Utrogestan 200 mg soft capsules for vaginal use

Patient Information Leaflet

Introduction

Patient Information Leaflet

Utrogestan 200 mg soft vaginal capsules

progesterone

Read the entire 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; do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Utrogestan is and what it is used for
2. What you need to know before using Utrogestan
3. How to use Utrogestan
4. Possible side effects
5. How to store Utrogestan
6. Contents of the pack and other information

1. What Utrogestan is and what it is used for

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

What Utrogestan is used for

As support during pregnancy in fertility treatment.

Utrogestan is indicated for luteal support in women who require additional progesterone while undergoing treatment in an assisted reproductive technology (ART) programme.

To prevent preterm birth in women with a singleton pregnancy

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

2. What you need to know before using Utrogestan

Do not use Utrogestan

• If you are allergic to progesterone, soya, peanuts, or any of the other ingredients of this medicine (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 or genital tract carcinoma
• 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 in the lungs (pulmonary embolism)
• If you have had a cerebral haemorrhage
• If you have a rare inherited blood disorder called "porphyria"
• If you are pregnant but your baby has died inside you (missed abortion)
• If your waters have broken.

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

Warnings and precautions

This medicine is not a contraceptive.

If you think you may have had a miscarriage, you should speak with your doctor, as you should stop using this medicine.

If you have vaginal bleeding, speak with your doctor.

If you are taking this medicine as pregnancy support during fertility treatment

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

If you are taking this medicine to prevent preterm 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 on which treatment is most appropriate.

If you are at risk of having a premature baby, you may be given this medicine from around week 20 to week 34 of your pregnancy. If your waters break while you are taking the medicine, you must consult your doctor as soon as possible. If this occurs, there may be an immediate risk to you and your baby.

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

Children and adolescents

This medicine should not be used in children and adolescents.

Tests and monitoring

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

Other medicines and Utrogestan

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines without a prescription and herbal medicines. This medicine may affect how other medicines work. In addition, some medicines may affect how this medicine works.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• Medicines used to help you relax or sleep (e.g., phenobarbital, pentobarbital)
• Medicines used to control seizures or epilepsy (e.g., phenytoin or carbamazepine)
• Medicines used to treat tuberculosis, particularly rifampicin
• Herbal remedies for low mood or anxiety containing St. John’s wort
• Medicines used to treat fungal infections (e.g., ketoconazole)

Use of Utrogestan with food and drink

This medicine is inserted into the vagina. Food and drink do not affect treatment.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

Utrogestan should not affect your ability to drive or use machines. However, in some people it may cause dizziness and fatigue. If you experience these effects, caution is advised when driving or operating machinery.

Utrogestan contains soya lecithin

If you are allergic to peanuts or soya, do not use this medicine.

Utrogestan contains highly refined sunflower oil, which very rarely causes reactions in adults allergic to refined oils.

3. How to use Utrogestan

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Use this medicine by inserting it deeply into the vagina.
• Do not use orally. If you accidentally take this medicine by mouth, it will not harm you, but your chances of becoming pregnant may be reduced.

Recommended dose

As support during in vitro fertilization (IVF) cycles:

• Treatment should start no later than the third day after egg retrieval.
• Each day, use 600 mg of this medicine as directed by your doctor. Insert one capsule deeply into the vagina in the morning, at midday, and at bedtime.
• If laboratory tests confirm that you are pregnant, continue the same dose until at least week 7 of pregnancy, but no later than week 12 of pregnancy, as instructed by your doctor.

For prevention of preterm birth in certain women:

• Each day, insert one capsule (200 mg) of this medicine deeply into the vagina at night before going to bed. This medicine may be administered from week 20 up to week 34 of pregnancy.

If you use more Utrogestan than you should

If you use too much Utrogestan, you must consult your doctor or go to a hospital. Take the medicine with you.

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.

The following effects may occur: feeling dizzy or tired.

If you forget to use Utrogestan

• If you forget a dose, insert it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
  • Do not use a double dose to make up for forgotten doses.

If you stop using Utrogestan

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur with this medicine:

Frequency not known (cannot be estimated from available data):

• itching
• oily vaginal discharge
• vaginal bleeding
• burning sensation
• dizziness
• feeling very tired (fatigue)

You may experience fatigue or dizziness for a short time within 1 to 3 hours after taking the medicine.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Utrogestan

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice any visible changes in its appearance.
• Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Utrogestan

• The active substance is progesterone. Each soft vaginal capsule contains 200 mg of progesterone.
• The other ingredients are sunflower oil and soya lecithin (E322). The other components of the capsule shell are gelatin (E441), glycerol (E422), titanium dioxide (E171) and purified water.

What Utrogestan looks like and contents of the pack

• Oval, slightly yellow soft capsules containing a white or whitish oily suspension.
• Supplied in boxes containing PVC/aluminum blisters of 15, 21, 45 or 90 capsules. Only certain pack sizes may be marketed.

Marketing Authorisation Holder:

Besins Healthcare Ireland Limited

Plaza 4, Level 4 Custom House Plaza

Harbourmaster Place, International Financial Services Centre

Dublin 1

D01 A9N3

Ireland

Manufacturer:

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 authorised in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under 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 cápsulas vaginales blandas

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

Latvia: Progesterone Besins 200 mg vaginalas mikstas kapsulas

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

Date of the most recent revision of the leaflet: February 2026

Detailed 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/)