Lolo - Consumer Medicine Information
|Condition:||Birth Control (Contraception), Contraception (Birth Control)|
|Ingredients:||norethindrone acetate, ethinyl estradiol, 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, acacia, lactose monohydrate, magnesium stearate, corn starch, sugar, talc and colours (FD&C Blue No.1, FD&C Red No.3, FD&C Red No. 40).|
About this medication
What the medication is used for:
- To prevent pregnancy
What it does:
LOLO is a birth control pill (combination oral contraceptive) that contains two female sex hormones: the progestin norethindrone acetate and the estrogen ethinyl estradiol. LOLO has been shown to be effective in preventing pregnancy when taken as prescribed by your doctor. Pregnancy is always more risky than taking birth control pills, except in smokers over 35.
Combination hormonal contraceptives work in two ways:
- They inhibit the monthly release of an egg by the ovaries.
- They change the mucus produced by the cervix. This slows the movement of the sperm through the mucus and through the uterus (womb).
The LOLO pill pack has 24 blue combination pills (with estrogen and progestin hormones) to be taken for 24 days, followed by 2 white estrogen-only pills, followed by 2 lilac placebo pills that do not contain hormone.
Effectiveness of LOLO
Based on the results of one clinical study, about 3 out of 100 women may get pregnant during the first year they use LOLO. The chance of becoming pregnant increases with incorrect use.
Women with a Body Mass Index (BMI) above 35 kg/m2 were not studied in the clinical trial, so it is not known how well LOLO protects against pregnancy in such women. If you are overweight (obese) discuss with your healthcare provider whether LOLO is the best choice for you.
Other Ways to Prevent Pregnancy
Other methods of birth control are available to you. They are usually less effective than birth control pills. Used properly, however, other methods of birth control are effective enough for many women.
The following table gives reported pregnancy rates for various forms of birth control, including no birth control. The reported rates represent the number of women out of 100 who would become pregnant in one year.
Reported Pregnancies per 100 Women per Year:
|Combination pill||less than 1 to 3*|
|Intrauterine device (IUD)||less than 1 to 6|
|Condom and spermicidal foam or gel||1 to 6|
|Mini-pill||3 to 6|
|Condom||2 to 12|
|Diaphragm with spermicidal foam or gel||3 to 18|
|Spermicide||3 to 21|
|Sponge with spermicide||3 to 28|
|Cervical cap with spermicide||5 to 18|
|Periodic abstinence (rhythm), all types||2 to 20|
|No birth control||60 to 85|
*Based on the results of one clinical study, about 3 out of 100 women may get pregnant during the first year they use LOLO.
Pregnancy rates vary widely because people differ in how carefully and regularly they use each method. (This does not apply to IUDs since they are implanted in the uterus.) Regular users may achieve pregnancy rates in the lower ranges. Others may expect pregnancy rates more in the middle ranges.
The effective use of birth control methods other than birth control pills and IUDs requires more effort than taking a single pill every day. It is an effort that many couples undertake successfully.
When it should not be used:
The birth control pill is not suitable for every woman. In a small number of women, serious side effects may occur. Your doctor can advise you if you have any conditions that would pose a risk to you. The use of the birth control pill always should be supervised by your doctor. You should not use LOLO if you have or have had any of the following conditions:
- blood clot in the legs, lungs, eyes or elsewhere, or thrombophlebitis (inflammation of the veins).
- stroke, heart attack or coronary artery disease (e.g. angina pectoris) or a condition that may be a first sign of stroke (such as transient ischemic attack or small reversible stroke).
- disease of the heart valves with complications
- severe high blood pressure
- diabetes with complications
- known abnormalities of the blood clotting system that increases your risk for developing blood clots
- very high blood cholesterol or triglyceride levels
- over age 35 and smoke
- migraine headaches
- you are scheduled for major surgery
- prolonged bed rest
- jaundice (yellowing of the eyes or skin), liver disease or liver tumour
- known or suspected cancer of the breast or uterus (womb) or other estrogen-dependant cancer
- unusual vaginal bleeding without a known reason
- loss of vision due to blood vessel disease of the eye
- you are pregnant or suspect you may be pregnant
- pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in your blood
- allergy (hypersensitivity) to ethinyl estradiol, norethindrone acetate or to any of the other ingredients in LOLO (see What the medicinal ingredients are and What the non- medicinal ingredients are).
Tell your doctor if you have ever had any of the above conditions (your doctor can recommend another method of birth control).
What the medicinal ingredients are:
Norethindrone acetate and ethinyl estradiol
What the non-medicinal ingredients are:
Non-medicinal ingredients for the blue tablets and white tablets include: 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.
Ingredients for lilac placebo tablets include: Acacia, lactose monohydrate, magnesium stearate, corn starch, sugar, talc and colours (FD&C Blue No.1, FD&C Red No.3, FD&C Red No. 40).
What dosage forms it comes in:
LOLO (norethindrone acetate and ethinyl estradiol, and ethinyl estradiol) tablets are available in a 28-day regimen.
Each blister pack contains 24 blue, 2 white and 2 lilac tablets. Each blue tablet contains 1.0 mg norethindrone acetate, and 0.010 mg ethinyl estradiol. Each white tablet contains 0.010 mg ethinyl estradiol. The lilac placebo tablets do not contain any active ingredients.
Warnings and precautions
|Serious Warnings and Precautions
Cigarette smoking increases the risk of serious cardiovascular side effects (heart and blood vessels problems) associated with the use of hormonal contraceptives. This risk increases with age, particularly in women over 35 years of age, and the number of cigarettes smoked. For this reason, LOLO should not be used by women who are over 35 years of age and smoke.
Birth control pills DO NOT PROTECT against sexually transmitted infections (STIs), including HIV/AIDS. For protection against STIs, it is advisable to use latex or polyurethane condoms IN COMBINATION WITH birth control pills.
BEFORE you use LOLO, talk to your doctor or pharmacist if you:
- are overweight
- have a history of breast disease (e.g. breast lumps) or family history of breast cancer
- have high blood pressure
- have high cholesterol
- have diabetes
- have heart or kidney disease
- have a history of seizures/epilepsy
- have a history of depression
- have a history of liver disease or jaundice
- wear contact lenses
- have uterine fibroid tumours (benign tumours of the uterus)
- may be pregnant or are breast feeding
- have systemic lupus erythematosus
- have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
- have haemolytic uremic syndrome
- have sickle cell disease
- have problems with the valves in your heart and/or have an irregular heart rhythm
- have been told that you have a condition called hereditary angioedema or if you have had episodes of swelling in body parts such as hands, feet, face or airway passages
You should also inform your doctor about a family history of blood clots, heart attacks and strokes.
If you see a different doctor, inform him or her that you are using LOLO.
Tell your doctor if you are scheduled for any laboratory tests since certain blood tests may be affected by hormonal contraceptives.
Also tell your doctor if you are scheduled for MAJOR surgery. You should consult your doctor about stopping the use of LOLO four weeks before surgery and not using LOLO for a time period after surgery or during bed rest.
LOLO should be used only under the supervision of a doctor, with regular follow-up to identify side effects associated with its use. Your visits may include a blood pressure check, a breast exam and a pelvic exam, including a Pap smear. Visit your doctor three months or sooner after the initial examination. Afterward, visit your doctor at least once a year. Use LOLO only on the advice of your doctor and carefully follow all directions given to you. You must use the birth control pill exactly as prescribed. Otherwise, you may become pregnant.
If you and your doctor decide that, for you, the benefits of LOLO outweigh the risks, you should be aware of the following:
THE RISKS OF USING LOLO
The information contained in this section is principally from studies carried out in women who used combination oral contraceptives with higher doses of hormones than those in common use today. The effect of long-term use of combination hormonal contraceptives with lower doses of both estrogen and progestin administered orally remains to be determined.
- Circulatory disorders (including blood clot in legs, lungs, heart, eyes or brain)
Women who use hormonal contraceptives have a higher incidence of blood clots. Blood clots are the most common serious side effects of birth control pills. The risk of developing clots is highest during the first year a woman uses a hormonal contraceptive. Clots may occur in many areas of the body.
Be alert for the following symptoms and signs of serious adverse effects. Call your doctor immediately if they occur:
- Sharp pain in the chest, coughing blood, or sudden shortness of breath. These symptoms could indicate a possible blood clot in the lung.
- Pain and/or swelling in the calf. These symptoms could indicate a possible blood clot in the leg.
- Crushing chest pain or heaviness. These symptoms could indicate a possible heart attack.
- Sudden severe or worsening headache or vomiting, dizziness or fainting, disturbance of vision or speech, or weakness or numbness in an arm or leg. These symptoms could indicate a possible stroke.
- Sudden partial or complete loss of vision. This symptom could indicate a possible blood clot in the eye.
- Other signs of a blood clot can include sudden pain, swelling and slight blue discoloration of an extremity.
Any of these conditions can cause death or disability. Clots also occur rarely in the blood vessels of the eye, resulting in blindness or impaired vision or in a blood vessel leading to an arm or leg, resulting in damage to or loss of a limb.
The risk of clotting seems to increase with higher estrogen doses. It is important, therefore, to use as low a dosage of estrogen as possible.
- 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.
If you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.
Some women who use hormonal contraceptives may be at increased risk of developing breast cancer before menopause, which occurs around age 50. These women may be long-term users of birth control pills (more than eight years) or women who start 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. Chronic infection with the Human Papilloma Virus (HPV) is believed to be the most important risk factor for cervical cancer. However, there is insufficient evidence to rule out the possibility that oral contraceptives may cause such cancers.
- Liver tumours
The short and long-term use of birth control pills also has been linked with the growth of liver tumours or liver injury (e.g., hepatitis, abnormal hepatic function). Such injury or tumours are extremely rare.
Contact your doctor immediately if you experience severe pain or a lump in the abdomen.
- Gallbladder disease
Users of birth control pills have a greater risk of developing gallbladder disease requiring surgery within the first year of use. The risk may double after four or five years of use.
- Use in pregnancy
Birth control pills should not be taken by pregnant women. They will not prevent the pregnancy from continuing. There is no evidence, however, that the birth control pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.
- Use after pregnancy, miscarriage or an abortion
Your doctor will advise you of the appropriate time to start the use of LOLO after childbirth, miscarriage or therapeutic abortion.
- Pregnancy after stopping LOLO
You will have a menstrual period when you stop using LOLO. You should delay pregnancy until another menstrual period occurs within four to six weeks. In this way, the pregnancy can be more accurately dated. Contact your doctor for recommendations on alternate methods of contraception during this time.
- Use while breast feeding
If you are breast-feeding, consult your doctor before starting the birth control pill. These hormones may decrease the flow of breast milk. If birth control pills are not resumed until nursing is established, however, the quantity and quality of breast milk does not seem to be affected. Adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. You should use another method of contraception. The use of oral contraceptives is generally not recommended until the nursing mother has completely weaned her child.
ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS OF REGULAR SELF-EXAMINATION OF YOUR BREASTS.
Interactions with this medication
Certain drugs may interact with birth control pills and prevent them from working properly making them less effective in preventing pregnancy or causing unexpected bleeding (spotting or breakthrough bleeding). Please inform your doctor or pharmacist if you are taking or have recently taken any other medications or herbal products, even those without a prescription. Also tell any doctor or dentist (or the dispensing pharmacist) who prescribes another medicine that you use LOLO. They can tell you if you need to use an additional method of contraception and if so, for how long.
Drugs that may interact with LOLO include:
- drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
- drugs used for the treatment of tuberculosis (e.g., rifampicin, rifabutin)
- drugs used for treatment of HIV infections (e.g., ritonavir)
- drugs used for Hepatitis C virus (HCV) (e.g., boceprevir, telaprevir)
- antibiotics (e.g., penicillins, tetracyclines, metronidazole) for infectious diseases
- antifungals (e.g. griseofulvin)
- cholesterol lowering agents (e.g. clofibrate)
- anti-coagulants (blood thinners)
- the herbal remedy St. John’s wort
- antihypertensive drugs (for high blood pressure)
- antidiabetic drugs and insulin (for diabetes)
- sedatives and hypnotics (e.g. benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate)
- pain medication (meperidine)
- antidepressants (e.g. clomipramine)
- other drugs such as phenylbutazone, antihistamines, analgesics, antimigraine preparations, Vitamin E and Vitamin B12
- antacids (use 2 hours before or after taking LOLO)
LOLO may also interfere with the working of other drugs. This is not a complete list of possible drug interactions with LOLO. Talk to your doctor for more information about drug interactions.
Proper use of this medication
BEFORE YOU START TAKING YOUR PILLS:
- BE SURE TO READ THESE DIRECTIONS:
- Before you start taking your pills
- Anytime you are not sure what to do
- LOOK AT YOUR PILL PACK: LOLO contains 24 "active" BLUE pills (with progestin and estrogen hormones) for weeks 1, 2, 3 and the first part of week 4, 2 WHITE estrogen only pills, and 2 "reminder" LILAC pills (without hormones) for the last part of week 4.
- Also, CHECK the pill pack for: 1) where to start taking pills and 2) in what order to take the pills (follow the arrows in the diagram).
- You should use a second method of birth control (e.g. latex or polyurethane condoms and spermicidal foam or gel) for the first seven days of the first cycle of pill use. This will provide a back-up in case pills are forgotten while you are getting used to taking them.
- When receiving any medical treatment, be sure to tell your doctor that you are using birth control pills.
- MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH WHILE TAKING THE FIRST 1 to 3 PACKS OF PILLS. If you have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. This type of bleeding is usually transient and without significance. The problem will usually go away. If it doesn't go away, check with your healthcare provider.
- MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even if you take these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
- TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
- IF YOU HAVE VOMITING OR DIARRHEA (within 3 to 4 hours after you take your pill) or IF YOU TAKE CERTAIN MEDICINES, including some antibiotics, or the herbal supplement St. John’s wort, your pills may not work as well. Use a back-up method of birth control (such as latex or polyurethane condoms or spermicide) until you check with your healthcare provider.
- IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.
- THERE IS NO NEED TO STOP TAKING BIRTH IMPORTANT: CONTROL PILLS FOR A REST PERIOD
- IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your healthcare provider.
WHEN TO START THE FIRST PACK OF PILLS
You have a choice of which day to start taking your first pack of pills. Decide with your healthcare provider which is the best day for you to start. Pick a time of day that will be easy to remember. It is important to take it at about the same time every day.
- Pick the day label strip that starts with the first day of your period. (This is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins.)
- Place this day label strip on the top edge of the tablet dispenser over the area that has “Place Day Label Here” printed on the plastic. Having the dispenser labelled with the days of the week will help remind you to take your pill every day.
- THE FIRST DAY OF YOUR MENSTRUAL PERIOD (BLEEDING) IS DAY 1 OF YOUR CYCLE. Your doctor may advise you to start taking the pills on Day 1 or on the first Sunday after your period begins. If your period starts on Sunday, start that same day.
- LOLO is effective from the first day of therapy if the tablets are begun on the first day of the menstrual cycle (1st day of period). If you start any day other than the day your period begins, use another method of birth control as a back-up method if you have sex anytime for the next 7 days. Latex or polyurethane condoms or spermicide are good back-up methods of birth control.
- Take one pill at approximately the same time every day for 28 days. Begin a new pack the next day, NOT MISSING ANY DAYS.
WHEN YOU SWITCH FROM A DIFFERENT METHOD OF HORMONAL CONTRACEPTION
- When you switch from another birth control pill, start LOLO on the first day you would have started your previous birth control pack.
- When you switch from a vaginal ring or skin patch, finish the 21 days of use, and wait 7 days after removal of the ring or patch before starting LOLO.
- When you switch from a progestin-only pill, you should start LOLO the next day.
- When you switch from an implant or injectable contraceptive, you should start LOLO on the day of implant removal or, if using an injectable contraceptive, the day on which the next injection would be due.
- If you switch from an IUD, discuss with your healthcare provider when to start LOLO.
WHAT TO DO DURING THE MONTH
- TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often.
- WHEN YOU FINISH A PACK OF YOUR LOLO Start the next pack on the day after your last lilac "reminder" pill. Do not wait any days between packs. It is not uncommon to miss your period. However, if you have been having regular periods and then do not have a period for 2 cycles or longer, it is possible that you may be pregnant. You should speak to your doctor.
Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, vomiting and withdrawal bleeding in women.
|In case of overdosage, contact your healthcare provider, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms.|
Birth control pills may not be as effective if you miss any blue or white pills, and particularly if you miss the first few or the last few blue pills in a pack. The following chart outlines the actions you should take if you miss one or more birth control pills. Match the number of pills missed with the appropriate starting time for your type of pill pack. If you miss one or more active pills and do not have a period that month, you may be pregnant, so you should speak to your doctor.
|Sunday Start||Day 1 Start|
|Miss 1 blue Pill||Miss 1 blue 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.|
|Miss 2 blue pills in a row in Week 1 or Week 2 of your pack||Miss 2 blue pills in a row in Week 1 or Week 2 of your pack|
|Miss 2 pills (blue or white) in a row in Week 3 or Week 4 of your pack||Miss 2 pills (blue or white) in a row in Week 3 or Week 4 of your pack|
If you miss 2 periods in a row, call your doctor or clinic.
If you miss 2 periods in a row, call your doctor or clinic.
|Miss 3 or more pills (blue or white) in a row at any time||Miss 3 or more pills (blue or white) in a row at any time|
|If you miss 2 periods in a row, call your doctor or clinic.|
If you forget either of the 2 lilac “reminder” pills in Week 4, follow these steps:
- Throw away the pills you missed.
- Keep taking one pill each day until the pack is empty.
- You do not need to use a BACK-UP METHOD of birth control.
If you are not sure what to do about the pills you have missed:
- Use a BACK-UP METHOD of birth control anytime you have sex.
- KEEP TAKING ONE ACTIVE (blue or white, depending on the day) PILL EACH DAY until you can reach your healthcare provider.
Always be sure you have on hand:
- non-hormonal back-up method of birth control (e.g. latex or polyurethane condoms and spermicidal foam or gel) in case you miss pills, and
- an extra, full pack of pills.
IF YOU FORGET MORE THAN ONE PILL TWO MONTHS IN A ROW, TALK TO YOUR DOCTOR OR CLINIC about ways to make pill-taking easier or about using another method of birth control.
Non-contraceptive benefits of Combined Hormonal Contraceptives
Several health advantages have been linked to the use of hormonal contraceptives.
- Reduction in the incidence of cancer of the uterus and ovaries
- Reduction in the likelihood of developing benign (noncancerous) breast disease and ovarian cysts.
- Less menstrual blood loss and more regular cycles. The risk of developing iron-deficiency anemia is thus reduced.
- There may be a decrease in painful menstruation and premenstrual syndrome (PMS).
- Acne, excessive hair growth and male-hormone- related disorders also may be improved.
- Ectopic (tubal) pregnancy may occur less frequently
- Acute pelvic inflammatory disease may occur less frequently.
Side effects and what to do about them
Most women do not develop serious and unpleasant side effects from using birth control pills. The most common side effects seen when using LOLO are similar to those seen with other birth control pills and include:
- metrorrhagia (irregular menstrual bleeding)
- breast tenderness
- dysmenorrhea (painful menstrual cramps)
- weight change
- mood swings
In addition, the following side effects have been observed in women taking combination hormonal contraceptives in general, including LOLO:
- Upper respiratory tract infection (bronchitis, runny or stuffy nose, sore throat, etc.)
- Urinary tract infection
- HPV (Human papilloma virus)
- Abnormal cervical (Pap) smear
- Fungal infection
- Abdominal pain
- Vaginal infection
Serious side effects, how often they happen and what to do about them
|Symptom / effect||Talk with your doctor or pharma-cist||Stop taking drug and call your doctor or pharmacist|
|Sharp chest pain, coughing of blood, or sudden shortness of breath||√|
|Pain in the calf||√|
|Crushing chest pain or heaviness in the chest||√|
|Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg||√|
|Sudden partial or complete loss of vision||√|
|Severe pain or tenderness in the stomach area||√|
|Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood||√|
|Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark-coloured urine, or light-coloured bowel movements||√|
|Unexpected (abnormal) vaginal bleeding||√|
|Unusual swelling of the extremities||√|
This is not a complete list of side effects. For any unexpected effects while taking LOLO, contact your doctor or pharmacist.
How to store it
- Keep LOLO and all other medications out of the reach of children.
- Keep the tablets in their original package and store at controlled room temperature (20o-25oC).
- Do not keep medicine that is out of date or that you no longer need.
|REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at:
or by contacting the sponsor, Warner Chilcott Canada Co., at: 1-800-565-0814.