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
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.
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:
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.
BLOOD CLOTS IN A VEIN What can happen if a blood clot forms in a vein?
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.
Factors that increase your risk of a blood clot in a vein The risk of a blood clot is higher:
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:
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
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:
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. 3. How to take Dretine dailyFollow 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
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.
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.
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.
Follow your doctor's recommendations.
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.
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:
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):
Consult your doctor.
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.
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.
You can choose between two options:
You may experience a small bleeding or bleeding similar to menstruation during the second strip.
If you follow one of these two recommendations, you will remain protected against pregnancy.
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 EffectsLike 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):
Rare side effects(may affect up to 1 in 100 people):
Very rare side effects(may affect up to 1 in 1,000 people):
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 ConservationKeep 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 informationComposition 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.
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:
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/ Country of registration Active substance Prescription required Yes Manufacturer Composition Lactosa monohidrato (62.00 mg mg),
Lactosa anhidra (89.50 mg mg) This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content. Talk to a doctor onlineHave questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care. See all doctors |
