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Zellminelle

Document: Zellminelle tablet ENG PL change

Package leaflet: Information for the user


Zellminelle 0.02 mg/ 3.0 mg tablets

(Ethinylestradioland Drospirenone)


Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception if used correctly

• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks

• Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”)


Read all of this leaflet carefully before you starts using this medicine because it contains important information for you.



What is in this leaflet


What Zellminelle is and what it is used for

What you need to know before you take Zellminelle

How to take Zellminelle

Possible side effects

How to store Zellminelle

Contents of the pack and other information


1. What Zellminelle is and what it is used for


Zellminelle is a contraceptive pilland is usedto prevent pregnancy.
Each tabletcontains a small amountof twodifferent femalehormones, namely

drospirenone and ethinylestradiol.
Contraceptive pills thatcontain two hormonesare called "combined oral contraceptives".


2. What you need to know before you use Zellminelle


General Comments


Before you start using Zellminelle you should read the information on blood clots (thrombosis) in section 2. It is particularly important to read the symptoms of a blood clot – see Section 2 “Blood clots”).


Before you start takingZellminelle, your doctor willask you about yourpersonal health history and the health history of your close relatives. Thedoctor will alsomeasure your blood pressureand, depending on your personal health situation, the doctor may also carry out some other tests.

In this leaflet, several situations are described where youshould stop usingZellminelle or where the reliabilityof Zellminelle may be decreased.In thosesituations you should eithernot have sex, or use an extra non-hormonal contraceptive precautions (for example use a condom) or another barrier method.Do not use thetemperature methodor periodicwithdrawal method. These methodsare unreliable becauseuse of Zellminelle changes body temperature and cervical mucus.

Like other hormonal contraceptives, Zellminelle does not protectagainst infection withthe HIV virus(AIDS) orothersexuallytransmitted diseases(STDs).


Do not take Zellminelle


You should not use Zellminelle 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.


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;

if you have (or have ever had) a blood clot in a blood vessel of your legs (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;

– severe diabetes with blood vessel damage

– very high blood pressure

– a very high level of fat in the blood (cholesterol or triglycerides)

– a condition known as hyperhomocysteinaemia


Warnings and precautions


Talk to your doctor, pharmacist or nurse before taking this medicine.


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 clot’ (thrombosis) 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.


If the condition develops, or gets worse while you are using Zellminelle, you should also tell your doctor.



BLOOD CLOTS


Using a combined hormonal contraceptive such as Zellminelle increases your risk of developing a blood clot compared with not using one. In rare cases a blood clot can block blood 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 having a harmful blood clot due to any Zellminelleis 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:

• pain or tenderness in the leg which may be felt only when standing or walking.

• increased warmth in the affected leg.

• 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 Zellminelle 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 Zellminelle is small.


Chances of getting a blood clot areincreased by taking the pill.


- 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 Zellminelle 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/patch/ring 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 Zellminelle


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 Zellminelle 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 (e.g. 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 Zellminelle may need to be stopped several weeks before surgery or while you are less mobile. If you need to stop Zellminelle 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 Zellminelle needs to be stopped.


If any of the above conditions change while you are using Zellminelle, for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight.

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 Zellminelle 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 Zellminelle, for example you start smoking, a close family member experiences a thrombosis for no known reason; or you gain a lot of weight.


Zellminelle andcancer


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 occurrence of breast tumours decreases 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.


Bleeding between periods


During the first few months that you are taking Zellminelle, 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 what is wrong.


What to do if no bleeding occurs in the seven pill-free days


If bleeding does not occur in the seven pill-free days, even if you have taken all the tablets correctly and if you have not vomited and did not have severe diarrhoea, and you have not taken any other medication, then it is very unlikely that you are pregnant.


If the expected bleeding does not happen twice in a row, 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 andDrospirenone /Ethinylestradiol

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.


Tell your doctor which medicines orherbal products you arealready using.Also tell anyother doctor or dentist whoprescribes another medicine(or thedispensing pharmacist) thatyou are usingZellminelle. They cantell you if youneed to use additionalcontraceptive precautions(for example condoms) and, if so, how longto do this.


Some medicines can makeZellminelle less effective in preventing pregnancy, or cancause unexpected bleeding. These include:

Medicines used for the treatment of:
o epilepsy (for example primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
o tuberculosis (for example rifampicin)
o infection with HIV (ritonavir, nevirapine) or other infections (antibiotics such as

griseofulvin, penicillin, tetracycline)
ohigh blood pressure in the blood vessels in the lung (bosentan)

The herbal remedy St. John's wort.


Zellminelle may influence the effect of other medicines, such as:


Ask your doctor orpharmacist foradvice before takingany medicine.


Zellminelle with food and drink

Zellminellemay be taken with orwithout food, if necessary with a little water.

Laboratoryinvestigations


Ifyou need a bloodtest, tell your doctor or thelaboratory staff that youare taking Zellminelle, because hormonalcontraceptivescan affect theresults of some tests.


Pregnancy, breast-feeding and fertility


If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


Do not useZellminelleifyou are pregnant. If youbecome pregnant while takingZellminelle,stop taking it immediatelyandcontactyourdoctor. Ifyouwant to become pregnant, you can stop using Drospirenone /Ethinylestradiol at any time.


The useofZellminelleis generallynot advisable whena woman isbreast-feeding.If youwant to useZellminellewhileyou are

breast-feeding, contact yourdoctor.


Ask your doctor or pharmacist for advice before taking any medicine.


Driving andusing machines


There is no information indicating that Zellminelle
affects driving or using machines.


Zellminelle contains lactose, E102, tartrazine and E110, sunset yellow FCF

Lactose:If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.


E102, E110:May cause allergic reactions.


3. How to take Zellminelle

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Take one tablet of Zellminelle dailywith a little water if necessary. Youmay take the tabletswith or without food, but youshould take the tabletsevery day around the same time.

Each strip contains 21tablets. Next to each tablet, is printed the day of the weekwhen it should be taken. For example, if you start on a Wednesday, take a tablet with"Wednesday"next to it. Follow thedirection of thearrow on the strip until you have taken all 21 tablets.


After you have taken all 21 pills in the strip, you have seven days when you take no pills.In the course ofthese 7 pill-free days (otherwise called stop or gap week), bleedingshould begin, (so called "withdrawal bleeding"). Usually bleeding startson the second or third day of thegap week.

On the eighth day, that is, after seven-day gap, you should start the next strip of tablets, whether your bleeding has stopped or not.This means that each stripbegins on the same dayof the week andwithdrawal bleedingshould occur on the same days each month.

If you use Zellminelle in this way, you are also protected against pregnancy in 7pill-free days.


When can youstartwith the first strip of Zellminelle


If you have not used a hormonal contraceptive in the previous month
You can start taking Zellminelle on the first day of your menstrual cycle and you are immediately protected against pregnancy. You may also start taking Zellminelle on the 2nd to 5th day of the menstrual cycle, but in this situation you should use additional contraceptive methods (for example condom) for the first 7 days.


Changing from a combined hormonal contraceptive, combined vaginal ring or

patch

You can start usingZellminelle on the dayafter the lastactive tablet(the last tablet containing the active substances) of your previous pill, butnot later than the day following the tablet-freedays of yourprevious pill (or after the last inactive tablet of yourprevious pill). If you switch from a combined contraceptive vaginal ring or patch, follow the advice of your doctor.


Changing from a progestogen-only method (progestogen-only pill, also called "mini-pill", injection or implant or a progestogen-releasing intrauterine device - 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 taking Zellminelle .


After a miscarriage or abortion

Follow the advice ofyour doctor.


After childbirth

You can start taking Zellminelle between 21 to 28 days after childbirth. If you start later than day 28, you should use additional barrier methods (for example, a condom) during the first seven days of using Drospirenone / Ethinylestradiol. If, after childbirth, you have had sex before starting Zellminelle, you must first be sure that you are not pregnant or wait until your next period.


If you are breastfeeding

Readthe section“Pregnancy and breast-feeding"


Ask your doctorwhatto do ifyou are not surewhen to start Zellminelle.


If you take more Zellminelle than you should

There are no reports of serious harmful effects because of taking too many Zellminelle tablets. If you take several tablets at once, you may experience nausea or vomiting and young girls may experience vaginal bleeding.

If you have taken too many tablets, or you discover that a child has taken some, ask your doctor or pharmacist for advice.


If you forget to take Zellminelle


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 you have forgotten, the greater is the risk of becoming 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 must keep to the following rules:


If you forgot more than one tablet in this strip
Contact your doctor.


If you forgot one tablet 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 an additional contraceptive method such as a condom for the next 7 days.
If you have had sex in the week before missing the tablet, you may be pregnant. In this case, contact your doctor.


If you forgot one tablet in week 2

Take the forgotten tablet as soon as you remember, even if that means that you have two tablets at the same time. Continue taking the tablets at the usual time. Contraceptive protection is not reduced and you do not need to take extra contraceptive precautions.

If you forgot one tablet inweek 3
You have two options:

1. Take the forgotten tablet as soon as you remember (evenif this meansthat you have to take two tabletsat the same time). Continue taking the tabletsat the usual time. Start the next strip as soon as the current strip iscompleted, so do not take a tablet-free breakbetween the strips. You may not have menstrual period until the end of the second strip, but you may havespotting orbreakthrough bleedingduring the days of tablet-taking.


2. You can also stop taking the tablets from your current stripand go directly to the 7 tablet-freedays (record the day when you forgot the tablet)and continue withthe next strip.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 no bleeding occurs during the

tablet-free period, you may be pregnant. Consult your doctor before starting the next strip.


Ask your doctor for advice


Several tablets forgotten in 1 strip

yes


In week 1


Had sex in the previous week before forgetting


no

Take the forgotten tablet

Use a barrier method (condom) for following 7 days

And finish strip


Only 1 tablet forgotten (taken more than 12 hrs late)



In week 2


Take the forgotten tablet and

Finish strip


Finish the strip

Take the forgotten tablet and Finish strip

Instead of the gap week

Go straight on next strip


or

In week 3


Stop the strip immediately

Begin the gap week (not longer than 7 days including the forgotten tablet)

Then go on to the next strip



What to do in case of vomitingor severediarrhoea


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 having severe 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 Zellminelle ".


Delaying your period


Although itis not recommended, you can delayyour period bydirectly going to a new strip of Zellminelle instead of takingthe tablet-free break,and finish this strip. During the second stripyou can experience minor ormenstrual-likebleeding. After the usual tablet-free period of 7 days, start the next strip.


Ask your doctor for advicebefore you decideto delay yourmenstrual period.


Changing the first day of your period


If you take the tablets as directed, your period will start during the tablet-free week. Ifyou need to changethat day, you can reduce the number of tablet-free days (but never increase them – 7 is the maximum!). For example, if your tablet-free days usually startson Friday,and you want to change to Tuesday (3days earlier), you should start a new strip3 days earlier than usual. Ifyou make theinterval between taking tabletsvery short (for example, 3 daysor less) bleeding may not occur duringthis period. You can then experience spotting (drops or flecks of blood)or breakthrough bleeding.
If you are not sure how to do this, ask your doctor for advice.


If you stop takingZellminelle:


You can stop taking Zellminelle 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 Zellminelle and wait until you have a menstrual period before trying to get pregnant. You can then calculate the expected delivery date more easily.

If you have any further questions on the use of this medicine, ask your doctor orpharmacist or nurse.


4. Possible side effects


Like all medicines, Zellminelle 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 Zellminelle, 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 use Zellminelle”.


The following is a list of side effects that have been associated with the use of Zellminelle.


Common (may affect up to 1 in 10 people):

Uncommon (may affect up to 1 in 100 people)



Rare (may affect up to 1 in 1,000 people)

ischaemic attack (TIA)

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 or nurse.This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Zellminelle


Keep this medicine out of thesight andreach of children.

Do not usethis medicineafterthe expiry datestated on the blister/ carton after ‘{EXP}’. Theexpiry date refersto the last dayof that month.

This medicinal product does not require any special storage condition


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 Zellminelle contains


The active substances are Ethinylestradioland Drospirenone. Each tablet contains 0.020 milligrams of Ethinylestradiol and 3 milligrams of Drospirenone.


The other ingredients are:

lactose monohydrate,

maize starch,

povidone,

crospovidone,

magnesium stearate,

lake blend yellow LB 520001 (composition: FD&C Yellow #5/Tartarazine Aluminum Lake E102, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake E110 and FD&C Blue #2/Indigo Carmine Aluminum Lake E132).


What Zellminelle look like and contents of the pack


The tablets are round, light yellow, 6.00 mm, biconvex, with '144' debossed on one side and plain on the other side.


Each pack contains 1, 3, 6 and 13 strips of 21 tablets each.

Each carton contains blisters packed separately in an aluminium laminated sachet.

Not all pack sizes may be marketed.


Marketing Authorization Holder

<To be completed nationally>


Manufacturer

<To be completed nationally>


This medicinal product is authorized in the Member States of the EEA under the following names:

This leaflet was last revised in 2 October 2015

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