SEIDIGESTAN 100 mg soft capsules

Introduction

Package Leaflet: Information for the User

SEIDIGESTAN 100 mg Soft Capsules

Progesterone

Contents of the Package Leaflet:

1. What Seidigestan 100 mg is and what it is used for
2. What you need to know before you take Seidigestan 100 mg
3. How to take Seidigestan 100 mg
4. Possible side effects
5. Storage of Seidigestan 100 mg
6. Contents of the pack and further information

1. What Seidigestan 100 mg is and what it is 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 100 mg

Do not takeSeidigestan

• If you are allergic to progesterone or any of the other ingredients of Seidigestan listed in section 6.
• This medicine contains soy lecithin. It should not be used in case of peanut or soy allergy.
• If you have undiagnosed vaginal bleeding.
• If you have a history of thromboembolic disorders.
• If 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 of use does not have a contraceptive effect.

Using Seidigestan with other medicines:

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

Taking Seidigestan with food and drinks:

The ingestion of food 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 might 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 the breastfeeding period is not advisable.

Driving and using machines:

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

3. How to take Seidigestan 100 mg

Follow exactly the administration instructions of Seidigestan 100 mg as 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 with Seidigestan. Do not stop the treatment before the indicated time.

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:

Insert the capsules into the vagina deeply, pushing them with your finger.

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 Toxicological 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 the forgotten doses.

4. Possible side effects

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

Orally:

• Drowsiness (tendency to sleep) and/or fleeting vertigo sensations. 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 mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Seidigestan 100 mg

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use Seidigestan after the expiry date stated on the carton after CAD. 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 medicines in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Seidigestan 100 mg capsules

• The active ingredient is micronized progesterone. One capsule contains 100 mg of progesterone.
• The other ingredients are sunflower oil, soy lecithin, gelatin, glycerol (E 422), titanium dioxide (E 171), and purified water.

Appearance of the product and contents of the pack

Spherical soft gelatin capsules. They are presented in boxes containing 30 capsules (2 blisters) or 60 capsules (4 blisters).

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: October 2022

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/.