Patient leaflet - YASMIN
1. What Yasmin is and what it is used for
► Yasmin is a contraceptive pill and is used to prevent pregnancy. ► Each light yellow film-coated tablet contains a small amount
of two different female hormones, namely drospirenone and ethinylestradiol.
► Contraceptive pills that contain two hormones are called
“combination” pills.
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 leaflet, 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
► if you have (or have ever had) a blood clot in a blood vessel of
your leg (deep vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs;
► if you know you have a disorder affecting your blood clotting – for
instance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies; ► if you need an operation or if you are off your feet for a long time
(see section ‘Blood clots’);
► if you have ever had a heart attack or stroke;
► if you have (or have ever had) angina pectoris (a condition that
causes severe chest pain and may be a first sign of a heart attack) or transient ischaemic attack (TIA – temporary stroke symptoms);
► if you have any of the following diseases that may increase
your risk of a clot in the arteries;
w severe diabetes with blood vessel damage w very high blood pressure
w a very high level of fat in the blood (cholesterol or triglycerides) w a condition known as hyperhomocysteinaemia ► 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 still not normal
► if your kidneys are not working well (renal failure) ► if you have (or have ever had) a tumour in the liver ► if you have (or have ever had) or if you are suspected of having
breast cancer or cancer of the genital organs
► if you have any unexplained bleeding from the vagina ► if you are allergic to ethinylestradiol or drospirenone, or any of
the other ingredients of this medicine (listed in section 6). This may cause itching, rash or swelling.
Do not use Yasmin if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/ voxilaprevir (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
► 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 ‘Blood clots’ section below).
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.
► if a close relative has or has ever had breast cancer ► if you have a disease of the liver or the gallbladder ► if you have diabetes
► if you have depression
► if you have Crohn’s disease or ulcerative colitis (chronic
inflammatory bowel disease);
► if you have haemolytic uraemic syndrome (HUS – a disorder of
blood clotting causing failure of the kidneys);
► if you have sickle cell anaemia (an inherited disease of the red
blood cells);
► if you have elevated levels of fat in the blood (hypertriglyceridaemia)
or a positive family history for this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
► if you need an operation, or you are off your feet for a long time
(see in section 2 ‘Blood clots’);
► if you have just given birth you are at an increased risk of blood
clots. You should ask your doctor how soon after delivery you can start taking Yasmin;
► If you have an inflammation in the veins under the skin
(superficial thrombophlebitis);
► If you have varicose veins;
► if you have epilepsy (see “Other medicines and Yasmin”); ► if you have systemic lupus erythematosus (SLE - a disease
affecting your natural defence system);
► if you have a disease that first appeared during pregnancy or
earlier use of sex hormones (for example, hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes), a disease of the nerves in which sudden movements of the body occur (Sydenham’s chorea)) ► if you have or have ever had chloasma (a discolouration of
the skin especially on the face or neck known as “pregnancy patches”). If so, avoid direct sunlight or ultraviolet light. ► If you experience symptoms of angioedema such as swollen face,
tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing contact a doctor immediately. Products containing oestrogens may cause or worsen the symptoms of
hereditary and acquired angioedema.
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
► in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE);
► in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
thromboembolism’ or ATE);
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?
► swelling of one leg or along a vein in
the leg or foot especially when
accompanied by:
w pain or tenderness in the leg
which may be felt only when
standing or walking
w increased warmth in the affected leg
w change in colour of the skin on the
leg e.g. turning pale, red or blue
Deep vein
thrombosis
► sudden unexplained breathlessness or
rapid breathing;
► sudden cough without an obvious
cause, which may bring up blood;
► sharp chest pain which may increase
with deep breathing;
► severe light headedness or dizziness;
► rapid or irregular heartbeat
► severe pain in your stomach;
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’).
Pulmonary embolism
Symptoms most commonly occur in one eye:
► immediate loss of vision or
► painless blurring of vision which can
progress to loss of vision
Retinal vein
thrombosis (blood clot in the eye)
► chest pain, discomfort, pressure,
heaviness
► sensation of squeezing or fullness in the
chest, arm or below the breastbone;
► fullness, indigestion or choking feeling;
► upper body discomfort radiating to the
back, jaw, throat, arm and stomach;
► sweating, nausea, vomiting or dizziness;
► extreme weakness, anxiety, or shortness
of breath;
► rapid or irregular heartbeats
Heart attack
► sudden weakness or numbness of the
face, arm or leg, especially on one side
of the body;
► sudden confusion, trouble speaking or
understanding;
► sudden trouble seeing in one or both eyes;
► sudden trouble walking, dizziness, loss
of balance or coordination;
► sudden, severe or prolonged headache
with no known cause;
► loss of consciousness or fainting with
or without seizure.
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.
Stroke
► swelling and slight blue discolouration
of an extremity;
► severe pain in your stomach
(acute abdomen)
Blood clots blocking 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
connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur 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 can cause a
deep vein thrombosis (DVT).
► If a blood clot travels from the leg and lodges in the lung it can
cause a pulmonary embolism.
► Very rarely a clot may form in a vein in another organ such as the
eye (retinal vein thrombosis).
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.
► Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
► Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year. ► Out of 10,000 women who are using a combined hormonal contraceptive that contains drospirenone such as Yasmin, between about 9 and 12 women will develop a blood clot in a year. ► The risk of having a blood clot will vary according to your personal medical history (see “Factors that increase your risk of a blood clot” below).
Risk of developing a blood clot in a year
Women who are not using a combined
hormonal pill and are not pregnant
About 2 out of
10,000 women
Women using a combined hormonal
contraceptive pill containing levonorgestrel,
norethisterone or norgestimate
About 5-7 out of 10,000 women
Women using Yasmin 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:
► if you are very overweight (body mass index or BMI over
30kg/m²);
► if one of your immediate family has had a blood clot in the leg, lung or other organ at a young age (eg. below the age of about 50). In this case you could have a hereditary blood clotting disorder; ► if you need to have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a cast. The use of Yasmin may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Yasmin ask your doctor when you can start using it again. ► as you get older (particularly above about 35 years); ► if you gave birth less than a few weeks ago.
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:
► with increasing age (beyond about 35 years);
► if you smoke. When using a combined hormonal contraceptive like Yasmin, you are advised to stop smoking. If you are unable to stop smoking and are older than 35 your doctor may advise you to use a different type of contraceptive;
► if you are overweight;
► if you have high blood pressure;
► if a member of your immediate family has had a heart attack or stroke at a young age (less than about 50). In this case you could also have a higher risk of having a heart attack or stroke; ► if you, or someone in your immediate family, have a high level of fat in the blood (cholesterol or triglycerides);
► if you get migraines, especially migraines with aura; ► if you have a problem with your heart (valve disorder, disturbance of the rhythm called atrial fibrillation);
► if you have diabetes.
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 doc-tor more often. The occurence 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, your doctor must find out what 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. Do not start the next strip until 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
► can have an influence on the blood levels of Yasmin ► can make it less effective in preventing pregnancy ► can cause unexpected bleeding
These include
► medicines used for the treatment of:
w epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
w tuberculosis (e.g. rifampicin)
w HIV and Hepatitis C Virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) w fungal infections (e.g. griseofulvin, ketoconazole) w arthritis, arthrosis (etoricoxib)
w high blood pressure in the blood vessels in the lungs
(bosentan)
w the herbal remedy St. John’s wort
► Yasmin may influence the effect of other medicines, e.g.
w medicines containing ciclosporin
w the anti-epileptic lamotrigine (this could lead to an increased frequency of seizures)
w theophylline (used to treat breathing problems) w tizanidine (used to treat muscle pain and/or muscle cramps). Do not use Yasmin if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/ voxilaprevir, as these products 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 hormone 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 immediately and contact your doctor.
If you want to become pregnant, you can stop taking Yasmin at any time (see also “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 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 one tablet of Yasmin every day, if necessary with a small amount of water. You may take the tablets with or without food, but you should take the tablets every day around the same time.
The strip contains 21 film-coated tablets. Next to each tablet is print-ed the day of the week that it should be taken. If, for example you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the strip until all 21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week) bleeding should begin. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
On the 8th day after the last Yasmin tablet (that is, after the 7-day gap week), you should start with the following strip, whether your bleeding has stopped or not. This means that you should start every strip on the same day of the week and that the withdrawal bleed should occur on the same days each month.
If you use Yasmin in this manner, you are also protected against pregnancy during the 7 days when you are not taking a tablet.
When can you start with the first strip?
► If you have not used a contraceptive with hormones in the
previous month
Begin with Yasmin on the first day of the cycle (that is, the first day of your period). If you start Yasmin on the first day of your period you are immediately protected against pregnancy. You may also begin on day 2-5 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.
► Changing from a combination hormonal contraceptive, or
combination contraceptive vaginal ring or patch You can start Yasmin preferably on the day after the last active tablet (the last tablet containing the active substances) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill (or after the last inactive tablet of your previous pill). When changing from a combination contraceptive vaginal ring or patch, follow the advice of your doctor. ► Changing from a progestogen-only-method (progestogen-only
pill, injection, implant or a progestogen-releasing IUD) You may switch any day from the progestogen-only pill (from an implant or an IUD on the day of its removal, from an injectable when the next injection would be due) but in all of these cases use extra protective measures (for example, a condom) for the first 7 days of tablet-taking.
► After a miscarriage
Follow the advice of your doctor.
► After having a baby
You can start Yasmin between 21 and 28 days after having a baby. If you start later than day 28, use a so-called barrier meth-od (for example, a condom) during the first seven days of Yasmin use.
If, after having a baby, you have had sex before starting Yasmin (again), be sure that you are not pregnant or wait until your next period.
► If you are breastfeeding and want to start Yasmin (again) after having
a baby
Read the section on “Breast feeding”.
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
► If you are less than 12 hours late taking a tablet, the protection
against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets again at the usual time.
► If you are more than 12 hours late taking a tablet, the protection
against pregnancy may be reduced. The greater the number of tablets that you have forgotten, the greater is the risk of becom-ing pregnant.
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 the diagram): ► More than one tablet forgotten in this strip
Contact your doctor.
► One tablet forgotten in week 1
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.
► One tablet forgotten in week 2
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.
► One tablet forgotten in week 3
► You can choose between two possibilities:
- 1.
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. Instead of having seven pill-free days start the next strip.
Most likely, you will have a period at the end of the second strip or you may also have light or menstruation-like bleeding during the second strip.
- 2.
You can also stop the strip and go directly to the tablet-free
period of 7 days (record the day on which you forgot your tablet). If you want to start a new strip on the day you always start, make the tablet-free period less than 7 days.
If you follow one of these two recommendations, you will remain protected against pregnancy.
► If you have forgotten any of the tablets in a strip, and you do not
have a bleeding during the first tablet-free period, you may be pregnant. Contact your doctor before you start the next strip.
More than
1 tablet
forgotten
in 1 strip
Only 1 tablet
forgotten
(taken more
than 12 hours
late)
Ask your doctor for advice
yes
Days
1 - 7
Days
8 - 14
Days
15 - 21
no
or
Had sex in the previous week before forgetting?
► Take the forgotten tablet ► Use a barrier method
(condom) for the following 7 days and ► Finish strip
► Take the forgotten
tablet
► Finish the strip
► Take the forgotten
tablet and
► Finish the strip
► Instead of the 7
tablet -free days
► Start the next strip
► Stop the strip
immediately
► Begin the gap week
(not longer than 7 days) ► Then start the next strip
What to do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours after 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”.
Delaying your period: what you need to know
Even though it is not recommended, you can delay your period by going straight to a new strip of Yasmin instead of the tablet-free period and finishing it. You may experience light or menstruation-like bleeding while using this second strip. After the usual tablet-free period of 7 days, start the next strip.
You might ask 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 tablet-free week. If you have to change this day, reduce the number of tablet-free days shorter – (but never increase them – 7 is the maximum!). For example, if your tablet-free days normally begin 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 tablet-free interval very short (for example, 3 days or less) you may not have any bleeding during these days. 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 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 your 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”.
Serious side effects
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing (see also section “Warnings and precautions”).
The following is a list of the side effects that have been linked with the use of Yasmin:
Common side effects (between 1 and 10 in every 100 users may be affected):
► menstrual disorders, bleeding between periods, breast pain,
breast tenderness
► headache, depressive mood
► migraine
► nausea
► thick whitish vaginal discharge, vaginal yeast infection Uncommon side effects (between 1 and 10 in every 1,000 users may be affected):
► breast enlargement, changes in interest in sex
► high blood pressure, low blood pressure
► vomiting, diarrhoea
► acne, severe itching, skin rash, hair loss (alopecia) ► infection of the vagina
► fluid retention and body weight changes
Rare side effects (between 1 and 10 in every 10,000 users may be affected):
► allergic reactions (hypersensitivity)
► breast secretion
► hearing impairment
► asthma
► the skin conditions erythema nodosum (characterized by painful
reddish skin nodules) or erythema multiforme (characterized by rash with target-shaped reddening or sores).
► harmful blood clots in a vein or artery for example:
w in a leg or foot (i.e. DVT)
w in a lung (i.e. PE)
w heart attack
w stroke
w mini-stroke or temporary stroke-like symptoms, known as a
transient ischaemic attack (TIA)
w blood clots in the liver, stomach/intestine, kidneys or eye. 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
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. If your tablets show signs of deterioration or discolouration seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Yasmin contains
The active substances are drospirenone and ethinylestradiol. Each film-coated tablet contains 0.03 mg ethinylestradiol and 3 mg drospirenone.
Also contains lactose monohydrate, maize starch, pregelatinised maize starch, povidone K25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide (E171) and iron oxide yellow (E172). What Yasmin looks like and content of the pack
Light yellow round film-coated tablets with convex faces, one side embossed with the letters ‘DO’ in a regular hexagon and plain on the reverse.
Available in calendar blister packs of 21 or 63 tablets. Manufactured by Bayer AG, 13342 Berlin, Germany. Procured from within the EU and repackaged by Product Licence Holder Uni Health Distribution Ltd, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent, DA1 5BS.
PLGB 45396/0058 POM
Leaflet date: 3 July 2024 Ref: Yas/v5
Yasmin is a registered trademark of Bayer Intellectual Property GmbH
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