Prostalad

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSTALAD (PROSTALAD)

Composition:

Active substance: 1 bottle (jar) contains herbal tincture [of St. John's wort herb (Hyperici herba), Canadian goldenrod herb (Solidaginis canadensis herba), shepherd's purse herb (Bursae pastoris herba), common agrimony herb (agrimony medicinal) (Agrimoniae eupatoriae herba), arnica flowers (Arnicae flos), marigold flowers (Calendulae flos), valerian roots (Valerianae radix), purple coneflower roots (Echinaceae purpureae radix)] (1 : 4.4) (extractant ethanol 70%) – 100 ml;

Excipients: none, except extractant.

Pharmaceutical form. Tincture for oral administration.

Main physicochemical properties: golden-brown liquid with a weak odor of valerian. Sediment may form during storage.

Pharmacotherapeutic group.

Medicinal product for the treatment of benign prostatic hyperplasia (BPH).

ATC code G04CX.

Pharmacological Properties.

Pharmacodynamics.

Prostalad promotes normalization of prostate-specific antigen and estriol levels in the blood, reduces lipid peroxidation in the prostate gland, decreases the size of the enlarged prostate gland, normalizes diuresis, reduces clinical symptoms of BPH, and has a moderate analgesic effect. The pharmacological properties of the tincture are due to the action of its constituent components.

Clinical characteristics.

Indications.

Use for prevention and as part of complex treatment of benign prostatic hyperplasia (BPH) at the initial stage of the disease (in case of urinary difficulties) and urinary tract infections.

Contraindications.

Hypersensitivity to components of the medicinal product (including plants of the Asteraceae family); history of alcoholism, use of preparations containing alcohol, and alcohol itself; gastric and duodenal peptic ulcer; liver cirrhosis; concomitant use of neuroleptics and tranquilizers; arterial hypertension, increased blood coagulation, thromboembolism (in history); diabetes mellitus; tuberculosis; leukocyte system blood disorders (leukemia, agranulocytosis); rheumatism; connective tissue diseases (collagenoses); oncological diseases; multiple sclerosis and other autoimmune diseases, systemic lupus erythematosus, immunosuppression or immunodeficiency of various etiologies, other chronic viral diseases, HIV infection, AIDS; depression and other disorders accompanied by central nervous system depression.

Interaction with other medicinal products and other forms of interaction.

The medicinal product should not be used in combination with neuroleptics, tranquilizers, sedatives, and preparations containing alcohol.

Prostalad is not recommended to be used simultaneously with drugs having hepatotoxic effects, such as amiodarone, methotrexate, ketoconazole, and steroid preparations. The tincture is capable of potentiating the action of cardiac, sedative, analgesic, and spasmolytic agents. Use is not recommended in patients taking anticoagulants, antibiotics, sulfonamides, contraceptives, calcium channel blockers, female sex hormones, hypocholesterolemic agents (statins), and cardiac glycosides. Due to its immunostimulatory effect, echinacea may reduce the effectiveness of immunosuppressive drugs.

Special precautions for use.

Regular monitoring of the genitourinary system function is required during treatment with this medication.

In peptic ulcer disease and gastritis with increased acidity, the drug should be used in combination with antacids and spasmolytics.

The medicinal product contains ethanol.

Use during pregnancy or breastfeeding.

The drug is intended for use in men only.

Ability to influence reaction speed when driving or operating machinery.

Not observed.

Dosage and Administration.

The drug should be taken orally by adult males, 1 teaspoon twice daily, previously diluted in 50 ml of water. The duration of treatment is up to 3 months.

Children.

Do not administer to children.

Overdose.

In case of overdose, the following symptoms may occur.

Central nervous system: drowsiness, depression, insomnia, sleep disturbances, increased nervous excitability, headache, dizziness, general weakness, decreased hearing and visual acuity, palpitations, mental excitement.

Gastrointestinal system: diarrhea, nausea, vomiting, constipation, abdominal pain; bitter taste in the mouth, discomfort in the liver area.

Hematological system: increased activity of the blood coagulation system.

The above-mentioned symptoms resolve spontaneously within 24 hours after discontinuation of the drug.

In case of overdose, discontinue the drug. Symptomatic therapy should be administered.

Adverse reactions.

In individual cases, hypersensitivity to the components of the drug may cause allergic reactions, including skin rashes, pruritus, hyperemia, skin edema, angioneurotic edema, urticaria, Stevens-Johnson syndrome, anaphylactic shock. With prolonged use – decreased arterial pressure, hypercoagulation; respiratory difficulty, bronchospasm with obstruction, bronchial asthma, dizziness; arterial hypotension; nausea; vomiting; dry mouth, abdominal pain; constipation or diarrhea. Isolated reports have indicated a possible association with autoimmune disorders (disseminated encephalomyelitis, nodular erythema, immune thrombocytopenia, Evans syndrome, Sjögren-Larsson syndrome with impaired renal tubular function). With prolonged use (over 8 weeks), leukopenia may occur; suppression of emotional responses, drowsiness, reduced work capacity; dizziness, headache; polyuria; sweating, chills; photosensitization (UV exposure should be avoided during treatment).

Shelf life.

3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

100 ml in bottles or jars.

Availability category.

Over-the-counter.

Manufacturer.

JSC "Biolic".

Manufacturer's location and address of business activity.

131 Sh, Ladizhin, Vinnytsia region, 24321, Ukraine.

Applicant.

LLC "Ukrainian Pharmaceutical Company".

Applicant's location.

1 U Starosilskа St., Kyiv, 02660, Ukraine.