Primolut N Tablets – Product Information
Primolut N tablets contain the active ingredient Norethisterone which is a progestogen with negligible androgenic effects. Primolut N is used for timing of menstruation and to treat disturbances of the monthly bleeding (dysfunctional bleeding), lack of the monthly bleeding (primary and secondary amenorrhoea), premenstrual complaints (premenstrual syndrome), in combination with oestrogen hormone replacement therapy, and endometriosis.
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Name of Drug
Primolut N tablets.
Manufacturer Of Primolut N Tablets
Manufactured in India by Zydus Cadila in cooperation with Bayer.
Website: www.zyduscadila.com
Active Pharmaceutical Ingredient in Primolut N Tablets
The active pharmaceutical ingredient present in Primolut N tablets is Norethisterone .
Primolut N Tablets – Dosage
Primolut N tablets are to be swallowed whole with a sufficient quantity of water or other suitable liquid. The dosage varies as per indication being treated.
Dysfunctional bleeding(Disturbances of your period):
The recommended dosage of Primolut N is 1 tablet of Primolut N 3 times daily for 10 days. In most cases bleeding will stop within 1 to 3 days, but Primolut N must be taken for the full 10 days. About 2 to 4 days after you stop taking the tablets, withdrawal bleeding will occur.
Primary and secondary amenorrhoea (lack of a period):
Hormone treatment of secondary amenorrhoea can be carried out only after pregnancy has been excluded. The doctor will prescribe the patient an oestrogen (usually for 14 days) before beginning treatment with Primolut N. After which the patient will have to take 1 tablet of Primolut N 1 to 2 times daily for 10 days. Normally withdrawal bleeding occurs a few days after taking the last tablet.
Premenstrual syndrome:
The recommended dosage is one tablet of Primolut N one to three times daily during the 2nd half (luteal phase) of the cycle may relieve or improve premenstrual symptoms such as headaches, depressive moods, water retention, and a feeling of tension in the breasts.
Delaying menstruation:
Monthly menstrual bleeding can be delayed by taking Primolut N. However, this method of delaying your monthly period can be used by you only if you are not at risk of pregnancy during the treatment cycle.
The recommended dosage is 1 tablet of Primolut N two to three times daily for no longer than 10 to 14 days, beginning about 3 days before expected menstruation. Usually bleeding will occur 2 to 3 days after you stop taking the tablets.
Endometriosis:
Treatment with Primolut N should begin between the first and 5th day of the cycle with 1 tablet twice daily. In the event of spotting, the dose can be increased to 2 tablets twice daily. If bleeding stops, dose reduction to the initial dose should be considered. Treatment is to be continued for at least 4 to 6 months.
Missed Dose
The efficacy of Primolut N could be reduced if the patient forgets to take a tablet as directed. The missed dose of Primolut N has to be taken as soon as the patient remember. Only the last missed dose should be taken and then the patient has to continue to take the tablet at the usual time on the next day. Do not take a double dose.
Storage Instructions for Primolut N Tablets
Primolut N tablets should be kept at room temperature, 15-30°C (59-86°F) in a light-resistant, tight container. Keep away from children.
Warnings and Precautions when using Primolut N Tablets
Before using Primolut N tablets please inform your doctor all the medicines that you take including no prescription medications, over the counter medicines and herbal remedies.
Contraindications
Primolut N is contraindicated in patients with any of the conditions listed below. In case any of the conditions appear during treatment with Primolut N, the use of this medication has to immediately discontinued.
- Hypersensitivity to the active ingredient Norethisterone or to any of the substances present in the medication.
- Known or suspected pregnancy
- Lactation
- Thromboembolic disorders, thrombophlebitis ,cerebral apoplexy or a history of these conditions
- Arterial and cardiovascular disease present in the patient or history of the same (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease)
- Diabetes mellitus with vascular involvement
- Presence or history of severe hepatic disease as long as liver function values have not returned to normal
- Presence or history of liver tumors (benign or malignant)
- Known or suspected sex hormone-dependent malignancies
- Dubin-Johnson syndrome
- Rotor syndrome
- Missed abortion
- Undiagnosed vaginal or urinary bleeding
- Undiagnosed breast pathology
Primolut N and Pregnancy
Use of Primolut N tablets during pregnancy is contraindicated. Primolut N may affect the developing baby if it is taken during pregnancy. Primolut N may provoke signs of virilization in female fetuses if administered during the hormone-sensitive stage of somatic sexual differentiation. Primolut N should also not be used during lactation.
Primolut N Overdose
Inadvertent intake of a large dose of norethisterone (Primolut N) did not result in a risk of acute adverse effects as per acute toxicity studies conducted.
Side Effects of Primolut N Tablets (Norethisterone)
The side effects reported by users of Primolut N are abnormal vision, nausea, headache, fluid retention, migraine, shortness of breath and hypersensitivity reactions (e.g rash, hives). Normally the side effects are more common during the first months after beginning treatmet with Primolut N but subside with the duration of treatment. The side effects listed below although not reported for Primolut N, have been associated with the use of other progestogens:
anaphylaxis and anaphylactoid like reactions, thrombophlebitis, pulmonary embolism, nervousness, problems with sleeping, drowsiness, tiredness, depression, dizziness, tremor pre-menstrual type depression, hives, itchiness, rash, acne, hirsutism, hair loss, sweating, irregular uterine bleeding, spotting and lack of menstruation, breast tenderness and discharge, changes in cervical excretions and secretions, high fever, Cushing’s syndrome, weight gain, moderate elevation of blood pressure, transient elevation of certain liver enzymes, elevations of serum calcium and potassium levels, increases in white cell and platelet counts.
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