Progesteron Besins (Progesterone) 200 mg 15 soft vaginal capsules

Progesteron Besins (Progesterone) 200 mg, 15 soft vaginal capsules — Besins Healthcare, Czech Republic

Progesteron Besins is a prescription medicine containing micronised progesterone in a soft vaginal capsule. The pack holds 15 capsules, each with 200 mg of progesterone, in a PVC/Al blister. It is the Czech-market version of the product registered as Utrogestan in Ireland, Italy, Bulgaria, Croatia, Estonia and Hungary, and as Progestan in Denmark and Iceland. The marketing-authorisation holder is Besins Healthcare Ireland Limited (Dublin, Ireland); the capsules are manufactured in Spain by Cyndea Pharma, S.L. (Ólvega, Soria) or Besins Manufacturing España S.L. (Muel, Zaragoza). The medicine is dispensed on a doctor's prescription only and is used under medical supervision.

Product overview

• Trade name: Progesteron Besins 200 mg měkké vaginální tobolky (Czech Republic)
• Active ingredient: progesterone (progesteronum) 200 mg per capsule
• Dosage form: soft vaginal capsules (měkké vaginální tobolky) — oval, yellowish, containing an almost white oil suspension
• Pack size: 15 soft capsules (PVC/Al blister)
• Marketing-authorisation holder: Besins Healthcare Ireland Limited (Dublin, Ireland)
• Manufacturer: Cyndea Pharma, S.L. (Ólvega, Soria, Spain) or Besins Manufacturing España S.L. (Muel, Zaragoza, Spain)
• Country: Czech Republic (EU), registered by SÚKL
• Product category: prescription progesterone (progestogen) for vaginal use

What progesterone is used for

The Czech label describes two approved uses, both in women and both under medical supervision:

• Support of pregnancy during infertility treatment — for women who need additional progesterone during in vitro fertilisation (IVF) cycles.
• Prevention of preterm birth in singleton pregnancy — for women who have previously given birth prematurely and/or who have a short cervix.

Progesterone is the natural progestogen hormone; in this form it is delivered locally, into the vagina. The product is not a contraceptive and does not treat the underlying cause of infertility.

How it is used

Progesteron Besins is a prescription medicine: the dose, the timing and the duration of treatment are decided by the treating physician, and treatment is accompanied by regular medical checks. For supervised use the official label describes a daily dose of 600 mg (three 200 mg capsules) in IVF cycles — started no later than the third day after egg retrieval and continued for at least 7 weeks and no longer than 12 weeks of pregnancy — and one 200 mg capsule in the evening for the prevention of preterm birth, usually from about week 20 to week 34 of pregnancy. The capsule is inserted deep into the vagina and is not intended to be taken by mouth. Follow your doctor's instructions, not this page.

Possible side effects

The frequency of the following reactions is not known from the available data: itching, oily vaginal discharge, vaginal bleeding and a burning sensation. Short-term fatigue or dizziness may occur within 1–3 hours after use. Report any reaction to your doctor or pharmacist.

Important precautions

Do not use Progesteron Besins if you are allergic to soy or peanuts, to progesterone or to any other ingredient (the capsules contain soy lecithin and refined sunflower oil); if you have liver problems or jaundice; unexplained vaginal bleeding; breast or genital cancer; inflammation of a vein with a blood clot (thrombophlebitis); a current or previous blood clot in a vein (deep vein thrombosis) or in the lungs (pulmonary embolism); a history of bleeding in the brain; the inherited blood disorder porphyria; a missed miscarriage; or if your waters have broken. The product is not intended for children and must not be used while breastfeeding. Tell your doctor about all the medicines you take — in particular bromocriptine, ciclosporin, rifampicin and ketoconazole. If you think you have miscarried, or if you have vaginal bleeding, contact your doctor, because treatment may need to be stopped.

Storage

No special storage conditions are required. Keep the product out of the sight and reach of children, do not use it after the expiry date marked EXP on the box and blister, and do not use it if you notice visible changes in the appearance of the capsules. Return unused medicines to a pharmacy.

Important notice

This page shows the original pack for identification purposes. Progesteron Besins is dispensed on a doctor's prescription only and this page is not a guide to self-treatment; the information above follows the official Czech patient leaflet. It is not a substitute for medical advice — the need for treatment and the dose are decided by your physician.

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