Mastodinon

PATIENT INFORMATION LEAFLET

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Mastodynon(Мастодинон)
tablets
Mastodynon and Мастодинон are the same names of the same drug written in Polish and Bulgarian.

Homeopathic medicinal product with therapeutic indications.

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 information leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a pharmacist if you need advice or additional information.
• If you experience any side effects, 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 a 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 packaging 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 using the medicinal product the symptoms persist or the patient feels worse, you should contact a doctor.

2. Important information before using Mastodynon

When not to use Mastodynon

• if the patient has been diagnosed with hypersensitivity (allergy) to the active substances or to any of the excipients (see section 6).

When to exercise special caution when using Mastodynon

You should consult a doctor:

• if the patient has or has had estrogen-dependent cancer
• if the patient is taking medicines that affect dopamine secretion (hormone of the sympathetic nervous system) or is undergoing hormone therapy
• if the symptoms worsen during the use of Mastodynon
• if the patient has a history of pituitary disorders
• if the symptoms have an unclear, recurrent or chronic nature, as they may result from a disease requiring more accurate diagnosis.

Children and adolescents

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 secretion (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 you are currently taking or have recently taken, as well as about medicines you plan 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, it is not recommended to use the medicine during breastfeeding.
Vitex agnus-castusfruits may affect fertility, so in case pregnancy is not planned, it is recommended to use contraception.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your 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 you have an intolerance to some sugars, you should consult your doctor before taking the medicine.
Information for diabetics:
One Mastodynon tablet contains on average 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 information leaflet or as directed by a doctor.
In case of doubts, you should consult a doctor or pharmacist.
The recommended dose is:

Patient Single dose Daily dose

Adult women
1 tablet
2 times a day, 1 tablet
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 using the medicinal product the symptoms persist, you should contact a doctor.
If the symptoms return after the end of therapy, you should contact a doctor.
If during therapy with Mastodynon its effect 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.

Using a higher than recommended dose of Mastodynon

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 than recommended dose of Mastodynon, 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, you should take it as soon as possible. However, if it is close to the time of taking the next dose, you should skip the missed dose.
You should not take a double dose 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 the 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, you should immediately stop using Mastodynon tablets. If you experience any side effects, including those not listed above, you should consult a doctor or pharmacist.

Note:

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

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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, you can help gather more information on the safety of the medicine.

5. How to store Mastodynon

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special precautions for the storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. 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 packaging 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 single cardboard box with printing, there are 60, 120 tablets along with the information leaflet.
To obtain more detailed information about the medicine, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20050035

Parallel import authorization number: 337/24

Date of approval of the leaflet: 09.09.2024

[Information about the trademark]