AGNUCASTON FILMTBL 4MG N30

ATC code: G02CX 

Active substances: Agni Casti Fructus Extractum Siccum

Vendor, principal: Bionorica Gmbh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

AGNUCASTON 4MG N30

Package leaflet: Information for the user

Agnucaston 4 mg film-coated tablets

Chaste tree (Vitex agnus-castus) fruit extract

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 3 months.

What is in this leaflet

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

1. What Agnucaston is and what it is used for

Agnucaston is a herbal medicine for premenstrual syndrome, mastodynia (painful breasts) and menstrual cycle disorders.

2. What you need to know before you take Agnucaston Do not take Agnucaston

-   if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Agnucaston:
-   if you have or have had an estrogen-dependent malignant tumor;
-   if you are using medicines that stimulate or block dopamine receptors;
-   if you are using oestrogens or anti-oestrogenic medicines;
-   if symptoms become worse during the use of Agnucaston,
-   if you have a history of pituitary disorder.

Children and adolescents

It is not recommended to use Agnucaston by children and adolescents under 18 years of age due to the lack of relevant data.

Other medicines and Agnucaston

The possible favorable effect of chaste tree fruits should be considered, when taking the following medicines:
-   dopamine agonists (e.g., medicines used to treat Parkinson's disease);
-   dopamine antagonists (e.g., medicines used to treat vomiting and mental disorders);
-   oestrogens (female hormones) or drugs blocking the oestrogenic effect (female hormonal production) (e.g., medicines used to treat breast cancer).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Agnucaston with food and drink

Food and drink do not influence the effect of the medicine.

Pregnancy, breast-feeding and fertility

There is no data on the use of Agnucaston in pregnant women Therefore, Agnucaston should not be used during pregnancy.
It is not known whether the chaste tree fruits or their metabolites are excreted in human milk.
A risk to a child being breast-fed cannot be ruled out. There is no safety data during lactation. Data from reproduction studies indicate that extracts of chaste tree fruits may affect lactation. Agnucaston should not be used during lactation.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.
Agnucaston contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

3. How to take Agnucaston

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
Recommended dose unless the doctor has prescribed otherwise: one Agnucaston tablet a day. The tablet should be swallowed whole with a sufficient amount of liquid (e.g. a glass of water).
Continuous treatment for three months (including during menstruation) is recommended to achieve optimal therapeutic response.

Use in children and adolescents

It is not recommended to use Agnucaston by children and adolescents under 18 years of age due to the lack of relevant data (see section 2).

If you take more Agnucaston than you should

There are no data about overdosing in humans. Please inform your doctor if you took more than the recommended dose of this medicine. Your doctor will decide on the necessary measures.

If you forget to take Agnucaston

Do not take a double dose to make up for a forgotten dose. Continue the treatment as described in the package leaflet or prescribed by the doctor.

If you stop taking Agnucaston

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of following possible side effects is not known (frequency can not be estimated from the available data):
-   severe allergic reactions with facial swelling, dyspnea and swallowing difficulty;
-   (allergic) skin reactions    (rash and    hives), acne;
-   headache, dizziness;
-   gastrointestinal disorders (e.g.,    nausea,    abdominal pain);
-   menstrual disorders
When first signs of allergic reaction occur, no more Agnucaston tablets should be taken.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Agnucaston

Keep this medicine out of the sight and reach of children!
This medicine does not require any special storage conditions.
Do not use Agnucaston after the expiry date stated on the package. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Agnucaston contains

One Agnucaston tablet contains 4 mg of chaste tree fruit extract (Agni casti fruct. Spir. Sicc.; 711:1). Extraction agent is 70% (vol.%) ethanol.
The other excipients are: povidone, silica, colloidal anhydrous, potato starch, lactose monohydrate, microcrystalline cellulose, magnesium stearate, talcum, titanium dioxide (E171), yellow iron oxide (E172), indigocarmine lake (E132), macrogol 6000, ammonium methacrylate copolymer

What Agnucaston looks like and contents of the pack

Bluish-green, round, biconvex, film-coated tablets.
Tablets are packaged in PVC-PVDC-foil blisters by 15 tablets. 30, 60 or 90 tablets in cardboard carton.

Marketing Authorisation Holder and Manufacturer

Bionorica SE
Kerschensteinerstrasse 11-15 D-92318 Neumarkt/Germany
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder:
Miecys-Pharm OÜ Vitamiini 4 Tartu 51014 Estonia
Tel.+372 738 0676 E-mail: [email protected].

This leaflet was last revised in April 2018.