Instructions for use Abyufen tablets 400 mg blister No. 30
Composition
active ingredient: 1 tablet contains beta-alanine 400 mg;
excipients: magnesium stearate, glycerol palmitostearate, colloidal silicon dioxide, wheat starch.
Dosage form
Pills.
Main physicochemical properties: white tablets with beveled edges.
Pharmacotherapeutic group
Means used in gynecology.
ATX code G02C X.
Pharmacological properties
Pharmacodynamics.
Beta-alanine is a pure amino acid with a chemical structure that is completely different from the hormone. The drug counteracts the sudden release of histamine. However, the drug does not have antihistamine activity (lack of H1-receptor blocking).
Beta-alanine has a direct effect exclusively on cutaneous peripheral vasodilation, which causes autonomic flushing, feelings of warmth, fever, and headache.
At the physiological level, vasomotor flushing is caused by the involvement of thermoregulatory centers in the hypothalamus, which leads to peripheral cutaneous vasodilation. This is the result of a mechanism that comes into play when the balance of cerebral neurotransmitters is disturbed, which occurs after the cessation of ovarian hormone secretion. The drug contributes to the saturation of peripheral neurotransmitter receptors involved in the process.
Indication
Abiufen is indicated for the treatment of hot flashes associated with menopause.
Contraindication
Increased individual sensitivity to the components of the drug.
Wheat allergy (different from celiac disease).
Interaction with other medicinal products and other types of interactions
Not detected.
Application features
The drug is recommended for use in premenopause, menopause of various etiologies, and the postmenopausal period.
Beta-alanine treatment does not exempt from any additional specific treatment.
Beta-alanine does not affect body weight.
No signs of addiction to the drug have been detected. There is no sedative effect.
If symptoms persist, worsen, or new symptoms appear, treatment should be reviewed.
In case of adverse skin reactions (rash, itching), treatment should be discontinued.
Abiufen can be prescribed to patients with celiac disease.
Wheat starch may contain gluten, but in small amounts, so it is considered safe for patients with celiac disease.
Use during pregnancy or breastfeeding
Do not use the drug during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Abyufen is to be used internally. Take 1 to 2 tablets per day (before the main meal). This dose can be increased to 3 tablets per day.
The minimum course of treatment is from 5 to 10 days (until the hot flashes stop).
If hot flashes resume, treatment can be continued throughout the entire period of clinical vasomotor disorders, without any time limit.
Children
The drug should not be used in children.
Overdose
No cases of overdose have been noted.
Side effects
Adverse reactions that have been reported worldwide since the drug was launched on the market and for which there is a reasonable causal relationship are listed below by MedDRA system organ class and frequency: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), very rare < 1/10,000), frequency not determined (cannot be estimated from the available data).
From the nervous system
Very rare: paraesthesia1.
Skin and subcutaneous tissue disorders
Very rare: allergic reactions (rash on the skin and mucous membranes, itching, redness of the skin, hives, bruising).
1 Transient, most often in the extremities.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua
Expiration date
3 years.
Storage conditions
Store out of the reach of children at a temperature not exceeding 25 °C.
Packaging
15 tablets in a blister; 2 or 4 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Bouchard Recordate Laboratories, France.
Location of the manufacturer and its business address
Mechatronic Park, 03410, Saint Victor, France.
Applicant
Bouchard Recordate Laboratories, France.
