Package Leaflet: Information for the User
Yasmin 3 mg/0.03mg film-coated tablets
drospirenone/ethinylestradiol
Read this package leaflet carefully before you start taking this medicine because it contains important information for you.
Important things to know about combined hormonal contraceptives (CHCs):
Contents of the package leaflet:
When not to use Yasmin 2
Warnings and precautions 3
Blood clots 5
Yasmin and cancer 9
Psychiatric disorders……………………………………………………………………...9
Irregular bleeding 9
What to do if you do not have your period during the week off 9
Other medicines and Yasmin 9
Taking Yasmin with food and drink 10
Lab tests 10
Pregnancy 10
Breast-feeding 11
Driving and using machines 11
Yasmin contains lactose 11
When you can start with the first blister 11
If you take more Yasmin than you should 12
If you forget to take Yasmin 13
What to do in case of vomiting or severe diarrhea 14
Delayed period: what you should know 14
Change of your first day of period: what you should know 15
If you stop taking Yasmin 15
Yasmin is a contraceptive. It is used to prevent pregnancy.
Each film-coated tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
Contraceptives that contain two hormones are called combined contraceptives.
General considerations
Before you start using Yasmin, 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 start taking Yasmin, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your personal situation, may carry out some other tests.
This prospectus describes several situations in which you should interrupt the use of Yasmin, or in which the effect of Yasmin may decrease. In such situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm method or the temperature method. These methods may not be reliable since Yasmin alters the monthly changes in body temperature and cervical mucus.
Yasmin, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
When you should not use Yasmin
You should not use Yasmin 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.
Do not use Yasmin
Do not use Yasmin if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and Yasmin").
Additional information on special populations
Children and adolescents
Yasmin is not indicated for use in women who have not yet had their first menstrual period.
Older women
Yasmin is not indicated for use after menopause.
Women with liver insufficiency
Do not take Yasmin if you suffer from liver disease. See sections "Do not use Yasmin" and "Warnings and precautions".
Women with renal insufficiency
Do not take Yasmin if you are suffering from kidney malfunction or acute renal failure. See sections "Do not use Yasmin" and "Warnings and precautions".
Warnings and precautions
Consult your doctor or pharmacist before starting to take Yasmin. When should you consult your doctor? Seek urgent medical attention
To obtain a description of the symptoms of these serious side effects, see "How to recognize a blood clot". |
Tell your doctor if you suffer from any of the following conditions
In some situations, you will need to be particularly careful while using Yasmin or any other combined contraceptive, and your doctor may need to examine you periodically. If the condition develops or worsens while you are using Yasmin, you should also inform your doctor.
BLOOD CLOTS
The use of a combined hormonal contraceptive like Yasmin increases your risk of having a blood clotcompared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can form:
Recovery from blood clots is not always complete. In rare cases, there can be serious lasting effects or, very rarely, they can be fatal.
It is essential to remember that the overall risk of a harmful blood clot due to Yasmin is small.
HOW TO RECOGNIZE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Are you experiencing any of these signs? | What might you be suffering from? |
| Deep vein thrombosis |
If you are unsure, consult a doctor, as some of these symptoms, such as cough or shortness of breath, can be confused with a milder condition, such as a respiratory infection (e.g., 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 can be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention, as you may be at risk of having 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?
When is the risk of developing a blood clot in a vein higher?
The risk of developing a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.
After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.
When you stop taking Yasmin, your risk of developing a blood clot returns to normal within a few weeks.
What is the risk of developing 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 developing a blood clot in the leg or lung (DVT or PE) with Yasmin is small.
Risk of developing a blood clot in a year | |
Women who do not usea combined hormonal contraceptive and are not pregnant | About 2 out of 10,000 women |
Women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate | About 5-7 out of 10,000 women |
Women who use Yasmin | About 9-12 out of 10,000 women |
Factors that increase your risk of a blood clot in a vein
The risk of having a blood clot with Yasmin is small, but some conditions increase the risk. Your risk is higher:
The risk of developing a blood clot increases with the number of conditions you have.
Long-distance air travel (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 above conditions, even if you are not sure. Your doctor may decide that you should stop using Yasmin.
If any of the above conditions change while you are using Yasmin, for example, a close relative experiences a thrombosis without a known cause or you gain a lot of weight, inform your doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a 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 Yasmin is very small, but it can increase:
If you have more than one of these conditions or if any of them are particularly severe, the risk of developing a blood clot may be increased further.
If any of the above conditions change while you are using Yasmin, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.
Yasmin and cancer
Breast cancer has been slightly more common in women using combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women taking combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have your breasts checked regularly, and you should see your doctor if you notice any lump.
In rare cases, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. See your doctor if you experience severe unusual abdominal pain.
Psychiatric disorders
Some women using hormonal contraceptives like Yasmin have reported depression or a depressive mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for advice.
Yasmin can be taken with or without food, and with some water if necessary.
Lab tests
If you need a blood test, tell your doctor or laboratory staff that you are taking a contraceptive, as hormonal contraceptives can influence the results of some tests.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, you should not take Yasmin. If you become pregnant during treatment with Yasmin, you must stop treatment immediately and contact your doctor. If you wish to become pregnant, you can stop taking Yasmin at any time (see "If you stop treatment with Yasmin", page 15).
Consult your doctor or pharmacist before taking any medication.
Breastfeeding
In general, it is not recommended to take Yasmin during the breastfeeding period (when you are giving breast milk). If you want to take the contraceptive while breastfeeding, you should consult your doctor.
Consult your doctor or pharmacist before taking any medication.
Driving and using machines
There is no information to suggest that the use of Yasmin has any effect on the ability to drive or use machinery.
Yasmin contains lactose
If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Take one Yasmin pill every day, with some water if necessary. You can take the pills with or without food, but all at approximately the same time every day.
The blister pack contains 21 film-coated pills. Next to each pill is printed the day of the week on which it should be taken. If, for example, you start on a Wednesday, take a pill with "WED" next to it. Follow the direction of the arrow on the blister pack until you have taken all 21 pills.
After that, you should not take any pills for 7 days. During these 7 days when you do not take pills (called the rest week), you should have your period. The period, which can also be called withdrawal bleeding, usually starts on the 2nd or 3rd day of the rest week.
On the 8th day after taking the last Yasmin pill (i.e., after the 7-day rest period), you should start with the next blister pack, even if you have not yet finished bleeding. This means that you should start each blister pack on the same day of the week, and your period should take place during the same days every month.
If you use Yasmin in this way, you are also protected against pregnancy during the 7 days when you do not take any pills.
When can you start with the first blister pack
Start taking Yasmin on the first day of your cycle (i.e., the first day of your period). If you start Yasmin on the first day of your period, you will be protected immediately against pregnancy. You can also start on days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.
You can start taking Yasmin preferably the day after taking the last active pill (the last pill that contains active ingredients) of your previous contraceptive, but no later than the day after the rest week of your previous contraceptive (or after taking the last inactive pill of your previous contraceptive). When switching from a vaginal ring or patch, follow your doctor's recommendations.
You can switch from the progestin-only pill at any time (if it's an implant or intrauterine system, on the same day it is removed; if it's an injectable, when the next injection is due), but in all cases, use additional contraceptive measures (e.g., a condom) during the first 7 days of pill taking.
Follow your doctor's recommendations.
You can start taking Yasmin between 21 and 28 days after giving birth. If you start later than day 28, use a barrier method (e.g., a condom) during the first 7 days of Yasmin use.
If, after having a child, you have had sexual intercourse before starting to take Yasmin again, you should be sure you are not pregnant or wait for your next menstrual period.
Read the section "Breastfeeding", page 11.
Ask your doctor if you are not sure when to start.
If you take more Yasmin than you should
No cases have been reported where an overdose of Yasmin has caused serious harm.
The symptoms that may appear if you take many pills at the same time may include feeling unwell or vomiting or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.
If you have taken too many Yasmin pills, or discover that a child has taken them, consult your doctor or pharmacist.
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 used.
If you forget to take Yasmin
The risk of incomplete protection against pregnancy is highest if you forget to take a pill at the beginning or end of the blister pack. Therefore, you should follow these recommendations (see the diagram on page 14):
Consult your doctor.
Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time and use additional precautions, for example, a condom, during the next 7 days. If you have had sexual intercourse in the week before forgetting the pill, you may be pregnant. In this case, consult your doctor.
Take the forgotten pill as soon as you remember, even if it means taking two pills at the same time. Continue taking the pills at the usual time. Your protection against pregnancy will not decrease, and you do not need to take additional precautions.
You can choose between two options:
You will probably have your period at the end of the second blister pack, although you may also experience light bleeding or spotting during the second blister pack.
If you follow one of these two recommendations, you will remain protected against pregnancy.
What to do in case of vomiting or severe diarrhea
If you vomit within 3-4 hours after taking a pill or have severe diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a pill. After vomiting or diarrhea, take a pill from a reserve blister pack as soon as possible. If possible, take it within 12 hoursafter the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forget to take Yasmin", page 13.
Delayed period: what you should know
Although it is not recommended, you can delay your period if you start taking a new Yasmin blister pack instead of continuing with the rest week and finish it. You may experience light bleeding or spotting during the use of the second blister pack. After the usual 7-day rest period, startthe next blister pack.
You should ask your doctor for advice before deciding to delay your menstrual period.
Changing the first day of your period: what you should know
If you take the pills according to the instructions, your period will start during the rest week. If you need to change that day, reduce the number of rest days (but never increase them - 7 at most). For example, if your rest days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new blister pack 3 days earlier than usual. If you make the rest period very short (e.g., 3 days or less), you may not have bleeding during these days. Then you may experience light bleeding or spotting.
If you are not sure how to proceed, consult your doctor.
If you stop treatment with Yasmin
You can stop taking Yasmin whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, stop taking Yasmin and wait until your period before trying to become pregnant. This way, you can more easily calculate the estimated date of delivery.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medications, this medication can cause side effects, although not everyone will experience them. If you suffer any side effect, especially if it is severe and persistent, or have any change in health that you think may be due to Yasmin, consult your doctor.
All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before you start taking Yasmin".
Severe side effects
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria with possible difficulty breathing (see also section "Warnings and precautions").
The following list of side effects has been associated with the use of Yasmin:
Common side effects(may affect up to 1 in 10 patients):
Uncommon side effects(may affect up to 1 in 100 patients):
Rare side effects(may affect up to 1 in 1000 patients):
The likelihood 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 side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original blister pack to protect from moisture.
Do not use this medicine after the expiry date which is stated on the packaging after “CAD:”. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.
Composition of Yasmin
Each active film-coated tablet contains 3 milligrams of drospirenone and 0.030 milligrams of ethinylestradiol.
Tablet core: lactose monohydrate, corn starch, pregelatinized corn starch, povidone K25, magnesium stearate (E-470b).
Tablet coating: hypromellose (E-464), macrogol 6,000, talc (E-553b), titanium dioxide (E-171), and yellow iron oxide (E-172), see section 2 “Yasmin contains lactose”.
Appearance of the Product and Package Contents
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bayer Hispania, S.L.
Av. Baix Llobregat, 3 - 5
08970 Sant Joan Despí – Barcelona
Spain
Manufacturer
Bayer AG
13342 Berlin, Germany
This medicine is authorized in the Member States of the European Economic Area under the following names:
Date of Last Revision of this Leaflet:November 2023
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)