Package Insert: Information for the User

Utrogestan 300 mg Vaginal Soft Capsules

progesterone

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it 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 they are not listed in this package insert. See section 4.

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

What is Utrogestan used for

Progesterone can be used as pregnancy support during in vitro fertilization (IVF) cycles.

Pregnancy support

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

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 genital tract cancer
• 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 (hereditary)
• If you are pregnant but your baby has died inside you (retained abortion)

Warnings and precautions

Utrogestan should only be used during the first three months of pregnancy. Consult your doctor or pharmacist before starting to use this medication.

This medication is not a contraceptive.

If you have diabetes and use insulin to control your blood sugar levels, progesterone treatment may affect your response to insulin and may require adjustment of your antidiabetic medication.

If you have vaginal bleeding, speak with your doctor.

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

You should contact your doctor if you feel unwell a few days after taking the medication.

Children

This medication should not be used in children.

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:

• anticoagulants such as coumarins or phenindione
• ciclosporin or tacrolimus (used to reduce the immune response)
• tizanidine (muscle relaxant)
• bromocriptine, used to treat problems related to the pituitary gland or Parkinson's disease
• selegiline (for the treatment of Parkinson's disease)
• diazepam, clordiazepoxide, alprazolam, oxazepam, or lorazepam (to treat anxiety or insomnia)
• medications for tuberculosis (such as rifampicin and rifabutin)
• antibiotics (for example, griseofulvin, ampicillin, amoxicillin, and tetracyclines), used to treat certain infections
• phenytoin, phenobarbital, carbamazepine, eslicarbazepine, oxcarbazepine, primidone/rufinamide, perampanel, or topiramate (used to treat epilepsy)
• herbal medications containing St. John's Wort
• darunavir, nelfinavir, fosamprenavir, or lopinavir (used to treat viral infections)
• bosentan (used to treat lung problems)
• fluconazole, itraconazole, voriconazole (for the treatment of fungal infections)
• ketoconazole (used to treat Cushing's syndrome, when the body produces too much cortisol)
• atorvastatin or rosuvastatin (used to control cholesterol)
• aprepitant (used to prevent nausea and vomiting).

If you have recently been administered an anesthetic, such as bupivacaine or

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

Utrogestan with food and beverages

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

Pregnancy,breastfeeding, and fertility

• This medication will help you maintain pregnancy if you are receiving fertility treatment. 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 for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is used to help you get pregnant

• 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

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 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 using 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:

Very rare (may affect up to 1 in 10,000 people):

• Severe allergic reaction that causes difficulty breathing or dizziness.

Unknown frequency (cannot be estimated from available data):

• Itching
• Oil secretion from the vagina
• Vaginal bleeding

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

If you notice side effects other than those mentioned above, inform your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor,pharmacist or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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.
• Once the bottle is opened, use the capsules within the next 15 days.
• Store in the original packaging (the bottle).
• Store below 30°C.
• 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. Deposit the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Composition of Utrogestan

• The active ingredient is progesterone. Each capsule contains 300 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 content of the container

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Besins Healthcare Ireland Limited

4th Floor Custom House Plaza, 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

Local Representative:

Laboratorios Rubió, S.A.

Pol.Ind. Comte de Sert

C/Industria 29

08755 Castellbisbal-Barcelona

Spain

This medicine is authorized in the EEA member states with the following names:

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

Belgium, Ireland, Luxembourg: Utrogestan Vaginal

Finland: Lugesteron

Lithuania, Latvia: Progesterone Besins

Czech Republic: Progesteron Besins

Denmark, Iceland: Progestan

Last review date of the leaflet:

December 2023

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