Dismegyn capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Dismegyn capsules
Dry extract of fruit of Vitex agnus-castus L. (Chasteberry)
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without a prescription. However, to obtain the best results, it must be used correctly.
- Keep this leaflet, as you may need to read it again.
- If you need additional information or advice, consult your pharmacist.
- If symptoms worsen or persist beyond 8 weeks, you should consult your doctor.
- If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Dismegyn is and what it is used for
- Before taking Dismegyn
- How to take Dismegyn
- Possible adverse effects
- How to store Dismegyn
- Further information
1. What Dismegyn is and what it is used for
It is hard capsules. Each cardboard box contains 30 capsules. This medicine is a gynecological preparation.
Dismegyn relieves breast swelling and painful breast tension associated with premenstrual syndrome, as well as the irritability resulting from these symptoms.
2. Before taking Dismegyn
Do not take Dismegyn in the following cases:
- If you are allergic (hypersensitive) to the active substance or to any of the other components of Dismegyn.
- Dismegyn must not be taken in cases of pituitary tumours (pituitary gland) or breast cancer.
Take special care with Dismegyn:
If symptoms persist or worsen after 8 weeks of treatment despite adequate dosage and regular intake, consult your doctor.
Use with other medicines:
- Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
- The effects of Dismegyn may be altered when taken together with certain medicines.
- There is evidence that mutual weakening of efficacy may occur if Dismegyn is administered simultaneously with dopamine receptor antagonists.
The dopaminergic action of Vitex agnus-castus L. could reciprocally cause an attenuating effect on the action of dopaminergic antagonists.
Children
This medicine must not be administered to children.
Pregnancy
Do not take Dismegyn during pregnancy.
If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may 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 administration of Vitex agnus-castus L. fruit.
Driving and using machines
No effects on the ability to drive and use machines have been reported.
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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Dismegyn
Follow these instructions unless your doctor has given you different advice. Remember to take your medicine.
Adults:
- The recommended dose is one capsule once daily.
- Dismegyn should be taken orally and, if possible, at the same time of day. A treatment duration of three months is recommended.
- If you feel that the effect of Dismegyn is too strong or too weak, inform 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 at 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Dismegyn:
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, Dismegyn may produce adverse effects, although not everyone experiences them.
Occasionally, it may cause skin rashes with pruritus.
If you experience this or any other adverse reaction not listed in this leaflet, stop treatment and consult your doctor or pharmacist.
5. Storage of Dismegyn
Expiry
Do not use Dismegyn after the expiry date stated on the outer box and on each blister. Do not store above 30°C. Keep in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.
Keep Dismegyn out of the reach and sight of children.
6. Contents of the pack and other information
Composition of Dismegyn:
- The active substance in Dismegyn is Vitex agnus-castus, L.
Each capsule contains 4 mg of dried extract from the fruit of Vitex agnus-castus, L. Ethanol 60% (v/v) has been used as the extraction solvent.
- The excipients are: liquid glucose, anhydrous colloidal silica, monohydrate lactose, magnesium stearate, corn starch and talc. The gelatin capsule consists of gelatin, sodium lauryl sulfate, titanium dioxide (E 171), yellow iron oxide (E171), red iron oxide (E172) and black iron oxide (E172).
This medicine is presented as hard capsules. Each cardboard box contains 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 most recent review of this leaflet: August 2023.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/