Susprin film-coated tablets 4 mg blister 10 pcs.

• active ingredient: ondansetron;
• Each film-coated tablet contains ondansetron hydrochloride dihydrate equivalent to 4 mg ondansetron or ondansetron hydrochloride dihydrate equivalent to 8 mg ondansetron.
• excipients: microcrystalline cellulose, anhydrous lactose, partially pregelatinized corn starch, magnesium stearate, Opadry 03B51322 green coating*;
• *Opadry 03B51322 green: hypromellose, titanium dioxide (E 171), iron oxide yellow (E 172), polyethylene glycol, indigo carmine (E 132).

Concomitant use of ondansetron with apomorphine hydrochloride.

Hypersensitivity to any component of the drug.

On the part of the immune system: rarely – immediate-type hypersensitivity reactions, in a number of cases – severe, including anaphylaxis, bronchospasm, urticaria, angioedema, laryngeal edema, stridor, laryngospasm.

Nervous system disorders: very common – headache; uncommon – movement disorders (including extrapyramidal reactions such as dystonia, oculogyric crisis and dyskinesia)1; rare – dizziness, convulsions; not known – weakness, serotonin syndrome, neuroleptic malignant syndrome.

On the part of the organs of vision: rarely – transient visual disturbances (blurred vision); very rarely – transient blindness2.

Cardiovascular system: often – feeling of heat or flushing; infrequently – arrhythmia, bradycardia, arterial hypotension; rarely – myocardial infarction, myocardial ischemia, angina pectoris, chest pain (with or without ST segment depression), arrhythmia (including ventricular or supraventricular tachycardia, premature ventricular contractions (extrasystole) and atrial fibrillation), ECG changes (including heart block, QT interval prolongation and Torsade de Pointes-type arrhythmia), palpitations and syncope, unknown – myocardial ischemia.

On the part of the respiratory system: infrequently – hiccups.

From the digestive tract: often – constipation, diarrhea; unknown – abdominal pain, dry mouth.

Nausea and vomiting caused by chemotherapy and radiation therapy

The choice of dosing regimen is determined by the emetogenicity of the anticancer therapy.

Adults

Emetogenic chemotherapy and radiation therapy – 8 mg of ondansetron 1–2 hours before the start of chemotherapy or radiation therapy, followed by 8 mg every 12 hours for no more than 5 days.

Highly emetogenic chemotherapy – 24 mg of ondansetron simultaneously with 12 mg of dexamethasone orally 1–2 hours before the start of chemotherapy.

To prevent delayed or prolonged vomiting after the first 24 hours, it is recommended to take 8 mg of ondansetron 2 times a day for no more than 5 days after the course of treatment.

Children aged 6 months and over

The dose is calculated by surface area or body weight.

Use during pregnancy or breastfeeding

Ondansetron should not be used during the first trimester of pregnancy.

In experimental studies, it has been shown that ondansetron passes into breast milk in animals. If necessary, women should stop breastfeeding.

Children

The drug is intended for use in children aged 6 months and older (treatment of nausea and vomiting caused by chemotherapy).

For the prevention or treatment of postoperative nausea and vomiting in children aged 1 month and older, it is recommended to use ondansetron in the form of an injectable solution.

Ability to influence reaction speed when driving vehicles or other mechanisms

Psychomotor tests have shown that ondansetron does not affect the ability to drive and use machines and does not have a sedative effect. Based on the pharmacology of ondansetron, no adverse effects on such activities are expected.

Symptoms

There is limited information on overdose with ondansetron. In most cases of overdose, the symptoms were similar to those experienced by patients at recommended doses. Visual disturbances, severe constipation, hypotension, and vasovagal reactions with transient second-degree atrioventricular block have been reported in overdose. Serotonin syndrome has been reported in children aged 12 months to 2 years following overdose.

Ondansetron dose-dependently prolongs the QT interval, therefore ECG monitoring is recommended in case of overdose.

Treatment

There is no specific antidote for ondansetron, therefore, in case of overdose, symptomatic and supportive therapy should be used.

The use of ipecacuanha is not recommended because the clinical response to its administration may be inhibited by the antiemetic action of ondansetron.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.