Do not take Leonore:

• if you have (or have ever had) a blood clot in a blood vessel of your legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs

• if you know you have a disorder affecting your blood clotting 

• if you need an operation or if you are off your feet for a long time

• if you have ever had a heart attack or a stroke

• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack

 if you have any of the following diseases that may increase your risk of a clot in the arteries:

1. severe diabetes with blood vessel damage
2. very high blood pressure
3. a very high level of fat in the blood (cholesterol or triglycerides) ο a condition known as hyperhomocysteinaemia

• if you have (or have ever had) a type of migraine called ‘migraine with aura’

• if you have (or have ever had) a liver disease and your liver function is still not normal

• if you have (or have ever had) a tumour in the liver

• if you have (or have ever had) or if you are suspected of having breast cancer or cancer of the genital organs

• if you have any unexplained bleeding from the vagina

• in missed period if the cause is undiagnosed

• if you are allergic to ethinylestradiol, levonorgestrel or any of the other ingredients of this medicine

Do not use Leonore if you have hepatitis C and are taking the medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir.

Additional information on special populations

Seek urgent medical attention

• if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke.

Tell your doctor if any of the following conditions apply to you:

• persistently elevated blood pressure values

• diabetes (diabetes mellitus)

• jaundice and/or itching due to bile stasis

• gallstones

• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)

• depressive mood

• epilepsy

• migraines.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Leonore increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood vessels and cause serious problems. Blood clots can develop

• in veins (referred to as a ‘venous thrombosis’)

• in arteries (referred to as an ‘arterial thrombosis')

It is important to remember that the overall risk of a harmful blood clot due to Leonore is small.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• Retinal vein thrombosis (blood clot in the eye)
• Heart attack
• Blood clots blocking other blood vessels

   Are you experiencing any of these signs?

• sudden weakness or numbness of the face, arm or leg, especially on one side of the body
• sudden confusion, trouble speaking or understanding
• sudden trouble seeing in one or both eyes
• sudden trouble walking, dizziness, loss of balance or coordination
• sudden, severe or prolonged headache with no known cause
• loss of consciousness or fainting with or without seizure.

Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.

    Stroke

Before you start taking Leonore, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure, and depending on your personal situation, may also carry out some other tests.

In this leaflet, several situations are described where you should stop using Leonore or where the reliability of Leonore may be decreased. In such situations, you should either not have sex or you should use other, non- hormonal contraceptive methods such as condoms. Do not use calendar or temperature methods. These methods can be unreliable because Leonore alters the monthly changes of body temperature and of the cervical mucus.

As with all oral ‘pills’ Levonorgestrel/Ethinylestradiol does not protect at all from a HIV infection, also called AIDS, or other sexually transmitted diseases.

• The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive.

• If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT).

• If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism.

• Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?

The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.

After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.

When you stop Leonore your risk of a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Leonore is small.

• Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.

• Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel such as Leonore, about 5-7 will develop a blood clot in a year.

• The risk of having a blood clot will vary according to your personal medical history.

‘Pill’ and cancer

Breast cancer is somewhat more frequently diagnosed in women taking the ‘pill’ than in women of the same age who do not practice birth control with the ‘pill’. After discontinuation of the ‘pill’, breast cancer figures slowly become more alike again, and after 10 years, there is no difference ascertainable between former ‘pill users’ and other women.

As breast cancer is relatively low in women below 40 years of age, the number of additional cases of breast cancer in previous or current users of the ‘pill’ is small in comparison with the overall risk of breast cancer.

It is important, that all women, in particular those over 35 years of age, have regular breast examinations while taking Leonore. You should contact your doctor if you feel any lump.

In rare cases, benign liver tumours and, even more rarely, malignant liver tumours were diagnosed in ‘pill’ users. In some few cases, these tumours led to life-threatening inner bleeding. If you suddenly develop severe abdominal pain, you must consult your doctor without delay.

Cancer of the cervix has somewhat more frequently been reported in women taking the ‘pill’ over a long-term period. However, there continues to be controversy to which extent sexual behaviour and other factors such as human papilloma virus contribute to this finding.

Reduced efficacy

The contraceptive effect can be reduced due to forgetting to take the ‘pill’, vomiting, bowel diseases with severe diarrhoea or using together with other medicines.

Irregular bleeding

All ‘pills’ can lead to irregular bleeding (spotting or breakthrough bleeding), particularly in the first months. Spotting and breakthrough bleeding were observed in half the users during the first 6 intake cycles. Please consult your doctor if this irregular bleeding continues to occur after 3 months.

No withdrawal bleeding may occur in some users in the intake-free interval. If you have taken correctly all the tablets, pregnancy is improbable. However if the pill was not taken as prescribed prior the first missing withdrawal bleeding or the withdrawal bleeding has not appeared already for the second time, you may be pregnant. Contact your doctor immediately. Do not start the next strip until a pregnancy has been excluded.

If you plan a pregnancy

Folic acid levels in the blood may decrease during use of the ‘pill’. Folic acid deficiency can lead to impaired development of brain and spinal cord (neural tube defects) in the unborn child. If you stop taking Leonore because you want to become pregnant, it is recommended that you eat food rich in folic acid (vegetables, fruit, wholemeal products) and that you take folic acid tablets before and after conception. Ask your doctor or pharmacist for a suitable preparation.

Other medicines and Leonore

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Also inform any doctor or dentist who prescribes other medicines (or the pharmacist) that you are taking Leonore. These can tell you if you need to use additional contraceptive precautions (e.g. condoms) and, if so, how long.

Some medicines can have an influence on the blood levels of Leonore and can make it less effective in preventing pregnancy, or can cause unexpected bleeding. These include:

Medicines for the treatment of:

  • 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’).

Leonore and other ‘pills’ can also influence the metabolism of other medicines.

The efficacy or tolerability of the following medicines may be impaired due to Levonorgestrel/Ethinylestradiol:

• ciclosporin, a medicine to suppress the immune system

• theophylline, a medicine for the treatment of asthma

• tizanidine (used to treat muscle pain and / or muscle cramps)

• cortinsone, used against e.g. inflammations

• certain tranquillizers, which active substance most ends with benzodiazepines

• lamotrigine, a certain medicine against epilepsy

• clofibrate, a medicine used to lower blood lipids

• paracetamol, a certain medicine against pain and fever

• morphine, a certain medicine against very severe pain

• troleandomycin, a medicine to treat bacterial infections. The concomitant

use of the “pill” and the antibiotic troleandomycin can increase the risk of biliary thrombus.

Please take note of the information provided in the package leaflets of any other prescribed medicines.

In women with diabetes, the need for blood sugar-lowering agents (e.g. insulin) may be changed.

Do not use Leonore if you are pregnant.

Pregnancy must be excluded before starting Leonore. If pregnancy occurs during use, you must stop taking Leonore immediately and consult your doctor.

Breast-feeding

You should not use Leonore when breast-feeding, as the quantity of milk can be reduced and the composition of the milk changed. Small amounts of the active substances and/or their degradation products can pass into mother’s milk.

Driving and using machines

No special precautionary measures are necessary.

Leonore contains lactose and sucrose

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose or sucrose), contact your doctor before taking this medicinal product.

How to take Leonore

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by the doctor, the recommended dose is 1 tablet daily.

Always take the tablets at about the same time of the day, if necessary with 1 glass of water. Further intake is in the direction of the arrow, according to the marked day of the week until all the 21 tablets have been taken.

Afterwards, do not take tablets for 7 days. Bleeding (withdrawal bleeding) should set in this interval, usually on day 2 or 3 after you have taken the last tablet.

If you forget to take Leonore

Time of intake exceeded by less than 12 hours:

Contraception of Leonore is still ensured. Immediately take the forgotten tablet. Afterwards, follow the usual rhythm of intake.

Time of intake exceeded by more than 12 hours:

Contraception is no longer ensured. The risk of unintentional pregnancy is particularly high if a tablet has been forgotten at the beginning or the end of the foil strip. In this case, proceed as described below.

− Only 1 tablet forgotten in week 1:

Take the missed tablet immediately even if you have to take 2 tablets

at the same time. Then continue intake as usual. However, further contraceptive measures such as condoms are necessary in the next 7 days. There is a risk of pregnancy, if you had had sexual intercourse in the week before forgetting the tablet. Immediately inform your doctor in this case.

− Only 1tablet forgotten inweek 2:

Take the missed tablet immediately even if you have to take 2 tablets at the same time. If the tablets have been taken correctly in the preceding 7 days, the contraceptive effect is ensured. No further protective measures are necessary. If this was not the case further contraceptive measures such as condoms are necessary in the next 7 days.

− Only1 tablet forgotten in week 3:

Only if you have taken the tablets correctly in the preceding 7 days and one of the two following possibilities is given, no further contraceptive measures are necessary. If this was not the case the first of these two options should be followed and further contraceptive measures such as condoms must be used for the next 7 days.

1. Immediately make up for the forgotten tablet even if you thus take 2 tablets at the same time. Take the next tablets as usual. Omit the intake-free break, and directly start taking the tablet from the next foil strip. A withdrawal bleeding will probably not occur, but spotting and breakthrough bleeding are possible during intake of the tablets from the second foil strip.

Or

2. Discontinue intake from the current foil strip immediately, and stop intake for a maximum of 7 days, including the forgotten day. Then start with the new foil strip as usual while it is possible that you shorten the intake-free break.

If no bleeding occurs in the intake-free break after you have forgotten Leonore, it may be possible that you are pregnant. Consult your doctor before starting with a new foil strip.

In case of vomiting or severe diarrhoea

If you vomit within 3-4 hours after taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip as soon as possible.

Serious side effects – see a doctor straight away

Rare side effects

 harmful blood clots in a vein or artery for example:

•  in a leg or foot (i.e. DVT) οr in a lung (i.e. PE)
•  heart attack
•  stroke
•  mini-stroke or temporary stroke-like symptoms, known as a transient ischaemic attack (TIA)
•  blood clots in the liver, stomach/intestine, kidneys or eye.

Common side effects

• vaginal inflammation including fungal infection (candidiasis)

• mood swings, including depression

• nervousness

• drowsiness

• vertigo

• headache

• visual disturbances

• nausea

• pain in the abdomen

• acne

• breast pain

• breast tenderness

• menstrual pain

• changed strength of menstrual bleeding

• increased secretion from the vagina

• non-appearance of the menstrual bleeding

• putting on weight.

References

https://www.dred.com/ie/leonore.html