DISMEGYN CAPSULES

Introduction

Package Leaflet: Information for the User

Dismegyn Capsules

Dry extract of fruits of Vitex agnus-castusL. (Chasteberry)

Read this package leaflet carefully because it contains important information for you.

This medicine can be obtained without a prescription. Nevertheless, to obtain the best results, it should be used properly.

• Keep this package leaflet, as you may need to read it again.
• If you need additional information or advice, consult your pharmacist.
• If symptoms worsen or persist after 8 weeks, you should consult your doctor.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What Dismegyn is and what it is used for
2. Before taking Dismegyn
3. How to take Dismegyn
4. Possible side effects
5. Storage of Dismegyn
6. Additional information

1. What Dismegyn is and what it is used for

They are hard capsules. Each cardboard box contains 30 capsules. This medicine is a gynecological preparation.

Dismegyn relieves breast swelling and painful tension of the premenstrual syndrome and the irritability derived from these symptoms.

2. Before taking Dismegyn

Do not take Dismegyn in the following cases:

• If you are allergic (hypersensitive) to the active ingredient or to any of the other components of Dismegyn.
• Dismegyn cannot be taken in case of pituitary tumors (pituitary gland) and breast cancer.

Be especially careful with Dismegyn:

If symptoms continue or worsen after 8 weeks of treatment despite sufficient dosing and regular intake, you should consult your doctor.

Use of other medicines:

• Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine, including those obtained without a medical prescription.
• The effects of Dismegyn may be altered due to concomitant use with some medicines.
• There is evidence that there may be a mutual weakening of efficacy if Dismegyn is administered simultaneously with dopamine receptor antagonists.

The dopaminergic action of Vitex agnus-castusL. could produce an attenuating effect on the action of dopaminergic antagonists in a reciprocal manner.

Children

This medicine should not be administered to children.

Pregnancy

Do not take Dismegyn during pregnancy.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The consumption of medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Breast-feeding

Do not take Dismegyn during breast-feeding. In experimental animals, a decrease in milk production has been observed after taking fruits of Vitex agnus castusL.

Driving and using machines

No effects on the ability to drive and use machinery have been described.

Important information about some of the components of Dismegyn:

This medicine contains 36 mg of glucose and 34 mg of lactose per capsule. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Dismegyn

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine.

Adults:

• The recommended dose is one capsule once a day.
• Dismegyn should be taken orally and, if possible, at the same time of day. A treatment duration of three months is recommended.
• If you think the action of Dismegyn is too strong or too weak, tell your doctor or pharmacist.

If you take more Dismegyn than you should:

So far, no overdose effects have been observed. In case of accidental ingestion of large quantities, go to a medical center or call the Toxicology Information Service, tel.: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Dismegyn:

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, Dismegyn can cause side effects, although not everyone will experience them.

Occasionally, it may cause the appearance of skin rashes with itching.

If you observe this or any other adverse reaction not described in this package leaflet, interrupt treatment and consult your doctor or pharmacist.

5. Storage of Dismegyn

Expiry date

Do not use Dismegyn after the expiry date indicated on the box and each of the blisters. Do not store above 30°C. Keep in the original package.

Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

Keep Dismegyn out of the reach and sight of children.

6. Package contents and additional information

Composition of Dismegyn:

• The active ingredient of Dismegyn is Vitex agnus-castus, L.

Each capsule contains 4 mg of dry extract of fruits of Vitex agnus-castus, L. Ethanol 60% (v/v) has been used as the extraction solvent.

• The excipients are: liquid glucose, anhydrous colloidal silica, lactose monohydrate, magnesium stearate, cornstarch, and talc. The gelatin capsule is composed of gelatin, sodium lauryl sulfate, titanium dioxide (E 171), yellow iron oxide (E 172), and black iron oxide (E 172).

This medicine is presented in hard capsules, with each cardboard box containing 30 capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

Wiewelhove GmbH

Dörnebrink 19,

49479 Ibbenbüren

Germany

Date of the last revision of this package leaflet: August 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/