Suavuret 0,15 mg/0,02 mg comprimidos
Introduction
Package Leaflet: Information for the User
Suavuret 0.15 mg/0.02 mg Tablets
desogestrel/etinilestradiol
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 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 package leaflet carefully before starting to take this medicine, as it contains important information for you.
- Keep this package 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 should not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
1. What Suavuret Tablets are and for what they are used
2. What you need to know before starting to take Suavuret Tablets
3. How to take Suavuret Tablets
4. Possible side effects
5. Storage of Suavuret Tablets
6. Contents of the pack and additional information
1. What is Suavuret tablets and for what it is used
Suavuret belongs to the group of medicines called monophasic oral contraceptives (“Combined Pill”). All the tablets in the pack contain the same combination of active principles.
Suavuret is indicated to prevent pregnancy.
2. What you need to know before starting to take Suavuret tablets
General Considerations
Before starting to use Suavuret, you must 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").
Do not take Suavuret
Do not use Suavuret 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. See also the section "When to have special care with Suavuret".
- 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, temporary 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 had pancreatitis (inflammation of the pancreas), along with high levels of fat in your blood.
- If you have jaundice (yellowish color of the skin) or severe liver disease.
- If you have or have had cancer that grows in response to sex hormones (for example, breast cancer or cancer of the reproductive organs).
- If you have or have had a tumor in the liver.
- If there is any unexplained vaginal bleeding.
- If you have an abnormal growth of the internal lining of the uterus.
- If you are pregnant or think you may be pregnant.
- If you are allergic to desogestrel or ethinylestradiol or to any of the other components of this medication (including in section 6).
- If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also the section "Taking Suavuret with other medications").
If any of these circumstances occur for the first time while using the pill, do not take more and consult your doctor immediately. Meanwhile, use non-hormonal contraceptive measures.
Warnings and Precautions
When to have special care with Suavuret
| 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". |
Before starting treatment with Suavuret
Inform your doctor if you suffer from any of the following conditions
If the condition develops or worsens while using Suavuret, you must also inform your doctor.
- If you are a smoker.
- If you are diabetic.
- If you are overweight.
- If you have high blood pressure.
- If you have heart rhythm disorders or certain heart diseases.
- If you have superficial thrombophlebitis (inflammation of the veins under the skin).
- If you have varicose veins.
- If a close relative has had a blood clot, heart attack or stroke.
- If you have migraines.
- If you have epilepsy.
- If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with a higher 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 recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Suavuret after childbirth.
- If a close relative has had breast cancer.
- If you have liver or gallbladder disease.
- If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease).
- If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
- If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
- If you have sickle cell anemia (a genetic disorder of red blood cells).
- If you have a disease that appeared or worsened during pregnancy or previous use of sex hormones (e.g., hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestational or a disease called Sydenham's chorea).
- If you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing, or urticaria possibly with difficulty breathing, contact your doctor immediately. Medications containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.
- If you have or have had melasma (brownish-yellow patches on the skin, particularly on the face); in this case, avoid intense exposure to the sun or ultraviolet radiation.
If any of the above situations occur for the first time, recur or worsen with treatment with the pill, consult your doctor, who may recommend that you stop taking the pill.
Suavuret, like all contraceptive pills, does not protect against HIV or any other sexually transmitted disease.
Once treatment with Suavuret has started
While taking the pill, your doctor will require you to undergo regular check-ups, usually once a year.
Contact your doctor as soon as possible in the following cases:
- If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack or a stroke (see section "Blood Clots" below).
For a description of the symptoms of these serious adverse effects, see "How to recognize a blood clot".
- If you notice any change in your health, especially in any of the points mentioned in this leaflet (see also "When not to use Suavuret" and "What you need to know before starting to take Suavuret"); do not forget to mention the points related to your close relatives;
- If you find any lump in the breasts;
- If you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing, or urticaria possibly with difficulty breathing (see also the section "When to have special care with Suavuret");
- If you are taking other medications (see also "Taking Suavuret with other medications");
- If you need to be immobilized or are about to undergo surgery, as in these cases the risk of thrombosis temporarily increases; consult your doctor at least four weeks in advance;
- If you have unexplained and intense vaginal bleeding;
- If you forget to take pills in the first week of the pack and have had sex in the previous seven days;
- If you have severe diarrhea;
- If you have two consecutive missed pills or suspect you may be pregnant, do not start the next pack until your doctor tells you to.
Blood Clots
The use of a combined hormonal contraceptive like Suavuret 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 "venous 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 Suavuret is small.
HOW TO RECOGNIZE A BLOOD CLOT
Seek urgent medical assistance if you notice any of the following signs or symptoms.
| Do you experience any of these signs? | What may you be suffering from? |
| Deep vein thrombosis |
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:
| Retinal vein thrombosis (blood clot in the eye). |
| Heart attack. |
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. |
| 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 thrombosis). 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 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 start taking 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 Suavuret, 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 overall risk of a blood clot in the leg or lung (DVT or PE) with Suavuret 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 or 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 desogestrel like Suavuret, 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 who do not use a combined hormonal contraceptive and who are not pregnant | About 2 of every 10,000 women |
| Women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimato | About 5-7 of every 10,000 women |
| Women who use Suavuret | About 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 with Suavuret is small, but some conditions increase the risk. Your risk is higher:
- If you are overweight (BMI greater than 30 kg/m2).
- 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). 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 illness or if you have a leg cast. You may need to stop taking Suavuret for several weeks before the surgery or while you have less mobility. If you need to stop taking Suavuret, ask your doctor when you can start taking it again.
- As you get older (especially over about 35 years).
- If you recently gave birth.
The risk of a blood clot increases the more conditions you have.
Long flights (over 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 have any of the conditions listed above, even if you are unsure. Your doctor may decide that you need to stop taking Suavuret.
If any of the conditions listed above change while you are using Suavuret, 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 Suavuret is very small, but it may increase:
- With age (over about 35 years).
- If you smoke. When using a combined hormonal contraceptive like Suavuret, 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). 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, heart rhythm disorder called atrial fibrillation).
- If you have diabetes.
If you have one or more of these conditions or if any of them are particularly severe, the risk of a blood clot may be increased even further.
If any of the conditions listed above change while you are using Suavuret, 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.
Blood Pressure
If you have high blood pressure or any related disease (including certain kidney diseases), it is recommended that you use other contraceptive methods. If you decide to use hormonal contraceptives, you will need to monitor your blood pressure, but if it increases and cannot be controlled with medication, you should stop treatment.
Tumors
Cases of breast tumors have been observed in women who use contraceptive pills, with a slightly higher frequency than in women of the same age who do not use them. This slight increase in diagnosed breast tumors decreases gradually over the next ten years after stopping treatment. It is not known whether this difference is due to the treatment with the pill. It may be that women who use contraceptive pills attend medical consultations more frequently.
Rarely, cases of benign liver tumors and even more rarely malignant liver tumors have been reported in women who use the contraceptive pill. This may cause internal bleeding, leading to severe abdominal pain. If this occurs, you should contact your doctor immediately.
The situation that most affects the risk of cervical cancer is the continued infection with the human papillomavirus. In women who use the contraceptive pill for many years, the possibility of developing cervical cancer is slightly higher. However, it is not clear whether the contraceptive pill plays a direct role in this risk or whether other factors (such as sexual habits and other factors) do.
Vaginal Bleeding
You may experience no bleeding during the week of rest. If the pill has been taken correctly, it is very unlikely that you are pregnant. However, if you have two missed pills, you should consult your doctor as you may need to rule out pregnancy. If you have not taken the pill correctly and have a missed pill, you should stop taking the pill and use a non-hormonal contraceptive method until your doctor tells you to start taking the pill again.
Suavuret may cause vaginal bleeding or spotting between periods. If this occurs, continue taking Suavuret and if the bleeding continues after three cycles, consult your doctor immediately. Errors in pill use may also cause spotting and vaginal bleeding.
When you stop using Suavuret, you may experience irregular, light, or no bleeding, especially in the first three months and especially if your periods were irregular before starting hormone treatment.
Mental Health Disorders
Some women who use hormonal contraceptives like Suavuret have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.
Children and Adolescents
There are no clinical data available on safety and efficacy in adolescents under 18 years.
Other Medications and Suavuret
Always inform your doctor if you are taking any medications or herbal supplements. Also, inform any doctor or dentist (or pharmacist) who prescribes another medication that you are using Suavuret. They can inform you if you need to use additional contraceptive measures (e.g., condoms) and if necessary, for how long, or if you need to modify the use of the other medication.
Some medications:
3. How to Take Suavuret Tablets
Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
The Suavuret blister has 21 marked tablets with the days of the week. Take your tablet approximately at the same hour every day, with liquid if necessary.
Each time you start a new Suavuret blister, take the tablet from the upper row that corresponds to the day of the week when you take it.
Follow the direction of the arrows until you finish the 21 tablets.
In the 7 days that follow, you should not take Suavuret, during which a period (bleeding due to deprivation) will appear that usually starts two or three days after the last Suavuret tablet. Continue with the next blister on the eighth day, even if you still have bleeding. In this way, you will always start the blisters on the same day of the week and will have bleeding due to deprivation approximately on the same days every month.
Use in children and adolescents
No clinical data are available on safety and efficacy in adolescents under 18 years.
First Suavuret blister
If you have not used hormonal contraception in the previous month.
Start taking Suavuret on the first day of the cycle, that is, the first day of menstruation. Suavuret will start acting immediately. You do not need to take additional contraceptive measures. You can also start on days 2 to 5 of your cycle, but in this case, make sure to use a complementary contraceptive method (for example, a barrier method) while taking the first 7 tablets of the first cycle. Do not use menstrual cycle-based methods or temperature-based methods, as these methods are not reliable while taking the pill.
Change from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch)
You can start taking Suavuret the day after taking the last tablet of the current blister. This means that you do not need to leave a break. If your current preparation has inactive tablets, you can start Suavuret the day after the last active tablet (if you are unsure, consult your doctor or pharmacist). You can also start later, but never after the break of your current preparation (or after the last inactive tablet of your current preparation). If you are using a vaginal ring or a transdermal patch, start taking Suavuret preferably on the day of removal of the vaginal ring, or on the day when the patch should be removed. You can also start, but no later than the day when the next patch or ring application would be due.
If you have taken the pill, or used the vaginal ring or patch continuously and correctly and are sure you are not pregnant, you can also stop taking the pill, or remove the vaginal ring or patch on any day of your cycle and start with Suavuret immediately.
If you follow these instructions, you do not need to use an additional contraceptive method.
Change from a progestin-only pill
You can stop taking your current pill on any day and start taking Suavuret the next day at the same hour, but make sure to use a complementary contraceptive method (for example, a barrier method) while taking the first 7 tablets, in case of sexual intercourse.
Change from an injectable, an implant, or an Intrauterine System (IUS) with progestin only
Start using Suavuret at the time when you should receive the next injection, or on the day when the implant or IUS is removed, but make sure to use a complementary contraceptive method (barrier method) while taking the first 7 tablets, in case of sexual intercourse.
After childbirth
If you have just given birth, your doctor may advise you to wait for your first normal period before starting Suavuret. Sometimes it is possible to start earlier, but your doctor will advise you how. If you are breastfeeding and want to use Suavuret, discuss it first with your doctor.
After an abortion
Consult your doctor.
You can stop Suavuret at any time. If you stop Suavuret because you want to become pregnant, it is generally recommended to wait until you have had your first natural period before trying to conceive, which will help you calculate the due date.
If you take more Suavuret than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
No serious effects have been cited for taking an excess of Suavuret tablets at one time. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.
If you forget to take Suavuret
If more than 12 hours have passed since the usual hour, the reliability of the pill may be reduced. The more consecutive tablets you have forgotten, the higher the risk of reduced contraceptive efficacy. The risk of becoming pregnant is particularly higher if you forget the tablets at the beginning or end of the blister. Therefore, you should follow the recommendations that are outlined below (see also the diagram).
If you forget more than one tablet in a blister
Consult your doctor.
If you forget 1 tablet in the first week
Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual hour. Take complementary contraceptive measures (barrier method) for the next 7 days.
If you have had sexual intercourse in the previous week, there is a possibility that you may be pregnant. Therefore, inform your doctor immediately.
If you forget 1 tablet in the second week
Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual hour. The reliability of the pill is maintained and you do not need to take complementary contraceptive measures.
If you forget 1 tablet in the third week
You can choose one of the following options, without needing to take complementary contraceptive measures.
1- Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual hour. Start the next blister the day after finishing the current blister without leaving a break between blisters. You may not have your period until the end of the second blister, although you may have spotting or a small period while taking the tablets of the second blister.
Or,
2- Stop taking the tablets of the current blister, leave a break of up to 7 days (also count the day you forgot the tablet) and continue with the next blister. Following this method, you can always start your next blister on the same day of the week as you do habitually.
If you have forgotten tablets in a blister and do not have your expected period in the first break, you may be pregnant.
Consult your doctor before starting the next blister.
If you vomit or have intense diarrhea
If you vomit or have intense diarrhea in the 3 or 4 hours after taking your Suavuret tablet, it may be that the active principles are not fully absorbed, which is equivalent to forgetting a tablet. Therefore, follow the recommendations for a forgotten tablet.
In the case of intense diarrhea, consult your doctor.
If you want to change the day when your period starts
If you take the tablets as instructed, you will have your period approximately on the same day every 4 weeks. If you want to change it, you must shorten (never lengthen) the next break. For example, if your period usually starts on Friday and you want it to start on Tuesday in the future, that is, three days earlier, you must start the next blister three days earlier than the day you started. If the break is too short, from 1 to 3 days, you may not have your period during the break and may have spotting during the next blister.
If you have unexpected bleeding
As with all pills, you may experience irregular vaginal bleeding between periods during the first few months (called spotting or intermenstrual bleeding). In this case, continue taking the tablets normally. This irregular vaginal bleeding usually disappears once your body has adapted to the pill, usually after three cycles.
If it continues, becomes more intense, or appears again, consult your doctor.
If you do not have your period
If you have taken all the tablets at the same hour and have not vomited, had intense diarrhea, or taken other medications, it is very unlikely that you are pregnant. Continue taking Suavuret as usual.
If you have two consecutive missed periods, you may be pregnant, so inform your doctor immediately. Do not start the next Suavuret blister until your doctor has confirmed that you are not pregnant.
4. Possible Adverse Effects
Like all medicines, this medicine can 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 change that you think may be due to Suavuret, 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 Suavuret”.
Contact your 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 possibly with difficulty breathing (see also section 2 “What you need to know before starting to take Suavuret tablets”).
The side effects are listed below classified by their frequency according to the following criterion:
Frequent: (may affect up to 1 in 10 people).
Infrequent: (may affect up to 1 in 100 people).
Rare: (may affect up to 1 in 1,000 people).
Frequent (may affect up to 1 in 10 people):
- depressed mood, mood changes
- headache
- nausea, abdominal pain
- breast pain, breast tenderness
- weight gain
Infrequent (may affect up to 1 in 100 people):
- fluid retention
- decreased libido
- migraines
- vomiting, diarrhea
- skin eruptions, urticaria
- breast enlargement
Rare (may affect up to 1 in 1,000 people):
- harmful blood clots in a vein or artery, for example:
- in a leg or foot (i.e., DVT),
- in a lung (i.e., PE),
- heart attack,
- stroke,
- mild or transient stroke-like symptoms, 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).
- allergic reactions
- increased libido
- contact lens intolerance
- erythema nodosum, erythema multiforme (which are skin diseases)
- altered menstrual flow, nipple discharge
- weight loss
Reporting of 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 to the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Storage of Suavuret Tablets
Keep this medication out of the sight and reach of children.
Do not store above 86°F (30°C).
Store in the original packaging.
Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.
Do not use this medication if you notice, for example, a change in color, broken tablets, or any other visible sign of deterioration.
Medications 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 Suavuret
- The active principles are: desogestrel and etinilestradiol. A tablet contains 0.15 mg of desogestrel and 0.02 mg of etinilestradiol.
- The other components are: anhydrous colloidal silica, all-rac-alpha-tocopherol, lactose monohydrate, potato starch, povidone and stearic acid.
Appearance of the product and contents of the packaging
The tablets are white, biconvex, round and 6 mm in diameter. Each tablet bears a code marked, TR over 4 on one face and Organon and an asterisk on the opposite face.
Suavuret is presented in aluminium/PVC blisters of 21 tablets, conditioned in a laminated aluminium sealed over. The overwraps are packaged in boxes with 1x21 and 3x21 tablets.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization:
Organon Salud, S.L.
Paseo de la Castellana, 77
28046 Madrid
Spain
Tel.: 915911279
Responsible for manufacturing:
N.V. Organon
Kloosterstraat 6,
5349 AB, Oss,
Netherlands
Date of the last review of this leaflet:September2022.
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/
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