Lizinna 250 microgram /35 microgram Tablets

• The Pill is one of the most reliable reversible methods of contraception if used correctly.
• This medicine slightly increases your risk of having a blood clot in the veins and arteries (especially in the first year or when restarting the Pill after a break of 4 or more weeks).
• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see Section 2.1 ‘The Pill and blood clots’, ‘How to recognise a blood clot’).
• The Pill may reduce your risk of cancer of the ovary and womb if used for a long time, but increase your risk of breast cancer.
• The Pill will not protect you against sexually transmitted diseases.
• Some women should not take the Pill because of current medical problems or illnesses. Please read the leaflet to make sure Lizinna is right for you.
• To prevent pregnancy it is important to take Lizinna as instructed and start each pack on time. Please make sure that you understand what to do if you miss a pill or think you are pregnant.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, family planning nurse or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them.
• If you get any side effects talk to your doctor, family planning nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Lizinna is and what it is used for
2. What you need to know before you take Lizinna
3. How to take Lizinna
3.3 A missed pill
4. Possible side effects
5. How to store Lizinna
6. Contents of the pack and other information

• it is one of the most reliable reversible methods of contraception if used correctly
• it doesn’t interrupt sex
• it usually makes your periods regular, lighter and less painful
• it may help with pre-menstrual symptoms

Lizinna will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.

Lizinna needs to be taken as directed to prevent pregnancy.

Using a Pill such as Lizinna 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 ana ‘venous thrombosis’, ‘venous thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’ or ATE)

Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or very rarely they may be fatal.

It is important to remember that the overall risk of a harmful blood clot caused by Lizinna is small.

How to recognise a blood clot

Seek urgent medical attention if you notice any of the following signs or symptoms.

Do you have any of these signs?

• swelling of one leg or along a vein in the leg or foot especially with:
  • 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 such as turning pale, red or blue.

What could you be suffering from?

Deep vein thrombosis (DVT) (blood clot in the large vein of the leg)

Do you have any of these signs?

• 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 (like a common cold).

What could you be suffering from?

Pulmonary embolism (PE) (blood clot in the lungs)

Do you have any of these signs?

symptoms most commonly in one eye:

• immediate loss of vision or
• painless blurring of vision which can become a loss of vision.

What could you be suffering from?

Retinal vein thrombosis (blood clot in the eye)

Do you have any of these signs?

• chest pain or discomfort, pressure,
• heaviness
• sensation of squeezing or fullness in the chest, arm or below the breastbone
• fullness, indigestion or choking feeling
• upper body discomfort spreading out to the back, jaw, throat, arm and stomach
• sweating, nausea, vomiting or dizziness
• extreme weakness, anxiety, or shortness of breath
• rapid or irregular heartbeats.

What could you be suffering from?

Heart attack

Do you have 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 a 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.

What could you be suffering from?

Stroke

(blood clot in the brain)

Do you have any of these signs?

• swelling and slight blue discolouration of an extremity such as hands and feet
• severe pain in your stomach (acute abdomen)

What could you be suffering from?

Blood clots blocking other blood vessels

Blood clots in a vein

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

• 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 the Pill for the first time. The risk may also be higher if you restart taking the Pill (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 the Pill.

When you stop using Lizinna 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 Pill you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Lizinna 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 taking a Pill containing levonorgestrel or norethisterone, or norgestimate such as Lizinna, 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 (see “Factors that increase your risk of a blood clot” below).

Risk of developing a blood clot in a year

Women who are not using a combined hormonal Pill/patch/ring and are not pregnant About 2 out of 10,000 women

Women using a Pill containing levonorgestrel, norethisterone or norgestimate About 5-7 out of 10,000 women

Women using Lizinna About 5-7 out of 10,000 women

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot with Lizinna is small but some conditions will increase the risk. Your risk is higher:

• if you are very overweight (body mass index or BMI over 30 kg/m²)
• if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (such as, below the age of about 50 years old). In this case you could have a hereditary blood clotting disorder
• if you need to have an operation or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of Lizinna may need to be stopped for several weeks before surgery or while you are less mobile. If you need to stop Lizinna ask your doctor when you can start using it again
• as you get older (particularly above about 35 years)
• if you gave birth less than a few weeks ago.

The risk of developing a blood clot increases the more conditions you have.

Air travel (for longer than 4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other risk factors listed.

• It is important to tell your doctor if any of these risk factors apply to you, even if you are unsure. Your doctor may decide that Lizinna needs to be stopped.

If any of the above conditions change while you are using Lizinna, for example a close family member has a thrombosis for no known reason or you gain a lot of weight, tell your doctor.

Blood clots in an artery

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke from using Lizinna is very small but can increase:

• with increasing age (particularly above about 35 years old)
• if you smoke. When using a Pill like Lizinna you are advised to stop smoking. If you are unable to stop smoking and are older than 35, your doctor may advise you to use a different type of contraceptive
• if you are overweight
• if you have high blood pressure
• if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50). In this case you could also have a higher risk of having a heart attack or stroke
• if you or someone in your immediate family has a high level of fat in the blood (cholesterol or triglycerides)
• if you get migraines, especially migraines with aura
• if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation)
• if you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe the risk of developing a blood clot may be increased even more.

• Tell your doctor if any of these risk factors applies to you. If any of the above conditions change while you are using Lizinna, for example you start smoking, a close family member has a thrombosis for no known reason, or you gain a lot of weight, tell your doctor. Taking the Pill may add to these risks so Lizinna may not be suitable for you.

The Pill reduces your risk of cancer of the ovary and womb if used for a long time. However, it also seems to slightly increase your risk of cancer of the cervix – although this may be due to having sex without a condom, rather than the Pill. All women should have regular smear tests.

If you have breast cancer, or have had it in the past, you should not take the Pill. The Pill slightly increases your risk of breast cancer. This risk goes up the longer you’re on the Pill, but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra cases of breast cancer in current and recent Pill users are small. For example:

• Of 10,000 women who have never taken the Pill, about 16 will have breast cancer by the time they are 35 years old.
• Of 10,000 women who take the Pill for 5 years in their early twenties, about 17–18 will have breast cancer by the time they are 35 years old.
• Of 10,000 women who have never taken the Pill, about 100 will have breast cancer by the time they are 45 years old.
• Of 10,000 women who take the Pill for 5 years in their early thirties, about 111 will have breast cancer by the time they are 45 years old.

Your risk of breast cancer is higher:

• as you get older
• if you have a close relative (mother, sister or grandmother) who has had breast cancer
• if you are seriously overweight

• See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel.

Taking the Pill has also been linked to liver diseases, such as jaundice and non-cancer liver tumors, but this is rare. Very rarely, the Pill has also been linked with some forms of liver cancer in women who have taken it for a long time.

• See a doctor as soon as possible if you get severe pain in your stomach, or yellow skin or eyes (jaundice). You may need to stop taking Lizinna.

You should not take Lizinna 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.

• Tell your doctor or family planning nurse if you have any medical problems or illnesses.

Do not take Lizinna if any of the following applies to you:

• 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 or antiphospholipid antibodies)
• If you need an operation or if you are off your feet for a long time (see Section 2.1 ‘The Pill and blood clots’)
• If you have ever had a heart attack or stroke
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain which may be a first sign of a heart attack) or transient ischaemic attack (TIA - temporary stroke symptoms)
• 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
  • very high blood pressure
  • very high level of fat in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinaemia
• If you have (or have ever had) a type of migraine called ‘migraine with aura’
• If you have breast or liver cancer
• If you have or have recently had a severe liver disease
• if you have hepatitis C and are taking the medicinal products containing ombitasvir/ paritaprevir/ritonavir, dasabuvir, glecaprevir/ pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section 2.5 ‘Other medicines and Lizinna Tablets’)
• If you are allergic to any of the ingredients in Lizinna.

• If you suffer from any of these, or get them for the first time while taking Lizinna, contact your doctor as soon as possible. Do not take Lizinna as it may put your health at risk.

When should you contact your doctor?

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 (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack or a stroke (see Section 2.1 ‘The Pill and blood clots’ above).

For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.

Tell your doctor if any of the following conditions applies to you

If the condition develops, or gets worse while you are using Lizinna, you must also tell your doctor. You may still be able to take Lizinna but you need to take special care and have check-ups more often:

• If you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.
• If you have problems with your heart, circulation or blood clotting, such as high blood pressure
• If you have diabetes without secondary problems
• If you have liver problems or gall bladder disease
• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• If you have systemic lupus erythematosus (SLE; a disease affecting your natural defence system)
• If you have porphyria
• If you have a history of migraines
• If you have elevated levels of fat in the blood (hypertriglyceridaemia) or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
• If you need an operation, or you are off your feet for a long time (see Section 2.1 ‘The Pill and blood clots’)
• If you have had any of the following problems while pregnant or during previous Pill use, such as itchy skin or blister-like rash, yellowing of skin or eyes, hearing problem, systemic lupus erythematosus (SLE), severe headaches, uncontrollable jerky movements
• If you have just given birth you are at an increased risk of blood clots. You should ask your doctor how soon after delivery you can start taking Lizinna
• If you have haemolytic uraemic syndrome (HUS, a disorder of blood clotting causing failure of the kidneys)
• If you have sickle cell anaemia (an inherited disease of the red blood cells)
• If you have varicose veins
• If you have inflammation in the veins under the skin (superficial thrombophlebitis).

• Tell your doctor or family planning nurse if any of these applies to you. Also tell them if you get any of these for the first time while taking the Pill, or if any get worse or come back, because you may need to stop taking Lizinna and use another method of contraception, such as condoms.

Psychiatric disorders:

Some women using hormonal contraceptives including Lizinna have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

Other conditions

• Chloasma (yellow-brownish patches on your skin, pigment spots during pregnancy, especially on your face) occasionally occur, especially if you have had a history of it. You may need to keep out of the sun or away from sunbeds (these patches may not completely disappear again).

If you ever need to take another medicine at the same time as being on the Pill, always tell your doctor, pharmacist or dentist that you’re taking Lizinna. Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.

Some medicines can stop Lizinna from working properly – for example:

• some medicines used to treat epilepsy (such as topiramate, carbamazepine, phenytoin, fosphenytoin, oxcarbazepine, felbamate, primidone, eslicarbazepine acetate, rufinamide)
• bosentan (for high blood pressure in the blood vessels of the lungs)
• certain medicines for tuberculosis such as rifampicin and rifabutin
• anti-HIV medicines
• boceprevir and telaprevir (for treatment of Hepatitis C infections)
• aprepitant and fosaprepitant (for prevention of nausea and vomiting caused by certain cancer drug treatment)
• griseofulvin (for fungal infections)
• modafinil (for excessive daytime sleepiness)
• certain sedatives (called ‘barbiturates’)
• St. John’s Wort (a herbal remedy)
• metoclopramide (to increase movement through the gut)
• charcoal
• colesevelam (to treat high cholesterol levels)
• etoricoxib (to help with pain and inflammation of arthritis)

If you do need to take one of these medicines, Lizinna may not be suitable for you or you may need to use extra contraception for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long.

Lizinna can also affect other medicines- for example:

• ciclosporin (to prevent transplant rejection and for rheumatoid arthritis or some skin problems)
• lamotrigine (for epilepsy)
• prednisolone (a steroid to reduce inflammation)
• selegiline (for Parkinson’s disease)
• theophylline (for asthma, bronchitis and emphysema)
• tizanidine (used to relax muscles)

Talk to your doctor before having Lizinna if you are taking any of these medicines. They may have to change how much of these medicines you are taking.

Do not use Lizzina Tablets if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Lizzina Tablets can be restarted approximately 2 weeks after completion of this treatment. See section 2.3 ‘Do not take Lizzina if any of the following applies to you:’

There are no special instructions about food and drink while on Lizinna.

Do not start to use Lizinna if you are pregnant. If you think you might be pregnant while taking Lizinna, do a pregnancy test to confirm that you are before you stop taking it.

If you are breast-feeding, your doctor or family planning nurse may advise you not to take Lizinna. Talk to them about alternative contraception. Breast-feeding may not stop you getting pregnant.

Lizinna has no known effect on the ability to drive or use machines.

If you have been told by your doctor that you have intolerance to some sugars contact your doctor before using Lizinna.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

To prevent pregnancy, always take Lizinna as described below. Check with your doctor or family planning nurse if you are not sure.

Take Lizinna every day for 21 days

Lizinna comes in a strip of 21 pills, each marked with a day of the week.

• Take your pill at the same time every day.
• Start by taking a pill marked with the correct day of the week.
• Follow the direction of the arrows on the strip. Take one pill each day.
• Swallow each pill whole, with water if necessary. Do not chew the pill.

Then have seven pill-free days

After you have taken all 21 pills in the strip, you have seven days when you take no pills. So, if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week.

Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills.

You don’t need to use extra contraception during these seven pill-free days – as long as you have taken your pills correctly and start the next strip of pills on time.

Then start your next strip

Start taking your next strip of Lizinna after the seven pill-free days – even if you are still bleeding. Always start the new strip on time.

As long as you take Lizinna correctly, you will always start each new strip on the same day of the week.

As a new user or starting the Pill again after a break

Either take your first Lizinna pill up to and including day 5 of your next period (counting the first day of your period as day 1). This way, you will have contraceptive protection with your first pill.

Or start taking Lizinna at any time, if you are sure you are not already pregnant. But then you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly.

Changing to Lizinna from another contraceptive

If you are currently taking another Pill and you are taking it correctly, you can start Lizinna at any time, if you are sure you are not already pregnant. There is no need to wait for your next period to start and you don’t need extra contraception. If you are currently using a non-hormonal method and your period started more than 5 days ago, you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly.

Starting Lizinna after a miscarriage or abortion

If you have had a miscarriage or an abortion, your doctor may tell you to start taking Lizinna straight away. This means that you will have contraceptive protection with your first pill.

Contraception after having a baby

If you have just had a baby, you are more at risk of blood clots (see Section 2.1, ‘The Pill and blood clots’).

Ask your doctor when you can start taking Lizinna again. If it is 21 days after the birth, you will have contraceptive protection with your first pill.

If you start Lizinna after this, you must use extra contraception, such as condoms, until you have taken the first 7 pills correctly.

Missing pills or starting a strip late may make your pill less effective. The chance of pregnancy after missing pills depends on when pills are missed and how many pills are missed.

Missing one pill anywhere in your strip or starting a new strip one day late is not a problem. Missing more than one or starting a strip more than one day late may affect your contraceptive cover.

It is more risky to start a strip late and miss more than one pill.

How many pills have you missed?

One pill

• Take the missed pill straight away, and further pills as usual. This may mean taking two pills in one day.
• Continue taking the rest of the strip as usual.
• Don’t worry - your contraceptive protection should not be reduced.

Two or more pills

• Take the most recently missed pill straight away
• Leave any earlier missed pills in the strip
• Take your next pill at the usual time. This may mean taking two pills in one day.
• Continue taking the rest of the strip as usual.
• Use extra precautions (condoms, for instance) for the next 7 days.
• Check how many pills are left in the strip after the most recently missed pill

7 or more pills left in the pack

• Use extra precautions for the next 7 days.
• When you have finished the strip, leave the usual 7-day break before starting the next strip..
• If you have missed any pills from the first week of your strip and you had sex in that week, you could become pregnant. Contact your doctor, family planning nurse or pharmacist for advice as soon as possible. They may recommend you use emergency contraception.

Fewer than 7 pills left in the pack

• Use extra precautions for the next 7 days
• When you finish the strip, start the next strip the next day without a break.
• If you do not have a withdrawal bleed after you have finished the second strip, do a pregnancy test

If you have missed any of the pills in a strip, and you do not bleed in the first pill-free break, you may be pregnant. Contact your doctor or family planning clinic, or do a pregnancy test yourself.

If you start a new strip of pills late, or make your ‘week off’ longer than eight days, you may not be protected from pregnancy. If you had sex in the last seven days, ask your doctor, family planning nurse or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days.

If you lose a pill, just take a pill from a spare strip. Then take all the other pills from your current strip as usual. You can then keep the opened spare strip in case you lose any more pills.

If you are sick or have very bad diarrhoea, your body may not get its usual dose of hormones from that pill. If you have been sick within 2 hours of taking Lizinna, just take a pill from a spare strip. Carry on taking your pills as normal if you can. You won’t need to use extra contraception.

If you are still sick or have diarrhoea for more than 1 day, follow the instructions for a missed pill – see section 3.3, A missed pill.

• Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception.

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 chemist or get a free test at your family planning clinic or doctor’s surgery. If you are pregnant, stop taking Lizinna and see your doctor.

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. Talk to your doctor if you have any of these symptoms.

If you want to delay having a period, finish the strip of pills you are taking. Start the next strip the next day without a break. Pill taking should then continue as usual.

When you use the second strip, you may have some unexpected bleeding or spotting on the days that you take the pill, but don’t worry. Take the next strip after the usual 7 day break even if you are still bleeding or spotting.

If you are planning a baby, it is best to use another method of contraception after stopping Lizinna until you have had a proper period. Your doctor or midwife relies on the date of your last natural period to tell you when your baby is due. The Pill may reduce the levels of folic acid in the blood. Talk to your doctor, nurse or pharmacist as this could be important if you get pregnant straight after stopping the Pill.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing (see also section “Warnings and precautions”).

Harmful blood clots in a vein or artery (frequency not known) for example:

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

An increased risk of blood clots in your veins (venous thromboembolism, VTE) or arteries (arterial thromboembolism, ATE) is present for all women taking the Pill. For more detailed information on the different risks from taking the Pill, please see Section 2 ‘Make sure Lizinna is OK for you’. The chance of having a blood clot may be higher if you have any other conditions that increase this risk (see Section 2.1 ‘The Pill and blood clots’ for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).

Breast cancer (frequency not known)

Signs include:

• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.

Severe liver problems (rare - affects fewer than 1 in 1000 patients)

Signs include:

• severe pain in your upper abdomen
• yellow skin or eyes (jaundice).

Other serious side effects include:

• increased blood pressure (uncommon - affects fewer than 1 in 100 patients)
• fits (convulsions) (frequency not known)
• hives (urticaria) (uncommon - affects fewer than 1 in 100 patients), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. These may be signs of allergy.

• If you think you may have any of these, see a doctor straight away. You may need to stop taking Lizinna.

Very common side effects (affects more than 1 in 10 patients)

• Headache (but if severe, unusual or long lasting, see a doctor as soon as possible)
• Stomach problems such as nausea, vomiting and diarrhoea
• Bleeding and spotting between your periods for the first few months (though this usually stops when your body adjusts to Lizinna) – see section 4.3, Bleeding between periods should not last long
• Painful or unusual periods

Common side effects (affects more than 1 in 100 patients)

• Migraine (see a doctor as soon as possible if this is your first migraine or it’s worse than usual)
• Swollen hands, ankles or feet
• Depression; mood changes; feeling nervous or dizzy
• Difficulty sleeping (insomnia)
• Stomach ache and bloating; constipation; wind
• Acne; rash
• Muscle spasms; pain in the legs, arms and back
• Painful breasts
• Urinary tract infections (pain on passing urine)
• Vaginal infections such as thrush
• Vaginal discharge
• No menstrual periods
• Feeling weak
• Weight gain.

Uncommon side effects (affects fewer than 1 in 100 patients)

• Breast problems, such as fuller breasts; producing fluid from the nipples
• Abnormal cells in the cervix (identified by a smear test)
• Feeling anxious or faint; tingling sensation or numbness
• Changes in skin colour
• Skin problems such as redness and itchiness
• Hair thinning (alopecia), excessive hair growth
• Changes in appetite
• Weight may vary
• Change in sex drive
• Dry eyes
• Changes in vision
• Palpitations (feeling your heart beat)
• Hot flushes
• Muscle pain
• Vaginal dryness
• Ovarian cysts (may cause pain and swelling of the abdomen, changes in periods)

Rare side effects (affects fewer than 1 in 1000 patients)

• Lumpy breasts
• Loss of sex drive
• Feeling giddy
• Faster heart beat
• Pancreatitis (inflammation of the pancreas, which causes severe pain in the abdomen and back)
• Increased sweating
• Sensitivity to light

Frequency not known

• Reduced amount of breast milk (if breast feeding)
• Contact lenses may feel uncomfortable
• Red painful lumpy swellings on the legs
• Changes in fat levels in the blood (seen by blood tests)
• Night sweats.
• liver enzymes increased (transaminase elevation).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine. Also tell your doctor, pharmacist or nurse if any existing conditions get worse while you are taking Lizinna.

Usually you should only have a withdrawal bleed like a period during the seven pill-free days. However, a few women have a little unexpected bleeding or spotting while they are taking Lizinna, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Lizinna as usual. The problem should disappear after the first few strips.

You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines.

• Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:

• carries on for more than the first few months
• starts after you’ve been taking Lizinna for a while
• carries on even after you’ve stopped taking Lizinna.

• Each pill contains 250 micrograms norgestimate and 35 micrograms ethinylestradiol.
• The other ingredients are
  Lactose Anhydrous, Lactose Monohydrate, Povidone K-25, dl-α-tocopherol, Microcrystalline cellulose, Croscarmellose sodium, Starch Pregelatinised (starch 1500), Magnesium Stearate, Indigo carmine aluminium lake (E 132).

Lizinna tablets are round, blue, uncoated flat beveled edge tablets with ‘146’ debossed on one side and plain on the other side, with a diameter of 6.4mm.

They are supplied in packs containing:

21, 63, 126 tablets.

Not all pack sizes may be marketed.