Varel

Leaflet accompanying the packaging: information for the user

Varel, 3 mg + 0.03 mg, film-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.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Varel and what is it used for

Varel is a contraceptive pill and is used to prevent pregnancy.
Each of the 21 yellow film-coated tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol.
7 white film-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 Varel

General notes

Before starting to take Varel, 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 starting to take Varel, the doctor will ask you a few questions about your health and 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 tests.
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 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 Varel modifies the monthly changes in body temperature and cervical mucus.

Varel, like other hormonal contraceptives, does not protect against HIV infection (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 be the cause of itching, rash, or swelling.

You should not take Varel if you have any of the conditions listed below.
If you have any of the conditions listed below, 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), in the lungs (pulmonary embolism), or in other organs;
• if you know that you have disorders that affect blood clotting - 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 (see section "Blood clots");
• 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 (transient symptoms of a stroke);
• if you have any of the following diseases that 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 hepatitis C virus 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 have (or have had) liver cancer;
• if you have (or have had) or suspect breast or genital cancer;
• if you have any unexplained vaginal bleeding;

Warnings and precautions

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

When to exercise special caution when taking Varel

When should you contact your doctor?
You should contact your doctor immediately

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

In certain situations, you should exercise special caution when taking Varel or any other combined hormonal contraceptive and may also need to be regularly examined by a doctor.

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

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

• if someone in your immediate family has had breast cancer;
• 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 hereditary disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or 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 just given birth, you are at an increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Varel 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 "Varel 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 swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives with potential breathing difficulties, you should contact your doctor immediately. Medicines containing estrogens may cause or worsen the symptoms of hereditary or acquired angioedema.

BLOOD CLOTS

Taking combined hormonal contraceptives, such as Varel, is associated with an increased risk of blood clots in women compared to when no therapy is used.
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 "venous thrombotic event")
• in arteries (also called "arterial thromboembolism" or "arterial thrombotic event")

Not everyone who has a blood clot will recover completely. In rare cases, the effects of a blood clot can be long-lasting or, very rarely, fatal.

Remember that the overall risk of having a harmful blood clot due to Varel is small.

HOW TO RECOGNIZE BLOOD CLOTS

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 undesirable effects are rare. They most often occur in the first year of taking combined hormonal contraceptives.

The risk of blood clots in the veins is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting 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 compared to when combined hormonal contraceptives are not used.
If you stop taking Varel, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

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 Varel 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 Varel, will develop blood clots.
• The risk of blood clots depends on the individual medical history of the patient (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 Varel is small, but some factors can increase this risk. The risk is higher:

• if you are overweight (body mass index (BMI) over 30 kg/m2);
• if someone in your immediate 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, if you are immobilized for a long time due to injury or illness, or if you have a leg in a cast. It may be necessary to stop taking Varel for a few weeks before surgery or immobilization. If you need to stop taking Varel, you should ask your doctor when you can restart it.
• with age (especially over 35 years old);
• if you have given birth in the last few weeks.

The risk of blood clots increases with the number of risk factors present in the patient.
Long-haul flights (>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 Varel.
You should inform your doctor if any of the above conditions change while taking Varel, e.g., if someone in your immediate 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?

Similarly to blood clots in veins, blood clots in arteries can cause serious consequences, 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 Varel is very small, but it may increase:

• with age (over about 35 years old);
• if you smoke.While taking a hormonal contraceptive like Varel, you are advised to stop smoking. If you are unable to stop 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 immediate family has had a heart attack or stroke at a young age (under 50 years old). In this case, you may also be at increased risk of having a heart attack or stroke;
• if you or someone in your immediate family has been diagnosed with 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, arrhythmia called atrial fibrillation)
• if you have diabetes.

If you have more than one of the above conditions or if any of them are severe, the risk of blood clots may be even higher.
You should inform your doctor if any of the above conditions change while taking Varel, e.g., if you start smoking, if someone in your immediate family is diagnosed with a blood clot without a known cause, or if you gain weight significantly.

Varel and cancer

Women taking combined contraceptives have been found to have a slightly increased 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 incidence 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.

Unwanted bleeding

During the first few months of taking Varel, you may experience unexpected bleeding (bleeding outside of your period). 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 you do not have bleeding during the period of taking placebo tablets

If you have taken all the active tablets correctly, have not vomited, have not had severe diarrhea, and have not taken any other medicines, it is very unlikely that you are pregnant.
If you do not have your expected bleeding, you may be pregnant. You should contact your doctor immediately. Do not start the next blister pack until you are sure you are not pregnant.

Mental disorders

Some women taking hormonal contraceptives, including Varel, 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.

Varel 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 Varel. They may tell you if you need to use additional contraceptive methods (e.g., condoms) and for how long.
Certain medicines may affect the level of Varel in your blood and may make it 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), or other infectious diseases (griseofulvin), or high blood pressure in the blood vessels of the lungs (bosentan)
• herbal medicines containing St. John's Wort.

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

Varel with food and drink

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

Lab tests

If you need to have a blood test, you should tell your doctor or laboratory staff that you are taking a contraceptive. Oral contraceptives may affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy

Pregnant women should not take Varel. If you become pregnant while taking Varel, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop taking Varel at any time (see also "Stopping Varel").

Breastfeeding

Varel is not usually recommended if you are breastfeeding. If you want to use a contraceptive while breastfeeding, you should contact your doctor.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Varel contains lactose

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

3. How to take Varel

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 yellow active tablets and 7 white placebo tablets.
The Varel 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 Varel 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 yellow active tablets are taken for the first 21 days, and then the white placebo tablets are taken for the last 7 days. A new blister pack should be started immediately (21 yellow active tablets, followed by 7 white placebo tablets). There is no break between the two blister packs.
Because the tablets have a different composition, it is essential to start taking the tablets from the first tablet in the top left corner of the packaging and continue taking the tablets every day. To maintain the correct order, you should move in the direction of the arrows on the blister pack.

Preparing the blister pack

To help you remember to take your contraceptive, each Varel 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 a tablet. The arrows show the order in which to take the tablets.
During the 7 days when the white placebo tablets from the 4th row are taken, you should have bleeding (so-called withdrawal bleeding). This bleeding usually starts on the 2nd or 3rd day after taking the last yellow active tablet of Varel. 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 also occur at about the same time every month.
If you take Varel 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 have not taken a hormonal contraceptive in the previous month.You should start taking Varel on the first day of your period (the first day of menstruation). If you start taking Varel on the first day of your period, you are immediately protected against pregnancy. You can also start taking Varel on days 2-5 of your period, but in this case, you should use additional contraceptive methods (e.g., condoms) for the first 7 days.
• Switching from a combined hormonal contraceptive or a combined contraceptive vaginal ring or patch.You can start taking Varel the next day after taking the last active tablet (the tablet containing the active substances) from the previous pack, but no later than the next day after the end of the tablet-free period of the previous contraceptive. In the case of switching from a combined contraceptive vaginal ring or patch, you should follow your doctor's advice.
• Switching from a progestogen-only method (mini-pill, injection, implant, or intrauterine system releasing progestogen).You can switch at any time from a mini-pill (from an implant or intrauterine system on the day it is removed, or from injections when the next injection is scheduled) but in all cases, you should use additional contraceptive methods (e.g., condoms) for the first 7 days of taking Varel.
• After a miscarriage.You should follow your doctor's advice.
• After childbirth.After giving birth, you can start taking Varel from the 21st to the 28th day after delivery. If you start taking Varel later than on the 28th day, you should use a mechanical method (e.g., condoms) for the first 7 days of taking Varel. If you have had sexual intercourse after giving birth before (re)starting Varel, you should first make sure you are not pregnant or wait for your next period.
• If you are breastfeeding and want to (re)start taking Varel after childbirth.You should read the section "Breastfeeding".

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

What to do if you take more Varel than you should

There are no reports of serious, harmful effects from taking too many Varel tablets at once.
If several tablets are taken at the same time, nausea and vomiting may occur. In young girls, vaginal bleeding may occur.
If you have taken too many Varel tablets or if a child has swallowed them, you should consult your doctor or pharmacist.

What to do if you forget to take Varel

The tablets in the 4throw of the blister pack are placebo tablets. If you forget to take one of them, the contraceptive efficacy of Varel is maintained. You should discard the missed tablet.
If you miss a yellow 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, contraceptive protection 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, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of becoming pregnant.

The risk of reduced contraceptive protection is highest if you miss a yellow 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 consult 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 the same time. You should then continue taking the 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 consult 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 the same time. You should then continue taking the tablets at the usual time. Contraceptive protection 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 the same time. Then continue taking the tablets at the usual time. Instead of taking the white placebo tablets from this blister pack, you should discard them and start a new 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 intermenstrual bleeding during the second blister pack.

• 2. You can also stop taking the yellow 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 a new 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, contraceptive protection will be maintained.

• If you forget to take any tablet from the blister pack and do not have bleeding during the placebo tablet period, it may mean that you are pregnant. In this case, you should consult your doctor before starting the next blister pack.

yes
in week 1.
Was there sexual intercourse in the week before missing the tablet?
no

• Take the missed tablet
• Use a mechanical method (condoms) for the next 7 days and
• Finish the tablets from the blister pack

Missed only 1 yellow tablet (taken more than 12 hours late)

• Take the missed tablet and
• Finish the tablets from the blister pack
• Take the missed tablet and
• Finish the yellow active tablets
• Discard the 7 white placebo tablets
• Start a new blister pack

or
in week 3.

• Stop taking the yellow active tablets immediately
• Go directly to the 7 white placebo tablets
• Start a new blister pack in week 2.

What to do if you vomit or have severe diarrhea

If you vomit within 3 to 4 hours after taking a yellow active tablet, or if you have severe diarrhea, there is a risk that the active substances from the tablet may not have 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 pack as soon as possible. If possible, you should take it within 12 hoursof the normal time of taking the tablet. If this is not possible or more than 12 hours have passed, you should follow the instructions given in the section "If you forget to take Varel".

Delaying your period: what you need to know

Although it is not recommended, you can delay your period by skipping the white placebo tablets from the 4th row and starting a new Varel blister pack immediately, until you finish it. You may experience spotting or intermenstrual bleeding during the second blister pack.
You should finish the second blister pack by taking the 7 white placebo tablets from the 4th row. Then start a new blister pack.
You can ask your doctor for advice before deciding to delay your period.

Changing the first day of your period: what you need to know

If you take the tablets as instructed, your period will start during the placebo tablet period. If you need to change this day, you can do so by shortening (but never lengthening - maximum 7 days!) the placebo tablet period - when you take the white placebo tablets.
For example, if your placebo tablet period starts on a Friday, and you want to change the day to Tuesday (3 days earlier), you should start a new blister pack 3 days earlier than usual. If the placebo tablet period is very short (e.g., 3 days or less), you may not have any bleeding during those days. As a result, you may experience spotting or intermenstrual bleeding.
If you are unsure what to do, you should consult your doctor.

4. POSSIBLE UNDESIRABLE EFFECTS

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them. If you experience any undesirable effects, especially severe and persistent ones, or changes in your health that you think are related to the use of Varel, you should consult a doctor. In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). 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". Severe undesirable effects You should contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (see also the "Warnings and precautions" section). The following undesirable effects have been associated with the use of Varel. Common undesirable effects (may affect up to 1 in 10 people):

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

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

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

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

• allergic reactions (hypersensitivity), asthma,
• breast discharge,
• hearing disorders,
• erythema nodosum (characterized by painful, red nodules on the skin) or erythema multiforme (characterized by a rash with red, painful edges),
• 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,
• so-called "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 section 2 for further information on risk factors for blood clots and symptoms of blood clots).

Reporting undesirable effects

If you experience any undesirable effects, including any 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 Undesirable Effects of 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 Varel

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

Expiry date

Do not use this medicine after the expiry date stated on the blister 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 no longer required. 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 and 7 white placebo tablets in the 4th row.

Active tablets:

The active substances are ethinylestradiol and drospirenone. Each tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone. The other ingredients are: Tablet core: lactose monohydrate, corn starch, pregelatinized starch, crosspovidone, povidone K30, 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 pack contents

The active tablets are yellow, round, film-coated tablets. The placebo tablets are white, round, film-coated tablets. Varel is available in packs of 1 or 3 blisters, each containing 28 tablets (21 active 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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Country names:

Date of last revision of the leaflet:May 2025