• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

To support pregnancy during fertility treatment

Utrogestan Vaginal is for women who need extra progesterone to support pregnancy while undergoing treatment in an Assisted Reproductive Technology (ART) programme.

To prevent premature birth in women with a singleton pregnancy

Utrogestan Vaginal is for women who have previously had a premature baby and/or who may have a problem with part of their womb, known as a short cervix.

• If you are allergic (hypersensitive) to soya 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 mammary 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 venous thrombosis) or the lungs (pulmonary embolism)
• If you have had a cerebral haemorrhage or stroke
• If you have a rare blood problem called “porphyria” which is passed down in families (inherited)
• If you are pregnant but your baby has died inside of you (missed abortion)
• If your “waters break”.

Do not use Utrogestan Vaginal if any of the following applies to you. If you are not sure, talk to your doctor or pharmacist before using Utrogestan Vaginal.

Utrogestan Vaginal is not a contraceptive.

If you think you may have miscarried, you should speak tor your doctor as you must to stop using Utrogestan Vaginal.

If you have unexpected vaginal bleeding speak to your doctor.

If you are taking this medicine as part of fertility treatment

Utrogestan Vaginal 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 singleton pregnancy

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

If you are at risk of having your baby prematurely, you may be given Utrogestan Vaginal from around week 20 to week 34 of your pregnancy. If your waters break while you are taking the medicine, you must see 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 trimester of pregnancy may lead to the development of liver problems. Contact your doctor if you experience itching which may be a sign of liver problems.

Utrogestan vaginal is not for use in children.

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

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 Vaginal can affect the way some other medicines work. Also some other medicines can affect the way Utrogestan Vaginal works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• Bromocriptine used for problems with the pituitary gland or Parkinson’s Disease.
• Ciclosporin (used to suppress the immune system).
• Rifamycin medicines such as rifampicin (used to treat infections).
• Ketoconazole (used for fungal infections).

Utrogestan Vaginal should be inserted into the vagina. Food and drink do not affect the treatment.

• Utrogestan Vaginal will help support pregnancy if you are having fertility treatment or if your doctor has told you that you are at risk of having your baby prematurely. For instructions on how to use Utrogestan Vaginal see Section 3.
• Do not use Utrogestan Vaginal if you are breast-feeding.

Utrogestan Vaginal has negligible effects on driving or using machinery.

If you are allergic to peanut or soya, do not use this medicinal product.

For support during in vitro fertilization (IVF) cycles:

• The treatment is started no later than the third day after egg retrieval.
• Every day, use 600 mg of Utrogestan Vaginalas instructed by the doctor. Insert one capsule deep into the vagina in the morning, at midday and at bedtime.
• If laboratory tests confirm that you are pregnant, continue with the same dose until at least the 7^th week of pregnancy but no longer than the 12^th week of pregnancy, according to your doctor’s instructions.

For prevention of premature birth in certain women:

• Every day, insert one capsule (200mg) of Utrogestan Vaginal deep into the vagina, in the evening at bedtime. This medicine may be given from around week 20 to week 34 of pregnancy.

If you use to much Utrogestan Vaginal, talk to your doctor or go to a hospital. Take the medicine pack with you.

The following effects may happen: feeling dizzy or feeling tired.

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

Talk to your doctor, pharmacist or nurse before stopping to use this medicine. If you stop using the medicine, it will not help you to get pregnant.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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

• Utrogestan Vaginal 200mg Capsules are oval and slightly yellow soft capsules, containing whitish oily suspension.
• They are supplied in cartons containing PVC/Aluminium blisters of 15, 21, 45 or 90 capsules

The Marketing Authorisation for Utrogestan Vaginal is held by

Or

This medicine is distributed in the UK by: