Lexilev 0,15 mg/0,03 mg Film-Coated Tablets

LEXILEV is a combined oral contraceptive, one of a group of medicines often referred to as the Pill. It contains two types of hormones: an estrogen, ethinylestradiol, and a progestogen, levonorgestrel. These hormones stop you from getting pregnant by working in three ways: by preventing an egg being released from your ovaries; by making the fluid (mucus) in your cervix thicker, which makes it more difficult for sperm to enter the womb; and by preventing the lining of your womb thickening enough for an egg to grow in it. LEXILEV is used for the prevention of pregnancy (oral contraception). Sometimes it is also prescribed for the control of cases of dysfunctional bleeding in the womb and in the symptomatic treatment of primary painful menstruation where contraception is also desired.

Do not take LEXILEV: You should not use LEXILEV if you have any of the conditions listed below. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.

• if you are hypersensitive (allergic) to levonorgestrel, ethinylestradiol or any of the other ingredients of LEXILEV (see section 6)
• if you have a recurring condition in which the flow of bile from the liver stops or slows, or if you have liver function problems
• if you have or suspect you have breast cancer, ovarian cancer, cervical cancer, cancer of the womb or any other cancer related to the reproductive system
• if you, or anyone in your family have ever had breast cancer
• if you have inherited genetic mutations: BRCA1 and BRCA2 genes, as you have a higher risk of developing cancer
• early menstrual periods (before the age of 12 years)
• if you have ever had other non-cancerous breast diseases such as atypical hyperplasia (a precancerous condition that affects cells in the breast) or lobular carcinoma in situ (abnormal cells growing in the lining of the milk glands)
• if you have ever had treatment using radiation therapy to the chest or breast
• if you have ever been exposed to diethylstilbestrol (DES), a synthetic estrogen medicine
• if you have (or ever had) a condition in which a blood clot in a vein causes inflammation and pain, or blood clotting disorders
• if you have severe migraine, or a history of migraine called ‘migraine with aura’
• if you have damage or disease in the heart's major blood vessels
• if you experience unexplained vaginal bleeding
• if you have ever had liver tumours
• if you have ever had a severe liver disease, and you have been told by your doctor that your liver function test results are not yet back to normal
• if you have active liver disease
• if you suffer with depression that is not well controlled, or if you previously suffered depression a side effect when taking any other contraceptives
• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolism, PE) or other organs
• if you know you have a disorder affecting your blood clotting, for instance protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden, antiphospholipid antibodies or an inherited disorder that makes your blood more likely to clot
• if you need an operation or if you are off your feet for a long time
• if you have had a heart attack or a stroke
• if you have, or previously suffered from, angina (severe chest pain that may be the first sign of a heart attack (shortness of breath, nausea, fatigue)) or a transient ischaemic attack (sudden onset of slurred speech, weakness, numbness or paralysis in your face, arm or leg, typically on one side of your body)
• if you suffer from certain forms of migraine which are associated with focal neurological symptoms (such as weakness, speech, vision or hearing problems)
• if you have any of the following diseases that may increase your risk of a clot in the arteries:
• severe diabetes with blood vessel damage
• high blood pressure
• a high level of fat in the blood (cholesterol or triglycerides)
• if you are also taking medicines containing ritonavir, ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir and ofosbuvir/velpatasvir/voxilaprevir
• if you are or suspect you might be pregnant (see Pregnancy, breastfeeding and fertility).

Warnings and precautions

It is important that you understand the benefits and risks of taking LEXILEV before you start taking it, or when deciding whether to carry on taking it. Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet. Your doctor will ask about you and your family’s medical problems, check your blood pressure and exclude the likelihood of you being pregnant. You may also need other checks, such as a breast examination, but only if these examinations are necessary for you, or if you have any special concerns.

UNDER NO CIRCUMSTANCES SHOULD YOU STOP TAKING LEXILEV WITHOUT HAVING ADOPTED A SATISFACTORY ALTERNATIVE METHOD OF CONTRACEPTION.

CIGARETTE SMOKING

CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR SIDE EFFECTS FROM THE USE OF ORAL CONTRACEPTIVES. THE RISK INCREASES WITH AGE AND WITH HEAVY SMOKING (15 OR MORE CIGARETTES PER DAY) AND IS QUITE MARKED IN WOMEN OVER 35 YEARS OF AGE. YOU ARE THEREFORE STRONGLY ADVISED TO STOP SMOKING.

Do not share medicines prescribed for you with any other person. Always take/use LEXILEV exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Take LEXILEV every day for 28 days. LEXILEV comes in strips of 28 pills. There are 21 active yellow tablets, and 7 inactive white tablets.

• take your pill at the same time every day, no longer than 24 hours apart, preferably after the evening meal or at bedtime
• swallow each pill whole, with water if necessary. Do not chew the pill
• if it is the first time you take LEXILEV, take one yellow tablet daily for 21 uninterrupted days, beginning on Day 1 of your menstrual cycle, i.e. the first day of bleeding
• one white inactive tablet is taken daily for the next 7 continuous days
• withdrawal bleeding should usually occur 2 to 4 days after the last yellow tablet is taken
• during this first cycle, an alternative method of contraception, such as a condom, should be used together with LEXILEV until 14 tablets have been taken. If the tablets are begun after Day 5 of your menstrual cycle, or after giving birth, it must be considered that ovulation and conception may have occurred before the tablets were started.

Then start your next strip. The next and all the following courses will begin on the day after the last package was completed, even if withdrawal bleeding has not occurred or is still in progress. Each course of LEXILEV is therefore begun on the same day of the week and follows the same schedule (21 days of yellow tablets, 7 days of white inactive tablets) as the first course.

Changing to LEXILEV from another contraceptive Pill: If you are changing from another oral contraceptive product to LEXILEV, start LEXILEV on the day you would usually start a new package of the other product. During the first LEXILEV cycle, an alternative method of contraception, such as a condom, should be used until 14 uninterrupted tablets have been taken. If temporary spotting or breakthrough bleeding occurs, continue the treatment since such bleeding is usually without significance. If the bleeding is persistent or prolonged, contact your doctor.

• If you are currently taking a 21-day Pill or a 28-day Pill: start LEXILEV the next day after the end of the previous strip.
• Or, if you are taking a progestogen-only Pill (POP or mini Pill): start LEXILEV on the first day of bleeding, even if you have already taken the progestogen-only Pill for that day. The remaining progestogen-only tablets should be discarded.

Starting LEXILEV after a miscarriage or abortion: If you have had a miscarriage or an abortion during the first three months of pregnancy, your doctor may tell you to start taking LEXILEV straight away. Discuss this with your healthcare provider.

If you have had a miscarriage or an abortion after the third month of pregnancy, ask your doctor for advice. You may need to use extra contraception, such as condoms, for a short time.

Contraception after having a baby: If you have just had a baby, your doctor may advise you that LEXILEV should be started 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom, until you start LEXILEV and for the first 7 days of pill taking.

If you are sick or have diarrhoea: If you are sick (vomit) or have very bad diarrhoea within 4 hours of taking LEXILEV, your body may not get its usual dose of hormones from that tablet. Take another tablet and continue with the pack. Talk to your doctor if your stomach upset carries on or gets worse. Your doctor may recommend another form of contraception.

Missed a period - could you be pregnant? Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the pharmacy. If you are pregnant, stop taking LEXILEV and see your doctor.

When you want to get pregnant: If you are planning a baby, it’s best to use another method of contraception after stopping LEXILEV until you have had a proper period. Your doctor relies on the date of your last natural period to tell you when your baby is due.

If you have missed a LEXILEV tablet, see If you forget to take LEXILEV.

If you have the impression that the effect of LEXILEV is too strong or too weak, tell your doctor or pharmacist.

If you take more LEXILEV than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. Symptoms of overdose may include: It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or have some vaginal bleeding.

If you forget to take LEXILEV: Always take LEXILEV as prescribed.

Take a missed yellow tablet as soon as you remember. If two consecutive yellow tablets are missed, they should both be taken as soon as you remember. In either case, the next tablet should be taken at its usual time. Each time you miss one or two consecutive yellow tablets, a mechanical method of contraception, such as a condom, should be supplemented until 14 consecutive daily tablets have been taken or until the package is finished if less than 14 yellow tablets remain. If you miss one or more white placebo tablets, you are still protected against pregnancy, provided you begin the yellow tablets on the proper day. If three consecutive yellow tablets are missed, LEXILEV should be discontinued and the remainder of the package discarded. A new package should be started on the eighth day after the last tablet was taken. A mechanical method of contraception, such as a condom, should be used until 14 consecutive daily tablets have been taken. If withdrawal bleeding does not occur and LEXILEV has been taken according to directions, it is unlikely that you could be pregnant. Begin a second course of LEXILEV on the usual day. If bleeding does not occur at the end of this second cycle, you should not take LEXILEV until you are certain that you are not pregnant, by consulting your doctor and having a pregnancy test done. If you have missed one or more yellow tablets or started taking them on a day later than recommended, the probability of pregnancy should be considered at the time of the first missed period before LEXILEV is restarted.

LEXILEV can have side effects. Not all side effects reported for LEXILEV are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using LEXILEV, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop using LEXILEV and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LEXILEV. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• liver tumours (with symptoms including severe abdominal pain and tenderness and in some cases internal bleeding), breast cancer and cervical cancer
• deep vein thrombosis (DVT) which include swelling of one leg or along a vein in the leg or foot especially when accompanied by: pain or tenderness in the leg which may be felt only when standing or walking, increased warmth in the affected leg, change in colour of the skin on the leg e.g. turning pale, red or blue
• pulmonary embolism includes sudden unexplained breathlessness or rapid breathing, sudden cough without an obvious cause, which may bring up blood, sharp chest pain which may increase with deep breathing, severe light headedness or dizziness, rapid or irregular heartbeat, severe pain in your stomach. If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’)
• stroke with symptoms including sudden weakness or numbness of the face, arm or leg, especially on one side of the body, sudden confusion, trouble speaking or understanding, loss of consciousness or fainting with or without seizure
• blood clots blocking other blood vessels causing swelling and slight blue discolouration of an extremity, severe pain in your abdomen
• heart attack (chest pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest, arm or below the breastbone, extreme weakness, anxiety, or shortness of breath, rapid or irregular heartbeats
• inflammation of the pancreas (pancreatitis)
• liver function disturbances
• systemic lupus erythematosus (SLE), an inflammatory disease caused when the immune system attacks its own tissues. SLE can affect the joints, skin, kidneys, blood cells, brain, heart and lungs.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• vaginal infection (vaginitis, vaginal candidiasis)
• depressed mood, altered mood, nervousness, decreased or increased libido
• headache, migraine
• nausea (feeling sick), abdominal pain, vomiting (being sick)
• acne
• breast pain, breast tenderness, spotting, break-through bleeding, enlarged breast, breast secretions
• increase or decrease in weight.

Less frequent side effects:

• a high level of a certain type of fat (triglycerides) in the blood, changes in appetite
• dizziness
• changes in corneal curvature (steepening), intolerance to contact lenses, cataracts, retinal vein thrombosis (a blockage of the small veins that carry blood away from the retina)
• increase in blood pressure
• diarrhoea, vomiting (being sick), chronic, abdominal cramps, bloating, gastrointestinal irritation
• gallbladder disease, a condition in which the flow of bile from the liver stops or slows, exacerbation of existing disease
• rash, skin inflammation located in a part of the fatty layer of skin causing reddish, painful, tender lumps, erythema multiforme, brown patches on the face (melasma) which may be persistent, skin pigmentation
• vaginal discharge, change in cervical erosion or cervical secretion, premenstrual-like syndrome
• fluid retention/swelling
• changes in blood fat levels.

The following side effects have been reported but the frequency for them to occur is not known:

• exacerbation of chorea (movement disorder)
• aggravation of varicose veins
• porphyria
• Crohn’s disease, vomiting (being sick), chronic, inflammatory bowel disease that causes inflammation in the digestive tract
• unwanted male-pattern hair growth on a woman's face, chest and back, loss of scalp hair, haemorrhagic eruption, chloasma (pigmentation disorder of the skin characterized by darker skin patches primarily affecting the face and other sun-exposed areas)
• chronic bladder health issue, low red blood cells, acute kidney failure, and low platelets
• suicidal thoughts/behaviour and suicide
• reduced menstrual flow, missed withdrawal bleeding, post pill amenorrhoea

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 ºC. Keep blister in the outer carton. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).