Femica®

Therapeutic Area:

Generic Name:

Dienogest/ ethinylestradiol

Dosage Form:

Dienogest 2 mg/ Ethinylestradiol 0.03 mg

Drug Dose

Therapeutic Indications:

Femica® is a contraceptive pill and is used to prevent pregnancy. It is also used for the treatment of heavy menstrual bleeding (not caused by any disease of the womb) in women who wish to use oral contraception.

Mechanism of Action:

Inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and the endometrium (which reduces the likelihood of implantation).

Method of Administration:

Femica® consists of 21 film-coated tablets

  • Take one tablet daily by mouth at the same time every day.

Notes

Contraindications:

  • Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
  • Presence or history of severe hepatic disease as long as liver function values have not returned to normal
  • Use of direct-acting antiviral (DAA) medicinal products containing ombitasvir, paritaprevir or dasabuvir and combinations of these.
  • Presence or history of liver tumors (benign or malignant)
  • Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
  • Undiagnosed vaginal bleeding
  • Known or suspected pregnancy
  • Hypersensitivity to any of the ingredients

Interactions:

Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.

Pregnancy and Lactation:

Do not take Femica® if you are pregnant. If you become pregnant while taking Femica®, stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Femica® at any time.
In general, you should not take Femica® while you are breast-feeding. If you want to take the pill while you are breast-feeding you should contact your doctor.

Warning and Precaution:

If any of the conditions/risk factors mentioned below are present, the benefits of Femica® use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start taking it. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her doctor. The doctor should then decide on whether use should be discontinued:
Circulatory disorders, Risk of venous thromboembolism (VTE), Risk of arterial thromboembolism (ATE), Tumours

Adverse Reactions:

Headache, abdominal pain, nausea, acne, no periods, breast discomfort, painful periods, irregular bleeding (heavy irregular bleeding), weight gain

Storage:

Store below 30 and protect from light and moisture.