Varel

Package leaflet: Information for the user

Varel, 3 mg + 0,03 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 blood clots in veins and arteries, especially during the first year of use or after restarting 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 patient.

• Keep this leaflet, so it can be consulted again if necessary.
• If in doubt, consult a doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Varel is and what it is used for

Varel is a contraceptive tablet used to prevent pregnancy.
Each of the 21 yellow 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 called placebo tablets.
Contraceptive tablets containing two hormones are known as "combined" pills.

2. Important information before taking Varel

General notes
Before starting to take Varel, 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 using Varel, 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 certain other examinations.
This leaflet describes several situations in which you should stop taking Varel or in which the effectiveness of Varel may be reduced. In such situations, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other barrier methods. Do not use the rhythm method or temperature-based methods. These methods may be unreliable because Varel alters the monthly changes in body temperature and cervical mucus.
Varel, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.

When not to take Varel

• 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 Varel if you have any of the conditions listed below.
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 currently have (or have ever had in the past) a blood clot in the deep veins of the legs (deep vein thrombosis), in the 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 are undergoing surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you currently 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 currently have (or have had in the past) any of the following diseases 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 currently have (or have 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 and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Varel 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 you have breast cancer or cancer of the genital organs;
• if you have any unexplained vaginal bleeding;

Warnings and precautions
Before starting to take Varel, discuss this with your doctor or pharmacist.
When to exercise special caution when using Varel
When should you contact your doctor?
You should seek immediate medical advice

• 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 stroke (see section below "Blood clots (thrombosis)"). For a description of symptoms of these serious adverse effects, see "How to recognize the development of blood clots".

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

• if breast cancer currently occurs or has occurred in the past 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 body's 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 are undergoing surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are then at increased risk of developing blood clots. Consult your doctor for advice on how soon after delivery you can start taking Varel;
• if you have superficial thrombophlebitis (inflammation of veins under the skin with blood clots);
• if you have varicose veins;
• if you have epilepsy (see section "Varel and other medicines");
• if you have a condition that first occurred during pregnancy or previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, blistering skin rash during pregnancy (pemphigoid gestationis), a nervous system disorder with involuntary movements (Sydenham's chorea));
• if you currently have or have ever had chloasma (skin pigmentation, especially on the face and neck, also known as "melasma" or "pregnancy mask"). If so, avoid direct exposure to sunlight or ultraviolet radiation;
• if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or urticaria with potential breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using combined hormonal contraceptives such as Varel is associated with an increased risk of blood clots compared to not using such medication.
In rare cases, a blood clot can 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 from 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 associated with the use of Varel is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.

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

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (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 blood clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of
combined hormonal contraceptives. The risk may also be higher 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 compared to not using combined hormonal contraceptives.
If a patient stops taking Varel, the risk of blood clots returns to normal
within a few weeks.

What factors influence the risk of developing blood clots?
The risk depends on the individual's natural 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 Varel 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 Varel, will develop blood clots.
• The risk of developing blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots" below).

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

• if the patient has significant overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member of the patient has been diagnosed with 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 inherited clotting disorders;
• if the patient needs to undergo surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Varel several weeks before surgery or periods of limited mobility. If the patient must stop taking Varel, ask the doctor when it is safe to resume treatment.
• with increasing age (especially over 35 years);
• if the patient has 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 inform the doctor if any of the listed factors apply to the patient, even if uncertain. The doctor may decide to discontinue Varel.
Inform the doctor if any of the above conditions change during treatment with Varel, for example, if a close family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

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

Factors increasing the risk of blood clots in arteries
It is important to emphasize that the risk of heart attack or stroke associated with the use of Varel is very small, but may increase:

• with age (above approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Varel, 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 family member 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 family member has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorders such 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 Varel, for example, if the patient starts smoking, a close family member is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Varel and cancer
A slightly higher incidence of breast cancer has been observed in women using combined hormonal contraceptives, but it is not known whether this is caused by the medication. For example, it may be that more cancers 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 breasts regularly and contact a doctor if any lump is detected.
Benign liver tumors have been reported rarely, and malignant liver tumors very rarely, in women using combined hormonal contraceptives. If the patient experiences unusual, severe abdominal pain, she should contact a doctor.

Breakthrough bleeding
During the first few months of taking Varel, unexpected bleeding (bleeding outside the period of taking the white placebo tablets) may occur. If such bleeding lasts longer than a few months, or starts after several months, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the placebo tablet period
If all yellow active tablets have been taken correctly, there has been no vomiting or severe diarrhoea, and no other medications have been taken, it is very unlikely that pregnancy has occurred.
If expected bleeding does not occur twice in a row, this may indicate pregnancy. Contact a doctor immediately. Do not start the next pack until pregnancy has been ruled out.

Psychiatric disorders
Some women using hormonal contraceptives, including Varel, 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 a doctor as soon as possible for further medical advice.

Varel and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Also inform any other doctor or dentist prescribing another medicine (or pharmacist) that Varel is being used. They will advise whether additional contraceptive methods (e.g. condoms) are needed and, if so, for how long.
Some medicines may affect the blood levels of Varel and may 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), other infectious diseases (griseofulvin), or pulmonary hypertension (bosentan);
• herbal products containing St. John's wort.

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

• medicines containing cyclosporine;
• antiepileptic medicines containing lamotrigine (may lead to increased frequency of seizures).

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

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

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

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

Breastfeeding
Varel is generally not recommended during breastfeeding. If the patient wishes to use a contraceptive during breastfeeding, she should consult her doctor.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
There is no information indicating that Varel affects the ability to drive or operate machinery.

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

3. How to take Varel

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
you should always consult your doctor or pharmacist.
Each blister contains 21 yellow tablets containing active substances and 7 white placebo tablets.
The Varel tablets in two different colours are arranged in the blister in a specific order. One
blister contains 28 tablets.
Take one Varel tablet daily, with or without a small amount of water. The tablets may be taken
with or without food, but they should be taken every day at approximately the same time.
Do not confuse the tablets: the yellow tablets should be taken for the first 21 days, followed by the white
placebo tablets for the last 7 days. A new blister should be started immediately (21 yellow tablets, followed by 7 white
tablets). There is therefore no break week between two blisters.
Due to the different composition of the tablets, it is necessary 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 Varel 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.
Choose the appropriate self-adhesive strip according to the day of the week you started taking the tablets. For example, if the first day of use was Wednesday, select the strip where the first day of the week is "Wed". Stick the label in the top left corner of the blister, in the area marked "Start". This way, each tablet will be 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 begins on the 2nd or 3rd day after taking the last active yellow Varel tablet. After taking the last white placebo tablet, start the next blister immediately, regardless of whether bleeding is still ongoing. This means that each new blister will be started on the same day of the week, and withdrawal bleeding should occur approximately on the same days each month.
If the patient takes Varel as described above, she is protected against pregnancy also during the 7 days when taking the placebo tablets.
When to start the first blister?

• If no hormonal contraceptive has been used in the previous month. Start taking Varel on the first day of the cycle (i.e. the first day of menstruation). If the patient starts taking Varel on the first day of menstruation, she is protected against pregnancy immediately. Alternatively, treatment may be started 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 ring or transdermal patch. Varel may be started the 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 tablet-free interval of the previous contraceptive (or after the last inactive tablet of the previous contraceptive). When switching from a combined contraceptive vaginal ring or transdermal patch, follow your doctor's advice.
• Switching from a progestogen-only method (progestogen-only 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 removal, or from injectable forms on the day the next injection is due), 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 delivery, Varel may be started between day 21 and day 28. If the patient starts taking the medicine later than on day 28, a barrier method (e.g. condoms) must be used for the first 7 days of taking Varel. If sexual intercourse has occurred after childbirth, before (re)starting Varel, 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 Varel after childbirth. Please read section "Breastfeeding".

If the patient is unsure when to start taking the medicine, she should consult her doctor.
Taking more Varel than you should
There have been no reports of serious harmful effects from taking too many Varel tablets.
If several tablets are taken at once, nausea and vomiting may occur. In young girls, vaginal bleeding may occur.
If too many Varel tablets are taken or if they are swallowed by a child, consult a doctor or pharmacist.
Missed dose of Varel
The tablets in the fourth row of the blister are placebo tablets. If the patient forgets to take one of these,
the contraceptive efficacy of Varel is maintained. The missed tablet should be discarded.
If a yellow tablet containing active substances from rows 1, 2, or 3 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 missed tablet as soon as possible, and take 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 greater the risk of becoming pregnant.

The risk of inadequate protection against pregnancy is greatest if a yellow 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 following tablets at the usual time and use additional contraception, such as condoms, for the next 7 days. If sexual intercourse occurred in the week before the tablet was missed, there is a risk of pregnancy. In this case, contact 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 following tablets at the usual time. Protection against pregnancy is not reduced, and additional contraception 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 following tablets at the usual time. Instead of taking the white placebo tablets from this blister, discard them and immediately start taking tablets from the next blister.

Withdrawal bleeding 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. Alternatively, you may stop taking the yellow active tablets and proceed directly to the 7 white placebo tablets ( before starting the placebo tablets, note the day on which the tablet was missed ). If the patient wishes to start a new blister on her usual starting day, the tablet-free interval may be shortened to less than 7 days.

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

• If the patient has missed 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, contact a doctor before starting the next blister.

yes
Was there sexual intercourse in the week
preceding week 1
before the missed tablet?
no

• Take the missed tablet
• Use a barrier method (condoms) for the next 7 days, and
• Continue taking tablets from the blister pack

Only 1 yellow tablet missed
(taken more than • Take the missed tablet and
12 hours late) in week 2 • Continue taking tablets
from the blister pack

• Take the missed tablet and
• Finish taking the yellow tablets
• Discard the 7 white tablets
• Start taking tablets from the next blister pack

or
in week 3

• Immediately stop taking the yellow tablets
• Proceed directly to the 7 white placebo tablets
• Start taking tablets from the next blister pack

What to do if vomiting or severe diarrhoea occurs
If vomiting occurs within 3 to 4 hours after taking the yellow active tablet or if severe diarrhoea develops, there is a risk that the active substances have not been completely absorbed by the body. This situation is similar in effect to missing a tablet. After vomiting or diarrhoea, take another tablet from a spare pack as soon as possible. If possible, take it within 12 hours of the usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the instructions given under the section “Missed dose of Varel”.
Delayed onset of withdrawal bleeding: what you should know
Although not recommended, delaying the onset of withdrawal bleeding is possible by skipping the white placebo tablets in the 4th row and immediately starting a new blister pack of Varel until it is finished.
Breakthrough bleeding or spotting may occur during intake of tablets from the second blister pack. Complete the second blister pack by taking the 7 white placebo tablets from the 4th row. Then start taking tablets from the next blister pack.
You may consult your doctor for advice before deciding to delay your period.
Changing the day when withdrawal bleeding starts: what you should know
If the patient takes the tablets as directed, withdrawal bleeding will begin during the week of placebo tablets. If it is necessary to change this day, it can be done by shortening ( but never extending – maximum 7 days !) the period of placebo tablet intake – i.e. 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 pack 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 consult her doctor.
Stopping Varel
You may stop taking Varel at any time. If the patient does not wish to become pregnant, she should consult her doctor regarding other effective methods of birth control. If pregnancy is desired, stop taking Varel and wait for a menstrual period before trying to conceive. This makes it easier to calculate the expected date of delivery.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them. If any adverse reactions occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Varel, medical advice should be sought immediately.

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 the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Varel".

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

The following adverse reactions have been associated with the use of Varel.

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

• menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
• headache, depression,
• migraine,
• nausea,
• thick, white vaginal discharge and fungal vaginal infections.

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

• changes in sexual desire (interest in sex),
• high blood pressure, low blood pressure,
• vomiting, diarrhoea,
• acne, skin rash, severe itching, hair loss,
• breast enlargement,
• vaginal infections,
• fluid retention and changes in body weight.

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

• allergic reactions (hypersensitivity), asthma,
• breast discharge,
• hearing disorders,
• nodular erythema (manifesting as painful red nodules on the skin) or erythema multiforme (manifesting as a rash with red, painful rings),
• harmful blood clots in veins or arteries, for example:
  • in the leg or foot (e.g. deep vein thrombosis),
  • in the lungs (e.g. pulmonary embolism),
  • heart attack,
  • stroke,
  • so-called "mini-stroke" or transient ischaemic attack (TIA),
  • blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has any other conditions that increase this risk (see section 2 for further information on factors increasing the risk of 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 your 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Varel

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

6. Contents of the pack and other information

What Varel contains
The Varel blister pack contains 21 yellow active tablets arranged in rows 1, 2, and 3, and 7 white placebo tablets in row 4.
Active tablets:
The active substances are ethinylestradiol and drospirenone.
Each tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone.
Other ingredients are:
Tablet core: monohydrate lactose, corn starch, pregelatinized corn starch, crospovidone, povidone K 30, polysorbate 80, magnesium stearate.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).
Placebo tablets:
Tablet core: lactose, povidone, magnesium stearate.
Tablet coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
What Varel looks like and contents of the pack
The active tablets are yellow, round, film-coated tablets.
The placebo tablets are white, round, film-coated tablets.
Varel is available in boxes containing 1 or 3 blisters, each blister containing 28 tablets (21 active tablets 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
This medicinal product is authorised in the Member States of the European Economic Area under the following names: