Steronate Nor Tablets

Steronate Nor Tablets

Description:

Steronate Nor Tablets are a prescription hormonal medicine containing the synthetic progestogen norethisterone. Each tablet is used to regulate the menstrual cycle, manage abnormal uterine bleeding, and treat various gynecological conditions related to progesterone deficiency. Steronate Nor is commonly prescribed for primary and secondary amenorrhoea, menorrhagia, dysmenorrhoea, premenstrual syndrome, endometriosis, and for timing or postponement of menstruation. It may also be used as part of contraceptive regimens under medical supervision. This product is intended for adult women and must be used strictly according to a doctor’s instructions.

Indications:

• Primary and secondary amenorrhoea (absence of menstrual periods) of long duration due to progesterone deficiency, after exclusion of pregnancy and other causes.
• Metropathia haemorrhagica and dysfunctional uterine bleeding (abnormal uterine bleeding not due to organic pathology).
• Menorrhagia (heavy menstrual bleeding) and polymenorrhoea (frequent menstrual periods) associated with hormonal imbalance.
• Dysmenorrhoea (painful menstruation) related to functional hormonal disorders.
• Premenstrual syndrome (PMS), including symptoms such as breast tenderness, mood changes, bloating, and irritability.
• Endometriosis: to suppress endometrial tissue growth and relieve associated pelvic pain and dysmenorrhoea.
• Timing of menstruation: to delay or adjust the onset of menstruation for medical or personal reasons, as directed by a physician.
• Female subfertility related to luteal phase insufficiency, as part of a fertility treatment plan prescribed by a specialist.
• May be used as a contraceptive drug in specific regimens or in combination with estrogen, only under medical supervision.

Active Ingredients / Key Components:

• Norethisterone (norethindrone) – 5 mg per tablet.
• Inactive ingredients/excipients: Not specified in available data (information on full excipient list is unavailable; refer to the package insert for details).

Dosage & Administration / How to Use:

• Use only as prescribed by a gynecologist or healthcare professional. Dosage and duration vary according to indication and individual response.
• Amenorrhoea: Usually taken after a course of estrogen (if prescribed). A common regimen is 5 mg norethisterone 2–3 times daily for about 5–10 days; withdrawal bleeding typically occurs a few days after stopping. Exact regimen must be determined by the doctor.
• Dysfunctional uterine bleeding / menorrhagia: Typical regimens may involve 5 mg 2–3 times daily for a defined number of days in the cycle (for example, day 5 to day 25), as directed by the physician.
• PMS and cycle regulation: Often given in the second half of the cycle (luteal phase), such as 5 mg 1–2 times daily from day 16 to day 25 of the cycle, or as advised by the doctor.
• Endometriosis: Higher or continuous dosing schedules may be used (for example, 5 mg 2–3 times daily for several months) under close medical supervision.
• Timing/postponement of menstruation: Treatment is usually started about 3 days before the expected onset of menstruation; a typical dose is 5 mg 2–3 times daily. Menstruation generally occurs 2–3 days after stopping the tablets. Only follow the schedule provided by your doctor.
• Contraceptive use: If used as a contraceptive, it must follow a specific regimen sometimes in combination with estrogen; do not use as birth control without explicit medical guidance.
• Tablets should be swallowed whole with water, with or without food, at the same time(s) each day to maintain consistent hormone levels.
• If a dose is missed, take it as soon as you remember unless it is almost time for the next dose; do not double the dose to make up for a missed tablet. For contraceptive regimens, follow your doctor’s specific instructions on missed doses.
• Do not exceed the prescribed dose or duration. Long-term use requires regular medical follow-up and monitoring.

Clinical Benefits:

• Helps restore and regulate normal menstrual cycles in women with amenorrhoea or irregular periods caused by progesterone deficiency.
• Reduces heavy or prolonged menstrual bleeding (menorrhagia, polymenorrhoea) by stabilizing the endometrium and correcting hormonal imbalance.
• Relieves painful periods (dysmenorrhoea) associated with functional uterine and hormonal disorders.
• Alleviates symptoms of premenstrual syndrome such as mood swings, breast tenderness, and abdominal discomfort by providing progestogen support in the luteal phase.
• Helps manage endometriosis by suppressing ectopic endometrial tissue growth, thereby reducing pelvic pain and bleeding.
• Allows medical control of the timing of menstruation for therapeutic or personal reasons under medical supervision.
• Can be incorporated into certain contraceptive regimens to prevent ovulation and thicken cervical mucus, thereby reducing the risk of pregnancy when used correctly.

Warnings & Contraindications:

• Use only under medical supervision. A complete medical history and physical examination, including gynecological assessment, should be performed before starting therapy.
• Contraindicated in known or suspected pregnancy; always exclude pregnancy before starting treatment for amenorrhoea or cycle irregularities.
• Contraindicated in women with active or previous venous thromboembolism (deep vein thrombosis, pulmonary embolism), known thrombophilic disorders, or severe arterial disease (e.g., stroke, myocardial infarction).
• Contraindicated in severe liver disease, liver tumors, or history of cholestatic jaundice; discontinue if jaundice or significant liver function impairment occurs.
• Contraindicated in known or suspected hormone-dependent malignancies such as breast cancer or genital tract cancers, unless specifically prescribed by an oncologist.
• Do not use in cases of unexplained vaginal bleeding until the cause has been diagnosed.
• Use with caution in patients with a history of depression, migraine, hypertension, diabetes mellitus, hyperlipidemia, obesity, or smoking, especially in women over 35 years of age.
• Hormonal therapy may increase the risk of thromboembolic events; stop treatment and seek urgent medical attention if you experience chest pain, shortness of breath, sudden leg pain or swelling, severe headache, or visual disturbances.
• May cause fluid retention; caution in patients with cardiac or renal dysfunction, epilepsy, or asthma.
• Consult your doctor before use if you are breastfeeding, as norethisterone may pass into breast milk and may not be suitable for nursing mothers.
• Inform your doctor about all medications you are taking, including enzyme-inducing drugs (such as some antiepileptics, rifampicin, herbal preparations like St. John’s wort) which may reduce the effectiveness of hormonal therapy.
• Not intended for use in children or adolescents unless specifically prescribed by a specialist.
• Do not use this product as an emergency contraceptive unless explicitly directed by a physician and following an appropriate regimen.
• Not intended to diagnose, treat, cure, or prevent any disease without proper medical evaluation and prescription.
• Keep out of reach of children.

Side Effects:

• Common side effects: Nausea, vomiting, mild abdominal discomfort, breast tenderness, headache, dizziness, fatigue, changes in menstrual bleeding pattern (spotting, breakthrough bleeding, lighter or heavier periods), and changes in libido.
• Metabolic and weight-related effects: Possible weight gain or fluid retention, mild changes in blood pressure, and alterations in lipid profile in some patients.
• Skin and hair: Acne, oily skin, or hirsutism (increased hair growth) may occur in susceptible individuals; some may experience hair loss or changes in scalp hair.
• Mood and central nervous system: Mood swings, irritability, or depressive symptoms may occur; inform your doctor if you notice significant changes in mood or behavior.
• Serious side effects (seek immediate medical attention): Signs of blood clots such as sudden leg pain or swelling, chest pain, shortness of breath, coughing up blood, sudden severe headache, visual disturbances, weakness or numbness on one side of the body, or speech difficulties.
• Hepatic effects: Yellowing of the skin or eyes (jaundice), dark urine, severe abdominal pain, or persistent nausea and fatigue may indicate liver problems; stop treatment and contact your doctor immediately.
• If you experience any unusual, persistent, or severe side effects, discontinue the tablets and consult your healthcare provider promptly.

Storage Instructions:

Store in a cool, dry place away from direct sunlight. Keep container tightly closed. Keep out of reach of children. Do not use after the expiry date printed on the pack. Do not store above the temperature recommended on the package insert (typically below 25°c), and protect from excessive heat and moisture.

Specifications:

• Product form: Tablets for oral use.
• Strength: 5 mg norethisterone per tablet.
• Pack size: 20 tablets per pack (20 tabs).
• Intended user group: Adult women, under medical supervision.
• Route of administration: Oral.

Disclaimer:
All pharmacy products are intended for general use only and do not replace professional medical advice, diagnosis, or treatment. Always consult a healthcare provider before use. Results may vary, and no specific outcomes are guaranteed. Products are not intended to diagnose, treat, cure, or prevent any disease unless stated. Follow label instructions carefully, as misuse may cause adverse effects. Compliance with local laws is the customer’s responsibility.