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ethynodiol diacetate - ethinyl estradiol
This combination product contains two active medications: estrogen and progestin. It is used to prevent pregnancy. This medication works by preventing ovulation (the release of an egg from an ovary) and causing changes in the mucus of the cervix, which make it difficult for sperm to penetrate and for an egg to implant.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
Each white, circular, biconvex, film-coated tablet, 6 mm in diameter, impressed "SEARLE" over "930"on one side, contains 2 mg of ethynodiol diacetate and 0.03 mg of ethinyl estradiol. Inert peach-coloured tablets are impressed "SEARLE" on one side and "P" on the other. Nonmedicinal ingredients: active tablets: cornstarch, ethylcellulose, hydroxypropyl cellulose, lactose, magnesium stearate, polyvidone, sodium acid phosphate, sodium phosphate dibasic anhydrous, and titanium dioxide; placebo tablets: FD&C Yellow No. 6 Lake, lactose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
21-day pack: One tablet daily for 21 days, followed by no pills for 7 days, then repeat the cycle.
28-day pack: One tablet daily for 21 days, followed by one "reminder" pill daily for 7 days, then repeat the cycle.
Talk with your doctor about the best time to start your pills. The first day of your menstrual period (bleeding) is known as "Day 1." Your doctor may have you start your pills on the first Sunday after your period starts, or on Day 1 of your period. The pills should be taken approximately the same time every day. Use a second method of birth control (e.g., latex condoms and spermicidal foam or gel) for the first 7 days of the first cycle of pill use. Many women have spotting or light bleeding or may feel sick to their stomach during the first 3 months of taking the pill. If you do feel sick, do not stop taking the pill. The problem will usually go away. If it does not go away, check with your doctor or clinic.
If you have vomiting or diarrhea, or if you take some medications such as antibiotics, your pills may not work as well. If you start a new medication while you are taking birth control pills, check with your doctor or pharmacist to make sure that it will not reduce the effectiveness of the pills. Use a backup method of birth control, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.
It is very important that you take this medication exactly as prescribed by your doctor. If you miss your pills at any time, the risk of becoming pregnant increases. If you miss 1 pill, take it as soon as you remember, and take the next pill at the usual time. This means that you might take 2 pills in one day.
If you miss 2 pills in a row during the first 2 weeks of your cycle, take 2 pills the day you remember and 2 pills the next day, then take 1 pill a day until you finish the pack. Use a second method of birth control if you have sex in the 7 days after you miss any pills.
If you miss 2 pills in a row during the third week of your cycle or 3 or more pills in a row anytime in your cycle and you start your pills on Sunday, keep taking 1 pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. If you miss 2 pills in a row during the third week of your cycle or 3 or more pills at anytime during your cycle and you start your pills on Day 1, safely dispose of the rest of the pill pack and start a new pack that same day. Use another method of birth control if you have sex in the 7 days after you miss the pills. You may not have a period this month. If you miss 2 periods in a row, call your doctor or clinic.
Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not take this medication if you:
- are allergic to ethynodiol diacetate, ethinyl estradiol, or any ingredients of the medication
- are or may be pregnant
- are a heavy smoker (more than 15 cigarettes per day) and are over age 35 years
- are planning to have surgery or have another condition that prevents regular mobility
- have uncontrolled high blood pressure
- have active liver disease
- have or have had pancreatitis associated with high triglycerides
- have any eye lesion resulting from vascular disease of the eye, such as partial or complete loss of vision or defect in visual fields
- have had a heart attack
- have, have had, or may have an estrogen-dependent tumour (such as breast or endometrial cancer)
- have or have had migraine with focal aura
- have diabetes with blood vessel complications (e.g., heart disease, eye disease, kidney disease, foot infections)
- have, have had, or may have breast cancer
- have or have had benign or malignant liver tumours
- have or have had cerebrovascular disorders (e.g., stroke)
- have presence of severe or multiple risk factors for thrombosis
- have or have had coronary artery disease or valvular heart disease with complications or irregular heart rhythm
- have or have had thrombophlebitis or thromboembolic disorders
- have undiagnosed abnormal vaginal bleeding
- have very high cholesterol or triglyceride levels
- are taking a combination medication to treat hepatitis C that contains dasabuvir, ombitasvir, paritaprevir with or without ribavirin
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal cramping or bloating
- acne (usually less common after 3 months of treatment, and may improve if acne already exists)
- breast pain, tenderness, or swelling
- brown, blotchy spots on exposed skin
- gain or loss of body or facial hair
- increased or decreased interest in sexual intercourse
- increased sensitivity of skin to sunlight
- swelling of the ankles and feet
- unusual tiredness or weakness
- weight gain or loss
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- changes in the uterine bleeding pattern during or between periods, such as:
- decreased bleeding during the period
- breakthrough bleeding or spotting between periods
- complete stopping of menstrual bleeding that occurs over several months in a row
- prolonged bleeding during the period
- stopping of menstrual bleeding that only occurs sometimes
- for women who smoke tobacco:
- pains in stomach, side, or abdomen
- yellow eyes or skin
- for women with a history of breast disease
- lumps in breast
- for women with diabetes
- mild increase in blood sugar - faintness, nausea, pale skin, or sweating
- headaches or migraines (although for many users, headaches may lessen, for others, they may increase in frequency or worsen)
- increased blood pressure
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- skin rash
- symptoms of liver problems (e.g., swelling, pain, or tenderness or lump in upper abdominal area, yellowing of eyes or skin, skin itching) swelling, pain, or tenderness in upper abdominal area
- unusual swelling of the hands and feet
- vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge
- vision changes
Stop taking the medication and seek immediate medical attention if any of the following occur:
- abdominal or stomach pain (sudden, severe, or continuing)
- headache (severe or sudden)
- signs of blood clots (e.g., coughing up blood; pains in chest, groin, or leg – especially in calf of leg)
- signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
- shortness of breath (sudden or unexplained)
- sudden or complete loss of vision
- swelling of the face, hands, feet, or airways
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Blood clots: As with any hormonal contraceptives, there is a risk of developing blood clots. Tell your doctor if you have a history of blood clots or are at risk of developing blood clots. Let your doctor know if you are planning an upcoming surgery or if you will be immobilized or inactive for a prolonged period of time, as there is an increased risk of blood clot formation when using oral contraceptives.
If you experience crushing chest pain or heaviness, pain in the calf, sudden shortness of breath, vision changes or speech changes, sudden severe headache, weakness or numbness in an arm or leg, or are coughing blood, get immediate medical attention as these symptoms could indicate a possible blood clot.
Blood pressure: If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
You may need to visit your doctor more frequently to have your blood pressure checked while using this medication. Occasionally, high blood pressure may develop with the use of hormonal contraceptives. This may require stopping this medication.
Breast cancer: Increasing age and a strong family history are the most significant risk factors for the development of breast cancer. Other established risk factors include obesity, not having had children, and a first full-term pregnancy at a late age. The identified groups of women that may be at increased risk of developing breast cancer before menopause are long-term users of birth control pills (more than 8 years) and women who started taking birth control pills at an early age. In a few women, the use of birth control pills may accelerate the growth of an existing but undiagnosed breast cancer.
If you are taking birth control pills, you should learn how to perform a breast self-examination. Notify your doctor any time a mass or lump is detected. A yearly clinical breast examination is also recommended because, if breast cancer should develop, medications that contain estrogen may cause a rapid progression.
Depression: Hormones, such as estrogen, have been known to cause mood swings and symptoms of depression. Women with a history of depression may find this medication makes the symptoms return or worsen. If you have a history of depression or other emotional problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.
Diabetes: Current low-dose birth control pills have very little affect on blood glucose control. People with diabetes and those with a family history of diabetes should monitor blood glucose closely to detect any worsening of blood glucose control after starting birth control pills.
Eye disorders: Women who are pregnant or are taking birth control pills may experience fluid buildup in the cornea of the eye causing visual disturbances and changes in tolerance to contact lenses, especially of the rigid type. Soft contact lenses usually do not cause disturbances. If visual changes or alterations in tolerance to contact lenses occur, you may be advised to stop wearing them temporarily or permanently.
Fibroids: This medication may worsen fibroids, causing sudden enlargement, pain, or tenderness. If you notice these symptoms, contact your doctor.
Heart disease: Cigarette smoking increases the risk of serious heart disease and death. Birth control pills add to this risk, especially with increasing age. Women over 35 years of age who are heavy smokers (more than 15 cigarettes per day) should not use the birth control pill. Other women who are at high risk for heart disease include those with diabetes, high blood pressure, abnormal cholesterol levels, or those with a family history of these. It is unclear whether taking birth control pills increases this risk.
For low-risk, non-smoking women of any age, the benefits of using low-dose birth control pills outweigh the possible heart disease risks.
Headache: Birth control pills may cause migraine symptoms to develop or become worse. If you have a history of migraine headache, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Gallbladder disease: If you use hormonal contraceptives you have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after 4 or 5 years of use. Talk to your doctor if you have any concerns.
Liver disease: Although uncommon, the use of hormonal contraceptives has been associated with liver problems, including liver tumours. See your doctor as soon as possible if you develop signs of liver problems such as yellow eyes or skin, abdominal pain, dark urine, pale stools, or itchy skin.
Regular checkups: Physical examinations and follow-up visits should be done yearly by your doctor.
Return to fertility: After stopping birth control pills, you should delay pregnancy until at least one normal, spontaneous cycle has occurred in order to date the pregnancy. An alternative birth control method (e.g., condoms) should be used during this time. If you do not menstruate for 6 months or more after stopping birth control pills, notify your doctor.
Sexually transmitted infections (STIs): Birth control pills do not protect against sexually transmitted infections, including HIV/AIDS. For protection against these, use latex condoms.
Surgery: If you have surgery planned, make sure all the health care professionals involved in your care are aware that you are taking this medication. Surgery may increase the risk of developing blood clots, particularly if you are not going to be able to get up and move around for a while. Your doctor may recommend stopping this medication for a time period before and after surgery.
Pregnancy: The hormones in birth control pills can affect the developing fetus if taken by a woman who is pregnant. If you become pregnant while taking birth control pills, contact your doctor.
Breast-feeding: It is not recommended to use birth control pills while breast-feeding. The hormonal components of the medication pass into breast milk and may reduce its quantity and quality. The long-term effects of this medication on the infant are not known.
Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.
There may be an interaction between ethynodiol diacetate - ethinyl estradiol and any of the following:
- barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
- benzodiazepines (e.g., lorazepam, diazepam)
- blood pressure lowering medications
- chloral hydrate
- cotrimoxazole (e.g., trimethoprim - sulfamethoxazole)
- corticosteroids (e.g., dexamethasone, prednisone, hydrocortisone)
- diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, rosiglitazone)
- hepatitis C antivirals (e.g., daclatasvir, dasabuvir, ledipasvir, paritaprevir, ombitasvir, sofosbuvir)
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- retinoic acid medications (e.g., etretinate, isotretinoin)
- St. John's wort
- seizure medications (e.g., carbamazepine, clobazam, , levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
- theophyllines (e.g., aminophylline, oxtryphylline, theophylline)
- thyroid replacements (e.g., dessicated thyroid, levothyroxine)
- tranexamic acid
- vitamin C
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Demulen-30
All material © 1996-2020 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.