Instructions for Simidon forte tablets 13 mg blister No. 30
Composition
active ingredients: 1 tablet contains 13 mg of dry extract of black cohosh rhizomes (Cimicifugae rhizoma), dry native extract (4.5-8.5:1), extractant – ethanol 60% (v/v);
Excipients: povidone; croscarmellose sodium; microcrystalline cellulose; lactose monohydrate; magnesium stearate; colloidal anhydrous silicon dioxide.
Dosage form
Pills.
Main physicochemical properties: round biconvex tablets of yellow-beige color with embossing and a characteristic odor, brown inclusions may be visible.
Pharmacotherapeutic group
Sex hormones and agents affecting the reproductive system. Other agents used in gynecology. Cimicifuga preparations. ATX code G02C X04.
Pharmacological properties
The drug helps to reduce or completely eliminate the symptoms of the disease in the pre-menopausal and menopausal periods. Simidona forte also exhibits sedative properties, has a positive effect on the autonomic nervous system and mental status.
Indication
To relieve symptoms during menopause (hot flashes, increased sweating, sleep disturbances, increased irritability and mood swings).
Contraindication
Individual hypersensitivity to the active substance, to other components of the drug or to other plants of the Ranunculaceae family. Estrogen-dependent tumors. Pregnancy and breastfeeding.
Special safety measures.
Simidona forte affects physical and mental disorders during menopause. Since there is currently no clinical data on the positive effect on bones, this drug should not be used for the prevention of osteoporosis.
Immediately discontinue use of Simidona forte if signs of liver damage appear (jaundice (including yellowing of the sclera), dark urine or change in stool color, weakness or loss of appetite and unwanted weight loss, unusual fatigue). Simidona forte should not be used in case of existing liver damage.
The drug contains lactose (44 mg), therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.
You should consult a doctor if you feel breast tenderness and swelling, as well as if you experience bleeding between periods, or if menstrual bleeding occurs or recurs.
If symptoms persist during treatment, you should consult a doctor.
Simultaneous use of estrogens is possible only under the supervision of a doctor, as their effect is likely to be enhanced.
Note for diabetics: The product contains approximately 44 mg of easily digestible carbohydrates per dose.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.
Interaction with other medicinal products and other types of interactions
There are no data on clinically significant interactions of cimicifuga rhizome extract with other drugs, but there is data on the enhancement of the effects of estrogens when used simultaneously with cimicifuga preparations.
Use during pregnancy or breastfeeding
Due to the lack of studies that can exclude the potential risk with sufficient probability, Simidona forte should not be used during pregnancy or breastfeeding (see section "Contraindications").
Ability to influence reaction speed when driving vehicles or other mechanisms
No relevant studies have been conducted.
Method of administration and doses
Unless otherwise prescribed by the doctor, the drug is taken 1 tablet once a day, preferably at the same time (morning or evening).
The tablets should be swallowed without chewing and washed down with sufficient liquid.
You should not take a double dose if you have missed one dose.
The therapeutic effect does not occur immediately. The recommended treatment period is 6 weeks. The drug should not be used for more than 6 months without consulting a doctor.
Children
The drug is not used in children.
Overdose
No cases of overdose have been reported.
If you have used a dose of the drug that significantly exceeds the recommended dose, you should seek medical help.
Adverse reactions
The following adverse reactions have been reported when using Simidon forte:
Immune system disorders: facial and body swelling (frequency unknown).
Gastrointestinal: Rarely, stomach complaints, nausea, dyspepsia and diarrhea have been reported.
Hepatobiliary: isolated cases of partial severe liver damage (e.g. abnormal biochemical liver function tests, jaundice, hepatitis) have been reported.
Skin: rash, itching, urticaria (frequency unknown).
On the part of the reproductive system and chest organs: in some cases, a feeling of tightness in the chest and swelling of the chest, slight spotting, bleeding between the cycles, as well as recurrence of menstrual bleeding are possible.
Expiration date
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 the reach of children.
Packaging
30 tablets in a blister, 1 or 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Max Zeller Söhne AG
Max Zeller Sohne AG
Location of the manufacturer and address of its place of business
Seeblickstrasse 4, 8590 Romanshorn, Switzerland
Seeblickstrasse 4, 8590 Romanshorn, Switzerland
Applicant
Amaxa Ltd.
Amaxa Ltd
Applicant's location
31 John Islip Street, London SW1P 4FE, United Kingdom
31 John Islip Street, London SW1P 4FE, United Kingdom
