Agnucaston
Italy
Table of Contents
PATIENT INFORMATION LEAFLET
Agnucaston film-coated tablets
Dry extract of the fruit of agnus castus
Please read this leaflet carefully before taking this medicine, as it contains
important information for you
- Keep this leaflet. You may need to read it again. For further information or advice, contact your doctor or pharmacist.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice any improvement after three months, or if your symptoms worsen.
Contents of the package leaflet
- What Agnucaston is and what it is used for
- What you need to know before taking Agnucaston
- How to take Agnucaston
- Possible side 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 medicine used for the treatment of premenstrual syndrome (a recurring monthly disorder occurring before the onset of menstruation) 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 (hypersensitive) to the dry extract of the chasteberry fruit 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 have or have had a cancer whose growth is sensitive to estrogens.
- if you are taking dopaminergic agonists (e.g. certain medicines used to treat Parkinson's disease), dopamine antagonists (some medicines used to treat schizophrenia, bipolar disorders, nausea or vomiting), estrogens (e.g. used in hormone replacement therapy), or antiestrogens (e.g. certain medicines used for breast cancer).
- if you have a history of pituitary disorders.
- Consult your doctor if your symptoms worsen during treatment with this medicine.
- If symptoms 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 reasons for use in prepubertal children. Use in pubertal children and adolescents under 18 years of age is not recommended due to lack of adequate data.
Other medicines and Agnucaston
Interactions between chasteberry and dopaminergic agonists (e.g. certain medicines used to treat Parkinson’s disease), dopamine antagonists (some medicines used to treat schizophrenia, bipolar disorders, nausea or vomiting), estrogens (e.g. used in hormone replacement therapy), and antiestrogens (e.g. certain medicines used for breast cancer) cannot be ruled out.
Inform your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines.
When visiting your doctor or other healthcare professionals, remember to tell them that you are taking or have recently taken this medicine.
Pregnancy and breastfeeding
There is no indication for use during pregnancy. Agnucaston is not recommended during pregnancy.
Due to lack of adequate data, use during breastfeeding is not recommended.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
No studies have been conducted on the ability to drive or use machinery. To date, there is no evidence that Agnucaston film-coated tablets impair the ability to drive or operate machinery. However, in patients who experience dizziness, the ability to drive and use machinery may be impaired.
Agnucaston contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Agnucaston contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is practically “sodium-free”.
3. How to take Agnucaston
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose for adult women from 18 years of age is 1 film-coated tablet once daily.
Method of administration
Swallow the film-coated tablets with sufficient liquid (e.g. a glass of water). Do not chew the tablets.
To achieve an optimal treatment effect, continuous use for 3 months is recommended (also during menstruation).
If symptoms persist after continuous use for three months, consult a doctor or pharmacist.
Paediatric population
There are no relevant indications for use in prepubertal children. Use in children and adolescents under 18 years of age is not recommended due to lack of adequate data (see section 2).
Special populations
There are no available data to define the appropriate dosing regimen in patients with impaired renal/hepatic function.
Consult your doctor before taking Agnucaston if you have impaired renal or hepatic function.
If you take more Agnucaston than you should
If you take more Agnucaston than you should, or if children accidentally ingest this medicine, please contact your doctor or go to hospital.
If you forget to take Agnucaston
Do not take a double dose to make up for the forgotten dose.
4. Possible side effects
Like all medicines, this medicinal product may cause side effects, although not everybody will experience them.
There is a risk of serious allergic reactions such as swelling of the face, dyspnoea (difficulty in breathing), and difficulty in swallowing. At the first signs of an allergic reaction, you must stop taking this medicine and contact your doctor immediately (see section 2).
Other side effects that may occur:
Skin (allergic) reactions (such as skin irritation and urticaria), acne, headache, dizziness, gastrointestinal disorders (such as nausea, abdominal pain), menstrual disorders.
The frequency of these adverse effects is not known (the frequency cannot be estimated from the available data).
If you experience any adverse reactions not mentioned above, you must consult a doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. How to store Agnucaston
This medicine does not require any special storage conditions.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Agnucaston contains
One film-coated tablet contains 20 mg of extract (as dry extract) of Vitex agnus castus L., fructus (chaste tree fruit) (7-11:1). Extraction solvent: ethanol 70% (v/v).
The other components are:
Povidone 30, Silica, anhydrous colloidal, potato starch, lactose monohydrate, microcrystalline cellulose,
sodium croscarmellose, magnesium stearate (vegetable), Opadry amb II (composed of polyvinyl alcohol, talc,
titanium dioxide (E171), glycerol monocaprylate and sodium lauryl sulfate).
Description of the appearance of Agnucaston and contents of the pack:
Packs of 30 film-coated tablets
Packs of 60 film-coated tablets
Packs of 90 film-coated tablets
It is possible that not all pack sizes are marketed.
Agnucaston is a film-coated tablet, white to light grey, round and biconvex, with a matt 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 is 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 apvalkotās tabletes
Lithuania Agnucaston intens plėvele dengtos tabletės
Romania Cyclodynon comprimate filmate
Slovakia Agnucaston forte
Spain Agnucaston 20 mg comprimidos recubiertos