Utrogestan

Utrogestan

progesterone

Manufacturer:

Besins Healthcare

Distributor:

The Glory Medicina
/
DKSH
Full Prescribing Info
Contents
Micronised progesterone.
Description
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 (E171).
Excipients known to have a recognized effect: soya-bean lecithin.
Action
Progesterone (G03DA04: Genito-urinary system and sex hormones). UTROGESTAN is a progestagen hormone treatment.
Indications/Uses
UTROGESTAN is prescribed for disorders related to a progesterone deficit.
By oral route: Menstrual irregularity due to dysovulation; premenstrual disorders; breast pain or benign breast disorders; bleeding (due to fibroma); therapy of menopause (complement to estrogen therapy).
By vaginal route: To help pregnancy in particular: In the case of repeated abortion; during in vitro fertilization cycles (IVF).
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).
Dosage/Direction for Use
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) 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 having 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 individual basis by the doctor.
If UTROGESTAN 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 UTROGESTAN is to be administered vaginally: Insert each capsule deeply in the vagina.
The duration of treatment will be specified by the doctor according to the patient's case.
The duration of treatment may be readjusted by the doctor depending on the indication and efficacy of treatment.
Forgotten intake of UTROGESTAN: Do not take a double dose to make up for the forgotten individual dose.
Overdosage
If more UTROGESTAN has been taken than necessary, talk to the doctor or pharmacist immediately.
Contraindications
Do not take UTROGESTAN: If allergic to any of the constituents of UTROGESTAN; In the case of severe hepatic disease.
Special Precautions
UTROGESTAN is not a treatment for all cases of spontaneous premature abortion. In particular, it has no effect on those induced by genetic complications (more than fifty percent).
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.
If UTROGESTAN is administered orally, it should be taken far from mealtimes, preferably in the evening at bedtime.
Driving and using machines: By oral route, UTROGESTAN may cause drowsiness or dizziness. Care should be taken when driving or using machines.
Use In Pregnancy & Lactation
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.
Side Effects
Like all medicines, 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, intramenstrual 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 any side effects not previously mentioned are noticed, inform the doctor or pharmacist.
Drug Interactions
Inform the doctor or pharmacist if taking or have recently taken any other medicine, even those not prescribed.
Caution For Usage
Do not use UTROGESTAN if signs of deterioration are noticed.
Storage
There are no special storage instructions.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Form
Utrogestan cap 100 mg
Packing/Price
30's
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