Seidigestan 200 mg soft capsules

Spain
Brand name Seidigestan 200 mg soft capsules
Form capsules, soft gelatin
Active substance / Dosage
PROGESTERONE · 200 mg
Prescription type Prescription Only Medicine. Long-Term Treatment
Registration number 64899
Manufacturer Seid S.A.

Patient Information Leaflet

Introduction

Patient Information Leaflet

Seidigestan 200 mg soft capsules

Progesterone

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Package leaflet contents:

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

1. What Seidigestan is and what it is used for

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

Seidigestan is used for disorders associated with progesterone deficiency, also in hormone replacement therapy for menopause, to address certain fertility problems, and for the prevention of certain types of premature birth and miscarriage.

2. What you need to know before starting to take Seidigestan

Do not take Seidigestan:

  • If you are allergic to progesterone or to any of the other ingredients of the medicine listed in section 6.
  • This medicine contains soy lecithin. It should not be used if you are allergic to peanuts or soy.
  • If you have undiagnosed vaginal bleeding.
  • If you have a history of thromboembolic disorders.
  • If you suffer from severe liver disorders.

Warnings and precautions

  • In case of drowsiness, it is recommended to take the capsules preferably at night before going to bed.
  • Treatment under the conditions described has no contraceptive effect.

Use of Seidigestan with other medicines:

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

Taking Seidigestan with food and drink:

Taking food after ingesting the capsules increases their absorption. Therefore, it is recommended to take the capsules at the same time each day, away from meals, to avoid variations in intake from one day to the next.

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; therefore, its administration during pregnancy does not produce adverse effects.

Progesterone is excreted in breast milk; therefore, administration during breastfeeding is not recommended.

Driving and using machines:

Since drowsiness and/or dizziness have been reported in association with oral progesterone use, activities requiring special alertness—such as driving vehicles or operating dangerous machinery—should not be performed during treatment.

3. How to take Seidigestan

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

Your doctor will indicate how long you should take the treatment; do not stop the treatment before the indicated time.

The dose to be administered should be established according to each patient's hormonal plasma levels and will vary depending on the indications.

The recommended dose is:

Oral route:

Take the capsules with a glass of water, outside mealtimes.

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

Vaginal route:

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

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

If you take more Seidigestan than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (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 missed doses.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them. The most common adverse reactions are:

Oral route:

  • Somnolence (drowsiness) and/or transient dizziness. These occur 1 to 3 hours after taking the product.
  • Shortening of the menstrual cycle or intercurrent bleeding.
  • Amenorrhea (absence of menstruation).

If you consider any of the adverse effects you experience to be severe, or if you notice any effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If you are in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Seidigestan

  • The active substance is micronized progesterone. One capsule contains 200 mg of progesterone.
  • The other components 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. Available in boxes containing 15 capsules (one PVC/aluminum blister) or 60 capsules (4 PVC/aluminum blisters).

Marketing Authorization Holder and Manufacturer

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Date of latest review of this leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.