Utrogestan

Package leaflet: Information for the user

Utrogestan, 300 mg, vaginal soft capsules
Progesterone (micronized)
Please read all of this leaflet carefully before 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, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Utrogestan is and what it is used for

The name of this medicine is Utrogestan. Utrogestan contains a hormone called progesterone.
For what purpose is Utrogestan used?
Utrogestan may be used to support early pregnancy during in vitro fertilization (IVF) cycles.
Pregnancy support
Utrogestan is intended for women who require additional progesterone supplementation during assisted reproductive technology (ART) treatment.

2. Important information before using Utrogestan

When not to use Utrogestan

• if the patient is allergic (hypersensitive) to soya or peanuts;
• 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 yellowing of the skin or eyes (jaundice);
• if the patient has vaginal bleeding of unknown cause;
• if the patient has breast cancer or cancer of the reproductive organs;
• if the patient has thrombophlebitis (inflammation of veins with blood clot formation);
• if the patient currently has or has had in the past venous thrombosis (blood clots in the veins), for example in the legs (deep vein thrombosis) or lungs (pulmonary embolism);
• if the patient has experienced cerebral haemorrhage or stroke;
• if the patient has a rare inherited blood disorder called porphyria;
• if the patient is pregnant, but fetal death has occurred (missed miscarriage).

Warnings and precautions
Utrogestan should only be used during the first 3 months of pregnancy. Before starting treatment with Utrogestan, discuss this with your doctor or pharmacist.
Utrogestan is not a contraceptive medicine.
If the patient has diabetes and is using insulin to control blood sugar levels, progesterone treatment may affect her response to insulin, which may require adjustment of antidiabetic medications.
Contact your doctor if vaginal bleeding occurs.
Contact your doctor if miscarriage is suspected, as treatment with Utrogestan must be discontinued.
Contact your doctor if you feel unwell within a few days after taking the medicine.

Children and adolescents
Utrogestan is not intended for use in children and adolescents.

Utrogestan with 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 certain other medicines. Likewise, some other medicines may affect how Utrogestan works.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• anticoagulants (blood thinners) such as coumarins or phenindione;
• cyclosporine or tacrolimus (used to suppress the immune system response);
• tizanidine (a muscle relaxant);
• bromocriptine, used in the treatment of pituitary disorders or Parkinson’s disease;
• selegiline (used in the treatment of Parkinson’s disease);
• diazepam, chlordiazepoxide, alprazolam, oxazepam or lorazepam (used to treat anxiety or insomnia);
• antituberculosis medicines (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 in the treatment of epilepsy);
• herbal remedies containing St. John’s wort (Hypericum perforatum);
• darunavir, nelfinavir, fosamprenavir or lopinavir (used in the treatment of viral infections);
• bosentan (used to treat lung conditions);
• fluconazole, itraconazole, voriconazole (used to treat fungal infections);
• ketoconazole (used in the treatment of 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 anaesthetic agent such as bupivacaine, or if you have recently undergone tests for liver or hormonal problems.

Taking Utrogestan with food and drink
Utrogestan is administered vaginally. Food and drink do not affect treatment.

Pregnancy, breastfeeding and fertility

• Utrogestan is used as an adjunctive treatment to support pregnancy during infertility therapy. Instructions for use are described in section 3, "How to use Utrogestan".
• Breastfeeding women should not use Utrogestan.

Driving and operating machinery
Utrogestan has no or negligible influence on the ability to drive and operate machinery.

Utrogestan contains soya lecithin
Patients who have been diagnosed with allergy to peanuts or soya should not use this medicine.

3. How to use Utrogestan

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult your
doctor or pharmacist.
This medicine helps support conception

• Do not take this medicine orally. Accidental oral intake of Utrogestan will not harm the patient, but may reduce the likelihood of achieving pregnancy.

Recommended dose

• Treatment should begin no later than on the third day after oocyte retrieval.
• The recommended daily dose is 600 mg of Utrogestan, as directed by the doctor. One capsule should be inserted deeply into the vagina in the morning and another before bedtime.
• If laboratory tests confirm that the patient is pregnant, the same dose should be continued for at least up to week 7 of pregnancy, but no longer than until week 12 of pregnancy, as directed by the doctor.

Use of more than the recommended dose of Utrogestan
If an excessive dose of Utrogestan has been used, consult a doctor or go to hospital immediately.
Bring the medicine package with you.
The following symptoms may occur: dizziness or feeling of fatigue.
Missed dose of Utrogestan

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

Stopping the use of Utrogestan
Before stopping the use of this medicine, consult your doctor, pharmacist, or nurse.
If the patient stops using this medicine, it will no longer support conception.
If you have any further questions regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. This medicine may cause the following adverse reactions:

Very rare (not more often than in 1 out of 10,000 patients):

• Severe allergic reactions causing difficulty in breathing or dizziness.

Frequency unknown (cannot be estimated from available data):

• Itching
• Vaginal bleeding
• Oily vaginal discharge

Within 1–3 hours after administration of the medicine, the patient may experience transient fatigue or dizziness.

If any adverse reactions occur other than those listed above, the physician should be informed.

Reporting of adverse reactions

If the patient experiences any adverse symptoms, including any adverse symptoms not listed in this leaflet, the physician, pharmacist, or nurse should be informed. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Utrogestan

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after the word "EXP". The expiry date refers to the last day of the stated month. The abbreviation "Lot" means batch number.
• After opening the bottle, the capsules should be used 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 in use. This helps protect the environment.

6. Contents of the package and other information

What Utrogestan contains

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

What Utrogestan looks like and contents of the pack
Utrogestan is a yellowish, elongated, 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 made of high-density polyethylene, with a white
polypropylene child-resistant screw cap and a removable silver seal.
Pack size: 1 bottle containing 15 capsules.
Marketing Authorisation 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 authorised in the EEA countries 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 detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Besins Healthcare Poland Sp. z o.o.
ul. Wiśniowa 40B/4
02-520 Warszawa
e-mail: [email protected]