More from Giane
Other strengths and forms by Renata PLC
Indications & Uses
Cyproterone Acetate + Ethinyl Estradiol tablet is used to treat women who have severe acne that hasn't improved with oral antibiotics or other available treatments. It is meant for women who also show signs of androgenization, such as seborrhea and mild hirsutism.
Pharmacology
Cyproterone is a steroid with strong antiandrogenic, progestogenic and antigonadotrophic activity. Its antiandrogenic effect comes from blocking androgen receptors. It also lowers androgen synthesis through a negative feedback effect on the hypothalamo-pituitary-ovarian systems. The estrogen component, Ethinylestradiol, raises the level of sex hormone binding globulin (SHBG), and this reduces the free androgens circulating in plasma. Cyproterone has no tendency to lower SHBG levels.
When Cyproterone is used alone in women, it causes menstrual cycle disturbances. Combining it with Ethinylestradiol avoids this. When the tablet is taken in a cyclic manner, it also prevents ovulation and possible conception.
Both components are absorbed rapidly after oral use. Cyproterone has a long terminal half-life, so its plasma levels rise 4-fold after 6 to 12 days of daily dosing. In long-term therapy (36 months) with this product, there was no significant influence on lipid metabolism. A trend towards higher plasma cholesterol and triglyceride levels was seen. Low density lipoprotein (LDL) fell slightly, while high density lipoprotein (HDL) rose at the same time.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Cyproterone Acetate + Ethinyl Estradiol tablets should not be prescribed only for their contraceptive effect. If the patient may not take the tablets reliably and contraception is needed, a supplementary nonhormonal contraceptive method should be considered.
First Treatment Course: The patient takes 1 tablet daily for 21 consecutive days, starting on day 1 of her menstrual cycle. (For the first cycle only, the first day of menstrual flow counts as Day 1.) The tablets are then stopped for 7 days (1 week). Withdrawal bleeding should usually happen during this week off. The first cycle will be a little shorter than usual, while all later cycles last 4 weeks. The patient should take the first tablet from the section of the blister pack marked with the matching day of the week (for example "Mon" for Monday) and swallow it with some liquid. She should take the tablet at the same time each day.
Subsequent Courses: The patient starts her next 21-day course, and every course after it, on the same day of the week she began the first one (the same 21 days on, 7 days off). She starts 7 days after stopping, whether or not withdrawal bleeding is still going on. Treatment should continue for several months, since improvement may not be seen for at least 3 months. The treating physician should review the need to continue the tablets from time to time. The medicine should be stopped 3 to 4 cycles after the signs have completely cleared.
Pregnancy should be ruled out before treatment with Cyproterone Acetate + Ethinyl Estradiol continues in a patient who has missed a menstrual period. If pregnancy is suspected, the medicine should be stopped.
Missed dose: If the patient forgets a tablet at the usual time, she may take it within the next 12 hours. If more than 12 hours have passed since the usual time, she must throw away the missed tablet and take the remaining tablets in the pack at the usual time, so that premature withdrawal bleeding is avoided in this cycle. A supplementary nonhormonal method of contraception must be used until the pack is empty, to prevent pregnancy, which would mean stopping this treatment immediately.
Side Effects
Common side effects of Cyproterone Acetate + Ethinyl Estradiol are bleeding, dizziness, depression, weight gain, headache, edema, breast pain, lactation, blood clot and gallstones.
Cautions & Contraindications
Warnings & Precautions
Predisposing factors for coronary artery disease Some women already have factors that predispose to coronary artery disease, such as cigarette smoking, hypertension, hypercholesterolemia, obesity, diabetes and increasing age. In these women, estrogen or progestogen combinations like Cyproterone Acetate + Ethinyl Estradiol have been reported as an additional risk factor. After the age of 35 years, these combinations should be considered only in exceptional circumstances, and only when both the patient and the physician have carefully weighed the risk/benefit ratio. Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from this class of medicine. The risk rises with age and with heavy smoking (15 or more cigarettes per day), and it is more marked in women over 35 years of age. Women who use such medicine should not smoke. Estrogen/progestogen combinations may increase plasma lipoproteins. They should be given with caution to women known to have pre-existent hyperlipoproteinemia, and lipid profiles should be checked regularly in these patients. Obesity, hypertension and diabetes together are particularly hazardous for women taking this class of medicine. To stop this triad of conditions from developing, the patient should be placed on an alternate form of therapy. Stop the medicine at the earliest manifestation of thromboembolic and cardiovascular disorders such as thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial ischemia, mesenteric thrombosis and retinal thrombosis. Estrogen/progestogen combination products should be avoided in conditions that predispose to venous stasis and to vascular thrombosis, for example immobilization after accidents or confinement to bed during a long-term illness. In such conditions, other nonhormonal methods of treatment should be considered. If surgery is contemplated, see Precautions. Stop the medicine as well at the earliest manifestation of visual defects, partial or complete, papilledema or ophthalmic vascular lesions, severe headache of unknown etiology or worsening of pre-existing migraine headache, onset of jaundice or hepatitis, and itching of the whole body. Hypertension Patients with essential hypertension whose blood pressure is well controlled may be given the medicine, but only under close supervision. If blood pressure rises significantly at any time during treatment, in people who were normotensive or hypertensive before, the medicine must be stopped. Migraine and headache If migraine starts or gets worse, or a new pattern of headache develops that is recurrent, persistent or severe, the medicine must be stopped and the cause evaluated. Diabetes Diabetic patients, and those with a family history of diabetes, should be observed closely to detect any change in carbohydrate metabolism. Patients predisposed to diabetes who can be kept under close supervision may be given estrogen/progestogen combinations, but under strict medical supervision. Young diabetic patients whose disease is of recent origin, well controlled, and not associated with hypertension or other signs of vascular disease such as ocular fundal changes should also be closely observed.
Contraindications
Cyproterone Acetate + Ethinyl Estradiol must not be used in people with thrombophlebitis, thromboembolic disorders, or a history of these conditions. The same applies to cerebrovascular disorders, myocardial infarction or coronary artery diseases, and active liver disease or hepatic adenomas or carcinomas. A history of cholestatic jaundice rules it out too, as do known or suspected carcinoma of the breast and known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal vaginal bleeding is another contraindication, and so is any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual fields. It is also not for use when pregnancy is suspected or diagnosed, or when there are previous or existing liver tumors. Last, it is contraindicated in severe diabetes with vascular changes and in a history of otosclerosis with deterioration during pregnancy.
Pregnancy & Breastfeeding
Babies born to women who took estrogen/progestogen combinations in early pregnancy have been reported to have fetal abnormalities. If pregnancy is suspected, rule it out as soon as possible. Using these combinations while breast-feeding may not be advisable, because the hormonal components pass into breast milk and may reduce both its quantity and its quality. What this means for the child in the long term is not known. This medicine may also cause fluid retention, which matters in conditions such as epilepsy.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
No overdose has been reported with this Cyproterone Acetate + Ethinyl Estradiol tablet. There is no specific antidote, so treatment is symptomatic and based on what is known about how each of the two ingredients acts in the body.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Cyproterone Acetate + Ethinyl Estradiol below 30°C, in a dry place. Protect it from light, and keep it out of the reach of children.
Drug Interactions
Common questions about Giane 2 mg+0.035 mg
What is Giane 2 mg+0.035 mg Tablet?
Giane 2 mg+0.035 mg Tablet is a medicine that contains Cyproterone Acetate + Ethinyl Estradiol. It is made by Renata PLC. It belongs to the Oral Contraceptive preparations group of medicines.
What is Giane used for?
Cyproterone Acetate + Ethinyl Estradiol tablet is used to treat women who have severe acne that hasn't improved with oral antibiotics or other available treatments. It is meant for women who also show signs of androgenization, such as seborrhea and mild hirsutism.
What are the side effects of Giane?
Common side effects of Cyproterone Acetate + Ethinyl Estradiol are bleeding, dizziness, depression, weight gain, headache, edema, breast pain, lactation, blood clot and gallstones.
Can I take Giane during pregnancy or while breastfeeding?
Babies born to women who took estrogen/progestogen combinations in early pregnancy have been reported to have fetal abnormalities. If pregnancy is suspected, rule it out as soon as possible. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Giane?
No overdose has been reported with this Cyproterone Acetate + Ethinyl Estradiol tablet. There is no specific antidote, so treatment is symptomatic and based on what is known about how each of the two ingredients acts in the body. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Giane?
Keep Cyproterone Acetate + Ethinyl Estradiol below 30°C, in a dry place. Protect it from light, and keep it out of the reach of children.
Can I take other medicines with Giane?
Some medicines can interact with Cyproterone Acetate + Ethinyl Estradiol, for example: Carbamazepine, Phenytoin, Isoniazid, Chloramphenicol, Theophylline, Rifampicin. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Giane?
Giane is a prescription (Rx) medicine. Take it as your doctor advises.