Spasmovax

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SPASMOVAX® (SPASMOVAX®)

Composition:

Active substance: floroglucinol dihydrate;

1 ampoule (4 ml) of injection solution contains floroglucinol dihydrate 51.43 mg (equivalent to anhydrous floroglucinol 40 mg);

Excipients: sodium chloride; sodium metabisulfite; sodium sulfite; water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical characteristics: clear, almost colorless solution.

Pharmacotherapeutic group. Agents used in functional gastrointestinal disorders. Other agents for the treatment of functional gastrointestinal disorders. Floroglucinol. ATC code A03AX12.

Pharmacological properties.

Pharmacodynamics.

The spasmolytic effect of the medicinal product SPASMOVAX is provided by inhibition of catechol-O-methyltransferase activity in tissues involved in catecholamine catabolism, followed by increased sympathetic tone. It has been established that phloroglucinol and its methyl derivative, trimethoxybenzene, do not cause changes in the physiological tone of smooth muscles, but selectively affect smooth muscles in a state of spasm. The drug exerts an active spasmolytic effect on the sphincter of Oddi, which was demonstrated in dogs with removed gallbladder receiving barium chloride.

Pharmacokinetics.

After administration of tritium-labeled phloroglucinol, the plasma half-life in animals was 15 minutes. The concentration of the compound rapidly decreases within the first four hours after administration. The drug selectively accumulates in the kidneys, liver, and intestine. Twenty-four hours after administration, radioactivity of tritium-labeled phloroglucinol is no longer detectable.

Clinical characteristics.

Indications.

Symptomatic treatment of pain associated with functional disorders of the gastrointestinal tract and biliary passages.

Treatment of acute spasmodic disorders of the urinary tract accompanied by pain: renal colic.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

Avoid combining the SPASMOVAX preparation with strong analgesics such as morphine or its derivatives due to their spasmogenic effect.

It is not recommended to mix the injectable solution of phloroglucinol with aminophenazone due to physico-chemical incompatibility (risk of phlebothrombosis).

Special precautions for use

Avoid concomitant use of the medicinal product SPASMOVAX with strong analgesics such as morphine or its derivatives due to their spasmogenic effects.

This medicinal product contains sodium metabisulfite and sodium sulfite, which may rarely cause hypersensitivity reactions and bronchospasm. Sodium metabisulfite and sodium sulfite may cause allergic reactions and severe asthma attacks in susceptible individuals, particularly in patients with asthma.

This medicinal product contains 12.1 mg of sodium per ampoule, equivalent to 0.61% of the maximum daily intake recommended by the WHO (2 g of sodium for adults).

Precautions for use

Currently, no precautions for use have been reported.

Use during pregnancy or breastfeeding

Animal studies have not revealed any teratogenic effects associated with phloroglucinol. Given the absence of teratogenic effects observed in animal studies, the occurrence of congenital malformations in humans is considered unlikely. It is known that substances causing congenital malformations in humans have also demonstrated teratogenic effects in animals during specific studies designed to assess this phenomenon. Extensive clinical use of phloroglucinol over a long period does not indicate a risk of congenital malformations. Phloroglucinol should be used during pregnancy only if clearly necessary and under medical supervision.

Breastfeeding
The use of the medicinal product SPASMOVAX during breastfeeding is not recommended due to lack of adequate data.

Ability to affect reaction speed when driving or operating machinery

SPASMOVAX has no effect or negligible effect on the ability to drive or operate machinery.

Dosage and Administration.

In urology and hepatology, in case of colic:

• Treatment: 1 ampoule (4 mL) (intravenously); a second dose may be administered after 30 minutes;
• Maintenance therapy: 1 ampoule (4 mL) once or twice daily (intravenously or intramuscularly).

Patients with renal/hepatic impairment.

There is no data available on the use of the medicinal product SPASMOVAX in such patients.

Children.

Studies on the use of the medicinal product SPASMOVAX in children have not been conducted.

Overdose.

Cases of overdose have not been reported.

Adverse reactions.

The adverse reactions listed below are classified according to MedDRA system organ classes and frequency.

Frequencies assigned to adverse reactions are defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10000, <1/1000), very rare (<1/10000), not known (frequency cannot be estimated from the available data).

Reporting of suspected adverse reactions

Reporting of adverse reactions following the registration of a medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C, in a protected from light place, in the original packaging. Do not freeze. Do not refrigerate. SPASMOVAX must not be stored at temperatures below 8 °C for more than 7 consecutive days. If SPASMOVAX is stored at 8 °C or lower, crystal formation may occur. These crystals disappear if the ampoules are kept for at least 1 day at 25 °C. Keep out of reach of children.

Packaging.

4 ml in an ampoule; 10 ampoules in a blister pack; 1 blister pack in a cardboard box.

Prescription status.

Prescription only.

Manufacturer. DOPPEL FARMACEUTICI S.R.L., Italy.

Manufacturer's address and location of its operations.

Via Volturno, 48 - Quinto De' Stampi, Rozzano (MI), 20089, Italy.

Marketing Authorization Holder. SHARPER S.P.A.

Address of the Marketing Authorization Holder.

Viale Ortles 12, Milan (MI), 20139, Italy.