Label: information for the user

Seidigestan 200 mg soft capsules

Progesterone

Label contents:

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

Seidigestan belongs to a group of medications called progestagens and contains natural progesterone.

Seidigestan is used for disorders related to progesterone deficiency, also in hormonal replacement therapy for menopause, to resolve some fertility problemsand for the prevention of certain types of premature birth and abortion.

Do not takeSeidigestan:

• If you are allergic toprogesterone or any of the other components of the medicationincluded in section 6.
• This medication contains soy lecithin. Do not use in case of allergy to peanuts or soy.
• If you haveundiagnosed vaginal bleeding.
• If you have a history of thromboembolic disorders.
• If you have severe liver dysfunction.

Warnings and precautions

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

Use of Seidigestan with other medications:

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication, including those acquired without a prescription.

Taking Seidigestan with food and drinks:

The ingestion of food after taking the capsules increases its 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Progesterone is the hormone that increases during pregnancy, so its administration during pregnancy does notproduceadverse effects.

Progesterone is eliminated through breast milk, so it is not recommended to administer it during the breastfeeding period.

Driving and operating machines:

Given the described risk of drowsiness and/or vertiginous sensations related to the use of progesterone by oral route, during treatmentshould not be performed activitiesthat require a special state of alertness, such as driving vehicles or operating hazardous machines.

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

Your doctor will indicate the duration of your treatment; do not discontinue treatment before the indicated time.

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

The recommended dose is:

Oral route:

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

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

Vaginal route:

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

The dose may 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, even amenorrhea (cessation 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 medication and the amount ingested.

If you forgot to take Seidigestan

Do not take a double dose to compensate for the missed doses.

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

Oral Route:

• Drowsiness (tendency to sleep) and/or brief episodes of dizziness. 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 consider that any of the adverse effects you are experiencing are severe or if you notice any effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use the medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Seidigestan

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

Appearance of Seidigestan and content of the packaging

Soft gelatin capsules. It is presented in boxes containing 15 capsules (a PVC/Aluminum blister and an applicator) or 60 capsules (4 PVC/Aluminum blisters and two applicators).

Holder of the marketing authorization and responsible for manufacturing

SEID, S.A.

Carretera de Sabadell a Granollers, Km. 15

08185 - Lliçà de Vall (Barcelona)

Last review date of this leaflet: April/2024

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.