Leaflet: information for the user

Utrogestan 200 mg vaginal soft capsules

progesterone

Read this leaflet carefully before you start using this medicine, as 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 only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Utrogestan and what it is used for

2. What you need to know before starting to use Utrogestan

3. How to use Utrogestan

4. Possible side effects

5. Storage of Utrogestan

6. Contents of the pack and additional information

The name of your medication is Utrogestan. Utrogestan contains a hormone called progesterone.

What is Utrogestan used for

As pregnancy support during fertility treatment

Utrogestan is indicated as pregnancy support for women who need additional progesterone while receiving treatment in an assisted reproductive techniques (ART) program.

To prevent premature birth in women with a single pregnancy

Utrogestan is for women who have previously had a premature baby and/or have a short cervix.

Do not use Utrogestan

• If you are allergic (hypersensitive) to soy or peanuts
• If you are allergic to progesterone or any of the other components of this medication (listed in section 6)
• If you have liver problems
• If you have yellowing of the skin or eyes (jaundice)
• If you have unexplained vaginal bleeding
• If you have breast cancer or cancer of the genital tract
• If you have thrombophlebitis
• If you have or have had blood clots in a vein (thrombosis), such as in the legs (deep vein thrombosis) or lungs (pulmonary embolism)
• If you have had a cerebral hemorrhage
• If you have a rare blood disorder called “porphyria” that is inherited from parents to children
• If you are pregnant but your baby has died inside you (retained abortion)
• If you have "ruptured membranes".

Do not use this medication if you are in any of the above situations. If you are unsure, consult your doctor or pharmacist before using this medication.

Warnings and precautions

This medication is not a contraceptive.

If you think you may have had a spontaneous abortion, you must speak with your doctor, as you should stop using this medication.

If you have vaginal bleeding, speak with your doctor.

If you are taking this medication as a pregnancy support during fertility treatment

Utrogestan should only be used during the first 3 months of pregnancy.

If you are taking this medication to prevent premature birth in women with a single pregnancy

Your doctor should discuss the risks and benefits of the available options with you. You and your doctor should make a shared decision about which treatment is most suitable.

If you are at risk of having a premature baby, you may be given this medication from around week 20 to week 34 of your pregnancy. If you rupture membranes while taking the medication, you should consult your doctor as soon as possible. If this happens, there may be an immediate risk to you and your baby.

In rare cases, use during the second and third trimester of pregnancy may cause the development of liver problems. Contact your doctor if you experience itching, which may be a sign of liver problems.

Children

This medication should not be used in children.

Tests and monitoring

Your doctor will perform a complete medical examination before starting treatment and periodically during treatment.

Other medications and Utrogestan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes over-the-counter medications and herbal medications. This medication may affect how other medications work. Additionally, some medications may affect how this medication works.

Particularly, inform your doctor or pharmacist if you are taking any of the following medications:

Use of Utrogestan with food and drinks

This medication should be inserted into the vagina. Food and drinks do not affect the treatment.

Pregnancy,breastfeeding and fertility

• This medication will help you maintain pregnancy if you are receiving fertility treatment or if your doctor has told you that you are at risk of having a premature baby. See section 3 to learn how to use Utrogestan.
• This medication should not be used during breastfeeding.

Driving and operating machinery

This medication has insignificant effects on driving or operating machinery.

Utrogestan contains soy lecithin

If you are allergic to peanuts or soy, do not use this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• Use this medication by inserting it deeply into the vagina.
• Do not use orally. If you accidentally take this medication orally, it will not harm you, but it will reduce your chances of getting pregnant.

Recommended dose

As support during in vitro fertilization (IVF) cycles:

For the prevention of premature birth in certain women:

If you use more Utrogestan than you should

If you use too much Utrogestan, you should consult your doctor or go to the hospital. Bring the medication with you.

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.

The following effects may occur: dizziness or fatigue.

If you forgot to use Utrogestan

• If you forget a dose, introduce it as soon as you remember. However, if it is almost time for the next dose, omit the missed dose.
• • Do not use a double dose to compensate for the missed doses.

If you interrupt the treatment with Utrogestan

Talk to your doctor, pharmacist, or nurse before stopping using this medication. If you stop using the medication, it will not help you get pregnant.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur with this medication:

Unknown frequency (cannot be estimated from available data):

• Itching
• Abnormal vaginal discharge
• Vaginal bleeding
• Burning sensation

You may experience temporary fatigue or dizziness within 1 to 3 hours after taking the medication.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor,pharmacist, or nurse, 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: www.notificaRAM.es By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box after EXP. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• Do not use this medication if you observe visible changes in the appearance of the medication.
• Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.
• Any unused medication or waste material must be disposed of in accordance with local requirements.

Composition of Utrogestan

• The active ingredient is progesterone. Each capsule contains 200 mg of progesterone.
• The other components are sunflower oil and soy lecithin. The other components of the capsule coating are gelatin, glycerol, titanium dioxide (E171), and purified water.

Appearance of the product and contents of the package

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Besins Healthcare Ireland Limited

Custom House Plaza, 4th Floor

Harbourmaster Place, International Financial Services Centre

Dublin 1

D01 A9N3

Ireland

Responsible for manufacturing:

Cyndea Pharma, S.L.

Polígono Industrial Emiliano Revilla Sanz

Avenida de Ágreda, 31, Olvega

42110 Soria

Spain

Or

BESINS MANUFACTURING ESPAÑA

Polígono Industrial El Pitarco, parcela nr. 4

50450 Muel (Zaragoza)

Spain

Local Representative:

Laboratorios Rubió, S.A.

Pol.Ind. Comte de Sert

C/Industria 29

08755 Castellbisbal-Barcelona

Spain

This medicinal product is authorized in the Member States of the EEA with the following names:

Bulgaria: Utrogestan 200 mg vaginal capsules, soft

Croatia: Utrogestan 200 mg meke kapsule za rodnicu.

Czech Republic: Progesteron Besins 200 mg mekké tobolky

Denmark: Progestan

Spain: Utrogestan 200 mg vaginal soft capsules

Estonia: Utrogestan 200 mg vaginaalpehmekapslid

Hungary: Utrogestan 200 mg lágy hüvelykapszula

Ireland: Utrogestan Vaginal 200mg Vaginal Capsules, soft

Iceland: Progestan 200 mg Mjúkt skeiðarhylki

Italy: Utrogestan Vaginale 200 mg Capsula molle

Lithuania: Progesterone Besins 200 mg makšties minkštosios kapsules

Netherlands: Utrogestan 200 mg, zachte capsules voor vaginaal gebruik

Malta: Utrogestan Vaginal 200 mg Capsules, soft

Norway: Utrogestan 200 mg vaginalkapsler, myke

Poland: Utrogestan 200 mg, kapsulki dopochwowe, miekkie

Portugal: Utrogestan Vaginal 200 mg Cápsula mole

Slovakia: Utrogestan 200 mg mäkké vaginálne kapsuly

Slovenia: Utrogestan 200 mg mehke vaginalne kapsule

Sweden: Utrogestan 200 mg mjuk Vaginalkapsel

United Kingdom: Utrogestan Vaginal 200mg Capsules

Last review date of the leaflet:November2023

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