ORGAMETRIL Tablet Ref.[10965] Active ingredients: Lynestrenol

Revision Year: 2007  Publisher: Manufactured by: N.V. Organon, Oss, The Netherlands. For: OBS Paksitan (Pvt.) Limited., C-14, S.I.T.E., Karachi – 75700 Pakistan

4.1. Therapeutic indications

  • Polymenorrhea
  • Menorrhagia and metrorrhagia
  • Selected cases of primary and secondary amenorrhea and oligomenorrhea
  • Endometriosis
  • Selected cases of endometrial carcinoma
  • Benign breast disease
  • Suppression of ovulation, ovulation pain and menstruation; dysmenorrhea
  • Postponement of menstruation
  • As an adjunct to estrogen therapy in peri- and postmenopause, in order to avoid endometrial hyperplasia

4.2. Posology and method of administration

Polymenorrhea

1 tablet daily on days 14-25 of the cycle.

Menorrhagia and metrorrhagia

2 tablets daily for 10 days. Usually the bleeding will cease within a few days after the start of the treatment. Treatment is repeated during the next 3 menstrual cycles with 1 tablet daily on days 14-25 of each cycle. Further diagnostic procedures are necessary if the complaints do not disappear during or after this treatment.

Selected cases of primary and secondary amenorrhea and oligomenorrhea

Treatment should start with the administration of an estrogen, e.g. 0.02 -0.05 mg ethinylestradiol per day for 25 days. In conjunction with this, 1 tablet daily of Orgametril is administered on days 14-25. After cessation of treatment, a withdrawal bleeding usually occurs with in 3 days. Treatment is resumed (second cycle) starting on day 5 of this withdrawal bleeding with the estrogen given on days 5-25 of the cycle and again with one tablet daily of Orgametril on days 14-25. This treatment should be repeated for at least another cycle.

Premenstrual syndrome

1 tablet daily on days 14 – 25 of the cycle.

Endometriosis

1-2 tablets daily for at least 6 months.

Selected cases of endometrial carcinoma

6-10 tablets daily for prolonged periods.

Benign breast disease

1 tablet daily on days 14-25 of the cycle for at least 3-4 months.

Suppression of menstruation, ovulation and ovulation pain; dysmenorrhea

Treatment with 1 tablet daily should start preferably on day 1, but no later than day 5 of the cycle. The treatment can be continued for many months (without tablet-free days). If inspite of treatment, breakthrough bleeding occurs, the dosage should be increased to 2 or 3 tablets daily for 3-5 days.

Post-ponement of menstruation

Treatment with 1 tablet daily should start preferably 2 weeks before the expected onset of menstruation. If treatment is started less than 1 week before the expected onset of menstruation the dosage should be 2-3 tablets per day. However, in that case a delay of more than 1 week is undesirable. The risk of breakthrough bleeding increases if treatment is started later. Therefore, treatment should not be started later than 3 days before the expected onset of menstruation.

As an adjunct to estrogen therapy in pre- and post menopause, in order to avoid endometrial hyperplasia

½ - 1 tablet daily for 12-15 days per month, e.g. on the first 2 weeks of every calendar month; the estrogen can be administered daily without tablet-free intervals at the lowest effective dose.

Administration

Orgametril tablets should be taken orally with some fluid.

4.9. Overdose

The toxicity of lynestrenol is very low. In case of overdose, e.g. young children taking several tablets simultaneously, no toxic symptoms are expected to occur. Symptoms that may occur are nausea and vomiting. There is no necessity for specific treatment. If necessary, symptomatic treatment can be given.

6.4. Special precautions for storage

Store at 2-30°C. Protect from sunlight and moisture.

Keep out of the reach of children.

6.5. Nature and contents of container

Pack of 1x30’s physician.

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