MASTODYNON

MASTODYNON tablets

Important notes (mandatory information)

Mastodynon Tablets Areas of application: Premenstrual symptoms, such as tension and swelling in the breasts (mastalgia); symptoms during menstruation and irregular menstrual bleeding (cycle disorders).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


Patient information: Information for the user
Mastodynon Tablets

For use in adults. Read the entire patient information carefully because it contains important information for you. This medicine is available without a prescription. However, Mastodynon Tablets must be used as directed to ensure the best possible treatment outcome.
- Keep the patient information. You may want to read it again later.
- Ask your doctor or pharmacist if you need more information or advice.
- If your symptoms worsen or do not improve after about 6 - 8 weeks, you must see a doctor.
- If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this patient information, please inform your doctor or pharmacist.

This patient information includes

1. WHAT ARE MASTODYNON TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MASTODYNON TABLETS?
3. HOW TO TAKE MASTODYNON TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MASTODYNON TABLETS BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE MASTODYNON TABLETS AND WHAT ARE THEY USED FOR?

Mastodynon Tablets are a homeopathic medicine for gynaecology. The areas of application are derived from the homeopathic drug profiles. These include

- Premenstrual symptoms, such as tension and swelling in the breasts (mastalgia)
- Symptoms during menstruation and irregular menstrual bleeding (cycle disorders).
In case of persistent, unclear or recurring symptoms, a doctor should be consulted, as it may be a condition that requires medical treatment.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MASTODYNON TABLETS?
Mastodynon Tablets MUST NOT be taken if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients (see section 6. "Further information"). Special care should be taken when taking Mastodynon Tablets: Patients who have or have had an estrogen-sensitive malignant tumor should only take Mastodynon Tablets after consulting their doctor. Patients should only take Mastodynon Tablets in consultation with their doctor at the same time as dopamine agonists, dopamine antagonists, estrogens or antiestrogens. If symptoms worsen during treatment with Mastodynon Tablets, a doctor should be consulted or a pharmacist asked. Patients with a history of pituitary disease should discuss taking this medicine with a doctor.
Children: There is not enough documented experience with the use of this medicine in children. It should therefore not be used in children and adolescents under 18 years of age.
When taking Mastodynon Tablets with other medicines: Interactions with dopamine agonists, dopamine antagonists, estrogens and anti-estrogens cannot be ruled out. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.
When taking Mastodynon with food and drink: General note: The effect of a homeopathic medicine can be adversely affected by generally harmful factors in the lifestyle and by stimulants and luxuries (including coffee). If you are taking any other medicines, ask your doctor.
Pregnancy and breastfeeding: Pregnancy is not an area of application for Mastodynon. Mastodynon should therefore not be used during pregnancy. The use of Mastodynon Tablets during breastfeeding is not recommended, as a reduction in milk production has been observed in animal models. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines: No studies have been conducted on the effects on driving and the ability to operate machines.
Important information about certain other ingredients of Mastodynon Tablets: This medicine contains lactose. Therefore, please only take Mastodynon Tablets after consulting your doctor if you know that you suffer from sugar intolerance.

3. HOW TO TAKE MASTODYNON TABLETS?
Always take Mastodynon Tablets exactly as described in this patient information. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: Adults Single dose 1 tablet, total daily dose 1 tablet twice a day. Take one tablet in the morning and one in the evening with a little liquid (e.g. a glass of water). Homeopathic medicines should not be taken for long periods of time without medical advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Mastodynon Tablets is too strong or too weak.
If you have taken more Mastodynon Tablets than you should: If you have taken more Mastodynon Tablets than you should, please notify a doctor. He/she can decide on any necessary measures.
Taking larger amounts of the medicine can lead to gastrointestinal problems or a laxative effect in people with lactose intolerance.
If you forget to take Mastodynon Tablets: Do not take a double dose to make up for a forgotten dose.
If you stop taking Mastodynon Tablets: Stopping Mastodynon Tablets is generally harmless.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Mastodynon Tablets can have side effects, although not everybody gets them. The following frequency categories are used to assess side effects

The following frequency categories are used to assess side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects: Severe allergic reactions with facial swelling, shortness of breath and difficulty swallowing have been reported. (Allergic) skin reactions (including rash, hives), headache, dizziness, gastrointestinal problems (including nausea, abdominal pain), acne and menstrual irregularities may occur. The frequency of occurrence of these possible side effects is not known. Mastodynon Tablets must not be taken again at the first signs of a hypersensitivity reaction. Note: When taking a homeopathic medicine, existing symptoms may temporarily worsen (initial aggravation). Please inform your doctor or pharmacist if any of the side effects listed here affect you significantly or if you notice any side effects not listed in this patient information.

5. HOW SHOULD MASTODYNON TABLETS BE STORED?
Keep out of reach of children! Do not use the medicine after the expiry date which is stated on the carton or blister with month/year. The expiry date refers to the last day of the month. Storage conditions: Store the container in the outer carton.

6. FURTHER INFORMATION
What Mastodynon Tablets contain: One tablet contains: Active ingredient: Agnus castus Ø (monk's pepper) 162.0 mg, Caulophyllum thalictroides Dil. D4 (squaw root) 81.0 mg, Cyclamen Dil. D4 (cyclamen) 81.0 mg, Ignatia Dil. D6 (St. Ignatius bean) 81.0 mg, Iris Dil. D2 (iris) 162.0 mg, Lilium tigrinum Dil. D3 (tiger lily) 81.0 mg. The other ingredients are: Lactose monohydrate, potato starch, magnesium stearate (Ph. Eur.).
Note for diabetics: One Mastodynon Tablet contains approx. 0.020 bread units (BE). The medicine is gluten-free.
What Mastodynon Tablets look like and contents of the pack: Beige-coloured tablets in packs of 60 (N1), 120 (N1), 240 (N2) tablets. The medicine is also available in liquid form (Mastodynon mixture).

Pharmaceutical entrepreneur and manufacturer

BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt
Telephone: 09181 / 231-90
Fax: 09181 / 231-265
Internet: www.bionorica.de
E-mail: info@bionorica.de

Co-distributor

PLANTAMED Arzneimittel GmbH
Kerschensteinerstraße 11-15
92318 Neumarkt
Telephone: 09181 / 231-0
Fax: 09181 / 21850

This patient information was last revised in January 2012.

Source: Information from the package leaflet
Status: 11/2014
Areas of application: Premenstrual symptoms, such as tension and swelling in the breasts (mastalgia); symptoms during menstruation and irregular menstrual bleeding (cycle disorders).