UTROGESTAN 300 mg SOFT VAGINAL CAPSULES

Introduction

Package Leaflet: Information for the User

Utrogestan 300 mg Soft Vaginal Capsules

progesterone

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Utrogestan and what is it used for

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

What Utrogestan is used for

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

As pregnancy support

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

2. What you need to know before you use Utrogestan

Do not use Utrogestan

• If you are allergic (hypersensitive) to peanuts or soya
• If you are allergic to progesterone 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 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 (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 3 months of pregnancy. Consult your doctor or pharmacist before starting to use this medicine.

This medicine is not a contraceptive.

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

If you have vaginal bleeding, talk to your doctor.

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

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

Children

This medicine should not be used in children.

Other medicines and Utrogestan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. This includes medicines without a prescription and herbal medicines. This medicine may affect the way other medicines work. Also, some medicines may affect the way this medicine works.

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

• anticoagulants such as coumarins or phenindione
• cyclosporin 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, chlordiazepoxide, alprazolam, oxazepam, or lorazepam (for anxiety or insomnia)
• medicines for tuberculosis (such as rifampicin and rifabutin)
• antibiotics (e.g., griseofulvin, ampicillin, amoxicillin, and tetracyclines), used to treat certain infections
• phenytoin, phenobarbital, carbamazepine, eslicarbazepine, oxcarbazepine, primidone/rufinamide, perampanel, or topiramate (used for epilepsy)
• herbal medicines containing St. John's Wort
• darunavir, nelfinavir, fosamprenavir, or lopinavir (used to treat viral infections)
• bosentan (used to treat pulmonary 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 given an anesthetic, such as bupivacaine or

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

Using Utrogestan with food and drinks

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

Pregnancy, breastfeeding, and fertility

• This medicine will help you maintain pregnancy if you are receiving fertility treatment. See section 3 to know how to use Utrogestan.
• This medicine should not be used during breastfeeding.

Driving and using machines

This medicine has negligible effects on driving or using machines.

Utrogestan contains soya lecithin

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

3. How to use Utrogestan

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

The use of this medicine is to help you get pregnant

• Do not use orally. If you accidentally take this medicine orally, it will not harm you, but it will reduce your chances of getting pregnant.

Recommended dose

• Treatment starts no later than the third day after egg retrieval.
• Every day, use 600 mg of this medicine according to your doctor's instructions. Insert one capsule deeply into the vagina in the morning and before bedtime.
• If laboratory tests confirm that you are pregnant, continue with the same dose until at least week 7 of pregnancy, but no more than week 12 of pregnancy, according to your doctor's instructions.

If you use more Utrogestan than you should

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

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

The following effects may occur: feeling of dizziness or fatigue.

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 missed 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 get pregnant.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur with this medicine:

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

• Severe allergic reaction that causes difficulty breathing or dizziness.

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

• Itching
• oily vaginal discharge
• vaginal bleeding

You may experience fatigue or dizziness shortly after taking the medicine.

If you notice side effects not mentioned above, inform your doctor.

Reporting of side effects

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

5. Storage of Utrogestan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.
• Once the bottle is opened, use the capsules within the next 15 days.
• Store in the original package (the bottle).
• Store below 30°C.
• Do not use this medicine if you notice visible changes in the appearance of the medicine.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Utrogestan

• The active substance is progesterone. Each capsule contains 300 mg of progesterone.
• The other ingredients are sunflower oil and soya lecithin. The other ingredients of the capsule shell are gelatin, glycerol, titanium dioxide (E171), and purified water.

Appearance of the product and pack contents

• The capsules are soft gelatin capsules, oblong, yellowish, containing a white oily suspension. The dimensions of the 300 mg capsule are approximately 2.5 cm x 0.8 cm.
• Utrogestan is supplied in white high-density polyethylene plastic bottles with a child-resistant polypropylene white screw cap and a silver tear-off seal. Pack size: 1 bottle containing 15 capsules.

Marketing authorisation holder and manufacturer

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

Local Representative:

Laboratorios Rubió, S.A.

Pol.Ind. Comte de Sert

C/Industria 29

08755 Castellbisbal-Barcelona

Spain

This medicine is authorised in the Member States of the EEA under 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

Latvia, Lithuania: Progesterone Besins

Czech Republic: Progesteron Besins

Denmark, Iceland: Progestan

Date of last revision of the leaflet:

December 2023

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/)