Dretinelle diario 0.02 mg/3 mg… leaflet – Spain

How to use Dretinelle diario 0.02 mg/3 mg comprimidos recubiertos con pelicula efg

Introduction

Package Leaflet: Information for the User

Dretinelle diario 0.02 mg/3 mg film-coated tablets

Ethinylestradiol/Drospirenone

Important information you should 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 suffering a blood clot in the veins and arteries,

especially in the first year or when restarting the use of a hormonal contraceptive

after a pause of 4 weeks or more.

Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “blood clots”)

Read this leaflet carefully before starting to take this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed only for you, and you must not give it to others, as it may harm them.
If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1 What is Dretinelle diario and for what it is used

2 What you need to know before starting to take Dretinelle diario

3 How to take Dretinelle diario

4 Possible side effects

5 Storage of Dretinelle diario

6 Contents of the pack and additional information

1. What is Dretinelle diario and what is it used for

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

Each of the 21 film-coated pink tablets contains a small amount of two different female hormones, known as drospirenona and etinilestradiol.

The 7 film-coated white tablets do not contain active ingredients and are called placebo tablets.

Contraceptive pills that contain two hormones are known as "combined" pills.

2. What you need to know before starting to take Dretinelle daily

General Considerations

Before starting to use Dretinelle daily, read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

Before you can start taking Dretinelle daily, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your personal situation, may perform other tests.

In this prospectus, several situations are described in which you should interrupt the use of Dretinelle daily, or in which the reliability of Dretinelle daily may decrease. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as the use of a condom or other barrier method. Do not use the rhythm or basal body temperature methods. These methods may not be reliable because Dretinelle daily alters the monthly changes in body temperature and cervical mucus.

Dretinelle daily, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.

When Not to Use Dretinelle Daily

Do Not Take Dretinelle Daily

Do not use Dretinelle daily 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 leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs
If you know that 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 surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
If you have ever had a heart attack or a 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 ischemic attack (TIA, symptoms of a stroke)
If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
- Severe diabetes with vascular damage
- Very high blood pressure
- Very high levels of fat in the blood (cholesterol or triglycerides)
- A condition called hyperhomocysteinemia
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 you have kidney problems (renal insufficiency).
If you have (or have ever had) a liver tumor.
If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Dretinelle Daily”).
If you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive 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 medication (including in section 6). This may cause itching, rash, or inflammation.

Additional Information on Special Populations

Children and Adolescents

Dretinelle daily is not indicated for use in women whose periods have not yet begun.

Older Patients

Dretinelle daily is not indicated for use after menopause.

Women with Liver Insufficiency

Do not take Dretinelle daily if you have liver disease. See also the sections "Do Not Take Dretinelle Daily" and "Warnings and Precautions".

Women with Renal Insufficiency

Do not take Dretinelle daily if you have kidney problems or acute renal insufficiency. See also the sections "Do Not Take Dretinelle Daily" and "Warnings and Precautions".

Warnings and Precautions

When to Have Special Care with Dretinelle Daily

Consult your doctor or pharmacist before taking Dretinelle daily

When to Consult Your Doctor?

Seek Urgent Medical Assistance

If you notice possible signs of a blood clot that may indicate that you are suffering from a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack, or a stroke (see section “Blood Clots”).

For a description of the symptoms of these serious adverse effects, see “How to Recognize a Blood Clot”

In some situations, you need to have special care while using Dretinelle daily or any other combined hormonal contraceptive, and may need to be examined periodically by your doctor

Inform Your Doctor if You Suffer from Any of the Following Conditions

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

If a close relative has had breast cancer
If you have any liver or gallbladder disease
If you have diabetes
If you have depression
If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis)
If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system)
If you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency)
If you have sickle cell anemia (a hereditary disorder of red blood cells)
If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas)
If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”)
If you have recently given birth, you are at greater risk of developing blood clots. Ask your doctor when you can start taking Dretinelle daily after childbirth.
If you have superficial thrombophlebitis (inflammation of the veins under the skin)
If you have varicose veins
If you have epilepsy (see “Dretinelle Daily and Other Medications”)
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 (for example, hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)
If you have or have had melasma (a skin discoloration, especially on the face or neck, known as “pregnancy mask”). In this case, you should avoid direct exposure to the sun or ultraviolet light.
If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria, with possible difficulty breathing, consult your doctor immediately. Medications containing estrogens can induce or worsen the symptoms of hereditary and acquired angioedema.

3. How to take Dretinelle daily

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

Each package contains 21 active pink tablets and 7 white placebo tablets

The two different colored tablets of Dretinelle diario are placed in order. A strip contains 28 tablets.

Take one Dretinelle diario tablet every day, with a small amount of water if necessary. You can take the tablets with or without food, but every day approximately at the same time.

Do not confuse the tablets: take a pink tablet for the first 21 days, and then a white tablet for the last 7 days. Then, you should start taking a new strip (21 pink tablets and 7 white tablets). Therefore, there is no break between two strips.

Due to the different composition of the tablets, you need to start with the first tablet located in the top left corner and then take one tablet every day. To follow the correct order, follow the direction of the arrows on the strip.

Preparation of the strip

To help you remember to take the daily contraceptive, each strip (blister) of Dretinelle diario comes with seven adhesive stickers that have the days of the week printed on them. You should know the day of the week when you will take the first tablet.

According to the day of the week when you will start taking the tablets, you should choose the corresponding weekly adhesive sticker, for example, if you start on Wednesday, stick the one that indicates “WED” as the initial tablet. Then, you should stick the corresponding sticker on the top left of the package, in the “Start” position. In this way, there is a day of the week indicated above each tablet and you can check visually if you have taken a specific tablet. The arrows show the order in which you should take the tablets.

During the 7 days when you take white placebo tablets (the placebo days), you usually start bleeding (also called withdrawal bleeding). Normally, this starts the second or third day after taking the last active tablet, which is pink, of Dretinelle diario. Once you have taken the last white tablet, you should start with the next strip, whether the bleeding has stopped or not. This means that you should start all the strips on the same day of the week and the bleeding should occur on the same days every month.

If you take Dretinelle diario in this way, you are also protected against pregnancy during the 7 days when you are taking placebo tablets.

When can you start with the first strip

?If you have not used any hormonal contraceptives in the previous month.

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

?Change from a combined hormonal contraceptive, combined vaginal contraceptive ring, or patch.

You can start taking Dretinelle diario preferably the day after the last active tablet (the last tablet containing the active ingredient) of the previous pill, but at the end of the next day after the usual interval without taking tablets of your previous pill (or after the last inactive tablet of your previous pill). When changing from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

?Change from a method based exclusively on progestagens (pill only with progestagens, injection, implant, or intrauterine system (IUS) of progestagens)

You can change from the pill only with progestagens any day (if it is an implant or an IUS, the same day of its removal; if it is an injectable, when it is the next injection) but, in all cases, use additional contraceptive methods (for example, a condom) during the first 7 days of taking tablets.

?After an abortion.

Follow your doctor's recommendations.

?After having a child.

After having a child, you can start taking Dretinelle diario between 21 and 28 days. If you start later than day 28, use one of the so-called barrier methods (for example, a condom) during the first 7 days of using Dretinelle diario.

If, after having a child, you have already had sexual relations before starting to take Dretinelle diario (again), you should first be sure that you are not pregnant or wait until your next menstrual period.

?If you are breastfeeding and want to start taking Dretinelle diario (again) after having a child.

Read the section “Breastfeeding”.

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

If you take more Dretinelle diario than you should

No serious cases of overdose of ethinylestradiol/drospirenone have been reported.

If you take many tablets at once, you may have symptoms of nausea or vomiting or vaginal bleeding. 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 diario tablets, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the package and the medication leaflet to the healthcare professional.

If you forget to take Dretinelle diario

The tablets in the4throw of the strip are the placebo tablets. If you forget to take one of these tablets, the effect of Dretinelle diario will not be affected. Throw away the forgotten placebo tablet.

If you forget to take an active pink tablet from the1st, 2nd, or 3rdrow, follow these recommendations:

?If you are lateless than 12 hoursin taking some tablets, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the next tablets again at the usual time.

?If you are latemore than 12 hoursin taking some tablets, 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 pink tablet at the beginning or end of the strip. Therefore, you should take the following measures (see also the diagram below):

More than one tablet forgotten in a strip

Consult your doctor.

One tablet forgotten in week 1

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the next tablets at the usual time and useextra precautions, for example, a condom, for the next 7 days. If you have had sexual relations in the week before forgetting the tablet, you should know that there is a risk of pregnancy. In that case, consult your doctor.

One tablet forgotten in week 2

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the next tablets at the usual time. The protection against pregnancy is not reduced and you do not need to take extra precautions.

One tablet forgotten in week 3

You can choose between two options:

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the next tablets at the usual time. Instead of taking a break without tablets, start taking the next strip.

You may experience small bleeding or bleeding similar to menstruation while using the next strip.

You can also interrupt the active pink tablets and go directly to a 7-day period of placebo tablets (before taking the placebo tablets,note the day when you forgot to take your tablet). If you want to start a new blister on your scheduled start day, take the placebo tabletsless than 7 days.

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

If you have forgotten to take one of the tablets in the strip and you do not have bleeding during the first period without tablets, you may be pregnant. Consult your doctor before continuing with the next strip.

What to do in case of vomiting or intense diarrhea

If you have vomiting in the 3-4 hours after taking an active pink tablet or have intense diarrhea, there is a risk that the active ingredients of the pill will not be fully absorbed by your body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, take another active pink tablet from a reserve strip as soon as possible. If possible, take itbefore 12 hourshave passed since the usual time when you take your contraceptive. If it is not possible or more than 12 hours have passed, you should follow the advice given in “If you forget to take Dretinelle diario”.

Delay of menstrual period: what you should know

Although it is not recommended, it is possible to delay your menstrual period by not taking the white placebo tablets from the 4th row and going directly to a new strip of Dretinelle diario and finishing it. You may experience small bleeding or bleeding similar to menstruation while using the next strip. Finish this second strip by taking the 7 white placebo tablets from the 4th row. Then start your next strip.

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

Change of first day of menstrual period: what you should know

If you take the tablets according to the instructions, your menstrual period will start during theplacebo week. If you have to change this day, reduce the number of placebo days(but never increase it – 7 is the maximum!). For example, if you normally start taking the placebo tablets on a Friday and want to change it to a Tuesday (3 days earlier), start a new strip 3 days earlier than usual. If you make the placebo period very short (for example, 3 days or less), you may not have any bleeding during these days. Then you may experience weak bleeding or similar to menstruation.

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

If you stop taking Dretinelle diario

You can stop taking Dretinelle diario whenever you want. 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 diario and wait until your menstrual period before trying to become pregnant. This way, you can calculate the estimated date of delivery more easily.

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

4. Possible Adverse Effects

Like all medicines, Dretinelle daily may cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be due to Dretinelle daily, consult your doctor.

All women taking 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 starting to use Dretinelle daily”.

Severe side effects

Contact a doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (also see section “Warnings and precautions”).

The following side effects have been associated with the use of Drospirenona/Ethinylestradiol:

Frequent side effects (may affect up to 1 in 10 people):

Mood changes
Headaches
Abdominal pain (stomach pain)
Acne
Breast pain, breast enlargement, breast tenderness, painful or irregular periods
Weight gain

Rare side effects (may affect up to 1 in 100 people):

Candida (fungal infection)
Herpes labialis (simple herpes)
Allergic reactions
Increased appetite
Depression, nervousness, sleep disorders,
Itching, dizziness (vertigo)
Visual problems
Irregular heartbeat or unusually fast heart rate
Pulmonary embolism, high blood pressure, low blood pressure, migraine, varicose veins
Sore throat
Nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation
Sudden swelling of the skin and/or mucous membranes (e.g., the tongue or throat), and/or difficulty swallowing or hives with difficulty breathing (angioedema), hair loss (alopecia), itching, eczema, dry skin, skin disorder with increased fat content (seborrheic dermatitis)
Neck pain, limb pain, muscle cramps
Urinary tract infection
Breast lumps (benign and cancerous), milk production while not pregnant (galactorrhea), ovarian cysts, hot flashes, absence of periods, heavy periods, vaginal discharge, vaginal dryness, pelvic pain,abnormal cervical smear (Papanicolaou or vaginal cytology), decreased interest in sex
Fluid retention, lack of energy, excessive thirst,increased sweating
Weight loss

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

Asthma
Loss of hearing
Obstruction of a blood vessel by a clot formed elsewhere in the body
Eructation nodosa (characterized by painful, red nodules)
Eructation multiforme (characterized by skin rash in the shape of a target with redness or blisters)
Detrimental blood clots in a vein or artery, for example:
- In a leg or foot (i.e., TVP)
- In a lung (i.e., EP)
- Heart attack
- Stroke
- Mild stroke or temporary symptoms similar to a stroke, known as transient ischemic attack (TIA)
- Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Usewww.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Daily Dretinelle Conservation

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

This medication does not require special storage conditions.

Expiration Date

Do not take Dretinelle daily after the expiration date that appears on the blister pack and on the packaging after the phrase “Do not use after:” or “CAD:”.The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Dretinelle daily

One strip of Dretinelle daily contains 21 active pink tablets in the 1st, 2nd, and 3rd rows of the strip and 7 placebo white tablets in the 4th row.

Active tablets:

The active principles are etinilestradiol and drospirenona.

Each tablet contains 0.02 mg of etinilestradiol and 3 mg of drospirenona.

The other components are:

Tablet core: lactose monohydrate, pregelatinized cornstarch, povidone, croscarmellose sodium, polisorbate 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).

Placebo tablets:

Tablet core: lactose, povidone, magnesium stearate.

Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc.

Appearance of Dretinelle daily and contents of the package

The active tablets are film-coated, round, pink tablets.

The placebo tablets are film-coated, round, white tablets.

Dretinelle daily is available in boxes of 1, 2, 3, 6, and 13 blisters, each containing 28 tablets (21 active tablets plus 7 placebo tablets).

Only some package 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.

Navatejera Industrial Estate.

C/ La Vallina s/n

24008 - Villaquilambre, León.

Spain

Local Representative

Theramex Healthcare Spain, S.L.

Calle Martínez Villergas 52, Edificio C, 2nd floor left.

28027 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Blood Clots

The use of a combined hormonal contraceptive like Dretinelle daily increases your 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 veins (called “deep vein thrombosis”, “venous thromboembolism”, or VTE)
in arteries (called “arterial thrombosis”, “arterial thromboembolism”, or ATE)

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek Urgent Medical Assistanceif you notice any of the following signs or symptoms.

Do you experience any of these signs?	What could you be suffering from?
Swelling of a leg or foot or along a vein in the leg or foot, especially when accompanied by: Pain or sensitivity in the leg, which may only be noticeable when standing up or walking Increased temperature of the affected leg Change in skin color of the leg, for example, if it becomes pale, red, or blue	Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing Sudden coughing without a clear cause, which may bring up blood Severe chest pain that may worsen with deep breathing Intense dizziness or fainting Irregular or rapid heartbeat Severe stomach pain If you are unsure, consult a doctor, as some of these symptoms, such as coughing or shortness of breath, can be confused with a milder condition like a common cold	Pulmonary embolism
Symptoms that occur more frequently in one eye: Sudden loss of vision, or Blurred vision without pain, which may progress to loss of vision	Retinal vein thrombosis (blood clot in the eye)
Chest pain, discomfort, pressure, or heaviness Sensation of oppression or fullness in the chest, arm, or below the sternum Sensation of fullness, indigestion, or choking Upper body discomfort that radiates to the back, jaw, throat, arm, or stomach Sweating, nausea, vomiting, or dizziness Extreme weakness, anxiety, or shortness of breath Irregular or rapid heartbeat	Heart attack
Sudden weakness or numbness in the face, arm, or leg, especially on one side of the body Sudden confusion, difficulty speaking, or understanding Sudden difficulty seeing in one eye or both eyes Sudden difficulty walking, dizziness, loss of balance, or coordination Sudden severe headache, intense or prolonged without a known cause Loss of consciousness or fainting, with or without seizures Sometimes the symptoms of a stroke may be brief, with almost immediate and complete recovery, but you should still seek medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of an extremity Severe stomach pain (abdominal pain)	Blood clots that block other blood vessels

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 veins (venous thromboembolism). However, these adverse 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 may cause deep vein thrombosis (DVT)
If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism (PE)
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 Greater?

The risk of a blood clot in a vein is greater during the first year in which you take a combined hormonal contraceptive for the first time. The risk may be greater if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break 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 daily, your risk of a blood clot returns to normal in 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 risk of a blood clot in the leg or lung (DVT or PE) with Dretinelle daily is small.

Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Dretinelle daily, 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 Your Risk of a Blood Clot” below)

	Risk of developing a blood clot in a year
Women whodo not usea combined hormonal contraceptive and who are not pregnant	About 2 of every 10,000 women
Women who use a combined hormonal contraceptive containinglevonorgestrel, noretisterone, or norgestimato	About 5-7 of every 10,000 women
Women who use Dretinelle daily	About 9-12 of every 10,000 women

Factors That Increase Your Risk of a Blood Clot in a Vein

Your risk of a blood clot with Dretinelle daily is small, but some conditions increase the risk. Your risk is greater:

If you are overweight (body mass index (BMI) of 30 kg/m2 or higher)
If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50). In this case, you may have an inherited disorder of blood clotting.
If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
With increasing age (especially above the age of 35)
If you have given birth recently

Your risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed above.

It is essential to inform your doctor if you suffer from any of the conditions above, even if you are unsure. Your doctor may decide that you should stop using Dretinelle daily.

If any of the conditions above change while you are using Dretinelle daily, for example, a close relative experiences a blood clot 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 a stroke.

Factors That Increase Your Risk of a Blood Clot in an Artery

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

With increasing age (above the age of 35)
If you smoke.When using a combined hormonal contraceptive like Dretinelle daily, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive.
If you are overweight
If you have high blood pressure
If a close relative has had a heart attack or stroke at a young age (i.e., before the age of 50). In this case, you may also be at greater risk of having a heart attack or stroke
If you or a close relative have high levels of fat in the blood (cholesterol or triglycerides)
If you have migraines, especially migraines with aura
If you have a heart problem (valve disorder, arrhythmia called atrial fibrillation)
If you have diabetes

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

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

Dretinelle Daily and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to undergo regular breast examinations and to consult your doctor if you notice any lump.

In rare cases, benign tumors in the liver and, even more rarely, malignant tumors have been reported in users of combined hormonal contraceptives. Consult your doctor if you experience severe abdominal pain.

Bleeding Between Periods

During the first few months of taking Dretinelle daily, you may experience unexpected bleeding (bleeding outside of the days of placebo pill use). If this bleeding persists beyond 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 Placebo Days

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

If your expected period does not arrive in two consecutive instances, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are certain that you are not pregnant.

Mental Health Disorders

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

Other Medications and Dretinelle Daily

Always inform your doctor about any medications or herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are using Dretinelle daily. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long or if you need to change the use of another medication.

Some medications may affect the levels of Dretinelle daily in the blood and may make itless effective in preventingpregnancy, or may cause unexpected bleeding. This can occur with:

Medications used in the treatment of
epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
tuberculosis (e.g., rifampicin)
the HIV and hepatitis C viruses (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
infectious fungal diseases (e.g., griseofulvin, ketoconazole)
Arthritis, osteoarthritis (etoricoxib)
High blood pressure in the blood vessels of the lungs (bosentan)
St. John's Wort.

Dretinelle mayinfluence the effectof other medications, for example:
Medications containing ciclosporin
the antiepileptic lamotrigine (may lead to an increase in seizure frequency)
theophylline (used to treat respiratory problems)
tiagabine (used to treat muscle pain or cramps).

Do not use Dretinelle daily if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated ALT enzyme levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Dretinelle daily can be restarted approximately 2 weeks after completing this treatment. See section “When Not to Use Dretinelle Daily”.

Consult your doctor or pharmacist before using any medication.

Dretinelle Daily with Food and Drinks

Dretinelle daily can be taken with or without food, and with a little water if necessary.

Laboratory Tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking the pill, as hormonal contraceptives can affect the results of some tests.

Pregnancy and Lactation

Pregnancy

If you are pregnant, do not take Dretinelle daily. If you become pregnant during treatment with Dretinelle daily, stop treatment immediately and consult your doctor.If you want to become pregnant, you can stop taking Dretinelle daily at any time (see “If You Want to Stop Taking Dretinelle Daily”). Consult your doctor or pharmacist before taking any medication.

Lactation

Generally, it is not recommended to take Dretinelle daily during lactation. If you want to take the contraceptive while breastfeeding, consult your doctor.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machinery

There is no information to suggest that the use of Dretinelle daily has any effect on your ability to drive or operate machinery.

Important Information About Some Components of Dretinelle Daily

Dretinelle daily contains lactose.

If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking the medication.

Dretinelle daily contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

Member State Name	Medicinal Product Name
Norway:	Dretinelle0.02 mg/3 mg tablets, film-coated
Spain:	Dretinelle diario 0.02 mg/3 mgfilm-coated tablets
Poland:	Varenelle
Romania:	Varena 0.02 mg/3 mgfilm-coated tablets

Last review date of this leaflet: September 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/