Desogestrel Tablets

COMPOSITION:

Each tablet contains
Desogestrel (a progestagen) 0.15 mg,
Ethinyloestradiol (an oestrogen) 0.02 mg.

ACTIONS:

INDICATIONS:

Contraception

Emergency Contraception

Regularisation of Menstrual Cycles

Postponement of Menstrual Cycles

DOSAGE AND ADMINISTRATION:

• Contraception: 5th Day of menstrual bleeding, continue till 21 days.
• Emergency Contraception- 4 tabs Stat & repeat after 12 hrs.
• Regularisation of Menstrual Cycles- Commence from 5th day of menstruation till 21 days followed by 7 day pill free period (max 3-6 months).
• Postponement of Menstrual Cycles- Dosage as directed by the Physician.)

CONTRAINDICATIONS:

• Pregnancy
• Cardiovascular or cerebrovascular disorders, e.g. thrombophlebitis, thrombo-embolic processes or a history of these conditions.
• Hereditary or acquired predisposition for venous or arterial thrombosis.
• Prodromal conditions for arterial disease (e.g. angina pectoris, transient ischaemic attack and 'classic' migraine with aura), valvular heart disease.
• Severe hypertension (blood pressure of diastolic 100 mm Hg and/or systolic = 160 mm Hg on repeated testing).
• Diabetes mellitus with vascular involvement.
• The presence of more than one of the risk factors for venous or arterial disease, respectively
• Severe liver disease or a history of this condition if the results of liver function tests have failed to return to normal; cholestatic jaundice; a history of jaundice of pregnancy or jaundice due to the use of steroids; Rotor syndrome and Dubin-Johnson syndrome.
• Known or suspected carcinoma of the breast or suspect oestrogen-dependent neoplasia.
• Endometrial hyperplasia
• PUndiagnosed vaginal bleeding.
• Porphyria
• Hyperlipoproteinaemia, especially in the presence of other risk factors predisposing to cardiovascular disorders.
• A history during pregnancy or previous use of steroids of severe pruritus or herpes gestationis.
• Classical migraine.
• Otosclerosis with deterioration in previous pregnancies.

Reduced Reliability:

When this product is taken according to the directions for use the occurrence of pregnancy is highly unlikely. However, the reliability of oral contraceptives may be reduced when:-

1.The tablets have not been taken in accordance with the directions for use e.g. one or more tablets have been missed.

2.Gastro-intestinal disturbances with diarrhoea and/or vomiting have occurred within 4 hours of tablet-intake.

3.Other medicines (see paragraph Interactions ) are used concomitantly.

If withdrawal bleeding fails to occur and none of the above mentioned events has taken place, pregnancy is highly unlikely and oral contraceptive use can be continued. If however any of these events has occurred, tablet intake should be discontinued and pregnancy excluded before oral contraceptive use can be resumed

ADVERSE EFFECTS:

The following adverse reactions have been associated with oestrogen and/or progestagen therapy:

Genito-urinary tract

Intermenstrual bleeding, cervical erosion and changes in cervical secretion, amenorrhoea during and after treatment, changes in menstrual flow, anovulation post treatment, increase in size of uterine fibromyomata, aggravation of endometriosis, certain vaginal infections e.g. candidiasis.

Breast

Tenderness, pain, enlargement, secretion.

Gastro-intestinal tract

Nausea, vomiting, cholelithiasis, cholestatic jaundice, abdominal cramps.

Cardiovascular system

Thrombosis, rise of blood pressure haemorrhagic eruption.

Skin

Chloasma, erythema nodosum, rash, pruritis, photosensitivity, alopecia, erythema multiforme, hirsutism.

Eyes

Discomfort of the cornea if contact lenses are used.

CNS

Headache, migraine, mood changes, dizziness, drowsiness.

Others

Fluid retention, reduced glucose tolerance, change in body weight, changes in appetite.

INTERACTIONS:

Irregular bleeding and reduced reliability may occur when oral contraceptives are used concomitantly with medicines such as anticonvulsants, antibiotics (e.g. tetracyclines, rifampicin, etc.), activated charcoal and certain laxatives.

Oral contraceptives may diminish glucose tolerance and increase the need for insulin or other antidiabetic medicines.

PRESENTATION:

Strip of 21 Tablets. (Calender Pack)

Box of 10 Strips.

FOR ORAL USE ONLY.