Utrogestan®100mg

Brand Name
Utrogestan® 100mg
Generic Name
Natural Micronised Progesterone
Therapeutic Segment
Obstetrics & Gynecology, Infertility
Form
Capsules

Utrogestan 100mg and 200mg, soft capsules for oral or vaginal route

The active substance is: micronised progesterone (INN).

The other ingredients are:

Marketing authorisation holder:

Manufacturer:

1: WHAT IS UTROGESTAN AND WHAT IS IT USED FOR?

This Medicine is prescribed for disorders related to a progesterone deficit:

By oral route:

By vaginal route to help pregnancy, in particular:

2: BEFORE YOU TAKE UTROGESTAN:

Do not take Utrogestan

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 induces 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.

Precaution for use

If the medicine is administered orally, it should be taken far from mealtimes, preferably in the evening at bedtime.

Pregnancy and breast-feeding

Driving and using machines

By oral route, this medicine may cause drowsiness or dizziness, care should be taken when driving or using machines.

Taking other medicine

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicine, even those not prescribed.

3: HOW T0 TAKE UTROGESTAN?

In all events, you should strictly comply with your doctor’s prescription.

You 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 bed time.

In some cases, notably to help pregnancy, your doctor may have to increase the dose to 600mg per day, divided into three intakes. If you have the impression that the treatment is too strong or too weak, talk to your 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 your individual basis by your 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 your 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 your doctor, according to your case.

The duration of treatment may be readjusted by your doctor depending on the indication and efficacy of treatment.

If you take more Utrogestan than you should

Talk to your doctor or pharmacist immediately.

If you forget to take Utrogestan

Do not take a double dose to make up for forgotten individual dose.

4: POSSIBLE SIDE EFFECTS

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.

These effects generally stemmed from overdosing. In these cases you should: 5. STORING UTROGESTAN

This leaflet was last approved in June 2002.

Further information: