VARENELLE

Package leaflet: Information for the user

Varenelle, 3 mg + 0,02 mg, coated tablets
Drospirenone + Ethinylestradiol
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the user suspects symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before taking the medicine, as it contains important information for the user.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm other people.
• If the user experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Varenelle is and what it is used for
2. Important information before taking Varenelle
3. How to take Varenelle
4. Possible side effects
5. How to store Varenelle
6. Contents of the pack and other information

1. What Varenelle is and what it is used for

Varenelle is a contraceptive tablet used to prevent pregnancy.
Each of the 21 pink coated tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
The 7 white coated tablets do not contain any active substances; they are also known as placebo tablets.
Contraceptive tablets containing two hormones are called "combined" pills.

2. Important information before taking Varenelle

General notes
Before starting Varenelle, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before you can start taking Varenelle, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out some additional tests.
This leaflet describes several situations in which you should stop taking Varenelle or in which the effectiveness of Varenelle may be reduced. In such cases, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use the calendar method or temperature measurement method. These methods may be unreliable because Varenelle alters the monthly changes in body temperature and cervical mucus.
Varenelle, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

When not to take Varenelle

• If you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of the medicine (listed in section 6). This allergy may cause itching, rash, or swelling.

Do not take Varenelle if you have any of the following conditions. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception may be more suitable.

• if you have (or have ever had in the past) a blood clot in the veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides);
• a condition called hyperhomocysteinemia;
• if you have (or have ever had in the past) a type of migraine called "migraine with aura";
• if you currently have (or have ever had in the past) liver disease and liver function remains abnormal;
• if you have kidney function disorders (kidney failure);
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir (see also section "Varenelle and other medicines");
• if you currently have (or have ever had in the past) liver tumour;
• if you currently have (or have ever had in the past) or suspect breast cancer or cancer of the genital organs;
• if you have any unexplained vaginal bleeding;

Additional information for special populations
Children and adolescents
Varenelle is not intended for use in girls who have not yet started menstruating.
Women of advanced age
Varenelle is not intended for use after menopause.
Women with liver function disorders
Do not take Varenelle if you have liver disease. See also sections "When not to use Varenelle" and "Warnings and precautions".
Women with kidney function disorders
Do not take Varenelle if you have kidney failure or acute kidney failure. See also sections "When not to use Varenelle" and "Warnings and precautions".

Warnings and precautions
Before starting Varenelle, discuss it with your doctor or pharmacist.
When to exercise special caution when using Varenelle
When should you contact your doctor?
You should immediately contact your doctor

• if you notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below "Blood clots (thrombosis)"). For a description of the symptoms of these serious adverse effects, see "How to recognize the development of blood clots".

In certain situations, special caution is required when using Varenelle or any other combined hormonal contraceptive, and regular medical check-ups may be necessary.
You should inform your doctor if you have any of the following conditions.
If any of these conditions appear or worsen during treatment with Varenelle, you should also inform your doctor.

• if there is currently or has ever been breast cancer in your close family;
• if you have liver or gallbladder disease;
• if you have diabetes;
• if you have depression;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease affecting the natural immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you are immediately postpartum, as you are then at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Varenelle after childbirth;
• if you have superficial thrombophlebitis (inflammation of veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see section "Varenelle and other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria), blistering skin rash during pregnancy (herpes gestationis), a nervous system disorder with involuntary body movements (Sydenham's chorea);
• if you currently have or have ever had chloasma (skin pigmentation, especially on the face and neck, so-called "pregnancy mask"). If so, avoid direct exposure to sunlight or ultraviolet radiation; if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria, which may cause breathing difficulties, contact your doctor immediately. Medicines containing estrogens may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Varenelle increases the risk of developing blood clots compared to not using hormonal contraception.
In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur

• in veins (referred to below as "venous thrombosis" or "venous thromboembolic disease")
• in arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic events").

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by taking Varenelle is low.
HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS
What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (venous thromboembolism). However, these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots the highest?
The risk of developing venous blood clots is highest during the first year of first-time use of combined hormonal contraceptives. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a woman stops taking Varenelle, the risk of developing blood clots returns to normal within a few weeks.

What does the risk of venous blood clots depend on?
The risk depends on the natural background risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with the use of Varenelle is low.

• In one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In one year, about 5 to 7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing drospirenone, such as Varenelle, will develop blood clots.
• The risk of developing blood clots depends on the individual woman's medical history (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Varenelle is small, but certain factors may increase this risk. The risk is higher:

• if the patient is very overweight (body mass index [BMI] above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs or other organs at a young age (e.g. under 50 years). In this case, the patient may have an inherited tendency to form blood clots;
• if the patient needs to undergo surgery, is immobilised for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to stop taking Varenelle several weeks before surgery or before a period of immobility. If the patient needs to stop taking Varenelle, ask the doctor when it is safe to restart taking the medicine.
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the last few weeks).

The risk of developing blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, particularly if the patient has another risk factor listed above.
It is important to tell the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue the use of Varenelle.
Inform the doctor if any of the above conditions change during treatment with Varenelle, for example, if a close relative is diagnosed with unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots can lead to serious consequences such as heart attack or stroke.

Factors increasing the risk of arterial blood clots
It is important to note that the risk of heart attack or stroke associated with the use of Varenelle is very small, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Varenelle, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve disorder, heart rhythm disorder known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Varenelle, for example, if the patient starts smoking, if a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Varenelle and cancer
A slightly increased incidence of breast cancer has been observed in women using combined hormonal contraceptives, but it is not known whether this is caused by the use of the contraceptive. For example, it may be that more tumours are detected in women using combined hormonal contraceptives because these women are examined more frequently by doctors. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to examine the breasts regularly and contact the doctor if any lump is detected.
Rarely, benign liver tumours and, even more rarely, malignant liver tumours have been reported in women using combined hormonal contraceptives. If the patient experiences an unusual, severe abdominal pain, she should contact the doctor.

Intermenstrual bleeding
During the first few months of taking Varenelle, unexpected bleeding (bleeding outside the period of taking the white placebo tablets) may occur. If such bleeding persists for more than a few months, or if it starts after several months of use, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the placebo tablet period
If all the pink active tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medicines have been taken, the likelihood of pregnancy is very low.
If the expected withdrawal bleeding does not occur twice in succession, this may indicate pregnancy. Contact the doctor immediately. Do not start the next pack until pregnancy has been ruled out.

Psychiatric disorders
Some women using hormonal contraceptives, including Varenelle, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Varenelle and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Also inform any other doctor or dentist prescribing another medicine (or pharmacist) that Varenelle is being used. They may advise whether additional contraceptive methods (e.g. condoms) are needed, and if so, for how long, or whether the dosage of other medicines should be adjusted.
Some medicines may affect the blood levels of Varenelle and may cause Varenelle to be less effective in preventing pregnancy or may cause unexpected bleeding. These include:

• medicines used to treat epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (e.g. rifampicin), HIV and hepatitis C virus infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz), fungal infections (griseofulvin, ketoconazole), arthritis or osteoarthritis (etoricoxib), high blood pressure in the pulmonary arteries (bosentan);
• herbal products containing St. John's wort (Hypericum perforatum).

Varenelle may affect the action of other medicines, for example:

• medicines containing cyclosporine;
• antiepileptic medicines containing lamotrigine (may lead to increased frequency of seizures);
• theophylline (used for breathing problems);
• tizanidine (used to treat muscle pain and/or muscle spasms).

Do not administer Varenelle to patients with hepatitis C virus infection who are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as this may lead to increased liver function test results in blood (increased liver enzyme activity AlAT).
The doctor will prescribe another type of contraception before starting treatment with these medicines.
Varenelle may be restarted approximately 2 weeks after completion of such treatment. See section "When not to take Varenelle".
Before taking any medicine, consult a doctor or pharmacist.

Varenelle with food and drink
Varenelle may be taken with or without food, as needed, with a small amount of water.

Laboratory tests
If a blood test is required, inform the doctor or laboratory staff that a contraceptive is being used, as oral hormonal contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
Pregnancy
Varenelle must not be used during pregnancy. If the patient becomes pregnant while taking Varenelle, she should stop taking it immediately and contact her doctor.
If the patient wishes to become pregnant, she may stop taking Varenelle at any time (see also "Discontinuing Varenelle").

Breastfeeding
Varenelle is generally not recommended during breastfeeding. If the patient wishes to use a contraceptive during breastfeeding, she should contact her doctor.

Driving and using machines
There is no information indicating that Varenelle affects the ability to drive or operate machinery.

Varenelle contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

Varenelle contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Varenelle

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Each blister contains 21 pink tablets containing active substances and 7 white placebo tablets.
The Varenelle tablets in two different colours are arranged in the blister in a specific order. One
blister contains 28 tablets.
You should take one Varenelle tablet daily, with or without a small amount of water if needed.
You may take the tablets with or without food, but you should take them daily at approximately the
same time.
Do not confuse the tablets: take the pink tablets for the first 21 days, followed by the white tablets
for the last 7 days. A new blister should be started immediately (21 pink tablets, followed by 7 white
tablets). Therefore, there is no break week between two blisters.
Due to the different composition of the tablets, it is essential to start from the first tablet in the top
left corner of the pack and continue taking the tablets each day. To maintain the correct order, follow
the direction of the arrows on the blister.
Preparing the blister
To help remember how to take the contraceptive, each Varenelle blister is supplied with 7 self-adhesive
strips printed with the days of the week. You should know the day of the week on which you start taking
the tablets.
Depending on the day of the week on which you started taking the tablets, select the appropriate
self-adhesive strip. For example, if the first day of use was Wednesday, choose the strip where the first
day of the week is “Wed”. Apply the label to the top left corner of the blister, in the area marked “Start”.
This way, each tablet is marked with the corresponding day of the week, allowing you to check whether
a tablet has been taken. The arrows indicate the order of tablet intake.
During the 7 days when the white placebo tablets are taken (placebo days), withdrawal bleeding
should occur (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after
taking the last pink Varenelle tablet containing active substances. After taking the last white tablet,
you should start the next blister immediately, regardless of whether bleeding is still ongoing. This means
that each new blister will begin on the same day of the week, and bleeding should occur approximately
on the same days each month.
If the patient takes Varenelle as described above, she is protected against pregnancy also during the
7 days when taking placebo tablets.
When to start the first blister?

• If no hormonal contraceptive has been used in the previous month. Start taking Varenelle on the first day of the cycle (i.e. the first day of menstruation). If the patient starts taking Varenelle on the first day of menstruation, she is immediately protected against pregnancy. You may also start on days 2–5 of the cycle, but in this case, additional contraceptive methods (e.g. condoms) must be used for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined contraceptive vaginal system or transdermal system. You may start taking Varenelle the next day after taking the last active tablet (tablet containing active substances) from the previous pack, but no later than the next day after the tablet-free interval of the previous contraceptive ends (or after the last inactive tablet of the previous contraceptive). When switching from a combined contraceptive vaginal system or transdermal system, follow your doctor’s advice.
• Switching from a progestogen-only method (progestogen-only mini-pill, injections, implants, or intrauterine system releasing progestogen). You may switch at any time from progestogen-only pills (from an implant or intrauterine system on the day of its removal, or from injectable forms on the day of the next scheduled injection), but in all cases, additional contraceptive methods (e.g. condoms) must be used for the first 7 days of tablet intake.
• After miscarriage. Follow your doctor’s advice.
• After childbirth. After childbirth, you may start taking Varenelle between day 21 and 28 postpartum. If the patient starts taking the medicine later than on day 28, a mechanical method (e.g. condoms) should be used for the first seven days of taking Varenelle. If sexual intercourse occurred after childbirth before (re)starting Varenelle, the patient should first ensure she is not pregnant or wait until the next menstrual bleeding.
• If the patient is breastfeeding and wishes to (re)start taking Varenelle after childbirth. Please read section “Breastfeeding”.

If the patient is unsure when to start taking the medicine, she should consult her doctor.
Taking more Varenelle than recommended
There are no reports of serious harmful effects from taking too many Varenelle tablets.
Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet
started menstruating but have accidentally taken this medicine.
In case of taking too many Varenelle tablets or if a child swallows them, consult a doctor or pharmacist.
Missing a dose of Varenelle
The tablets in the fourth row of the blister are placebo tablets. If the patient misses one of these,
the contraceptive efficacy of Varenelle remains unchanged. Discard the missed placebo tablet.
If a pink tablet containing active substances from the 1st, 2nd, or 3rd row of the blister is missed,
follow the instructions below:

• If less than 12 hours have passed since the missed tablet, protection against pregnancy is not reduced. Take the tablet as soon as possible, and continue taking the next tablets at the usual time.
• If more than 12 hours have passed since the missed tablet, protection against pregnancy may be reduced. The more tablets missed, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greatest if a pink tablet is missed at the beginning or
end of the blister. Therefore, follow the rules below (see also the chart below):

• Missing more than one tablet in a blister Contact your doctor.
• Missing one tablet in week 1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, there is a risk of pregnancy. In this case, consult your doctor.
• Missing one tablet in week 2. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the next tablets at the usual time. Protection against pregnancy is not reduced and additional protection is not required.
• Missing one tablet in week 3.

There are two options:

1. Take the missed tablet as soon as possible, even if this means taking two tablets at once. Continue taking the next tablets at the usual time. Instead of taking the white placebo tablets from this blister, discard them and start taking tablets from the next blister.

Menstruation will most likely occur at the end of taking tablets from the second blister,
during the intake of the white placebo tablets, but spotting or intermenstrual bleeding may also
occur during the intake of tablets from the second blister.

2. You may also stop taking the pink active tablets and go directly to the 7 white placebo tablets ( before starting the placebo tablets, you should note the day on which the tablet was missed ). If the patient wishes to start the next blister on her usual starting day, the tablet-free interval can be shortened to less than 7 days.

If either of these two recommendations is followed, protection against pregnancy will be maintained.

• If the patient forgot to take any tablet from the blister and no bleeding occurs during the placebo tablet period, this may indicate that the patient is pregnant. In this case, consult a doctor before starting the next blister.

Missed more than 1
Consult your doctor
pink tablet in the blister
Yes
Was there sexual intercourse in the week
in week 1.
preceding the missed tablet?
no

• Take the missed tablet
• Use a mechanical method (condoms) for the next 7 days and
• Finish taking the tablets in the blister
• Take the missed tablet and
• Finish taking the tablets Missed only 1 pink in the blister tablet (taken more than 12 hours late) 2.
• Take the missed tablet and
• Finish taking the pink tablets
• Discard the 7 white tablets
• Start taking tablets from the next blister or in week 3.
• Immediately stop taking the pink tablets
• Go directly to the 7 white placebo tablets
• Start taking tablets from the next blister

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking a pink tablet containing active substances, or if severe diarrhoea occurs, there is a risk that the active substances from the tablet have not been completely absorbed into the body. This situation has similar consequences to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare blister as soon as possible.
If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the advice given in the section “Missed dose of Varenelle”.
Delayed withdrawal bleeding: what you should know
Although not recommended, delaying withdrawal bleeding is possible by skipping the white placebo tablets in the 4th row and moving directly to a new Varenelle blister until it is finished.
Spotting or intermenstrual bleeding may occur during the intake of tablets from the second blister.
Finish the second blister by taking the 7 white placebo tablets from the 4th row. Then start taking tablets from the next blister.
You may ask your doctor for advice before deciding to delay your period.
Changing the first day of bleeding: what you should know
If the patient takes the tablets as instructed, bleeding will start during the placebo tablet week.
If you need to change this day, you may do so by shortening ( but never lengthening – maximum 7 days! ) the placebo tablet period – when the white placebo tablets are taken.
For example, if the placebo tablet period starts on Friday and the patient wishes to change the day to Tuesday (3 days earlier), start the new blister 3 days earlier than usual. If the placebo tablet period is very short (e.g. 3 days or less), no bleeding may occur during these days. As a result, spotting or intermenstrual bleeding may occur.
If the patient is unsure how to proceed, she should contact her doctor.
Stopping Varenelle
You may stop taking Varenelle at any time. If the patient does not wish to become pregnant, she should consult her doctor about other effective methods of birth control. If she wishes to become pregnant, she should stop taking Varenelle and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected due date.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them. If any adverse reactions occur, especially severe and persistent ones, or changes in health that the user considers related to the use of Varenelle, medical advice should be sought.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, see section 2, "Important information before taking Varenelle".

Serious adverse reactions
Seek immediate medical advice if the user experiences any of the following symptoms of angioedema: swelling of the face, tongue and (or) throat and (or) difficulty swallowing, or urticaria that may cause breathing difficulties (see also section "Warnings and precautions").

Common adverse reactions (may affect up to 1 in 10 people):

• mood swings,
• headaches,
• abdominal (stomach) pain,
• acne,
• breast pain, breast enlargement, painful or irregular menstruation,
• weight gain.

Uncommon adverse reactions (may affect up to 1 in 100 people):

• candidiasis (fungal infection),
• cold sores (herpes simplex),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• sensations of tingling and numbness, vertigo,
• visual disturbances,
• heart rhythm disorders or abnormally rapid heartbeat,
• blood clot (thrombosis) in the lung (pulmonary embolism),
• high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, gastritis and (or) enteritis, diarrhoea, constipation,
• sudden swelling of the skin and (or) mucous membranes (e.g. tongue or throat) and (or) difficulty swallowing or urticaria with breathing difficulties (angioedema), hair loss (alopecia), rash, itching, skin eruptions, dry skin, seborrhoeic skin disorders (seborrhoeic dermatitis),
• neck pain, limb pain, muscle cramps,
• urinary tract infection,
• breast lump (benign and malignant), milk secretion in non-pregnant women (galactorrhoea), ovarian cysts, sudden flushing of the face, absence of menstruation, very heavy menstruation, vaginal discharge, vaginal dryness, lower abdominal (pelvic) pain, abnormal cervical smear (Pap test), decreased sexual desire,
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.

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

• asthma,
• hearing disorders,
• nodular erythema (characterised by painful red nodules on the skin),
• erythema multiforme (characterised by a rash with red, painful rings),
• harmful blood clots in a vein or artery, for example:
  • in the leg or foot (e.g. deep vein thrombosis),
  • in the lungs (e.g. pulmonary embolism),
  • heart attack,
  • stroke,
• mini-stroke or transient stroke-like symptoms, known as transient ischaemic attack,
• blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing blood clots may be higher if the user has any other risk factors (see section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Varenelle

Keep this medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
Expiry date
Do not use this medicine after the expiry date stated on the blister pack and the cardboard box
after "Expiry date" or "EXP:". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Varenelle contains
The Varenelle blister pack contains 21 pink tablets containing active substances in rows 1, 2 and 3, and
7 white placebo tablets in row 4.
Tablets containing active substances:
The active substances are ethinylestradiol and drospirenone.
Each tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone.
The other ingredients are:
Tablet core: monohydrate lactose, pregelatinized starch, corn starch, povidone K 30, sodium croscarmellose,
polysorbate 80, magnesium stearate.
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Placebo tablets:
Tablet core: lactose, povidone K30, magnesium stearate.
Tablet coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
What Varenelle looks like and contents of the pack
The tablets containing active substances are pink, round, film-coated tablets.
The placebo tablets are white, round, film-coated tablets.

• Varenelle is available in boxes containing 1 or 3 blisters, each blister containing 28 tablets (21 tablets containing active substances and 7 placebo tablets).

Not all pack sizes may be marketed.
Marketing Authorisation Holder
Theramex Ireland Limited
3rd Floor, Kilmore House,
Park Lane, Spencer Dock,
Dublin 1
D01 YE64
Ireland
Manufacturer
Laboratorios León Farma S.A.
C/ La Vallina s/n, Pol. Ind. Navatejera
24193 Villaquilambre – Leon
Spain
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
This medicinal product is authorised in the European Economic Area countries under the following names: