Patient Information Leaflet

Utrogestan, 400 mg, soft vaginal capsules
Progesterone
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as your doctor, pharmacist, or nurse has advised.

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 give it 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

What Utrogestan is and what it is used for
Important information before using Utrogestan
How to use Utrogestan
Possible side effects
How to store Utrogestan
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.
What Utrogestan is used for
Utrogestan may be used to support pregnancy.
Maintenance of pregnancy
Utrogestan may be used to reduce the risk of miscarriage in women who have vaginal 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 hypersensitivity (allergy) 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 vaginal bleeding of unknown cause
if the patient has breast cancer or cancer of the reproductive organs
if the patient currently has or has had in the past blood clots in the veins (thrombosis), which may sometimes cause pain (thrombophlebitis), 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.

Warnings and precautions
Utrogestan should only be used during the first three months of pregnancy. Before starting treatment with Utrogestan, discuss this with your doctor, pharmacist, nurse or midwife.
Utrogestan is not a contraceptive.
If miscarriage is suspected, contact your doctor, as treatment with Utrogestan must be discontinued.
Contact your doctor:

if the patient experiences any vaginal bleeding
if feeling unwell 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 currently taking or has recently taken, as well as any medicines she plans 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, tell your doctor or pharmacist if the patient is taking any of the following medicines:

Cyclosporine (used to suppress the immune system)
Bromocriptine, used to treat disorders related to the pituitary gland or 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 tests for liver problems or hormonal disorders.
Utrogestan with food and drink
Utrogestan is administered vaginally. Food and drink do not affect treatment.
Pregnancy and breastfeeding
Women who are breastfeeding should not use Utrogestan.
Driving and operating machinery
If the medicine causes drowsiness, do not drive or 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 as directed by a physician. If you experience any adverse reactions, consult your doctor, pharmacist, nurse, or midwife.
The use of Utrogestan to reduce the risk of miscarriage in women with bleeding in the current pregnancy should be initiated after the first signs of vaginal bleeding in the first trimester and continued at least until week 16 of pregnancy.
Use of the medicine to reduce the risk of threatened or recurrent miscarriage

Insert the medicine deeply into the vagina.
Do not swallow.

Recommended dose

The recommended dose is one Utrogestan capsule twice daily, one in the morning and one in the evening before bedtime, or as directed by your physician.
Continue following the same dosing schedule until your physician advises otherwise.

Use of a higher than recommended dose of Utrogestan
If an overdose of Utrogestan is used, speak to your doctor or go to the hospital immediately. Bring the medicine packaging with you.
The following symptoms may occur: dizziness or feeling of fatigue.
Missed dose of Utrogestan

If a dose is missed, administer 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 the use of Utrogestan
Before stopping the use of this medicine, consult your doctor, pharmacist, nurse, or midwife.
If you have any questions about how to use this medicine, consult your doctor, pharmacist, nurse, or midwife.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them. This medicine may cause the following adverse reactions:
Frequency unknown (cannot be estimated from the available data):

Itching or burning sensation
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 that are not listed above, inform a doctor, pharmacist, nurse, or midwife.
Reporting of adverse reactions
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, nurse, or midwife.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone +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.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Utrogestan

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation "EXP". The expiry date refers to the last day of the stated month. The abbreviation "Lot" indicates the batch number.
Store in the original packaging.
Medicines must 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 pack and other information

What Utrogestan contains

The active substance is progesterone. Each 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 yellowish soft gelatin capsules containing a white, oily suspension. The dimensions of the 400 mg capsule are approximately 2.5 cm x 0.9 cm.
Pack sizes:

15 capsules in a bottle (HDPE). The bottle is placed in a cardboard box.
Blister packs made of PVC/Aluminium containing 15, 30 or 45 capsules. The blisters are placed in a cardboard box.

Not all pack sizes may be marketed.
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
or
Besins Manufacturing España S.L.
Polígono industrial el Pitarco, Parcela 4
Muel
50450 Zaragoza
Spain
This medicinal product is authorised in the EEA Member States 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
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Besins Healthcare Poland Sp. z o.o.
Wiśniowa Street 40B/4
02-520 Warsaw
e-mail: [email protected]