UTROGESTAN 100 mg and 200 mg, soft capsules for oral or vaginal route.
The active substance is: micronised progesterone (INN).
Excipients/Inactive Ingredients: The other ingredients are: Excipients of the contents of the capsule: sunflower oil, soya-bean lecithin.
Constituents of the capsule: gelatin, glycerol, titanium dioxide (E 171).
Progesterone (G03DA04: Genito-urinary system and sex hormones).
This medicine is a progestogen hormone treatment.
This medicine is prescribed for disorders related to a progesterone deficit: By oral route: Disorders related to Progesterone insufficiency and in particular: Pre-menstrual syndrome.
Menstrual irregularities due to ovulation disorders or anovulation.
Benign mastopathy.
Premenopause.
Adjunctive use with oestrogen in post-menopausal women; prevention of endometrial hyperplasia in non-hysterectomised postmenopausal women who are receiving estrogen therapy.
Infertility due to luteal phase defect.
Menace of abortion.
Menace of preterm delivery.
By vaginal route to help pregnancy, in particular: Progesterone support during ovarian insufficiency or complete ovarian failure in women lacking ovarian function (oocyte donation).
Luteal phase support during in vitro fertilization cycles.
Luteal phase support during spontaneous or induced cycles, in primary or secondary infertility or subfertility in particular due to dysovulation.
Threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to the 12th week of pregnancy.
Preterm labour.
For all other Progesterone indications, the vaginal route represents an alternative to the oral route, in case of adverse events due to Progesterone (somnolence, dizziness).
In all events, the patient should strictly comply to the doctor's prescription.
The patient should not take more than 200 mg per intake (two 100 mg capsules or one 200 mg capsule), by oral or vaginal route.
On average for progesterone insufficiencies, the daily dose is 200 to 300 mg divided into one or two intakes, 100 mg in the morning, and 100 mg or 200 mg at bedtime.
In some cases, notably to help pregnancy, the doctor may have to increase the dose to 600 mg per day, divided into three intakes.
If the patient has the impression that the treatment is too strong or too weak, talk to the doctor or pharmacist.
Treatment however may be prescribed continuously, or sequentially for some days per month, and possibly associated with estrogen therapy.
Two routes of administration are possible, oral and vaginal. This will be decided according to the individual basis by the doctor.
If the medicine is to be administered orally: swallow the capsule(s) with a glass of water far from mealtimes, in one to three intakes, following the doctor's prescription.
If the medicine is to be administered vaginally: insert each capsule deeply in the vagina.
The duration of the treatment will be specified by the doctor, according to the case.
The duration of treatment may be readjusted by the doctor depending on the indication and efficacy of treatment.
If the patient takes more UTROGESTAN than they should: Talk to the doctor or pharmacist immediately.
If the patient forgets to take UTROGESTAN: Do not take a double dose to make up for forgotten individual dose.
Do not take UTROGESTAN: If the patient is allergic to any of the constituents of UTROGESTAN.
In the case of severe hepatic disease.
Take special care with UTROGESTAN: This medicine is not a treatment of all cases of spontaneous premature abortion. In particular it has no effect on those induced by genetic complications (more than fifty per cent).
UTROGESTAN should only be used in pregnancy during the first trimester and only by the vaginal route. There are some risks of undesirable effects on the liver during the second and third trimesters of pregnancy.
The treatment, in the recommended conditions of use, is not contraceptive.
Precaution for use: If the medicine is administered orally, it should be taken far from mealtimes, preferably in the evening at bedtime.
Driving and using machines: By oral route, this medicine may cause drowsiness or dizziness, care should be taken when driving or using machines.
Many epidemiological studies on more than a thousand patients have not revealed any association between progesterone and foetal malformations.
Ask the doctor or pharmacist for advice before taking any medicine.
Like all medicine, UTROGESTAN can have side effects.
Only by oral route, these effects have been observed: possible drowsiness or somnolence which may occur 1 to 3 hours after intake, menstrual irregularities, interruption of the menses, intra menstrual bleeding.
These effects generally stemmed from overdosing.
In these cases the patient should: reduce the dose per intake, change interval between intakes, change to vaginal administration.
However, in all cases, the patient should not take more than 200 mg per intake.
In case of overdosage signs, consult the doctor who will adapt the treatment.
Due to soya-bean lecithin, there is a risk of allergic reactions (rash, generalized allergic reaction).
If the patient notices any side effects not mentioned in this monograph, inform the doctor or pharmacist.
Inform the doctor or pharmacist if the patient is taking or has recently taken any other medicine, even those not prescribed.
There are no special storage instructions.
Do not use UTROGESTAN if the patient notices signs of deterioration.
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Soft cap (oral/vag) 100 mg x 2 x 15's. 200 mg x 15's (7's + 8's).
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