Granufink® prosta

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

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, dry native extract of saw palmetto fruits (Serenoa repens (Bartram) Small) (7–13 : 1) (extraction solvent — ethanol 90% m/m) — 75 mg;

Excipients: lactose monohydrate, colloidal anhydrous silicon dioxide;

capsule shell: gelatin, black iron oxide (E 172), yellow iron oxide (E 172), red iron oxide (E 172), purified water.

Pharmaceutical form. Hard capsules.

Main physicochemical characteristics: hard gelatin capsules of brown color.

Pharmacotherapeutic group. Urological agents. ATC code G04.

Pharmacological Properties.

Pharmacodynamics.

Seeds of specially cultivated varieties of medicinal pumpkin C. pepo L. convar. citrullina I. Greb. var. styriaca I. Greb contain a fatty plant oil with specific non-ubiquitous phytosterols (delta-7-sterols) responsible for the oil's activity, and a large amount of amino acids (arginine, linoleic and oleic acids) involved in regulating bladder function as direct and indirect neurotransmitters. Collectively, phytosterols and amino acids provide urodynamically active and anti-inflammatory effects by establishing a balance between contraction and relaxation of muscles responsible for urination, promoting relaxation of the urinary bladder sphincter, reducing pressure within the bladder, increasing its tone, and decreasing swelling. This action is further enhanced by the spasmolytic and anti-inflammatory effects of the extract from Serenoa repens fruit, which, in addition, affects the prostate, exerts antiestrogenic and antiandrogenic effects, and inhibits cellular proliferation.

Pharmacological studies have confirmed the positive effect of biologically active substances in pumpkin seed powder, pumpkin seed oil, and Serenoa repens fruit extract on symptoms such as frequent urgent needs to urinate and discomfort during urination, as well as the efficacy of this combination of components in the treatment of urinary bladder and prostate disorders.

GRANUFINC® Prosta 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 bladder atony, to facilitate bladder emptying, and to support normal bladder function.

Prior to initiating treatment, the physician must rule out other serious diseases.

Contraindications.

Hypersensitivity to pumpkin seeds or to plants of the Cucurbitaceae family (e.g., watermelon, zucchini, etc.), saw palmetto fruit, or to any of the excipients of the medicinal product; cholelithiasis, hepatitis, pancreatitis.

This medicinal product must not be used in patients with rare hereditary forms of galactose intolerance, congenital lactase deficiency, or glucose-galactose malabsorption.

Interaction with other medicinal products and other forms of interaction.

There have been several reports of a possible interaction between this product and warfarin. Cases of increased international normalized ratio (INR) in patients have been described.

The patient should inform the physician if taking other medicinal products concurrently.

Special precautions for use.

If symptoms worsen during administration of the medicinal product, or if the following symptoms occur — fever, spasms, blood in urine, pain during urination, urinary retention — medical advice should be sought immediately.

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.

GRANUFINC® Simple is not intended for use in women.

Fertility. There are no data regarding the effect on fertility.

Ability to influence reaction rate while driving or operating machinery. The medicinal product does not affect the ability to drive vehicles or the reaction speed during work with machinery.

Dosage and Administration.

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

The capsules should be taken with sufficient amount of liquid, preferably before meals.

Long-term use is possible. The treatment course is determined by a physician.

If a patient forgets to take the GRANUFINC® Prosta medication on time, do not take a double dose instead of the missed dose. Take the next dose at the scheduled time.

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

Overdose. Cases of overdose have not been reported.

If you accidentally exceed the recommended dose of GRANUFINC® Prosta, you may experience an intensification of adverse reactions. If any adverse reaction is severe, inform your doctor immediately.

Adverse reactions.

The frequency of adverse reactions is classified as follows:

very common (≥ 1/10);

common (from ≥ 1/100 to <1/10);

uncommon (from ≥ 1/1000 to <1/100);

rare (from ≥ 1/10,000 to <1/1,000);

very rare (<1/10,000);

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

In exceptional cases, in individuals hypersensitive to the components of the medicinal product, the following reactions are possible:

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

Gastrointestinal disorders: (common) mild gastrointestinal disturbances such as nausea, vomiting, diarrhea, abdominal pain (especially when taken on an empty stomach).

Nervous system disorders: (frequency not known) headache.

The patient should inform the physician about the occurrence of gastrointestinal disturbances so that the physician can assess the severity and need for treatment.

The patient should discontinue use of this medicinal product and immediately consult a physician if allergic reactions occur.

In case of occurrence of any other adverse reactions, the patient should consult a physician.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after medicinal product registration. This allows continuous 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 the 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 indicated month.

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

Packaging. Hard capsules, 30 (10 × 3), 60 (20 × 3), 120 (20×6), 150 (10 × 15), or 200 (20 × 10) in blisters in a cardboard package.

Supply classification. 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.