Ovcon

Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products such as OVCON (norethindrone and ethinyl estradiol tablets) 50, 28-Day, which contain 50 mcg of estrogen, should not be used unless medically indicated.

Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

TABLE 1: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD
% of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use

A seguir, é apresentado um resumo das instruções dadas ao paciente no "COMO TOMAR O COMPRIMIDO" seção do PACIENTE DETALHADO INSERIR DO PACOTE.

O paciente recebe instruções em cinco (5) categorias.

1. PONTOS IMPORTANTES PARA LEMBRAR: Dizem à paciente (a) que ela deveria tome uma pílula todos os dias ao mesmo tempo; (b) muitas mulheres têm manchas ou sangramento leve ou angústia gástrica durante o primeiro a três ciclos, (c) pílulas ausentes também podem causar manchas ou sangramento leve; (d) ela deve usar um método de contracepção se ela tiver vômito ou diarréia ou tomar alguns medicamentos concomitantes e / ou se ela tiver problemas para se lembrar da pílula (e) se ela tiver outras perguntas, deve consultar seu médico.
2. ANTES DE COMEÇAR A PEGAR SEUS COMPRIMIDOS: Ela deve decidir a que horas do dia ela deseja tomar a pílula, verifique se o pacote de comprimidos tem 21 ou 28 comprimidos e observe a ordem em que ela deve tomar os comprimidos (diagramática desenhos do pacote de comprimidos estão incluídos no paciente inserir).
3. QUANDO DEVE COMEÇAR O PRIMEIRO PACOTE: O início do primeiro dia está listado como a primeira escolha e o início de domingo (o domingo após o início do período) é dada como a segunda escolha. Se ela usa o início de domingo, ela deve usar um método de backup no primeiro ciclo, se ela tiver relações sexuais antes dela tomou sete comprimidos.
4. O QUE FAZER DURANTE O CICLO: O paciente é aconselhado a tomar um pílula ao mesmo tempo todos os dias até que o pacote esteja vazio. Se ela estiver em um dia de 21 dias regime, ela deve esperar sete dias para começar o próximo pacote. Se ela estiver no Regime de 28 dias, ela deve começar o próximo pacote no dia seguinte ao último inativo tablet e não espere dias entre as embalagens.
5. O QUE FAZER SE PERDER UMA COMPRIMIDA OU COMPRIMIDOS: O paciente recebe instruções sobre o que ela deve fazer se perder um, dois ou mais de dois comprimidos tempos variados em seu ciclo para o primeiro dia e o domingo. O a paciente é avisada de que pode engravidar se tiver relações sexuais desprotegidas nos sete dias. Para evitar isso, ela deve usar outro método de controle de natalidade como preservativo, espuma ou esponja nesses sete dias.

Os contraceptivos orais não devem ser utilizados em mulheres que atualmente têm as seguintes condições :

• Tromboflebite ou distúrbios tromboembólicos
• Uma história passada de tromboflebite venosa profunda ou distúrbios tromboembólicos
• Doença arterial cerebrovascular ou coronariana
• Carcinoma conhecido ou suspeito da mama
• Carcinoma do endométrio ou outro dependente de estrogênio conhecido ou suspeito neoplasia
• Sangramento genital anormal não diagnosticado
• icterícia colestática da gravidez ou icterícia com o uso prévio da pílula
• Adenomas ou carcinomas hepáticos
• Gravidez conhecida ou suspeita

WARNINGS

The use of oral contraceptives is associated with increased risk of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population.* For further information, the reader is referred to a text on epidemiological methods.

*Adapted from Stadel BB: Oral contraceptives and cardio-vascular disease. N Engl J Med, 1981;305:612­618, 672-677; with author"s permission.

Thromboembolic Disorders And Other Vascular Problems

The physician should be alert to the earliest manifestations of thromboembolic thrombotic disorders as discussed below. Should any of these occur or be suspected the drug should be discontinued immediately.

Myocardial Infarction

An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is primarily in smokers or women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolemia, morbid obesity, and diabetes. The relative risk of heart attack for current oral contraceptive users has been estimated to be two to six. The risk is very low under the age of 30.

Smoking in combination with oral contraceptive use has been shown to contribute substantially to the incidence of myocardial infarctions in women in their mid-thirties or older, with smoking accounting for the majority of excess cases. Mortality rates associated with circulatory disease have been shown to increase substantially in smokers over the age of 35 and nonsmokers over the age of 40 (Figure 1) among women who use oral contraceptives.

FIGURE 1: CIRCULATORY DISEASE MORTALITY RATES PER 100,000 WOMEN-YEARS BY AGE, SMOKING STATUS AND ORAL CONTRACEPTIVE USE

Layde PM, Beral V: Further analyses of mortality in oral contraceptive users: Royal College of General Practitioners" oral contraception study. (Table 5) Lancet1981;1:541-546.

Oral contraceptives may compound the effects of well-known risk factors, such as hypertension, diabetes, hyperlipidemias, age, and obesity. In particular, some progestogens are known to decrease HDL cholesterol and cause glucose intolerance, while estrogens may create a state of hyperinsulinism. Oral contraceptives have been shown to increase blood pressure among users . Such increases in risk factors have been associated with an increased risk of heart disease and the risk increases with the number of risk factors present. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.

Thromboembolism

An increased risk of thromboembolic and thrombotic disease associated with the use of oral contraceptives is well established. Case control studies have found the relative risk of users compared to non-users to be 3 for the first episode of superficial venous thrombosis, 4 to 11 for deep vein thrombosis or pulmonary embolism, and 1.5 to 6 for women with predisposing conditions for venous thromboembolic disease. Cohort studies have shown the relative risk to be somewhat lower, about 3 for new cases and about 4.5 for new cases requiring hospitalization. The risk of thromboembolic disease due to oral contraceptives is not related to length of use and disappears after pill use is stopped.

A two- to four-fold increase in relative risk of postoperative thromboembolic complications has been reported with the use of oral contraceptives. The relative risk of venous thrombosis in women who have predisposing conditions is twice that of women without such medical conditions. If feasible, oral contraceptives should be discontinued at least four weeks prior to and for two weeks after elective surgery of a type associated with an increase in risk of thromboembolism and during and following prolonged immobilization. Since the immediate postpartum period is also associated with an increased risk of thromboembolism, oral contraceptives should be started no earlier than four to six weeks after delivery in women who elect not to breastfeed.

Cerebrovascular diseases

Oral contraceptives have been shown to increase both the relative and attributable risk of cerebrovascular events (thrombotic and hemorrhagic strokes); although, in general, the risk is greatest among older ( > 35 years), hypertensive women who also smoke. Hypertension was found to be a risk factor for both users and nonusers, for both types of strokes, while smoking interacted to increase the risk for hemorrhagic strokes.

In a large study, the relative risk of thrombotic strokes has been shown to range from 3 for normotensive users to 14 for users with severe hypertension. The relative risk of hemorrhagic stroke is reported to be 1.2 for nonsmokers who used oral contraceptives, 2.6 for smokers who did not use oral contraceptives, 7.6 for smokers who used oral contraceptives, 1.8 for normotensive users and 25.7 for users with severe hypertension. The attributable risk is also greater in older women.

Dose-related risk of vascular disease from oral contraceptives

A positive association has been observed between the amount of estrogen and progestogen in oral contraceptives and the risk of vascular disease. A decline in serum high density lipoproteins (HDL) has been reported with many progestational agents. A decline in serum high density lipoproteins has been associated with an increased incidence of ischemic heart disease. Because estrogens increase HDL cholesterol, the net effect of an oral contraceptive depends on a balance achieved between doses of estrogen and progestogen and the nature and absolute amount of progestogens used in the contraceptive. The amount of both hormones should be considered in the choice of an oral contraceptive.

Minimizing exposure to estrogen and progestogen is in keeping with good principles of therapeutics. For any particular estrogen/progestogen combination, the dosage regimen prescribed should be one which contains the least amount of estrogen and progestogen that is compatible with a low failure rate and the needs of the individual patient. New acceptors of oral contraceptive agents should be started on preparations containing 0.05 mg or less of estrogen. Products containing 50 mcg estrogen should be used only when medically indicated.

Persistence of risk

There are two studies which have shown persistence of risk of vascular disease for ever-users of oral contraceptives. In a study in the United States, the risk of developing myocardial infarction after discontinuing oral contraceptives persists for at least 9 years for women 40-49 years old who had used oral contraceptives for five or more years, but this increased risk was not demonstrated in other age groups. In another study in Great Britain, the risk of developing cerebrovascular disease persisted for at least 6 years after discontinuation of oral contraceptives, although excess risk was very small. However, both studies were performed with oral contraceptive formulations containing 50 micrograms or higher of estrogens.

Estimates Of Mortality From Contraceptive Use

One study gathered data from a variety of sources which have estimated the mortality rate associated with different methods of contraception at different ages (Table 2).

TABLE 2: ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY FERTILITY CONTROL METHOD ACCORDING TO AGE

Ory HW: Mortality associated with fertility and fertility control: 1983. Fam Plann Perspect 1983; 15:50-56.

These estimates include the combined risk of death associated with contraceptive methods plus the risk attributable to pregnancy in the event of method failure. Each method of contraception has its specific benefits and risk. The study concluded that with the exception of oral contraceptive users 35 and older who smoke and 40 and older who do not smoke, mortality associated with all methods of birth control is low and below that associated with childbirth.

The observation of a possible increase in risk of mortality with age for oral contraceptive users is based on data gathered in the 1970s - but not reported until 1983. However, current clinical practice involves the use of lower estrogen dose formulations combined with careful restriction of oral contraceptive use to women who do not have the various risk factors listed in this labeling.

Because of these changes in practice and, also, because of some limited new data which suggest that the risk of cardiovascular disease with the use of oral contraceptives may now be less than previously observed (Porter JB, Hunter J, Jick H, et al. Oral contraceptives and nonfatal vascular disease. Obstet Gynecol 1985;66:1-4 and Porter JB, Jick H, Walker AM. Mortality among oral contraceptive users. Obstet Gynecol 1987;70:29-32), the Fertility and Maternal Health Drugs Advisory Committee was asked to review the topic in 1989. The Committee concluded that although cardiovascular disease risk may be increased with oral contraceptive use after age 40 in healthy nonsmoking women (even with the newer low-dose formulations), there are greater potential health risks associated with pregnancy in older women and with the alternative surgical and medical procedures which may be necessary if such women do not have access to effective and acceptable means of contraception.

Therefore, the Committee recommended that the benefits of oral contraceptive use by healthy nonsmoking women over 40 may outweigh the possible risks. Of course, older women, as all women who take oral contraceptives, should take the lowest possible dose formulation that is effective.

Carcinoma Of The Reproductive Organs

Numerous epidemiological studies have been performed on the incidence of breast, endometrial, ovarian, and cervical cancer in women using oral contraceptives. The overwhelming evidence in the literature suggests that use of oral contraceptives is not associated with an increase in the risk of developing breast cancer, regardless of the age and parity of first use or with most of the marketed brands and doses. The Cancer and Steroid Hormone (CASH) study also showed no latent effect on the risk of breast cancer for at least a decade following long-term use. A few studies have shown a slightly increased relative risk of developing breast cancer, although the methodology of these studies, which included differences in examination of users and nonusers and differences in age at start of use, has been questioned.

Some studies suggest that oral contraceptive use has been associated with an increase in the risk of cervical intraepithelial neoplasia in some populations of women.

However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.

In spite of many studies of the relationship between oral contraceptive use and breast cancer and cervical cancers, a cause-and-effect relationship has not been established.

Hepatic Neoplasia

Benign hepatic adenomas are associated with oral contraceptive use, although their occurrence is rare in the United States. Indirect calculations have estimated the attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

Studies from Britain have shown an increased risk of developing hepatocellular carcinoma in long-term ( > 8 years) oral contraceptive users. However, these cancers are extremely rare in the U.S. and the attributable risk (the excess incidence) of liver cancers in oral contraceptive users approaches less than one per million users.

Ocular Lesions

There have been clinical case reports of retinal thrombosis associated with the use of oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions. Appropriate diagnostic and therapeutic measures should be undertaken immediately.

Oral Contraceptive Use Before Or During Early Pregnancy

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. Oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion.

It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period. Oral contraceptive use should be discontinued if pregnancy is confirmed.

Gallbladder Disease

Earlier studies have reported an increased lifetime relative risk of gallbladder surgery in users of oral contraceptives and estrogens. More recent studies, however, have shown that the relative risk of developing gallbladder disease among oral contraceptive users may be minimal.

The recent findings of minimal risk may be related to the use of oral contraceptive formulations containing lower hormonal doses of estrogens and progestogens.

Carbohydrate And Lipid Metabolic Effects

Oral contraceptives have been shown to cause glucose intolerance in a significant percentage of users. Oral contraceptives containing greater than 75 micrograms of estrogens cause hyperinsulinism, while lower doses of estrogen cause less glucose intolerance. Progestogens increase insulin secretion and create insulin resistance, this effect varying with different progestational agents.

However, in the nondiabetic woman, oral contraceptives appear to have no effect on fasting blood glucose. Because of these demonstrated effects, prediabetic and diabetic women should be carefully observed while taking oral contraceptives.

A small proportion of women will have persistent hypertriglyceridemia while on the pill. As discussed earlier , changes in serum triglycerides and lipoprotein levels have been reported in oral contraceptive users.

Elevated Blood Pressure

An increase in blood pressure has been reported in women taking oral contraceptives and this increase is more likely in older oral contraceptive users and with continued use. Data from the Royal College of General Practitioners and subsequent randomized trials have shown that the incidence of hypertension increases with increasing concentrations of progestogens.

Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception. If women elect to use oral contraceptives, they should be monitored closely and if significant elevation of blood pressure occurs, oral contraceptives should be discontinued. For most women, elevated blood pressure will return to normal after stopping oral contraceptives, and there is no difference in the occurrence of hypertension among ever- and never-users.

Headache

The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.

Bleeding Irregularities

Breakthrough bleeding and spotting are sometimes encountered in patients on oral contraceptives, especially during the first three months of use. Nonhormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy in the event of breakthrough bleeding, as in the case of any abnormal vaginal bleeding. If pathology has been excluded, time or a change to another formulation may solve the problem. In the event of amenorrhea, pregnancy should be ruled out.

Women with a history of oligomenorrhea or secondary amenorrhea or young women without regular cycles prior to taking oral contraceptives may again have irregular bleeding or amenorrhea after discontinuation of oral contraceptives.

PRECAUTIONS

Sexually - Transmitted Diseases

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Physcial Examination And Follow -Up

It is good medical practice for all women to have annual history and physical examinations, including women using oral contraceptives. The physical examination, however, may be deferred until after initiation of oral contraceptives if requested by the woman and judged appropriate by the clinician. The physical examination should include special reference to blood pressure, breasts, abdomen and pelvic organs, including cervical cytology, and relevant laboratory tests. In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a strong family history of breast cancer or who have breast nodules should be monitored with particular care.

Lipid Disorders

Women who are being treated for hyperlipidemias should be followed closely if they elect to use oral contraceptives. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.

Liver Function

If jaundice develops in any woman receiving such drugs, the medication should be discontinued. Steroid hormones may be poorly metabolized in patients with impaired liver function.

Fluid Retention

Oral contraceptives may cause some degree of fluid retention. They should be prescribed with caution, and only with careful monitoring, in patients with conditions which might be aggravated by fluid retention.

Emotionl Disorders

Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related.

Contact Lenses

Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.

Carcinogenesis

Pregnancy

Pregnancy Category X.

Nursing Mothers

Small amounts of oral contraceptive steroids have been identified in the milk of nursing mothers and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child.

Vomitting And/Or Diarrhea

Although a cause-and-effect relationship has not been clearly established, several cases of oral contraceptive failure have been reported in association with vomiting and/or diarrhea. If significant gastrointestinal disturbance occurs in any woman receiving contraceptive steroids, the use of a back-up method of contraception for the remainder of that cycle is recommended.

Pediatric Use

Safety and efficacy of OVCON 50 (norethindrone and ethinyl estradiol tablets, USP) have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 16 years and in users ages 16 years and older. Use of this product before menarche is not indicated.

Information For The Patient

A eficácia reduzida e o aumento da incidência de sangramento e irregularidades menstruais foram associados ao uso concomitante de rifampicina. Uma associação semelhante, embora menos acentuada, foi sugerida com barbitúricos, fenilbutazona, fenitoína sódica e possivelmente com griseofulvina, ampicilina e tetraciclinas.

Interações com testes de laboratório

Certos testes de função endócrina e hepática e componentes sanguíneos podem ser afetados por contraceptivos orais :

1. Protrombina aumentada e fatores VII, VIII, IX e X; diminuição da antitrombina 3; aumento da agregabilidade plaquetária induzida por noradrenalina.
2. Aumento da globulina de ligação à tireóide (TBG), levando ao aumento da circulação hormônio tireoidiano total, medido por iodo ligado a proteínas (PBI), T₄ por coluna ou por radioimunoensaio. T grátis₃ a captação de resina é diminuída refletindo o TBG elevado, livre T₄ a concentração é inalterada.
3. Outras proteínas de ligação podem ser elevadas no soro.
4. As globulinas de ligação ao sexo aumentam e resultam em níveis elevados de total esteróides sexuais circulantes e corticóides; no entanto, livre ou biologicamente ativo os níveis permanecem inalterados.
5. Triglicerídeos podem ser aumentados.
6. A tolerância à glicose pode ser diminuída.
7. Os níveis séricos de folato podem ser deprimidos pela terapia contraceptiva oral. Este pode ter um significado clínico se uma mulher engravidar logo depois descontinuação de contraceptivos orais.

Um risco aumentado das seguintes reações adversas graves foi associado com o uso de contraceptivos orais:

• Tromboflebite
• Tromboembolismo arterial
• Embolia pulmonar
• Infarto do miocárdio
• Hemorragia cerebral
• Trombose cerebral
• Hipertensão
• Doença da vesícula biliar
• Adenomas hepáticos ou tumores benignos do fígado

Há evidências de uma associação entre as seguintes condições e as uso de contraceptivos orais, embora sejam necessários estudos confirmatórios adicionais :

• Trombose mesentérica
• Trombose da retina

As seguintes reações adversas foram relatadas em pacientes recebendo contraceptivos orais e acredita-se que estejam relacionados a medicamentos :

• Náusea
• Vômitos
• Sintomas gastrointestinais (como cãibras abdominais e inchaço)
• Sangramento inovador
• Spotting
• Mudança no fluxo menstrual
• Amenorréia
• Infertilidade temporária após a descontinuação do tratamento
• Edema
• Melasma que pode persistir
• Alterações mamárias: sensibilidade, ampliação e secreção
• Mudança de peso (aumento ou diminuição)
• Mudança na ectropia cervical e secreção
• Possível diminuição da lactação quando administrada imediatamente após o parto
• icterícia colestática
• Enxaqueca
• Erupção cutânea (alérgica)
• Depressão mental
• Tolerância reduzida a carboidratos
• Candidíase vaginal
• Mudança na curvatura da córnea (aumento)
• Intolerância às lentes de contato

As seguintes reações adversas foram relatadas em usuários de contraceptivos orais, e a associação não foi confirmada nem refutada :

• Síndrome pré-menstrual
• Cataratas
• Mudanças no apetite
• Síndrome do tipo cistite
• Dor de cabeça
• Nervosismo
• Tontura
• Hirsutismo
• Perda de pêlos no couro cabeludo
• Eritema multiforme
• Eritema nodoso
• Erupção hemorrágica
• Vaginite
• Porfiria
• Função renal comprometida
• Síndrome hemolítica urêmica
• Síndrome de Budd-Chiari
• Acne
• Mudanças na libido
• Colite

Efeitos graves de doenças não foram relatados após ingestão aguda de grandes doses de contraceptivos orais por crianças pequenas. Sobredosagem pode causar náusea e sangramento por abstinência pode ocorrer em mulheres.

Efeitos não contraceptivos na saúde

Os seguintes benefícios não contraceptivos à saúde relacionados ao uso de contraceptivos orais são apoiados por estudos epidemiológicos que utilizaram amplamente formulações contraceptivas orais contendo doses de estrogênio superiores a 0,035 mg de etinilestradiol ou 0,05 mg de mestranol.

Efeitos na menstruação :

• Aumento da regularidade do ciclo menstrual
• Diminuição da perda de sangue e diminuição da incidência de anemia por deficiência de ferro
• Diminuição da incidência de dismenorreia

Efeitos relacionados à inibição da ovulação :

• Diminuição da incidência de cistos ovarianos funcionais
• Diminuição da incidência de gestações ectópicas

Efeitos do uso a longo prazo :

• Diminuição da incidência de fibroadenomas e doença fibrocística da mama
• Diminuição da incidência de doença inflamatória pélvica aguda
• Diminuição da incidência de câncer endometrial
• Diminuição da incidência de câncer de ovário

Os contraceptivos orais combinados agem pela supressão de gonadotrofinas. Embora o mecanismo primário dessa ação seja a inibição da ovulação, outras alterações incluem alterações no muco cervical (que aumentam a dificuldade de entrada de espermatozóides no útero) e no endométrio (que reduzem a probabilidade de implantação).

OVCON® 50 (comprimidos de noretindrona e etinilestradiol, USP) é disponível em regimes de 28 dias. Cada embalagem contém 21 comprimidos redondos amarelos de 1,0 mg de noretindrona e 0,05 mg de etinilestradiol, impresso com WC de um lado e 585 no outro. Cada comprimido verde em forma de cápsula entra o regime de 28 dias contém ingredientes inertes e é impresso com WC de um lado e 850 no outro.

OVCON (comprimidos de noretindrona e etinilestradiol) ® 50, 28 dias

N 0430-0585-14 Caixa de 6 cartões blister (dispensadores)

Armazene abaixo de 30o C (86o F).

As referências estão disponíveis mediante solicitação.

Fabricado por: Warner Chilcott Company, Inc. Fajardo, PR 00738. Comercializado por: Warner Chilcott (EUA), Inc. Rockaway, NJ 07866. 1-800-521-8813. Revisado: julho de 2008. Data de revisão do FDA: 22/07/08