UTROGESTAN VAGINAL

Posology Vaginal use only. The recommended dose is 600 mg/day, given in two divided doses, one in the morning and the other at bedtime. The treatment is started not later than the third day after oocyte retrieval day and is continued until at least the 7th week of pregnancy and not later than the 12th week of pregnancy or until menstruation begins.

Paediatric population There is no relevant use of Utrogestan Vaginal 300 mg in the paediatric population. Elderly patients There is no relevant use of Utrogestan Vaginal 300 mg in the elderly. Method of administration Vaginal Each Utrogestan Vaginal 300 mg capsule must be inserted deep into the vagina.

One capsule should be inserted deep into the vagina in the morning and the other at bedtime.

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 authorisation The information below is based on experience gathered after the authorisation of progesterone administered into the vagina.

The following frequency conventions are used in the rating of undesirable effects:

Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1000 to < 1/100); Rare (≥1/10000 to < 1/1000); Very rare (< 1/10000); Not known (cannot be estimated from the available data). System Organ Class (SOC) Frequency very rare (< 1/10000) Frequency Not known (Cannot be estimated from the available data) Immune system disorders Anaphylactic reactions Skin and subcutaneous tissue disorders Pruritus Reproductive system and breast disorders Vaginal haemorrhage Vaginal discharge 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Warnings:

A complete medical examination must be performed before starting the treatment and regularly during the treatment. Utrogestan Vaginal 300 mg should only be used during the first three months of pregnancy and must only be administered by the vaginal route.

Utrogestan Vaginal 300 mg is not suitable as a contraceptive. Utrogestan Vaginal 300 mg is not intended to treat an imminent premature delivery. 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.

Glucose tolerance may be impaired during progesterone treatment, and more frequent monitoring should be performed. Progesterone has been linked to an increase in Type 2 diabetes, and adjustments in the medication of diabetes-treated patients may be required.

Treatment should be discontinued upon diagnosis of a missed abortion.

Precautions:

Any vaginal bleeding should always be investigated. Utrogestan Vaginal 300 mg contains soybean lecithin and may cause hypersensitivity reactions (urticarial and anaphylactic shock in hypersensitive patients). 3).

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