Product Description

Utrogestan ® 100 mg capsules, soft

utrogestan

Progesterone
Read this leaflet carefully before you start taking this medicine.
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 and you should not pass it on to others. It may harm them, no matter if their symptoms are the same as yours.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Utrogestan and what it is used
2. Before you use Utrogestan
3. How to use Utrogestan
4. Possible side effects
5. How to store Utrogestan
6. Further information

1. WHAT UTROGESTAN AND WHAT IT IS USED

Utrogestane hormonal medicinal product containing a progesterone. It belongs to a group of medicines known as progestins. oral
Utrogestan is used to treat the symptoms that sometimes occur before the menstrual cycle: chest pain or discomfort (mastodynia), a swollen belly and / or swelling of the legs syndrome “heavy legs” and / or extreme fatigue, frequent change moods, nervousness and irritability.
Utrogestan can be used by women with menstrual irregularities, experiencing some of the above symptoms. These simptomitsikalat becomes irregular.
Utrogestan is used to treat benign disease of the breast (mastopathy). which can be found in self-examination. Breast self-examination should be done according to your doctor’s recommendations, as should be immediately before the beginning of menstruation.
In women whose menstrual cycle is irregular for 1 year or more ie at menopause. Utrogestan may be administered in addition to hormone replacement therapy (HRT) with estrogen. to benefit patients all the benefits of therapy with estrogen and avoid its risks.
Utrogestan is indicated for the treatment of infertility in women. that due to hormonal disorders can not conceive or carry a pregnancy.
vaginal administration
Vaginal administration is an alternative to oral.
Utrogestan be used to treat a particular type of infertility in women, as well as primary and secondary infertility in women due to hormonal disorders are unable to conceive or carry a pregnancy, especially during the programs for in vitro fertilization and / or donor eggs.
Utrogestan is indicated for the treatment of threatened abortion or prevention of repeated abortions due to proven progesterone deficiency.
All other indications for oral progesterone provided that there are:
Side effects upon oral administration of progesterone (sleepiness);
Contraindications to oral administration (liver disease).

2. BEFORE YOU USE UTROGESTAN

Do not use Utrogestan if any of the following status applies to you
are allergic (hypersensitivity) to progesterone, peanut oil, soy lecithin or any of the other ingredients of Utrogestan;
if you have severe liver dysfunction;
if you have or have had a blood clot in the blood vessels of the legs or lungs (like deep vein thrombosis or pulmonary embolism);
if you have a suspected or diagnosed hormone-dependent disorders or tumors of the uterus, breast or ovarian cancer;
if you had breast cancer;
if you have abnormal vaginal bleeding, which is diagnosed by your doctor;
Take special care with Utrogestan treatment when done according to recommended dosages, is not contraceptive method.
Unlike other drugs of the same group, vaginal administration Utrogestan did not affect the liver and no reported cases of elevated blood clotting. Moreover Utrogestan no effects that could affect blood pressure. The menstrual cycle can be shortened and / or monitor bleeding outside if intake was started too early, especially before) five days of the menstrual cycle.
More than half earlier, miscarriages are caused by genetic complications. Furthermore, they can be caused by infection or mechanical trauma. In these cases, the only result of the use of progesterone will delay the release of dead fetus. Therefore, progesterone should be used only in case of progesterone deficiency and according to the directions of your doctor.
Medical examination / follow
Before you start or resume hormone replacement therapy (HRT) Your doctor will lift the complete medical and family history. He can review your chest and / or abdomen, as well as to examine your internal organs.

Once you start HRT periodically (at least annually) You should be conducted medical examinations, during which your doctor will discuss with you the benefits and risks of continuing HRT.
HRT should stop immediately and contact your doctor if you experience any of the following symptoms:
– onset of migraine-type headache for the first time;
– symptoms of blockage of blood vessels for example. vision disorders;
– if you have yellow skin and eyes (jaundice) or other liver problems;
– if you become pregnant;
– a significant increase in blood pressure;
– zachestyavne of epileptic pripadatsi;
– VTE.
If you are having surgery, tell your doctor. To reduce the risk of a blood clot, you may need to stop HRT 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 required to benefit patients the benefits of treatment with estrogen.
Certain drugs used to treat epilepsy and certain antibiotics may influence the use of Utrogestan. Utrogestan in turn may affect the action of medicines to treat 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 lactation
The application of Utrogestan is not contraindicated during pregnancy included. the first few weeks of pregnancy.
Your doctor may prescribe Utrogestan to prevent a recurrence abortion or increasing number of contractions that can lead to premature birth.
No studies have been conducted and it is unknown whether progesterone is secreted in human milk, therefore the use of Utrogestan during lactation is not recommended.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
If you experience dizziness or drowsiness, do not drive or
operate machinery.
Important information about some of the ingredients of Utrogestan
Utrogestan capsules, soft contains groundnut oil. If you are allergic to peanuts or soya, do not use this product.

3. HOW TO USE UTROGESTAN

Always use Utrogestan exactly as you have been told your doctor. If you’re not sure, ask your doctor or pharmacist.

oral
The usual dose is 2 capsules in the evening before bedtime, and 1 capsule
morning if necessary. The maximum daily dose is 2-3 capsules
Utrogestan. The capsules must be taken with a small amount
water.
Treatment of symptoms sometimes occurs before the onset of menstruation (premenstrual syndrome, menstrual irregularities, premenopausal benign mastopathy) 2 or H capsules daily per cycle than 10 days, usually from 17 to 26 day menstrual cycle.
Hormone replacement therapy in menopause: not recommended monotherapy with estrogen. Progesterone is considered in addition to therapy, the dose is 2 capsules per day for 14 days (the last two weeks of the three week treatment cycle) followed by hormonal therapy is stopped for 1 week. During this one week can be seen bleeding.
Prevention of abortion and premature birth: 3-4 capsules Utrogestan every 6 to 8 hours, depending on the clinical results obtained in the acute phase, followed by administration of a maintenance dose of up to 36 weeks of gestation.
vaginal administration
The usual dose is one capsule in the morning and 1 capsule at bedtime, the capsules must be inserted into the vagina. This dose may be increased depending on the individual response to the treatment provided.
Insufficiency of the luteal phase (disturbances in ovulation, irregular menstruation): daily dose of 2 capsules a day for a period of 10 days, usually from 17 to 26 day menstrual cycle.
Infertility due to total progesterone deficiency (donation of ova): the usual dose is 1 capsule of the 13th and 14th day of the cycle of the transfer, and then from the 15th to the 25th day of the cycle 1 capsule in the morning and bedtime. From the 26th day in the case of pregnancy, the dosage is increased by 1 capsule per day each week until a maximum daily dose of 6 capsules per day in three divided doses. This prescription should be continued until day 60 of pregnancy.
Supplementing the luteal phase in IVF cycle (IFV): the recommended dose is 6 capsules per day (6 capsules distributed in three divided doses in the morning, at noon and at night before going to bed), starting from the day of transfer.
Supplementing the luteal phase of spontaneous and induced cycles in case of subfertility or primary / secondary infertility (due to disturbances in ovulation) recommended administration of 2 capsules per day, on the 17th day of the cycle for 10 days.
In the case of threatened abortion or prevention of repeated abortions due to progesterone deficiency, it is recommended that application of 2-4 capsules per day in two applications to the 12th week of pregnancy.
Always use Utrogestan according to these recommendations, except when your doctor prescribes something else.
Tell your doctor if your symptoms worsen or do not improve.
The duration of treatment is determined by the attending physician.
If you take more than the amount Utrogestan
Side effects most often symptoms of overdose, which resolve spontaneously reduce the dose of Utrogestan or by increasing the daily dose of estrogen (in the treatment of
menopause).
In some women, the usual dose may be too high and cause certain symptoms. In this case it should take any of these actions:
– In case of drowsiness and dizziness brief dose should be reduced gradually or Utrogestan should be administered at bedtime for a period of 10 days per cycle.
– In case of bleeding during the menstrual cycle or shorter cycle, therapy should be initiated later in the cycle (ie. On the 19th day of the cycle, instead of the 17th).
– In case you take more dose Utrogestan, please immediately contact your doctor or pharmacist.
If you forget to take or you take less Utrogestan
Do not take a double dose to make up the missed dose.
If you stop taking Utrogestan
There are no known adverse effects following discontinuation of therapy with this medicinal product.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

 

4. POSSIBLE SIDE EFFECTS

As with all drugs, Utrogestan can cause side effects, although not everyone gets them.
Undesirable effects may occur with the frequency defined as follows:
Very common: affects more than 1 in 10 patients treated;
common: affects 1 to 10 of 100 patients treated;
uncommon: affects 1 to 10 per 1000 patients treated;
rare: affects 1 to 10 of 10 000 patients treated;
very rare: affects less than 1 in 10 000 patients treated;
Not known: from the available data can not be estimated.
The table below lists the side effects that are observed after oral administration, grouped by frequency and system organ class

It is possible that shortening of the menstrual cycle or bleeding during the cycle, if treatment is started too early, especially before the 15th day of the cycle.
At higher doses may be observed drowsiness and / or transient dizziness. These symptoms disappear with dose reduction Utrogestan without compromising therapeutic success.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

 

5. HOW TO STORE UTROGESTAN

Do not store above 25 ° C.
Keep out of reach of children.
Do not use Utrogestan after the expiry date stated on the packaging and in case of poor integrity of the capsules! The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste, as they can be harmful to the environment. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 

6. FURTHER INFORMATION

What Utrogestan
Each capsule, soft, Utrogestan comprises:
Active substance: 100 mg progesterone;
The other ingredients are peanut butter, soy lecithin, gelatin, glycerol. titanium dioxide (E171).
Utrogestan looks like and contents of the pack
In a cardboard box Utrogestan contained 2 blisters of 15 capsules, soft.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratoires Besins International H rue du Bourg L’Abbe 75003 Paris. France
manufacturers:
Laboratoires Besins International 13, rue Perier, 92120 Montrouge, France
Besins Manufacturing Belgium
Groot Bijgaardenstraat-128, B-1620 Drogenbos
Belgium

 

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