PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

VIOLITE

100/20 micrograms film-coated tablets

levonorgestrel/ethinylestradiol

Important things to know about combined hormonal contraceptives (CHCs).

•    They are one of the most reliable reversible methods of contraception if used correctly

•    They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following 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 “Blood clots”)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Violite is and what it is used for

2.    What you need to know before you take Violite

3.    How to take Violite

4.    Possible side effects

5.    How to store Violite

6.    Contents of the pack and other information

1.    WHAT VIOLITE IS AND WHAT IT IS USED FOR

Violite is a combined oral contraceptive pill for the prevention of pregnancy. It contains two different female hormones, levonorgestrel and ethinylestradiol.

Each of the 21 round pink tablets contains 100 micrograms of levonorgestrel and 20 micrograms ethinylestradiol.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIOLITE General notes

Before you start using Violite you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot - see Section 2 “Blood clots”).

Before you can start taking Violite your doctor will ask you some questions around your personal health history and that of your close relatives. Your doctor will also measure your blood pressure and may also carry out some other tests.

In this leaflet some situations are described where you should stop using Violite or where the reliability of Violite may be decreased and there is a higher risk of pregnancy. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions (e.g. use a condom or other barrier method). Do not use the rhythm or temperature methods. These methods can become unreliable because Violite alters the monthly changes in body temperature and cervical mucus.

When you should not use Violite

You should not use Violite 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 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

-    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 'Blood clots');

•    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 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

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

•    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 ever had liver tumours

•    if you are pregnant or suspect you may be pregnant

•    if you are allergic (hypersensitive) to any of the ingredients in Violite

When to take special care with Violite

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 go to “How to recognise a blood clot”.

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

If the condition develops, or gets worse while you are using Violite, you should also tell your doctor

•    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 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 elevated levels of fat in the blood (hypertrigly-ceridaemia) 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 in section 2 'Blood clots');

•    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 Violite;

•    if you have an inflammation in the veins under the skin (superficial thrombophlebitis);

•    if you have varicose veins;

•    if you have constantly elevated blood pressure or a significant increase in blood pressure which does not respond adequately to your blood pressure medication.

•    if you have diabetes;

•    if you are overweight (obese);

•    if you have a disease of the heart valves or heart rhythm disorder (atrial fibrillation);

•    if you or your close family have ever had problems with blood clotting ;

•    if you have the inherited disease called porphyria;

•    if you have migraines;

•    if you suffer from depression;

•    if you have a loss of hearing due to a disorder known as otosclerosis;

•    if you suffer from a disease known as Sydenham's Chorea. The symptoms include irregular, sudden involuntary movements;

•    if you have had during a pregnancy or when using another contraceptive pill a skin condition which caused itching, red patches and blisters (herpes gestationis);

•    if you have had during a pregnancy temporary brown patches on your skin (chloasma). The pill can make this recur so you should avoid strong sunlight or sunbeds while taking Violite;

•    if you experience any sudden unexplained changes in your vision;

•    if you have gallstones, gallbladder disease or have problems caused by a blockage of the bile ducts (cholestasis) - this may cause intense itching;

•    if you have hereditary angioedema, products containing oestrogens may cause or worsen the symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue and/or pharynx and/or difficulty swallowing, or hives together with difficulty in breathing.

BLOOD CLOTS

Using a combined hormonal contraceptive such as Violite 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', '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 due to Violite is small.

HOW TO RECOGNISE A BLOOD CLOT

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

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 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 Violite 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 Violite 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 Violite, 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).

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

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

•    if you are very overweight (body mass index or BMI over 30kg/m²);

•    if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (e.g. below the age of about 50). 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 Violite may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Violite 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 (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.

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

If any of the above conditions change while you are using Violite, for example a close family member experiences 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 Violite is very small but can increase:

•    with increasing age (beyond about 35 years);

•    if you smoke. When using a combined hormonal contraceptive like Violite 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, have 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.

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

Violite and cancer

•    Cervical cancer in long-term users has been reported, but the effect of sexual behavior or other factors such as human papilloma virus (HPV) is not clear.

•    Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether this is caused by the treatment. For example, it may be that more tumours are detected in women on combined pills because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less after stopping the combined hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.

•    Benign liver tumours (non-cancerous) are rare, and malignant liver tumours (cancerous) are even more rarely reported in combined pill users. Contact your doctor if you have unusually severe stomach pain.

Bleeding between periods

During the first few months that you are taking Violite, you may have unexpected bleeding (bleeding or spotting outside the tablet free week). If this bleeding lasts longer than a few months, or if it begins after some months, your doctor must investigate the cause.

What to do if no bleeding occurs in the tablet free week

If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.

If this is not the case or if the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately as pregnancy must be ruled out before the pill is continued. Do not start the next blister pack until you are sure that you are not pregnant.

Other medicines and Violite

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. There are some medicines that may interact with Violite.

Medicines can sometimes interfere with each other. If you receive treatment from any other doctor, nurse or qualified healthcare professional make sure they are aware that you are using Violite as a contraceptive.

They can advise if it will be necessary to take any additional precautions (e.g. using a condom or other barrier contraceptive) while you are taking other medicines while you are taking Violite. Some medicines can make Violite less effective in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for treatment of:

•    HIV infections (ritonavir, nevirapine)

•    epilepsy (e.g. phenobarbital, phenytoin, primidone, felbamate, carbamazepine, oxcarbazepine or topiramate)

•    infections (e.g. rifabutin, rifampicin, griseofulvin, ampicilline or other penicillins or tetracycline)

•    sleep disorders (modafinil)

•    gout (phenylbutazone)

•    the herbal remedy St. John's Wort (Hypericum perforatum), which is used to treat certain types of depression

If you have been told to take additional contraceptive precautions while taking any of the above medicines follow your doctor's instructions carefully. If you need to take the medicine beyond the end of your current tablet pack, miss your tablet-free week and start the next pack straight away.

In some cases you may need to continue to use additional barrier contraception for several weeks after you have stopped taking the medicine.

Violite may interfere with the following medicines:

•    Cyclosporine (to reduce the body's immune response)

•    Lamotrigine (for epilepsy)

Taking an antibiotic medicine called troleandomycin may increase the risk for intrahepatic cholestasis (retention of bile in the liver) while taking the combined pill.

Pregnancy

Do not take Violite if you are pregnant. If you think you may have become pregnant while using Violite tell your doctor immediately.

Breastfeeding

It is not recommended that you take the combined pill while you are breastfeeding as the hormones can affect your milk. If you wish to breastfeed, your doctor will be able to advise you on suitable alternative methods of contraception.

Always ask your doctor, nurse, or healthcare professional for advice before taking any medicine.

Driving and using machines

The effect of Violite on the ability to drive or operate machinery has not been studied. Dizziness has been reported as a side effect. If you experience dizziness do not drive or operate machinery until it has resolved.

Violite contains lactose

If you suffer from intolerance to certain sugars you should consult your doctor before taking Violite.

3. HOW TO USE VIOLITE

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

Each blister strip of Violite contains 21 tablets. Take your first tablet from the blister showing the correct day of the week. You must take one tablet every day, with water if necessary, at the same time each day until the pack is finished. You will then have a tablet free-week before you start your next pack of tablets. You will always start your next pack on the same day of the week. During the tablet free week you will have bleeding similar to a period. This bleeding will usually start after two or three days, and may not finish before you start the next pack of tablets.

If this is the first time you are starting the pill or you have not used a hormonal contraceptive for the past month

Take the first tablet on the first day of your period.

Starting later than the first day of bleeding (from days 2-5 of the cycle) will mean you will have to use additional barrier contraception for the first 7 days.

If you are changing from another combined contraceptive pill, vaginal ring, or transdermal patch

Changing from pills containing 21 tablets in each pack

Finish the pack of the current pill before starting Violite the next day without a break.

Changing from 'every day' pills containing 28 tablets in each pack

If your current pill contains any inactive tablets (placebo tablets), do not take these, and start Violite straight away the next day without leaving any tablet-free break.

Changing from vaginal ring or transdermal patch You should start to take the pill preferably on the day the last ring or patch of a cycle pack is removed, or, at the latest, when the next application is due.

If you are changing from a progestogen-only method (oral pill, injection, implant or an intrauterine system (IUS))

You may change to Violite on any day from a progestogen-only pill (from an implant or an IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) for the first 7 days of tablet taking.

If you are starting Violite after a termination that occurred during the first trimester (three months) of pregnancy

You can start taking Violite immediately but should follow the advice of your doctor before doing so. No additional barrier contraception is needed.

If you are starting Violite after giving birth or after a termination of pregnancy that occurred during the second trimester

As with any other contraceptive pill, Violite should not be started less than 28 days after giving birth or after termination of a second trimester pregnancy because you are at an increased risk of blood clots. If you start later, you are advised to use a barrier contraceptive method during the first 7 days of taking the pill. If you have had sex before starting Violite be sure you are not pregnant or wait until your next period.

Always ask your doctor for advice if you are not sure.

If you forget to take Violite

If you forget to take a tablet there is a risk you could become pregnant

If you realise you have missed a tablet within 12 hours of the time you normally take your tablet, take the missed tablet immediately and continue as normal, taking the next tablet at the usual time until the end of the blister pack.

If you realise you have missed a tablet more than 12 hours after you normally take it, there is a risk you could become pregnant. In this case:

•    take the last missed tablet immediately, even if this means taking 2 tablets on the same day

•    continue taking the tablets until the end of the blister pack

•    in addition, use a barrier method of contraception (e.g. condom) for the next 7 days

•    if this 7-day period extends beyond the last tablet in the pack, start the next blister pack straight away without a tablet free break. You may have some spotting or bleeding while taking the second pack, this is nothing to worry about.

If you have forgotten one or more tablets in a blister pack and you do not have any bleeding in the tablet-free week, you may be pregnant and you should ask your doctor for advice.

If you have vomiting or diarrhoea

Vomiting or diarrhoea may make Violite less effective in preventing pregnancy.

If you vomit within 3-4 hours of taking a tablet or 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 as soon as possible

How to delay a period

You can delay your period by starting another pack of Violite without any tablet-free week. You may have some spotting or bleeding while taking the second pack, this is nothing to worry about.

You should have a normal bleed after finishing the second course of tablets.

If you take more Violite than you should

If you accidentally take more Violite than you should, you may have symptoms including gastrointestinal problems (e.g. nausea, vomiting, abdominal pain), breast tenderness, dizziness, drowsiness/fatigue and vaginal bleeding. These symptoms will reduce naturally as your body deals with the excess hormones.

If you are worried ask your doctor for advice.

4.    POSSIBLE SIDE EFFECTS

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 Violite, 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 “What you need to know before you use Violite”.

If you experience any of the following serious side effects, seek medical help immediately:

Rare side effects (may affect up to 1 in 1,000 people)

•    harmful blood clots in a vein or artery for example:

-    in a leg or foot (i.e. DVT)

-    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.

The chance of having a blood clot may be higher if you have any other conditions that increase this risk (see section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot)

•    A serious allergic reaction - Rare side effect (may affect up to 1 in 1,000 people)

Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips or throat, skin rash, hives

•    A blood clot in the eye - it is not known how frequently this occurs

Symptoms include loss of vision, pain and swelling of the eye especially if sudden.

•    Haemolytic uremic syndrome (a condition which affects your blood and kidneys) - it is not known how frequently this occurs

Symptoms include vomiting, diarrhoea (which may be bloody), fever, feeling weak, passing less urine than usual.

•    Pancreatitis - it is not known how frequently this occurs

Symptoms include severe upper abdominal pain which may spread to your back.

•    Erythema multiforme - Rare side effect (may affect up to 1 in 1,000 people)

Symptoms include a skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister. You may also have ulcers in the mouth, eyes or genitals and have a fever.

Other side effects include:

Common (may affect up to 1 in 10 people)

•    Mood swings, depression

•    Headache, dizziness

•    Nausea, abdominal pain

•    Breast pain or tenderness

•    Weight increase

Uncommon (may affect up to 1 in 100 people)

•    Decreased interest in sex

•    skin rash

•    migraine

•    vomiting diarrhoea

•    itching or raised bumps on the skin

•    swollen breasts

•    fluid retention

Rare (may affect up to 1 in 1,000 people)

•    Contact lens intolerance

•    allergic reactions

•    increased interest in sex

•    breast or vaginal discharge

•    red skin lesions or nodules

•    skin redness or blotchiness

•    weight decrease

If you are at all worried about any new symptoms or other aspects of your health while taking Violite, please tell your doctor.

Reporting of side effects - United Kingdom

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effect directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

Reporting of side effects - Ireland

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971; Fax: +353 1 6762517.

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    HOW TO STORE VIOLITE

•    Keep this medicine out of the sight and reach of children.

•    Do not store above 25° C

•    Do not use this medicine after the expiry date stated on the blister pack and the carton after EXP. The expiry date refers to the last day of that month.

If you stop taking Violite: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Violite contains

The active substances are ethinylestradiol and levonorgestrel.

•    Each coated tablet contains 20 microgram ethinylestradiol and 100 microgram levonorgestrel.

The other ingredients are:

Tablet core: Lactose monohydrate, Polacrilin potassium, Microcrystalline cellulose, Magnesium stearate.

Tablet coating: Opadry II pink, consisting of: Macrogol 3350, Titanium dioxide (E171), Polyvinyl alcohol, Talc (E553b),

Iron oxide red (E172), Iron oxide yellow (E172).

What Violite looks like and contents of the pack

Pink, cylindrical, biconvex, film coated tablet of 6 mm approximately.

Violite is packed in PVC/PVDC/Aluminium blister packs of 21 tablets.

Each pack may contain either:

1 x 21 film-coated tablets or

3 x 21 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Consilient Health Limited 5th Floor, Beaux Lane House,

Mercer Street Lower, Dublin 2, Ireland

Manufacturer

Cyndea Pharma, S.L.

Poligono Industrial Emiliano Revilla Sanz Av. de Agreda 31, 42110 Olvega (Soria), Spain

This leaflet was last revised in March 2016