Prospect: Information for the user

Dismegyn capsules

Dried extract of fruits ofVitex agnus-castusL. (Chaste tree)

Read this prospect thoroughly as it contains important information for you.

This medication can be purchased without a prescription. However, for the best results, it must be used properly.

• Keep this prospect, 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 must consult your doctor.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

They are hard capsules. Each carton contains 30 capsules. This medication is a gynecological preparation.

Dismegynrelieves breast swelling and painful tension associated with premenstrual syndrome and irritability caused by these symptoms.

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.
• No Dismegyn can be taken in case of pituitary gland tumors and breast cancer.

Be especially careful with Dismegyn:

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

Use of other medications:

• Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those acquired without a prescription.
• The effects of Dismegyn may be altered due to concurrent use with some medications.
• There is evidence of a mutual weakening of efficacy if Dismegyn is administered simultaneously with dopamine receptor antagonists.

The dopaminergic action of Vitex agnus-castus L. may produce a reciprocal attenuating effect on the action of dopamine antagonists.

Children:

This medication will not be administered to children.

Pregnancy:

Do not take Dismegyn during pregnancy.

If you are pregnant or believe you may be pregnant, consult your doctor before taking this medication. The consumption of medications during pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

Lactation:

Do not take Dismegyn during lactation. In animal experimentation, a decrease in milk production has been observed after taking Vitex agnus castus L. fruits.

Driving and operating machinery:

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

Important information about some of the components of Dismegyn:

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

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

Adults:

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

If you take more Dismegyn than you should:

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

If you forgot to take Dismegyn:

Do not take a double dose to compensate for the missed doses.

Like all medications,Dismegynmay cause adverse effects, although not everyone will experience them.

It may occasionally cause the appearance of skin rashes with pruritus.

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

Expiration Date

Do not useDismegynafter the expiration date indicated on the box and each blister pack. Do not store at a temperature above 30°C. Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

KeepDismegynout of the reach and sight of children.

Composition of Dismegyn:

• The active principle ofDismegynisVitex agnus-castus,L.

Each capsule contains 4 mg of dried fruit extract ofVitex agnus-castus,L.It has been used as a solvent for extraction ethanol 60% (v/v).

• 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 (E171), red iron oxide (E172), and black iron oxide (E172).

This medication is presented in hard capsules, containing 30 capsules per carton box.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

WIEWELHOVE GmbH

GildestraBe 39

49477 Ibbenbüren

Germany

Last review date of this leaflet: August 2023.

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/