Levonorgestrel 0.10 Mg Tablets

COMPOSITION:

Each pink active tablet contains:
Levonorgestrel 0.10 mg
Ethinylestradiol 0.02 mg

Levonorgestrel is a progestogen. Levonorgestrel is a white, odourless crystalline powder. It is practically insoluble in water, slightly soluble in alcohol, acetone, ether, and soluble in chloroform.

Ethinyloestradiol is an oestrogen. Ethinyloestradiol is a white to creamy white, odourless, crystalline powder. It is insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils, and aqueous solutions of alkali hydroxides.

INDICATIONS:

• Contraceptive
• Cycle Regulator
• Emergency Contraception
• Postponement of Menstrual cycles

ACTIONS:

DEARLOE is a combined oral contraceptive tablet containing the synthetic progestogen, levonorgestrel, and the synthetic oestrogen, ethinyloestradiol. The contraceptive effect of the hormonal components contained in DEARLOE are based on the inhibition of ovulation (by suppression of gonadotropin release) and changes in the cervical mucus, which increase the difficulty of sperm penetration into the uterus. Additionally, changes in the endometrium reduce the likelihood of implantation.

Non Contraceptive Benefits

The following non-contraceptive health benefits related to the use of combination oral contraceptives are supported by epidemiological studies which largely utilised oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyloestradiol or 0.05 mg mestranol.

• Effects on menses
  Increased menstrual cycle regularity.
  Decreased blood loss and decreased incidence of iron deficiency anaemia.
  Decreased incidence of dysmenorrhoea.
• Effects related to inhibition of ovulation
  Decreased incidence of ectopic pregnancies.
• Effects on long-term use
  Decreased incidence and severity of acne.
  Decreased incidence of fibroadenomas and fibrocystic disease of the breast.
  Decreased incidence of acute pelvic inflammatory disease.
  Decreased incidence of endometrial carcinoma.
  Decreased incidence of ovarian carcinoma.

DOSAGE:

To start: DEARLOE should be started on the first day of menstrual bleeding. The dosage is one pill per day until all 21 tablets have been taken.

Then: There should be a gap of 7 days. The second pack should be started on 8th day.It will be the same day of the week on which the first pack was started.

DEARLOE should be taken in this way : 3 weeks on and 1 week off as long protection is desired.

CONTRAINDICATIONS:

DEARLOE is contraindicated in patients with:

• Deep vein thrombosis, thrombophlebi t is or thromboembolic disorders; a past history of deep-vein thrombophlebitis or thromboembolic disorders; cerebrovascular or coronary artery disease; thrombogenic valvulopathies or thrombogenic rhythm disorders.
• Current or previous history of known or suspected steroid-dependent neoplasias (e.g. breast or endometrial carcinoma).
• Hepatic adenomas or carcinomas, cholestatic jaundice of pregnancy, jaundice with prior combined oral contraceptive use or active liver disease.
• Diabetes with vascular involvement.
• Uncontrolled hypertension.
• Undiagnosed vaginal bleeding.
• Known or suspected pregnancy
• Hypersensitivity to any of the ingredients contained in DEARLOE

SIDE EFFECTS:

The most frequent adverse events were headache, dysmenorrhoea and infections. None of the infections was considered to be medicine-related.

OVERDOSAGE:

Overdosage may cause nausea and vomiting; withdrawal bleeding may occur in females. In children, serious ill effects have not been reported following large doses of oral contraceptives.

PRECAUTIONS:

A complete personal and family medical history and physical examination should be taken prior to the initiation of DEARLOE use, and should be repeated periodically during the use of DEARLOE. Special attention should be given to blood pressure, breasts, abdomen and pelvic organs. A Papanicolaou smear and relevant laboratory tests should be carried out.

PRESENTATION:

Each Strip contains 21 Tablets. (Calender Pack)

Box of 10 Strips.

FOR ORAL USE ONLY.