DRELLE 0.02 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Drelle0.02mg/3 mg film-coated tablets EFG

Ethinylestradiol/Drospirenone

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Drelle and what is it used for
2. What you need to know before you start taking Drelle
3. How to take Drelle
4. Possible side effects
5. Storing Drelle
6. Package contents and further information

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

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and see your doctor if you think you might have symptoms of a blood clot (see section 2 “Blood clots”).

1. What is Drelle and what is it used for

• Drelle is a contraceptive and is used to prevent pregnancy.
• • Each of the 24 pink tablets contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
  • The 4 white tablets do not contain active ingredients and are also called placebo tablets.
  • Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before taking Drelle

Do not take Drelle

You should not take Drelle if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs,

• severe diabetes with blood vessel damage,
• very high blood pressure,
• very high levels of fat in the blood (cholesterol or triglycerides),
• a condition called hyperhomocysteinemia.

Do not take Drelle if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and Drelle").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Drelle.

Tell your doctor if you suffer from any of the following conditions.

In some situations, you should be particularly careful while using Drelle or any other combined hormonal contraceptive, and it may be necessary for your doctor to perform regular check-ups. If you develop any of the following conditions, you should inform your doctor before taking Drelle. If the condition develops or worsens while you are using Drelle, you should also inform your doctor.

avoid direct exposureto the sun or ultraviolet rays,contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drelle increases the risk of developing a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (which is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (which is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious lasting effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Drelle is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

BLOOD CLOTS IN A VEIN

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Drelle, the risk of a blood clot returns to normal within a few weeks.

What is the risk of a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Drelle is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Drelle, between 9 and 12 women will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see "Factors that increase the risk of a blood clot" below).

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

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

The risk of a blood clot increases with the number of conditions you have.

Long-haul flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Drelle.

If any of the above conditions change while you are using Drelle, for example, a close relative experiences a thrombosis without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase the risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to Drelle is very small, but it may increase:

smoke. When using a combined hormonal contraceptive like Drelle, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive,

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 increased further.

If any of the above conditions change while you are using Drelle, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

Drelle and cancer

In women who use combined contraceptives, a slightly higher incidence of breast cancer has been observed, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts checked regularly and to see your doctor if you notice any lump.

Rarely, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. See your doctor if you experience unusually severe abdominal pain.

Psychiatric disorders:

Some women who use hormonal contraceptives like Drelle have reported depression or a depressed mood. Depression can be severe and sometimes can induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Intermenstrual bleeding

During the first few months in which you are taking Drelle, you may have unexpected bleeding (bleeding outside of the days of placebo pill use). If this bleeding persists for more than a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

If you have taken all the active pink pills correctly, have not had vomiting or severe diarrhea, and have not taken any other medications, it is highly unlikely that you are pregnant.

If your expected period does not come in two consecutive instances, you may be pregnant.

3. How to take Drelle

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist.

Each blister contains 24 active pink tablets and 4 white placebo tablets.

The Drelle tablets of different colors are ordered. A blister contains 28 tablets.

Take one Drelle tablet every day, with some water if necessary. You can take the tablets with or without food, but you must take the tablets every day at approximately the same time.

Do not confuse the tablets:take a pink tablet for the first 24 days and then a white tablet for the last 4 days. Then you must start another blister immediately (24 pink tablets and then 4 white tablets). Therefore, there is no interval between two blisters.

Since the composition of the tablets is different, you must start the blister with the tablet in the top left corner and take the tablets every day. Follow the direction of the arrows on the blister to take the tablets in the correct order.

Preparing the blister

To help you follow the order of intake, each Drelle package contains 7 self-adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with “WED”.

Stick the weekly adhesive strip on the top of the Drelle blister, where it says “Place the strip here!”, so that the first day is placed above the tablet marked with “1”. Now you will have a day marked above each tablet and you can visually check if you have taken your tablet. The arrows indicate the order of taking the tablets.

During the 4 days when you take the placebo tablets (the placebo days), you should have your period (the so-called withdrawal bleeding). It usually starts on the 2nd or 3rd day after taking the last active pink Drelle tablet. After taking the last white tablet, start the next blister, even if your period has not finished. This means you must start the next blister on the same day of the weekthat you started the previous one, and your withdrawal bleeding should take place during the same days every month.

If you take Drelle in this way, you are also protected against pregnancy during the 4 days when you take the placebo tablet.

When can you start with the first blister?

• If you have not taken any hormonal contraceptive in the previous month.

Start taking Drelle on the first day of your cycle (i.e., the first day of your period). If you start Drelle on the first day of your period, you will be immediately protected against pregnancy. You can also start between days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

• Changing from another combined hormonal contraceptive, combined vaginal ring, or patch.

You can start taking Drelle preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the tablet-free days (or after the last inactive tablet of your previous contraceptive). When changing from a combined vaginal ring or patch, follow your doctor's recommendations.

• Changing from a progestin-only method (progestin-only pill, injection, implant, or IUD).

You can change from the progestin-only pill at any time (if it's an implant or IUD, on the day of its removal; if it's an injectable, when the next injection is due), but in all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) during the first 7 days of tablet intake.

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

After having a child, you can start taking Drelle between 21 and 28 days later. If you start later, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of Drelle use.

If, after having a child, you have already had sexual intercourse before starting to take Drelle again, you must be sure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Drelle again after having a child.

Read the section “Breastfeeding”.

Consult your doctor if you have doubts about when to start.

If you take more Drelle than you should

No cases have been reported where an overdose of Drelle has caused serious harm.

The symptoms that may appear if you take many tablets at once are nausea and vomiting. Adolescent girls may experience vaginal bleeding.

If you have taken more Drelle tablets than you should, or discover that a child has taken them, consult your doctor or pharmacist immediately or go to the nearest hospital or call the Toxicology Information Service 91 562 04 20 indicating the medicine and the amount used.

If you forget to take Drelle

The last 4 tablets of the 4th rowof the blister are placebo tablets. If you forget one of these tablets, the contraceptive effect of Drelle is not lost. You must discard the forgotten placebo tablet.

If you forget an active pink tablet (tablets 1-24 of the blister), you must follow these steps:

• if you delay less than 24 hoursin taking a tablet, the protection against pregnancy will not be reduced. Take the tablet as soon as you remember and the following tablets at the usual time,
• if you delay more than 24 hoursin taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take a tablet at the beginning of the package. Therefore, you should take the following measures (see also the diagram below):

• Forgetfulness of more than one tablet from the blister

Consult your doctor.

• Forgetfulness of a tablet during days 1-7 (first row)

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the following tablets at the usual time and use additional precautions, e.g., a condom, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you should know that there is a risk of pregnancy. In this case, consult your doctor.

• Forgetfulness of a tablet during days 8-14 (second row)

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the following tablets at the usual time. The contraceptive protection does not decrease, and you do not need to take additional precautions.

• Forgetfulness of a tablet between days 15 and 24 (third or fourth row)

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the following tablets at the usual time. Instead of continuing with the white placebo tablets, discard them and start taking the next blister (the day you take the first tablet will be different).

You will probably have your period at the end of the second blister, during the intake of the white placebo tablets, although you may experience spotting or bleeding during the intake of the second blister.

1. You can also stop taking the active pink tablets and go directly to the 4 white placebo tablets (before taking the placebo tablets, note the day you forgot to take your tablet). If you want to start a new blister on your fixed start day, take the placebo tablets for less than 4 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

If you have forgotten to take a tablet from a blister and do not have your period during the placebo days, this may mean that you are pregnant. In this case, you must consult your doctor before continuing with the next blister.

What should you do in case of vomiting or severe diarrhea?

If you vomit within 3-4 hours after taking a tablet or have severe diarrhea, there is a risk that the active ingredients will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you must take a tablet from a reserve package as soon as possible. If possible, take it before 24 hours have passed since the usual time you take your contraceptive. If it is not possible or more than 24 hours have passed, follow the advice in the section “If you forget to take Drelle”.

Delayed menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period if you do not take the white placebo tablets from the 4th row and start taking the tablets from a new Drelle blister until you finish this new blister. You may experience spotting (drops or spots of blood) or bleeding during the use of the second blister. Finish this second blister by taking the 4 white tablets from the 4th row. Then start the next blister.

Before deciding to delay your menstrual period, ask your doctor.

Changing the first day of your period: what should you know?

If you take the tablets according to the instructions, your menstrual period will start during the placebo days. If you need to change that day, you can do so by reducing the placebo days (but never extending - 4 days is the maximum!). For example, if you start the placebo days on a Friday and want to change it to Tuesday (3 days earlier), you must start a new blister 3 days earlier than usual. You may not have bleeding during these days. Then you can experience spotting or bleeding.

If you are not sure how to proceed, consult your doctor.

If you stop treatment with Drelle

You can stop taking Drelle whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, it is advisable to stop taking Drelle and wait until your menstrual period before trying to become pregnant. This way, you can more easily calculate the estimated date of delivery.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you suffer from any adverse effect, especially if it is severe and persistent, or have any change in health that you believe may be due to Drelle, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking Drelle".

Severe Adverse Effects

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 urticaria potentially with difficulty breathing (see also the "Warnings and Precautions" section).

The following adverse effects are related to the use of Drelle:

• Frequent(may affect up to 1 in 10 patients):

• mood changes,
• headache,
• nausea,
• breast pain, menstrual problems such as irregular periods, absence of periods.

• Uncommon(may affect up to 1 in 100 patients):

• depression, nervousness, drowsiness,
• dizziness, tingling and numbness,
• migraine, varicose veins, increased blood pressure,
• stomach pain, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhea,
• acne, itching, skin rash,
• discomfort and pain, such as back pain, pain in the limbs, muscle cramps,
• vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during treatment), vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual problems, painful periods, shorter periods, heavier periods, vaginal dryness, abnormal cervical smear, loss of interest in sex,
• lack of energy, increased sweating, fluid retention,
• weight gain.

• Rare(may affect up to 1 in 1,000 patients):

• candidiasis (a fungal infection),
• anemia, increased platelet count in blood,
• allergic reaction,
• hormonal disorder (endocrine),
• increased appetite, loss of appetite, abnormally high potassium levels in blood, abnormally low sodium levels in blood,
• absence of orgasm, insomnia,
• vertigo, tremors,
• eye disorders, such as eyelid inflammation, dry eyes
• abnormally fast heart rate,
• vein inflammation, nosebleeds, fainting,
• abdominal enlargement, intestinal disorder, feeling of bloating, gastric hernia, oral thrush, constipation, dry mouth,
• bile duct or gallbladder pain, gallbladder inflammation,
• brownish-yellow spots on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, stretch marks on the skin, skin inflammation, skin inflammation due to photosensitivity, skin nodules,
• difficult or painful intercourse, vaginal inflammation (vulvovaginitis), post-coital bleeding, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the cervical mucosa, shrinkage or loss of uterine lining, ovarian cysts, uterine enlargement,
• discomfort,
• weight loss,
• harmful blood clots in a vein or artery, for example:
• • in a leg or foot (i.e., DVT).
  • in a lung (i.e., PE).
  • heart attack.
  • stroke.
  • mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
  • blood clots in the liver, stomach/intestine, kidneys, or eye.

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

• Unknown:the following adverse effects have also been reported, but their frequency cannot be estimated from the available data:
• • hypersensitivity,
  • erythema multiforme (skin rash with target-like redness or ulcers).

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Drelle

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

Expiry Date

Do not use this medicine after the expiry date stated on the packaging and blister after "CAD/EXP". The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Drelle Composition

• The active ingredients are ethinylestradiol and drospirenone.

Each pink-colored tablet contains: 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The white tablets do not contain active ingredients.

• The other components are:

Active pink-colored tablets:

Core: lactose monohydrate, pregelatinized corn starch, povidone (E-1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E-572).

Coating: polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).

White placebo tablets:

Core: anhydrous lactose, povidone (E1201), magnesium stearate (E572).

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Product Appearance and Package Contents

Each Drelle blister pack contains 24 active film-coated pink-colored tablets in the 1st, 2nd, 3rd, and 4th rows of the blister pack and 4 white film-coated placebo tablets in the 4th row.

Drelle tablets, both pink and white, are film-coated tablets, the tablet core is coated.

Drelle is available in packs of 1, 3, 6, and 13 blister packs, each containing 28 (24+4) tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n

Polígono Industrial de Navatejera

24193 Villaquilambre, León

Spain

or

Lek Pharmaceutical d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

Date of the Last Revision of this Leaflet:March 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.