1. WHAT THROUGH IS AND WHAT IT IS USED FOR A
thrombotic hormone product containing progesterone. It belongs to the group of medicinal products known as progestins. Oral use
Utrogestan is used to treat the symptoms that sometimes occur before the start of the menstrual cycle: chest pain or discomfort (mastodynia), swollen stomach and / or swelling of the leg , heavy legs syndrome and / or severe fatigue, common mood swings, increased nervousness and irritability.
Utrogestan can also be used by women with irregular menstruation who experience some of the symptoms described above. These symptom cycles begin to become irregular.
Utrogestan is used to treat benign breast disease (mastopathy). which can be detected in self-examination. Breast self-examination should be done according to your doctor's recommendation, and should not be immediately prior to menstruation.
In women whose menstrual cycle is irregular for 1 year and over, when menopause occurs. Utrogestan may be prescribed in addition to hormone replacement therapy (HRT) with estrogen. in order to benefit patients from all the benefits of estrogen therapy and to avoid its risks.
Utrogestan is indicated for the treatment of infertility in women. who due to hormonal disorders can not become pregnant or wean the pregnancy.
Vaginal administration is an alternative to oral.
Utrogestan is used to treat a certain type of infertility in women as well as for primary and secondary infertility in women who, due to hormonal disorders, can not become pregnant or wean out pregnancy, especially during IVF and / or egg donation programs.
Utrogestan is indicated for the treatment of threatening abortion or prevention of repeated abortions due to proven progesterone deficiency.
All other indications for oral progesterone administration provided that:
Adverse effects on oral administration of progesterone (somnolence);
Contraindications for oral administration (liver disease).
2. BEFORE YOU USE UTROGESTAN
Do not use Utrogestan if any of the following applies to you
if you are allergic (hypersensitive) to progesterone, peanut oil, soya lecithin or any of the other ingredients of Utrogestan;
if you have severe liver function abnormalities;
if you have or have had a blood clot in the leg or lung blood vessels (such as deep vein thrombosis or pulmonary embolism);
if you have suspected or diagnosed hormone-dependent or uterine, breast or ovarian tumors;
if you have had breast cancer;
if you have abnormal vaginal bleeding that is not diagnosed by your doctor;
Take special care with Utrogestan Treatment when taken according to the recommended dosage is not a contraceptive method.
Unlike other drugs in the same group, vaginal administration of Utrogestan did not affect the liver and there were no cases of increased coagulation. Moreover, Utrogestan has no effects that could affect blood pressure. The menstrual cycle may be shortened and / or bleeding seen outside of it if the intake is started too early, especially before 5th day of the menstrual cycle.
More than half of the early, spontaneous abortions are caused by genetic complications. In addition, they can be caused by infections or mechanical injuries. In these cases, the only result of using progesterone will be delaying the release of the dead fruit. Therefore, progesterone should only be used in case of progesterone deficiency and according to your doctor's prescriptions.
Medical examination / follow-up
Before starting or resuming HRT, your doctor will take a complete medical and family history. He can examine your chest and / or the abdomen, as well as examine your internal organs. Once you start HRT, you should have periodic medical examinations (at least once a year) during which your doctor will discuss with you the benefits and risks of continuing HRT.
You should stop HRT and contact your doctor immediately if any of the following symptoms
occur : - Migraine-type headache occurs for the first time;
- the appearance of blood vessel occlusion symptoms, visual disturbances;
- if yellow skin and eyes (jaundice) or other liver problems occur;
- if you become pregnant
- significant increase in blood pressure;
- frequency of epileptic seizures;
- development of venous thromboembolism.
If you are going to have surgery, talk to your doctor. To reduce the risk of blood clotting, you may need to stop HRT for 4 to 6 weeks before surgery. Your doctor will tell you when you can start HRT again.
Taking other medicines
The use of Utrogestan for a minimum of 12 days per cycle during hormone replacement therapy (HRT), including estrogen, is highly recommended and even necessary to benefit patients from the benefits of estrogen therapy.
Certain medicines used to treat epilepsy and some antibiotics may affect the action of Utrogestan. In turn, Utrogestan may affect the effect of medicinal products for the treatment of diabetes.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding The
use of Utrogestan is not contraindicated during pregnancy, the first few weeks of pregnancy.
Your doctor may prescribe Utrogestan to prevent a repeat abortion or more frequent contractions that may lead to premature birth.
No studies have been performed and it is not known whether progesterone is excreted in human milk, therefore the use of Utrogestan during breast-feeding is not recommended.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or
operate machinery if you experience dizziness or drowsiness .
Important information about some of the ingredients of Utrogestan
Utrogestan capsules, soft contains peanut butter. If you are allergic to peanut or soy, do not use this medicine.
3. HOW TO USE UTREGASTAN
Always use Utrogestan exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is 2 capsules in the evening before bedtime and another 1 capsule
in the morning if necessary. The maximum daily dose is 2-3 capsules of
Utrogestan. The capsules should be taken with a small amount of
Treatment of symptoms that sometimes occur before the onset of the menstrual cycle (premenstrual syndrome, irregular menstruation, premenopause, benign mastopathy): 2 or 3 capsules per day for a 10 day cycle, usually from 17 to 26 days of the menstrual cycle.
Hormone replacement therapy in menopause: estrogen-only monotherapy is not recommended. Progesterone is taken as an adjunct to therapy, the dose being 2 capsules per day for 14 days (the last two weeks of a three-week treatment cycle), after which the hormone therapy is stopped for 1 week. During this week, bleeding may occur.
Preventing abortion and premature birth: 3-4 capsules of Utrogestan every 6 to 8 hours, depending on the clinical results obtained in the acute phase, followed by maintenance doses up to 36 weeks of gestation.
The usual daily dose is 1 capsule in the morning and 1 capsule at bedtime, and the capsules should be placed deep into the vagina. This dose may be increased depending on the individual response to treatment.
Luteal phase deficiency (ovulation disorders, irregular menstruation): the daily dose is 2 capsules daily for a period of 10 days, usually 17 to 26 days of the menstrual cycle.
Infertility due to total progesterone deficiency (egg donation): the usual dose is 1 capsule on the 13th and 14th day of the transfer cycle, then from the 15th to the 25th day of the 1 capsule morning cycle, and night before bed. From day 26 and in case of pregnancy, the dose is increased by 1 capsule per day each week until a maximum daily dose of 6 capsules per day divided into three applications is reached. This prescription should continue until day 60 of pregnancy.
LVF supplementation: The recommended dose is 6 capsules a day (6 capsules divided into three intakes morning, midday and evening before bedtime) starting on the day of transfer.
Luteal phase supplementation in spontaneous and induced cycles in the case of subfertility or primary / secondary sterility (due to ovulation disorders): 2 capsules per day are recommended from the 17th day of the cycle for 10 days.
In case of threatening abortion or prevention of repeat abortions due to progesterone deficiency: 2-4 capsules per day is recommended in two applications up to the 12th week of pregnancy.
Always use Utrogestan according to these recommendations, except when your doctor has not prescribed anything else to you.
Tell your doctor if your symptoms get worse or worse.
The duration of treatment is determined by the attending physician.
If you take more than the necessary dose of Utrogestan
Adverse reactions are most often symptoms of overdose, which resolve spontaneously when decreasing the dose of Utrogestan or increasing the daily dose of estrogen (in the treatment of
In some women, the usual dose may be too high and cause certain symptoms. In this case, one of the following actions should be taken:
- In the case of drowsiness and short-term dizziness, the dose should be gradually reduced or Utrogestan should be administered at bedtime for a period of 10 days per cycle.
- In case of menstrual bleeding or shortening of the cycle, treatment should be started later in the cycle (eg on day 19 of cycle instead of 17th).
- If you take more Urogestan than you should, please contact your doctor or pharmacist immediately.
If you forget to take or take less Utrogestan
Do not take a double dose to make up for the missed dose.
If you stop taking Utrogestan
No side effects are known after stopping treatment with this medicine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Utrogestan can cause side effects, although not everybody gets them.
Adverse reactions may occur with the frequency defined as follows:
very common: affects more than 1 in 10 patients treated;
common: affects 1 to 10 users in 100 treated patients;
uncommon: affects 1 to 10 in 1,000 patients treated;
rare: affects 1 to 10 users in 10,000 treated;
very rare: affects less than 1 in 10,000 patients treated;
not known: can not be estimated from the available data.
The table below lists the adverse reactions that are observed by oral administration, grouped by frequency and system organ class.
Menstrual cycle shortening or bleeding may occur during the cycle if treatment is started too early, especially before the 15th day of the cycle.
Drowsiness and / or short-term dizziness may occur at higher doses. These symptoms disappear by decreasing the dose of Utrogestan without compromising therapeutic success.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE UTREGASTAN
Store below 25 ° C.
Keep out of the reach and sight of children.
Do not use Utrogestan after the expiry date which is stated on the carton and in case of breakage of the capsules. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewage system or in the household waste container, as they may be harmful to the environment. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
What Urotgestan contains
Each soft capsule, Utrogestan contains:
Active substance: 100 mg progesterone;
The other ingredients are: peanut oil, soya lecithin, gelatin, glycerol. titanium dioxide (E171).
What Utrogestan looks like and contents of the pack
One carton of Utrogestan contains 2 blisters of 15 soft capsules.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratoires Besins International Le Rouge du Bourg L'Abbe 75003 Paris. France
Laboratoires Besins International 13, rue Perier, 92120 Montrouge, France
Besins Manufacturing Belgium
Groot-Bijgaardenstraat 128, B-1620 Drogenbos