UTROGESTAN 200 mg SOFT VAGINAL CAPSULES

2. What you need to know before you use Utrogestan

Do not use Utrogestan

• If you are allergic (hypersensitive) to soy or peanuts
• 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)
• If your water has broken.

Do not use this medicine if you are in any of the above situations. If you are not sure, 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 talk to your doctor, as you should stop using this medicine.

If you have vaginal bleeding, talk to your doctor.

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

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

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

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

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 water breaks while you are taking the medicine, 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 liver problems to develop. Contact your doctor if you experience itching, which may be a sign of liver problems.

Children

This medicine should not be used in children.

Tests and checks

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

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. Additionally, 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:

• Bromocriptine used for pituitary gland problems or Parkinson's disease.
• Ciclosporin (used to suppress the immune system).
• Medicines containing rifamicin, such as rifampicin (used to treat infections).
• Ketoconazole (used for fungal infections).

Using Utrogestan with food and drink

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

Pregnancy, breast-feeding, and fertility

• This medicine 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 know how to use Utrogestan.
• This medicine should not be used during breast-feeding.

Driving and using machines

This medicine has negligible effects on driving or using machines.

Utrogestan contains soy lecithin

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

3. How to use Utrogestan

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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 orally, it will not harm you, but it will reduce your chances of becoming pregnant.

Recommended dose

As support during in vitro fertilization (IVF) cycles:

• Treatment starts no later than the third day after egg retrieval.
• Every day, use 600 mg of this medicine according to the doctor's instructions. Insert one capsule deeply into the vagina in the morning, at noon, 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.

For the prevention of premature birth in certain women:

• Every day, insert one capsule (200 mg) of this medicine deeply into the vagina, at night before bedtime. This medicine can be administered from week 20 to week 34 of pregnancy.

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 use of this medicine. If you stop using the medicine, it will not help you become pregnant.

If you have any further questions on 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:

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

• Itching
• greasy discharge in the vagina
• vaginal bleeding
• burning sensation

You may experience fatigue or dizziness shortly after taking the medicine, within 1 to 3 hours.

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 side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website (http://www.aemps.gob.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.
• This medicine does not require any special storage conditions.
• 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.
• Any unused medicine or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information

Composition of Utrogestan

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

Appearance of the product and contents of the pack

• Utrogestan is soft, oval, and slightly yellow vaginal capsules containing a white oily suspension.
• They are supplied in boxes containing PVC/Aluminum blister packs of 15, 21, 45, or 90 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

Bulgaria: Utrogestan 200 mg vaginal capsules, soft

Croatia: Utrogestan 200 mg soft vaginal capsules.

Czech Republic: Progesteron Besins 200 mg soft capsules

Denmark: Progestan

Spain: Utrogestan 200 mg soft vaginal capsules

Estonia: Utrogestan 200 mg vaginal soft capsules

Hungary: Utrogestan 200 mg soft vaginal capsules

Ireland: Utrogestan Vaginal 200mg Vaginal Capsules, soft

Iceland: Progestan 200 mg soft vaginal capsules

Italy: Utrogestan Vaginale 200 mg soft capsules

Latvia: Progesterone Besins 200 mg vaginal soft capsules

Lithuania: Progesterone Besins 200 mg soft vaginal capsules

Netherlands: Utrogestan 200 mg, soft capsules for vaginal use

Malta: Utrogestan Vaginal 200 mg Capsules, soft

Norway: Utrogestan 200 mg vaginal soft capsules

Poland: Utrogestan 200 mg, soft vaginal capsules

Portugal: Utrogestan Vaginal 200 mg soft capsules

Slovakia: Utrogestan 200 mg soft vaginal capsules

Slovenia: Utrogestan 200 mg soft vaginal capsules

Sweden: Utrogestan 200 mg soft vaginal capsules

United Kingdom: Utrogestan Vaginal 200mg Capsules

Date of last revision of the leaflet:November 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/)