Yaz 0,02/3 mg 28 tablets

Available at Pharmaegy Pharmacy. Use as directed by your doctor.

Trade Name: Yaz Active ingredients: Drospirenone 3 mg Ethinylestradiol 0,02 mg(as betadex clathrate) Inactive ingredients: Lactose monohydtate, maize starch, magnesium stearate,hypromellose, talc,titanium dioxide, iron oxide Pharmacological properties: The contraceptive effect of combined oral contraceptives is based on the interaction of various factors, the most important of which are seen as the inhibition of ovulation and the changes in the cervical secretion. As well as protection against pregnancy, combined oral contraceptives have several positive properties which, next to the negative properties, can be useful in deciding on the method of birth control. The cycle is more regular and the menstruation is often less painful and bleeding is lighter. The latter may result in a decrease in the occurrence of iron deficiency. Drospirenone has antimineralocorticoid activity, counteracting oestrogen-related sodium retention. In combination with ethinyloestradiol, drospirenone displays a favourable lipid profile with an increase in high density lipoprotein (HDL). Drospirenone exerts antiandrogenic activity. Drospirenone does not counteract the ethinyloestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens. Drospirenone is devoid of any androgenic, oestrogenic, glucocorticoid, and antiglucocorticoid activity. This, in combination with the antimineralocorticoid and antiandrogenic properties, gives drospirenone a biochemical and pharmacological profile closely resembling the natural hormone progesterone. Apart from this, with the higher-dosed Combined Oral Contraceptives (COCs) (50 µg ethinyloestradiol), there is evidence of a reduced risk of fibrocystic tumours of the breasts, ovarian cysts, pelvic inflammatory disease, ectopic pregnancy and endometrial and ovarian cancer. Whether this also applies to lower-dosed combined oral contraceptives such as YAZ remains to be confirmed. Indications: YAZ is indicated for use as: • an oral contraceptive. • treatment of moderate acne vulgaris in women who seek oral contraception. • treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of YAZ for PMDD was not assessed beyond 3 cycles. YAZ has not been evaluated for treatment of PMS (premenstrual syndrome). Dosage and administration: Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. A withdrawal bleed usually starts on Day 2-3 after starting the white placebo tablets and may not have finished before the next pack is started. CONTRAINDICATIONS: Combined hormonal contraceptives (CHCs) including YAZ should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately. • Presence or risk of venous thromboembolism (VTE) •Current VTE (on anticoagulants) or history of deep venous thrombosis [DVT] or pulmonary embolism [PE] - Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency - Major surgery with prolonged immobilisation - A high risk of venous thromboembolism due to the presence of multiple risk factors • Presence or risk of arterial thromboembolism (ATE) (see PRECAUTIONS) - Current ATE or history of ATE (e.g. myocardial infarction or stroke) or prodromal condition (e.g. angina pectoris or transient ischaemic attack [TIA]) - Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (eg. anticardiolipin- antibodies and lupus anticoagulant) - History of migraine with focal neurological symptoms - A high risk of arterial thromboembolism due to multiple risk factors or to the presence of one serious risk factor such as: diabetes mellitus with vascular symptoms severe hypertension severe dyslipoproteinaemia • 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 • Severe renal insufficiency or acute renal failure • Use of direct-acting antiviral (DAA) medicinal products containing ombitasvir, paritaprevir or dasabuvir and combinations of these • Presence or history of liver tumours (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 contained in YAZ PRECAUTIONS If any of the conditions/risk factors mentioned below are present, the benefits of YAZ 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 whether YAZ should be discontinued. Circulatory Disorders Risk of venous thromboembolism (VTE) Risk factors for VTE Symptoms of VTE (deep vein thrombosis and pulmonary embolism) Risk factors for ATE Symptoms of ATE Tumours Other conditions: Potassium excretion capacity may be limited in patients with renal insufficiency. In a clinical study, drospirenone intake did not show an effect on the serum potassium concentration in patients with mild or moderate renal impairment. A theoretical risk for hyperkalaemia can be assumed only for patients whose pre-treatment serum potassium is in the upper reference range, and who are additionally using potassium sparing medicines. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when taking COCs. Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases are rare. The antimineralocorticoid effect of drospirenone may counteract ethinyloestradiol-induced increases in blood pressure observed in normotensive women taking other combined oral contraceptives. However, if a sustained clinically significant hypertension develops during the use of a COC, it is prudent for the doctor to withdraw the COC and treat the hypertension. Where considered appropriate, COC use may be resumed if normotensive values can be achieved with antihypertensive therapy. The following conditions have been reported to occur or deteriorate with both pregnancy and COC use, but the evidence of an association with COC use is inconclusive: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria ; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham’s chorea; herpes gestationis; otosclerosis-related hearing loss. In women with hereditary angioedema exogenous oestrogens may induce or exacerbate symptoms of angioedema. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal. Recurrence of cholestatic jaundice which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of COCs. Although COCs may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics taking low dose COCs (containing < 50 µg ethinyloestradiol). However, diabetic women should be carefully observed while taking COCs. Crohn’s disease and ulcerative colitis have been associated with COC use. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking COCs. Each light pink active tablet contains 48.18 mg of lactose and each white placebo tablet contains 23.21 mg of lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption who are on a lactose-free diet should take this amount into consideration. Side effects: •Infections and infestations: Candidiasis •Blood and lymphatic system disorders: Anaemia Thrombocythemia •Immune system disorders: Allergic reaction •Endocrine disorders •Metabolism and nutrition disorders: Increased appetite Anorexia Hyperkalaemia Hyponatraemia •Psychiatric disorders: Emotional lability Depression/ depressive mood Decrease and loss of libido Nervousness Somnolence Anorgasmia Insomnia •Nervous system disorders: Headache Migraine Dizziness Paresthesia Vertigo Tremor •Eye disorders: Conjunctivitis Dry eye Eye disorder •Cardiac disorders: Tachycardia •Vascular disorders: Varicosises Hypertension Phlebitis •Vascular disorders: Venous and arterial thromboembolic cases Epistaxis Syncope •Gastrointestinal disorders: Nausea Abdominal pain Vomiting Dyspepsia Flatulence Gastritis Diarrhoea Enlarged abdomen •Gastrointestinal disorders: Gastrointestinal fullness Hiatus hernia Oral candidiasis Constipation Dry mouth •Hepatobiliary disorders: Biliary pain Cholecystitis •Skin and subcutaneous tissue disorders: Acne Pruritus Rash Chloasma Eczema Alopecia Dermatitis acneiform Dry skin Erythema nodosum Hypertrichosis •Skin disorders: Skin striae Contact dermatitis Photosensitive dermatitis Skin nodule •Musculoskeletal and connective tissue disorders: Back pain Pain in extremity Muscle cramps •Reproductive system and breast disorders: Breast pain Unscheduled uterine/Genital tract bleeding not further specified* Metrorrhagia Amenorrhoea Vaginal candidiasis Pelvic pain Breast enlargement Fibrocystic breast Genital discharge Hot flushes Vaginitis Menstrual disorder Dysmenorrhea Hypomenorrhea Menorrhagia Vaginal dryness Papanicolaou smear suspicious Dyspareunia Vulvovaginitis Postcoital bleeding Withdrawal bleeding Breast cyst Breast hyperplasia Breast neoplasm Cervical polyp Endometrial atrophy Ovarian cyst Uterine enlargement •General disorders and administration site conditions Asthenia Increase sweating Oedema (Generalised oedema, Peripheral oedema, Face oedema) Weight increase Weight decrease Package: YAZ active tablet 24 light pink round tablets marked on one side with the letters "DS" in a regular hexagon, each containing ethinyloestradiol 20 µg and drospirenone 3 mg. YAZ placebo tablet 4 white round tablets marked on one side with the letters "DP" in a regular hexagon. YAZ tablets are contained in blister packs. Each blister contains 24 light pink tablets followed by 4 white placebo tablets. Carton containing memo packs of 1 x 28, 2 x 28, 3 x 28, 4 x 28 or 6 x 28 tablets. Not all pack sizes may be marketed. Storage: Store below 30 °C.