Utrogestan Vaginal API

Prescribing Information

UTROGESTAN VAGINAL (progesterone) 200 mg CAPSULES

For full prescribing information, including side effects, precautions and contraindications, please consult the Summary of Product Characteristics (SPC).

Presentation: Each soft vaginal capsule contains 200 mg progesterone (micronised) (INN). Indication: Supplementation of the luteal phase during Assisted Reproductive Technology (ART) cycles. Dosage and Administration: The recommended dose is 600 mg/day in three divided doses, inserted deep into the vagina, from the day of embryo transfer until at least the 7th week of pregnancy and not later than the 12th week of pregnancy. For full details of usage please refer to the SPC. Contraindications: Known allergy or hypersensitivity to progesterone or any of the excipients; severe hepatic dysfunction; undiagnosed vaginal bleeding; mammary or genital tract carcinoma; thrombophlebitis; thromboembolic disorders; cerebral haemorrhage; porphyria, missed abortion. Warnings and Precautions: Utrogestan vaginal capsules should only be used during the first three months of pregnancy and must only be administrated by the vaginal route. Prescription of progesterone beyond the first trimester may reveal gravidic cholestasis. Utrogestan vaginal capsules are not suitable as a contraceptive. Treatment should be discontinued upon diagnosis of a missed abortion. Utrogestan vaginal capsules contain soyabean lecithin and may cause urticaria and anaphylactic shock in hypersensitive patients. As there is a possible relationship between allergy to soyabean lecithin and allergy to peanuts, patients with peanut allergy should avoid using Utrogestan vaginal capsules. Interactions: Utrogestan vaginal capsules may interfere with the effects of bromocriptine and may raise the plasma concentration of ciclosporin. They may also affect the laboratory tests of hepatic and/or endocrine functions. Metabolism of Utrogestan vaginal capsules is accelerated by rifamycin medicines. The metabolism of progesterone by human liver microsomes was inhibited by ketoconazole (a known inhibitor of cytochrome P450 3A4), so ketoconazole may increase the bioavailability of progesterone. The clinical relevance of this in vitro finding is unknown. Pregnancy and lactation: No association has been found between the maternal use of natural progesterone in early pregnancy and foetal malformations. Detectable amounts of progesterone enter the breast milk. Utrogestan vaginal capsules are not indicated during lactation. Undesirable effects: vaginal haemorrhage, vaginal discharge, pruritus. For further information on side effects and risk estimates please consult the SPC. Overdose: Symptoms may include somnolence, dizziness, euphoria or dysmenorrhoea. Treatment is observation and if necessary symptomatic and supportive measures should be provided. NHS Price: 21 capsules supplied with 21 disposable applicators £21. Legal category: POM. Marketing Authorisation Number: PL 28397/0005. Marketing Authorisation Holder: Besins Healthcare, Avenue Louise, 287, Brussels, Belgium. Date of preparation of Prescribing Information: September 2019 BHUK/2019/167

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Adverse events should also be reported to Besins Healthcare (UK) Ltd,
Drug Safety on 0203 862 0920 Email: pharmacovigilance@besins-healthcare.com

UTV/2020/021 | December 2020