Utrogestan

Leaflet attached to the packaging: information for the user

Utrogestan, 300 mg, vaginal soft capsules

Progesterone(micronized)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 side 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 medicine is Utrogestan. Utrogestan contains a hormone called progesterone.

What is Utrogestan used for

Utrogestan can be used to support pregnancy during in vitro fertilization (IVF) cycles.

Pregnancy support

Utrogestan is intended for women who need additional doses of progesterone during assisted reproductive technology (ART) treatment.

2. Important information before using Utrogestan

When not to use Utrogestan

• if the patient is allergic (hypersensitive) to peanuts or soya;
• if the patient is allergic to progesterone or any of the other ingredients of this medicine (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 vaginal bleeding of unknown cause;
• if the patient has breast cancer or cancer of the genital tract;
• if the patient has venous thromboembolism;
• if the patient has or has had blood clots in the veins (thrombosis), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• if the patient has had a stroke or cerebral hemorrhage;
• if the patient has a rare blood disorder called porphyria, which is inherited;
• if the patient is pregnant, but the fetus has died (missed abortion).

Warnings and precautions

Utrogestan should only be used during the first three months of pregnancy. Before starting Utrogestan, discuss it with your doctor or pharmacist.
Utrogestan is not a contraceptive.
If the patient has diabetes and is using insulin to control blood sugar levels, progesterone treatment may affect their response to insulin, and may require adjustment of antidiabetic drugs.
In case of vaginal bleeding, consult a doctor.
In case of suspected miscarriage, consult a doctor, as it may be necessary to stop using Utrogestan.
Consult a doctor if you feel unwell for several days after taking the medicine.

Children and adolescents

Utrogestan is not intended for use in children and adolescents.

Utrogestan and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This includes medicines available without a prescription, including herbal medicines. This is because Utrogestan may affect the action of some other medicines. Also, some other medicines may affect the action of Utrogestan.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• blood-thinning medicines, such as coumarins or phenindione;
• cyclosporine or tacrolimus (used to weaken the immune system);
• tizanidine (a muscle relaxant);
• bromocriptine, used to treat disorders related to the pituitary gland or Parkinson's disease;
• selegiline (used to treat Parkinson's disease);
• diazepam, chlordiazepoxide, alprazolam, oxazepam, or lorazepam (used to treat anxiety or insomnia);
• antituberculosis medicines (such as rifampicin and rifabutin);
• antibiotics (such as griseofulvin, ampicillin, amoxicillin, and tetracyclines), which are used to treat certain infections;
• phenytoin, phenobarbital, carbamazepine, eslicarbazepine, oxcarbazepine, primidone/rufinamide, perampanel, or topiramate (used to treat epilepsy);
• herbal medicinal products containing St. John's Wort;
• darunavir, nelfinavir, fosamprenavir, or lopinavir (used to treat viral infections);
• bosentan (used to treat pulmonary disorders);
• fluconazole, itraconazole, voriconazole (used to treat fungal infections);
• ketoconazole (used to treat Cushing's syndrome - when the body produces too much cortisol);
• atorvastatin or rosuvastatin (used to control cholesterol levels);
• aprepitant (used to prevent nausea and vomiting).

Tell your doctor or pharmacist if you have recently received an anesthetic, such as bupivacaine, or if you have recently had tests for liver or hormonal problems.

Using 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. The method of using Utrogestan is described in section 3. "How to use Utrogestan".
• Breastfeeding women should not use Utrogestan.

Driving and using machines

Utrogestan has no or negligible influence on the ability to drive and use machines.

Utrogestan contains soya lecithin

Patients with a known allergy to peanuts or soya should not use this medicine.

3. How to use Utrogestan

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor or pharmacist.

Using this medicine supports pregnancy

• Do not take this medicine orally. Accidental oral ingestion of Utrogestan will not harm the patient, but it reduces the likelihood of becoming pregnant.

Recommended dose

• Treatment starts no later than the third day after egg retrieval.
• Use 600 mg of Utrogestan daily, as directed by your doctor. Insert one capsule deeply into the vagina in the morning and the second before bedtime.
• If laboratory tests confirm that the patient is pregnant, continue using the same dose for at least 7 weeks of pregnancy, but no longer than 12 weeks of pregnancy, as directed by your doctor.

Using a higher dose of Utrogestan than recommended

In case of overdose, consult a doctor or go to the hospital. Take the packaging with you.
The following disorders may occur: dizziness or fatigue.

Missing a dose of Utrogestan

• If a dose is missed, insert it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
• Do not use a double dose to make up for a missed dose.

Stopping Utrogestan treatment

Before stopping Utrogestan treatment, consult your doctor, pharmacist, or nurse.
If you stop using Utrogestan, it will not help you become pregnant.
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Utrogestan can cause side effects, although not everybody gets them. Utrogestan may cause the following side effects:
Very rare (less than 1 in 10,000 patients):

• Severe allergic reactions causing difficulty breathing or dizziness. Frequency not known (cannot be estimated from available data):
• Itching
• Vaginal bleeding
• Oily vaginal discharge.

Within 1-3 hours after using the medicine, the patient may experience temporary fatigue or dizziness.
If you experience any side effects other than those listed above, inform your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Utrogestan

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
  The "Lot" abbreviation means batch number.
• After opening the bottle, use the capsules within 15 days.
• Store in the original packaging (bottle).
• Store below 30°C.
• Do not use this medicine if you notice any changes in its appearance.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Utrogestan contains

• The active substance is progesterone. One capsule contains 300 mg of progesterone.
• The other ingredients are: refined sunflower oil, soya lecithin, gelatin, glycerol (E422), titanium dioxide (E171), and purified water.

What Utrogestan looks like and contents of the packaging

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

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

This medicinal product is authorized in the Member States of the EEA under the following names:

Bulgaria, Estonia, Hungary, Croatia, Cyprus, France, Malta, Netherlands, Norway, Poland, Portugal, Sweden, Slovakia, Slovenia, Italy, Spain: Utrogestan
Belgium, Ireland, Luxembourg: Utrogestan Vaginal
Finland: Lugesteron
Lithuania, Latvia: Progesterone Besins
Czech Republic: Progesteron Besins
Denmark, Iceland: Progestan
For more information about this medicine, contact the local representative of the marketing authorization holder.
Besins Healthcare Poland Sp. z o.o.
ul. Wiśniowa 40B/4
02-520 Warsaw
e-mail: [email protected]

Date of last revision of the leaflet: 09/2024