UTROGESTAN 200 mg Soft Vaginal Capsule

Зміст інструкції

1. Utrogestan 300 mg soft gelatin capsules
   1. What is Utrogestan and what is it 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

Utrogestan 300 mg soft gelatin capsules

progesterone

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is Utrogestan and what is it used for

The name of your 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.

To support pregnancy
Utrogestan is for women who need an extra amount of progesterone during treatment
as part of an assisted reproductive technology (ART) program.

2. What you need to know before using Utrogestan

Do not use Utrogestan

• if you are allergic (hypersensitive) to soya or peanuts
• if you are allergic to progesterone or to any of the other ingredients of this medicine (listed in section 6)
• if you have problems with your liver
• if you have yellowing of the skin or eyes (jaundice)
• if you have unexplained vaginal bleeding
• if you have breast cancer or a carcinoma of the genital tract
• if you have thrombophlebitis
• if you have or have had blood clots in a vein (thrombosis), such as in the leg (deep vein thrombosis) or in the lungs (pulmonary embolism)
• if you have had a cerebral haemorrhage or a stroke
• if you suffer from a rare blood disease called porphyria, which is passed down in families (inherited)
• if you are pregnant but your baby has died inside you (missed miscarriage).

Warnings and precautions
Utrogestan must only be used during the first 3 months of pregnancy. Ask your doctor or pharmacist
before using Utrogestan
Utrogestan is not a contraceptive.
If you have diabetes and use insulin to control your blood sugar levels, progesterone treatment
may affect your response to insulin and it may be necessary to adjust your antidiabetic therapy.
If you have vaginal bleeding, talk to your doctor.
If you believe you have had a miscarriage, you should talk to your doctor, as you must stop using
Utrogestan.
You should contact your doctor if you feel unwell within a few days of taking the medicine.

Children and adolescents
Utrogestan should not be used in children and adolescents.

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 can affect the way some other medicines work. Also, some
other medicines can affect the way Utrogestan works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• blood thinners such as coumarins or phenindione
• cyclosporine or tacrolimus (used to reduce the immune response)
• tizanidine (muscle relaxant)
• bromocriptine, which is used in the treatment of problems related to the pituitary gland or Parkinson's disease
• selegiline (for the treatment of Parkinson's disease)
• diazepam, chlordiazepoxide, alprazolam, oxazepam or lorazepam (for the treatment of anxiety or insomnia)
• medicines for tuberculosis (such as rifampicin and rifabutin)
• antibiotics (e.g. griseofulvin, ampicillin, amoxicillin and tetracyclines), used to treat some infections
• phenytoin, phenobarbital, carbamazepine, eslicarbazepine, oxcarbazepine, primidone/rufinamide, perampanel or topiramate (used for epilepsy)
• herbal products, containing St John's wort
• darunavir, nelfinavir, fosamprenavir or lopinavir (used to treat viral infections)
• bosentan (used to treat lung problems)
• fluconazole, itraconazole, voriconazole (for the treatment of fungal infections)
• ketoconazole (used to treat Cushing's syndrome - when the body produces too much cortisol)
• atorvastatin or rosuvastatin (used to control cholesterol)
• aprepitant (used to prevent nausea and vomiting). If you have recently been given an anaesthetic, such as bupivacaine or If you have recently had tests for liver or hormonal problems.

Utrogestan with food and drink
Utrogestan must be inserted into the vagina. Food and drink do not affect the treatment.

Pregnancy, breastfeeding and fertility

• Utrogestan will support the pregnancy if you are undergoing treatment for fertility. For instructions on how to use Utrogestan, see section 3.
• Do not use Utrogestan if you are breastfeeding.

Driving and using machines
Utrogestan has no or negligible effects on driving or operating machines.
Utrogestan contains soya lecithin
If you are allergic to peanuts or soya, do not use this medicine.

3. How to use Utrogestan

Use this medicine following the instructions of your doctor exactly. Check with your doctor or pharmacist if you are not sure.

The use of this medicine is to help you become pregnant

• Do not take it orally. If you accidentally take Utrogestan by mouth, it will not harm you, but your chances of becoming pregnant will be reduced. Recommended dose
• Treatment should be started within and no later than the third day after egg retrieval.
• Each day, use 600 mg of Utrogestan as directed by your doctor. Insert one capsule deep into the vagina in the morning and the other before bedtime.
• If laboratory tests confirm that you are pregnant, continue with the same dose for at least until the 7th week of pregnancy and no longer than the 12th week of pregnancy as instructed by your doctor.

If you use more Utrogestan than you should
If you use too much Utrogestan, you should talk to your doctor or go to hospital. Bring the package of
medicine with you.
The following effects may occur: feeling dizzy 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 the next dose, skip the forgotten dose.
• Do not use a double dose to make up for a forgotten dose.

If you stop using Utrogestan
Talk to your doctor, pharmacist or nurse before stopping the use of this medicine. If
you stop using the medicine, it will not help you become pregnant.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine:
Very rare (may affect up to 1 in 10,000):

• A type of allergic reaction called anaphylaxis. Frequency not known (the frequency cannot be estimated based on available data):
• Itching
• Vaginal bleeding
• Oily discharge from the vagina. Within 1-3 hours of using the medicine, short-term fatigue or dizziness may occur. If you notice any side effects not listed above, tell your doctor. Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: 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 which is stated on the packaging after SCAD. The expiry date refers to the last day of the month.
• Once the bottle is opened, use the capsules within 15 days.
• Store in the original packaging (the bottle).
• Store at a temperature below 30°C.
• Do not use this medicine if you notice visible changes in the appearance of the medicine.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Utrogestan contains

• The active ingredient is progesterone. One capsule contains 300 mg of progesterone.
• The other components of the capsule are refined sunflower oil, soybean lecithin, gelatin, glycerol (E422), titanium dioxide (E171) and purified water. Description of the appearance of Utrogestan and contents of the packOblong, soft, yellowish gelatin capsules containing a whitish oily suspension. The dimensions of the 300 mg capsule are approximately 2.5 cm x 0.8 cm.

Utrogestan is supplied in white high-density polyethylene plastic bottles with a white child-resistant screw cap and a silver tear-off seal. Pack size: 1 bottle containing
15 capsules.

Marketing authorisation holder
The marketing authorisation for Utrogestan is held by
Besins Healthcare Ireland Ltd
16 Pembroke Street Upper
D02 HE63
Dublin 2,
Ireland

Manufacturer
Cyndea Pharma S.L
Poligono Industriale Emiliano Revilla Sanz
Avenida de Agreda, 31
Olvega 42110 (Soria)
Spain
This medicinal product is authorised in the Member States of the EEA under the following denominations:
Bulgaria, Estonia, Hungary, Croatia, Cyprus, France, Italy, Malta, Netherlands, Norway, Poland,
Portugal, Sweden, Slovenia, Slovakia, Spain: Utrogestan
Belgium, Ireland, Luxembourg: Utrogestan Vaginal
Finland,: Lugesteron
Latvia, Lithuania: Progesterone Besins
Czech Republic: Progesteron Besins
Denmark, Iceland: Progestan