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SYNPHASIC.Pdf IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION • You take other medications that may interact with SYNPHASIC Pr SYNPHASIC* (Norethindrone and Ethinyl Estradiol Other Ways to Prevent Pregnancy Tablets) Other methods of birth control are available to you. They are usually less effective than birth This leaflet is part III of a three-part control pills. However, when used properly, "Product Monograph" published when they are effective enough for many women. SYNPHASIC was approved for sale in The following table gives reported pregnancy Canada and is designed specifically for rates for various forms of birth control, including Consumers. This leaflet is a summary and will no birth control. The reported rates represent the not tell you everything about SYNPHASIC. number of women out of 100 who would become Contact your doctor or pharmacist if you pregnant in one year. have any questions about the drug. Reported Pregnancies per 100 Women per Year ABOUT THIS MEDICATION Combination pill less than 1 to What the medication is used for: 2 SYNPHASIC is used for the prevention of Intrauterine system (IUS) less than 1 to pregnancy. 6 What it does: Condom with spermicidal 1 to 6 SYNPHASIC is a birth control pill (oral foam or gel contraceptive) that contains two female sex Mini-pill (progesterone-only 3 to 6 hormones (ethinyl estradiol and norethindrone). pill) SYNPHASIC has been shown to be highly Condom 2 to 12 effective in preventing pregnancy when taken as Diaphragm with spermicidal 3 to 18 prescribed by your doctor. Pregnancy is always foam or gel more risky than taking birth control pills, except Spermicide 3 to 21 in smokers over 35. The chance of becoming 3 to 28 pregnant increases with incorrect use. Sponge with spermicide 5 to 18 Birth control pills work by inhibiting the Cervical cap with monthly release of an egg(s) by the ovaries. spermicide Some studies have demonstrated changes in 2 to 20 the endometrium (lining of the womb) and Periodic abstinence mucus produced by the cervix (opening of the (rhythm), all types uterus) with the use of birth control pills. 60 to 85 No birth control Effectiveness of Birth Control Pills Combination birth control pills (like Pregnancy rates vary widely because people SYNPHASIC) are more than 99 percent differ in how carefully and regularly they use effective in preventing pregnancy when: each method. (This does not apply to IUSs since they are implanted in the uterus.) Regular users The pill is TAKEN AS DIRECTED, and may achieve pregnancy rates in the lower ranges. The amount of estrogen is 20 micrograms Others may expect pregnancy rates more in the or more. middle ranges. A 99 percent effectiveness rate means that if 100 The effective use of birth control methods other women used birth control pills for one year, one than birth control pills and IUSs requires more woman in the group would get pregnant. effort than taking a single pill every day. It is an effort that many couples undertake successfully. Birth control pills may become less effective When it should not be used: when: The birth control pill is not suitable for every • You miss taking tablets woman. In a small number of women, serious • You have vomiting or diarrhea side effects may occur. Your doctor can advise you if you have any conditions that would pose a 31 IMPORTANT: PLEASE READ risk to you. The use of the birth control pill Prolonged bed rest, or immobility (e.g.: always should be supervised by your doctor. long air travel) Have varicose veins Do not use SYNPHASIC if you have any of the Need a leg cast following: Have not yet started to menstruate History of or actual thrombophlebitis Are in menopause (inflammation of the veins) or Are using medicines to treat Hepatitis C thromboembolic disorders., such as blood which contain combination of ombitasvir, clots in the legs, lungs, eyes, or elsewhere. paritaprevir, ritonavir and dasabuvir., with History of or actual cerebrovascular or without ribavirin. disorders, such as a stroke or a condition that may be a first sign of stroke (e.g. mini- What the medicinal ingredient is: stroke). The medicinal ingredients are: norethindrone and History of or actual myocardial infarction ethinyl estradiol or coronary arterial disease, heart attack or chest pain (e.g. angina pectoris). What the important nonmedicinal ingredients Jaundice or active liver disease, or history are: of or actual benign or malignant liver Active tablets: corn starch, FD & C Blue No. 2 tumours. (0.5 mg/ 0.035mg (35 mcg) tablets only), lactose History of or known or suspected hydrous, polyvidone, magnesium stearate. carcinoma of the breast or sex organs. Inactive tablets: FD & C Yellow No. 6 Lake, History of or known or suspected tumours lactose, lactose monohydrate, magnesium associated with estrogen containing stearate, microcrystalline cellulose. products. Undiagnosed abnormal vaginal bleeding. What dosage forms it comes in: Loss of vision due to blood vessel disease 21 day dispensers (9 (1.0 mg/ 0.035 mg (35 of the eye. mcg)) active tablets and 12 (0.5 mg/ 0.035 mg When pregnancy is suspected or diagnosed. (35 mcg)) active tablets). Disease of the heart valves with complications 28 day dispensers (9 (1.0 mg/0.035 mg (35 Irregular heart rhythm mcg)) active tablets and 12 (0.5 mg/0.035 mg Migraines with visual and/or sensory (35 mcg)) active tablets and 7 inactive tablets). disturbances. You may be at increased risk of having a stroke. Norethindrone 1.0 mg/ethinyl estradiol 0.035 mg Diabetes affecting you circulation (35 mcg) active tablets: White circular tablets, impressed "SEARLE" on one side and "BX" on Severe or uncontrolled high blood pressure the other. History of or actual pancreatitis (inflammation of the pancreas) associated Norethindrone 0.5 mg/ethinyl estradiol 0.035 mg with high levels of fatty substances in your (35 mcg)active tablets: Blue circular tablets, blood. impressed "SEARLE" on one side and "BX" on Allergic reaction to norethindrone, ethinyl the other. estradiol or to any other ingredients in SYNPHASIC (see What the important Inactive tablets: orange tablets, impressed nonmedicinal ingredients are) "SEARLE" on one side and "P"on the other. Known abnormalities of the blood clotting system that increases your risk for developing blood clots WARNINGS AND PRECAUTIONS Very high blood cholesterol or triglyceride levels Heavy smoking (>15 cigarettes per day) and over age 35 You had an injury or trauma, or are scheduled for major surgery Severe obesity (body mass index of 30 or more) 32 IMPORTANT: PLEASE READ Serious Warnings and Precautions Overweight Systemic lupus erythematosus Cigarette smoking increases the risk of serious Inflammatory bowel disease such as adverse effects on the heart and blood vessels. Crohn’s disease or ulcerative colitis This risk increases with age and becomes Hemolytic uremic syndrome significant in OC- users over 35 years of age. Sickle cell disease You should not use birth control pills while Problems with the valves in your heart smoking. and/or have an irregular heart rhythm Have Hepatitis C Oral contraceptives do not protect against sexually transmitted infections (STIs) including If you detect any new masses on your breasts HIV/AIDS. For protection against STIs, it is while taking SYNPHASIC you should advise advisable to use latex condoms in combination your doctor. with oral contraceptives. If you have to undergo a major elective surgery, There are also conditions that your doctor will you should advise your surgeon that you are want to watch closely or that might cause your taking SYNPHASIC. You should consult your doctor to recommend a method of contraception doctor about stopping the use of SYNPHASIC other than birth control pills. four weeks before surgery and not use SYNPHASIC for a time period after surgery or If you see a different doctor, inform him or during bed rest. her that you are taking SYNPHASIC. Tell your doctor if you are scheduled for any BEFORE you use SYNPHASIC talk to your laboratory tests since certain blood tests may be doctor or pharmacist if: affected by hormonal contraceptives. Pregnant or breastfeeding History of jaundice or other liver SYNPHASIC should be used only under the disease supervision of a doctor, with regular follow-up to High blood pressure identify side effects associated with its use. Your Migraines and headaches visits may include a blood pressure check, a breast exam, an abdominal exam and a pelvic Diabetes or family history of diabetes exam, including a Pap smear. Visit your doctor Wear contact lenses three months or sooner after the initial Family history of breast disease (e.g. examination. Afterward, visit your doctor at least breast lumps) or a family history of once a year. Use SYNPHASIC only on the breast cancer advice of your doctor and carefully follow all Fibroid tumours on the uterus directions given to you. You must use the birth History of emotional disorders, control pill exactly as prescribed. Otherwise, you especially depression may become pregnant. Metabolic or endocrine diseases and abnormal metabolism of calcium and Breakthrough bleeding/spotting may occur while phosphorus you are taking an oral contraceptive, especially Rheumatoid arthritis or synovitis during the first three months of use. If this Hereditary or history of angioedema bleeding persists or recurs, you should advise (episodes of swelling in body parts such your doctor. Women with history of amenorrhea as hands, feet, face, or airway passage) (absence of menstrual periods) or Abnormal level of fat in the blood oligomenorrhea (irregular or infrequent stream (high cholesterol or menstrual periods) may remain anovulatory or triglycerides) become amenorrheic following discontinuation Smoke cigarettes of oral contraceptives. Heart or kidney disease Epilepsy/seizures The Risks of Using Birth Control Pills Gallbladder or pancreatic disease Family history of blood clots, heart 1.
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