Yaz (Ethinylestradiol + Drospirenone): dosage, composition and side effects

Index

  • Introduction: what is it?
  • Dosage: how is it used and how does it work?
  • Warnings and Precautions
  • Interactions and side effects
  • Pregnancy and breastfeeding
  • Notes (methods of storage, disposal)

Questions and answers

Introduction: what is it?

YAZ is a contraceptive pill used to prevent pregnancy. Furthermore, it is used for the therapy and treatment of various diseases and pathologies such as endometriosis .
YAZ is a combined pill as it contains two active ingredients: Ethinylestradiol (a semi-synthetic estrogen) and Drospirenone (a progestin), two compounds that belong to the category of systemic hormonal contraceptives. YAZ belongs to the class of monophasic combinations, that is, they contain a fixed dosage of both compounds.
YAZ can be prescribed with RR Recipe – prescription medicines.

YAZ is available in packs of24 film-coated tablets (light pink) containing 0.020 mg of ethinylestradiol (as betadxtrin clathrate) and 3 mg of drospirenone. The pack of YAZ also contains 4 placebo-coated tablets (white colored) which do not contain any active ingredients.

Dosage: how is it used and how does it work?

YAZ is a combined oral contraceptive that contains two active substances: ethinylestradiol and drospirenone . At the therapeutic dose, drospirenone also possesses antiandrogenic properties and weak antimineralocorticoid properties . It is devoid of estrogenic, glucocorticoid and antiglucocorticoid activity. This gives drospirenone a pharmacological profile similar to that of natural progesterone. Furthermore, drospirenone appears to have healing effects on acne and reduces fluid accumulation .

The associations of estrogens and progestogens act mainly by selectively inhibiting the function of the pituitary gland . This leads to ablocking of ovulation and ovarian function . Furthermore, there is a modification of the cervical mucus, of the endometrium and of the motility and secretion of the tubes. All these associated effects reduce the likelihood of conception and implantation of the fertilized egg. Continuous intake of progestogen alone is not always able to inhibit ovulation. Administration of estrogen and progestogen tends to suppress lactation .

Seek advice from your gynecologist to decide which is the best birth control pill to take.
The decision to prescribe and take YAZ must take into account the results of blood tests and any risk factorspresent in the single woman, in particular those related to the appearance of venous thromboembolism (VTE) and the assessment of the risk of VTE associated with the intake of YAZ and that associated with other combined hormonal contraceptives (COCs). The presence of blood hypertension should also be evaluated .

The tablets should be taken by mouth , one tablet per day for 28 consecutive days , each day possibly at the same time, if needed with a small amount of liquid, and in the order indicated on the blister pack. One light pink tablet should be taken every day for the first 24 days and then one white tabletin the last 4 days.
The tablets are to be taken continuously . Each subsequent pack should be started the day after the last tablet from the previous pack . It is not necessary to make an interval between the two blisters.
Commonly, a withdrawal bleed occurs 2-3 days after starting the placebo tablets (the 4 white tablets in the last row of tablets in the blister) and may not have finished before the next pack is started. YAZ tablets can be taken with or without food. Treatment with YAZ must begin according to some

recommendations that may vary depending on the individual patient’s situation.

  • If the patient has not made a previous use of hormonal contraceptives (in the previous month), the first tablet should be taken on the first day of the natural menstrual cycle(ie the first day of menstruation);
  • If the patient has previously taken a combined hormonal contraceptive (combined oral contraceptive, vaginal ring or transdermal patch), YAZ should preferably be started on the day after the last active tablet (the last tablet containing the active substances). of the previous combined oral contraceptive, or at the latest on the day after the usual tablet-free break or after the last placebo tablet of the previous combined oral contraceptive;
  • If a vaginal ring or transdermal patch has been used , YAZ should preferably be started on the day of removal , or at the latest when the next application is to be made;
  • If the patient has previously taken a progestogen-only contraceptive (progestogen-only pill , injection, implant ) or from a progestogen-releasing intrauterine system ( IUS ), the woman can switch to YAZ at any time if use the progestogen-only pill (in the case of an implant or an IUS, the day of its removal; in the case of an injectable, the day the next injection is to be given). However, in all these cases, the woman should be advised to use an additional barrier method of contraception for the first 7 days of intake;
  • If the woman has had an abortionin the first trimester of pregnancy, it can be started immediately without the need for additional contraceptive measures;
  • After deliveryor abortion in the second trimester of pregnancy, tablet-taking should be started between day 21 and 28 after delivery or abortion in the second trimester of pregnancy. In case of later initiation, the woman should be advised to use an additional barrier method of contraception for the first 7 days. However, if intercourse has taken place in the meantime, pregnancy should be ruled out, or the next menstruation must be waited before starting COC use.

If blood tests are to be done , you should tell your doctor or healthcare professional that you are taking the pill, as hormonal contraceptives can affect the results of some clinical tests.

If no tablets are taken, the placebo (white) tablets can be ignored . However, they must be eliminated to avoid inadvertently prolonging the placebo phase.

  • If you are less than 24 hours late in taking an active (pink) tablet , contraceptive protection is maintained . The woman should take the tablet as soon as she remembers and then take the following tablets at the usual time;
  • If you are more than 24 hours late in taking an active tablet , contraceptive protection may be reduced. In case of missed tablet-taking, the following rules apply: tablet-taking must never be interrupted for more than 7 days . It takes 7 days of uninterrupted tablet-taking to achieve adequate suppression of the hypothalamus-pituitary-ovarian axis.

In any case, refer to the package leaflet contained in the package (summary of product characteristics, or “leaflet”) or ask your doctor / pharmacist for advice if in doubt.

Warnings and Precautions

Taking combined hormonal contraceptives increases the risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)).
An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction , stroke, transient ischemic attacks , venous thrombosis and pulmonary embolism, has been observed in CHC users.
Taking YAZ is contraindicated in the following conditions:

  • Presence or risk of current (with anticoagulant intake) or previous VTE (eg deep vein thrombosis [DVT] or pulmonary embolism [PE]);
  • Known hereditary or acquired predisposition to VTE , such as resistance to activated protein C (including factor V Leiden), antithrombin III deficiency, protein C deficiency, protein S deficiency;
  • Major surgery with prolonged immobilization;
  • High risk of VTE due to the presence of multiple risk factors ;
  • Presence or risk of arterial thromboembolism ( ATE );
  • Current or previous ATE (e.g. myocardial infarction) or anticipatory conditions (e.g. angina pectoris);
  • Cerebrovascular disease – current or previous stroke or anticipatory conditions (e.g. transient ischaemic attack (TIA));
  • Known hereditary or acquired predisposition to ATE, such as hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
  • History of migrainewith focal neurological symptoms
  • High TEA risk due to the presence of multiple risk factors or the presence of a serious risk factor such as diabetes mellituswith vascular symptoms, severe hypertension , severe dyslipoproteinaemia , severe liver disease or a history , until the return to normal values liver function, severe or acute renal failure, existing or previous liver tumors (benign or malignant), known or suspected sex hormone dependent malignancies (e.g. of the genital organs or breast ), undiagnosed vaginal bleeding , hypersensitivity the active ingredients or any of the excipients.

If any of these conditions occur for the first time while using the COC, the medicinal product should be discontinued immediately.
In the event that any of the conditions or risk factors mentioned are present, the suitability of taking YAZ should be evaluated with the doctor .
In the event of worsening or first appearance of any of these risk factors or conditions, the woman should contact her doctor to determine whether the use of YAZ should be discontinued.
In the event of a suspected or known VTE or ATE, CHC use should be discontinued. If anticoagulant therapy is initiated, an alternative method of contraception must be used due to the risk of teratogenicity associated with anticoagulant therapy (coumarins).

If you decide to take the pill, check your blood pressure every two weeks for the first few cycles , then once a month is enough.
No studies on the ability to drive and use machines have been performed. No effect on the ability to drive or use machines has been observed in COC users.
YAZ contains lactose . People who are intolerant to this substance should warn your doctor before taking the drug.

Interactions and side effects

While taking YAZ it is important to tell your doctor , pharmacist or dentist if you are taking, have recently taken or might take any other medicines. Always tell your doctor if you are taking any medicines or herbal products. You may need to take additional contraceptive measures (for example, condoms) or change the use of another medicine that you need.

Concomitant use of YAZ with medicinal products containing certain antiretroviral drugs (ombitasvir / paritaprevir / ritonavir and dasabuvir) is contraindicated.as this can cause an increase in the hepatic ALT enzyme. If necessary, your doctor may prescribe another type of contraceptive before starting treatment with these medicines. YAZ can be resumed approximately 2 weeks after the completion of this treatment.

Some medications affect the levels of YAZ in the blood and can make it less effective at preventing pregnancy or can cause unexpected bleeding. These drugs include: medicines for the treatment of epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g. rifampicin), HIV infection and hepatitis C virus(ritonavir, nevirapine, efavirenz known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors), fungal infections (griseofulvin, ketoconazole), arthritis, osteoarthritis (etoricoxib), pulmonary arterial hypertension (bosentan), antidepressants (Hypericum).
YAZ may affect the effect of other medicines: cyclosporine, lamotrigine (antiepileptic, with an increase in the frequency of seizures), theophylline , tizanidine .

As with all medicines, this drug can cause side effectsalthough not all people manifest them. You should tell your doctor if you notice any side effects, especially if they are severe or persistent, or if there is any change in your health that could be associated with taking YAZ.
Some common effects associated with taking YAZ are mood swings , headaches , nausea , breast pain , problems with menstruation (irregular or absent) .

Less commonly were observed: depression , nervousness, drowsiness, dizziness, tingling, migraine, varicose veins, hypertension, stomach pain, vomiting, indigestion, flatulence, stomach inflammation, diarrhea , acne, itching, rash , pain, such as back pain, pain in limb, muscle cramps, vaginal fungal infection, pain pelvic, enlarged breasts, benign breast lumps, uterine / vaginal bleeding (which usually decreases with continued treatment), genital discharge, flushing, inflammation of the vagina (vaginitis), problems with menstruation (painful, scanty or very abundant), vaginal dryness, abnormal PAP test , decreased interest in sex, lack of energy, increased sweating, water retention, weight gain.

In rare cases , candidiasis (fungal infection), anemia , increased number of platelets in the blood , allergic reaction, hormonal disturbances, both increase and loss of appetite, hyperkalaemia, hyponatremia, problems reaching orgasm, intercourse have been observed sexual difficulties, insomnia, dizziness, tremor, eye disorders (inflammation of the eyelid, dry eye), tachycardia, inflammation of the veins, nosebleeds, fainting, abdominal swelling, intestinal disorders, hiatal hernia, fungal infection or dry mouth, constipation, pain in the bile ducts or gallbladder, inflammation of the gallbladder, yellowish-brown patches on the skin, eczema, hair loss, hirsutism, skin disorders (inflammation, dryness, stretch marks, lumps, acne, sensitivity to light), inflammation of the vagina (vulvovaginitis), breast cyst, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth cervical mucosa, reduction or narrowing of the lining of the uterus, ovarian cysts, uterine enlargement, generally feeling unwell, weight loss.
If you get any side effects, including any possible side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Pregnancy and breastfeeding

YAZ is taken to prevent pregnancy , therefore YAZ is not indicated for pregnant women. It is advisable to ask your doctor or pharmacist for information before taking any medication.
In the event of pregnancy occurring while using YAZ, the medicinal product should be discontinued immediately , even if the available data on the use of YAZ in pregnancy are too limited to be able to draw any conclusions about any adverse effects of YAZ on pregnancy or on the health of the fetus or newborn. No relevant epidemiological data are currently available.
If YAZ is resumed, the increased risk of thromboembolism in the postpartum period should be considered.

Feeding time

Small amounts of contraceptive steroids and / or their metabolites may be excreted in breast milk during COC use. These quantities can affect the baby. Also, COCs can decrease the amount and change the composition of breast milk. Therefore, the use of COCs should not normally be recommended until weaning has been completed.

Notes (methods of storage, disposal)

YAZ tablets are valid for 5 years and do not require any special storage conditions.
This medicine may pose a risk to the environment. Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.

Questions and answers

WHAT IS YAZ USED FOR?

YAZ is used to prevent pregnancy. In addition, it is used for the therapy and treatment of various diseases and pathologies such as endometriosis.

DOES TAKING YAZ LEAD TO WEIGHT GAIN? 

In some cases, taking YAZ can cause a small weight gain, mostly due to an increase in water retention due to the presence of estrogen.

HOW DOES THE YAZ WORK?

YAZ works primarily by selectively inhibiting the function of the pituitary gland. This leads to a blockage of ovulation and ovarian function. It also causes a change in cervical mucus, endometrium and tubal motility and secretion. All these associated effects reduce the likelihood of conception and implantation of the fertilized egg.

WHAT ARE THE 4 WHITE PILLS? 

The 4 white pills are placebo pills, i.e. they do not contain the active ingredient. They are used only to cover the 4-day period in which the active ingredient is not taken and to facilitate the establishment of the habit of taking the pill every day. This, over time, reduces the possibility of forgetting to take the pill.

 

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