GRANUFINK® URO

I N S T R U C T I O N for medical use of the medicinal product GRANUFINK® Uro GRANUFINK® Blase

Composition:

Active substances: 1 capsule contains: powdered pumpkin seeds (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb) — 400 mg, pumpkin seed oil (Cucurbita pepo L. convar. citrullina I. Greb. var. styriaca I. Greb) — 340 mg;

Excipients (capsule shell): gelatin, titanium dioxide (E 171), iron oxide red (E 172).

Pharmaceutical form. Hard capsules.

Main physico-chemical properties: hard gelatin capsules of red-brown color, size 00.

Pharmacotherapeutic group. Urological agents. ATC code G04BX.

Pharmacological Properties

Pharmacodynamics. The seeds of specially cultivated varieties of medicinal pumpkin C. pepo L. convar. citrullina I. Greb. var. styriaca I. Greb contain fatty vegetable oil with specific non-ubiquitous phytosterols (delta-7 sterols), which provide the oil's activity, and a large amount of amino acids (arginine, linoleic and oleic acids) that participate in the regulation of bladder function as direct and indirect mediators. Collectively, phytosterols and amino acids provide urodynamically active 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 pressure in the urinary bladder, increasing its tone, and reducing swelling.

Specific pharmacodynamic studies of the medicinal product GRANUFINC® Uro have not been conducted.

GRANUFINC® Uro is considered a traditional herbal medicinal product for use according to specified indications.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Used to strengthen and enhance bladder function in cases of atony, to support normal bladder function, and to facilitate bladder emptying.

Before starting treatment, the physician must rule out other serious diseases.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Studies on interactions with other medicinal products have not been conducted.

Cases of interactions with other medicinal products have not been reported.

Special precautions for use

If symptoms worsen during the use of the medicinal product, or if symptoms such as fever, spasms, blood in the urine, pain during urination, or urinary retention occur, consult a physician.

The use of this medicinal product in children (under 18 years of age) is not recommended, as treatment of lower urinary tract symptoms in this age group should be conducted under medical supervision.

This medicinal product contains less than 1 mmol (23 mg) of sodium per capsule, i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding

Pregnancy

The safety of using this medicinal product during pregnancy has not been established. Due to insufficient data, its use during pregnancy is not recommended. The medicinal product may be used during pregnancy only if clinically necessary and under medical supervision.

Breastfeeding

The safety of using this medicinal product during breastfeeding has not been established. Due to insufficient data, its use during breastfeeding is not recommended. The medicinal product may be used during breastfeeding only if clinically necessary and under medical supervision.

Prior to using this medicinal product during pregnancy or breastfeeding, consult a physician or pharmacist.

Fertility

There is no data available on the effect of the medicinal product on fertility.

Ability to influence reaction speed when driving or operating machinery
The medicinal product has no effect or has a negligible effect on the ability to drive vehicles or operate machinery.

Dosage and Administration.

Adults, including elderly patients: take 1 capsule 3 times a day with plenty of fluid, preferably before meals.

Prolonged use is possible. The duration of treatment is determined by a physician.

Children: use of the medicinal product in children (under 18 years of age) is not recommended.

Overdose. Cases of overdose have not been reported.

In the event of accidental exceeding of the recommended dose of GRANUFINC® Uro, adverse reactions may be intensified.

Side effects

The frequency of adverse reactions is classified as follows:

very common (≥ 1/10);

common (≥ 1/100 to <1/10);

uncommon (≥ 1/1,000 to <1/100);

rare (≥ 1/10,000 to <1/1,000);

very rare (<1/10,000);

frequency not known (cannot be estimated from the available data).

Gastrointestinal disorders: (common) mild gastrointestinal disturbances.

Immune system disorders: (frequency not known) hypersensitivity reactions (skin rash, urticaria, facial swelling, sensation of lump in the throat, and sensation of tightness with dyspnea due to hemodynamic disturbances (anaphylactic shock).

If any other adverse reactions occur, the patient must consult a physician.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after the medicinal product has been authorized. This allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions via the website: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Keep out of reach of children.

The medicinal product does not require special storage conditions.

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 stated month.

Do not dispose of any medicinal products into wastewater or household waste. Ask your pharmacist for advice on how to dispose of medicinal products no longer in use.

Packaging. Hard capsules, 50 units (10 × 5), 100 units (20 × 5), or 160 units (20 × 8) in blisters, packed in a cardboard box.

Supply category. 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, Germany.