Mastodynon

Warning! Keep the package leaflet! Information on the immediate packaging in a foreign language.
Mastodynon (Mastodynon)
tablets
Mastodynon and Mastodynon are the same names of the same medicinal product written in Polish
and Bulgarian.
Homeopathic medicinal product with specified therapeutic indications.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used in accordance with the instructions provided in the patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in the leaflet, inform your doctor or pharmacist.
• If there is no improvement after 6 weeks of treatment, or if the patient feels worse, consult a doctor.

Table of contents of the leaflet :

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

1. What is Mastodynon and for what purposes is it used

Mastodynon, tablets is a homeopathic medicinal product used as supportive treatment in
premenstrual syndrome with symptoms such as: mastodynia (breast pain),
emotional imbalance, after serious underlying causes have been excluded by a physician.
This medicine is indicated for use in adult women over 18 years of age.
If there is no improvement after 6 weeks of treatment, or if the patient feels worse, consult a doctor.

2. Important information before using Mastodynon

When not to use Mastodynon

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

When to exercise special caution when using Mastodynon
Consult a doctor:

• if the patient suffers or has suffered from estrogen-dependent cancer
• if the patient is taking medications affecting dopamine secretion (a hormone of the sympathetic nervous system) or undergoing hormonal therapy
• if symptoms worsen during treatment with Mastodynon
• if the patient has previously suffered from pituitary gland disorders
• if symptoms are of unclear, recurrent or chronic nature, as they may stem from a condition requiring more detailed diagnosis.

Children and adolescents
Due to insufficient 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.

Use of Mastodynon with other medicines
Since Vitex agnus-castus fruit extract may influence dopamine secretion (a hormone of the sympathetic nervous system) and female sex hormones, an interaction between Mastodynon and other medications with similar indications cannot be excluded.
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Use of Mastodynon with food and drink
Generally harmful lifestyle habits as well as irritant-stimulating substances such as coffee may negatively affect the action of homeopathic medicines.

Pregnancy and breastfeeding
There are no indications for using this medicine during pregnancy.
Fertility studies suggest that Vitex agnus-castus fruit extract may affect lactation. Therefore, use during breastfeeding is not recommended.
Vitex agnus-castus fruit may affect fertility; therefore, if pregnancy is not planned, contraception is advised.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
The effect of Mastodynon on the ability to drive vehicles and operate machinery has not been studied.

Important information about certain other ingredients in Mastodynon
Mastodynon tablets contain monohydrate lactose. Therefore, if the patient has intolerance to certain sugars, she should consult a doctor before taking the medicine.
Information for diabetics:
One Mastodynon tablet contains on average 0.3 g of readily assimilable carbohydrates.
Mastodynon tablets do not contain gluten.

3. How to use Mastodynon

The medicine should always be taken according to the instructions in the patient leaflet or as directed by a physician.
In case of doubt, consult a doctor or pharmacist.
Recommended dosage:
Patients      Single dose      Daily dose
Adult women     1 tablet          2 tablets
Orally, 1 tablet twice daily in the morning and evening (can be taken with water – e.g. a glass of water).
Mastodynon should be taken for at least 2–3 months – including during menstruation.
If symptoms persist after 6 weeks of treatment, consult a doctor.
If symptoms return after completion of therapy, consult a doctor.
If during treatment with Mastodynon the effect seems too strong or too weak, consult a doctor.

Use in children and adolescents
Mastodynon must not be used in children and adolescents under 18 years of age.

Overdose of Mastodynon
In individuals with lactose intolerance, ingestion of a large amount of the medicine may cause gastrointestinal disturbances and a laxative effect.
In case of overdose of Mastodynon, consult a doctor who will decide on further management.

Missed dose of Mastodynon
If a dose is missed at the scheduled time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Discontinuation of Mastodynon
Discontinuation of Mastodynon is usually safe.
In case of any doubts regarding use of the medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Mastodynon may cause adverse reactions, although not everyone experiences them.
The frequency of occurrence of the following adverse reactions cannot be classified based on available data:

• severe allergic reactions with facial swelling, dyspnea, and swallowing difficulties
• (allergic) skin reactions (rash and urticaria), acne
• headaches, dizziness
• gastrointestinal disturbances (such as nausea, abdominal pain)
• menstrual disorders

If any signs of hypersensitivity or allergic reactions occur, treatment with Mastodynon tablets should be discontinued immediately. If any adverse reactions occur, including those not listed above, consult a physician or pharmacist.

Note:
Taking homeopathic medicines may lead to a temporary worsening of existing symptoms (initial aggravation). In such a case, therapy should be discontinued and medical advice sought.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Mastodynon

Keep this medicine 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 stated month.
There are no special requirements regarding storage conditions for this medicinal product.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Mastodynon contains
Active substances:
Vitex agnus- castus TM 162.0 mg
Caulophyllum thalictroides D4 81.0 mg
Cyclamen purpurascens D4 81.0 mg
Strychnos ignatii D6 81.0 mg
Iris versicolor D2 162.0 mg
Lilium lancifolium D3 81.0 mg
Excipients: monohydrate lactose, potato starch, magnesium stearate.

What Mastodynon looks like and contents of the pack
Mastodynon tablets are packed in PVC/PVDC/Aluminium blisters containing 20 tablets each.
A single cardboard box with printed label contains 60 or 120 tablets together with the patient information leaflet.

For more detailed information about this medicinal product, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Bulgaria, 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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Bulgaria, country of export: 20050035
Parallel Import Licence Number: 337/24