MARVELON 28 TB

Generic Name: desogestrel - ethinyl estradiol
Brand Name: Marvelon
Drug class: Contraceptives

WHAT IS THE DOSAGE OF THIS MEDICATION?

Marvelon and its generic desogestrel/ethinyl estradiol are available in the strength of 0.15 mg/0.03 mg/21 day and 0.15 mg/0.03 mg/28 day tablets.

WHAT IS THIS MEDICATION USED FOR?

Desogestrel - ethinyl estradiol is an estrogen and progestin combination pill used for the prevention of pregnancy. It works by preventing ovulation (the release of an egg from an ovary) and causing changes in the mucus of the cervix that make it difficult for sperm to penetrate and for an egg to implant. It may also be taken to regulate the menstrual cycle.

21-day pack: Take one tablet daily for 21 days, then do not take any pills for 7 days, and then begin the next pack.

28-day pack: Take one tablet daily for 21 days, then take one "reminder" pill daily for 7 days, and then begin the next pack.

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.

It may be advisable to 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 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 back-up method of birth control, such as latex condoms and spermicidal foam or gel, until you can check with your doctor or clinic.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss pills at any time the risk of becoming pregnant increases. If you miss one 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 one 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 the pills.

If you start your pills on Sunday, and 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, keep taking one pill a day until Sunday. On Sunday, safely discard the rest of the pack and start a new pack that day. You may not have a menstrual period this month.

If you start your pills on Day 1, and you miss 2 pills in a row during the third week of your cycle, or 3 or more pills at anytime during your cycle, 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. 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.

WHO SHOULD NOT TAKE THIS MEDICATION

Do not use desogestrel - ethinyl estradiol if you:

• are allergic to desogestrel, ethinyl estradiol, or any ingredients of this medication

• are or may be pregnant

• have active liver disease

• 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 a tumour reliant on estrogen

• have, have had, or may have breast cancer

• have or have had signs of thrombosis (e.g., transient ischaemic attack, angina)

• have or have had benign or malignant liver tumors

• have or have had cerebrovascular disorders (e.g., stroke)

• have or have had coronary artery disease or valvular heart disease

• have or have had migraine with focal aura

• have or have had pancreatitis

• have or have had steroid-dependant jaundice, cholestatic jaundice, history of jaundice of pregnancy

• have or have had thrombophlebitis or thromboembolic disorders

• have presence of severe or multiple risk factors for thrombosis

• have diabetes with blood vessel complications (e.g., heart disease, eye disease, kidney disease, foot infections)

• have very high cholesterol or triglyceride levels

• have uncontrolled high blood pressure

• have undiagnosed abnormal vaginal bleeding

• are taking a hepatitis C treatment regimen that contains ombitasvir, paritaprevir,  and ritonavir with or without dasabuvir

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POTENTIAL INTERACTION WITH OTHER 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.

Inform your doctor 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.

The following medications could potentially interact with desogestrel - ethinyl estradiol:

• acitretin

• alpha agonists (e.g., clonidine, methyldopa)

• ampicillin

• anastrozole

• angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)

• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)

• antacids (use 2 hours before or after)

• anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)

• apixaban

• aprepitant

• ascorbic acid (Vitamin C)

• barbiturates (e.g., butalbital, pentobarbital phenobarbital)

• benzodiazepines (e.g., lorazepam, diazepam)

• beta-blockers (e.g., propranolol, metoprolol)

• bosentan

• caffeine

• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)

• celecoxib

• cholestyramine

• cobicistat

• colestipol

• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)

• cyclosporine

• dabigatran

• dacarbazine

• dabrafenib

• deferasirox

• dehydroepiandrosterone

• diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, rosiglitazone)

• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)

• dofetilide

• duloxetine

• estrogens (e.g., estradiol, conjugated/equine, esterified, estropipate)

• exemestane

• fluvoxamine

• hepatitis C antiviral combinations (e.g., ombitasvir/paritaprevir/ritonavir/dasabuvir, ombitasvir/paritaprevir/ritonavir)

• heparin

• hepatitis C protease inhibitors (e.g., dasabuvir, telaprevir)

• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)

• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)

• hyaluronidase

• lenalidomide

• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)

• melatonin

• mexiletine

• mifepristone

• mirtazapine

• mitotane

• modafinil

• mycophenolate

• nitrofurantoin

• penicillin

• prucalopride

• rasagiline

• retinoic acid medications (e.g., etretinate, isotretinoin)

• rifabutin

• rifampin

• rivaroxaban

• ropinirole

• St. John's wort

• seizure medications (e.g., carbamazepine, gabapentin, levetiracetam, phenytoin, topiramate)

• selegiline

• siltuximab

• tetracyclines

• thalidomide

• theophyllines (e.g., aminophylline, oxtriphylline, theophylline)

• thyroid replacements (e.g., dessicated thyroid, levothyroxine)

• tizanidine

• tranexamic acid

• tricyclic antidepressants (e.g., amitriptylline, clomipramine, desipramine, trimipramine)

• tocilizumab

• ulipristal

• ursodiol

• voriconazole

• warfarin

WHAT ARE THE SIDE EFFECTS OF 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.

Inform your doctor 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.

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.

This is not a complete list of possible side effects. If you notice other effects not listed, please contact your doctor or pharmacist.

Possible side effects include:

• abdominal cramping or bloating

• acne (usually less common after 3 months of treatment, and may improve if acne already exists)

• back pain

• breast pain, tenderness, or swelling

• diarrhea

• dizziness

• general feeling of being unwell

• headaches

• heartburn

• nausea

• painful menstrual cramps

• unusual tiredness or weakness

• vomiting

• weight gain or loss

• breast lumps (for women with a history of breast disease)

• changes in the uterine bleeding pattern during or between menstrual periods, such as:

  • breakthrough bleeding or spotting between periods

  • complete stop of menstrual bleeding for several months in a row, or stop of menstrual bleeding that only occurs sometimes

  • decreased bleeding during periods

  • prolonged bleeding during periods

• depression

• flu-like symptoms (sudden lack of energy, fever, cough, sore throat)

• headaches or migraines (for many users, headaches may lessen but for others, they may increase frequency or severity)

• increased blood pressure

• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)

• signs of  liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

• swelling, pain, or tenderness in upper abdominal area

• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)

• unusual swelling of the extremities

• vaginal infection with vaginal itching or irritation, or thick, white, or curd-like discharge

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