AGNUCASTON 20 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Agnucaston 20 mg coated tablets

Dry extract of Vitex agnus castus fruit

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 months.

Contents of the leaflet

1. What is Agnucaston and what is it used for
2. What you need to know before taking Agnucaston
3. How to take Agnucaston
4. Possible side effects
5. Storage of Agnucaston
6. Package contents and additional information

1. What is Agnucaston and what is it used for

Agnucaston is a herbal medicine for the treatment of premenstrual syndrome (monthly discomfort that occurs before regular menstrual bleeding) in adult women aged 18 years or older.

2. What you need to know before taking Agnucaston

Do not take Agnucaston

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

Warnings and precautions

Consult your doctor before taking Agnucaston:

• if you have or have had an estrogen-dependent cancer.
• if you are using dopamine agonists (e.g., some medications used for Parkinson's disease), dopamine antagonists (some medications used to treat schizophrenia, bipolar disorders, nausea, or vomiting), estrogens (e.g., used for hormone replacement therapy), and/or anti-estrogens (e.g., some medications used to treat breast cancer).
• if you have had pituitary gland disorders.

Talk to your doctor if your symptoms worsen during treatment with Agnucaston.

If signs of an allergic reaction are observed, you should stop taking this medicine and contact your doctor immediately (see section 4).

Children and adolescents

There are no relevant reasons for the use of Agnucaston in prepubertal children. Use in pubertal and adolescent children under 18 years is not recommended due to the lack of adequate information.

Other medicines and Agnucaston

Interactions between Agnucaston and dopamine agonists (e.g., some medications used for Parkinson's disease), dopamine antagonists (some medications used to treat schizophrenia, bipolar disorders, nausea, or vomiting), estrogens (e.g., used for hormone replacement therapy), and/or anti-estrogens (e.g., some medications used to treat breast cancer) cannot be ruled out.

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. If you visit your doctor or any other healthcare professional, remember to inform them if you are taking or have recently taken any non-prescription medicine.

Pregnancy and breastfeeding

There are no reasons for the use of this medicine during pregnancy. Agnucaston is not recommended during pregnancy. Due to the lack of sufficient data on the use of Agnucaston during breastfeeding, its use is not recommended during breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines. To date, there is no evidence that the ability to drive and use machines is impaired by the use of Agnucaston. However, the ability to drive and use machines may be impaired in patients who experience dizziness.

Agnucaston contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Agnucaston contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per coated tablet; it is essentially "sodium-free".

3. How to take Agnucaston

Follow exactly the administration instructions of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adult women over 18 years is 1 coated tablet once a day.

Method of administration

For oral use: Swallow the coated tablets with a sufficient amount of liquid (e.g., a glass of water). Do not chew the tablets.

To achieve an optimal effect with the treatment, continuous use for more than 3 months (even during menstruation) is recommended.

If symptoms persist after continuous use for more than three months, consult a doctor, pharmacist, or qualified healthcare professional.

Pediatric population

There are no relevant reasons for the use of Agnucaston in prepubertal children. Use in pubertal and adolescent children under 18 years is not recommended due to the lack of adequate information (see section 2).

Special populations

No data are available on dosage administration instructions for patients with hepatic or renal impairment. Talk to your doctor before taking Agnucaston in case of renal or hepatic dysfunction.

If you take more Agnucaston than you should

If you have taken more Agnucaston than you should, or if a child has taken this medicine by accident, please contact your doctor or hospital for further instructions.

If you forget to take Agnucaston

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

There is a risk of serious allergic reactions such as facial swelling, dyspnea (difficulty breathing), and difficulty swallowing. If you experience any signs of an allergic reaction, stop treatment with Agnucaston and contact your doctor immediately (see section 2).

Other side effects that may occur

(Allergy) skin reactions (such as rash and urticaria), acne, headache, dizziness, gastrointestinal disorders (such as nausea, abdominal pain), menstrual disorders.

The frequency of these side effects is unknown (the frequency cannot be estimated from the available data).

If you experience any other side effects not mentioned above, consult a doctor or pharmacist.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online platform: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Agnucaston

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

6. Package contents and additional information

Composition of Agnucaston

• One coated tablet contains 20 mg of extract (as dry extract) of Vitex agnus castusL., fructus (Agnus castus fruit) (7-11:1). Extraction solvent: ethanol 70% (v/v).
• The other components are: Povidone 30, Silica, colloidal anhydrous, Potato starch, Lactose monohydrate, Microcrystalline cellulose, Sodium croscarmellose, Vegetable magnesium stearate, Opadry amb II (which consists of polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, and sodium lauryl sulfate.

Appearance of Agnucaston and package contents

Packages with 30 coated tablets

Packages with 60 coated tablets

Packages with 90 coated tablets

Not all pack sizes may be marketed.

The Agnucaston coated tablet is white-gray, round, biconvex, and has a smooth surface. The tablet has a diameter of 9.0 - 9.2 mm.

Marketing authorization holder and manufacturer

BIONORICA SE

Kerschensteinerstraße 11-15

92318 Neumarkt

Germany

Tel 09181 / 231-90

Fax 09181 / 231-265

This medicine has been authorized in the EEA member states with the following names:

Austria Agnucaston forte Filmtabletten

Bulgaria, Denmark Cyclodynon forte

Croatia, France, Poland, Slovenia, Sweden Cyclodynon

Czech Republic Agnucaston pro ženy

Estonia Agnucaston intens

Germany, Luxembourg Agnucaston 20 mg

Hungary Agnucaston Forte 20 mg filmtabletta

Italy Agnucaston

Latvia Agnucaston 20 mg apvalkotas tabletes

Lithuania Agnucaston intens plévele dengtos tabletés

Romania Cyclodynon comprimate filmate

Slovakia Agnucaston forte

Spain Agnucaston 20 mg coated tablets

Date of the last revision of this leaflet: August 2021.