Can i take generess fe with water

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications 4 ]. Chew and swallow one tablet without water at the same time every day.

Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. One light green tablet should be taken daily for 24 consecutive days followed by one brown tablet daily for 4 consecutive days [see FDA-Approved Patient Labeling ]. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking GENERESS Fe other than on the first day of her menstrual cycle.

Recommend use of a non-hormonal back-up method for the first 7 days. When combined oral contraceptives COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered.

The possibility of ovulation and conception before starting COCs should also be considered. If the patient is switching from a combination hormonal method such as: - Another pill - Vaginal ring - Patch. If the patient is switching from a progestin-only method such as: - Progestin-only pill - Implant - Intrauterine system - Injection.

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within hours after taking a light green tablet, this can be regarded as a missed tablet [see FDA-Approved Patient Labeling ]. Although the use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10, woman-years.

The excess risk is highest during the first year of use of a COC. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.

COCs also increase the risk for stroke in women with other underlying risk factors. Evaluate for retinal vein thrombosis immediately. There is substantial evidence that COCs do not increase the incidence of breast cancer. Although some past studies have suggested that COCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.

Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded.

Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. However, the attributable risk of liver cancers in COC users is less than one case per million users. Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis.

Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs. An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin. Studies suggest the relative risk of developing gallbladder disease may be increased among COC users. COCs may decrease glucose tolerance in a dose-related fashion.

Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs. An increase in frequency or severity of migraine during COC use which may be prodromal of a cerebrovascular event may be a reason for immediate discontinuation of the COC.

Unscheduled breakthrough or intracyclic bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy.

If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC. A total of 15 subjects out of 1, 0. Women who are not pregnant and use GENERESS Fe may not have scheduled withdrawal bleeding every cycle or may experience amenorrhea absence of any bleeding and spotting.

The incidence of amenorrhea in the clinical trial increased from 8. For those women who had scheduled withdrawal bleeding, the average duration of bleeding per cycle in Cycles was 3.

If the patient has not adhered to the prescribed dosing schedule missed one or more active tablets or started taking them on a day later than she should have , consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Some women may encounter amenorrhea or oligomenorrhea after stopping COCs, especially when such a condition was pre-existent.

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb-reduction defects are concerned, when taken inadvertently during early pregnancy. The administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy [see Use in Specific Populations 8.

The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of COCs.

A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare. In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.

Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs. The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The study was a multicenter, non-comparative, open-label study with a treatment duration of 12 months thirteen day cycles.

Adverse Reactions Leading to Study Discontinuation: 8. The most common adverse reactions leading to discontinuation were nausea 1. Serious Adverse Reactions: Hypertension, depression, cholecystitis, and deep vein thrombosis. If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception.

Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives or increase breakthrough bleeding.

Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include:. HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors: Significant changes increase or decrease in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors.

Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation.

CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels. COCs containing some synthetic estrogens e. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations. There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects including cardiac anomalies and limb-reduction defects following exposure to low dose COCs prior to conception or during early pregnancy.

The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion. When possible, advise the nursing mother to use other forms of contraception until she has weaned her child.

Estrogen-containing OCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal [see Contraindications 4 , and Warnings and Precautions 5.

There have been no reports of serious ill effects from overdose of oral contraceptives including ingestion by children. Overdosage may cause nausea, and withdrawal bleeding may occur in females. GENERESS Fe provides an oral contraceptive regimen consisting of 24 tablets that contain the active ingredients specified below, followed by four non-hormonal placebo tablets:.

Each brown, round tablet contains ferrous fumarate, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium starch glycolate, spearmint flavor and sucralose.

The ferrous fumarate chewable tablets do not serve any therapeutic purpose. Ferrous fumarate chewable tablets are not USP for dissolution and assay. The empirical formula of ethinyl estradiol is C 20 H 24 O 2 and the chemical structure is:. The empirical formula of norethindrone is C 20 H 26 O 2 and the chemical structure is:. COCs lower the risk of becoming pregnant primarily by suppressing ovulation.

Other possible mechanisms may include cervical mucus changes that inhibit sperm penetration and endometrial changes that reduce the likelihood of implantation.

The plasma norethindrone and ethinyl estradiol pharmacokinetics following single- and multiple-dose administrations of GENERESS Fe in 17 healthy female volunteers are provided in Table 1. Norethindrone undergoes extensive biotransformation, primarily via reduction, followed by sulfate and glucuronide conjugation. The majority of metabolites in the circulation are sulfates, with glucuronides accounting for most of the urinary metabolites.

A small amount of norethindrone is metabolically converted to ethinyl estradiol, such that exposure to ethinyl estradiol following administration of 1 mg of norethindrone acetate is equivalent to oral administration of 2. Ethinyl estradiol is also extensively metabolized, both by oxidation and by conjugation with sulfate and glucuronide.

Sulfates are the major circulating conjugates of ethinyl estradiol and glucuronides predominate in urine. The primary oxidative metabolite is 2-hydroxy ethinyl estradiol, formed by the CYP3A4 isoform of cytochrome P Part of the first-pass metabolism of ethinyl estradiol is believed to occur in gastrointestinal mucosa.

Ethinyl estradiol may undergo enterohepatic circulation. Norethindrone and ethinyl estradiol are excreted in both urine and feces, primarily as metabolites. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like a condom and spermicide, until you check with your healthcare provider.

If you forgot to start a new blister pack, you may already be pregnant. Use back-up contraception such as a condom and spermicide anytime you have sex. Call your healthcare provider if you are unsure whether you are pregnant. Your birth control pills may not be as effective if you miss any light green pills, and particularly if you miss the first few or the last few light green pills in a pack. The more pills missed and the closer they are to the end of the cycle, the higher the risk of a pregnancy.

You should call your doctor or healthcare provider if you are unsure whether you are already pregnant. Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.

Some examples of serious blood clots are blood clots in the:. This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children. Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners. Unscheduled irregular vaginal bleeding or spotting may occur while you are taking Generess Fe. Unscheduled bleeding may vary from slight staining to breakthrough bleeding, which is a flow much like a regular period, but which occurs between menstrual periods.

Unscheduled bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems.

Approximately one-third of the women who use Generess Fe have unscheduled bleeding or spotting in the first months of use. About one-quarter of users continue to have unscheduled bleeding or spotting after one year of use. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle, is unusually heavy, or lasts for more than a few days, call your healthcare provider.

If you miss more than two periods in a row or miss one period when you have not taken your birth control pills according to directions, call your healthcare provider. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider checks you to find out if you are pregnant. Stop taking Generess Fe if you are pregnant.

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

Your healthcare provider prescribed Generess Fe for you. Please do not share Generess Fe with anyone else.