SIMIDONA UNO

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CIMIDONA UNO (Cimidona®uno)

Composition:

Active substance: 1 tablet contains 6.5 mg of dry extract of rhizomes of black cohosh (Cimicifugae rhizoma), native dry extract (4.5–8.5:1), extraction solvent – ethanol 60% (v/v);

Excipients: povidone; sodium croscarmellose; microcrystalline cellulose; lactose monohydrate; magnesium stearate; colloidal anhydrous silicon dioxide.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: round, biconvex tablets of yellow-beige color with a characteristic odor; brown specks may be visible.

Pharmacotherapeutic group. Sex hormones and agents affecting the reproductive system. Other agents used in gynecology. Cimicifuga preparations. ATC code G02CX04.

Pharmacological properties.

The drug promotes alleviation or complete disappearance of disease symptoms during the premenopausal and menopausal periods. Simidona Uno also exhibits sedative properties and positively affects the autonomic nervous system and mental status.

Clinical characteristics.

Indications.

For relief of symptoms during menopause (hot flashes, excessive sweating, sleep disturbances, increased irritability, and mood swings).

Contraindications.

Individual hypersensitivity to the active substance, to other components of the medicinal product, or to other plants of the family Ranunculaceae (Ranunculus family). Estrogen-dependent tumors. Pregnancy and breastfeeding.

Special precautions.

Cimifuga uno affects physical and psychological disorders during menopause. Since there are currently no clinical data on a beneficial effect on bones, this medicinal product should not be used for the prevention of osteoporosis.

Discontinue Cimifuga uno immediately if signs of liver damage occur (jaundice (including yellowing of the sclera), dark urine or changes in stool color, weakness or loss of appetite, and unintended weight loss, unusual fatigue). Cimifuga uno should not be used in case of existing liver damage.

The product contains lactose (44 mg); therefore, patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome should not take this medicinal product.

Consult a physician if experiencing breast tension or swelling, intermenstrual bleeding, or onset or recurrence of menstrual bleeding.

If symptoms do not resolve during treatment, consult a physician.

Concomitant use of estrogens is possible only under medical supervision due to the potential for enhanced estrogenic effects.

Note for diabetic patients. The product contains approximately 44 mg of readily absorbable carbohydrates per dose.

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

Interaction with other medicinal products and other forms of interaction.

There are no data on clinically significant interactions of Cimicifuga rhizome extract with other medicinal products. However, data exist regarding enhanced estrogenic effects when Cimicifuga products are used concomitantly with estrogens.

Usage notes.

Use during pregnancy or breastfeeding.

Due to insufficient studies that could exclude a potential risk with adequate certainty, Simidona Uno should not be used during pregnancy or breastfeeding (see section "Contraindications").

Ability to influence reaction speed when driving or operating machinery.

Appropriate studies have not been conducted.

Dosage and Administration.

Unless otherwise prescribed by a physician, the recommended dose is 1 tablet once daily, preferably at the same time each day (in the morning or evening).

The tablets should be swallowed whole with sufficient liquid and not chewed.

Do not take a double dose if you miss a dose.

Therapeutic effect does not occur immediately. The recommended treatment duration is 6 weeks. Do not use the drug for longer than 6 months without consulting a physician.

Children.

This medicine is not intended for use in children.

Overdose.

Cases of overdose have not been reported.

If you have taken a dose significantly higher than recommended, seek medical advice immediately.

Adverse reactions.

The following adverse reactions have been reported with the use of Simidone Uno:

Immune system: facial and body swelling (frequency unknown).

Gastrointestinal tract: rare reports of stomach complaints, nausea, dyspeptic symptoms, and diarrhea.

Liver and biliary system: isolated cases of severe partial liver damage have been reported (e.g., abnormal liver function biochemical parameters, jaundice, hepatitis).

Skin: rash, pruritus, urticaria (frequency unknown).

Reproductive system and breast: in isolated cases, breast tension and breast swelling, slight vaginal bleeding, intermenstrual bleeding, and recurrence of menstrual bleeding may occur.

Shelf life.

3 years.

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

Storage conditions.

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

Packaging.

30 tablets in a blister, 1 or 3 blisters per cardboard box.

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

Manufacturer.

Max Celler Soehne AG

Max Zeller Sohne AG

Manufacturer's address.

Seeblickstrasse 4, 8590 Romanshorn, Switzerland

Seeblickstrasse 4, 8590 Romanshorn, Switzerland

Marketing authorization holder.

Amaxa Ltd

Amaxa Ltd

Address of the marketing authorization holder.

31 John Islip Street, London SW1P 4FE, United Kingdom

31 John Islip Street, London SW1P 4FE, United Kingdom