YASMIN 21 TAB ياسمين 21 قرص

* Yasmin (Drospirenone / Ethinylestradiol) 21 film-coated tabs. oral.
* 1 film-coated tablet contains:
& & Drospirenone 3.000 mg + Ethinylestradiol 0.030 mg
* INDICATIONS AND USAGE:
& & YASMIN is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.
* DOSAGE AND ADMINISTRATION:
& & – To achieve maximum contraceptive effectiveness, YASMIN (drospirenone and ethinyl estradiol)
& & must be taken exactly as directed at intervals not exceeding 24 hours.
& & – The dosage of YASMIN is one yellow tablet daily for 21 consecutive days. A patient should begin to take
& & YASMIN either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the
& & onset of her menstrual period (Sunday Start).
* CONTRAINDICATIONS: YASMIN should not be used in women who have the following:
& & – Renal insufficiency
& & – Hepatic dysfunction
& & – Adrenal insufficiency
& & – Thrombophlebitis or thromboembolic disorders
& & – A past history of deep-vein thrombophlebitis or thromboembolic disorders
& & – Cerebral-vascular or coronary-artery disease
& & – Valvular heart disease with thrombogenic complications
& & – Severe hypertension
& & – Diabetes with vascular involvement
& & – Headaches with focal neurological symptoms
& & – Known or suspected carcinoma of the breast
& & – Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
& & – Undiagnosed abnormal genital bleeding
& & – Cholestatic jaundice of pregnancy or jaundice with prior pill use
& & – Liver tumor (benign or malignant) or active liver disease
& & – Known or suspected pregnancy
& & – Heavy smoking (>/= 15 cigarettes per day) and over age 35
* PRECAUTIONS:
& & 1- GENERAL: Patients should be counseled that this product does not protect against HIV infection
& & (AIDS) and other sexually transmitted diseases.
& & 2- PHYSICAL EXAMINATION AND FOLLOW-UP: It is good medical practice for all women to have
& & annual history and physical examinations, including women using oral contraceptives. The physical
& & examination, however, may be deferred until after initiation of oral contraceptives if requested by the
& & woman and judged appropriate by the clinician. The physical examination should include special reference
& & to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology and relevant laboratory
& & tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should
& & be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast
& & nodules should be monitored with particular care.
& & 3- LIPID DISORDERS: Women who are being treated for hyperlipidemias should be followed closely
& & if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render
& & the control of hyperlipidemias more difficult.
& & 4- LIVER FUNCTION: If jaundice develops in any woman receiving oral contraceptives, the medication
& & should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired
& & liver function.
& & 5- FLUID RETENTION: Oral contraceptives may cause some degree of fluid retention. They should
& & be prescribed with caution, and only with careful monitoring, in patients with conditions which might
& & be aggravated by fluid retention.
& & 6- EMOTIONAL DISORDERS: Women with a history of depression should be carefully observed
& & and the drug discontinued if depression recurs to a serious degree.
& & 7- CONTACT LENSES: Contact-lens wearers who develop visual changes or changes in lens
& & tolerance should be assessed by an ophthalmologist.
* Do not store above 30 degrees C.