Levette Film-Coated Tablets

LEVETTE is used to prevent pregnancy by suppressing ovulation and thickening the cervical mucus. LEVETTE is also used in the management of dysfunctional or irregular periods and painful periods where birth control is also required.

Do not take LEVETTE: Do not take LEVETTE if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting LEVETTE. Your doctor may advise you to use a different type of contraceptive pill or an entirely different (non-hormonal) method of birth control.

• If you have (or have had in the past) venous thrombosis: deep vein thrombosis (formation of blood clots in the blood vessels of the leg); pulmonary embolism (formation of blood clots in the blood vessels of the lungs); or the formation of blood clots in other organs. See also the section “The contraceptive pill and thrombosis”.
• If you have (or have had in the past) arterial thrombosis (formation of blood clots in the arteries such as heart attack or a stroke). See also the section “The contraceptive pill and thrombosis”.
• If you have (or have had in the past) any illness which could lead to a heart attack (for example, angina pectoris which causes serious pain in the chest) or a stroke.
• If you have (or have had in the past) a stroke.
• If you suffer from high blood sugar (diabetes mellitus) with heart or circulatory problems.
• If you suffer from severe high blood pressure.
• If you have severe dyslipoproteinaemia (abnormal distribution of lipoproteins in the blood).
• If you have (or have ever had) a certain form of migraine (with focal neurological symptoms e.g. visual symptoms, speech difficulties, or weakness or numbness in any part of your body).
• If you have (or have had in the past) a liver illness or jaundice and your liver function is still not normal.
• If you have (or have ever had) a liver tumour (benign or malignant).
• If you have (or have ever had), or you suspect you have breast cancer or cancer of the genital organs.
• If you have vaginal bleeding and the cause is unknown.
• If you are pregnant or think you might be pregnant, or if you have had jaundice, itching, blistering skin or hearing problems with a previous pregnancy.
• If you are allergic to levonorgestrel or ethinylestradiol or any other ingredients in LEVETTE.
• If you have an inherited or acquired risk for thrombosis (formation of a blood clot in a blood vessel).
• If you do not have menstrual periods and the cause is not known.

If any of these conditions occur for the first time while using LEVETTE, stop taking it at once and consult your doctor. Use a barrier contraceptive measure (e.g. condoms) in the meantime. (See “Take special care with LEVETTE”).

Always take LEVETTE exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. Remember to take your medicine because missing tablets could reduce the effectiveness of LEVETTE. Each blister strip contains 21 active yellow tablets and 7 white placebo (inactive) tablets. The two differently coloured tablets of LEVETTE are arranged in order. Each blister strip contains 28 tablets in total. Take one tablet of LEVETTE every day, if necessary with a small amount of water. You should take the tablets every day around the same time.

Follow the direction of the arrows on the blister strip until you have taken all 28 tablets. Do not confuse the tablets: take a yellow tablet once per day for the first 21 days, and then one white tablet once per day for the last 7 days. Then you should start a new strip (21 yellow tablets and 7 white tablets). Consequently there is no tablet-free interval between strips. During the 7 days when you are taking the white placebo tablets (the placebo days), bleeding should begin (withdrawal bleeding). This usually starts on the 2nd to 4th day after the last yellow (active) tablet of LEVETTE. Once you have taken the last white tablet, you should start with the next pack (strip), whether your bleeding has stopped or not. If you use LEVETTE in this manner, you are protected against pregnancy also during the 7 days when you are taking a placebo tablet.

LEVETTE can have side effects. Not all side effects reported for LEVETTE are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LEVETTE, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happen, stop taking LEVETTE and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Hives or rash, itching.
• Collapse or fainting. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LEVETTE. You may need urgent medical attention or hospitalisation.

Stop taking LEVETTE and tell your doctor immediately if any of the following happens (see “Take special care with LEVETTE – The contraceptive pill and thrombosis”):

• Yellowing of the skin and whites of the eyes, also called jaundice.
• Severe pain and/or swelling in one of your legs, stomach and chest which may reach the left arm.
• Sudden breathlessness, cough without an obvious cause.
• Any unusual, severe or long-lasting headache or worsening of migraine.
• Partial or complete blindness or double vision.
• Difficulty speaking or inability to speak.
• Dizziness or fainting.
• Weakness, strange feeling or numbness in any part of the body.
• Sudden changes to your hearing, sense of smell or taste.
• Disturbances of movements, muscular rigidity or incoordination. These are all very serious side effects. They are all signs of a blood clot, heart attack or a stroke. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Vaginal inflammation (including fungal infection), manifested as itching, pain and/or discharge.
• Changes in appetite (increase or decrease), glucose intolerance, nausea, vomiting, stomach pain, diarrhea, colic, bloating, weight changes (increase or loss), fluid retention.
• Inflammation of the pancreas, manifested as severe stomach pain, nausea, fatigue, irritability, headache, or fast heartbeat.
• Mood swings including depression, change in sex drive, headache, nervousness, illusion or sense of whirling or spinning movements.
• Intolerance to contact lens, complete or partial loss of vision.
• Acne, skin patches and skin discolouration, hair loss, excessive hair growth in certain parts of the body.
• Bleeding, spotting, breast pain / tenderness, breast enlargement, breast discharge, changes in menstrual flow, painful periods, changes in cervix and vaginal discharge, lack of periods.
• Haemolytic uraemic syndrome, manifested as bloody diarrhea, stomach pain, pale skin, irritability, fatigue, fever, unexplained bruises or bleeding, decreased urination.
• Worsening of varicose veins (swollen and twisted veins under the skin), porphyria (metabolic disorder), worsening of abnormal involuntary movements in certain parts of the body.

The following side effects may be noticed when doing blood tests:

• Changes in lipid levels, reduction in folate levels, increased blood pressure, cancer tumors of the liver, gallstones.

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

Keep out of the reach and sight of children. Store at or below 30 °C. Keep blisters in the carton until required for use. Do not use LEVETTE after the expiry date which is stated on the blister strip and carton. Medicines should not be disposed in drains or sewerage systems (e.g. toilets). Return all unused medicines to your pharmacist. These measures will help to protect the environment.