Patient leaflet - Progesterone Leman 200 mg vaginal capsules, soft
1. What Progesterone Vaginal is and what it is used for
The name of your medicine is Progesterone Leman 200 mg Vaginal Capsules, (called Progesterone Vaginal in this leaflet). Progesterone Vaginal contains a hormone called progesterone.
What Progesterone Vaginal is used for
To support pregnancy during fertility treatment
Progesterone Vaginal is for women who need extra progesterone to support pregnancy while undergoing treatment in an Assisted Reproductive Technology (ART) program.
To prevent premature birth in women with a singleton pregnancy
Progesterone 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 Progesterone Vaginal
Do not use Progesterone 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 Progesterone Vaginal if any of the following applies to you. If you are not sure talk to your doctor or pharmacist before using Progesterone Vaginal.
Warnings and precautions
Progesterone Vaginal is not a contraceptive. If you think you may have miscarried, you should speak to your doctor as you must stop using Progesterone Vaginal. If you have unexpected vaginal bleeding speak to your doctor.
If you are taking this medicine as part of fertility treatment
Progesterone 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 Progesterone 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
Progesterone 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 Progesterone 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 Progesterone Vaginal can affect the way some other medicines work. Also some other medicines can affect the way Progesterone 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).
Progesterone Vaginal with food and drink
Progesterone Vaginal should be inserted into the vagina.
Food and drink do not affect the treatment.
Pregnancy, breast-feeding and fertility
- Progesterone 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 Progesterone Vaginal see Section 3.
- Do not use Progesterone Vaginal if you are breast-feeding.
Driving and using machines
Progesterone Vaginal has negligible effects on driving or using machinery.
Progesterone Vaginal contains soybean lecithin
If you are allergic to peanut or soya, do not use this medicinal product.
3. How to use Progesterone Vaginal
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 Progesterone 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 600 mg of Progesterone 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 capsule (200 mg) of Progesterone 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 more Progesterone Vaginal than you should
If you use too much Progesterone 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 Progesterone 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 Progesterone 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme 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.
5. How to store Progesterone Vaginal
- 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.
- Do not store above 25°C.
- Do not use this medicine if you notice visible changes in the appearance of the medicine.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
- Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
6. Contents of the pack and other information
What Progesterone Vaginal contains
- The active substance is progesterone. Each capsule contains 200 mg micronised progesterone.
- The other ingredients are sunflower oil (refined) and soybean lecithin (E322). The other ingredients in the capsule shell are gelatin (E441), glycerol (E422), titanium dioxide (E171) and purified water. Package leaflet: Information for the user
Progesterone Leman 200 mg Vaginal Capsules
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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.
CLIENT
LEMAN
PRODUCT NAME
PROGESTERONE LEMAN 200 mg - Voie
vaginale - notice
NOTES
Police 1 : Renogare Police 2 : Proxima nova Corps mini : 9 pts
MEASURES 140 x 600 mm COUNTRY UK
DATE 14/04/2026
What Progesterone Vaginal look like and contents of the pack
Progesterone Leman 200 mg Vaginal Capsules are off white opaque, round shape soft gelatin capsules containing off white to white coloured suspension. Each pack contains blister strips of 15 and 45 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LEMAN SKL S.R.L., Largo Augusto 8, Milano 20122, ITALY
Manufacturer
Qualimetrix S.A., 579 Mesogeion Avenue, Agia Paraskevi, Athens, 15343, Greece.
This leaflet was last revised in April 2026.
CLIENT
LEMAN
PRODUCT NAME
PROGESTERONE LEMAN 200 mg - Voie vaginale - notice
NOTES
Police 1 : Renogare Police 2 : Proxima nova Corps mini : 9 pts
MEASURES 140 x 600 mm COUNTRY UK
DATE 14/04/2026