Rovatynex

I N S T R U C T I O N for medical use of the medicinal product ROWATINEX (ROWATINEX)

Composition:

Active substance:

1 capsule contains: α-pinene 24.8 mg, β-pinene 6.2 mg, camphene 15.0 mg, cineole 3.0 mg, fenchone 4.0 mg, borneol 10.0 mg, anethole 4.0 mg.

Excipients: purified olive oil, enteric soft capsule: gelatin, glycerol (85%), sodium ethylparahydroxybenzoate (E215), sodium propylparahydroxybenzoate (E217), colouring agent "Yellow West FCF" (E110), quinoline yellow (E104).

Pharmaceutical form. Enteric soft capsules.

Main physicochemical properties: enteric soft capsules, yellow in colour, spherical in shape.

Pharmacotherapeutic group. Other medicinal agents for the treatment of urological diseases. ATC code G04BX.

Pharmacological properties.

Pharmacodynamics.

Rovatynex promotes disintegration and elimination of kidney stones and urinary tract stones. Bornyl and terpenes are completely metabolized in the human body and subsequently excreted by the kidneys in the form of glucuronides. As a result, the solubility of calcium salts, which are the main components of kidney and urinary tract stones, increases. Experimental studies have shown that Rovatynex also prevents stone formation.

The drug has a spasmolytic effect, stimulates the passage of stones through the urinary tract, reduces the intensity of pain during ureteral and renal colic, normalizes renal blood flow, thereby improving kidney function and increasing diuresis.

Rovatynex exerts pronounced anti-inflammatory and antimicrobial effects (against many gram-negative and gram-positive microorganisms) and increases the content of colloids and glucuronic acid in urine.

Pharmacokinetics.

Individual components of the drug are well absorbed and metabolized in the liver (glucuronidation reaction) and are excreted with bile and urine.

Clinical characteristics.

Indications.

Treatment of urolithiasis.

Contraindications.

Hypersensitivity to the components of the drug.

Children under 6 years of age.

Interaction with other medicinal products and other forms of interactions.

Rovatineks should be used with caution in patients taking oral anticoagulants.

Caution should be exercised when co-administering medicinal products that are primarily metabolized in the liver and/or excreted via the liver.

Special precautions for use.

See section "Interaction with other medicinal products and other forms of interaction".

Rovatinex is not recommended in cases of pronounced anuria, renal colic, and severe urinary tract infections.

During Rovatinex therapy, fluid intake should be increased.

The capsule contains sodium ethylparahydroxybenzoate (E 215) and sodium propylparahydroxybenzoate (E 217), as well as the colouring agent "Yellow West FCF" (E 110), which may cause allergic reactions (including delayed-type reactions).

Use during pregnancy or breast-feeding.

There is no information available regarding the use of this medicinal product during pregnancy. There is no evidence of teratogenic effects in animal studies. Some components of the drug can cross the placental barrier. During breast-feeding, Rovatinex should not be used to avoid potential adverse effects on the infant.

Use of the drug during pregnancy is justified only if the expected benefit to the mother outweighs the potential risk to the fetus.

Ability to influence reaction speed when driving or operating machinery.

There are no data available regarding the influence of Rovatinex on reaction speed when driving or operating machinery.

Method of Administration and Dosage

The medication should be taken before meals. Capsules should be swallowed whole; chewing or crushing the capsules is not recommended. Rovatinex should be taken with sufficient amount of water, not less than 100 ml.

Adults and adolescents aged 14 years and older

Recommended dose: 1 capsule 4–5 times daily, before meals.

Children aged 6 to 14 years

Recommended dose: 1 or 2 capsules twice daily, before meals.

The duration of therapy is determined by the physician.

If you miss a dose, take it as soon as you remember. Take the next dose at your usual time (do not take a double dose to make up for the missed one).

If you accidentally take more than the recommended dose, inform your doctor immediately.

Children

The medication is not intended for children under 6 years of age. For children aged 6 to 14 years, the medication should be used only as prescribed and under medical supervision.

Overdose

Cases of overdose have not been reported.

If the medication is taken in a higher than recommended dose and this occurred recently, gastric lavage should be performed. In such cases, monitor the patient's vital functions and administer symptomatic treatment if necessary.

Gastrointestinal irritation may occur, potentially leading to an increase in gastrointestinal side effects such as nausea, vomiting, or diarrhea.

Side effects.

Individually, adverse reactions from the gastrointestinal tract may occur, such as mild stomach discomfort and vomiting.

In rare cases, allergic reactions are possible in individuals hypersensitive to any component of the medicinal product.

The capsule contains sodium ethylparahydroxybenzoate (E 215) and sodium propylparahydroxybenzoate (E 217), and the colorant "Yellow Sunset FCF" (E 110), which may cause allergic reactions (including delayed-type reactions).

Shelf life. 5 years.

Storage conditions. Store in the original packaging, in a place inaccessible to children, at a temperature not exceeding 25 °C.

Packaging. 10 capsules in a PVC/PVdC aluminum blister. 5 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer. Rowa Pharmaceuticals Ltd.

Manufacturer's address and place of business. Newtown, Bantry, Co. Cork, P75 V009, Ireland.