Linessa

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 Linessa 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause nausea or, rarely, vomiting; it could cause water retention and swelling; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun; it may cause your breasts to feel swollen and tender; it may affect your appetite. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Linessa 21
Each 21-day treatment cycle pack consists of 3 active dosing phases: 7 light yellow, coated, round tablets, with "TR" above "0" on one side and "Organon*" on the other side, contains 0.100 mg of desogestrel and 0.025 mg of ethinyl estradiol; 7 orange, coated, round tablets, with "TR" above "0" on one side and "Organon*" on the other side, contains 0.125 mg of desogestrel and 0.025 mg of ethinyl estradiol; and 7 red, coated, round tablets, with "TR" above "0" on one side and "Organon*" on the other side, contains 0.150 mg of desogestrel and 0.025 mg of ethinyl estradiol. Nonmedicinal ingredients: hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, pregelatinized starch, red ferric oxide (in orange and red tablets), stearic acid, talc, titanium dioxide, vitamin E, and yellow ferric oxide (in light yellow and orange tablets).

Linessa 28
Each 28-day treatment cycle pack consists of 3 active dosing phases: 7 light yellow, coated, round tablets, with "TR" above "0" on one side and "Organon*" on the other side, contains 0.100 mg of desogestrel and 0.025 mg of ethinyl estradiol; 7 orange, coated, round tablets, with "TR" above "0" on one side and "Organon*" on the other side, contains 0.125 mg of desogestrel and 0.025 mg of ethinyl estradiol; and 7 red, coated, round tablets, with "TR" above "0" on one side and "Organon*" on the other side, contains 0.150 mg of desogestrel and 0.025 mg of ethinyl estradiol.

The pack also contains 7 green, round tablets, debossed with "KH" above "2" on one side and "Organon*" on the other side, with the following Nonmedicinal ingredients: lactose monohydrate, corn starch, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, FD&C Blue No. 2 Aluminum Lake, yellow ferric oxide, and talc.

Do not take Linessa if you:

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

There may be an interaction between desogestrel - ethinyl estradiol and any of the following:

• 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

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 Linessa. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications 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.

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 Linessa.

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 (i.e., due to accident or illness), 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 Linessa may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Linessa, and whether any special monitoring is needed.

You may need to visit your doctor more frequently to have your blood pressure checked while using Linessa. Occasionally, high blood pressure may develop with the use of hormonal contraceptives. This may require stopping Linessa.

Breast cancer: The most significant risk factors for breast cancer are increasing age and a strong history of breast cancer in the family (mother or sister). Other established risk factors include Obesity, never having children, and having your first full-term pregnancy at a late age.

Some women who use birth control pills may be at increased risk of developing breast cancer before Menopause. These women may be long-term users of birth control pills (more than 8 years) or women who started using 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. Early diagnosis, however, can reduce the effect of breast cancer on a woman's life expectancy. The potential risks related to birth control pills seem to be small; however, a yearly breast examination is recommended for all women.

Cervical cancer: Some studies have found an increase of cancer of the cervix in women who use hormonal contraceptives, although this finding may be related to factors other than the use of oral contraceptives. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.

Chronic infection with the human papillomavirus (HPV) is believed to be the most important risk factor for cervical cancer. Women who use combination oral contraceptives (COCs) for a long time may have a slightly higher chance of getting cervical cancer. This finding may not be caused by the contraceptive itself but may be related to sexual behavior and other factors.

Cigarette smoking and heart disease: Cigarette smoking is known to increase the risk of serious heart disease and death. Birth control pills also increase this risk, particularly as a woman gets older. Women over 35 years of age who are heavy smokers (more than 15 cigarettes per day) should not use the birth control pill.

All women are urged not to smoke while taking Linessa. Other factors that increase your risk of heart disease include diabetes, high blood pressure, high cholesterol levels, or a family history of these conditions. It is unclear whether taking the birth control pill increases this risk.

For women who have a low risk of heart disease and do not smoke, the benefits of using low-dose birth control pills outweigh the possible risks of heart disease, regardless of age. These women may continue to use birth control pills up to the age of menopause.

Decreased Effectiveness: The effectiveness of desogestrel – ethinyl estradiol may be decreased as a result of missing doses, conditions that cause digestive tract disturbances such as diarrhea, or other drug interactions that decrease the amount of desogestrel – ethinyl estradiol in the bloodstream.

Depression: Women with a history of depression may find Linessa makes the symptoms return or worsen. If you have a history of depression or other emotional problems, discuss with your doctor how Linessa may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Linessa, and whether any special monitoring is needed.

If you have a history of depression or other emotional problems you may be more likely to have a recurrence while taking oral birth control medications.

Diabetes: If you have diabetes, or have a family history of diabetes, discuss with your doctor how Linessa may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Linessa, and whether any special monitoring is needed.

If you have diabetes, it may be necessary to test your blood sugar more often to detect any worsening of blood sugar control after starting birth control pills.

Eye disorders: Women who are taking birth control pills may experience fluid buildup in the cornea of the eye that may cause vision changes. This fluid buildup may also mean that your contact lenses may not fit as well as they used to, especially if you have hard contact lenses. Soft contact lenses usually do not cause problems. If your contact lenses feel uncomfortable, talk to your eye doctor.

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.

Return to fertility: After stopping birth control therapy, you should delay pregnancy until at least one normal spontaneous menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method should be used during this time. If you do not menstruate for 6 months or more after stopping birth control pills, notify your doctor.

Serious warnings and precautions: The use of oral contraceptive pills is associated with increased risk of several serious conditions including myocardial infarction (heart attack), thromboembolism (blood clot that breaks loose and travels to another part of the body), stroke, liver cancer, and gallbladder disease, although the risk of serious morbidity and mortality is small in healthy women without underlying risk factors.

Sexually transmitted infections (STIs): Birth control pills do not protect against HIV/AIDS and other sexually transmitted infections (STIs; formerly known as sexually transmitted diseases or STDs). It is recommended that latex condoms be used in combination with Linessa to protect against these infections.

Surgery: If you are having scheduled surgery in the near future, make sure you let all the doctors involved in your care know that you are taking Linessa. Being immobile for a period of time, such as when you are recovering from surgery, may increase your risk of developing a blood clot. Your doctor may want you to stop taking Linessa for a short time before your surgery and while you are recovering.

Pregnancy: Linessa should not be used during pregnancy. If you become pregnant while taking Linessa, or think that you may be pregnant, contact your doctor as soon as possible.

Breast-feeding: The hormones in Linessa pass into breast milk. These hormones may reduce the quantity and quality of the breast milk. Breast-feeding women should use another form of birth control until they are no longer breast-feeding. Talk to your doctor about your options.

Children: The safety and effectiveness of using Linessa have not been established for children less than 18 years of age.

To ensure effectiveness, this medication should be taken at the same time each day. It may be taken with or without food.<br/><br/>Birth control pills are dispensed in specific packaging. It is important to follow the sequence of tablets. Always start a new pack at the set date.<br/><br/>If you forget a pill, take it as soon as you remember and then continue to take one pill every day as usual. If you are more than 24 hours late in taking your pill, contact your pharmacist. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects.