Utrogestan

Leaflet attached to the packaging: Information for the user

Utrogestan, 400 mg, vaginal soft capsules

Progesterone

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

This medicine should always be used exactly as described in this leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• 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 a specific person. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your 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.

Pregnancy support

Utrogestan may be used to reduce the risk of miscarriage in women with bleeding in the current pregnancy and a history of recurrent miscarriages.

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 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 bleeding from the genital tract of unknown cause
• if the patient has breast cancer or genital tract cancer
• if the patient has had blood clots in the veins (thrombosis), which can sometimes cause pain (thrombophlebitis), for example in the lower limbs (deep vein thrombosis) or lungs (pulmonary embolism)
• if the patient has had a cerebral hemorrhage or stroke
• if the patient has a rare blood disorder called porphyria, which is inherited in families.

Warnings and precautions

Utrogestan should only be used during the first 3 months of pregnancy. Before starting Utrogestan, discuss it with your doctor, pharmacist, nurse, or midwife.
Utrogestan is not a contraceptive.
If miscarriage is suspected, contact your doctor, as it is necessary to discontinue Utrogestan.
Contact your doctor:

• if the patient experiences any vaginal bleeding
• in case of malaise within a few days of taking the medicine.

Children and adolescents

Utrogestan is not intended for use in children.

Utrogestan and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, including those 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 the patient is taking any of the following medicines:

• Cyclosporine (used to weaken the immune system)
• Bromocriptine, which is used to treat disorders related to the pituitary gland or to treat Parkinson's disease
• Rifamycin derivatives, such as rifampicin (used to treat infections)
• Ketoconazole (used to treat fungal infections).

Tell your doctor if the patient has recently had liver function tests or hormone level tests.

Utrogestan with food and drink

Utrogestan should be inserted into the vagina. Eating and drinking have no effect on the treatment.

Pregnancy and breastfeeding

Breastfeeding women should not use Utrogestan.

Driving and using machines

If the medicine causes drowsiness, do not drive or operate machinery.

Utrogestan contains soy lecithin

Patients who have been diagnosed with an allergy to peanuts or soy should not use this medicine.

3. How to use Utrogestan

This medicine should always be used as directed by your doctor. If side effects occur, consult your doctor, pharmacist, nurse, or midwife.
Using Utrogestan to reduce the risk of miscarriage in women with bleeding in the current pregnancy should be started after the first signs of vaginal bleeding in the first trimester and continued until at least the 16th week of pregnancy.

Using Utrogestan to reduce the risk of threatened or recurrent miscarriage

• The medicine should be inserted deep into the vagina.
• Do not swallow.

Recommended dose

• Take one Utrogestan capsule twice a day, one in the morning and one in the evening before bedtime, or as directed by your doctor.
• Continue using the same dosing schedule until your doctor advises you to stop the treatment.

Using a higher dose of Utrogestan than recommended

If you have used too much Utrogestan, talk to your doctor or go to the hospital. Take the packaging with you.
The following disorders may occur: dizziness or a feeling of fatigue.

Missing a dose of Utrogestan

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

Stopping Utrogestan

Before stopping Utrogestan, talk to your doctor, pharmacist, nurse, or midwife.
If you have any questions about using this medicine, ask your doctor, pharmacist, nurse, or midwife.

4. Possible side effects

Like all medicines, Utrogestan can cause side effects, although not everybody gets them. Utrogestan may cause the following side effects:
Frequency not known (cannot be estimated from the available data):

• Itching or burning sensation
• Oily discharge from the vagina. Within 1-3 hours after using the medicine, the patient may experience short-term fatigue or dizziness.

If you experience any side effects other than those listed above, tell your doctor, pharmacist, or nurse.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, nurse, or midwife.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the 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.
By reporting side effects, you can help provide 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 the term "EXP". The expiry date refers to the last day of the month stated.
  The term "Lot" refers to the batch number.
• Store in the original packaging (bottle).
• 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.
• Do not use this medicine if you notice any changes in its appearance.

6. Contents of the packaging and other information

What Utrogestan contains

• The active substance is progesterone. One capsule contains 400 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 soft gelatin capsule containing a white, oily suspension. The dimensions of the 400 mg capsule are approximately 2.5 cm x 0.9 cm.
Pack size: 15 capsules in a bottle (HDPE). The bottle is placed in a cardboard box.

Marketing authorization holder

Besins Healthcare Ireland Limited
16 Pembroke Street Upper
D02HE63 Dublin 2
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, Cyprus, Croatia, Estonia, France, Spain, Ireland, Malta, Netherlands, Norway, Poland, Slovakia, Slovenia, Sweden, Hungary, Italy: Utrogestan
Belgium, Luxembourg, Portugal: Utrogestan Vaginal
Finland: Lugesteron
Lithuania, Latvia: Progesterone Besins
Czech Republic: Progesteron Besins
Denmark, Iceland: Progestan
To obtain more detailed information on 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: