Utrogestan

Package leaflet: Information for the user

Utrogestan 200 mg soft vaginal capsules

progesterone
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 the medicine is Utrogestan. Utrogestan contains a hormone called progesterone.
What Utrogestan is used for
To support pregnancy during fertility treatment
Utrogestan is for women who need extra progesterone to support pregnancy during treatment in an Assisted Reproductive Technology (ART) programme.
To prevent premature birth in women with a single pregnancy
Utrogestan is for women who have previously had a premature baby and/or who have a short cervix.

2. What you need to know before using Utrogestan

Do not use Utrogestan:

• If you are allergic (hypersensitive) to soy or peanuts
• If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6).
• If you have liver problems
• If you have yellowing of the skin or eyes (jaundice)
• If you have unexplained vaginal bleeding
• If you have breast or genital tract carcinoma
• If you have thrombophlebitis
• If you have or have had blood clots in a vein (thrombosis), such as in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism)
• If you have had a cerebral haemorrhage
• If you have a rare inherited blood disorder called “porphyria”
• If you are pregnant but your baby has died inside you (missed abortion)
• If your waters have broken.

Do not use Utrogestan if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist before using Utrogestan.

Warnings and precautions

Talk to your doctor or pharmacist before using Utrogestan.

Utrogestan is not a contraceptive.

If you think you have had a miscarriage, you must speak to your doctor, as you may need to stop using Utrogestan.

If you have vaginal bleeding, talk to your doctor.

If you are taking this medicine to support pregnancy during fertility treatment

Utrogestan should only be used during the first 3 months of pregnancy.

If you are taking this medicine to prevent preterm birth in women with a single pregnancy

Your doctor should discuss the risks and benefits of the available options. You and your doctor should make a shared decision on which treatment is most suitable.

If you are at risk of having a premature baby, you may be given Utrogestan from week 20 up to around week 34 of pregnancy. If your waters break while you are taking this medicine, you must consult your doctor as soon as possible. If this happens, there may be an immediate risk to you and your baby.

In rare cases, use during the second and third trimesters of pregnancy may lead to liver problems. Contact your doctor if you experience itching, as this could be a sign of liver problems.

Children

Utrogestan is not intended for use in children.

Tests and check-ups

Your doctor will perform a full medical examination before starting treatment and regularly during treatment.

Other medicines and Utrogestan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This includes medicines obtained without a prescription, including herbal medicines.

This is because Utrogestan may affect how other medicines work. 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:

• Bromocriptine, used for pituitary gland disorders or Parkinson’s disease.
• Cyclosporine (used to suppress the immune system).
• Rifamycin-containing medicines such as rifampicin (used to treat infections).
• Ketoconazole (used for fungal infections).

Utrogestan with food and drink

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

Pregnancy, breastfeeding and fertility

• Utrogestan will help support your pregnancy if you are undergoing fertility treatment or if your doctor has told you that you are at risk of having a premature baby. For instructions on how to use Utrogestan, see Section 3.
• Do not use Utrogestan if you are breastfeeding.

Driving and using machines

Utrogestan has negligible effects on driving or operating machinery.

Utrogestan contains soy lecithin

If you are allergic to peanuts or soy, do not use this medicine.

3. How to use Utrogestan

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Use this medicine by inserting it deeply into the vagina.
• Do not take this medicine by mouth. If you accidentally take Utrogestan orally, it will not harm you, but your chances of becoming pregnant may be reduced.

Recommended dose:
For support during in vitro fertilization (IVF) cycles:

• Treatment should start no later than the third day after oocyte retrieval.
• Each day, use 600 mg of Utrogestan as directed by your doctor. Insert one capsule deeply into the vagina in the morning, at midday, and before bedtime.
• If laboratory tests confirm that you are pregnant, continue with the same dose at least until the 7th week of pregnancy, but not beyond the 12th week of pregnancy, as instructed by your doctor.

For prevention of preterm birth in certain women:

• Each day, insert one capsule (200 mg) of Utrogestan deeply into the vagina in the evening before going to bed. This medicine can be administered from approximately week 20 to week 34 of pregnancy.

If you use more Utrogestan than you should
If you use too much Utrogestan, you should speak to your doctor or go to the hospital. Take the medicine package with you.
The following effects may occur: dizziness or feeling tired.

If you forget to use Utrogestan

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

If you stop using Utrogestan
Talk to your doctor, pharmacist, or nurse before stopping treatment with this medicine.
If you stop using this medicine, it will not help you to remain pregnant.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• itching
• oily vaginal discharge
• vaginal bleeding
• burning sensation

Short-term fatigue or dizziness may occur within 1 – 3 hours after taking the medicine.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Utrogestan

• Keep this 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 that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice any visible signs of deterioration.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
• Any unused medicine or waste material must be disposed of in accordance with local regulations.

6. Package contents and other information

What Utrogestan contains

• The active substance is progesterone. Each capsule contains 200 mg of progesterone.
• The other ingredients are: sunflower seed oil and soybean lecithin. The other components of the capsule shell are gelatin, glycerol, titanium dioxide (E171), and purified water.

Description of the appearance of Utrogestan and contents of the pack

• Utrogestan are soft, oval, slightly yellow capsules containing a white, oily suspension.
• They are supplied in boxes containing PVC/Aluminum blisters of 15, 21, 45, or 90 capsules.

Marketing Authorisation Holder and Manufacturer
Besins Healthcare Ireland Limited
Plaza 4, Level 4 Custom House Plaza
Harbourmaster Place, IFSC
Dublin 1, D01 A9N3
Ireland

Utrogestan vaginal is manufactured by:
Cyndea Pharma, S.L.,
Poligono Industrial Emiliano Revilla Sanz,
Avenida de Agreda, 31,
Ólvega 42110 (Soria) - Spain
or
BESINS MANUFACTURING ESPANA
Poligono Industrial El Pitarco, parcela nr. 4
50450 Muel (Zaragoza)
Spain

This medicinal product is authorised in the EEA Member States under the following names:
Bulgaria: Utrogestan 200 mg vaginal capsules, soft
Croatia: Utrogestan 200 mg meke kapsule za rodnicu.
Czech Republic: Progesteron Besins 200 mg měkké tobolky
Denmark: Progestan
Estonia: Utrogestan 200 mg vaginaalpehmekapslid
Hungary: Utrogestan 200 mg lágy hüvelykapszula
Iceland: Progestan 200 mg Mjúkt skeiðarhylki
Ireland: Utrogestan Vaginal 200mg Vaginal Capsules, soft
Italy: Utrogestan
Latvia: Progesterone Besins 200 mg vaginālās mīkstās kapsulas
Lithuania: Progesterone Besins 200 mg makšties minkštosios kapsulės
Malta: Utrogestan Vaginal 200 mg 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
Spain: Utrogestan Vaginal 200 mg Cápsula blanda
Sweden: Utrogestan 200 mg mjuk Vaginalkapsel
United Kingdom: Utrogestan Vaginal 200mg Capsules