Remensuro

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

Composition:

Active substances: 1 capsule contains: pumpkin seed oil (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb) – 227.3 mg, dry native extract of aromatic sumac bark (Rhus aromatica Aiton) (5–7 : 1) (extraction solvent – water) – 56 mg, dry native extract of hops strobiles (Humulus lupulus L.) (5.5–6.5 : 1) (extraction solvent – water) – 18 mg;

Excipients: all-rac-ɑ-tocopheryl acetate, soybean oil, partially hydrogenated; beeswax, yellow; glycerin; purified water; glucose solution; maltodextrin; lecithin.

Capsule shell: gelatin, iron oxide red (E 172), iron oxide yellow (E 172), titanium dioxide (E 171).

Pharmaceutical form. Hard capsules.

Main physicochemical characteristics: hard gelatin capsules of red-brown color, size 0.

Pharmacotherapeutic group. Urological agents. ATC code G04BX.

Pharmacological properties

Seeds of specially cultivated varieties of medicinal pumpkin C. pepo L. convar. citrullina I. Greb. var. styriaca I. Greb contain vegetable oil rich in specific non-ubiquitous phytosterols (delta-7-sterols) responsible for the oil's activity, as well as a high content of amino acids (arginine, linoleic and oleic acids) involved in regulating bladder function as direct and indirect neurotransmitters. In combination, phytosterols and amino acids provide urodynamic and anti-inflammatory effects by establishing a balance between contraction and relaxation of the muscles responsible for urination, promoting relaxation of the urinary bladder sphincter, reducing intravesical pressure, increasing bladder tone, and reducing swelling. This effect is further enhanced by the extract of hop cones and by flavonoids, sterins, tannins, and phenolic components of the extract of aromatic sumach bark, which exert anti-inflammatory, antimicrobial, and diuretic actions and affect muscle contractions, providing spasmolytic and calming effects in cases of overactive bladder and urinary incontinence.

This combined medicinal product based on pumpkin seeds, hop cones, and aromatic sumach bark, as well as corresponding single-component herbal medicinal products, is used for the treatment of bladder dysfunction. Remensuron is considered a traditional herbal medicinal product for use according to specified indications.

Pharmacodynamics.

Specific pharmacodynamic studies of the medicinal product Remensuron have not been conducted.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For relief of symptoms occurring in the lower urinary tract in women due to overactive bladder; for supporting and enhancing bladder function in cases of weak bladder.

Contraindications.

Hypersensitivity to the active ingredients of this medicinal product, to plants of the Cucurbitaceae family (e.g., watermelon, zucchini, etc.), peanuts, soy, or to any other components of this medicinal product.

Interaction with other medicinal products and other types of interactions.

The possibility of interaction with other medicinal products has not been studied.

Special precautions for use.

Before initiating treatment, the physician should rule out other significant diseases.

The patient is advised to consult a physician if symptoms worsen or new symptoms occur during use of this medicinal product, such as fever, spasms, blood in the urine, pain during urination, or urinary retention.

The medicinal product contains glucose. Patients with rare hereditary glucose-galactose malabsorption should not take this medicinal product.

The medicinal product contains soybean oil. If the patient is allergic to peanuts or soy, this medicinal product should not be used.

Use in children under 18 years of age is not recommended, due to insufficient data in this age group. Moreover, treatment of lower urinary tract symptoms in this age group should be performed under medical supervision.

Use during pregnancy or breastfeeding.

Clinical studies on the use of this medicinal product in pregnant or breastfeeding women have not been conducted; therefore, its use is not recommended in pregnant or breastfeeding women.

Fertility.

Studies on the effect of the medicinal product on fertility have not been conducted.

Ability to affect reaction speed when driving or operating machinery.
This medicinal product may affect the ability to drive or operate machinery. After taking this medicinal product, patients should not drive vehicles or operate machinery.

Dosage and Administration.

Adults, including elderly patients: 1 capsule 3 times a day.

The capsules should be taken with plenty of fluid, preferably before meals. Long-term use is possible. The duration of treatment is determined by the physician.

Children. The use of the medicinal product in children under 18 years of age is not recommended due to insufficient data in this age group (see section "Special Instructions").

Overdose. Cases of overdose have not been reported.

In case of accidental exceeding of the recommended dose of Remensuro, an increase in adverse reactions is possible.

Side effects

The frequency of adverse reactions is classified as follows:

very common (≥ 1/10);
common (≥ 1/100 to <1/10);
uncommon (≥ 1/1000 to <1/100);
rare (≥ 1/10000 to <1/1000);
very rare (<1/10000);
frequency not known (cannot be estimated from the available data).

In exceptional cases, individuals hypersensitive to any component of the medicinal product may experience the following reactions:

Immune system disorders (frequency not known): allergic reactions such as skin rashes, itching, and swelling;

Gastrointestinal disorders (frequency not known): discomfort, nausea, vomiting, diarrhea.

Soybean oil may very rarely cause allergic reactions.

Patients should inform their doctor if gastrointestinal symptoms occur, so that the physician can assess the severity and need for treatment.

This medicinal product must be discontinued and immediate medical advice sought if hypersensitivity reactions occur.

Patients should seek medical advice if any other adverse reactions occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicinal product authorization is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua/.

Shelf life: 27 months.

Storage conditions

Store at temperatures not exceeding 25 °C.

Keep out of reach and sight of children.

Do not use this medicinal product after the expiry date stated on the blister and carton packaging. The expiry date refers to the last day of the specified month.

Do not dispose of any medicinal products via wastewater or household waste. Patients should ask their pharmacist for guidance on how to properly dispose of unused medicinal products.

Packaging

10 capsules in a blister; 3, 6, or 12 blisters in a cardboard box.

20 capsules in a blister with a perforation line; 3 or 6 blisters in a cardboard box.

Availability: Over-the-counter.

Manufacturer: Omega Pharma Manufacturing GmbH & Co. KG /
Omega Pharma Manufacturing GmbH & Co. KG.

Manufacturer's address and place of business:
Benzstr. 25, Herrenberg, Baden-Wuerttemberg, 71083, Germany /
Benzstr. 25, Herrenberg, Baden-Wuerttemberg, 71083, Germanу.