ALDIZEM

INSTRUCTIONS FOR MEDICAL USE OF ROVATINEKSA MEDICINAL PRODUCT

Composition:

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

excipients: purified olive oil, enteric-coated, soft capsule: gelatin, glycerin (85%), sodium ethyl para-hydroxybenzoate (E215), sodium propyl para-hydroxybenzoate (E217), colorant "yellow west FCF" (E110), quinoline yellow (E104).

Pharmaceutical Form

Enteric-coated, soft capsules.

Main Physical and Chemical Properties

enteric-coated, soft yellow capsules, spherical in shape.

Pharmacotherapeutic Group

Other medicinal products for the treatment of urological diseases. ATC code G04B X.

Pharmacological Properties

Pharmacodynamics

Rovatineksa promotes the disintegration and removal of kidney stones and urinary tract stones. Borneol and terpenes are completely modified in the human body, after which they are excreted in the form of glucuronides by the kidneys. As a result, the solubility of calcium salts, which are the main components of kidney stones and urinary tract stones, increases. In experimental conditions, it was found that Rovatineksa also prevents the formation of stones.

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, which leads to an improvement in renal function and an increase in diuresis.

Rovatineksa has a pronounced anti-inflammatory and antimicrobial (against many gram-negative and gram-positive microorganisms) effect, increases the content of colloids and glucuronic acid in the urine.

Pharmacokinetics

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

Clinical Characteristics

Indications

Treatment of urolithiasis.

Contraindications

Hypersensitivity to the components of the drug.

Childhood age up to 6 years.

Interaction with Other Medicinal Products and Other Types of Interactions

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

When taking medications that are mainly metabolized in the liver and/or excreted through the liver, caution should be exercised.

Special Instructions

See the section "Interaction with Other Medicinal Products and Other Types of Interactions".

Rovatineksa is not recommended for patients with pronounced anuria, renal colic, and severe infections of the urinary tract.

During therapy with Rovatineksa, it is necessary to increase fluid intake.

The capsule contains sodium ethyl para-hydroxybenzoate (E215) and sodium propyl para-hydroxybenzoate (E217), colorant "yellow west FCF" (E110), which can cause allergic reactions (including delayed ones).

Use During Pregnancy or Breastfeeding

Information on the use of the medicinal product during pregnancy is absent. There is no evidence of a teratogenic effect when used in animals. Some components of the drug penetrate the placenta. During breastfeeding, to avoid unwanted effects on the infant, Rovatineksa should not be used.

The use of the drug during pregnancy is justified only when the expected benefit to the pregnant woman outweighs the risk to the fetus.

Ability to Affect Reaction Speed When Driving a Vehicle or Operating Other Mechanisms

Data on the effect on reaction speed when driving a vehicle or operating other mechanisms are absent.

Method of Administration and Dosage

The drug is administered before meals. Capsules should be taken whole, it is not recommended to chew or crush the capsules. Rovatineksa should be washed down with a sufficient amount of water, at least 100 ml.

Adults and adolescents over 14 years old

Recommended dose - 1 capsule 4-5 times a day, before meals.

Children from 6 to 14 years old

Recommended dose - 1 or 2 capsules 2 times a day, before meals.

The duration of therapy is determined by the doctor.

If you missed a dose, you should take it as soon as you remember. The next dose should be taken at the usual time (do not take two doses at the same time).

If you accidentally took a larger dose than recommended, you should inform your doctor about it.

Children

Children under 6 years old should not be given the drug. Children from 6 to 14 years old should be given the drug under the supervision of a doctor.

Overdose

Cases of overdose have not been detected.

If the medicinal product was used in a larger dose than recommended, and this happened recently, it is necessary to rinse the stomach. In this case, it is necessary to monitor the patient's vital functions and, if necessary, apply symptomatic treatment.

Possible irritation of the stomach, which can lead to an increase in side effects from the gastrointestinal tract, such as nausea, vomiting, or diarrhea.

Side Effects

Individually, side effects from the gastrointestinal tract may occur in the form of mild discomfort in the stomach, vomiting.

In rare cases, in persons with hypersensitivity to any component of the drug, allergic reactions are possible.

The capsule contains sodium ethyl para-hydroxybenzoate (E215) and sodium propyl para-hydroxybenzoate (E217), colorant "yellow west FCF" (E110), which can cause allergic reactions (including delayed ones).

Shelf Life

5 years.

Storage Conditions

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

Packaging

10 capsules in a PVC/PVDC aluminum blister pack. 5 blister packs in a cardboard box.

Release Category

By prescription.

Manufacturer

Rova Pharmaceuticals Ltd.

Manufacturer's Location and Address

Newtown, Bantry, Co. Cork, R75 V009, Ireland.