Seidigestan 100 mg soft capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

SEIDIGESTAN 100 mg soft capsules

Progesterone

Package leaflet contents:

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

1. What Seidigestan 100 mg 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 related to a deficiency of progesterone, also in hormone replacement therapy for menopause, to address certain fertility problems, and for the prevention of certain types of preterm birth and miscarriage.

2. What you need to know before starting Seidigestan 100 mg

Do not take Seidigestan

• If you are allergic to progesterone or to any of the other components of Seidigestan listed in section 6.
• This medicine contains soya lecithin. It must not be used if you are allergic to peanuts or soya.
• 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 does not have a 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:

Food intake after taking the capsules increases their absorption; therefore, it is recommended to take the capsules at the same time each day, apart from meals, to avoid variations in intake from one day to the next.

Pregnancy and breastfeeding

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

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

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

Driving and use of machines:

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

3. How to take Seidigestan 100 mg

Follow exactly the instructions for use of Seidigestan 100 mg provided by your doctor. If you have any doubts, consult your doctor or pharmacist. Remember to take your medication.

Your doctor will indicate the duration of your treatment with Seidigestan. Do not stop treatment earlier than instructed.

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 of mealtimes.

The recommended average 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).

Vaginal route:

Insert the capsules deeply into the vagina, pushing them with a 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 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 medication 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, Seidigestan may produce adverse effects, although not everyone experiences 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 that any of the adverse effects you experience is severe, or if you notice any effect not mentioned in this leaflet, inform 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 EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Seidigestan 100 mg capsules

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

Appearance of the medicine and contents of the pack

Soft gelatin capsules, spherical in shape. Packaged 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 most recent revision of this leaflet: October 2022

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