Besins Healthcare


Full Prescribing Info
Micronised progesterone.
Each capsule contains micronised progesterone 100 mg.
Constituents of the capsule: Gelatin, glycerol, titanium dioxide (E 171).
Excipients/Inactive Ingredients: Excipients of the contents of the capsule: Sunflower oil, soya-bean lecithin.
Constituents of the capsule: Gelatin, glycerol, titanium dioxide (E 171).
Excipients known to have recognized effect: Soya-bean lecithin.
Progesterone (G03DA04: Genitourinary system and sex hormones).
Utrogestan is a progestogen hormone treatment.
Disorders related to a progesterone deficit.
By oral route (vaginal route is recommended as an alternative if oral route is not suitable). Menstrual irregularities due to ovulation disorders or anovulation, premenstrual disorders, breast pain or benign breast disorders (mastopathies), bleeding (due to fibroma), therapy of the menopause (adjunctive use with estrogen in post-menopausal women for prevention of endometrial hyperplasia), menace of preterm delivery and can be used up to 36 week of pregnancy, threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to the 12th week of pregnancy, treatment of subfertility or primary or secondary infertility related to progesterone insufficiency in particular in In Vitro fertilization (IVF) cycles and/or oocyte donation.
For all other progesterone indications, the vaginal route represents an alternative to the oral route, in case of adverse events due to progesterone (somnolence, dizzinesss).
Dosage/Direction for Use
Do not take more than 200 mg per intake (two 100 mg capsules), 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 physician may have to increase the dose to 600 mg per day, divided into three intakes.
For threatened abortion, two-four 100 mg capsules (200-400 mg per day) to be taken in the acute phase from the start to 12th week of pregnancy.
Menace of preterm delivery, 400 mg every 6 to 8 hours depending on the clinical response during the acute phase then a dosage of 3 x 200 mg/day as maintenance treatment until the 36th week of pregnancy.
If the treatment is too strong or too weak, talk to the physician or pharmacist.
In hormone replacement therapy in post-menopausal women receiving estrogen therapy, treatment may be prescribed continuously or sequentially for at least 12 days per month.
Two routes of administration are possible, oral and vaginal. This will be decided according to the individual basis by the physician.
Overdose: Talk to the physician or pharmacist immediately.
Missed Dose: Do not take a double dose to make up for forgotten individual dose.
Administration: If the medicine is to be administered orally: Swallow the capsule(s) with a glass of water, preferably in the evening before going to bed, or in one to three intakes, following physician's prescription.
If the medicine is administered vaginally: Insert each capsule deeply into the vagina.
The duration of the treatment will be specified by the physician according to the patient's case.
The duration of the treatment may readjusted by the physician depending on the indication and efficacy of treatment.
Allergy to any of the constituents of UTROGESTAN.
In case of severe hepatic disease.
Special Precautions
This medicine is not a treatment for all cases of spontaneous premature abortion (see Indications). In particular, it has no effect on those induced by genetic complications (more than fifty percent).
If the medicine is administered orally, it should be preferably taken in the evening or at bedtime.
UTROGESTAN is not suitable for use as a contraceptive.
Driving and using machines: By oral route, this medicine may cause drowsiness or dizziness, care should be taken when driving or using machines. Taking the capsules at bedtime should reduce these effects during the day.
Use In Pregnancy & Lactation
Pregnancy and Breast-feeding: Many epidemiological studies on more than a thousand patients have not revealed any association between progesterone and fetal malformations.
Side Effects
Like all medicines, UTROGESTAN can have side effects.
Oral route: 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; re-adapt the dose or change to vaginal administration.
However, in all cases, the patient should not take more than 200 mg per intake.
Due to soya-bean lecithin, there is a risk (usually affects only patients with known hypersensitivities) of allergic reactions (rash, generalized allergic reaction).
Store at or below 30°C, away from direct sun and heat.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Cap 100 mg x 30's. 200 mg x 15's.
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