Package Leaflet: Information for the User Ethinylestradiol 0,035 Mg
Packageethinylestradiol leaflet and cyproterone acetate 1/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
Package leaflet: Information for the user
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, coated tablets
Read all of this leaflet carefully before you start using this medicine because it contains important information for you Keep this leaflet. You may need to read it again If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.
What is in this leaflet: 1. What Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is and what it is used for 2. What you need to know before you use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg 3. How to use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg 4. Possible side effects 5. How to store Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg 6. Contents of the pack and other information
1. What Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is and what it is used for
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate.
You should only take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg if your skin condition has not improved after use of other anti- acne treatments, including topical treatments and antibiotics.
2. What you need to know before you use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg
Do not take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg Tell your doctor if any of the following conditions applies to you before starting to use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg. Your doctor may then advise you to use a different treatment: if you are using another hormonal contraceptive if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism) or other part of your body if you have (or have ever had) a disease that may be an indicator of a heart attack in the future (e.g angina pectoris which cases severe pain in the chest) or ‘mini-stroke’ (transient ischaemic attack) if you have (or have ever had) a heart attack or stroke if you have a condition that may increase the risk of a blood clot in your arteries. This applies to the following conditions: common-pl-en-clean-varIB/042 Pg. 1
09187 Packageethinylestradiol leaflet and cyproterone acetate 2/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
o diabetes affecting your blood vessels o very high blood pressure o a very high level of fat in your blood (cholesterol or triglycerides) if you have problems with blood clotting (e.g. protein C deficiency) if you have (or have ever had) a migraine, with visual disturbances if you are pregnant or breastfeeding. if you are allergic to cyproteronacetate, ethinylestradiol or any of the other ingredients of this medicine (listed in section 6). Allergy may be recognised from itch, rash or swollen face. if you have – or have had - a liver disease or jaundice If you have meningioma or have ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull).
If you have a medical condition which makes you more at risk of developing arterial thrombosis.. if you have or had in the past an inflammation of the pancreas gland (pancreatitis) if you have or had in the past a (benign or malignant) tumour of the liver. if you have serious or multiple risk factors for developing arterial or venous thrombosis, this could be a reason not to use this medicine. See `Warnings and precautions ´ if you have a hormone-dependent, malignant tumor in genitals, breasts or liver, or if you have a suspicion of it Vaginal bleeding of unknown cause if you have hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also in section ‘Other medicines and Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg’).
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg should not be used for treatment of men.
Special populations
Use in children Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is not intended for women who do not menstruate yet.
Use in older women Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is not indicated after menopause.
Women with hepatic impairment Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is contraindicated in women with severe hepatic diseases as long as liver function values have not returned to normal. See also ‘Do not take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg’ and ‘Warnings and precautions’.
Women with renal impairment Check with your doctor. The available data suggest no need to change the use of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg.
Warnings and precautions Talk to your doctor or pharmacist before taking Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg.
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09187 Packageethinylestradiol leaflet and cyproterone acetate 3/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
When should you contact your doctor?
In the following cases, you should contact your doctor as soon as possible:
• changes in your health (or that of direct family) related with items mentioned earlier in this leaflet. (see under: ‘Do not take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg’ and ‘Warnings and precautions’). • If you find that you have a knob in your breast • if you start taking other medicines (see ”Other medicines and Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg’). • at least 4 weeks before surgery, or if you are bedridden for some time or can’t walk. • continuing or worsening irregular bleeding • if you have forgotten tablets in the first week of the blister and have had intercourse in the 7 days before the missed tablets. • if you haven’t had your period for two times in a row (do not start a new blister without your doctors permission).
Stop taking tablets and contact your doctor immediately if you notice possible signs of a blood clot. The symptoms are described in section 2 ‘Blood clots (Thrombosis)’.
Please note that the above situations and signs are described in more detail elsewhere in this Package Leaflet.
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg also works as an oral contraceptive. You and your doctor will have to consider all the things that would normally apply to the safe use of oral hormonal contraceptives.
For high doses (25 mg and above) of cyproterone acetate an increased risk of a benign brain tumour (meningioma) has been reported. If you are diagnosed with meningioma, your doctor will stop all cyproterone containing products, including Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg as a precautionary measure (see section ‘Do not take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg). Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg should not be used for treatment of men.
Blood clots (thrombosis) Taking Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg may slightly increase your risk of having a blood clot (called a thrombosis). Your chances of having a blood clot are only increased slightly by taking Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg compared with women who do not take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg or any contraceptive pill. A full recovery is not always made and in 1-2% of cases, can be fatal.
Blood clots in a vein A blood clot in a vein (known as a ‘venous thrombosis’) can block the vein. This can happen in veins of the leg, the lung (a lung embolus), or any other organ. Using a combined pill increases a woman’s risk of developing such clots compared with a woman not taking any combined pill. The risk of developing a blood clot in a vein is highest during the first year a woman uses the pill. The risk is not as high as the risk of developing a blood clot during pregnancy. common-pl-en-clean-varIB/042 Pg. 3
09187 Packageethinylestradiol leaflet and cyproterone acetate 4/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
The risk of blood clots in a vein in users of a combined pill increases further:
· with increasing age; · if you smoke. When using a hormonal contraceptive like Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg you are strongly advised to stop smoking, especially if you are older than 35 years; · if one of your close relatives has had a blood clot in the leg, lung or other organ at a young age; · if you are overweight; · if you must 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 plaster cast. · and with superficial phlebitis and varicose veins. It is not yet clear whether these conditions increase the risk of thrombosis.
If this applies to you, it is important to tell your doctor that you are using Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, as the treatment may have to be stopped. Your doctor may tell you to stop using Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg several weeks before surgery or while you are less mobile. Your doctor will also tell you when you can start using Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg again after you are back on your feet.
Blood clots in an artery A blood clot in an artery can cause serious problems. For example, a blood clot in an artery in the heart may cause a heart attack, or in the brain may cause a stroke.
The use of a combined pill has been connected with an increased risk of clots in the arteries. This risk increases further: · with increasing age; · if you smoke. When using a hormonal contraceptive like Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg you are strongly advised to stop smoking, especially if you are older than 35 years; · if you are overweight; · if you have high blood pressure; · if a close relative has had a heart attack or stroke at a young age; · if you have a high level of fat in your blood (cholesterol or triglycerides); · if you get migraines; · if you have a problem with your heart (valve disorder, disturbance of the rhythm).
Symptoms of blood clots
Stop taking tablets and see your doctor immediately if you notice possible signs of a blood clot, such as: · an unusual sudden cough; · severe pain in the chest which may reach the left arm; · breathlessness; · any unusual, severe, or long-lasting headache or worsening of migraine; · partial or complete loss of vision, or double vision; · slurring or speech disability; common-pl-en-clean-varIB/042 Pg. 4
09187 Packageethinylestradiol leaflet and cyproterone acetate 5/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
· sudden changes to your hearing, sense of smell, or taste; · dizziness or fainting; · weakness or numbness in any part of your body; · severe pain in your abdomen; · severe pain or swelling in either of your legs.
Following a blood clot, recovery is not always complete. Rarely serious permanent disabilities may occur or the blood clot may even be fatal. Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg.
You should tell your doctor if any of the above situations applies to you, because Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg may not be appropriate in your case.
Other diseases where vascular disorders may occur, are PCO syndrome (polycystic ovarian syndrome, a disturbance of maturation of oocytes, which also involves excessive hair growth), SLE (systemic lupus erythematosus, a disease of the immune system), HUS (haemolytic uremic syndrome, a blood disorder that causes kidney damage), chronic intestinal inflammation (Crohn's disease or ulcerative colitis) and sickle cell anaemia (a disease of the blood), chronic intestinal inflammation (Crohn’s disease or ulcerative colitis) and sickle cell anaemia (as specific disease of the blood).
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg and cancer
Breastcancer has been found slightly more often in women who take the pill than in women of the same age who do not.
10 years after stopping the pill, the risk of finding breast cancer is the same as for women who have never taken the pill. It is not certain whether the pill causes the increased risk of breast cancer. It may be that women taking the pill are examined more often, so that breast cancer is noticed earlier. The earlier the cancer is diagnosed, the better the results of therapy. On rare occasions, the use of the pill has led to benign liver tumours, and, very rarely, it has been associated with malignant liver tumours. Liver tumours may lead to life-threatening bleeding in the abdomen. Therefore, if you have pain in the upper abdomen, you should immediately contact your doctor. In women who have been using the pill for a rather long time, cancer of the cervix is now found more frequently. However, this may not be caused by the pill but may be related to sexual behaviour and other factors. It is still unclear how great its influence is on the development of cervical cancer. It is quite clear that the most significant cause of cervical cancer is a prolonged infection with the so- called human papilloma virus (HPV).
Contact your doctor in case one of these warnings applies to you, of has applied in the past.
Psychiatric disorders: Some women using hormonal contraceptives including {product name} have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you common-pl-en-clean-varIB/042 Pg. 5
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experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.
Other conditions
Extra control during the use of the combination pill could be needed in certain circumstances. If any of the here after situations is applicable, you should inform your doctor before starting this medicine. He will explain the extent of the risks to you.
- if you have epilepsy - if anyone in your immediate family has/had breast cancer - if you have a disease of the liver or gallbladder disease - if you have an inherited form of deafness (otosclerose) - if you have - or have ever had – chloasma (yellow-brown patches, mainly in the face; also know as pregnancy marks). In this case you should avoid direct sunlight or UV light. - if you have hereditary angioedema (temporary bouts of fluid build-up and itching in skin and / or mucous membranes, often as an allergic reaction). Products containing estrogens may induce or worsen symptoms of angioedema. You should immediately contact your doctor if you experience symptoms of angioedema, such as swollen face, tongue and / or throat and / or difficulty swallowing or hives together with difficulty breathing.
If any of these conditions gets worse or you have them for the first time, while using Ethinylestradiol 0,035 mg/ cyproteronacetate 2 mg, you should contact your doctor.
General remarks:
In this leaflet several situations have been described , in which you should stop the use of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, or in which the reliability of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg could been diminished. You should have no sexual intercourse unless you use an extra contraceptive method (without hormones). Usually a condom or another barrier method should do. Do not use a calendar- or temperature- method: they could be unreliable because Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg could influence the monthly changes in body temperature and the mucus in the neck of the womb.
Oral contraceptives, incl. Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, do not protect against HIV-infections (AIDS) nor against any other sexually transmissible diseases.
Other medicines and Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. 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.
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09187 Packageethinylestradiol leaflet and cyproterone acetate 7/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
Do not use Ethinylestradiol 0,035 mg/Cyproteronacetate 2 mg if you have Hepatitis C and are taking the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir as this may cause increases in liver function blood test results (increase in ALT liver enzyme).
Some medicines can have an influence on the blood level of Ethinylestradiol 0,035 mg/Cyproteronacetate 2 mg can make it less effective in preventing pregnancy can cause unexpected bleeding These include: medicines used for the treatement of o epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate) o tuberculosis (e.g. rifampicin) o HIV and Hepatitis C Virus infections (so-called protease inhibitors and non- nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz) o Fungal infections (e.g. griseofulvin, ketoconazole) o arthritis, arthrosis (etoricoxib) o high blood pressure in the blodd vessels in the lungs (bosentan) the herbal remedy St. John’s wort
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg may influence the effect of other medicines, e.g. medicines containing cyclosporine (a drug used after an organ transplant to prevent rejection) and lamotrigine (an anti-epileptic agent). A reduced effect of lamotrigine may lead to an increased number of epilepsy attacks. theophylline (used to treat breathing problems) tizanidine (used to treat muscle pain and/or muscle cramps)
Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg can be restarted approximately 2 weeks after completion of this treatment. See section ‘Do not use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg’.
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breast-feeding Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg should not be used during pregnancy. If you get pregnant during the use of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, you should immediately stop taking the tablets.
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg should not be used during the period you are breastfeeding your baby.
Ask your doctor or pharmacist for advice before you use any medicine. common-pl-en-clean-varIB/042 Pg. 7
09187 Packageethinylestradiol leaflet and cyproterone acetate 8/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
Driving and using machines There are no indications that the use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg has an effect on the driving of vehicles or the operation of machines
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg lactose monohydrate and sucrose If you know that you suffer from intolerance of certain sugars, consult your doctor before taking of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg tablet. Cyproteronacetate
3. How to use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg?
Duration of use
Your doctor will tell you how long you need to keep taking Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg.
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg will protect you against pregnancy. While you are taking this medicine, you should not take any other oral contraceptive pill.
How to take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg? Take the tablets at the same time every day, preferably in the evening, with some fluid.
Each blister contains 21 tablets. Start with a pill with the correct day of the week. For instance, if you start on a Wednesday, start with a pill marked ‘wed’. After taking your first pill, take one pill each day, following the directions of the arrows. After you have taken all 21 tablets in the pack, you have 7 days when you take no tablets. During these 7 tablet-free days (also called stop- or pause week), your period should start. This so called ‘withdrawal bleeding’ usually will start on day 2 or 3 of this pause-week.
Start taking your next pack of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg on day 8 after your last tablet, even if you are still bleeding. Each new pack will begin on the same day of the week as the one before, and also your bleeding will be on approx. the same days every month.
If you use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg in this way, you are also protected against pregnancy during the 7 days when you are not taking a tablet.
Starting your first blister. You have not used a contraceptive pill in the past month(s) Take the first tablet on the first day of your cycle (this is the first day of your period). Starting on the first day of your period taking Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg will prevent you getting pregnant at once. If you prefer to start on day 2 – 5 of your period, you should use extra contraceptive measures (such as condom) for the first 7 days.
Changing from another combination pill: You could start taking Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg the next day after you have taken the last tablet of your previous pill (thus do not leave a gap between packs). If your common-pl-en-clean-varIB/042previous pill also contained non-active tablets, you should directly take Ethinylestradiol 0,035 mg/Pg. 8
09187 Packageethinylestradiol leaflet and cyproterone acetate 9/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
Cyproteronacetate 2 mg after the last active one of your previous pill. (if you are not sure which tablets are the active ones, ask your doctor or pharmacist). If you have taken your previous pill correctly, you also could start later, but never later than the next day after the usual tablet-free period of your previous pill (or after the last non-active tablet of your previous pill).
Changing from vaginal ring or contraceptive patch If you have used a vaginal ring or a contraceptive patch, you should preferably start using Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg on the day of its removal but no later than on the day on which a new ring was to be installed or a new patch was to be put on.
Switching over from the mini-pill You can switch from the one to the other day to Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, but you must used an additional contraceptive agent for the first 7 days (e.g. a condom)
Changing from injectable contraceptive, implant or IUS Start taking Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg when you should have had the next injection or on the day when the implant or Intrauterine system releasing progesterone (IUS) should have been removed. However, the first 7 days you should use extra contraceptive measures (e.g. a condom).
After having a baby If you are not breast feeding it is recommended to start taking the tablets 21 to 28 days after childbirth. If you start taking the tablets later than 28 days after childbirth, you should additionally use a barrier method for contraception for the first seven days. If you have already had intercourse, a pregnancy should be ruled out before starting to take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg or you should wait for your first menstrual bleeding. For use during breast feeding see section "Pregnancy and breast feeding".
After a miscarriage or an abortion Follow the instructions from your doctor.
Your doctor will tell you how long you should take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg. The length of treatment with Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg will depend on how serious the symptoms are (greasy skin, acne or excessive hair growth). Treatment usually will be continued for several months.
It is advised to discontinue Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg 3 to 4 cycli (‘months’) after the greasy skin, acne and/or excessive hair growth have been completely resolved, and that this product is not continued solely to provide oral contraception.
If you have the impression that the effect of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is too strong or too weak, consult your doctor or pharmacist.
You should contact your doctor because your treatment with Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg should be reconsidered: - if your symptoms of severe acne or seborrhoea do not improve, at least within 6 months of treatment; common-pl-en-clean-varIB/042 Pg. 9
09187 Packageethinylestradiol leaflet and cyproterone acetate 10/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
- if your symptoms of hirsutism do not improve, at least within 12 months
If you take more Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg than you should If you have taken more Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg than you should, this may lead to nausea, vomiting or vaginal bleeding. There are no observations of serious harmful effects after taking too many tablets Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg. If a child has taken a large number of tablets, you should immediately contact your doctor or pharmacist.
If you have taken too many Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, immediately contact your doctor or pharmacist.
If you forget to take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg
1) if one pill is 12 hours late or less, contraceptive protection should not be affected, if you take the late pill at once, and keep taking your next pills at the usual time.
2) if you are more than 12 hours late in taking the pill, contraceptive protection may be lower. Forgetting more consecutive tablets may further reduce the contraceptive protection. The risk for insufficient contraceptive protection is highest when tablets have been forgotten at the start or at the end of a blister.
Follow the instructions given below: if you forgot more than one tablet from this blister: Contact your doctor if you forgot 1 tablet in week 1 Take the ‘late’ tablet at once, even if this means taking two tablets at the same time. Continue taking the next tablets as usual, but use an extra method of contraception for the following 7 days. If you have had sexual intercourse in the week before missing the tablet, you should consider a possible pregnancy. Contact your doctor immediately. if you forgot 1 tablet in week 2 Take the ‘late’ tablet at once, even if this means taking two tablets at the same time. Continue taking the next tablets as usual. The contraceptive protection is not affected; you don’t have to use extra method of contraception if you forgot 1 tablet in week 3 You have two options: 1. Take the ‘late’ tablet at once, even if this means taking two tablets at the same time. Continue taking the next tablets as usual. Start the next pack the next day without a break. You will not have a period until you have finished the second pack, but during the second pack you may see some spotting or bleeding. 2. stop with the current pack and start taking tablets after a tablet-free period of 7 days (note to include the ‘missed’ day!). If you prefer to start on your usual day, you could start after a tablet-free period of less than 7 days.
If you follow one of these two suggestions, you will remain protected against pregnancy.
If you forgot tablets and have no bleeding after the first normal tablet-free period, pregnancy should be considered. Contact your doctor before starting a new blister. common-pl-en-clean-varIB/042 Pg. 10
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Or schematically:
If you forgot more Ask your doctor for advice than 1 tablet
yes
In week 1 Intercourse in week before the missed tablet?
no
Take the ‘late’ tablet ; Use an extra method of contraception (condom) for 7 days and Continue taking the tablets
If you forgot only 1 tablet (more Take the ‘late’ tablet; than 12 hours In week 2 Continue taking the tablets late)
Take the ‘late’ tablet; Continue taking the tablets ; Start the next pack without a break;
In week 3 or
Stop immediately with the blister; Start a tablet-free week (never longer than 7 days, incl. the ‘missed’ day); Continue with the next blister.
What you should do in the case of vomiting or serious diarrhoea If you have to vomit or suffer from serious diarrhoea within 3-4 hours after tablet intake, the active substances may not be fully absorbed. The effect is comparable to that when missing a tablet. After vomiting or diarrhoea, you should take a new tablet, from a spare blister, as soon as possible, preferably within 12 hours after the usual time you take the tablet. If this is not possible, or if 12 hours have already passed, follow the instructions under: ‘What to do if you forgot to take Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg’
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09187 Packageethinylestradiol leaflet and cyproterone acetate 12/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
What should you do if you want to delay your menstruation once: You can postpone your period (withdrawal bleeding) by continuing with a new pack Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg without a tablet-free break. You could take all tablets from this second pack, or else stop earlier. During the second pack you may see spotting (drops of blood or bloodstains) or bleeding. After the usual tablet-free period of 7 days you continue with a next blister.
What to do if you want to change the first day of your period: If you take the tablets following the instructions, your period/ withdrawal bleeding will start at approx the same day of the week. If you want to change this day, you could shorten the normal tablet-free period between 2 blisters (but never make it longer!). For example, if your period usually starts at Friday and you would like to change this to Tuesday (3 days earlier), you should start a new pack 3 days earlier than you used to. If you make the tablet-free period very short (e.g. 3 days or less) you may not have a bleeding during this tablet-free period. You may see spotting (drops of blood or bloodstains) or bleeding.
What to do if you have unexpected bleeding: With all ‘pills’, during the first couple of months occasionally unexpected bleeding may occur (spotting or bleeding). You may need sanitary towels. Continue taking the tablets. The irregular blood loss normally stops as your body gets used to the pill in question (after approx 3 blisters). If this takes longer, gets worse or starts again, you should contact your doctor.
What should you do if the expected bleeding does not occur: If you have taken all tablets correctly, have not been sick and have not been taking other medicines, it is very unlikely that you are pregnant. You could then continue the next pack. If, however, the expected bleeding stays away two times in a row, you may be pregnant. Contact your doctor immediately. Do not continue with a next blister of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg, before your doctor has established that you are not pregnant.
Effects when treatment with Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg is stopped: If you stop the use of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg the problems, for which you started taking this medicine, may return.
You can stop the use of Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg whenever you may wish. A few days after you stopped taking tablets, you will probably have a withdrawal-bleeding, like in the tablet-free period. This will depend on the number of tablets you have been taken before you stopped.
If you do not want to get pregnant, ask your doctor’s advice for another reliable contraceptive. If you stop because you want to have a baby, it is best to wait until you have had a true period, before you try to get pregnant (this is not the withdrawal bleeding you have after your last Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg tablets). You could then calculate easier when your baby will be born.
4. Possible side-effects
Like all medicines, this medicine can cause side-effects, although not everybody gets them. common-pl-en-clean-varIB/042 Pg. 12
09187 Packageethinylestradiol leaflet and cyproterone acetate 13/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
Serious side-effects Serious side-effects related to the use of the pill are described under "Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg and thrombosis" and "Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg and cancer". Read these sections for more information and consult your doctor immediately if needed.
Other possible side-effects The following side-effects have been mentioned by pill users. These side-effects may occur mainly in the first few months after starting the pill. They usually disappear after some time:
The following side effects are common (affects 1 to 10 user in 100): Headaches Weight changes (increase) abdominal pain sensitive and sore breasts Mood changes including depression
The following side effects are uncommon (affects 1 to 10 user in 1,000): Migraine Skin rash Skin eruption with itching Fluid retention Breast enlargement Loss of interest in sex
The following side effects are rare (affects 1 to 10 user in 10,000): Weight changes (decrease) Irritation due to contact lenses Skin rash with red and painful lumps Hypersensitivity reactions Vaginal discharge and secretion from the nipple Increase of libido Venous blood clot
The frequency of the following side effects are not known (cannot be estimated from the available data: Increase in blood pressure
If you have hereditary angioedema medicines containing certain female sex hormones (estrogens) may induce or worsen the symptoms of angioedema (see section “When should you contact your doctor?”
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of thiscommon-pl-en-clean-varIB/042 medicine. Pg. 13
09187 Packageethinylestradiol leaflet and cyproterone acetate 14/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
5. How to store Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg Keep this medicine out of the sight and reach of children.
Do not use Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg tablets after the expiry date which is stated on the blister and the carton.
The expiry date refers to the last day of the 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 Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg tablets contains
The active substances are: cyproterone acetate and ethinylestradiol. 1 coated tablet contains 2 mg cyproterone acetate and 0.035 mg ethinylestradiol.
The other ingredients are: Tablet core: Lactose monohydrate, maize starch, povidone K25, magnesium stearate (Ph. Eur.) [of plant origin], talc; Tablet coating: Sucrose, calcium carbonate, macrogol 6000, titanium dioxide (E 171), povidone K90, glycerol 85 %, montan glycol wax
What Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg tablets looks like and contents of the pack Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg tablets is a white, round, biconvex coated tablet
Ethinylestradiol 0,035 mg/ Cyproteronacetate 2 mg tablets is available in PVC/aluminium blister memo packs with 21, 3 x 21 and 6 x 21 coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder [to be completed nationally]
Manufacturer [to be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic Vreya Denmark Vreya common-pl-en-clean-varIB/042 Pg. 14
09187 Packageethinylestradiol leaflet and cyproterone acetate 15/15 MRP NL/H/623/01May 2020 Ethinylestradiol 0,035 mg / cyproteronacetaat 2 mg
Finland Vreya Germany Morea Sanol Hungary Cypromix Netherlands Ethinylestradiol 0,035 mg/Cyproteronacetaat 2 mg Slovakia Vreya
This leaflet was last revised in
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