Agnucaston 20 mg coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Agnucaston 20 mg film-coated tablets
Dry extract of Vitex agnus castus fruit
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration of this medicine contained in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 3 months.
Contents of the leaflet
- What Agnucaston is and what it is used for
- What you need to know before taking Agnucaston
- How to take Agnucaston
- Possible adverse effects
- How to store Agnucaston
- Contents of the pack and other information
1. What Agnucaston is and what it is used for
Agnucaston is a herbal medicinal product indicated for the treatment of premenstrual syndrome (monthly discomfort occurring before regular menstrual bleeding) in adult women aged 18 years and 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 ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Agnucaston:
- if you currently have or have previously had an estrogen-dependent cancer.
- if you are taking dopamine agonists (e.g., certain medications used for Parkinson's disease), dopamine antagonists (some medications used to treat schizophrenia, bipolar disorders, nausea or vomiting), estrogens (e.g., used in hormone replacement therapy), and/or antiestrogens (e.g., certain medications used to treat breast cancer).
- if you have had disorders of the pituitary gland.
Talk to your doctor if your symptoms worsen during treatment with Agnucaston.
If signs of an allergic reaction occur, you must stop taking this medicine and contact your doctor immediately (see section 4).
Children and adolescents
There are no relevant indications for the use of Agnucaston in prepubertal children. Use in pubertal children and adolescents under 18 years of age is not recommended due to lack of adequate information.
Other medicines and Agnucaston
Interactions between the fruit of agnus castus and dopamine agonists (e.g., certain medications used for Parkinson's disease), dopamine antagonists (some medications used to treat schizophrenia, bipolar disorders, nausea or vomiting), estrogens (e.g., used in hormone replacement therapy), and/or antiestrogens (e.g., certain medications used to treat breast cancer) cannot be ruled out.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. 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 medicines.
Pregnancy and breastfeeding
There are no indications for the use of this medicine during pregnancy. Agnucaston is not recommended during pregnancy. Due to insufficient data on the use of Agnucaston during breastfeeding, its use is not recommended during this period.
If you are pregnant or breastfeeding, think you might be pregnant, or are planning 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 informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Agnucaston contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per coated tablet; i.e., essentially "sodium-free".
3. How to take Agnucaston
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adult women over 18 years of age is 1 coated tablet once daily.
Method of administration
For oral use: Swallow the coated tablets with sufficient liquid (e.g. a glass of water). Do not chew the tablets.
To achieve an optimal effect from treatment, continuous use for more than 3 months is recommended (including during menstruation).
If symptoms persist after continuous use for more than three months, consult a doctor, pharmacist, or qualified healthcare professional.
Paediatric population
There are no relevant reasons for the use of Agnucaston in prepubertal children. Use in pubertal children and adolescents under 18 years of age is not recommended due to lack of adequate information (see section 2).
Special populations
No data are available regarding dosage instructions for patients with hepatic or renal impairment. Speak with your doctor before taking Agnucaston if you have 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 accidentally taken this medicine, please contact your doctor or hospital for further advice.
If you forget to take Agnucaston
Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
There is a risk of experiencing severe allergic reactions such as facial swelling, dyspnea (difficulty breathing), and difficulty swallowing. If you notice any signs of an allergic reaction, stop treatment with Agnucaston and contact your doctor immediately (see section 2).
Other possible adverse effects
(Allergy) skin reactions (such as rash and urticaria), acne, headache, dizziness, gastrointestinal disorders (such as nausea, abdominal pain), menstrual disorders.
The frequency of these adverse effects is unknown (frequency cannot be estimated from the available information).
If any other side effect not mentioned above occurs, consult a doctor or pharmacist.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Agnucaston
Keep this medicine out of 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. Contents of the container and other information
Composition of Agnucaston
- Each coated tablet contains 20 mg of extract (as dry extract) from Vitex agnus castus L., fructus (Agnus castus fruit) (7-11:1). Extraction solvent: 70% ethanol (v/v).
- Other components: Povidone 30, Colloidal anhydrous silica, Potato starch, Lactose monohydrate, Microcrystalline cellulose, Sodium croscarmellose, Magnesium stearate (vegetable), Opadry amb II (consisting of polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, and sodium lauryl sulfate).
Appearance of Agnucaston and contents of the container
Blisters containing 30 coated tablets
Blisters containing 60 coated tablets
Blisters containing 90 coated tablets
Not all pack sizes may be marketed.
Agnucaston coated tablets are greyish-white, round, biconvex, and have 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 medicinal product has been authorized in the EEA Member States under 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 comprimidos recubiertos
Date of latest revision of this leaflet: August 2021.