Rosen 28 Plus

Indicated for use by women to, Prevent pregnancy (contraception), Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception. Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. Raise folate levels in women who choose to use an oral contraceptive for contraception.

1. If you have decided to take this for contraception, wait for your next menstruation begins. 2. From the first day of your menstruation, start taking the first orange tablet from the left corner of the top row (with arrow mark) of your tablet pack. 3. Continue taking one orange tablet each day along the arrow mark. 4. After taking 21 orange tablets for 21 days, then continue taking one light orange non-hormonal tablet every day from the last row in the pack for next 7 days. 5. It is most likely that your menstruation will start while taking the light orange tablets. Do not discontinue taking the light orange tablets. Taking of the light orange tablets for 7 days will help you keep your tablet taking routine. If your menstruation does not start during this time, check with your doctor to make sure you are not pregnant. 6. After completing the seven light orange tablets, start taking orange tablets from another pack and continue taking the tablet as long as you don't want to be pregnant.

Adult Tablet Take 1 tablet daily by mouth at the same time every day. Tablets must be taken in the order directed on the administration section.

This tablet should not be used in pregnancy, renal impairment, adrenal insufficiency, high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen-or progestin-sensitive cancer (exists or in the past), liver tumor (benign or malignant) or liver disease, use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir.

Ethinylestradiol is a synthetic version of oestrogen and Drospirenone is a synthetic form of progesterone. The hormonal components inhibit ovulation by suppressing gonadotropin release. Secondary mechanism includes changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation). Drospirenone has antimineralocorticoid activity, counteracting oestrogen related sodium retention. Drospirenone exerts antiandrogenic activity and does not counteract the ethinylestradiol-related sex hormone binding globulin (SHBG) increase which is useful for binding and inactivating the endogenous androgens. Levomefolate Calcium is a metabolite of vitamin B9. Rosen 28 plus Plus is indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Epidemiological studies have suggested an association between the use of COCs and an increased risk of arterial, venous thrombotic and thromboembolic diseases such as myocardial infarction, deep venous thrombosis, pulmonary embolism and of cerebrovascular accidents. These events occur rarely. Venous thromboembolism (VTE) manifesting as deep venous thrombosis and/or pulmonary embolism may occur during the use of all COCs. In a clinical study it has been found that after the use of drospirenon containing COCs cause the prevalence of VTE & ATE may be upto 9.8 for 10,000 women/ year. Folate Supplementation The U.S. Preventive Services Task Force recommends that women of childbearing age consume supplemental folic acid in a dose of at least 0.4 mg (400 mcg) daily. Consider other folate supplementation that a woman may be taking before prescribing this. Lactation: When possible, advise the nursing mother to use other forms of contraception until she has weaned her child.

The most frequent adverse reactions (> 2%)in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness(3.2%). The most frequent adverse reactions (>2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%). The most common side effects of birth control pills are spotting or bleeding between menstrual periods, nausea, breast tenderness, headache etc. These side effects are usually mild and usually disappear with time. After starting oral contraceptive tablet, if you feel any inconvenience such as depression, less sexual desire, botchy darkening of the skin, especially on the face, high blood sugar especially in women who already have diabetes, fluid retention, rise in blood pressure take advice from your doctor or contact the nearest family planning centre.

Pregnancy: Birth control pills should not be taken during pregnancy.

Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs.