Dretine diario 0.03 mg/3 mg co… leaflet – Spain

How to use Dretine diario 0.03 mg/3 mg comprimidos recubiertos con pelicula efg

Introduction

Prospect: information for the user

Dretine daily 0.03 mg/3 mg film-coated tablets EFG

Ethinylestradiol/drospirenone

Important things 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 veins and arteries, especially in the first year or when restarting use of a combined 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 prospectus carefully before starting to take this medicine, because it contains important information for you.

Keep this prospectus, as you may have to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed only to you. Do not give it to other people as it may harm them.
If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section 4.

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

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

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

The 7 white-coated 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 Dretine daily

General Considerations

Before starting to use Dretine daily, you should 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 Dretine 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 Dretine daily, or in which the reliability of Dretine 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 Dretine daily alters the monthly changes in body temperature and cervical mucus.

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

When Not to Use Dretine Daily

You should not use Dretine 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 homocysteineemia
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 do not function well (renal insufficiency).
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 Dretine Daily”).
If you have (or have ever had) a tumor in the liver.
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.
If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir (see also the section Taking Dretine Daily with Other Medications)

Additional Information on Special Populations

Children and Adolescents

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

Older Adults

Dretine daily is not indicated for use after menopause.

Women with Liver Insufficiency

Do not take Dretine daily if you have a liver disease. See also the sections "Do not take Dretine daily" and "Warnings and Precautions".

Women with Renal Insufficiency

Do not take Dretine daily if you have kidney dysfunction or acute renal insufficiency. See also the sections "Do not take Dretine daily" and "Warnings and Precautions".

Warnings and Precautions

When to Have Special Care with Dretine Daily

Consult your doctor or pharmacist before taking Dretine daily

When to Consult Your Doctor?

Seek Urgent Medical Assistance

If you notice possible signs of a blood clot that may mean 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 should have special care while using Dretine daily or any other combined hormonal contraceptive, and it may be necessary for your doctor to examine you periodically.

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

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

If a close relative has or has ever 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 disease of red blood cells)
If you have high levels of fat in the blood (hypertriglyceridemia) or a 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 blood clots. Ask your doctor when you can start taking Dretine 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 “Dretine Daily and Use of Other Medications”)
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 ever 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 Dretine 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 yellow tablets and 7 white placebo tablets.

The two different colored tablets of Dretine daily are placed in order. A strip contains 28 tablets.

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

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

Due to the different composition of the tablets, you must start with the first tablet located in the upper 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 Dretine daily 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 have to stick the corresponding sticker on the upper left part 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 certain 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 yellow tablet of Dretine daily. 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 Dretine daily in this way, you are also protected against pregnancy during the 7 days when you are taking the placebo tablets.

When can you start with the first strip

If you have not used any hormone-based contraceptive in the previous month.

Start taking Dretine daily on the first day of the cycle (i.e., the first day of your period). If you start Dretine daily 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 (e.g., a condom) during the first 7 days.

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

You can start taking Dretine daily 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 break without taking tablets of your previous pill (or after the last inactive tablet of your previous pill). When switching from a combined vaginal contraceptive ring or patch, follow your doctor's recommendations.

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

You can switch from the pill only with progestin on any day (if it is an implant or an IUS, on the day of its removal; if it is an injectable, on the day of the next injection) but, in all cases, use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.

After an abortion.

Follow your doctor's recommendations.

After giving birth.

You can start taking Dretine daily between 21 and 28 days after giving birth. If you start later, use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Dretine daily.

If, after giving birth, you have already had sex before starting to take Dretine daily (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 Dretine daily (again) after giving birth.

Read the section “Breastfeeding”.

Ask your doctor if you are unsure when to start.

If you take more Dretine daily than you should

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

If you take many tablets at once, you may experience 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 Dretine daily tablets, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology 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 Dretine daily

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

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

If you are lateless than 12 hoursin taking some tablets, the protection against pregnancy does not decrease. 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 decrease. The more tablets you have forgotten, the greater the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take a yellow active 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, even if this means taking two tablets at once. Continue taking the next tablets at the usual time and useextra precautions, for the next 7 days, for example, a condom. If you have had sex 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, even if this means taking two tablets at once. Continue taking the next tablets at the usual time. The protection against pregnancy does not decrease 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, even if this means taking 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 a small bleeding or bleeding similar to menstruation during the second strip.

You can also interrupt the active yellow 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 do not have bleeding during the first break without tablets, you may be pregnant. Go to 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 yellow tablet or have intense diarrhea, there is a risk that the active principles 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 yellow tablet from a reserve strip as soon as possible. If possible, take itbefore 12 hourshave passed since the usual time when you normally 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 Dretine daily”.

Delayed 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 Dretine daily 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 in the first day of the menstrual period: what you should know

If you take the tablets according to the instructions, your menstrual period will startduring the placebo week. If you have to change this day, reduce the number of placebo days (but never increase – 7 is the maximum!). For example, if you normally start taking the placebo tablets on Friday and want to change it to 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 unsure what to do, consult your doctor.

If you stop taking Dretine daily

You can stop taking Dretine daily 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, stop taking Dretine daily and wait until your period before trying to become pregnant. This way, you can calculate your estimated due date more easily.

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

4. Possible Adverse Effects

Like all medicines, Dretine 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 Dretine 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 Dretine 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 list of side effects has been associated with the use of Drospirenona/Ethinylestradiol:

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

menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
headaches, depressive mood
migraines
nausea
thick, white vaginal discharge and vaginal yeast infection

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

changes in sex drive
high blood pressure, low blood pressure
vomiting, diarrhea
acne, skin rash, intense itching, hair loss (alopecia)
breast enlargement
vaginal infection
fluid retention and changes in body weight

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

allergic reactions (hypersensitivity)
asthma
breast secretion
hearing problems
skin conditions such as erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by skin rash with red spots or ulcers)
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
- transient ischemic attack (TIA) or symptoms similar to a stroke
- 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 Dretine 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 Dretine daily after the expiration date that appears on the blister pack and the container after the phrase “Do not use after:” or “CAD:”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. 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 ethinylestradiol and drospirenone.

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

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 medicine 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 Dretine daily increases your risk of suffering 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 (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE)
In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA)

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 Dretine 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 confusion 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: Immediate 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, or pressure Fullness or indigestion in the chest, arm, or below the sternum Discomfort in the upper body that radiates to the back, jaw, neck, 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 on one side of the face, arm, or leg, especially on one side of the body Sudden confusion, difficulty speaking, or difficulty understanding Sudden difficulty seeing in one eye or both eyes Sudden difficulty walking, dizziness, loss of balance, or coordination Sudden severe headache, without a known cause Sudden loss of consciousness or fainting, with or without convulsions Sometimes the symptoms of a stroke may be brief, with almost immediate and complete recovery, but you should still seek urgent medical assistance 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
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 be higher 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 Dretine 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 Dretine daily is small.

Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 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, 5-7 will develop a blood clot in a year.
Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like Dretine daily, 9-12 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	Approximately 2 of every 10,000 women
Women who use a combined hormonal contraceptive containinglevonorgestrel, noretisterone, or norgestimato	Approximately 5-7 of every 10,000 women
Women who use Dretine daily	Approximately 9-12 of every 10,000 women

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

The risk of a blood clot is higher:

If you are overweight (body mass index (BMI) of 30 kg/m2or higher)
If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before about 50 years). In this case, you may have a hereditary disorder of blood clotting.
If you need surgery or spend a lot of time without standing up due to an injury or disease or if you have your leg immobilized. You may need to interrupt the use of Dretine daily for several weeks before the surgical procedure or while you have less mobility. If you need to interrupt the use of Dretine daily, ask your doctor when you can start using it again.
With increasing age (especially above about 35 years)
If you have given birth recently

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

Long 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 conditions listed above, even if you are unsure. Your doctor may decide that you should interrupt the use of Dretine daily.

If any of the conditions listed above change while you are using Dretine 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 Dretine daily is very small, but it may increase:

With age (above 35 years)
If you smoke.When using a combined hormonal contraceptive like Dretine daily, 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 are overweight
If you have high blood pressure
If a close relative has 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 a heart attack or stroke
If you or a close relative has 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, the risk of a blood clot may be increased even further.

If any of the conditions listed above change while you are using Dretine 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.

Dretine 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.

Spotting

During the first few months of taking Dretine daily, you may experience unexpected bleeding (bleeding outside of the days of placebo pill use). If these bleeding episodes occur beyond a few months or start after a few months, your doctor should investigate what is wrong.

What to Do If You Do Not Have Your Period During the Placebo Days

If you have taken all the active yellow pills correctly, have not had intense vomiting or diarrhea, and have not taken 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. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.

Mental Health Disorders

Some women who use combined hormonal contraceptives like Dretine daily have reported depression or a depressed mood. Depression can be severe and sometimes may 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 Dretine 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 Dretine daily. They may advise you to take additional contraceptive precautions (for example, 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 Dretine daily in the blood and may make itless effective in preventing pregnancyor may cause unexpected bleeding. This may occur with:

Medications used in the treatment of
epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
tuberculosis (for example, rifampicin)
infections with HIV and hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapina, efavirenz)
fungal infections (griseofulvin, ketoconazole)
arthritis, osteoarthritis (etoricoxib)
high blood pressure in the blood vessels of the lungs (bosentan)
The medicinal herb St. John's Wort.

Dretine daily may affect the effect of other medications, for example:
medications containing ciclosporin
the antiepileptic lamotrigine (may lead to an increase in seizure frequency)
theophylline (used to treat respiratory problems)
tizanidine (used to treat muscle pain or cramps).

Do not use Dretine 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 (increase in the liver enzyme ALT).

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

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

Consult your doctor or pharmacist before using any medication.

Dretine Daily with Food and Drinks

Dretine daily can be taken with or without food, and with some 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 may affect the results of some tests.

Pregnancy and Lactation

Pregnancy

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

Consult your doctor or pharmacist before taking any medication.

Lactation

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

Consult your doctor or pharmacist before taking any medication.

Driving and Operating Machinery

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

Important Information on Some Components of Dretine Daily

Dretine daily contains lactose.

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

Member State Name	Medicine Name
Norway:	Dretinelle0.02 mg/3 mg tablets, film-coated
Spain:	Dretinelle daily 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

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/