YAZ. 28 tablets

YAZ. 28 tablets
€ 25.00
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Active tablet is a pale pink, round with convex faces, one side embossed with the letters "DS" in a regular hexagon.
Placebo tablet is white, round with convex faces, one side embossed with the letters "DP" in a regular hexagon.

YAZ. 28 tablets

 
 
QUALITATIVE AND QUANTITATIVE COMPOSITION

24 light pink tablets
Each tablet contains 0,020 mg ethinylestradiol [ethinilestradiol) (as betadeksov clathrate) (betadex clathrate) and 3 mg drospirenone (drospirenone).
Excipients: Lactose 46 mg.
4 white film-coated placebo tablets: The tablet does not contain active substances.
Excipients: Lactose 50 mg.
For a full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
/ Yaz tabl. film 0,02 mg / 3 mg - 1 x 28; 3 x 28; 6 x 28 /

tablet
Active tablet is a pale pink, round with convex faces, one side embossed with the letters "DS" in a regular hexagon.
Placebo tablet is white, round with convex faces, one side embossed with the letters "DP" in a regular hexagon.
 
CLINICAL DATA
4.1 Therapeutic indications

Oral contraception.
4.2 Posology and method of administration

Method of administration: Oral.

How to take YAZ?
The tablets must be taken every day at the same time, if necessary with some liquid in the order indicated on the blister. Taking the tablets is successively. Take one tablet daily for 28 consecutive days. Each subsequent pack is started the day after taking the last tablet from the front pack. Bleeding stopped administration of the active ingredient usually appear 2-3 days after initiation of the placebo tablets (and the last row can not be finished before the start of the next pack.

How to start taking YAZ?
• No prior hormonal contraceptive use (last month)
Tablet-taking has to start on Day I-you from the natural monthly cycle of a woman (ie the first day of her menstrual bleeding).

• Changing from another combined hormonal contraceptive method (combined oral contraceptive, SMC) (combined oral contraceptive pill, vaginal ring or transdermal patch)
The user should start accepting Jazz preferably on the day after the last active tablet (the last tablet, which contains the active substance) of its preceding combined contraceptive method, but not later than the day after the normal range for her preceding combined contraceptive method, in which not take tablets or placebo tablets. If it has been used a vaginal ring or transdermal patch woman should start taking Jazz possible on the day of removal, but not later than the day on which would be the next placement.

• Changing from a progestogen-only-method (progestogen-only pill, injection, implant) or progestogen-delivering intrauterine system (IUS)
The woman may switch any day from the period of administration of progestogen-only pill (from an implant or the IUS on the day of removal, from an injectable when you need to apply after injection), but in all these cases should be advised to apply a barrier method for the first 7 days of tablet taking.

• After an abortion in the first three months of pregnancy
The woman may start immediately. When doing so, it should not take additional contraceptive measures.

• Following delivery or abortion in the second trimester of pregnancy
The woman should be advised to start the adoption in 21 to 28 days after birth or abortion in the second trimester of pregnancy. When starting later, the woman should be advised to additionally use a barrier method for the first 7 days. At the same time, it has already had sexual intercourse, should be excluded pregnancy before the actual start of COC use or the woman has to wait for her first menstrual period.
Nursing, cf. Section 4.6.

Management of missed tablets
Placebo tablets of the last (fourth) number of the blister may be disregarded. At the same time, they must be discarded in order to prevent inadvertent extension of the period of administration of placebo tablets. The following advice only refers to missed active tablets:

If the woman is overdue less than 12 hours in taking any tablet, contraceptive protection is not reduced. The woman should take the tablet as soon as you remember and the next tablet should be taken at the usual time.

If it is delayed more than 12 hours in taking any tablet, contraceptive protection may be reduced. Management of missed tablets can be guided by the following two basic rules:
1. Acceptance of tablets should never be suspended for more than 4 days
2. 7 are needed to continuous reception of the tablets to attain adequate suppression of the hypothalamic-pituitary-ovarian axis.

In everyday practice, therefore, can give the following advice:

• Day 1-7

The woman should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then we will continue to take tablets at the usual time. Furthermore, during the next 7 days to be applied barrier method, e.g., with a condom. If you had sexual intercourse in the preceding 7 days, it should be borne in mind that there is likely to be pregnant. The more tablets are missed and the closer they are to the stage with placebo tablets, the greater is the risk of pregnancy.

• Day 8-14

The woman should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then we will continue to take tablets at the 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 take additional contraceptive measures. At the same time, if you miss 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 not immediate, because the forthcoming placebo tablet phase. At the same time, by adjusting the scheme taking pills reduced contraceptive protection can still be prevented. While respecting one of the following two options, there is no need to use an additional contraceptive protection, provided that in the 7 days preceding the first missed tablet the woman is taking the tablets correctly. However, if it is not, it should go to the first of the two options as apply extra precautions for the next 7 days.

1. The woman should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. It will then continue to take the tablets at the usual time while using all active tablets. The 4 tablets of the last row should not be ignored. Immediately to begin the next blister pack. Less likely to receive bleeding stopped taking the active ingredient before close of tablets from the active part of the second pack, but she may experience spotting or breakthrough bleeding on days when taking tablets.

2. A woman may also be advised to stop taking active tablets from the current blister pack. Then she should take placebo tablets last row for no more than four days, including the days when she missed tablets, and subsequently continue with the next blister pack.

If the woman missed tablets and subsequently has no withdrawal bleed adoption of active ingredient in the phase when placebo tablets should be borne in mind that there is a possibility of pregnancy.

Advice in case of gastro-intestinal disorders

In case of severe gastro-intestinal disorders (eg, vomiting or diarrhea), absorption may not be complete and should take additional contraceptive measures. If vomiting occurs within 3-4 hours after taking the active tablet as soon as possible to take a new (replacement) tablet. The new tablet should be taken, if possible, within 12 hours after the usual time of taking the tablets. If more than 12 hours should be given advice on missed tablet similar to that in section 4.2 "Management of missed tablets." If the woman is unwilling to change its normal schedule of making tablets, she should take extra tablet (s) from another blister pack.

How to hold the bleeding stopped taking the active ingredient
To delay the onset of bleeding, the woman should continue with another blister pack Jazz without taking the placebo tablets from the current pack. The extension can continue as desired to finish the active tablets in the second pack. During the extension the woman may experience breakthrough bleeding or spotting. Therefore, regular intake of Jazz recovered after phase placebo tablets.

To displace regular bleeding on another day of the week other than that in which it is not used in the existing schedule of adoption of tablets, it can be advised to shorten the forthcoming placebo tablet phase by as much as desired. The shorter the interval, the greater the risk that she does not get breakthrough bleeding or spotting in the adoption of the next pack (just as when delaying the onset of bleeding).
4.3 Contraindications / Yaz tabl. film 0,02 mg / 3 mg - 1 x 28; 3 x 28; 6 x 28 /

Combined oral contraceptives (COCs) should not be used in the presence of any of the following conditions. If any of these conditions appear for the first time in the application of SMC, the acceptance of the product should be stopped immediately.
• Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)
• Arterial thrombosis present or in history (eg myocardial infarction) or prodromal conditions (eg angina pectoris and transient ischemic attack)
• Cerebrovascular accident present or in history
• Presence of heavy (s) or set (s) risk (s) factor (s) for arterial thrombosis:
• diabetes mellitus with vascular symptoms
• severe hypertension
• severe dyslipoproteinemia
• Hereditary or acquired predisposition for venous or arterial thrombosis, such as APC resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hiperhomotsistei dumb and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant)
• Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
• Presence or history of severe hepatic disease provided that liver function values have not returned to normal
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumors (benign or malignant)
• Known or suspected malignancy influenced by hormones (such as the genitals or breasts)
• Nediagiostitsirano vaginal bleeding
Anamnestic migraine with focal neurological symptoms
• Hypersensitivity to the active substance or to any of the excipients in coated tablet Jazz
4.4 Special warnings and precautions for use

warnings

If any of the conditions / risks mentioned below, the benefit of using the SMC should be weighed by the possible risks for each individual woman and discussed with her before the woman to decide whether to start using the product. In aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should consult a doctor. When the doctor should decide whether SMC should be discontinued.

• Circulatory disorders
The use of any combined oral contraceptive has been associated with an increased risk of venous thromboembolism (VTE) in comparison to those women who do not use such preparations. Increased risk of VTE is highest during the first year in which the woman uses combined, oral contraceptive.
Epidemiological studies show that the incidence of VTE in women with no known risk factors for VTE, used oral contraceptives with estrogen-deficient (<0,05 mg ethinylestradiol) is in the range of 20 cases per 100,000 women years (for levonorgestrel containing a "second generation" COCs) to 40 cases per 100 000 women-years (desogestrel / gestodene containing "third" generation COC). In comparison, use such female contraception frequency is 5 to 10 cases per 100 000 women 60 years and cases per 100 000 pregnancies. VTE ends fatal in 1-2% of cases.
Data from a large, prospective 3-branched group study showed that the incidence of VTE in women with or without other risk factors for VTE, who used ethinylestradiol / drospirenone 0,03 mg | / 3 mg is in the same range as in Use another sauce with low estrogen, including levonorgestrel-containing OC (so-called 'second' generation OS). The risk of Ute at Jazz currently unknown.
Epidemiological studies have also shown a link between the use of combined COCs and an increased risk for arterial (myocardial infarction, transient ischemic attack) thromboembolism.
Extremely rare in oral contraceptives thrombosis observed in other blood vessels, eg. hepatic, mesenteric, renal, cerebral or retinal veins and arteries. There is no general agreement on the existence of a relationship between the occurrence of these events and the use of hormonal contraceptives.

Symptoms of venous or arterial thrombosis / embolism or cerebrovascular accident which may include:
• unusual unilateral leg pain and / or swelling • sudden severe chest pain with or without radiation to the left arm

• sudden shortness of breath

• suddenly started coughing
• any unusual, severe or prolonged headache

• sudden partial or complete loss of vision

• diplopia
• drawl or aphasia

• dizziness
• collapse with or without focal seizure
• weakness or marked numbness suddenly affecting one side or one part of the body

• movement disorders
• "acute" abdomen.
The risk of venous thromboembolism as a complication of applying SMC increased by
• age
• a positive family history (venous thromboembolism ever in a sibling or parent at a relatively early age). If it is suspected hereditary predisposition, the woman should be referred to a specialist for advice before deciding about any COC use.
• prolonged immobilisation, major surgery, any surgery to the legs, or major trauma. In these situations it is appropriate to adopt the pill be discontinued (in the case of elective surgery at least four weeks in advance) and not resume until two weeks after complete remobilisation. Should be given to initiating antithrombotic treatment if the pills have not been discontinued in advance.
• obesity
• there is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.

The risk of arterial thromboembolic complications or cerebrovascular events in COC users increases with:
• age
• smoking (women over the age of 3 5 years should be strongly advised not to smoke if they want to apply SMC)
• dyslipoproteinaemia
• hypertension
• migraine
• obesity
• a positive family history (venous thromboembolism ever in a sibling or parent at a relatively early age). If it is suspected hereditary predisposition, the woman should be referred to a specialist for advice before deciding about any COC use.
• valvular heart disease
• atrial fibrillation
The presence of significant risk factors or multiple risk factors respectively for venous or arterial disease, may also constitute a contraindication. The possibility of anticoagulant therapy should also be taken into account. COC should be specifically directed to consult with your doctor if you develop a possible symptoms of thrombosis. In suspected or confirmed thrombosis, COC use should be discontinued. Shall immediately initiate adequate alternative contraception due to teratogenicity of anticoagulant therapy (coumarins).

In the postpartum period should be taken into account the increased risk of thromboembolism

Other medical conditions that are associated with side effects on cardiovascular system are diabetes mellitus, systemic lupus erythematosus, haemolytic uraemic syndrome, and chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

Increased incidence of severe migraine during COC use (which may be prodromal phenomenon cerebrovascular event) may be a reason for immediate discontinuation of the COC.
• Tumors
In some epidemiological studies reported an increased risk of cervical cancer in long used SMC (more than 5 years), but there are still controversies about the extent to which similar findings are the result of sexual behavior or other factors such as human papilloma virus (HPV ).
Meta-analysis of 54 epidemiological studies reported that there is a slightly increased relative risk (RR = 1,24) of breast cancer in women using COCs. The increased risk gradually declined during the 10-year follow-up after discontinuation of the COC.
 
 
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