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CERAZETTE 75MCG 28TAB

CERAZETTE 75MCG 28TAB

CERAZETTE 75MCG 28TAB

SAR 17.85

Ex Tax: SAR 17.85

Model: 0001948

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If any of the conditions/risk factors mentioned below is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with Cerazette.

In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician.

The physician should then decide on whether the use of Cerazette should be discontinued.

The risk for breast cancer increases in general with increasing age.

During use of combined oral contraceptives (COCs) the risk of having breast cancer diagnosed is slightly increased.

This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC.

The expected number of cases diagnosed per 10,000 women who use COCs (up to 10 years after stopping) relative to never users over the same period has been calculated for the respective age groups and is presented in the table below.

The risk in users of progestogen-only contraceptives (POCs), such as Cerazette, is possibly of similar magnitude as that associated with COCs.

However, for POCs the evidence is less conclusive.

Compared to the risk of getting breast cancer ever in life, the increased risk associated with COCs is low.

The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs.

The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.

Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer.

When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.

Epidemiological investigations have associated the use of COCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an oestrogenic component is unknown, Cerazette should be discontinued in the event of a thrombosis.

Discontinuation of Cerazette should also be considered in case of long-term immobilisation due to surgery or illness.

Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence.

Although progestogens 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 using progestogen-only pills. However, diabetic patients should be carefully observed during the first months of use.

If a sustained hypertension develops during the use of Cerazette, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Cerazette should be considered.

Treatment with Cerazette leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase.

It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density.

The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills.

Despite the fact that Cerazette consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exp