PATIENT INFORMATION LEAFLET

Agnucaston 20 mg coated tablets

Dried extract of Vitex agnus castus fruits

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• For advice on any matter relating to this medicine or for information about any aspect of its use, consult your pharmacist.
• Report any side effects you may get to your doctor or pharmacist. This includes very rare side effects. See section 4.
• You must see a doctor if your symptoms worsen or do not improve after 3 months.

1. What is Agnucaston and what it is 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. Contents of the pack and additional information

Agnucaston is a plant-based medication for the treatment of premenstrual syndrome (monthly discomforts that occur before regular menstrual bleeding) in adult women 18 years of age or older.

Do not take Agnucaston

-if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Agnucaston:

• if you have or have had 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 antiestrogens (e.g. some medications used to treat breast cancer).
• if you have had pituitary gland disorders.

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

If signs of an allergic reaction are observed, discontinue taking this medication and contact your doctor immediately (see section 4).

Children and adolescents

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

Other medications and Agnucaston

Interactions with the fruit of agnus castus cannot be ruled out with 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 antiestrogens (e.g. some medications used to treat breast cancer).

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. If you visit your doctor or any other healthcare professional, remember to inform them if you are taking or have taken recently any over-the-counter medication.

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. To date, there is no evidence that the ability to drive and operate machinery is impaired by the use of Agnucaston. However, the ability to drive and operate machinery 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 with them before taking this medication.

Agnucaston contains sodium

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

Follow exactly the administration instructions for this medication contained in this leaflet or those 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 old is 1 coated tablet once a day.

Administration Form

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 treatment, it is recommended to use continuously for more than 3 months (even during menstruation).

If symptoms persisted after continuous use for more than three months, consult a doctor, pharmacist, or a 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 old is not recommended due to lack of adequate information (see section 2).

Special Populations

No data are available on dosage administration instructions for patients with liver or renal impairment. Consult 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 medication by accident, please contact your doctor or hospital for further instructions.

If You Forget to Take Agnucaston

Do not take a double dose to compensate for the missed dose.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

There is a risk of experiencing severe allergic reactions such as facial swelling, dyspnea (difficulty breathing), and difficulty swallowing. In case of any indication that you are experiencing an allergic reaction, discontinue treatment with Agnucaston and contact your doctor immediately (see section 2).

Other Adverse Effects That May Occur

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

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

If any other secondary effect occurs that is not mentioned above, consult a doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require any special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Agnucaston

• One coated tablet contains 20 mg of extract (as dry extract) ofVitex agnus castusL, fruit (fruit of Agnus castus) (7-11:1). Solvent for extraction: ethanol at 70% (v/v).
• The other components are:Povidone 30, Silica, anhydrous colloidal, Potato starch, Lactose monohydrate, Microcrystalline cellulose, Sodium croscarmellose, Magnesium stearate (vegetal), Opadry amb II (which consists of polyvinyl alcohol, talc, titanium dioxide (E171), glyceryl monocaprilocaprato and lauril sodium sulfate.

Appearance of Agnucaston and contents of the package

Packages with 30 coated tablets

Packages with 60 coated tablets

Packages with 90 coated tablets

Not all package sizes may be marketed.

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

Holder of the marketing authorization and responsible for manufacturing

BIONORICA SE

Kerschensteinerstraße 11-15

92318 Neumarkt

Germany

Phone 09181 / 231-90

Fax 09181 / 231-265

This medicinal product has been authorized in the Member States of the EEA with the following names:

AustriaAgnucaston forte Filmtabletten

Bulgaria, DenmarkCyclodynon forte

Croatia, France, Poland, Slovenia, SwedenCyclodynon

Czech RepublicAgnucaston pro ženy

EstoniaAgnucaston intens

Germany, Luxembourg,Agnucaston 20 mg

HungaryAgnucaston Forte 20 mg filmtabletta

ItalyAgnucaston

LatviaAgnucaston 20 mg apvalkotas tabletes

LithuaniaAgnucaston intens plévele dengtos tabletés

RomaniaCyclodynon comprimate filmate

SlovakiaAgnucaston forte

SpainAgnucaston 20 mg coated tablets

Last review date of this leaflet: August 2021.