The instruction
for medical use
of Tsiklodinon medicine
A trade name
Tsiklodinon
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
of the Tablet, coated
Structure
One tablet contains
active agent - a summer cypress of ordinary extract of fruits of dry 20 mg from: summer cypress of ordinary extract of fruits native dry (7 11: 1) - 4 mg and povidone of 30 - 16 mg
excipients: silicon dioxide colloidal anhydrous, potato starch, lactoses monohydrate, cellulose microcrystalline, magnesium stearate
cover: talc, the titan dioxide (E 171), gland (III) oxide yellow (E 172), indigo carmine (E 132), a macrogoal-6000, methacrylic acid and ethyl acrylate copolymer (eudragit RL 30 D)
the Description
of the Tablet of round shape, with a biconvex surface,
Other drugs covered with an opaque cover of green-blue color Pharmacotherapeutic group for treatment of gynecologic diseases
the ATX G02CX Code
the Pharmacological
Pharmacokinetics According to the International Convention properties (EMEA/HMPWG/11/99) when conducting clinical trials of drugs of plant origin is not required the isolated research of pharmacokinetic parameters.
A pharmacodynamics
Not clinical experiments showed that aqueous-alcoholic Vitex agnus castus (VAC) extract contains the components possessing dofaminergichesky and prolactin in the drug Tsiklodinon - the inhibiting activity. Bicyclic diterpenes were defined as group of the substances promoting the action directed to decrease in products of prolactin. High level of prolactin breaks secretion of gonadotrophins, therefore there can be disturbances during the maturing of follicles, an ovulation and forming of a yellow body that conducts further to an imbalance between oestradiol and progesterone and can cause disturbances of a menstrual cycle and a mastodynia. Unlike estrogen and other hormones, prolactin has also promoting effect on proliferative processes in mammary glands, strengthening formation of connective tissue and causing expansion of milk channels. Decrease in content of prolactin leads to involution of pathological processes in mammary glands and stops a pain syndrome. Cyclic production of gonadotropic hormones and normalization of their ratio leads to normalization of the second phase of a menstrual cycle. Some clinical trials showed that prescribing of extract of a summer cypress of ordinary (Agnus castus) to women with easy manifestation of the increased concentration of prolactin or with the increased release of prolactin in the conditions of a stress (so-called latent giperprolaktinemiya) led to decrease in levels of prolactin. The Dofaminergichesky effect offers a plausible explanation to therapeutic success of the drugs containing Vitex agnus castus at disturbances of a menstrual cycle, at premenstrual complaints and a cyclic mastodynia.
Indications
- disturbances of a menstrual cycle
- a premenstrual syndrome
- a mastodynia
the Route of administration and doses.
Tablets, coated, accept inside on 1 tablet once a day, in the morning, without chewing, washing down with enough liquid (for example a glass of water)
Treatment is carried out within 3 months, without interruption during periods
Side effects
With an unknown frequency
- from central nervous system: a headache, dizziness,
- from a GIT: nausea, an abdominal pain,
- heavy allergic reactions with a face edema, short wind and the complicated
swallowing,
- rash, urticaria, an acne
in case of any of the listed side effects stop administration of drug and see
a doctor Protivopokazaniya
- pregnancy and the period of a lactation
- hypersensitivity on active, or on any of auxiliary components of this medicine
- hereditary intolerance of a galactose, insufficiency of lactase or malabsorption of glucose and a galactose
Medicinal interactions
In case the patient accepts other medicines it is necessary to report about it to the attending physician. Because of possible dofaminergichesky and estrogenic effects of extract of fruits of a summer cypress ordinary strengthening of effect of agonists of dopamine and estrogen, and lowering of pharmacological action of antagonists of dopamine and anti-estrogen
Special instructions Use for patients with diabetes
1 tablet Tsiklodinon (single dose) is possible contains less than 0.01 grain units (GU) that does not influence glucose level at patients with diabetes.
Tsiklodinon tablets contain lactose therefore it is not recommended to patients with hereditary intolerance of a galactose, insufficiency of lactase or malabsorption of glucose and a galactose.
Patients who suffer or suffered from estrogen - a dependent tumor, diseases of a hypophysis have to consult with the doctor before drug use.
Patients, the accepting dopamine agonists, antagonists of dopamine, estrogen and anti-estrogen have to consult with the doctor before use of drug
there Are no sufficient data on use of drug for children and teenagers up to 18 years.
If symptoms, such as stethalgia, premenstrual syndrome, disturbances of a menstrual cycle, worsen at medicine use, it is necessary to consult with the doctor.
Active component of the drug Vitex Agnus Castus has effect on a hypophysis hypothalamus therefore the patients having in the anamnesis of disorder of a hypophysis have to consult with the doctor before drug use.
In those a case prolactin - the producing hypophysis tumor at the use of the medicines containing Vitex Agnus castus, symptoms of a tumor can be hidden.
Important note:
Please note that with establishment of regularity of a menstrual cycle the probability to become pregnant can increase.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
At use in the recommended doses, drug does not affect ability to driving of motor transport and control of mechanisms
Overdose
Cases of overdose are unknown.
If you accepted a high dose of Tsiklodinon, than it is required, report about it to the doctor. He can take if necessary the appropriate measures
the Form of release and packing
On 15 tablets in blister strip packaging from aluminum foil (top side) and films from PVC, PE, PVDH (bottom side).
On the 2 or 4 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place at a temperature not over 25C.
To store out of children's reach!
A period of storage
3 years
not to use after term
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Bionorica SE/Bionorik XIE/g Representation of Almaty, Central post office, p.o. box No. 200, ph. 250-93-99
e-mail specified on packing Prescription status Without prescription the Producer Bionorika XIE, D-92308 of Noymarkt / Germany the Owner of the registration certificate Bionorika XIE, D-92308 of Noymarkt / Germany: info@bionorica.kz
for medical use
of Tsiklodinon medicine
A trade name
Tsiklodinon
Mezhdunarodnoye the unlicensed name
Is not present
the Dosage form
of the Tablet, coated
Structure
One tablet contains
active agent - a summer cypress of ordinary extract of fruits of dry 20 mg from: summer cypress of ordinary extract of fruits native dry (7 11: 1) - 4 mg and povidone of 30 - 16 mg
excipients: silicon dioxide colloidal anhydrous, potato starch, lactoses monohydrate, cellulose microcrystalline, magnesium stearate
cover: talc, the titan dioxide (E 171), gland (III) oxide yellow (E 172), indigo carmine (E 132), a macrogoal-6000, methacrylic acid and ethyl acrylate copolymer (eudragit RL 30 D)
the Description
of the Tablet of round shape, with a biconvex surface,
Other drugs covered with an opaque cover of green-blue color Pharmacotherapeutic group for treatment of gynecologic diseases
the ATX G02CX Code
the Pharmacological
Pharmacokinetics According to the International Convention properties (EMEA/HMPWG/11/99) when conducting clinical trials of drugs of plant origin is not required the isolated research of pharmacokinetic parameters.
A pharmacodynamics
Not clinical experiments showed that aqueous-alcoholic Vitex agnus castus (VAC) extract contains the components possessing dofaminergichesky and prolactin in the drug Tsiklodinon - the inhibiting activity. Bicyclic diterpenes were defined as group of the substances promoting the action directed to decrease in products of prolactin. High level of prolactin breaks secretion of gonadotrophins, therefore there can be disturbances during the maturing of follicles, an ovulation and forming of a yellow body that conducts further to an imbalance between oestradiol and progesterone and can cause disturbances of a menstrual cycle and a mastodynia. Unlike estrogen and other hormones, prolactin has also promoting effect on proliferative processes in mammary glands, strengthening formation of connective tissue and causing expansion of milk channels. Decrease in content of prolactin leads to involution of pathological processes in mammary glands and stops a pain syndrome. Cyclic production of gonadotropic hormones and normalization of their ratio leads to normalization of the second phase of a menstrual cycle. Some clinical trials showed that prescribing of extract of a summer cypress of ordinary (Agnus castus) to women with easy manifestation of the increased concentration of prolactin or with the increased release of prolactin in the conditions of a stress (so-called latent giperprolaktinemiya) led to decrease in levels of prolactin. The Dofaminergichesky effect offers a plausible explanation to therapeutic success of the drugs containing Vitex agnus castus at disturbances of a menstrual cycle, at premenstrual complaints and a cyclic mastodynia.
Indications
- disturbances of a menstrual cycle
- a premenstrual syndrome
- a mastodynia
the Route of administration and doses.
Tablets, coated, accept inside on 1 tablet once a day, in the morning, without chewing, washing down with enough liquid (for example a glass of water)
Treatment is carried out within 3 months, without interruption during periods
Side effects
With an unknown frequency
- from central nervous system: a headache, dizziness,
- from a GIT: nausea, an abdominal pain,
- heavy allergic reactions with a face edema, short wind and the complicated
swallowing,
- rash, urticaria, an acne
in case of any of the listed side effects stop administration of drug and see
a doctor Protivopokazaniya
- pregnancy and the period of a lactation
- hypersensitivity on active, or on any of auxiliary components of this medicine
- hereditary intolerance of a galactose, insufficiency of lactase or malabsorption of glucose and a galactose
Medicinal interactions
In case the patient accepts other medicines it is necessary to report about it to the attending physician. Because of possible dofaminergichesky and estrogenic effects of extract of fruits of a summer cypress ordinary strengthening of effect of agonists of dopamine and estrogen, and lowering of pharmacological action of antagonists of dopamine and anti-estrogen
Special instructions Use for patients with diabetes
1 tablet Tsiklodinon (single dose) is possible contains less than 0.01 grain units (GU) that does not influence glucose level at patients with diabetes.
Tsiklodinon tablets contain lactose therefore it is not recommended to patients with hereditary intolerance of a galactose, insufficiency of lactase or malabsorption of glucose and a galactose.
Patients who suffer or suffered from estrogen - a dependent tumor, diseases of a hypophysis have to consult with the doctor before drug use.
Patients, the accepting dopamine agonists, antagonists of dopamine, estrogen and anti-estrogen have to consult with the doctor before use of drug
there Are no sufficient data on use of drug for children and teenagers up to 18 years.
If symptoms, such as stethalgia, premenstrual syndrome, disturbances of a menstrual cycle, worsen at medicine use, it is necessary to consult with the doctor.
Active component of the drug Vitex Agnus Castus has effect on a hypophysis hypothalamus therefore the patients having in the anamnesis of disorder of a hypophysis have to consult with the doctor before drug use.
In those a case prolactin - the producing hypophysis tumor at the use of the medicines containing Vitex Agnus castus, symptoms of a tumor can be hidden.
Important note:
Please note that with establishment of regularity of a menstrual cycle the probability to become pregnant can increase.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
At use in the recommended doses, drug does not affect ability to driving of motor transport and control of mechanisms
Overdose
Cases of overdose are unknown.
If you accepted a high dose of Tsiklodinon, than it is required, report about it to the doctor. He can take if necessary the appropriate measures
the Form of release and packing
On 15 tablets in blister strip packaging from aluminum foil (top side) and films from PVC, PE, PVDH (bottom side).
On the 2 or 4 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place at a temperature not over 25C.
To store out of children's reach!
A period of storage
3 years
not to use after term
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Bionorica SE/Bionorik XIE/g Representation of Almaty, Central post office, p.o. box No. 200, ph. 250-93-99
e-mail specified on packing Prescription status Without prescription the Producer Bionorika XIE, D-92308 of Noymarkt / Germany the Owner of the registration certificate Bionorika XIE, D-92308 of Noymarkt / Germany: info@bionorica.kz
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