Utrogestan

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Utrogestan (Utrogestan 200 mg), 200 mg, Vaginal Soft Capsules

Progesteronum
Utrogestan and Utrogestan 200 mg are different trade names for the same drug.

You Should Carefully Read the Contents of the Leaflet Before Using the Medication, as it Contains Important Information for the Patient.

• You Should Keep this Leaflet, so that You Can Read it Again if Necessary.
• In Case of Any Doubts, You Should Consult a Doctor or Pharmacist.
• This Medication has been Prescribed to a Specific Person. Do not Pass it on to Others. The Medication may Harm Another Person, even if the Symptoms of their Illness are the Same.
• If the Patient Experiences any Undesirable Effects, including any Undesirable Effects not Mentioned in the Leaflet, they Should Inform their Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet

• 1. What is Utrogestan and what is it Used for
• 2. Important Information Before Using Utrogestan
• 3. How to Use Utrogestan
• 4. Possible Undesirable Effects
• 5. How to Store Utrogestan
• 6. Contents of the Packaging and Other Information

1. What is Utrogestan and what is it Used for

The Name of this Medication is Utrogestan. Utrogestan Contains a Hormone Called Progesterone.

What is Utrogestan Used for

Maintenance of Pregnancy During Infertility Treatment

Utrogestan is Intended for Women who Need Additional Doses of Progesterone to Maintain Pregnancy During Treatment as Part of an Assisted Reproductive Technology (ART) Program.

Prevention of Premature Birth in Single Pregnancies

Utrogestan is Intended for Women who have Previously Given Birth Prematurely and/or have a Short Cervix.

2. Important Information Before Using Utrogestan

When not to Use Utrogestan:

• If the Patient has been Diagnosed with an Allergy (Hypersensitivity) to Soy or Peanuts;
• If the Patient is Allergic to Progesterone or any of the Other Ingredients of this Medication (listed in Section 6);
• If the Patient has Liver Function Disorders;
• If the Patient has Jaundice (Yellowing of the Skin or Eyes);
• If the Patient has Bleeding from the Genital Tract of Unknown Cause;
• If the Patient has Cancer of the Breast or Genital Tract;
• If the Patient has Thrombophlebitis;
• If the Patient has had Blood Clots in the Veins (Thrombosis), for example in the Lower Limbs (Deep Vein Thrombosis) or Lungs (Pulmonary Embolism);
• If the Patient has had a Cerebral Hemorrhage;
• If the Patient has a Rare Blood Disease Called Porphyria, which is Inherited;
• If the Patient is Pregnant, but the Fetus has Died (Missed Abortion);
• If the Patient's Water has Broken.

Utrogestan should not be Used if any of the Above Situations Apply to the Patient. In Case of Doubt, the Patient should Discuss this with their Doctor or Pharmacist before Using Utrogestan.

Warnings and Precautions

Utrogestan is not a Contraceptive. If the Patient Suspects that they may have had a Miscarriage, they should Consult their Doctor, as it may be Necessary to Stop Using Utrogestan. If the Patient Experiences Vaginal Bleeding, they should Consult their Doctor.
If the Patient is Taking this Medication to Maintain Pregnancy During Infertility Treatment
Utrogestan should only be Used During the First 3 Months of Pregnancy.
If the Patient is Taking this Medication to Prevent Premature Birth in a Single Pregnancy
The Doctor will Discuss the Risks and Benefits of the Available Treatment Options with the Patient. The Doctor and Patient will Together Decide on the Most Suitable Treatment. If the Patient is at Risk of Premature Birth, they may Take Utrogestan from around the 20th to the 34th Week of Pregnancy. If the Patient's Water Breaks while Taking this Medication, they should Contact their Doctor Immediately. This Situation may Pose a Direct Threat to the Patient and their Child.
In Rare Cases, Use in the Second and Third Trimester may Lead to Liver Problems. If the Patient Experiences Itching, which may be a Sign of Liver Problems, they should Contact their Doctor.

Children

Utrogestan is not Intended for Use in Children.

Diagnostic and Monitoring Tests

Before Starting Treatment and Regularly During Treatment, the Doctor will Perform a Full Medical Examination.

Utrogestan and Other Medications

The Patient should Inform their Doctor or Pharmacist about all Medications they are Currently Taking or have Recently Taken, as well as any Medications they Plan to Take. This includes Medications Available without a Prescription, including Herbal Remedies. This is because Utrogestan may Affect the Action of some Other Medications. Some Other Medications may also Affect the Action of Utrogestan.
In Particular, the Patient should Inform their Doctor or Pharmacist if they are Taking any of the Following Medications:

• Bromocriptine, Used to Treat Disorders Related to the Pituitary Gland or Parkinson's Disease;
• Cyclosporine (Used to Weaken the Immune System);
• Rifamycin Derivatives, such as Rifampicin (Used to Treat Infections);
• Ketoconazole (Used to Treat Fungal Infections).

Utrogestan with Food and Drink

Utrogestan should be Inserted into the Vagina. Food and Drink do not Affect the Treatment.

Pregnancy, Breastfeeding, and Fertility

• Utrogestan is Used to Support Pregnancy During Infertility Treatment or if the Doctor has Determined that the Patient is at Risk of Premature Birth. Instructions for Using Utrogestan are Described in Section 3.
• Breastfeeding Women should not Use Utrogestan.

Driving and Operating Machinery

Utrogestan has a Negligible Influence on Driving and Operating Machinery.

Utrogestan Contains Soy Lecithin

Patients who have been Diagnosed with an Allergy to Peanuts or Soy should not Use this Medication.

3. How to Use Utrogestan

This Medication should always be Used in Accordance with the Doctor's Recommendations. In Case of Doubt, the Patient should Consult their Doctor or Pharmacist.

• This Medication should be Used by Inserting it Deep into the Vagina.
• The Medication should not be Taken Orally. However, Accidental Oral Ingestion is not Harmful, but it may Reduce the Chances of Becoming Pregnant.

Recommended Dose

Support in IVF Cycles:

• Treatment should Begin no Later than the Third Day after Egg Retrieval.
• 600 mg of Utrogestan should be Used Daily, as Recommended by the Doctor. One Capsule should be Inserted Deep into the Vagina in the Morning, at Noon, and Before Bedtime.
• If Laboratory Test Results Confirm that the Patient is Pregnant, the Same Dosing Schedule should be Continued for at Least 7 Weeks of Pregnancy, but no Longer than 12 Weeks of Pregnancy, as Recommended by the Doctor.

Prevention of Premature Birth in some Patients

• One Capsule (200 mg) of Utrogestan should be Inserted Deep into the Vagina Every Evening, Before Going to Bed. This Medication can be Used from around the 20th to the 34th Week of Pregnancy.

Using a Higher than Recommended Dose of Utrogestan

In Case of an Overdose of Utrogestan, the Patient should Consult their Doctor or Go to the Hospital. The Patient should Bring the Medication Packaging with them.
The Following Disorders may Occur: Dizziness or a Feeling of Fatigue.

Missing a Dose of Utrogestan

• If a Dose is Missed, it should be Taken as Soon as Possible. However, if it is Almost Time for the Next Dose, the Missed Dose should be Skipped.
• A Double Dose should not be Taken to Make up for a Missed Dose.

Stopping Utrogestan Treatment

Before Stopping Utrogestan Treatment, the Patient should Consult their Doctor, Pharmacist, or Nurse. If the Patient Stops Using Utrogestan, the Medication will not Help them Become Pregnant.
In Case of any Further Questions about Using this Medication, the Patient should Consult their Doctor, Pharmacist, or Nurse.

4. Possible Undesirable Effects

Like all Medications, Utrogestan can Cause Undesirable Effects, although not Everybody will Experience them.
The Following Undesirable Effects may Occur:

• Itching
• Oily Vaginal Discharge
• Genital Tract Bleeding
• Burning Sensation

Within 1-3 Hours after Taking the Medication, the Patient may Experience Temporary Fatigue or Dizziness.

Reporting Undesirable Effects

If any Undesirable Effects Occur, including any Undesirable Effects not Mentioned in the Leaflet, the Patient should Inform their Doctor or Pharmacist. Undesirable Effects can be Reported Directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Reporting Undesirable Effects will Help to Gather more Information on the Safety of the Medication.

5. How to Store Utrogestan

• The Medication should be Stored in a Place that is Inaccessible to Children.
• The Medication should not be Used after the Expiration Date Stated on the Packaging. The Expiration Date refers to the Last Day of the Specified Month.
• There are no Special Precautions for Storage.
• The Medication should not be Used if any Changes in its Appearance are Observed.
• Medications should not be Disposed of in the Drain or Household Waste. The Patient should Ask their Pharmacist how to Dispose of Unused Medications. This will Help to Protect the Environment.
• Any Unused Medication or its Waste should be Disposed of in Accordance with Local Regulations.

6. Contents of the Packaging and Other Information

What Utrogestan Contains

• The Active Substance of Utrogestan is Progesterone. Each Capsule Contains 200 mg of Progesterone.
• The Other Ingredients are Sunflower Oil and Soy Lecithin. The Other Ingredients in the Capsule Shell are Gelatin, Glycerol, Titanium Dioxide (E 171), and Purified Water.

What Utrogestan Looks like and what the Packaging Contains

Utrogestan is an Oval, Yellowish Soft Capsule Containing a White, Oily Suspension.
It is Packaged in Cardboard Boxes, which Contain PVC/Aluminum Blisters Containing 15, 21, 45, or 90 Capsules.
For more Detailed Information, the Patient should Contact the Marketing Authorization Holder or the Parallel Importer.

Marketing Authorization Holder in France, the Country of Export:

Laboratoires Besins International, 3, rue du Bourg l’Abbe, 75003 Paris, France

Manufacturer:

Cyndea Pharma SL
Poligono Industrial Emiliano Revilla Sanz
Avenida de Agreda 31
42110 Olvega (Soria), Spain
Besins Manufacturing Belgium SA
128 Groot-Bijgaardenstraat
1620 Drogenbos
Belgium

Parallel Importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing Authorization Number in France, the Country of Export:34009 358 768 4 3

Parallel Import Authorization Number: 216/24

This Medicinal Product is Authorized for Marketing in the EEA Member States under the Following Names:

Bulgaria: Утрогестан 200 mg вагинални капсули, меки
Croatia: Utrogestan 200 mg meke kapsule za rodnicu.
Czech Republic: Progesteron Besins 200 mg měkké tobolky
Denmark: Progestan
Estonia: Utrogestan 200 mg vaginaalpehmekapslid
Spain: Utrogestan Vaginal 200 mg Cápsula blanda
Ireland: Utrogestan Vaginal 200mg Capsules, soft
Iceland: Progestan 200 mg Mjúkt skeiðarhylki
Latvia: Progesterone Besins 200 mg vaginālās mīkstās kapsulas
Lithuania: Progesterone Besins 200 mg makšties minkštosios kapsulės
Malta: Utrogestan Vaginal 200mg Capsules, soft
Netherlands: Utrogestan 200 mg, zachte capsules voor vaginaal gebruik
Norway: Utrogestan 200 mg vaginalkapsler, myke
Poland: Utrogestan, 200 mg, kapsułki dopochwowe miękkie
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
Hungary: Utrogestan 200 mg lágy hüvelykapszula
United Kingdom: Utrogestan Vaginal 200mg Capsules
Italy: Utrogestan Vaginale 200 mg Capsula molle

Date of Approval of the Leaflet: 28.05.2024

[Information about the Trademark]