Castagnus

Package Leaflet: Information for the Patient

Castagnus

Agni casti fructus extractum siccum
45 mg, tablets

Read the package 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 package leaflet or as directed 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 90 days there is no improvement or the patient feels worse, consult a doctor.

Table of Contents of the Leaflet

• 1. What is Castagnus and what is it used for
• 2. Important information before taking Castagnus
• 3. How to take Castagnus
• 4. Possible side effects
• 5. How to store Castagnus
• 6. Contents of the pack and other information

1. What is Castagnus and what is it used for

Castagnus is a traditional herbal medicinal product used for the treatment of mild symptoms that occur before menstruation (premenstrual syndrome, i.e., short-term symptoms before the onset of menstruation, characterized by breast tenderness and swelling, emotional disturbances, migraine-like headaches, swelling of the face, hands, and feet).
The indications are based solely on long-term use.
If after 90 days there is no improvement or the patient feels worse, consult a doctor.

2. Important information before taking Castagnus

When not to take Castagnus:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• do not use during pregnancy and breastfeeding
• do not use the medicine in children under 18 years of age

Warnings and precautions

Before taking Castagnus, discuss it with your doctor or pharmacist.
Patients who have had or have estrogen-dependent tumors should consult their doctor before taking the medicine.
Patients taking dopamine receptor agonists or antagonists, or estrogens should consult their doctor before taking the medicine.
The use of the medicine in children and adolescents under 18 years of age is not recommended due to the lack of appropriate data.
If symptoms worsen during treatment, consult a doctor.
It is suggested that the extract of Vitex agnus castus affects the hypothalamic-pituitary axis, and therefore patients with pituitary disorders should consult their doctor before taking the medicine.
In the case of pituitary tumors that secrete prolactin, the use of Vitex agnus castus preparations may mask the symptoms of the tumor.

Castagnus and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.
Due to the possible dopaminergic and estrogenic effects of Vitex agnus castus, interactions with dopamine receptor agonists or antagonists, and estrogens (e.g., antipsychotics, anti-Parkinson's drugs, hormone replacement therapy, oral contraceptives, metoclopramide, bromocriptine) cannot be ruled out.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take the medicine during pregnancy.
Breastfeeding
Data from preclinical reproductive studies indicate that extracts of Vitex agnus castus may affect lactation. The use of the medicine during breastfeeding is not recommended.
Fertility
The effect on fertility is unknown.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

Castagnus contains lactose monohydrate

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

3. How to take Castagnus

Take this medicine always exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Dosage
Adult women: 1 tablet once daily.
Take the medicine orally, in the morning.
Method of administration
Take the medicine orally.
Children and adolescents
Do not use the medicine in children under 18 years of age.

Overdose of Castagnus

Do not take more than the recommended dose.
In case of overdose, consult a doctor.

Missed dose of Castagnus

Take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Castagnus

If you have any further questions on the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Castagnus can cause side effects, although not everybody gets them.
Side effects are listed according to the organ system and frequency of occurrence: unknown (cannot be estimated from the available data).
The following side effects may occur during treatment with Castagnus:
Immune system disorders - severe allergic reactions with facial swelling, difficulty breathing, and swallowing difficulties.
Skin and subcutaneous tissue disorders - allergic skin reactions (rash, urticaria), acne.
Nervous system disorders - pain and dizziness.
Gastrointestinal disorders - nausea, abdominal pain.
Reproductive system and breast disorders - menstrual cycle disturbances.
The frequency of these symptoms is unknown.
Reporting side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. 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.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Castagnus

Store in a temperature below 25°C.
Keep out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging after: Expiry Date (EXP). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Castagnus contains

1 tablet contains 4.5 mg extract (as dry extract) from Vitex agnus castusL. fructus (equivalent to an average of 45 mg of Vitex agnus castus fruit)
Extraction solvent - ethanol 60% [m/m]
Other ingredients of the medicine are: lactose monohydrate, potato starch, povidone K 30, magnesium stearate.

What Castagnus looks like and contents of the pack

Castagnus are round, biconvex tablets, beige-gray in color with a marbling effect.
The tablets are packaged in aluminum/PVC blisters. 1 blister contains 10 tablets. 3 blisters are packaged with the patient information leaflet in a cardboard box.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie „Herbapol” SA

• 50 – 951 Wrocław, ul. Św. Mikołaja 65/68 tel. +48 71 335 72 25 fax: + 48 71 372 47 40 e-mail: herbapol@herbapol.pl

To obtain more detailed information, contact the marketing authorization holder: tel. 71 321-86-04 w.123

Date of last revision of the leaflet:

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