Morningside Healthcare Contraceptives

Lizinna^® is a combined oral contraceptive pill. It is used to prevent pregnancy. Lizinna^® needs to be taken as directed to prevent pregnancy.
This contraceptive contains two types of female sex hormones, oestrogen and progestogen. Because it contains two hormones, Lizinna^® is called a ‘combined hormonal contraceptive’.
These hormones prevent an egg being released from your ovaries so you cannot get pregnant. Also, Lizinna^® makes the fluid (mucus) in your cervix thicker which makes it more difficult for sperm to enter the womb.
Lizinna^® is a 21-day Pill – you take one tablet each day for 21 days, followed by 7 days when you take no pills.

Before you start using Lizinna^® you should read the information on blood clots in the patient information leaflet contained in your pack of Lizinna^®. It is important that you understand the benefits and risks of taking Lizinna^® before you start taking it, or when deciding whether to carry on taking it. Although Lizinna^® is suitable for most healthy women it is not suitable for everyone. When you should not use Lizinna:
You should not use 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.Do not take Lizinna

• If you are allergic to norgestimate, ethinylestradiol or any of the other ingredients in this medicine (listed in Section 6)
• 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 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 (TIA – temporary stroke symptoms)
• if you are breast feeding and your baby is less than 6 weeks old
• if you have an illness which runs in your family which affects fat levels in your blood (called dyslipoproteinemia)
• 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 have ever been told you might have breast cancer or cancer of the womb, cervix or vagina
• if you have unexplained vaginal bleeding
• if you need an operation or if you are off your feet for a long time (see section ‘Blood clots’)
• if you have an irregular heartbeat (atrial fibrillation), problems with heart valves or heart failure
• if you have (or have ever had) a type of migraine called ‘migraine with aura’
• if you smoke 15 or more cigarettes a day and you are 35 years of age or older
• if you have or have recently had a severe liver disease;
• if you have breast or liver cancer
• if you have (or have ever had) an inflammation of the pancreas (pancreatitis)
• if your period has not yet started (girls in puberty)
• 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
  • a very high level of fat in the blood (cholesterol or triglycerides)
  • a condition known as hyperhomocysteinaemia

Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet.

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 (i.e. deep vein thrombosis), a blood clot in the lung (i.e. pulmonary embolism), a heart attack or a stroke (see ‘Blood clot’ (thrombosis) section below. For a description of the symptoms of these serious side effects please read the detailed sections on “How to recognise a blood clot” in your Patient Information Leaflet.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take Lizinna^® every day for 21 days
Lizinna^® comes in a strip of 21 tablets, each marked with a day of the week. Take your tablet at the same time every day.Start by taking a tablet marked with the correct day of the week.Follow the direction of the arrows on the strip. Take one tablet each day.

Swallow each tablet whole, with water if necessary. Do not chew the tablet.

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

Within a few days of taking the last tablet 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 tablets.

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

Then start your next strip
Start taking your next strip of Lizinna^® after the seven tablet-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.

• If you have not used a contraceptive with hormones in the previous month
  Begin with Lizinna^® on the first day of the cycle (that is the first day of your period). If you start Lizinna^® on the first day of your period you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.
• Changing from a combination hormonal contraceptive, or combination contraceptive vaginal ring or patch
  You can start Lizinna^® preferably on the day after the last active tablet (the last tablet containing active substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill (or after the last inactive tablet of your previous pill). When changing from a combination contraceptive vaginal ring or patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing IUD)
  You may switch any day from the progestogen-only pill (from an implant or an IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.
• After a miscarriage
  Follow the advice of your doctor.
• After having a baby
  You can start Lizinna^® between 21 and 28 days after having a baby, If you start later than day 28, use a so-called barrier method (for example, a condom) during the first seven days of Lizinna^® use. If, after having a baby, you have had sex before starting Lizinna^® (again), be sure that you are not pregnant or wait until your next period.

Ask your doctor what to do if you are not sure when to start.

If you have absence of bleeding
Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your tablets 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 tablets or taking other medicines), or if you miss a second bleed, you should do a pregnancy test.

If you are pregnant, stop taking Lizinna^® and see your doctor.

If you are less than 12 hours late taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time. If you are more than 12 hours late taking a tablet, the protection against pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becoming pregnant. The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip. Therefore, you should keep to the following rules:More than one tablet forgotten in this strip
Contact your doctor.One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet you may be pregnant. In that case, contact your doctor.

One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.

One tablet forgotten in week 3
You can choose between two possibilities:

1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. Instead of taking the tablet-free period start the next strip.

Most likely, you will have a period at the end of the second strip but you may have light or menstruation-like bleeding during the second strip.

1. You can also stop the strip and go directly to the tablet-free period of 7 days (record the day on which you forgot your tablet). If you want to start a new strip on the day you always start, make the tablet-free period less than 7 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

If you have forgotten any of the tablets in a strip, and you do not have a bleeding during the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.

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

What to do in the 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. If possible take it within 12 hours of when you normally take your pill. If that is not possible or 12 hours have passed, you should follow the advice given under “If you forget to take Lizinna^®”.

Before you have any blood tests

If you need a blood test tell your doctor that you are taking Lizinna, because it can affect the results of some tests.

Other medicines and Lizinna^®

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

Certain medicines and herbal remedies may stop Lizinna^® from working properly. If this happens you could get pregnant.

Tell your doctor if you are taking:

• medicines for HIV infection (such as ritonavir, nevirapine)
• medicines for infection called antibiotics (such as rifampicin and griseofulvin)
• medicines for epilepsy (such as topiramate, phenytoin sodium, carbamazepine, primidone, oxcarbamazepine and felbamate)
• medicine for high blood pressure in the blood vessels in the lungs (bosentan)
• medicine for excessive daytime sleepiness (modafinil)
• medicine for relaxation and difficulty in sleeping (sedatives such as barbiturates)
• St. John’s Wort – a herbal remedy used for depression. 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)
• theophylline (for asthma, bronchitis and emphysema)

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Lizinna^®, please talk to your doctor. An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 of your Patient Information Leaflet “What you need to know before you use Lizinna^®”. Tell your doctor, pharmacist or nurse if you are worried about any side effects which you think may be due to Lizinna^®. This includes any side effects not listed in your Patient Information Leaflet.Most common side effects are as follows:-Very common: may affect more than 1 in 10 people:

• Headache (but if severe, unusual or long lasting, see a doctor as soon as possible)
• Upset stomach
• Nausea
• Vomiting
• Diarrhoea
• Vaginal bleeding
• Bleeding and spotting between your periods for the first few months
• Painful or unusual periods

Common: may affect up to 1 in 10 people:

• Urinary tract infections (pain on passing urine)
• Vaginal infections such as thrush
• Allergic reactions (hypersensitivity)
• Fluid retention
• Depression
• Mood changes
• Feeling nervous
• Feeling dizzy
• Difficulty sleeping (insomnia)
• Migraine (see a doctor as soon as possible if this is your first migraine or it’s worse than usual)
• Stomach ache
• Bloating
• Constipation
• Passing wind
• Acne
• Rash
• Muscle spasms
• Pain in the legs and arms
• Back-ache
• Vaginal discharge
• No menstrual bleeding (periods)
• Painful breasts
• Chest pain
• Swollen hands, ankles or feet
• Feeling weak
• Weight gain

Uncommon: may affect up to 1 in 100 people:

• Abnormal cells in the cervix (identified by a smear test)
• Changes in appetite
• Weight may vary
• Feeling anxious
• Change in sex drive
• Feeling faint
• Having a tingling sensation or numbness
• Changes in vision
• Dry eyes
• Feeling your heart beat (palpitations)
• Creation of blood clots (thrombosis)
• High blood pressure
• Hot flushes
• Sudden chest pain, difficulty breathing
• Hair thinning (alopecia)
• Excessive hair growth (hirsutism)
• Hives (urticaria)
• Itchiness of the skin
• Redness of the skin
• Changes in skin colour
• Muscle pain
• Breast problems, such as:
  • fuller breasts
  • producing fluid from the nipples
• Ovarian cysts (may cause pain and swelling of the abdomen, changes in periods)
• Vaginal dryness
• Weight loss

Rare: may affect up to 1 in 1000 people:

• Lumpy breasts
• Fluctuation in your appetite
• Loss of sex drive
• Feeling dizzy or spinning
• Faster heart beat
• Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
• Inflammation of the liver (hepatitis)

Please read your Patient Information Leaflet for information on risks of very rare side effects and how to identify them. Tell your doctor, pharmacist or nurse if any existing conditions get worse while you are taking Lizinna^®.

Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in your Patient Information Leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not use Lizinna^® after the expiry date shown on the strip. The expiry date refers to the last day of that month. Store in the original package to protect from light.Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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.Marketing Authorisation Holder
Morningside Healthcare Limited
115 Narborough Road
Leicester, LE3 0PA
United Kingdom