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ACI Pharmaceuticals LtdProduct Description
**Active Composition & Class**
* **Active Ingredient:** Norethisterone
* **Therapeutic Class:** Female Sex Hormones / Oral Contraceptive & HRT Preparations (Progestin)
**Indications**
* Metropathia haemorrhagica (dysfunctional uterine bleeding)
* Premenstrual syndrome (PMS, including premenstrual mastalgia)
* Postponement of menstruation
* Endometriosis
* Menorrhagia (hypermenorrhea)
**Mechanism of Action**
* Exerts progestational actions similar to natural progesterone. It strongly inhibits ovulation and possesses weak estrogenic and androgenic properties to stabilize the uterine lining and regulate the menstrual cycle.
**Dosage & Administration** *(Oral; Not intended for pediatric use)*
* **Dysfunctional Uterine Bleeding:** 1 tablet 3 times daily for 10 days. Bleeding usually stops within 1–3 days; withdrawal bleeding occurs 2–4 days after stopping.
* **Prophylaxis against Recurrence of Dysfunctional Bleeding:** 1 tablet twice daily from the 19th to the 26th day of the cycle.
* **Premenstrual Syndrome:** 2–3 tablets daily from the 19th to the 26th day of the cycle for several cycles.
* **Postponement of Menstruation:** 1 tablet 3 times daily starting 3 days before expected onset. Normal period resumes 2–3 days after stopping.
* **Endometriosis:** Started on Day 5 of the cycle at 2 tablets daily. Increase to 4–5 tablets daily if spotting occurs until bleeding stops. Continued for 4–6 months or longer.
* **Menorrhagia:** 1 tablet 2–3 times daily from the 19th to the 26th day of the cycle.
* *Note: Always follow a registered physician's precise instructions.*
**Contraindications**
* Pregnancy and lactation.
* Severe liver function disturbances, active or previous liver tumors, Dubin-Johnson or Rotor syndromes.
* History during pregnancy of idiopathic jaundice, severe pruritus, or herpes gestationis.
* Active thromboembolic processes (blood clots).
* Hypersensitivity to Norethisterone or its excipients.
**Precautions & Reasons for Immediate Discontinuation**
* **Thromboembolic Risk:** Use caution in patients with a history of vascular disease, severe diabetes with vascular changes, or sickle-cell anemia.
* **Liver Function:** Monitor for severe upper abdominal pain or liver enlargement (rare risk of liver tumors).
* **Carbohydrate Metabolism:** Diabetes parameters should be regularly monitored.
* **Stop Treatment Immediately If:** First occurrence of migrainous headaches or unusually severe headaches, sudden visual or hearing disturbances, signs of blood clots or chest tightness, scheduled surgery (stop 6 weeks prior), prolonged immobilization, jaundice/hepatitis, significant blood pressure rise, or suspected pregnancy.
**Side Effects & Interactions**
* **Side Effects:** Most common in early treatment; includes nausea, headache, fluid retention (edema), visual disturbances, dyspnea, and skin rash/urticaria.
* **Drug Interactions:** Hepatic enzyme inducers (e.g., phenytoin, carbamazepine, barbiturates, rifampicin, oxcarbazepine, griseofulvin) increase hormone clearance and reduce drug effectiveness.
**Storage Conditions**
* Store below 30°C in a cool and dry place. Keep out of reach of children.
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