Lolo

Take 1 blue tablet daily for 24 days, then 1 white tablet daily for 2 days then 1 lilac-coloured tablet daily for 2 days. The blue tablets contain both norethindrone acetate and ethinyl estradiol, the white tablets contains ethinyl estradiol only and the lilac tablet contains no active medication.

Lolo can be taken with food or on an empty stomach. For it to be most effective, it needs to be taken at the same time every day. 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.

It is 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, if you choose to start taking Lolo on the first Sunday after your period starts.

Many women have spotting or light bleeding or may feel nauseous 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 experience vomiting or Diarrhea, or if you take certain medications (such as antibiotics), your pills may not work as well. Use a backup method, 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 very important to take Lolo exactly as prescribed by your doctor. If you miss pills at any time, the risk of becoming pregnant increases. If you vomit or have diarrhea within 3 to 4 hours after taking a blue or a white pill, follow the instructions for missing 1 pill.

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 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 miss 2 pills in a row during the 3rd or 4th 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 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 period this month. If you miss 2 periods in a row, call your doctor or clinic.

If you miss 2 pills in a row during the 3rd or 4th week of your cycle or 3 or more pills at any time 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.

If you forget to take either of the two lilac (no active medication) pills on the last 2 days of Week 4, discard the pill(s) you have missed and keep taking one pill each day until the pack is empty. Start a new pack the following day.

If you are not sure what to do after missing pills, contact your doctor or pharmacist for advice.

Store Lolo at room temperature, protect it from light and 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.

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.

Each blue, round tablet contains 1 mg of norethindrone acetate and 10 µg of ethinyl estradiol and is imprinted with "WC" on one side and "421" on the other. Each white, hexagonal tablet contains 10 µg of ethinyl estradiol and is imprinted with "WC" on one side and "422" on the other side. Nonmedicinal ingredients: lactose monohydrate, mannitol, microcrystalline cellulose, magnesium stearate, povidone, sodium starch glycolate, and vitamin E. The blue tablets also contain FD&C Blue No. 1 Aluminum Lake.

Do not take norethindrone acetate - ethinyl estradiol if you:

• are allergic to norethindrone acetate, to ethinyl estradiol, or any ingredients of the medication
• are or may be pregnant
• have eye damage resulting from blood vessel disease of the eye, such as a partial or complete loss of vision
• have had a Heart Attack or Coronary Artery Disease, including Angina or a ministroke
• have or may have Breast Cancer
• have migraine Headaches
• have or have had pancreatitis (inflammation of the pancreas) as a result of high levels of triglycerides
• have heart valve disease with complications
• have liver disease
• have multiple risk factors for a blood clot, such as:
  • Diabetes with blood vessel damage
  • smoking tobacco products and age over 35
  • inherited blood clotting problems
  • major surgery
  • prolonged bed rest
  • severe high blood pressure (blood pressure of 160/100 or higher)
  • uncontrolled high blood pressure
  • High Cholesterol or triglycerides
• have or have had cancerous or non-cancerous liver tumours
• have had decreased liver function because of pregnancy or taking corticosteroid medication
• have or have had cerebrovascular disorders (e.g., Stroke)
• have or have had Thrombophlebitis or thromboembolic disorders (blood clotting problems)
• have a history of Blood Clots
• have or may have a tumour dependent on estrogen
• have undiagnosed abnormal vaginal bleeding
• are taking certain medications for the treatment of Hepatitis C

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

• ampicillin
• Anastrozole
• anticoagulants (e.g., Dalteparin, Enoxaparin, Heparin, Warfarin, Apixaban, dabigatran, Rivaroxaban)
• antihypertensive medications (medications that are used to treat high blood pressure)
• antiseizure medications (e.g., Carbamazepine, Clobazam, Lamotrigine, Levetiracetam, Phenobarbital, Phenytoin, primidone, Topiramate, Valproic acid, zonisamide)
• Aprepitant
• barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
• benzodiazepines (e.g., Diazepam, Lorazepam)
• Bosentan
• caffeine
• chloral hydrate
• Cholestyramine
• clofibrate
• Clomipramine
• Clonidine
• Cobicistat
• Colestipol
• corticosteroids (e.g., Hydrocortisone, Prednisone)
• cotrimoxazole
• Cyclosporine
• Dabrafenib
• dehydroepiandrosterone
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Diltiazem
• Dronedarone
• elvitegravir
• Flibanserin
• grapefruit juice
• hepatitis C antivirals (e.g., glecaprevir and pibrentasvir, ledipasvir, sofosbuvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Lomitapide
• lumacaftor and Ivacaftor
• mifepristone
• Mitotane
• Modafinil
• mycophenolate
• Nitrofurantoin
• Octreotide
• other estrogens
• penicillin
• Pomalidomide
• retinoic acid medications (e.g., acitretin, etretinate, Isotretinoin)
• rifabutin
• rifampin
• St. John's wort
• Sarilumab
• saw palmetto
• soybean
• sulfonamides (e.g., sulfamethoxazole)
• tetracyclines (e.g., Minocycline, Tetracycline)
• theophyllines (e.g., Aminophylline, Oxtriphylline, Theophylline)
• Tizanidine
• Tocilizumab
• Tranexamic acid
• Ulipristal

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 Lolo. 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 Lolo.

Blood clots: Lolo may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how Lolo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lolo, and whether any special monitoring is needed.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Blood pressure: If you have high blood pressure, discuss with your doctor how Lolo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lolo, and whether any special monitoring is needed.

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

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 late age at first full-term pregnancy. The identified groups of women that may be at increased risk of developing breast cancer before Menopause are women who have used birth control pills for more than 8 years or who started using them at an early age. For 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, learn how to perform a breast self-examination. Notify your doctor any time you detect a lump. A yearly clinical breast examination is also recommended because, if breast cancer develops, medications that contain estrogen may cause it to grow quickly.

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.

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 may not be caused by the contraceptive itself but may be related to sexual behavior and other factors.

Cholesterol: Blood cholesterol or triglyceride levels may increase while taking Lolo. People with cholesterol problems should discuss with their doctor how Lolo may affect their medical condition, and whether any special monitoring is needed.

Depression: Hormones, such as estrogen, have been known to cause mood swings and symptoms of depression. If you have had clinical depression in the past, you may be more likely to experience it again while taking Lolo. If you have depression or a history of depression, discuss with your doctor how Lolo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lolo, 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 Lolo, contact your doctor as soon as possible.

Diabetes: Current low-dose birth control pills have very little effect on blood glucose control. If you have diabetes or a family history of diabetes, your doctor may want you to monitor your blood glucose closely to detect any worsening of blood sugar control after starting birth control pills.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Lolo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lolo, and whether any special monitoring is needed.

Eyes: Women who are pregnant or who take birth control pills may experience fluid build-up in the cornea of the eye, which may cause visual disturbances and changes in tolerance to contact lenses, especially rigid contact lenses. Women who wear soft contact lenses usually do not experience difficulties. If you experience visual changes or alterations in tolerance to contact lenses, you may need to stop wearing the lenses temporarily or permanently.

Rarely, blood clots may form in the blood vessels in the eye, causing vision loss. Report any vision changes to your doctor immediately.

Fibroids: If you have fibroids (leiomyomata), your doctor should closely monitor your condition. If sudden enlargement, pain, or tenderness occurs, contact your doctor to see if you need to stop taking the medication.

Gallbladder disease: Women who use birth control pills have a greater risk of developing gallbladder disease. If you notice severe pain in the abdomen (stomach area), fever, or yellowing of skin or eyes (jaundice), contact your doctor immediately.

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 Lolo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lolo, and whether any special monitoring is needed.

Heart disease: Cigarette smoking increases the risk of serious heart disease and death. Taking birth control pills increases this risk, especially with increasing age. Studies show evidence that women who smoke and are over 35 years old should not use birth control pills.

Other women who have a high risk for heart disease include those with diabetes, high blood pressure, or abnormal cholesterol levels, or those with a family history of these conditions. Whether taking birth control pills increases this risk is unclear.

For low-risk, non-smoking women of any age, the benefits of birth control pill use outweigh the possible cardiovascular risks of low-dose pills.

Liver function: If you have reduced liver function or have had liver problems, discuss with your doctor how Lolo may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Lolo, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Lolo.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Regular check-ups: You should have a yearly physical examination and follow-up visit with your doctor.

Return to fertility: After stopping birth control therapy, you should delay pregnancy until at least one normal menstrual 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: 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 Lolo. 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.

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 Lolo, contact your doctor immediately.

Breast-feeding: The use of birth control pills while breast-feeding is not recommended. The hormonal components of the medication pass into breast milk and may reduce the quantity and quality of the breast milk. The long-term effects on the developing child are not known.

To ensure effectiveness, this medication should be taken at the same time each day. It may be taken with or without food.

Birth control pills are dispensed in specific packaging. It is important to follow the sequence of tablets and take all the pills which are in the packaging. Always start a new pack at the set date.

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.