Details

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• MAL Registration Number: MAL16075031ACRZ

• Manufacturer: Abbott Biologicals B.V., The Netherlands

Content

• Active Ingredients:

  • Brick-red tablets: 2 mg estradiol (as hemihydrate)

  • Yellow tablets: 2 mg estradiol (as hemihydrate) and 10 mg dydrogesterone

• Excipients: Each brick-red tablet contains 118.2 mg of lactose monohydrate; each yellow tablet contains 109.4 mg of lactose monohydrate.

• Formulation: Film-coated tablets; brick-red tablets marked "379" and yellow tablets marked "379"

Indications

Femoston 2/10mg is indicated for:

• Hormone Replacement Therapy (HRT): For the relief of estrogen deficiency symptoms in postmenopausal women at least 6 months since their last menstruation.

• Prevention of Osteoporosis: In postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

Instructions for Use

• Dosage:

  • Take one tablet daily for a 28-day cycle.

  • For the first 14 days, take one brick-red tablet containing 2 mg estradiol daily.

  • For the next 14 days, take one yellow tablet containing 2 mg estradiol and 10 mg dydrogesterone daily.

• Administration: Swallow the tablet whole with water; can be taken with or without food.

• Timing: Take at the same time each day, preferably in the morning.

• Missed Dose: If a dose is missed, take it as soon as possible unless it's almost time for the next dose. Do not double the dose.

• Starting Treatment:

  • If not currently on HRT or switching from continuous combined HRT, start on any convenient day.

  • If switching from a cyclic or sequential HRT regimen, start the day after completing the previous regimen.