Spazmovax oro

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

Composition:

Active substances: phloroglucinol dihydrate, 1,3,5-trimethoxybenzene;

Each tablet contains phloroglucinol dihydrate 102.85 mg (equivalent to anhydrous phloroglucinol 80 mg), 1,3,5-trimethoxybenzene 80 mg;

Excipients: lactose monohydrate; sucrose; magnesium stearate; talc.

Pharmaceutical form. Tablets.

Main physicochemical properties: round tablets, white to almost white.

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

Pharmacological properties.

Pharmacodynamics.

The spasmolytic effect of the medicinal product SPASMOVAX ORAL is provided by inhibition of catechol-O-methyltransferase activity in tissues involved in catecholamine catabolism, resulting in 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 pronounced spasmolytic action on the sphincter of Oddi, as 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 drug concentration rapidly decreases within the first four hours. The drug selectively accumulates in the kidneys, liver, and intestine. Radioactivity is not detectable 24 hours after administration.

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 medicinal product SPASMOVAX ORO with strong analgesics such as morphine or its derivatives due to their spasmogenic effect.

Special precautions for use.

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

If you have an intolerance to certain sugars, consult your doctor before taking this medicinal product.

SPASMOVAX ORA contains lactose. Patients with rare hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicinal product.

SPASMOVAX ORA contains sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency should not take this medicinal product.

Use during pregnancy or breastfeeding. Fertility.

Animal studies have not revealed any teratogenic effects associated with phloroglucinol. Therefore, the occurrence of congenital malformations in humans is considered unlikely. Substances known to cause congenital malformations in humans have also demonstrated teratogenic effects in animals during specific studies designed to evaluate this effect. The widespread clinical use of phloroglucinol to date indicates absence of risk for congenital malformations. Phloroglucinol should be used during pregnancy only if strictly necessary and under medical supervision.

Use of the medicinal product SPASMOVAX ORA during lactation is not recommended due to lack of adequate data.

Ability to affect reaction speed when driving or operating machinery.

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

Dosage and Administration.

In urology and hepatology: 6 tablets per day.

Patients with renal/hepatic impairment. There are no data regarding the use of the medicinal product SPASMOVAX ORAL in such patients.

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

Overdose.

No cases of overdose have been reported.

Adverse reactions.

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

Frequency categories for 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).

*Since these reactions have been reported for SPASMOVAX injection solution in post-marketing experience, it is not possible to reliably estimate their frequency; therefore, the frequency is defined as "unknown".

Reporting of suspected adverse reactions

Reporting of adverse reactions after medicinal product authorization is important. It allows ongoing 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 suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 4 years.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging.

10 tablets in a blister; 2 blisters in a cardboard box.

Prescription status.

Prescription only.

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

Manufacturer's address and place of business.

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

Marketing Authorization Holder. SHARPER S.P.A., Italy.

Address of the Marketing Authorization Holder. Viale Ortles 12, Milan (MI), 20139, Italy.