Yaz 0,02/3 mg 28 tablets

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.