200 mg soft vaginal capsule
progesterone
What Utrogestan is and what it is used for
Your medicine is called Utrogestan. Utrogestan contains a hormone called progesterone.
What Utrogestan is used for
To facilitate pregnancy during fertility treatment
Utrogestan is intended for women who need extra progesterone to facilitate pregnancy while undergoing treatment in an assisted reproduction program (ART).
To prevent premature birth in women with a singleton pregnancy
Utrogestan is for women who previously had a premature birth and/or who may have problems with part of their uterus, which is called a short cervix.
The progesterone contained in Utrogestan may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
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 vaginal bleeding of unknown cause
- if you have breast or genital cancer
- if you have thrombophlebitis (a blood clot in a superficial vein)
- if you have or have had a blood clot in a vein ( thrombosis ), e.g. in the legs (deep vein thrombosis ) or the lungs ( pulmonary embolism )
- if you have had a brain bleed
- if you have a rare inherited blood disorder called porphyria
- if you are pregnant but the fetus has died in the womb (absent miscarriage)
- if you have a premature water break.
Do not use Utrogestan if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Utrogestan.
Warnings and precautions
Utrogestan is not a contraceptive.
If you think you may have had a miscarriage, consult your doctor because
you must stop using Utrogestan.
If you experience vaginal bleeding, talk to your doctor.
If you are taking this medicine to help you get pregnant during fertility treatment
Utrogestan should only be used during the first three months of pregnancy.
If you are taking this medicine to prevent premature birth in a singleton pregnancy
Your doctor should discuss the risks and benefits of the options available to you. You and your doctor must make a joint decision about which treatment is most suitable.
If there is a risk of your baby being born prematurely, you can receive Utrogestan between the 20th to 34th week of pregnancy. If your water breaks while taking the medicine, you must see a 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 the development of liver problems. Contact a doctor if you experience itching, as this may be a symptom of liver problems.
Children
Utrogestan is not intended for children.
Tests and checks
Your doctor will do a full medical examination before starting treatment and then regularly during treatment.
Other medicines and Utrogestan
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. This also applies to non-prescription drugs and herbal remedies. This is because Utrogestan can affect the effectiveness of other medicines. Some other medicines can also affect the effect of Utrogestan.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- bromocriptine is used for problems with the pituitary gland or Parkinson’s disease
- cyclosporine (used to suppress the immune system)
- rifamycin medicines such as rifampicin (used to treat infections )
- ketoconazole (used to treat fungal infections).
Utrogestan with food, drink, and alcohol
The medicine must be inserted into the vagina. The treatment is not affected by food or drink
Pregnancy, breastfeeding, and fertility
- Utrogestan facilitates pregnancy if you are undergoing fertility treatment or if your doctor has advised that there is a risk of your baby being born prematurely. See section 3 for instructions on how to use Utrogestan.
- Do not use Utrogestan if you are breastfeeding.
Driving ability and use of machinery
Utrogestan has a negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Utrogestan contains soy lecithin
If you are allergic to peanuts or soy, do not use this medicine.
How to use Utrogestan
Use for children and adolescents
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
- The medicine must be inserted deep into the vagina.
- The medicine should not be taken by mouth. However, accidental ingestion of Utrogestan will not harm you, but will only reduce your chances of becoming pregnant.
Recommended dose
To facilitate pregnancy during in vitro fertility treatment (IVF):
- The treatment starts no later than the third day after egg retrieval.
- Use 600 mg of Utrogestan daily according to the doctor’s instructions. Insert one capsule deep into the vagina in the morning, one at lunchtime, and one at bedtime.
- If laboratory tests show that you are pregnant, continue with the same dosage schedule until at least the 7th week of pregnancy but no later than the 12th week of pregnancy, as directed by your doctor.
To prevent premature labor in some women:
- Use 200 mg Utrogestan daily at bedtime from approximately the 20th to the 34thpregnancy week.
If you have used too much Utrogestan
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take the medicine package with you.
You may experience dizziness or fatigue
If you forget to use Utrogestan
- If you have forgotten a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose instead.
- Do not take a double dose to make up for a missed dose.
If you stop using Utrogestan
Talk to your doctor or pharmacist before you stop using this medicine. If you stop using the medicine, it will not make it easier for you to get pregnant.
Talk to your doctor, pharmacist, or nurse if you have any further questions about the use of this medicine.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Has been reported (occurring in an unknown number of users):
- itching
- oily discharge from the vagina
- bleeding from the vagina
You may experience temporary tiredness or dizziness within 1-3 hours of taking the medicine.
How Utrogestan should be stored
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the packaging after Exp. The expiration date is the last day of the specified month.
- No special storage instructions.
- Do not use this medicine if you notice any visible changes in the appearance of the medicine.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is progesterone. One capsule contains 200 mg of progesterone .
- Other ingredients are sunflower oil and soy lecithin. Other ingredients in the capsule shell are gelatin, glycerol, titanium dioxide (E171), and water.
Appearance and package sizes of the medicine
- Utrogestan is oval and light yellow soft capsules containing a whitish oil suspension.
- The medicine is supplied in PVC/aluminum blisters containing 15, 21, 45, or 90 capsules
Marketing Authorisation Holder
Besins Healthcare Ireland Limited
16 Pembroke Street Upper
Dublin 2
D02HE63
Ireland
Manufacturer
- Cyndee Pharma, SL
Poligono Industrial Emiliano Revilla Sanz
Avenida de Agreda, 31
Ólvega 42110 (Soria)
Spain
This medicine is approved in the European Economic Area under the names:
Bulgaria: Utrogestan Vaginal 200 mg Capsules
Croatia: Utrogestan 200 mg meke kapsule za rodnicu.
Czech Republic: Progesterone Besins 200 mg soft tobolky
Estonia: Utrogestan 200 mg vaginal alpehmekapslid
Hungary: Utrogestan 200 mg lágy únkapszula
Ireland: Utrogestan Vaginal 200mg Vaginal Capsules Soft
Latvia: Progesterone Besins 200 mg vaginālās mīksās kapsulas
Lithuania: Progesterone Besins 200 mg makšties moššosios kapsulės
The Netherlands: Utrogestan 200 mg, zachhe capsules voor vaginalal gebruik
Norway: Utrogestan 200 mg vaginal capsules, soft
Poland: Utrogestan 200 mg, kapsułki dopochwowe, mołękke
Slovakia: Utrogestan 200 mg mökké vaginálne kapsuly
Slovenia: Utrogestan 200 mg mehke vaginalne kapsule
United Kingdom: Utrogestan Vaginal 200mg Capsules