Cyclodynon
Poland
Table of Contents
Package leaflet: Information for the patient
Cyclodynon, 20 mg, coated tablets
Agni casti fructus extractum siccum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a physician or pharmacist.
- Keep this leaflet for possible future reference.
- If advice or further information is needed, consult a pharmacist.
- If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
- If there is no improvement or if the patient feels worse after 3 months, consult a doctor.
Contents of the leaflet:
- What Cyclodynon is and what it is used for
- Important information before taking Cyclodynon
- How to take Cyclodynon
- Possible side effects
- How to store Cyclodynon
- Contents of the pack and other information
1. What Cyclodynon is and what it is used for
Cyclodynon is a herbal medicinal product used for the treatment of premenstrual syndrome (cyclical complaints occurring before regular menstrual bleeding) in adult women over 18 years of age.
2. Important information before using Cyclodynon
When not to use Cyclodynon
- if the patient has hypersensitivity (allergy) to the dry extract of the fruit of Vitex agnus-castus L. fructus or to any of the excipients of the medicinal product (see section 6).
Warnings and precautions
Before using Cyclodynon, consult a doctor:
- if the patient has or has had an estrogen-sensitive tumour;
- if the patient is taking medicines belonging to the group of dopamine agonists (e.g. certain medicines used in Parkinson's disease), dopamine antagonists (certain medicines used in schizophrenia, bipolar affective disorders, nausea or vomiting), estrogens (e.g. used in hormone replacement therapy) or antiestrogens (e.g. medicines used in the treatment of breast cancer);
- if the patient has a history of pituitary gland disorder. Consult a doctor if symptoms worsen during treatment.
If symptoms of an allergic reaction occur, discontinue use of this medicine immediately and contact a doctor (see section 4).
Children and adolescents
There is no relevant indication for use in children before puberty. Use in adolescents under 18 years of age is not recommended due to lack of appropriate data.
Cyclodynon and other medicines
An interaction between Vitex agnus-castus fruit and dopamine agonists (e.g. certain medicines used in Parkinson's disease), dopamine antagonists (certain medicines used in schizophrenia, bipolar affective disorders, nausea or vomiting), estrogens (e.g. medicines used in hormone replacement therapy) and antiestrogens (e.g. certain medicines used in breast cancer treatment) cannot be ruled out.
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take. Remember to inform your attending physician or other healthcare professionals about current or recent use of Cyclodynon, which is available without a prescription.
Pregnancy and breastfeeding
There is no indication for use during pregnancy. Cyclodynon is not recommended during pregnancy. Due to lack of adequate data, use during lactation is not recommended.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Studies on the influence of Cyclodynon on the ability to drive vehicles and operate machinery have not been conducted. To date, there is no evidence that use of Cyclodynon coated tablets impairs the ability to drive or operate machinery. However, in patients who experience dizziness, the ability to drive and operate machinery may be impaired.
Cyclodynon contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Cyclodynon contains sodium.
This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, i.e. the medicine is considered "sodium-free".
3. How to use Cyclodynon
This medicine should always be taken as described in this leaflet or as advised by your doctor or
pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adult women aged 18 years and older is 1 coated tablet once daily.
Method of administration
The tablets should be swallowed whole with an adequate amount of liquid (e.g. a glass of water). Do not chew the tablets.
To achieve the optimal treatment effect, continuous use for 3 months is recommended (including during menstruation).
If symptoms persist after continuous use for more than three months, consult your doctor or pharmacist.
Children and adolescents
There is no relevant indication for use in children and adolescents. Use in children and adolescents under 18 years of age is not recommended due to lack of appropriate data (see section 2).
Special populations
There are no available data on dosing in patients with renal and/or hepatic impairment.
In case of renal and/or hepatic impairment, consult your doctor before taking Cyclodynon.
Use of more than the recommended dose of Cyclodynon
If you take more Cyclodynon than recommended, or if the medicine is accidentally taken by children, contact your doctor or hospital for advice.
Missed dose of Cyclodynon
Do not take a double dose to make up for a missed dose.
4. Possible adverse reactions
Like all medicines, Cyclodynon may cause adverse reactions, although not everyone experiences them.
There is a risk of severe allergic reactions, such as facial swelling, shortness of breath (difficulty breathing), and difficulty swallowing. If the first signs of an allergic reaction occur, discontinue use of this medicine immediately and contact a doctor immediately (see section 2).
Other possible adverse reactions include:
Allergic skin reactions (such as rash and urticaria), acne, headache, dizziness, gastrointestinal disturbances (such as nausea, abdominal pain), and menstrual disorders.
The frequency of these adverse reactions is not known (frequency cannot be estimated from the available data).
If any adverse reactions not listed above occur, consult a doctor or pharmacist.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store Cyclodynon
This medicinal product does not require any special storage conditions.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
6. Contents of the pack and other information
What Cyclodynon contains
One coated tablet contains 20 mg of extract (as dry extract) from Vitex agnus-castus L. fructus
(Chaste tree fruit) (DER 7-11:1). Extraction solvent: 70% ethanol (v/v).
Other ingredients of the medicine are: povidone K 30, colloidal anhydrous silica, potato starch, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, Opadry AMB II coating (polyvinyl alcohol, talc, titanium dioxide (E171), glycerol monocaprylocaprate, and sodium lauryl sulfate).
What Cyclodynon looks like and contents of the pack
Pack containing 30 coated tablets
Pack containing 60 coated tablets
Pack containing 90 coated tablets
Cyclodynon is a white to light grey, round, biconvex coated tablet with a matte surface. The tablet has a diameter of 9.0 – 9.2 mm.
Marketing Authorisation Holder and Manufacturer:
BIONORICA SE
Kerschensteinerstrasse 11 - 15
92318 Neumarkt
Tel.: 09181 / 231-90
Fax.: 09181 / 231-265
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Agnucaston forte Film Tablets
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