LOLO TABS 28 TB

Generic Name: norethindrone acetate - ethinyl estradiol
Brand Name: Lolo
Drug class: Contraceptives

WHAT IS THE DOSAGE OF THIS MEDICATION?

Lolo is available in the strength of 1 mg/10 mcg, 28 day tablets.

WHAT IS THIS MEDICATION USED FOR?

Norethindrone acetate - ethinyl estradiol belongs to the class of medications called oral contraceptives (birth control pills). It is an estrogen (ethinyl estradiol) and progestin (norethindrone acetate) combination used to prevent pregnancy.

Norethindrone acetate - ethinyl estradiol works by preventing ovulation (the release of an egg from an ovary) and by causing changes in the mucus of the cervix which make it difficult for sperm to penetrate the egg and for an egg to implant in the wall of the uterus.

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.

This medication 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 this medication 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 this medication 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 this medication 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.

WHO SHOULD NOT TAKE THIS MEDICATION

Do not use 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

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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 norethindrone acetate - ethinyl estradiol:

• 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

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:

• 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

• cold or flu symptoms (e.g., cough, runny or stuffy nose, fever, sore throat)

• headache

• mood swings

• nausea

• painful menstrual cramps

• vomiting

• weight change

• abdominal or stomach pain (sudden, severe, or continuing)

• anxiety

• breast lumps

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

  • breakthrough bleeding or spotting between periods

  • complete stopping of menstrual bleeding that occurs over several months in a row

  • decreased bleeding during periods

  • prolonged bleeding at periods

  • stopping of menstrual bleeding that only occurs sometimes

• fluid retention (e.g., swelling of ankles, legs, wrists)

• increased blood pressure

• new or worsening migraines

• severe abdominal pain or tenderness

• 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)

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

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

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

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