REMIFEMIN®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Remifemin®

Composition:

Active substance: dry extract of black cohosh rhizome;

1 tablet contains:

2.5 mg of dry extract of black cohosh rhizome (Cimicifuga racemosa rhizoma) (6–11:1); extraction solvent: 40% isopropyl alcohol (v/v);

Excipients: lactose monohydrate, powdered cellulose, potato starch, magnesium stearate.

Pharmaceutical form. Tablets.

Main physico-chemical properties: round, slightly biconvex tablets, white to beige in color, with a line on one side.

The line is not intended for breaking the tablet.

Pharmacotherapeutic group. Drugs affecting the urinary system and sex hormones. Other drugs used in gynecology. Black cohosh rhizome.

ATC code G02CX04

Pharmacological Properties

Pharmacodynamics. Clinical-pharmacological studies show that psychological and neurovegetative disorders due to menopause (such as hot flashes and profuse sweating) can be alleviated with medicinal products derived from the rhizome of Cimicifuga racemosa.

Pharmacokinetics. Data on pharmacokinetics are lacking.

Clinical Characteristics

Indications. Remifemin® is a herbal medicinal product used to relieve menopausal symptoms such as hot flushes and excessive sweating.

Contraindications. Hypersensitivity to the active substance or to any of the excipients contained in the medicinal product.

Interaction with other medicinal products and other forms of interaction. There is currently no information available regarding interactions. Interaction studies have not been conducted.

Special precautions for use.

Remifemin® should be used with caution in patients with existing or past liver disease. If signs and symptoms indicating liver damage occur (loss of appetite, fatigue, yellowing of the skin or eyes, severe pain in the upper abdomen with nausea and vomiting, or dark urine), the patient must immediately discontinue Remifemin® and consult a physician.

In case of menstrual cycle disturbances or recurrence of menstruation, as well as if unexplained symptoms do not resolve or new symptoms appear, a physician should be consulted, as these disorders may require medical evaluation.

Medicinal products containing black cohosh should not be taken concomitantly with estrogens without prior medical consultation.

Patients who have been treated or are currently being treated for breast cancer or other hormone-dependent tumors should not use black cohosh preparations without consulting a physician.

If symptoms worsen during treatment with this medicinal product, the patient should consult a physician.

If a patient has been diagnosed with intolerance to certain sugars, she should consult a physician before taking this medicinal product.

Use during pregnancy and breastfeeding

Use during pregnancy

There are no data on the use of Remifemin® in pregnant women.

The use of Remifemin® during pregnancy is not recommended.

Women of reproductive potential

Women of reproductive potential should consider using an effective method of contraception during treatment.

Use during lactation

It is unknown whether active substance components or their metabolites are excreted in breast milk. Remifemin® must not be used during lactation.

Effect on ability to drive and use machinery. The negative impact of Remifemin® on the ability to drive or operate machinery is unknown.

Method of administration and dosage. For adult women in menopause: take Remifemin® twice daily, one tablet in the morning and one in the evening.

No dose adjustment recommendations are available in case of renal or hepatic impairment.

Tablets should be taken orally with a small amount of liquid; do not chew or suck. Can be taken independently of food intake.

Remifemin® does not produce immediate pharmacological effects: symptom relief occurs no earlier than 2 weeks after starting treatment. Remifemin® should not be used for longer than 6 months without medical consultation.

This medicinal product is not intended for use in males.

Pediatric population. This medicinal product is not intended for use in children (under 18 years of age).

Overdose. No cases of overdose have been reported.

In case of overdose with Remifemin®, adverse effects listed below may be intensified.

Side effects

The following frequency categories are used to describe the incidence of side effects:

Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1000)
Very rare (< 1/10,000)
Not known: frequency cannot be estimated from the available data.

The following adverse reactions may occur during use of this medicinal product (frequency not known): facial swelling or peripheral edema, skin allergic reactions (urticaria, pruritus, rash), gastrointestinal disorders (dyspepsia, diarrhea).

There have been reports of negative effects of Cimicifuga on liver function: hepatitis, jaundice, increased levels of liver transaminases (frequency not known).

In such cases, the medication should be discontinued immediately and medical advice should be sought urgently.

Reporting of suspected adverse reactions after marketing authorization is highly important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua

Shelf life: 3 years.

Storage conditions: Store at a temperature not exceeding 25 °C. Keep the blister in the cardboard box to protect from light.
Keep out of reach and sight of children.

Packaging: 20 tablets in a blister, 3 or 5 blisters per cardboard box.

Supply classification: Over-the-counter (without prescription).

Manufacturer: Schaper & Brümmer GmbH & Co. KG

Manufacturer's address and location of operations:
Bahnhofstraße 35,
38259 Salzgitter,
Germany

Marketing Authorization Holder: Schaper & Brümmer GmbH & Co. KG

Address of the Marketing Authorization Holder:
Bahnhofstraße 35,
38259 Salzgitter,
Germany