Utrogestan 400 mg soft vaginal capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Utrogestan 400 mg soft vaginal capsules

progesterone

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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 adverse 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

This medicine can be used as pregnancy support.

As pregnancy support

This medicine can be used to help reduce the risk of miscarriage in women who are experiencing bleeding during the current pregnancy and who have a history of recurrent miscarriages.

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

Do not use Utrogestan

• if you are allergic to progesterone, soy, peanut, 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 undiagnosed vaginal bleeding.
• if you have or have had breast or genital cancer.
• if you have or have had blood clots in a vein (thrombosis), which may sometimes be painful (thrombophlebitis), for example in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism).
• if you have had cerebral haemorrhage or stroke.
• if you suffer from a rare inherited blood disorder called porphyria, which is passed from parents to children (hereditary).

Warnings and precautions

This medicine should only be used during the first three months of pregnancy. Consult your doctor, pharmacist, or nurse before starting to use this medicine.

This medicine is not a contraceptive.

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

You should contact your doctor if:

• you experience any vaginal bleeding.
• you do not feel well within a few days of using the medicine.

Children and adolescents

This medicine should not be used in children or adolescents.

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 is because Utrogestan may affect how other medicines work. In addition, some medicines may affect how Utrogestan 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)

If you have recently undergone tests for liver or hormonal problems.

Use of Utrogestan with food and drink

This medicine is administered vaginally. Food and drink do not affect treatment.

Pregnancy and breastfeeding

Do not use this medicine during breastfeeding.

Driving and using machines

Utrogestan should not affect your ability to drive or operate machinery. 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 soy lecithin

Do not use this medicine if you are allergic to peanut or soy.

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 as indicated by your doctor. If you experience adverse reactions, consult your doctor, pharmacist, nurse, or midwife.

To reduce the risk of miscarriage in women with bleeding during the current pregnancy, this medicine should be started at the first sign of vaginal bleeding during the first trimester and must be continued at least until week 16 of pregnancy.

Use of this medicine to reduce the risk of threatened or recurrent miscarriage

• Insert this medicine deeply into the vagina.
• Do not swallow.

How much Utrogestan to use

• Use one capsule of this medicine twice daily, once in the morning and once before bedtime, or as directed by your doctor.
• Continue with the same dosing regimen until your doctor tells you to stop.

If you use more Utrogestan than you should

If you have used too much of this medicine, you must speak with your doctor or go to a hospital. Take the medicine packaging with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount ingested.

The following effects may occur: dizziness or tiredness.

If you forget to use Utrogestan

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

If you stop treatment with Utrogestan

Talk to your doctor, pharmacist, nurse, or midwife before stopping this medicine.

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

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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 on the vial after “EXP”. The expiry date refers to the last day of the month indicated.

• Store in the original packaging.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

• Do not use this medicine if you notice any visible changes in the appearance of the capsules.

6. Contents of the pack and other information

Composition of Utrogestan

• The active substance is progesterone. Each soft vaginal capsule contains 400 mg of progesterone.
• The other components (excipients) of the capsule are sunflower oil, soya lecithin (E322), gelatin (E422), glycerol (E422), titanium dioxide (E171), and purified water.

Appearance of Utrogestan and contents of the pack

Oblong soft gelatin capsules (approximately 2.5 cm x 0.9 cm), yellowish, containing a whitish oily suspension.

Available in:

• White high-density polyethylene bottle containing 15 soft vaginal capsules
• PVC/Aluminum blisters of 15, 30 or 45 capsules in a cardboard box.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Besins Healthcare Ireland Limited

Plaza 4, Level 4 Custom House Plaza

Harbourmaster Place, IFSC

Dublin 1, D01 A9N3

Ireland

Manufacturer

Cyndea Pharma S.L.

Poligono Industrial Emiliano Revilla Sanz

Avenida de Agreda, 31

Olvega 42110 (Soria)

Spain

or

BESINS MANUFACTURING ESPAÑA S.L.

Polígono Industrial El Pitarco, Parcela 4

Muel, 50450 Zaragoza,

Spain

Further information on this medicine is available upon request from the local representative of the marketing authorization holder

Laboratorios Rubió, S.A.

Pol.Ind. Comte de Sert

C/Industria 29

08755 Castellbisbal-Barcelona

Spain

This medicine is authorized in the European Economic Area member states under the following names:

Bulgaria, Estonia, Hungary, Croatia, Cyprus, France, Ireland, Italy, Malta, Netherlands, Norway, Poland, Sweden, Slovenia, Slovakia, Spain: Utrogestan

Belgium, Luxembourg, Portugal: Utrogestan Vaginal

Finland: Lugesteron

Latvia, Lithuania: Progesterone Besins

Czech Republic: Progesteron Besins

Denmark, Iceland: Progestan

Date of most recent review of this leaflet: February 2026

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