YAZ FILM-COATED TABLET [SIN13584P]

Product Info

YAZ FILM-COATED TABLET

[SIN13584P]

Indication

4.1 Indications

YAZ is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

YAZ is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. YAZ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

YAZ is indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been evaluated.

Dosing

4.2 Dosage and method of administration
4.2.1 Method of administration
Oral use

4.2.2 Dosage regimen

How to take Yaz; 24 + 4 film-coated tablets

Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly.

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 to be taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts on day 2–3 after starting the hormone-free white film-coated tablets and may not have finished before the next pack is started.

How to start Yaz; 24 + 4 film-coated tablets

• No preceding hormonal contraceptive use (in the past month)

Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2–5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking.

• Changing from a combined hormonal contraceptive (combined oral contraceptive /COC), vaginal ring, or transdermal patch

The woman should start with Yaz; 24+4 preferably on the day after the last hormone-containing tablet of her previous COC, but at the latest on the day following the usual tablet-free or hormone-free tablet interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using Yaz; 24+4 preferably on the day of removal of the last ring or patch of a cycle pack, but at the latest when the next application would have been due.

• Changing from a progestogen-only-method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS)

The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method for the first 7 days of tablet-taking.

• Following first-trimester abortion

The woman may start immediately. When doing so, she does not need additional contraceptive measures.

• Following delivery or second-trimester abortion

Women should be advised to start at day 21 to 28 after delivery or second-trimester abortion. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of COC use or the woman has to wait for her first menstrual period.

Management of missed tablets

Missed hormone-free white film-coated tablets can be disregarded. However, they should be discarded to avoid unintentionally prolonging the hormone-free white film-coated tablets phase. The following advice only refers to missed hormone-containing light pink film-coated tablets:

If the user is less than 24 hours late in taking any hormone-containing tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as she remembers and should take further tablets at the usual time.

If she is more than 24 hours late in taking any hormone-containing tablet, contraceptive protection may be reduced. The management of missed tablets can be guided by the following two basic rules:

1. tablet-taking must never be discontinued for longer than 4 days

2. 7 days of uninterrupted hormone-containing tablet-taking are required to attain adequate suppression of the hypothalamic-pituitary-ovarian-axis.

Accordingly the following advice can be given in daily practice:

• Day 1–7

The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. In addition, a barrier method such as a condom should be used for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed and the closer they are to the hormone-free white film-coated tablets phase, the higher the risk of a pregnancy.

• Day 8–14

The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time. Provided that the woman has taken her tablets correctly in the 7 days preceding the first missed tablet, there is no need to use extra contraceptive precautions. However, if this is not the case, or if she missed more than 1 tablet, the woman should be advised to use extra precautions for 7 days.

• Day 15–24

The risk of reduced reliability is imminent because of the forthcoming hormone-free white film-coated tablets phase. However, by adjusting the tablet-intake schedule, reduced contraceptive protection can still be prevented. By adhering to either of the following two options, there is therefore no need to use extra contraceptive precautions, provided that in the 7 days preceding the first missed tablet the woman has taken all tablets correctly. If this is not the case, the woman should be advised to follow the first of these two options and to use extra precautions for the next 7 days as well.

1. The user should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. She then continues to take tablets at her usual time until the light pink film-coated tablets are used up. The 4 white hormone-free film-coated tablets must be discarded. The next pack must be started right away. The user is unlikely to have a withdrawal bleed until the end of the hormone-containing light pink film-coated tablets section of the second pack, but she may experience spotting or breakthrough bleeding on tablet-taking days.

2. The woman may also be advised to discontinue taking the light pink film-coated tablet from the current pack. She should then have a tablet-free interval of up to 4 days, including the days she missed tablets, and subsequently continue with the next pack.

If the woman missed tablets and subsequently has no withdrawal bleed in the hormone-free white film-coated tablets phase, the possibility of a pregnancy should be considered.

Advice in case of gastro-intestinal disturbances

In case of severe gastro-intestinal disturbances, absorption may not be complete and additional contraceptive measures should be taken.

If vomiting occurs within 3–4 hours after taking a light pink hormone-containing film-coated tablet, the advice concerning missed tablets is applicable. If the woman does not want to change her normal tablet-taking schedule, she has to take the extra tablet(s) needed from another pack.

How to shift periods or how to delay a period

To delay a period the woman should continue with another pack of Yaz; 24 + 4 film-coated tablets without taking the hormone-free white film-coated tablets from her current pack. The extension can be carried on for as long as wished until the end of the light pink film-coated tablets in the second pack. During the extension the woman may experience breakthrough-bleeding or spotting. Regular intake of Yaz; 24 + 4 Film Tablets is then resumed after the hormone-free white tablet phase.

To shift her periods to another day of the week than the woman is used to with her current scheme, she can be advised to shorten her forthcoming hormone-free white film-coated tablets phase by as many days as she likes. The shorter the interval, the higher the risk that she does not have a withdrawal bleed and will experience breakthrough-bleeding and spotting during the second pack (just as when delaying a period).

4.2.3 Additional information on special populations

4.2.3.1 Pediatric patients
Yaz is only indicated after menarche. There are no data suggesting the need for a dosage adjustment.

4.2.3.2 Geriatric patients
Not applicable. Yaz is not indicated after menopause.

4.2.3.3 Patients with hepatic impairment
Yaz is contraindicated in women with severe hepatic diseases. See also sections ‘Contraindications’ and ‘Pharmacokinetic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2.3.4 Patients with renal impairment
Yaz is contraindicated in women with severe renal insufficiency or acute renal failure. See also sections ‘Contraindications’ and ‘Pharmacokinetic properties’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3 Contraindications

Combined oral contraceptives (COCs) 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 COC use, the product should be stopped immediately.

• Presence or risk of venous thromboembolism (VTE)

  • Venous thromboembolism – current VTE (on anticoagulants) or history of deep venous thrombosis [DVT], 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 immobilization (see under “Special Warnings and Special Precautions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

  • A high risk of venous thromboembolism due to the presence of multiple risk factors (see under “Special Warnings and Special Precautions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Presence or risk of arterial thromboembolism (ATE)

  • Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris)

  • Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA)

  • Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia, and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)

  • History of migraine with focal neurological symptoms

  • A high risk of arterial thromboembolism due to multiple risk factors (see under “Special Warnings and Special Precautions for Use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) or to the presence of one serious risk factor such as:

    • Diabetes mellitus with vascular symptoms

    • Severe hypertension

    • Severe dyslipoproteinaemia

• Hepatic dysfunction

• Use of direct-acting antiviral (DAA) medicinal products containing ombitasvir, paritaprevir, or dasabuvir, and combinations of these (see ‘Interaction with other medicinal products and other forms of interaction’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Renal impairment

• 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 the active substances or to any of the excipients

• Cholestatic jaundice of pregnancy or jaundice with prior pill use