Cyclodynon tablets film-coated

দেশ: আর্মেনিয়া

ভাষা: ইংরেজি

সূত্র: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

সক্রিয় উপাদান:

agnus castus dry extract

থেকে পাওয়া:

Bionorica SE

এটিসি কোড:

G02CX

INN (আন্তর্জাতিক নাম):

agnus castus dry extract

ডোজ:

4mg

ফার্মাসিউটিকাল ফর্ম:

tablets film-coated

প্যাকেজ ইউনিট:

(30/2x15/) in blister

প্রেসক্রিপশন টাইপ:

Prescription

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2018-01-10

তথ্য লিফলেট

PATIENT LEAFLET INFORMATION
CYCLODYNON
®
Film-Coated Tablets
ACTIVE SUBSTANCE:
Dry extract from chaste tree fruits (agni casti fructus)
COMPOSITION:
1 film-coated tablet contains 4.0 mg (7-11:1) of dry extract from
chaste tree fruits as active
substance. Extractant: 70% ethyl alcohol (v/v).
OTHER INGREDIENTS:
Povidone, colloidal anhydride of silicum dioxide, potato starch,
microcrystalline cellulose,
lactose monohydrate, macrogol, magnesium stearate, talc, E 171, E 172,
E 132, poly (ethyl
acrylate, methyl acrylate) trimethylamine-acetyl-methacrylate-chloride
1 : 2 : 0.2, molecular
weight - 150 000.
INDICATIONS:
Cyclodynon
®
film-coated tablets constitute the phytogenous therapeutic agent,
which is used for
complex therapy (see interactions with other medicinal products and
other forms of interactions),
in the cases as follows:
-
menstrual cycle disturbances
-
premenstrual syndrome
-
cyclic mastodynia (cyclic breast pain)
In cases of tension and tumescence in the area of mammary glands as
well as with menstrual
disturbances, medical advice should be sought, to investigate whether
there are other diseases
that need additional medical research.
CYCLODYNON
® SHOULD NOT BE USED:
In case of hypersensitivity to the active substance or to any of the
excipients of the medicinal
product.
PRECAUTIONS:
A) PREGNANCY: There is no indication for the use during pregnancy.
Cyclodynon
®
film-coated tablets must not be taken during pregnancy.
B) LACTATION: Data from reproductive studies suggest that extracts of
chaste tree fruit may affect
lactation. Cyclodynon
®
film-coated tablets must not be taken during lactation.
C) EFFECTS ON THE ABILITY TO DRIVE A VEHICLE AND OPERATE MACHINERY:
No studies on the effect on the ability to drive and use machines have
been performed.
SPECIFIC INSTRUCTIONS:
Patients who suffer or suffered from an oestrogen-sensitive cancer
should consult their doctor
before using this medicinal product.
Patients who are using dopamine agonists, dopamine antagonists,
oestrogens and antioestrogens
should consu

পণ্য বৈশিষ্ট্য

Cyclodynon Film-Coated Tablets (096AGF)
SPC Cycldoynon

Film-coated tablets
Page: 1 of 6
April 2016
SUMMARY OF PRODUCT CHARACTERISTICS
CYCLODYNON
 FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Cyclodynon
®
Film-Coated Tablets
Active substance: Dry extract derived from chaste tree fruit
(
agni casti fructus)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains:
4.0 mg dry extract derived from chaste tree fruit (7-11:1);
extracting agent: ethanol 70 % (V/V)
Excipients:
Lactose monohydrate
25.0 mg
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
The film-coated tablets are greenish blue, round, biconvex with dull
surface.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cyclodynon® film-coated tablets constitute the phytogenous
therapeutic agent, which is
used for complex therapy (see interactions with other medicinal
products and other forms
of interactions), in the cases as follows:
Cyclodynon Film-Coated Tablets (096AGF)
SPC Cycldoynon

Film-coated tablets
Page: 2 of 6
April 2016
menstrual cycle disturbances
premenstrual syndrome
cyclic mastodynia (cyclic breast pain)
In cases of tension and tumescence in the area of mammary glands as
well as with
menstrual disturbances, medical advice should be sought, to
investigate whether there are
other diseases that need additional medical research.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Take 1 times daily 1 film-coated tablet.
To achieve an optimal treatment effect, continued use – even during
menstruation over
three months is recommended.
If the symptoms persist after a continued use over three months, a
doctor or a qualified
health care practitioner should be consulted.
The use in children and adolescents under 18 years of age is not
rcommended (see
section 4.4 “Special warnings and precautions for use!).
Swallow film-coated tablets with sufficient liquid (e.g. a glass of
water). Do not chew
tablets.
4.3
CONTRAINDICATIONS
Cyclodynon Film-Coated Tablets must not be taken in case of
hy