physician before taking this medicine.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
Oral use:
Adults:
For treatment of acute vomiting and nausea, the recommended dose is one tablet three times daily at regular intervals.
For prevention of vomiting and nausea, the recommended dose is 1–2 tablets.
Elderly:
Reduced doses are recommended for patients over 65 years of age.
Children:
Use reduced doses.
Rectal use:
Adults:
The recommended dose is two suppositories daily, one in the morning and one in the evening.
In some cases, such as intractable vomiting, one or two suppositories may be administered initially, followed by oral treatment.
Elderly: use reduced doses.
Children: the use of Stemetil suppositories is not recommended in children.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
OVERDOSE
The most common symptoms of overdose are of extrapyramidal type, usually accompanied by restlessness, agitation, hypotension, and CNS depression.
Treatment is symptomatic and supportive of vital functions. Gastric lavage should be performed as soon as possible. Particular attention must be paid to maintaining adequate respiration.
In case of accidental ingestion of an excessive dose, contact your doctor immediately or go to the nearest hospital.
UNDESIRABLE EFFECTS
Like all medicines, this one can cause side effects, although not everybody experiences them.
The following frequency convention is used for the adverse reactions described below: very common (>10%); common (≥1%, <10%); uncommon (≥0.1%, <1%); rare (≥0.01%, <0.1%); very rare (<0.01%).
The most frequent adverse reactions affect the central nervous system.
Nervous system disorders
At the beginning of therapy, sedation and drowsiness are very common but mostly disappear with appropriate dose reduction. Other manifestations of variable frequency include restlessness, insomnia, euphoria, psychomotor agitation, and depression.
Seizures may also occur.
Extrapyramidal reactions are common during therapy with phenothiazines, although their frequency and severity are related to dose and duration of treatment.
These include dyskinesia, akathisia, parkinsonian symptoms, and tardive dyskinesia.
Gastrointestinal disorders
Due to the anticholinergic activity of phenothiazines, dry mouth, constipation, and rarely paralytic ileus may occur.
Blood and lymphatic system disorders
Effects on blood counts are rare but serious. These include leukopenia, agranulocytosis, thrombocytopenia, purpura, and hemolytic anemia.
Skin and subcutaneous tissue disorders
Hypersensitivity reactions (general or contact) and photosensitivity may occur, mostly manifesting as erythema, urticaria, eczema, exfoliative dermatitis, and systemic lupus erythematosus-like reactions.
Hypersensitivity reactions
Cholestatic jaundice, laryngeal edema, laryngospasm and bronchospasm, anaphylactoid reactions. In such cases, treatment must be immediately discontinued.
Endocrine system disorders
Effects on the endocrine system are possible but related to dose and duration of therapy. The most frequent include galactorrhea and menstrual disorders in women, gynecomastia and decreased libido in men.
Metabolism and nutrition disorders
Hyperglycemia and glycosuria.
Cardiac disorders
Very rare cases of QT interval prolongation and arrhythmias have been reported.
Vascular disorders
Peripheral edema.
Urinary system disorders
Urinary retention.
General disorders
Visual disturbances.
Unexplained hyperpyrexia may be due to intolerance to the product and requires discontinuation of therapy.
Neuroleptic Malignant Syndrome (NMS) (hyperthermia, muscular rigidity, autonomic dysfunction, and fluctuations in consciousness) is a very rare but serious event requiring immediate discontinuation of treatment.
Following the instructions in this leaflet reduces the risk of side effects.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
EXPIRY DATE AND STORAGE INSTRUCTIONS
Film-coated tablets: store protected from light, at a temperature not exceeding 25°C.
Suppositories: if the suppositories appear softened, immerse the container in cold water before opening.
Expiry date: see the date indicated on the packaging.
The expiry date refers to the product stored in its original, unopened packaging under recommended conditions.
Warning: do not use the product after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
COMPOSITION
Stemetil 5 mg film-coated tablets
Each tablet contains:
Active substance: prochlorperazine maleate 8.25 mg equivalent to prochlorperazine 5 mg.
Excipients: lactose, povidone, magnesium stearate, maize starch, zein, castor oil.
Stemetil 10 mg suppositories
Each suppository contains: Active substance: prochlorperazine 10 mg
Excipients: solid semisynthetic glycerides
PHARMACEUTICAL FORM AND CONTENT
Box of 20 film-coated tablets
Box of 5 suppositories
MARKETING AUTHORISATION HOLDER
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
MANUFACTURER AND FINAL CONTROLLER
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia
November 2007 issue