Package Insert: Information for the User

SEIDIGESTAN 100 mg Soft Capsules

Progesterone

Package Insert Content:

1. What Seidigestan 100 mg is and for what it is used
2. What you need to know before starting to 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 package and additional information

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

Seidigestan is used for disorders related to progesterone deficiency, also in hormone replacement therapy for menopause, to resolve some fertility issues and to prevent certain types of premature birth and abortion.

Do not takeSeidigestsan

• If you are allergic toprogesterone or any of the other components ofSeidigestan listed 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 bedtime.
• 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 doses 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 the pregnancy period, so its administration during this period does not produce adverse 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 risk of drowsiness and/or vertiginous sensations related to the use of progesterone by oral route, during treatment, activities that require a special state of alertness, such as driving vehicles or operating hazardous machines, should not be performed.

Follow exactly the administration instructions for Seidigestan 100 mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts. Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Seidigestan. 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:

Insert the capsules deeply into the vagina using your finger.

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 may occur such as menstrual disorders, including amenorrhea (cessation of menstruation), and also sedation and liver alterations.

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, Seidigestan may cause 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 any of the adverse effects you are experiencing to be severe or if you notice any effect not mentioned in this prospect, inform your doctor or pharmacist.

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use Seidigestan 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 100 mg capsules

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

Appearance of the product and contents of the packaging

Soft gelatin capsules. It is presented in boxes containing 30 capsules (2 blisters) or 60 capsules (4 blisters).

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: October 2022

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/.