SOLIDAGOREN

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOLIDAGOREN® (SOLIDAGOREN®)

Composition:

Active substance: liquid extract from a mixture of the herb of giant goldenrod (Solidago gigantea Aiton) or Canadian goldenrod (Solidago canadensis L.), goosegrass cinquefoil herb (Potentilla anserina L.), and field horsetail herb (Equisetum arvense L.);

10 ml of the preparation contain 7.9 ml of liquid extract (1 : 1.5–2.1) from a mixture of the herb of giant goldenrod (Solidago gigantea Aiton) or Canadian goldenrod (Solidago canadensis L.), goosegrass cinquefoil herb (Potentilla anserina L.), and field horsetail herb (Equisetum arvense L.) (4.2 : 1.4 : 1), extracted with 50% ethanol (v/v);

Excipients: purified water, ethanol 96%.

Pharmaceutical form. Oral drops.

Main physicochemical characteristics: clear brown liquid.

Pharmacotherapeutic group.

Agents used in urology. ATC code G04B.

Pharmacological properties.

Pharmacodynamics. Studies have not been conducted.

Pharmacokinetics. Studies have not been conducted.

Clinical characteristics.

Indications.

Acute and chronic urinary tract infections (cystitis, pyelonephritis) of mild to moderate severity as part of complex therapy.

Prevention of urinary bladder stone formation, including after their removal.

Contraindications.

Hypersensitivity to the active substance or to any other component of the medicinal product. Solidago cannot be used in cases of allergy to plants of the Asteraceae family (Asteraceae), as these plants are used in the production of the herbal extract contained in the medicinal product.

Severe cardiac and renal insufficiency, edema due to cardiac and/or renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

Cases of interaction with other medicinal products are unknown.

Due to the presence of ethanol in this medicinal product, an effect on the action of other drugs is possible.

Special precautions for use.

It is contraindicated to use Solidagoren as a diuretic for the treatment of edema caused by cardiac or renal insufficiency, especially in elderly patients.

If blood appears in the urine, high body temperature occurs, or if symptoms persist for more than 5 days, it is recommended to consult a physician.

The medicinal product contains 45% (v/v) ethanol. With each dose (30 drops), 0.6 g of ethanol enters the body. Therefore, this medicinal product is harmful for patients suffering from alcoholism. Caution should be exercised when administering to pregnant and breastfeeding women, children, patients with liver disorders, and patients with epilepsy.

Use during pregnancy or breastfeeding.

The medicinal product is not recommended for use during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

When used at recommended doses, the product does not affect reaction speed.

Dosage and Administration.

For adults and children aged 12 years and older, take orally 20–30 drops of Solidagoren with 100–200 ml of water, three times daily. 30 drops correspond to 1.4 ml of the medicinal product.

Daily fluid intake during Solidagoren treatment should be at least 1.5–2 liters.

The duration of treatment with the medicinal product is determined by a physician and depends on the course and severity of the disease. If symptoms do not improve, or if any adverse reactions occur, the use of this medicinal product must be discontinued and medical advice should be sought.

Children.

The medicinal product must not be used in children under 12 years of age.

Overdose.

No reports available. In case of overdose, adverse reactions may be intensified.

Side effects.

Very rarely, hypersensitivity reactions and allergic reactions are observed. Mild gastrointestinal disturbances are possible (frequency unknown).

If the first signs of hypersensitivity reaction occur (e.g. rash), administration of the medicinal product should be discontinued.

If adverse reactions not listed in this instruction appear, consult a physician.

Shelf life.

3 years.

After opening the bottle – 3 months.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

20 ml, or 50 ml, or 100 ml in a bottle with dropper; 1 bottle in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Dr. Gustav Klein GmbH & Co. KG

Manufacturer's address and location of business activity.

Steinenfeld 3, 77736 Zell am Harmersbach, Germany.