Mastodynon

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Mastodynon tablets
Homeopathic medicinal product with therapeutic indications
Mastodynon and Мастодинон are the same brand names of the same medicinal product written in the Polish and Bulgarian languages.
Please read the leaflet carefully before use, 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 require advice or additional information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this 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.

Contents of the leaflet:

1. What Mastodynon is and what it is used for
2. What you need to know before taking Mastodynon
3. How to take Mastodynon
4. Possible side effects
5. How to store Mastodynon
6. Contents of the pack and other information

1. What Mastodynon is and what it is used for

Mastodynon tablets are a homeopathic medicinal product used as supportive treatment in premenstrual tension syndrome with symptoms such as mastodynia (breast pain), emotional imbalance, after a physician has excluded serious underlying causes of these symptoms.
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 particular caution when using Mastodynon
Consult a doctor:

• if the patient currently has or has previously had 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 indicate an underlying condition requiring more thorough diagnosis.

Children and adolescents
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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.

Using Mastodynon with other medicines
Due to the possible influence of Vitex agnus-castus fruit on dopamine secretion (a hormone of the sympathetic nervous system) and female sex hormones, an interaction between Mastodynon and other medicines with similar indications cannot be excluded.
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to take.

Using Mastodynon with food and drink
A generally unhealthy lifestyle, as well as irritant-stimulating substances such as coffee, may negatively affect the efficacy of homeopathic medicines.

Pregnancy and breastfeeding
There are no indications for using Mastodynon during pregnancy.
Fertility studies suggest that the extract from Vitex agnus-castus fruit may affect lactation. Therefore, use of Mastodynon during breastfeeding is not recommended.
Vitex agnus-castus fruit may affect fertility; therefore, if pregnancy is not planned, use of contraception is advised.
If the patient is pregnant, 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 the medicine on the ability to drive 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 an intolerance to certain sugars, she should consult a doctor before taking the medicine.
Information for diabetics:
One tablet of Mastodynon contains on average 0.3 g of readily available carbohydrates.
Mastodynon tablets do not contain gluten.

3. How to use Mastodynon

The medicine should always be taken exactly as described in the patient leaflet or as directed by the physician.
In case of doubt, consult your doctor or pharmacist.
The recommended dose is:

Orally, 1 tablet twice daily, in the morning and evening (can be taken with e.g. a glass of water).
Mastodynon should be taken for at least 2–3 months – also during menstruation.
If symptoms persist after 6 weeks of treatment, consult a doctor.
If symptoms recur after completion of therapy, consult a doctor.
If during Mastodynon treatment its 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.
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Use of a higher than recommended dose of Mastodynon
In individuals with lactose intolerance, ingestion of a large amount of the medicinal product may cause gastrointestinal disturbances and a laxative effect.
In case of administration of a higher than recommended dose of Mastodynon, consult a doctor who will decide on further management.
Missed dose of Mastodynon
If a dose is missed 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 omitted.
Do not take a double dose to make up for the missed dose.
Discontinuation of Mastodynon treatment
Discontinuation of Mastodynon is usually safe.
In case of any doubts concerning the use of the medicinal product, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, 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, shortness of breath, and swallowing difficulties
• (allergic) skin reactions (rash and urticaria), acne
• headache, dizziness
• gastrointestinal disorders (such as nausea, abdominal pain)
• menstrual disturbances

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

Note:
Taking homeopathic medicines may lead to a temporary worsening of existing symptoms (initial aggravation). In such a case, treatment 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:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Mastodynon

Keep out of the reach and sight of children.
Do not use Mastodynon after the expiry date stated on the packaging.
No special storage instructions apply.
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Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package 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, with 20 tablets per blister, placed in a cardboard box.
Each individual cardboard box contains 60, 120 or 240 tablets together with the package leaflet.
For more detailed information, 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

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

Bulgaria, country of export, Marketing Authorisation Number: 20050035
Parallel Import Licence Number: 161/25
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