Active ingredient
- ethinylestradiol
- drospirenone
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00010/0571.
Yasmin film-coated tablets 0.03mg/3mg
Due to regulatory changes, the content of the following Patient Information Leaflet may vary from the one found in your medicine pack. Please compare the 'Leaflet prepared/revised date' towards the end of the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact your doctor or pharmacist.
Package leaflet: Information for the user
Yasmin 0.03 mg / 3 mg film-coated tablets
Ethinylestradiol / Drospirenone
Read all of this booklet carefully before you start taking this medicine because it contains important information for you.
Important things to know about combined hormonal contraceptives (CHCs):
What is in this booklet
1. What Yasmin is and what is it used for
2. What you need to know before you take Yasmin
When you should not use Yasmin
Warnings and precautions
BLOOD CLOTS
Yasmin and cancer
Psychiatric disorders
Bleeding between periods
What to do if no bleeding occurs during the seven pill-free days
Other medicines and Yasmin
Yasmin with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Yasmin contains lactose
3. How to take Yasmin
When can you start with the first strip?
If you take more Yasmin than you should
If you forget to take Yasmin
What to do in the case of vomiting or severe diarrhoea
Delaying your period: what you need to know
Changing the first day of your period: what you need to know
If you stop taking Yasmin
4. Possible side effects
5. How to store Yasmin
6. Contents of the pack and other information
1. What Yasmin is and what is it used for
2. What you need to know before you take Yasmin
General notes
Before you start using Yasmin, you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see section 2 “Blood clots”.
Before you can begin taking Yasmin, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests.
In this booklet, several situations are described where you should stop using Yasmin, or where the reliability of Yasmin may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Yasmin alters the monthly changes of 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. If you do have any of the conditions listed below, you must tell your doctor. Your doctor will discuss with you what other form of birth control would be more appropriate.
Do not use Yasmin
Do not use Yasmin if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also in section “Other medicines and Yasmin”).
Additional information on special populations
Children and adolescents
Yasmin is not intended for use in females whose periods have not yet started.
Older women
Yasmin is not intended for use after the menopause.
Women with liver impairment
Do not take Yasmin if you suffer from liver disease. See also sections ‘Do not use Yasmin’ and ‘Warnings and precautions’.
Women with kidney impairment
Do not take Yasmin if you are suffering from poorly functioning kidneys or acute kidney failure. See also sections ‘Do not use Yasmin’ and ‘Warnings and precautions’.
Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention
For a description of the symptoms of these serious side effects please go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you
Talk to your doctor before taking Yasmin. In some situations you need to take special care while using Yasmin or any other combination pill, and your doctor may need to examine you regularly. If the condition develops, or gets worse while you are using Yasmin, you should also tell your doctor.
BLOOD CLOTS
Using a combined hormonal contraceptive such as Yasmin increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block vessels and cause serious problems.
Blood clots can develop
Recovery from blood clots is not always complete. Rarely, there may be serious lasting effects or, very rarely, they may be fatal;
It is important to remember that the overall risk of a harmful blood clot due to Yasmin is small.
HOW TO RECOGNISE 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 are you possibly suffering from?
Deep vein thrombosis
Are you experiencing any of these signs?
If you are unsure, talk to a doctor as some of these symptoms such as coughing or being short of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a ‘common cold’).
What are you possibly suffering from?
Pulmonary embolism
Are you experiencing any of these signs?
Symptoms most commonly occur in one eye:
What are you possibly suffering from?
Retinal vein thrombosis (blood clot in the eye)
Are you experiencing any of these signs?
What are you possibly suffering from?
Heart attack
Are you experiencing any of these signs?
Sometimes the symptoms of stroke can be brief with an almost immediate and full recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.
What are you possibly suffering from?
Stroke
Are you experiencing any of these signs?
What are you possibly suffering from?
Blood clots blocking 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 highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive.
When you stop Yasmin your risk of 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 a blood clot in the leg or lung (DVT or PE) with Yasmin is small.
Women who are not using a combined hormonal pill and are not pregnant
Risk of developing a blood clot in a year - About 2 out of 10,000 women
Women using a combined hormonal contraceptive pill containing levonorgestrel, norethisterone or norgestimate
Risk of developing a blood clot in a year - About 5-7 out of 10,000 women
Women using Yasmin
Risk of developing a blood clot in a year - About 9-12 out of 10,000 women
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Yasmin is small but some conditions will increase the risk. Your risk is higher:
The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that Yasmin needs to be stopped.
If any of the above conditions change while you are using Yasmin, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell 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 important to note that the risk of a heart attack or stroke from using Yasmin is very small but 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 even more.
If any of the above conditions change while you are using Yasmin, for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
Yasmin and cancer
Breast cancer has been observed slightly more often in women using combination pills, but it is not known whether this is caused by the treatment. For example it may be that more tumours are detected in women on combination pills because they are examined by their doctor more often. The risk of breast tumours becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check your breasts and you should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in pill users. Contact your doctor if you have unusually severe abdominal pain.
Psychiatric disorders
Some women using hormonal contraceptives including Yasmin have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts, If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
Bleeding between periods
During the first few months that you are taking Yasmin, you may have unexpected bleeding (bleeding outside the seven pill-free days). If this bleeding occurs for more than a few months, or if it begins after some months, contact your doctor as they must find out if anything is wrong.
What to do if no bleeding occurs during the seven pill-free days
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor immediately. Only start the next strip if you are sure that you are not pregnant.
Other medicines and Yasmin
Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you take Yasmin. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or, whether the use of another medicine you need must be changed.
Some medicines
These include
medicines used for the treatment of
Yasmin may influence the effect of other medicines, e.g.
Do not use Yasmin if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Yasmin can be restarted approximately 2 weeks after completion of this treatment. See section “Do not use Yasmin”.
Ask your doctor or pharmacist for advice before taking any medicine.
Yasmin with food and drink
Yasmin may be taken with or without food, if necessary with a small amount of water.
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because hormonal contraceptives can affect the results of some tests.
Pregnancy
If you are pregnant, you must not take Yasmin. If you become pregnant while taking Yasmin you must stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Yasmin at any time (see also page 15 “If you stop taking Yasmin”).
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding
Use of Yasmin is generally not advisable when a woman is breast-feeding. If you want to take the pill while you are breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of Yasmin affects driving or the use of machines.
Yasmin contains lactose
If you cannot tolerate certain sugars, contact your doctor before you take Yasmin.
3. How to take Yasmin
Take Yasmin every day for 21 days
Yasmin comes in strips of 21 pills, each marked with a day of the week.
Then have seven pill-free days
After you have taken all 21 pills in the strip, you have seven days when you take no pills. So, if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week.
Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills.
You don’t need to use extra contraception during these seven pill-free days – as long as you have taken your pills correctly and start the next strip of pills on time.
Then start your next strip
Start taking your next strip of Yasmin after the seven pill-free days – even if you are still bleeding. Always start the new strip on time.
During the seven pill-free days, when you take no tablets, bleeding should begin (so-called withdrawal bleeding). This usually starts on the 2nd or 3rd day after the last tablet of Yasmin. Start the following strip after the last day of the seven pill-free days, whether your bleeding has stopped or not.
When can you start with the first strip?
Ask your doctor what to do if you are not sure when to start.
If you take more Yasmin than you should
There are no reports of serious harmful results of taking too many Yasmin tablets.
If you take several tablets at once then you may feel sick or vomit or you may bleed from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding.
If you have taken too many Yasmin tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice
If you forget to take Yasmin
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or at the end of the strip. Therefore, you should keep to the following rules (see also the diagram on page 14):
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time and use extra precautions for the next 7 days, for example, a condom. If you have had sex in the week before forgetting the tablet you may be pregnant. In that case, contact your doctor.
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same time. Continue taking the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to take extra precautions. If you forget more than one tablet use an additional barrier method such as a condom for 7 days.
If you follow one of these two recommendations, you will remain protected against pregnancy.
What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active substances in the pill will not be fully taken up by your body. The situation is almost the same as forgetting a tablet. After vomiting or diarrhoea, take another tablet from a reserve strip as soon as possible. If possible take it within 12 hours of when you normally take your pill. If that is not possible or 12 hours have passed, you should follow the advice given under “If you forget to take Yasmin” on page 13.
Delaying your period: what you need to know
Although it is not recommended, you can delay your period by skipping the seven pill-free days and going straight to a new strip of Yasmin and finishing it. You may experience light or menstruation-like bleeding while using this second strip. After the usual pill-free period of 7 days start your next strip.
It is advisable to consult your doctor for advice before deciding to delay your menstrual period.
Changing the first day of your period: what you need to know
If you take the tablets according to the instructions, then your period will begin during the seven pill-free days. If you have to change this day, make the pill-free period shorter – (but never longer – 7 days is the maximum!). For example, if you start the seven pill-free days on a Friday, and you want to change this to a Tuesday (3 days earlier) start a new strip 3 days earlier than usual. If you make the pill-free period very short (for example 3 days or less) you may not have any bleeding during this time. You may then experience light or menstruation-like bleeding.
If you are not sure what to do, consult your doctor.
If you stop taking Yasmin
You can stop taking Yasmin whenever you want. If you do not want to become pregnant, ask your doctor for advice about other reliable methods of birth control. If you want to become pregnant, stop taking Yasmin and wait for a menstrual period before trying to become pregnant. You will be able to calculate the expected delivery date more easily.
If you have any further questions on the use of this medicine, ask a doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Yasmin, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you take Yasmin”.
The following is a list of the side effects that have been linked with the use of Yasmin:
Serious side effects: – see your doctor straight away
Signs of a severe allergic reaction to Yasmin:
Signs of breast cancer include:
Signs of cancer of the cervix include:
Signs of severe liver problems include:
Common side effects (between 1 and 10 in every 100 users may be affected):
Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
Rare side effects (between 1 and 10 in every 10,000 users may be affected):
The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Yasmin
Keep this medicine out of the sight and reach of children.
Do not store above 30 °C. Store in the original package.
Do not use this medicine after the expiry date which is stated on the packaging after “Do not use after:” or “EXP”.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Yasmin contains
What Yasmin looks like and content of the pack
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
This booklet was last revised in June 2021
V035_0
400 South Oak Way, Reading, Berkshire, RG2 6AD
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