SEIDIGESTAN 200 mg Soft Capsules

Contents of the leaflet

1. Introduction
   1. Contents of the package leaflet:
2. What is Seidigestan and what is it used for
3. What you need to know before you take Seidigestan
4. How to take Seidigestan
5. Possible side effects
6. Storage of Seidigestan
7. Contents of the pack and further information

Introduction

Package Leaflet: Information for the User

Seidigestan 200 mg Soft Capsules

Progesterone

Contents of the package leaflet:

1. What is Seidigestan and what is it used for
2. What you need to know before you take Seidigestan
3. How to take Seidigestan
4. Possible side effects
5. Storage of Seidigestan
6. Contents of the pack and further information

1. What is Seidigestan and what is it used for

Seidigestan belongs to the group of medicines called progestogens and contains natural progesterone.

Seidigestan is used for disorders related to a progesterone deficiency, also in hormone replacement therapy for menopause, to resolve some fertility problems, and for the prevention of certain types of preterm labor and abortion.

2. What you need to know before you take Seidigestan

Do not takeSeidigestanif:

• You are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6).
• This medicine contains soybean lecithin. It should not be used in case of peanut or soy allergy.
• You have undiagnosed vaginal bleeding.
• You have a history of thromboembolic disorders.
• You have severe liver disorders.

Warnings and precautions

• In case of drowsiness, it is recommended to take the capsules preferably at night before bedtime.
• Treatment in the described conditions does not have a contraceptive effect.

Using Seidigestan with other medicines:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Taking Seidigestan with food and drinks:

Food intake after taking the capsules increases their absorption, so it is recommended to take the capsules at the same time, outside of meals, avoiding variations in intake from one day to another.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Progesterone is the hormone that increases during pregnancy, so its administration during this period does not produce adverse effects.

Progesterone is eliminated in breast milk, so its administration during breastfeeding is not recommended.

Driving and using machines:

Given that there is a risk of drowsiness and/or vertigo related to the use of progesterone orally, during treatment, activities that require a special state of alertness, such as driving vehicles or handling hazardous machinery, should not be performed.

3. How to take Seidigestan

Follow exactly the administration instructions of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have doubts. Remember to take your medicine.

Your doctor will indicate the duration of your treatment; do not stop the treatment before it is indicated.

The dose to be administered should be established according to the hormonal plasma levels of each patient and will vary according to the indications.

The recommended dose is:

Orally:

Take the capsules with the help of a glass of water outside of meals.

The average recommended dose is 200 to 300 mg per day (i.e., 200 mg at night before bedtime or 100 mg in the morning and 200 mg at night before bedtime).

Vaginally:

It can be used again in the next application (with a minimum environmental impact since it is not disposable):

The dose can range from 200 mg to 600 mg per day.

If you take more Seidigestan than you should

Consult your doctor or pharmacist immediately or go to the nearest hospital. In case of overdose or massive ingestion, various effects such as menstrual disorders, including amenorrhea (disappearance of menstruation), and also sedation (drowsiness) and liver alterations may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Seidigestan

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The most common adverse reactions are:

Orally:

• Drowsiness (tendency to sleep) and/or fleeting vertigo sensation. They appear 1 to 3 hours after ingestion of the product.
• Shortening of the menstrual cycle or intercurrent bleeding.
• Amenorrhea (disappearance of menstruation).

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Seidigestan

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use the medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Seidigestan

• The active ingredient is micronized progesterone. One capsule contains 200 mg of progesterone.
• The other ingredients are sunflower oil, soybean lecithin, gelatin, glycerol (E 422), titanium dioxide (E 171), and purified water.

Appearance of Seidigestan and contents of the pack

Ovoid soft gelatin capsules. They are presented in boxes containing 15 capsules (one PVC/Aluminum blister and one applicator) or 60 capsules (4 PVC/Aluminum blisters and two applicators).

Marketing authorization holder and manufacturer

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Date of last revision of this leaflet: April/2024

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/.