Utrogestan 100 mg soft capsules – progesterone for oral and vaginal use

Utrogestan is a medicine containing natural (micronised) progesterone – a sex hormone that the body naturally produces in the second phase of the menstrual cycle and during pregnancy. In Serbia it is authorised as 100 mg soft capsules which, depending on the indication and the doctor’s decision, are used orally (swallowed) or vaginally.

It is used for disorders caused by progesterone deficiency: premenstrual syndrome and cycle irregularities, hormone replacement therapy in menopause (together with oestrogen), treatment of certain forms of infertility and in vitro fertilisation, and certain conditions in pregnancy. The route of administration and dose are always determined by a doctor.

What is Utrogestan (progesterone) used for and how should it be used correctly?

Key facts about the medicine

What is Utrogestan used for?

According to the official leaflet, Utrogestan is used to treat disorders caused by progesterone deficiency:

• premenstrual syndrome (breast tenderness, bloating, heavy legs, mood changes, nervousness, irritability)
• menstrual cycle irregularities due to ovulation disorders or absence of ovulation
• certain benign breast conditions (benign mastopathy)
• premenopause
• hormone replacement therapy in menopause – together with oestrogen
• certain forms of reduced fertility or infertility in women: dysovulation, luteal phase support during in vitro fertilisation (IVF), oocyte donation programmes
• in pregnancy: threatened miscarriage or prevention of recurrent miscarriage due to insufficient progesterone secretion, risk of preterm labour (oral use only) and prevention of preterm birth in certain women at risk

Which indication and route of administration apply to a particular patient is determined solely by the doctor.

How is it used and dosed?

The medicine can be used orally (the capsule is swallowed) or vaginally (the capsule is inserted as deep as possible into the vagina). The vaginal route is an alternative to oral use for all indications when oral use causes side effects or is contraindicated. The doses below are the general dosing from the leaflet:

Oral use

• Usual dose: 200–300 mg progesterone daily, in one or two doses – e.g. 200 mg in the evening at bedtime and, if needed, 100 mg in the morning; preferably on an empty stomach (do not take with food).
• Luteal insufficiency (premenstrual syndrome, cycle disorders, premenopause, benign mastopathy): 10 days per cycle, from day 17 to day 26.
• Hormone replacement therapy in menopause: with oestrogen, during the last two of the three weeks of oestrogen use per month, followed by a one-week break when bleeding usually occurs.
• Risk of preterm labour: 400 mg every 6–8 hours in the acute phase, followed by a maintenance dose (e.g. 3 × 200 mg daily) until week 36 of pregnancy.

Vaginal use

• Usual dose: 200 mg progesterone daily (e.g. two 100 mg capsules – one in the morning and one in the evening), deep into the vagina; the dose may be increased according to response.
• Partial luteal insufficiency: 200 mg daily, 10 days per cycle (day 17 to day 26).
• Oocyte donation programme: 100 mg on days 13 and 14 of the transfer cycle, then 100 mg in the morning and 100 mg in the evening from day 15 to day 25; if pregnancy occurs, from day 26 the dose is increased by 100 mg per week up to a maximum of 600 mg daily (in three doses), until day 60.
• In vitro fertilisation (IVF): from the evening of transfer, on average 600 mg daily in three doses (morning, midday and evening).
• Threatened miscarriage or prevention of recurrent miscarriage: 200–400 mg daily in two doses, until week 12 of pregnancy.
• Prevention of preterm birth in women with a short cervix: 200 mg in the evening at bedtime, from week 20 to week 34 of pregnancy.

These values are not an individual recommendation. The dose, route and duration of treatment are determined by a doctor, and treatment should not be stopped early without agreement with the doctor.

Special patient groups

• Liver impairment: the medicine must not be used in severe liver dysfunction; in mild to moderate liver dysfunction it is used with caution.
• Conditions that may be worsened by fluid retention (high blood pressure, heart and kidney disease, epilepsy, migraine, asthma), depression and diabetes require caution and medical monitoring.
• The medicine is intended for women; the leaflet does not provide for use in children.

Contraindications – when the medicine must not be used

• hypersensitivity to progesterone, soya or peanuts, or to any of the excipients
• severe liver dysfunction
• unexpected or unexplained vaginal bleeding that is not menstrual
• current or previous breast or reproductive system cancer
• thrombophlebitis
• current or previous thrombosis (e.g. deep vein thrombosis, pulmonary embolism)
• current or previous bleeding in the brain
• porphyria

The other conditions listed below are not contraindications, but require special caution and medical supervision.

Precautions and warnings

• Treatment has no contraceptive effect.
• In uterine bleeding, the medicine is not prescribed before the cause of bleeding has been established (a gynaecological examination is needed).
• If treatment is started too early in the cycle, especially before day 15, bleeding or a shortened cycle may occur.
• The doctor stops treatment in case of visual disturbances (loss of vision, double vision, optic disc swelling), venous thromboembolism, or migraine and severe headaches.
• Cases of liver disease and cholestatic jaundice have been reported during use in the second and third trimesters of pregnancy.
• Before hormone replacement therapy in menopause, a full examination (gynaecological and breast) is needed, with periodic check-ups; report any breast changes to your doctor.
• For vaginal use, the capsule should be inserted deep into the vagina.
• The medicine may affect the results of endocrine and liver function tests.

Interactions with other medicines, alcohol and food

• Some antiepileptic medicines and certain antibiotics may affect the action of Utrogestan.
• Utrogestan may affect the action of medicines used to treat diabetes.
• Consult your doctor or pharmacist before use if you take bromocriptine, ciclosporin, phenylbutazone, spironolactone, griseofulvin, rifampicin or ketoconazole.
• During oestrogen hormone replacement therapy, progesterone is added for 12 days per month to obtain the full benefit and protection of the uterine lining.
• Food: when used orally, the medicine should not be taken with food.

Pregnancy and breastfeeding

Utrogestan is used in certain conditions in pregnancy according to the doctor’s indication and dosing. According to the leaflet, many epidemiological studies have not shown an association between progesterone use and foetal malformations. Excretion of progesterone into breast milk has not been studied, so use during breastfeeding should be avoided.

Driving and using machines

If you feel drowsy or dizzy (more common with oral use), do not drive or operate machinery.

Possible side effects

• Common (up to 1 in 10 patients): menstrual cycle disorders, absence of menstruation, bleeding between periods, headache.
• Uncommon (up to 1 in 100): breast discomfort, drowsiness, transient dizziness, vomiting, diarrhoea, constipation, cholestatic jaundice, itching, acne.
• Rare (up to 1 in 1,000): nausea.
• Very rare (up to 1 in 10,000): anaphylaxis, depression, hives, melasma (dark skin patches).
• Fluid retention, weight changes, libido changes, insomnia, fever, hair loss and excessive hair growth may also occur; venous thromboembolism is more common in women on hormone replacement therapy.

If drowsiness or dizziness occur, contact your doctor – the dose is usually reduced. Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose: drowsiness, dizziness, euphoria and painful periods may occur and resolve when the dose is reduced; contact your doctor or pharmacist. No overdose has been reported with vaginal use.
• Missed dose: do not take a double dose to make up for a missed one.
• Stopping treatment: the doctor determines the duration of treatment – do not stop early on your own, especially in pregnancy.

Related information

Progesterone therapy is always carried out under the supervision of a gynaecologist. For questions about using the medicine and related care, ask a pharmacist at the pharmacy.

For additional care and support with women's health concerns, see also the Ovaries, menopause and PMS category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: progesterone (micronised), 100 mg per soft capsule.
• Capsule content: sunflower oil, soya lecithin.
• Capsule shell: gelatin, glycerol, titanium dioxide (E171), purified water.
• Appearance: round, light yellow soft gelatin capsules filled with a whitish oily suspension.
• Pack: 2 PVC/Al blisters of 15 capsules (30 in total) in a carton with a patient leaflet.
• Marketing authorisation holder: BIESSEN PHARMA DOO BEOGRAD; manufacturer: CYNDEA PHARMA SL, Spain.

Storage

• The medicine does not require any special storage conditions.
• Keep out of the sight and reach of children; do not use after the expiry date stated on the pack.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Are Utrogestan capsules used orally or vaginally?

The same capsule can be used both ways. The doctor determines the route according to the indication: e.g. in risk of preterm labour only the oral route is used, while for IVF and threatened miscarriage the dosing is described for vaginal use.

Does Utrogestan protect against pregnancy?

No. According to the leaflet, the treatment has no contraceptive effect when the medicine is used as recommended.

Should Utrogestan be taken with food?

For oral use, no – it is best taken on an empty stomach, with the larger dose usually in the evening at bedtime.

Can Utrogestan cause drowsiness?

Yes, drowsiness and transient dizziness are possible side effects, especially with oral use. In that case do not drive; the doctor may reduce the dose.

What if I am allergic to soya?

The medicine contains soya lecithin, so you must not use it if you are allergic to soya or peanuts.

Sources

• ALIMS – Utrogestan® 100 mg soft capsule, Patient Information Leaflet (October 2025)
• ALIMS – Utrogestan® 100 mg soft capsule, Summary of Product Characteristics

Sources checked on: 23 October 2026.