Ciclodinon

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Cyclodynon, 20 mg, coated tablets

Agni casti fructus extractum siccum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 months there is no improvement or you feel worse, consult a doctor.

Table of contents of the leaflet:

• 1. What is Cyclodynon and what is it used for
• 2. Important information before taking Cyclodynon
• 3. How to take Cyclodynon
• 4. Possible side effects
• 5. How to store Cyclodynon
• 6. Package contents and other information

1. What is Cyclodynon and what is it used for

Cyclodynon is a herbal medicine for the treatment of premenstrual syndrome (monthly complaints occurring before regular menstrual bleeding) in adult women over 18 years of age.

2. Important information before taking Cyclodynon

When not to take Cyclodynon

• if you are hypersensitive (allergic) to dry extract of Vitex agnus-castus L. fructus or any of the excipients of the medicine (see section 6).

Warnings and precautions

Before taking Cyclodynon, consult a doctor:

• if you have or have had an estrogen-sensitive tumor
• if you are taking dopamine agonists (e.g. certain medicines for Parkinson's disease), dopamine antagonists (certain medicines for schizophrenia, bipolar disorder, nausea or vomiting), estrogens (e.g. used in hormone replacement therapy) and anti-estrogens (e.g. medicines used in breast cancer treatment).
• if you have a history of pituitary disease. Consult a doctor if symptoms worsen during treatment.

If you experience symptoms of an allergic reaction, stop taking this medicine and consult a doctor immediately (see section 4).

Children and adolescents

There is no significant reason to use in children before puberty. It is not recommended to use in adolescents under 18 years of age due to lack of appropriate data.

Cyclodynon and other medicines

It cannot be excluded that interactions with Vitex agnus-castus may occur with dopamine agonists (e.g. certain medicines for Parkinson's disease), dopamine antagonists (certain medicines for schizophrenia, bipolar disorder, nausea or vomiting), estrogens (e.g. used in hormone replacement therapy) and anti-estrogens (e.g. medicines used in breast cancer treatment).
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Remember to inform your doctor or other healthcare professionals about taking Cyclodynon, which is available without a prescription.

Pregnancy and breastfeeding

There are no indications for use during pregnancy. Cyclodynon is not recommended during pregnancy. Due to lack of data, it is not recommended during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult a doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.
So far, there is no evidence that taking Cyclodynon affects the ability to drive and use machines. However, in patients who experience dizziness, the ability to drive and use machines may be impaired.

Cyclodynon contains lactose.

If you have been diagnosed with intolerance to some sugars, consult a doctor before taking the medicine.

Cyclodynon contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet, which means it is considered "sodium-free".

3. How to take Cyclodynon

This medicine should always be taken as described in this leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose for adult women over 18 years of age is 1 coated tablet once a day.
Method of administration
Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water). Do not chew the tablets.
To achieve the optimal treatment effect, it is recommended to continue taking for 3 months (also during menstruation).
If symptoms persist after uninterrupted use for more than three months, consult a doctor or pharmacist.
Children and adolescents
There is no significant reason to use in adolescents. It is not recommended to use in adolescents under 18 years of age due to lack of appropriate data (see section 2).
Special populations
There are no available data on dosing in cases of renal and/or hepatic impairment.
In case of renal and/or hepatic impairment, consult a doctor before taking Cyclodynon.

Taking a higher dose of Cyclodynon than recommended

In case of taking a larger amount of Cyclodynon than recommended or accidental ingestion by children, consult a doctor or hospital for advice.

Missing a dose of Cyclodynon

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Cyclodynon can cause side effects, although not everybody gets them.
There is a risk of severe allergic reactions, such as facial swelling, difficulty breathing and difficulty swallowing. If you experience the first symptoms of an allergic reaction, stop taking this medicine and consult a doctor immediately (see section 2).
Other side effects that may occur
(Allergic) skin reactions (such as rash and urticaria), acne, headaches, dizziness, gastrointestinal disorders (such as nausea, abdominal pain), menstrual disorders.
The frequency of side effects is not known (frequency cannot be estimated from available data).
If you experience other side effects not mentioned above, consult a doctor or pharmacist.
Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help 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 month stated.

6. Package contents and other information

What Cyclodynon contains

One coated tablet contains 20 mg of extract (as dry extract) of Vitex agnus-castus L. fructus (Vitex agnus-castus 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 monokaprylate and sodium lauryl sulfate).

What Cyclodynon looks like and contents of the pack

Package containing 30 coated tablets
Package containing 60 coated tablets
Package 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 authorization holder and manufacturer:

BIONORICA SE
Kerschensteinerstrasse 11 - 15
92318 Neumarkt
Tel.: 09181 / 231-90
Fax.: 09181 / 231-265

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: