Patient leaflet - Utrogestan vaginal 200 mg capsules
1. What Utrogestan is and what it is used for
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 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.
2. What you need to know before you use Utrogestan
Do not use Utrogestan Vaginal:
- 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.
Warning and precautions
Utrogestan Vaginal is not a contraceptive.
If you think you may have miscarried, you should speak to 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.
Children
Utrogestan vaginal is not for use in children.
Tests and Check-ups
Your doctor will perform a complete medical examination before starting the treatment and regularly during the treatment.
Other medicines and Utrogestan vaginal
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:
- 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 with food and drink
Utrogestan Vaginal should be inserted into the vagina.
Food and drink do not affect the treatment.
Pregnancy, breast-feeding and fertility
- 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 see Section 3.
- Do not use Utrogestan Vaginal if you are breast-feeding.
Driving and using machines
Utrogestan has negligible effects on driving or using machinery.
Utrogestan Vaginal contains soybean lecithin
If you are allergic to peanut or soya, do not use this medicinal product.
3. How to use Utrogestan
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
- Use this medicine by inserting it deep into the vagina.
- Do not take it by mouth. If you accidentally take Utrogestan Vaginal by mouth, it will not harm you, but your chances of becoming pregnant will be reduced.
Recommended dose
For support during in vitro fertilization (IVF) cycles:
- The treatment is started no later than the third day after egg retrieval.
- Every day, use 600mg of Utrogestan Vaginal as 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 7th week of pregnancy but no longer than the 12th week of pregnancy, according to your doctor’s instructions.
For prevention of premature birth in certain women:
- Every day, insert one capsules (200mg) of Utrogestan 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 more Utrogestan Vaginal than you should
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 to use Utrogestan Vaginal
- 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.
If you stop using Utrogestan Vaginal
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 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 happen with this medicine.
Frequency not known (frequency cannot be estimated from the available data):
- itching
- oily discharge from the vagina
- vaginal haemorrhage
- burning sensation
Short-term tiredness or dizziness may be experienced within 1 – 3 hours after taking the medicine.
Reporting of side effects
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 Yellow Card Scheme at: 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.
5. How to store Utrogestan
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use the capsules after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day of that month.
If the capsule becomes discoloured or show any signs of deterioration, seek the advice of your pharmacist.
Remember if your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Utrogestan contains
The active ingredient in the Utrogestan is progesterone.
Each capsule contains 200mg progesterone (micronised).
The other ingredients are sunflower oil and soybean lecithin.
The other ingredients in the capsule shell are gelatin, glycerol, titanium dioxide (E171) and purified water.
What Utrogestan looks like and contents of the pack
Utrogestan capsules are oval, slightly yellow soft capsules, containing whitish oily suspension.
It is available in pack size of 21 capsules.
Manufactured by: BESINS MANUFACTURING ESPAÑA, Poligono Industrial El Pitarco, parcela nr. 4, 50450 Muel (Zaragoza), spain.
OR
Cyndea Pharma, S.L., Poligono Industrial Emiliano Revilla Sanz, Avenida de Agreda, 31, Ólvega 42110 (Soria), Spain.
OR
Besins Healthcare Netherlands B.V., Servaasbolwerk 14, 3512NK Utrecht, Netherlands.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
UTROGESTAN® VAGINAL 200mg Capsules; PL 18799/4208
Leaflet date: 10.02.2026
POM
Utrogestan is the registered trademark of BESINS HEALTHCARE LUXEMBOURG S.A.R.L.
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