Mastodynon drops oral

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

agnus castus D1, blue cohosh D4, european cyclamen D4, strychnos ignatia D6, iris versicolor D2, tiger lily D3

Available from:

Bionorica SE

ATC code:

G02CX

INN (International Name):

agnus castus D1, blue cohosh D4, european cyclamen D4, strychnos ignatia D6, iris versicolor D2, tiger lily D3

Dosage:

0.2g/g+ 0.1g/g+ 0.1g/g+ 0.1g/g+ 0.2g/g+ 0.1g/g

Pharmaceutical form:

drops oral

Units in package:

50ml glass bottle

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-02-08

Patient Information leaflet

INFORMATION LEAFLET
MASTODYNON
®
COMPOSITION:
100 grams of drops contain:
Vitex agnus castus D1
(Lilac chaste tree or monk’s pepper tree)
20 g
Caulophyllum thalictroides D4 (Blue cohosh)
10 g
Cyclamen purpurascens D4
(European cyclamen)
10 g
Strychnos Ignatia D6
(Ignatia)
10 g
Iris versicolor D2
(Iris)
20 g
Lilium tigrinum D3
(Tiger lily)
10 g
Ethanol content:
53% (by volume)
DESCRIPTION:
Clear, pale yellow liquid; sweet-smelling odor; initially sweet, then
acrid, bitter.
THERAPEUTIC INDICATIONS
For symptomatic treatment in the complex therapy of:
- premenstrual syndrome (breast tension, mental lability,
constipation, edemas, headache/migraine)
- cyclic mastodynia
- mastopathy
- menstrual cycle disorders
CONTRAINDICATIONS:
Hypersensitivity to Vitex agnus castus and/or Caulophyllum
thalictroides and/or Cyclamen purpurascens
and/or Strychnos ignatia and/or Iris versicolor and/or Lilium tigrinum
or to any of the excipients of the
medicinal product.
METHOD OF ADMINISTRATION AND DOSAGE:
Take 30 drops twice a day (morning and evening), diluting them with a
little water or other liquid.
Mastodynon
®
should be taken for at least 3 months, including during menstruation.
Improvement
generally begins after 6 weeks. If symptoms return after the
medication is discontinued, treatment should
be continued after consulting with the attending physician.
Shake before using!
IF YOU TAKE MORE MASTODYNON THAN YOU SHOULD:
No case of overdose has been reported.
IF YOU FORGET TO USE MASTODYNON:
If you have forgotten to take one dose, take it as soon as you
remember. However, if it is almost time for
the next dose, take only this one. Do not take a double dose to make
up for a forgotten dose.
IF YOU STOP USING MASTODYNON:
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
SIDE EFFECTS:
The frequency of the following possible side effects cannot be
estimated from the available data:
- Severe allergic reactions with face swelling, dyspnoea and
swallowing difficulties
- Allergic skin reactions (r

Summary of Product characteristics

SPC Mastodynon

oral drops
page 1/5
Feb 2017
SUMMARY OF PRODUCT CHARACTERISTICS
MASTODYNON

ORAL DROPS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Mastodynon

oral drops
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
10 g (10.8 ml) Mastodynon

oral drops contain:
_Active ingredients: _
2.0 g
Vitex agnus castus

1.0 g
Caulophyllum thalictroides (HAB 34) Dil. D4 (HAB; V.3a)
1.0 g
Cyclamen purpurascens Dil. D4
1.0 g
Strychnos ignatia Dil. D6
2.0 g
Iris versicolor Dil. D2
1.0 g
Lilium tigrinum Dil. D3
_Other ingredients: _
Mastodynon

oral drops contains ethanol: 53 % [v/v]
3.
PHARMACEUTICAL FORM
Oral drops, solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For symptomatic treatment in the complex therapy of:
-premenstrual
syndrome
(breast
tension,
mental
lability,
constipation,
edemas,
headache/migraine)
-cyclic mastodynia
-mastopathy
-menstrual cycle disorders
Relevant information:
In case of persistent, unclear or recurrent complaints a physician
should be consulted since these
may be illnesses requiring medical clarification.
SPC Mastodynon

oral drops
page 2/5
Feb 2017
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Unless otherwise prescribed: 30 Mastodynon

oral drops twice a day diluted with some water (in
the morning and in the evening).
Mastodynon

oral drops should be taken for at least 3 months, also during
menstruation.
An improvement happens usually after 6 weeks. If complaints reappear
after discontinuation of
intake the therapy should be continued after consulting the attending
physician.
The drops may be administered together with other liquids. Due to the
good tolerability the
medicine is suitable for a long-term therapy.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
of the medicinal product.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients who suffer or suffered from an oestrogen-sensitive cancer
should consult their doctor
before using Vitex agnus castus.
Patients who are using dopamine agonists, dopamine antagonists,
oest