PROGESTERONE VAGINAL

Posology For supplementation of the luteal phase during Assisted Reproductive Technology cycles. The recommended dose is 600 mg/day, given in three divided doses, one in the morning, one at midday and the third at bedtime. The treatment is started not later than the third day after oocyte retrieval.

If pregnancy has been confirmed, continue treatment until at least the 7th week but no longer than the 12th week of pregnancy. For prevention of preterm birth in pregnant women with a singleton pregnancy who have a short cervix and/or history of spontaneous preterm birth, the recommended dosage is 200 mg/day in the evening at bedtime, from around week 20 to week 34 of pregnancy.

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Local intolerance (burning, itching or oily discharge) has been observed in clinical studies and has been reported in publications, but the incidence is extremely rare. When used as recommended, transient fatigue or dizziness may occur within 1 – 3 hours of taking the medicine.

Reporting of suspected adverse reactions after authorization. The information given below is based on extensive post marketing experience, primarily from vaginal administration of progesterone. Adverse effects have been ranked under headings of frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); frequency not known (cannot be estimated from the available data).

System organ class Frequency Not known (cannot be estimated from the available data) Skin and subcutaneous tissue disorders Pruritus Reproductive system and breast disorders Vaginal haemorrhage Vaginal discharge General disorders and administration site conditions Burning sensation Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. Paediatric population There is no relevant use of Progesterone Vaginal in the paediatric population. Elderly patients There is no relevant use of Progesterone Vaginal in the elderly. Method of administration Vaginal Each capsule of Progesterone Vaginal 100 mg soft capsules must be inserted deep into the vagina.

4 Special warnings and precautions for use Warnings • A complete medical examination must be performed before starting and regularly during the treatment. • Progesterone Vaginal 100 mg soft capsules is not suitable as a contraceptive.

• In rare cases, the use of micronised progesterone during the second and third trimester of pregnancy may lead to the development of gravidic cholestasis or hepatocellular liver disease. • Treatment should be discontinued upon diagnosis of a missed abortion.

Precautions: • Any vaginal bleeding should always be investigated. Warning specific for supplementation of the luteal phase during Assisted Reproductive Technology cycles: • Progesterone Vaginal 100 mg soft capsules should only be used during the first three months of pregnancy and must only be administrated by vaginal route.

Precautions specific for prevention of preterm birth in women with a singleton pregnancy who have a short cervix and/or a history of spontaneous preterm birth: Before treatment is initiated: • The risks and benefits of the options available, should be discussed with the patient.

1). 3). Should rupture of membranes occur during treatment, further treatment with Progesterone Vaginal 100 mg soft capsules should be discontinued. Progesterone Vaginal 100 mg soft capsules contain soybean lecithin and may cause hypersensitivity reactions (urticarial and anaphylactic shock in hypersensitive patients).

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