Varenelle

Leaflet accompanying the packaging: information for the user

Varenelle, 3 mg + 0.02 mg, coated tablets

Drospirenone + Ethinylestradiol

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots").

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be passed on to others. The medicine may harm another person.
• If the patient experiences any undesirable effects, including any undesirable effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Varenelle and what is it 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 packaging and other information

1. What is Varenelle and what is it used for

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

2. Important information before taking Varenelle

General notes

Before starting to take Varenelle, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before Varenelle can be started, the doctor will ask a few questions about your health and about the health of your close relatives. The doctor will also measure your blood pressure and, depending on the individual case, may also perform some other examinations.
This leaflet describes several situations in which you should stop taking Varenelle, or in which the effectiveness of Varenelle may be reduced. In such situations, you should either not have sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. You should not use the calendar method or the temperature measurement method. These methods may be unreliable because Varenelle modifies the monthly changes in body temperature and cervical mucus.

Varenelle, like other hormonal contraceptives, does not protect against HIV (AIDS) 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.

You should not take Varenelle if you have any of the conditions listed below. If you have any of these conditions, you should inform your doctor. The doctor will discuss with you which other contraceptive method will be more suitable.

• if you have (or have ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if you know you have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Varenelle for a few weeks before surgery or immobilization. If you need to stop taking Varenelle, you should ask your doctor when you can resume taking the medicine.
• if you have had a heart attack or stroke;
• if you have (or have had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (temporary stroke symptoms);
• if you have any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides);
• a disease called hyperhomocysteinemia;
• if you have (or have had) a type of migraine called "migraine with aura";
• if you have (or have had) liver disease, and liver function is still abnormal;
• if you have kidney problems (kidney failure);
• if you have viral 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 have (or have had) liver cancer;
• if you have (or have had) or suspect you have breast cancer or cancer of the genital organs;
• if you have unexplained vaginal bleeding;

Additional information for special populations

Children and adolescents
Varenelle is not intended for use in girls who have not yet started their menstrual cycle.
Elderly women
Varenelle is not intended for use after menopause.
Women with liver disease
You should not take Varenelle if you have liver disease. See also sections "When not to take Varenelle" and "Warnings and precautions".
Women with kidney disease
You should not take Varenelle if you have kidney failure or acute kidney failure. See also sections "When not to take Varenelle" and "Warnings and precautions".

Warnings and precautions

You should discuss this with your doctor or pharmacist before starting to take Varenelle.

When to be particularly careful when taking Varenelle

When should you contact your doctor?

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

In certain situations, you should be particularly careful when taking Varenelle or any other combined hormonal contraceptive and may need to be regularly examined by your doctor.

You should tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Varenelle, you should also tell your doctor.

• if there is a history of 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 (a chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a genetic disorder that affects red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a family history of this condition. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots";
• if you have recently given birth, you are at a higher risk of blood clots. You should consult your doctor to find out how soon you can start taking Varenelle after giving birth.
• If you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have epilepsy (see section "Varenelle and other medicines");
• if you have a disease that first occurred during pregnancy or while taking sex hormones (e.g., hearing loss, a blood disease called porphyria), a skin rash with blisters during pregnancy (pemphigoid gestationis), a neurological disease characterized by involuntary movements of the body (Sydenham's chorea);
• if you have chloasma (skin discoloration, especially on the face and neck, so-called pregnancy spots). If so, you should avoid direct exposure to sunlight or ultraviolet radiation; if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medications may cause or worsen symptoms of both hereditary and acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Varenelle, is associated with an increased risk of blood clots in women compared to not taking them.
In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

• in veins (also called "venous thromboembolism" or "deep vein thrombosis")
• in arteries (also called "arterial thromboembolism").

Not everyone recovers fully after a blood clot. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

Remember that the overall risk of a blood clot caused by taking Varenelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

You should contact your doctor immediately if you notice any of the following symptoms.

BLOOD CLOTS IN VEINS

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

• Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. They most often occur in the first year of taking combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to deep vein thrombosis.
• If a blood clot breaks loose from the leg and travels to the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein highest?

The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always higher than when not taking combined hormonal contraceptives.
If you stop taking Varenelle, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The overall risk of blood clots in the legs or lungs associated with taking Varenelle is small.

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

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with taking Varenelle is small, but some factors can increase this risk. The risk is higher:

• if you are severely overweight (body mass index [BMI] over 30 kg/m);
• if someone in your close family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, you may have a hereditary blood clotting disorder;
• if you need to have surgery or will be immobilized for a long time due to injury or illness or have a leg in a cast. It may be necessary to stop taking Varenelle for a few weeks before surgery or immobilization. If you need to stop taking Varenelle, you should ask your doctor when you can resume taking the medicine;
• with age (especially over 35 years old);
• if you have recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-distance air travel (>4 hours) may temporarily increase the risk of blood clots, especially if you have another risk factor.
It is essential to tell your doctor if any of these risk factors apply to you, even if you are not sure. Your doctor may decide to stop Varenelle.
You should inform your doctor if any of these conditions change while taking Varenelle, e.g., if someone in your close family is diagnosed with a blood clot without a known cause or if you gain weight significantly.

BLOOD CLOTS IN ARTERIES

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

Similar to blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

It is essential to note that the risk of a heart attack or stroke associated with taking Varenelle is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke.While taking a hormonal contraceptive like Varenelle, it is recommended to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend a different type of contraception;
• if you are overweight;
• if you have high blood pressure;
• if someone in your close family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at a higher risk of having a heart attack or stroke;
• if you or someone in your close family has high levels of fats in the blood (cholesterol or triglycerides);
• if you have migraines, especially migraines with aura;
• if you have heart disease (valve damage, irregular heartbeat 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 a blood clot may be even higher.
You should inform your doctor if any of these conditions change while taking Varenelle, e.g., if you start smoking, someone in your close family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Varenelle and cancer

Women taking combined contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the medicine. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by doctors more often. The frequency of breast tumors decreases gradually after stopping combined hormonal contraceptives.
It is essential to examine your breasts regularly and contact your doctor if you feel any lump.
Women taking combined contraceptives have also been reported to have, in rare cases, benign liver tumors, and in even rarer cases, malignant liver tumors. If you experience unusual, severe abdominal pain, you should contact your doctor.

Irregular bleeding

During the first few months of taking Varenelle, you may experience unexpected bleeding (bleeding outside of the period when taking the white placebo tablets). If such bleeding lasts longer than a few months or starts after a few months, your doctor should investigate the cause.

What to do if bleeding does not occur during the period when taking the placebo tablets

If all the pink active tablets have been taken correctly, no vomiting or severe diarrhea has occurred, and no other medicines have been taken, it is very unlikely that you are pregnant.
If the expected bleeding does not occur twice in a row, it may mean that you are pregnant. You should contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Psychological disorders

Some women taking hormonal contraceptives, including Varenelle, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible for further medical advice.

Varenelle and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should also tell any other doctor or dentist prescribing another medicine (or pharmacist) that you are taking Varenelle. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and for how long, or if you need to change the dosage of other medicines you are taking.
Certain medicines may affect the levels of Varenelle in your blood and may make Varenelle 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 (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) fungal infections (griseofulvin, ketoconazole) rheumatoid arthritis, osteoarthritis (etoricoxib) pulmonary hypertension (bosentan)
• herbal medicines containing St. John's Wort.

Varenelle may affect the action of other medicines, such as:
medicines containing cyclosporin,
antiepileptic medicines containing lamotrigine (may increase the frequency of seizures),
theophylline (used for breathing problems)
tizanidine (used to treat muscle pain and/or muscle spasms).
You should not take Varenelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, or glecaprevir/pibrentasvir or sofosbuvir with velpatasvir and voxilaprevir, as this may cause increased liver enzyme levels in the blood (increased ALT activity). Your doctor will prescribe a different type of contraception before starting treatment with these medicines.
Varenelle can be taken again about 2 weeks after finishing this treatment. See section "When not to take Varenelle".
Before taking any medicine, you should consult your doctor or pharmacist.

Varenelle with food and drink

Varenelle can be taken with or without food, with a small amount of water if necessary.

Lab tests

If a blood test is necessary, you should tell your doctor or laboratory staff that you are taking a contraceptive, as oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant should not take Varenelle. If you become pregnant while taking Varenelle, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop taking Varenelle at any time (see also "Stopping Varenelle").
Breastfeeding
It is usually not recommended to take Varenelle while breastfeeding. If you want to take a contraceptive while breastfeeding, you should contact your doctor.

Driving and using machines

There is no information to suggest that taking Varenelle affects your ability to drive or use machines.

Varenelle contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

Varenelle contains sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which means that the medicine is considered "sodium-free".

3. How to take Varenelle

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Each blister pack contains 21 pink active tablets and 7 white placebo tablets.
Varenelle tablets in two different colors are arranged in the blister pack in a specific order. One blister pack contains 28 tablets.
You should take one Varenelle tablet every day, with a small amount of water if necessary.
You can take the tablets with or without food, but you should take them every day at about the same time.
Do not confuse the tablets:the pink active tablets are taken for the first 21 days, followed by the white placebo tablets for the last 7 days. You should start a new blister pack immediately (21 pink active tablets, followed by 7 white placebo tablets). There is no gap between the two blister packs.
Due to the different composition of the tablets, it is essential to start taking the tablets from the first tablet in the top left corner of the packaging and continue taking them every day in the direction of the arrows on the blister pack.

Preparing the blister pack

To help you remember to take your contraceptive, each Varenelle blister pack comes with 7 self-adhesive strips with the days of the week printed on them. You should know the day of the week you start taking the tablets.
According to the day of the week you start taking the tablets, you should choose the corresponding self-adhesive strip. For example, if the first day of taking the tablets was on a Wednesday, you should choose the strip with "Wed" as the first day of the week. You should stick the strip in the top left corner of the blister pack, where it says "Start". This way, each tablet has the corresponding day of the week, and you can check if you have taken the tablet. The arrows show the order in which to take the tablets.
During the 7 days when the white placebo tablets are taken (placebo days), you should experience bleeding (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last pink active tablet. After taking the last white placebo tablet, you should start a new blister pack, regardless of whether the bleeding has stopped. This means that each new blister pack will be started on the same day of the week, and the bleeding should occur at about the same time every month.
If you take Varenelle in this way, you are also protected against pregnancy during the 7 days when you take the placebo tablets.

When can you start the first blister pack?

• If you did not take a hormonal contraceptive in the previous month.You should start taking Varenelle on the first day of your menstrual cycle (i.e., the first day of your period). If you start taking Varenelle on the first day of your period, you are immediately protected against pregnancy. You can also start taking the medicine on days 2-5 of your cycle, but you will need to use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch.You can 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 day after the end of the period without tablets from the previous contraceptive. In the case of switching from a combined hormonal contraceptive vaginal ring or patch, you should follow your doctor's instructions.
• Switching from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine system releasing progestogen).You can switch at any time from a progestogen-only pill (from an implant or intrauterine system on the day of its removal, or from injections on the day of the planned next injection), but in all cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Varenelle.
• After a miscarriage.You should follow your doctor's instructions.
• After childbirth.You can start taking Varenelle from 21 to 28 days after giving birth. If you start taking the medicine later than 28 days after giving birth, you should use a mechanical method (e.g., condoms) for the first 7 days of taking Varenelle. If you have had sexual intercourse after giving birth before (re)starting Varenelle, you should first ensure that you are not pregnant or wait for your next menstrual period.
• If you are breastfeeding and want to (re)start taking Varenelle after childbirth.You should read the section "Breastfeeding".

If you are unsure when to start taking Varenelle, you should consult your doctor.

What to do if you take more Varenelle than you should

There are no reports of serious, harmful effects from taking too many Varenelle tablets.
You may experience nausea, vomiting, or vaginal bleeding. This type of bleeding may occur even in girls who have not yet started their menstrual cycle but have taken the medicine by mistake.
If you have taken too many Varenelle tablets or if a child has swallowed them, you should consult your doctor or pharmacist.

What to do if you forget to take Varenelle

The tablets in the fourthrow of the blister pack are placebo tablets. If you forget to take one of them, the contraceptive effectiveness of Varenelle is maintained. You should discard the missed placebo tablet.
If you miss a pink active tablet from the 1st, 2nd, or 3rdrow of the blister pack, you should follow these instructions:

• if it has been less than 12 hourssince you missed the tablet, your protection against pregnancy is not reduced. You should take the tablet as soon as possible, and then take the next tablets at the usual time.
• if it has been more than 12 hourssince you missed the tablet, your protection against pregnancy may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of reduced protection against pregnancy is highest if you miss a pink active tablet at the beginning or end of the blister pack. Therefore, you should follow these rules (see also the diagram below):

• Missing more than one tablet in a blister packYou should contact your doctor.
• Missing one tablet in week 1You should take the missed tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time and use additional protection, such as condoms, for the next 7 days. If you had sexual intercourse in the week before missing the tablet, there is a risk of pregnancy. In this case, you should contact your doctor.
• Missing one tablet in week 2You should take the missed tablet as soon as possible, even if it means taking two tablets at once. You should then take the next tablets at the usual time. Your protection against pregnancy is not reduced, and you do not need to use additional protection.
• Missing one tablet in week 3

There are two options to choose from:

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

Menstruation will most likely occur at the end of the second blister pack, during the white placebo tablets, but you may also experience spotting or breakthrough bleeding during the second blister pack.

• 2. You can 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 you missed the tablet). If you want to start the next blister pack on your usual start day, you can shorten the tablet-free period to less than 7 days.

If you follow one of these two instructions, your protection against pregnancy will be maintained.

• If you forget to take any of the tablets in the blister pack and do not experience bleeding during the placebo days, you may be pregnant. In this case, you should contact your doctor before starting the next blister pack.

Missed more than 1
pink tablet from 1
blister pack
You should consult your doctor
Yes
in week 1.
Was there sexual intercourse in the week before missing the tablet?

• Take the missed tablet
• Use a mechanical method (condoms) for the next 7 days and
• Finish taking the tablets from the blister pack without
• Take the missed tablet and
• Finish taking the tablets from the blister pack Missed only 1 pink tablet (taken more than 12 hours late) in week
• 2.
• Take the missed tablet and
• Finish taking the pink active tablets
• Discard the 7 white placebo tablets
• Start taking the tablets from the next blister pack or in week 3.
• Stop taking the pink active tablets immediately
• Go directly to the 7 white placebo tablets
• Start taking the tablets from the next blister pack

What to do if you vomit or have severe diarrhea

If you vomit within 3 to 4 hours of taking a pink active tablet, or if you have severe diarrhea, there is a risk that the active substances from the tablet have not been fully absorbed into your body. The situation is similar to missing a tablet. After vomiting or diarrhea, you should take another tablet from a reserve blister pack as soon as possible.
If possible, you should take it within 12 hoursof the normal time you take the tablet. If this is not possible or more than 12 hours have passed, you should follow the instructions in the section "If you forget to take Varenelle".

4. Possible Undesirable Effects

Like all medicines, this medicine can cause undesirable effects, although they do not occur in everyone. If any undesirable effects occur, especially severe and persistent ones, or changes in health status that the patient considers related to the use of Varenelle, they should consult their doctor.
In all women taking combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). To obtain detailed information about the various risk factors associated with the use of combined hormonal contraceptives, you should refer to point 2 "Important information before taking Varenelle".
Severe undesirable effects
You should immediately contact your doctor if you experience any of the following symptoms of angioedema: facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or hives that may cause difficulty breathing (see also the section "Warnings and precautions").
Common undesirable effects (may affect up to 1 in 10 people):

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

Uncommon undesirable effects (may affect up to 1 in 100 people):

• candidiasis (fungal infection),
• herpes simplex (cold sore),
• allergic reactions,
• increased appetite,
• depression, nervousness, sleep disorders,
• tingling and numbness, dizziness of labyrinthine origin,
• vision disturbances,
• heart rhythm disorders or extremely rapid heart rate,
• blood clots (thrombosis) in the lung (pulmonary embolism)
• high blood pressure, low blood pressure, migraine, varicose veins,
• sore throat,
• nausea, vomiting, gastritis and/or enteritis, diarrhea, constipation,
• sudden swelling of the skin and/or mucous membranes (e.g., tongue or throat) and/or difficulty swallowing or hives with difficulty breathing (angioedema), hair loss (alopecia), rash, itching, skin rashes, dry skin, seborrheic dermatitis (seborrheic eczema),
• neck pain, limb pain, muscle cramps,
• urinary tract infection,
• breast lump (benign and malignant), milk secretion in non-pregnant women (galactorrhea), ovarian cysts, sudden facial flushing, amenorrhea, very heavy periods, leukorrhea, vaginal dryness, lower abdominal pain (pelvic), abnormal Pap smear (Pap test), decreased libido,
• fluid retention, lack of energy, strong thirst, increased sweating,
• weight loss.

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

• asthma,
• hearing disorders,
• erythema nodosum (characterized by painful, red nodules on the skin),
• erythema multiforme (characterized by a rash with red, painful borders),
• 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 symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach/intestine, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see point 2 for further information about risk factors for blood clots and symptoms of blood clots)

Reporting Undesirable Effects

If any undesirable effects occur, including any undesirable effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Undesirable effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Undesirable effects can also be reported to the marketing authorization holder.
By reporting undesirable effects, you can help provide more information on the safety of this medicine.

5. How to Store Varenelle

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.

Expiry Date

Do not use this medicine after the expiry date stated on the blister pack and carton after "Expiry Date" or "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Varenelle Contains

A Varenelle blister pack contains 21 pink tablets containing active substances in rows 1, 2, and 3, and 7 white placebo tablets in row 4.

Active Substance Tablets:

The active substances are ethinylestradiol and drospirenone.
Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
The other ingredients are:
Tablet core: lactose monohydrate, cornstarch, povidone K30, croscarmellose sodium, polysorbate 80, magnesium stearate.
Tablet coating: partially hydrolyzed 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 hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

What Varenelle Looks Like and Contents of the Pack

Active substance tablets are pink, round, film-coated tablets.
Placebo tablets are white, round, film-coated tablets.

• Varenelle is available in packs of 1 or 3 blister packs, each containing 28 tablets (21 active substance tablets and 7 placebo tablets).

Not all pack sizes may be marketed.

Marketing Authorization 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 Authorized in the Member States of the European

Economic Area Under the Following Names:

Date of Last Revision of the Leaflet:May 2025