Mastodinon

PATIENT LEAFLET: INFORMATION FOR THE USER

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Mastodynon, tablets

Homeopathic medicinal product with therapeutic indications

Mastodynon and Мастодинон are the same trade names of the same drug written in Polish and Bulgarian.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• You should consult a pharmacist if advice or additional information is needed.
• If any side effects occur, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist.
• If after 6 weeks there is no improvement or the patient feels worse, you should contact your doctor.

Table of contents of the leaflet:

• 1. What is Mastodynon and what is it used for
• 2. Important information before using Mastodynon
• 3. How to use Mastodynon
• 4. Possible side effects
• 5. How to store Mastodynon
• 6. Contents of the pack and other information

1. What is Mastodynon and what is it used for

Mastodynon, tablets is a homeopathic medicinal product used as a supportive treatment for premenstrual syndrome with symptoms such as mastodynia (breast tenderness), emotional balance disorders, after excluding serious causes of the disorder by a doctor. The medicine is indicated for use in adult women over 18 years of age. If after 6 weeks of taking the medicine there is no improvement or the patient feels worse, you should contact your doctor.

2. Important information before using Mastodynon

When not to use Mastodynon

When to exercise special caution when using Mastodynon

You should consult a doctor:

Children and adolescents

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Due to the lack of sufficient data, Mastodynon should not be used in children and adolescents under 18 years of age.
Mastodynon should not be used in patients who have not yet started regular menstruation during puberty.

Using Mastodynon with other medicines

Due to the possible effect of Vitex agnus-castusfruits on dopamine release (a hormone of the sympathetic nervous system) and female sex hormones, it cannot be excluded that Mastodynon may affect the action of other medicines with similar indications.
You should tell your doctor or pharmacist about all medicines currently being taken or recently taken, as well as about medicines that the patient plans to take.

Using Mastodynon with food and drink

A negative impact on the action of homeopathic medicines may have a generally understood harmful lifestyle, as well as irritating-stimulating substances, such as coffee.

Pregnancy and breastfeeding

There are no indications for the use of the medicine during pregnancy.
Data from reproductive studies suggest that the extract of Vitex agnus-castusfruits may affect lactation. For this reason, the use of the medicine during breastfeeding is not recommended.
Vitex agnus-castusfruits may affect fertility, therefore, in case pregnancy is not planned, the use of contraception is recommended.
If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines

The effect of the medicine on the ability to drive and use machines has not been studied.

Important information about some other ingredients of Mastodynon

Mastodynon, in the form of tablets, contains lactose monohydrate. Therefore, if the patient has intolerance to some sugars, she should consult a doctor before taking the medicine.
Information for diabetics:
One tablet of Mastodynon contains an average of 0.3 g of easily absorbable carbohydrates.
Mastodynon tablets do not contain gluten.

3. How to use Mastodynon

The medicine should always be taken in accordance with the description in the patient leaflet or as directed by a doctor.
In case of doubts, you should consult a doctor or pharmacist.
The recommended dose is:
Orally, 1 tablet, twice a day, in the morning and evening (can be taken with a glass of water).
Mastodynon should be taken for at least 2-3 months - also during menstruation.
If after 6 weeks of taking the medicine the symptoms persist, you should contact your doctor.
If the symptoms return after the end of therapy, you should contact your doctor.
If during therapy with Mastodynon its action seems too strong or too weak, you should consult a doctor.

Use in children and adolescents

Mastodynon should not be used in children and adolescents under 18 years of age.
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Using a higher dose of Mastodynon than recommended

In case of people with lactose intolerance, taking a large amount of the medicine may cause gastrointestinal disorders and a laxative effect.
In case of using a higher dose of Mastodynon than recommended, you should consult a doctor, who will decide on further action.

Missing a dose of Mastodynon

In case of missing a dose at the scheduled time, it should be taken as soon as possible. However, if the time for the next dose is approaching, the missed dose should be skipped.
A double dose should not be taken to make up for the missed dose.

Stopping the use of Mastodynon

Stopping the use of Mastodynon is usually safe.
In case of doubts related to the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Mastodynon can cause side effects, although they may not occur in everyone.
The frequency of the following side effects cannot be classified based on available data:

• severe allergic reactions with facial swelling, shortness of breath, and swallowing disorders
• (allergic) skin reactions (rash and urticaria), acne
• headaches, dizziness
• gastrointestinal disorders (such as nausea, abdominal pain)
• menstrual disorders. In case of the first symptoms of hypersensitivity or allergic reactions, the use of Mastodynon tablets should be stopped immediately. If any side effects occur, including those not listed above, you should consult a doctor or pharmacist.

Warning:

Taking homeopathic medicines may lead to temporary worsening of existing symptoms (initial worsening). In such a case, the therapy should be stopped and a doctor consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Mastodynon

Store in a place inaccessible and invisible to children.
Do not use Mastodynon after the expiry date stated on the packaging.
There are no special precautions for storage.
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Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Mastodynon contains

Active substances:
Vitex agnus-castusTM 162.0 mg
Caulophyllum thalictroidesD4 81.0 mg
Cyclamen purpurascensD4 81.0 mg
Strychnos ignatiiD6 81.0 mg
Iris versicolorD2 162.0 mg
Lilium lancifoliumD3 81.0 mg
Excipients: lactose monohydrate, potato starch, magnesium stearate.

What Mastodynon looks like and what the pack contains

Mastodynon, tablets are packaged in 20 pieces in PVC/PVDC/Aluminum blisters in a cardboard box.
A single cardboard box with printing contains 60, 120, or 240 tablets along with the patient information leaflet.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Bionorica SE
Kerschensteinerstraße 11-15
92318 Neumarkt, Germany

Manufacturer:

Bionorica SE
Kerschensteinerstraße 11-15
92318 Neumarkt, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
License number in Bulgaria, the country of export: 20050035

Parallel import license number: 161/25

Date of approval of the leaflet: 30.04.2025

[Information about the trademark]
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