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

The active substance is: micronised progesterone (INN).

The other ingredients are:

• Excipients of the contents of the capsule: arachis oil, soya-bean lecithin.
• Constituents of the capsule: gelatin, glycerol, titanium dioxide (E 171).
• Excipients known to have a recognized effect: arachis oil, soya-bean lecithin.

Marketing authorisation holder:

• Laboratories Besins lnternational
• 13 rue Perier - 92120MONTROUGE (France)

Manufacturer:

• Besins Manufacturing Belgium
• 128 Groot-Bijgaardenstraat - 1620 Drogenbos (Belgium)

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

• Utrogestan 100 mg: box of 30 capsules.
• Utrogestan 200 mg: box of 15 capsules.
• Progesterone (GO3DA04: 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:

• - menstrual irregularity due to dysovulation,
• - premenstrual disorders,
• - breast pain or benign breast disorders,
• - bleeding (due to fibroma),
• - therapy of the menopause (complement to estrogen therapy).

By vaginal route to help pregnancy, in particular:

• - in the case of repeated abortion, during ln 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).

2: BEFORE YOU TAKE UTROGESTAN:

Do not take Utrogestan

• - lf you are allergic to any of the constituents of Utrogestan.
• - ln 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 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

• - Many epidemiological studies on more than a thousand patients have not revealed any association between progesterone and foetal malformations.
• - Ask your doctor or pharmacist for advice before taking any medicine.

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:

• Reduce the dose per intake,
• Change interval between intakes,
• Change to vaginal administration.

• However, in all cases, you should not take more than 200mg per intake.
• In case of over dosage signs, consult your doctor who will adapt your treatment.
• Due to arachis oil and soya-bean lecithin, there is a risk of allergic reactions (rash, generalized allergic reaction).
• If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING UTROGESTAN

• Keep out of the reach and sight of children.
• There are no special storage instructions.
• Do not use after expiry date stated on the blister and the box.
• Do not use Utrogestan if you notice signs of deterioration.

This leaflet was last approved in June 2002.

Further information:

• Your pharmacist can only supply this medicine on presentation of your doctor’s prescription. This medicine may not be supplied again unless otherwise
• Indicated by your doctor, or a new prescription is written.