Neopregnan
Overview
Neopregnan
Ovules, 200 mg / 400 mg
COMPOSITION
Each ovule contains the active substance progesterone 200 mg or 400 mg, depending on the strength.
Excipient: semi-synthetic solid glycerides.
WHAT IT IS USED FOR
A medicine containing progesterone, a natural female hormone. It is used for:
treatment of premenstrual syndrome, including premenstrual tension and depression;
treatment of postnatal (puerperal) depression;
luteal phase support in women undergoing assisted reproduction (in vitro fertilisation) programmes.
HOW IT WORKS
Progesterone is a hormone produced naturally by the body. It prepares the lining of the womb for implantation of an embryo and helps maintain pregnancy, and also plays a role in the hormonal balance in the second half of the menstrual cycle.
HOW TO USE
Administered vaginally or rectally, as directed by your doctor.
premenstrual syndrome and postnatal depression: from 200 mg once a day up to 400 mg twice a day; for premenstrual syndrome, treatment starts on day 14 of the cycle (or day 12 if symptoms appear at ovulation) and continues until menstruation begins;
luteal phase support (assisted reproduction): 400 mg vaginally twice a day, starting from egg retrieval; if pregnancy is confirmed, treatment continues for a further 38 days.
The rectal route is preferred with barrier contraception, vaginal infections (especially candidiasis), chronic cystitis or after childbirth; the vaginal route is preferred with colitis or faecal incontinence. Not for use in children and adolescents.
WHEN IT SHOULD NOT BE USED
hypersensitivity to progesterone or to any of the excipients;
undiagnosed vaginal bleeding;
known or suspected progesterone-sensitive malignant tumours;
porphyria;
severe liver dysfunction or disease;
missed abortion or known ectopic pregnancy;
arterial or venous thromboembolism or severe thrombophlebitis, active or in the past.
Important to know
Stop treatment and seek medical advice immediately if signs of blood clots occur (pain or swelling in a leg, chest pain, difficulty breathing, vision disturbances). Patients with a history of depression, diabetes, epilepsy, migraine, asthma or heart or kidney disease need careful monitoring.
Do not use in case of threatened miscarriage. Do not stop treatment abruptly (anxiety or emotional instability may occur) without consulting your doctor. Progesterone may cause drowsiness or dizziness; take care when driving or operating machinery. Read the package leaflet carefully before use.
Possible side effects
Common: drowsiness, abdominal pain or discomfort, breast tenderness, fatigue, hot flushes; diarrhoea and flatulence may occur with rectal use.
Uncommon: headache, dizziness, mood changes, skin rash, itching, vaginal bleeding or irregular menstruation, weight gain.
If side effects occur, stop using the product and consult a doctor or pharmacist.
STORAGE
Store below 25 °C. Keep out of the reach of children. Shelf life: 36 months.
QUESTIONS AND CONTACTS
For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.
Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.