DRETINELLE 0.02 mg/3 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Dretinelle 0.02 mg/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 or pharmacist.

? This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.

? If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

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 may have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of the package leaflet:

1. What is Dretinelle and what is it used for
2. What you need to know before you start taking Dretinelle
3. How to take Dretinelle
4. Possible side effects
5. Storage of Dretinelle

Package contents and further information

1. What is Dretinelle and what is it used for

Dretinelle is a contraceptive pill and is used to prevent pregnancy.

Each film-coated tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.

Contraceptive pills that contain two hormones are known as “combined” pills

2. What you need to know before taking Dretinelle

When you should not use Dretinelle

Do not take Dretinelle

You should not use Dretinelle 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 of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs
• if you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• if you need an operation or if you spend a long time sitting or lying down (see section "Blood clots").
• if you have ever had a heart attack or stroke
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms)
• if you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fat in the blood (cholesterol or triglycerides)
  • a condition called hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called "migraine with aura"
• if you have (or have ever had) a liver disease and your liver function is not yet normal.
• if your kidneys are not working well (renal insufficiency).
• if you have (or have ever had) a liver tumour.
• if you have (or have ever had), or if you suspect you have breast cancer or cancer of the genital organs.
• if you have vaginal bleeding, whose cause is unknown.
• if you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medicine (listed in section 6). This may cause itching, rash or inflammation.
• if you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also section "Taking Dretinelle with other medicines")

Additional information on special populations

Children and adolescents

Dretinelle is not indicated in women whose periods have not yet started.

Elderly patients

Dretinelle is not indicated after menopause.

Patients with liver disorders

Do not take Dretinelle if you have liver disease. See also sections "Do not take Dretinelle" and "Warnings and precautions".

Patients with kidney disorders

Do not take Dretinelle if you have kidney failure or acute renal insufficiency. See also sections "Do not take Dretinelle" and "Warnings and precautions".

Warnings and precautions

Consult your doctor or pharmacist before taking Dretinelle.

When you should be careful with Dretinelle

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

Consult your doctor before taking Dretinelle. In some situations, you need to be careful while using Dretinelle or any other combined contraceptive, and it may be necessary for your doctor to examine you regularly.

If the condition develops or worsens while you are using Dretinelle, you should also inform your doctor.

• if a close relative has had or has breast cancer
• if you have any 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 (SLE, a disease that affects your natural defence system)
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder that causes kidney failure)
• if you have sickle cell anaemia (an inherited disease of the red blood cells)
• if you have high levels of fat in the blood (hypertriglyceridaemia) or a known family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas)
• if you need an operation or spend a long time sitting or lying down (see section 2 "Blood clots")
• if you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Dretinelle after childbirth.
• if you have inflammation of the veins just under the skin (superficial thrombophlebitis).
• if you have varicose veins
• if you have epilepsy (see "Dretinelle and use of other medicines")
• if you have a disease of the immune system called SLE (systemic lupus erythematosus)
• if you have any disease that first appeared during pregnancy or during early use of sex hormones (e.g. loss of hearing, a blood disease called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disease in which involuntary movements appear (Sydenham's chorea))
• if you have or have ever had chloasma (a skin discoloration, especially on the face or neck, known as "pregnancy patches"). In this case, you should avoid direct exposure to the sun or ultraviolet light.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing or urticaria, with possible difficulty breathing, consult your doctor immediately. Medicines containing oestrogens may induce or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Dretinelle increases your risk of having 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 (this is called "venous thrombosis", "venous thromboembolism" or VTE)
• in the arteries (this is called "arterial thrombosis", "arterial thromboembolism" or ATE)

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

It is important to remember that the overall risk of a harmful blood clot due to Dretinelle 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 of another organ, such as the eye (retinal vein thrombosis)

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

The risk of having 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 medicine 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 Dretinelle, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having a blood clot?

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

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

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have 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 have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains drospirenone, such as Dretinelle, between 9 and 12 women will have a blood clot in a year.
• The risk of having a blood clot depends on your personal history (see "Factors that increase your risk of a blood clot" below)

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

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

• if you are overweight (body mass index or BMI over 30 kg/m2)
• if any of your close relatives have had a blood clot in the leg, lung or other organ at a young age (i.e. before the age of about 50). In this case, you may have a hereditary blood clotting disorder.
• if you need an operation or spend a long time sitting or lying down due to an injury or illness, or if you have a leg in a plaster cast. You may need to stop using Dretinelle several weeks before the operation or while you have less mobility. If you need to stop using Dretinelle, ask your doctor when you can start using it again.
• as you get older (especially above the age of about 35)
• if you have just given birth

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

Long-distance 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 important to inform your doctor if you suffer from any of the conditions mentioned above, even if you are not sure. Your doctor may decide that you should stop using Dretinelle.

If any of the conditions mentioned above change while you are using Dretinelle, 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 your risk of a blood clot in an artery

It is important to note that the risk of a heart attack or stroke due to Dretinelle is very small, but it can increase:

• with age (above 35 years)
• if you smoke.When using a combined hormonal contraceptive like Dretinelle, you are advised to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• if you are overweight
• if you have high blood pressure
• if any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke
• if you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides)
• if you have migraines, especially migraine with aura
• if you have a heart condition (valvular heart disease, heart rhythm disorder called atrial fibrillation)
• if you have diabetes

If you have one or more of these conditions or if any of them are particularly severe, the risk of having a blood clot may be increased even further.

If any of the conditions mentioned above change while you are using Dretinelle, 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.

Dretinelle and cancer

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

In rare cases, benign liver tumours, and even more rarely, malignant liver tumours, have been reported in users of combined pills. See your doctor if you experience severe unusual abdominal pain.

Bleeding between periods

During the first few months that you are taking Dretinelle, you may have bleeding between periods.

3. How to take Dretinelle

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

Take one Dretinelle pill every day with a glass of water if necessary. You can take the pills with or without food, but always approximately at the same time every day.

The strip contains 21 pills. The day of the week on which you should take the pill is printed next to each pill. For example, if you start on a Wednesday, you should take a pill with "WED" next to it. Follow the direction of the arrow on the package until you have taken all 21 pills.

Then, you should not take any pills for 7 days. During these 7 days without pills (also called the stop or rest week), you should have your period. Usually, the period, which can also be called withdrawal bleeding, starts on the second or third day of the rest week.

On the 8th day after taking the last Dretinelle pill (i.e., after the 7-day rest period), you should start with the next strip, even if you have not yet finished your period. This means that you should start all strips on the same day of the week, and your period should take place during the same days every month.

If you use Dretinelle in this way, you will also be protected against pregnancy during the 7 days when you are not taking any pills.

When can you start with the first strip

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

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

• Switching from a combined hormonal contraceptive, vaginal ring, or patch

You can start taking Dretinelle preferably on the day after the last active pill (the last pill containing the active ingredient) of your previous pill, but at the end of the next day after the usual pill-free interval of your previous pill (or after the last inactive pill of your previous pill). When switching from a combined vaginal ring or patch, follow your doctor's recommendations.

• Switching from a progestin-only method (progestin-only pill, injection, implant, or intrauterine system (IUS))

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

• After an abortion.

Follow your doctor's recommendations.

• After having a child.

After having a child, you can start taking Dretinelle between 21 and 28 days later. If you start later than day 28, use a barrier method (e.g., a condom) for the first 7 days of Dretinelle use. If, after having a child, you have already had sexual intercourse before starting to take Dretinelle again, you should first make sure you are not pregnant or wait until your next menstrual period.

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

Read the section "Lactation".

Ask your doctor if you are not sure when to start.

If you take more Dretinelle than you should

No cases have been reported where an overdose of ethinylestradiol/drospirenone has caused serious harm.

If you take many pills at the same time, you may feel sick or vomit or bleed from the vagina.

Even girls who have not yet started menstruating but have accidentally taken this medication may experience this type of bleeding.

If you have taken too many Dretinelle pills or discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service at phone number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the package and prospectus of the medication to the healthcare professional.

If you forget to take Dretinelle

• If you are less than 12 hourslate in taking a pill, the protection against pregnancy is not reduced. Take the pill as soon as you remember and then take the following pills at the usual time.
• If you are more than 12 hourslate in taking a pill, the protection against pregnancy may be reduced. The more pills you have forgotten, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is highest if you forget to take a pill at the beginning or end of the strip. Therefore, you should take the following measures (see also the diagram below):

• More than one forgotten pill in a strip

Consult your doctor.

• One forgotten pill in week 1

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the following pills at the usual time and use extra precautionsfor the next 7 days, for example, a condom. If you have had sexual intercourse in the week before forgetting the pill, you should know that there is a risk of pregnancy. In that case, consult your doctor.

• One forgotten pill in week 2

Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the following pills at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions.

• One forgotten pill in week 3

You can choose between two options:

1. Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Instead of taking the pill-free period, start with the next strip.

You will probably have a period at the end of the second strip, but you may experience some bleeding or bleeding similar to menstruation during the second strip.

1. You can also stop the strip and go directly to a 7-day pill-free period (note the day you forgot to take your pill). If you want to start a new blister pack on your fixed start day, reduce the pill-free period to less than 7 days.

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

• If you have forgotten to take any of the pills in the strip and do not have a period during the first pill-free period, you may be pregnant. See your doctor before continuing with the next strip.

What to do in case of vomiting or severe diarrhea

If you vomit within 3-4 hours after taking a pill or have severe diarrhea, there is a risk that the active ingredients of the pill are not fully absorbed by your body. This is similar to what happens when you forget a pill. After vomiting or diarrhea, take another pill from a reserve strip as soon as possible. If possible, take it before 12 hourshave passed since the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice given in "If you forget to take Dretinelle".

Delayed menstrual period: what you should know

Although it is not recommended, it is possible to delay your menstrual period by going directly to a new strip of Dretinelle instead of starting the pill-free period and finishing it. You may experience some bleeding or bleeding similar to menstruation while using the next strip. After the usual 7-day pill-free period, continue with the next strip.

You should consult your doctor before deciding to delay your menstrual period.

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

If you take the pills according to the instructions, your menstrual period will start during the pill-free week. If you need to change this day, reduce the number of pill-free days (but never increase them – 7 is the maximum!). For example, if your pill-free period starts on a Friday and you want to change it to a Tuesday (3 days earlier), start a new strip 3 days earlier than usual. If you make the pill-free period very short (e.g., 3 days or less), you may not have any bleeding during these days. Then you may experience some bleeding or bleeding similar to menstruation.

If you are not sure what to do, consult your doctor.

If you want to stop taking Dretinelle

You can stop taking Dretinelle at any time. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, it is recommended that you stop taking Dretinelle and wait until your menstrual period before trying to become pregnant. This way, you will be able to calculate the estimated date of delivery more easily.

If you have any additional questions about the use of this medication, 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 experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Dretinelle, 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 Dretinelle".

Severe Adverse Effects

Contact a 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 with possible difficulty breathing (see also section "Warnings and Precautions").

The following adverse effects have been associated with the use of Drospirenone/Ethinylestradiol

Frequent Adverse Effects (may affect up to 1 in 10 people):

• mood changes
• headache
• abdominal pain (stomach pain)
• acne
• breast pain, breast enlargement, breast tenderness, painful or irregular periods
• weight gain

Uncommon Adverse Effects (may affect up to 1 in 100 people):

• Candida (fungal infection)
• cold sore (herpes simplex)
• allergic reactions
• increased appetite
• depression, nervousness, sleep disorders
• tingling sensation, dizziness (vertigo)
• vision problems
• irregular heartbeat or unusually fast heart rate
• blood clot (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins
• sore throat
• nausea, vomiting, inflammation of the stomach and/or intestine, diarrhea, constipation
• hair loss (alopecia), itching, eczema, dry skin, skin disorder with increased fat content (seborrheic dermatitis)
• neck pain, pain in the limbs, muscle cramps
• bladder infection
• breast lumps (benign and cancer), milk production while not pregnant (galactorrhea), ovarian cysts, hot flashes, absence of periods, very heavy periods, vaginal discharge, vaginal dryness, pain in the lower abdomen (pelvis), abnormal cervical smear (Pap or vaginal cytology), decreased interest in sex
• fluid retention, lack of energy, excessive thirst, increased sweating
• weight loss

Rare Adverse Effects (may affect up to 1 in 1,000 people):

• asthma
• hearing loss
• blockage of a blood vessel by a clot formed in another part of the body
• erythema nodosum (characterized by painful red nodules)
• erythema multiforme (characterized by a skin rash in the shape of a target with redness or blisters)
• 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 risk 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).

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 Medicines and Healthcare Products Agency (AEMPS) Website: www.notificaram.es

5. Storage of Dretinelle

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

This medicine does not require special storage conditions.

Do not take this medicine after the expiration date stated on the blister pack and carton after the phrase "Do not use after:" or "EXP:".

The expiration date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dretinelle

The active ingredients are ethinylestradiol and drospirenone.

Each tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The other ingredients are:

Core of the tablet: lactose monohydrate, pregelatinized corn starch, povidone, sodium croscarmellose, polysorbate 80, magnesium stearate.

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

Appearance of Dretinelle and Package Contents

Film-coated tablets, round, pink in color.

Dretinelle is available in packs of 1, 2, 3, 6, and 13 blisters, each containing 21 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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, Polígono Industrial Navatejera;

Villaquilambre 24193 (León)

Spain

Or

Merckle GmbH

Ludwig-Merckle-Strasse, 3

Blaubeuren

Germany

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, planta 2ª izquierda.

28027 Madrid

Spain

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

Date of the Last Revision of this Leaflet: October 2024

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