2 mg/35 micrograms coated tablets
cyproterone acetate and Ethinyl estradiol
What Zyrona is and what it is used for
Zyrona is used to treat skin problems such as acne, very oily skin, and heavy hair growth in women of childbearing age. As it has the same properties as the birth control pill, it should only be prescribed to you if the doctor considers that treatment with a hormonal contraceptive is suitable.
You should only take Zyrona if the skin problems have not improved after using other anti-acne treatments, such as topical treatments and antibiotics.
Cyproterone acetate and ethinylestradiol found in Zyrona may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Zyrona
Do not take Zyrona
Talk to your doctor before you start using Zyrona if any of the following apply to you. In such cases, the doctor may recommend another treatment:
- if you are allergic to cyproterone acetate, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6)
- if you are using another hormonal contraceptive
- if you have hepatitis C and are being treated with medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section “Other medicines and Zyrona”)
- if you have (or have ever had) a blood clot in the leg ( thrombosis ), lung (pulmonary embolism), or any other part of the body
- if you have (or have ever had) a disease that can precede a heart attack (eg angina pectoris causing severe chest pain) or “mini-stroke” ( transient ischemic attack)
- if you have (or have ever had) a heart attack or stroke
- if you have a condition that can increase the risk of blood clots in the arteries. This applies to the following conditions:
- diabetes that affects the blood vessels
- very high blood pressure
- very high levels of fat in the blood ( cholesterol or triglycerides )
- if you have problems with blood clotting (e.g. protein C deficiency)
- if you have (or have ever had) migraine with visual disturbances
- if you have or have had severe liver disease and have not yet recovered normal liver function
- if you have or have had a form of cancer that can grow when exposed to sex hormones (eg breast cancer or cancer of the ovaries, uterus, or cervix)
- if you or have had a benign or malignant liver tumor
- if you have meningioma or have ever been diagnosed with meningioma (a usually benign tumor of tissue between the brain and the skull)
- if you have vaginal bleeding and the cause of the bleeding is not known
- if you are breastfeeding
- if you are pregnant.
If you experience any of the conditions mentioned above, or if you become pregnant while using Zyrona, you should immediately stop treatment and consult a doctor. Use other contraceptives in the meantime (without hormones ).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Zyrona.
Be especially careful with Zyrona
Stop taking tablets and contact your doctor immediately if you notice signs that may indicate a blood clot. The symptoms are described in section 2 “Blood clots ( thrombosis )”.
Contact a doctor immediately if you develop symptoms of angioedema , such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives along with difficulty breathing. Products containing estrogen can induce or worsen the symptoms of hereditary and acquired angioedema .
At high doses of cyproterone acetate (25 mg and higher), an increased risk of a benign brain tumor (meningioma) has been reported. If you are diagnosed with meningioma, your doctor will stop treatment with all medicines containing cyproterone, including Zyrona, as a precaution (see the section “Do not take Zyrona”).
Zyrona also works as a birth control pill . You and your doctor must think about everything that normally applies to the safe use of birth control pills .
If you belong to one of the risk groups below and also take a combined birth control pill , you probably need to go for regular check-ups. Your doctor can tell you more about it. Before taking Zyrona, your doctor will examine you, and you should tell the doctor about the following:
- If you have serious skin problems that affect the skin all over your body (systemic lupus erythematosus).
- If you have a disease that affects the blood’s ability to coagulate and leads to kidney failure ( hemolytic uremic syndrome ).
- If you have Crohn’s disease or chronic intestinal inflammation ( ulcerative colitis ).
- If you have an inherited form of low red blood cell count (sickle cell anaemia).
Blood clots ( thrombosis )
Treatment with Zyrona may be associated with a small increased risk of getting a blood clot (so-called thrombosis ). Your risk of getting a blood clot increases only slightly as a result of treatment with Zyrona compared to women who do not take Zyrona or any birth control pill . Full recovery is not always achieved and 1-2% of cases can be fatal.
Blood clot in a vein
A blood clot in a vein (so-called venous thrombosis ) can block the vein. This can happen in the veins of the legs, the lungs ( pulmonary embolism ) or any other organ.
A woman who uses combined oral contraceptives is at greater risk of developing such blood clots compared to a woman who does not take combined oral contraceptives . The risk of developing a blood clot in a vein is greatest during the first year when the woman uses birth control pills . This risk is not as great as the risk of developing a blood clot during pregnancy.
When using combined oral contraceptives , the risk of blood clots increases further:
- with increasing age
- if you smoke . When using hormonal contraceptives such as Zyrona, you are strongly advised not to smoke , especially if you are over 35 years of age
- if a close relative has had a blood clot in the leg, lung or other organ at a young age
- if you are overweight
- if you have to undergo an operation, or if due to illness or injury you are bedridden for a long time, or if you get a plaster cast on a leg.
If this applies to you, it is important that you tell the doctor that you are using Zyrona as treatment may need to be stopped. The doctor may tell you to stop using Zyrona several weeks before an operation or while you are less mobile. The doctor will also tell you when you can start using Zyrona again after you are back on your feet.
Blood clot in an artery
A blood clot in an artery can cause serious problems. For example, a blood clot in an artery in the heart can cause a heart attack, while it in the brain can cause a stroke .
The use of combined oral contraceptives has been linked to an increased risk of clots in the arteries . This risk increases further:
- with increasing age
- if you smoke. When using a hormonal contraceptive such as Zyrona, you are strongly advised not to smoke, especially if you are over 35 years of age
- if you are overweight
- if you have high blood pressure
- if you have a close relative who 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 a migraine
- if you have had heart problems (valvular disease, rhythm disorders).
Symptoms of blood clots
| Stop taking tablets and see a doctor immediately if you notice any signs of a blood clot such as: unusual and sudden coughsevere chest pain that may radiate to the left armshortness of breathunusual, severe or prolonged headache or worsening migrainepartial or complete loss of vision or double visionslurred speech or inability to speak,sudden change in hearing, smell or tastedizziness or faintingweakness or numbness in any part of the bodysevere pain in the abdomensevere pain or swelling in a leg.After a blood clot, you do not always recover completely. In rare cases, serious permanent disabilities can occur and a blood clot can even lead to death. Immediately after giving birth, women are at increased risk of blood clots and you should therefore ask the doctor how soon after giving birth you can start taking Zyrona. |
Cancer:
Breast cancer occurs slightly more often in women who take birth control pills than in women of the same age who do not take birth control pills . This difference gradually disappears over the next 10 years after you stop using the pill. However, it is not known whether the increased incidence of breast cancer actually has any connection to the birth control pill. This may be because women who take birth control pills are examined more often and breast cancer can therefore be detected earlier.
In rare cases, benign liver tumors have been reported in women taking birth control pills . Malignant liver tumors have been reported in very rare cases. These tumors (both benign and malignant) can cause internal bleeding. Malignant tumors can be life-threatening and in some cases have a fatal outcome. Contact your doctor immediately if you experience severe abdominal pain.
An increased incidence of cervical cancer has been reported in women who have taken birth control pills for a long time. This is not necessarily due to the pill.
In addition to the precautions mentioned in the sections “Blood clots…” and “Cancer”, care should be taken when taking Zyrona.
- This applies in the following cases:
- If you have any disease of the liver or biliary tract.
- If you have a disease that occurred or worsened during pregnancy or during previous use of sex hormones, such as hearing loss, abnormal porphyrin metabolism ( porphyria ), a rare skin disease that occurs during pregnancy ( herpes gestationis), or a neurological disease (Sydenham’s chorea).
- If you have or have had patchy yellow-brown discoloration of the skin, especially on the face (chloasma). In such cases, you should avoid staying in the sun for long periods and exposing yourself to UV radiation.
- If you have excessive body hair with a masculine pattern and it gets worse.
- If you get depressed. Some women using hormonal contraceptives, including Zyrona, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If you experience mood changes and symptoms of depression, you should contact a doctor for advice as soon as possible.
- If you have vision problems. Contact your doctor.
- If you give a blood or urine sample, you must always tell the healthcare staff that you are taking Zyrona.
- The effect of Zyrona is reduced if you take the natural remedy St. John’s wort (Hypericum perforatum) at the same time.
- If you forget to take a tablet, the effectiveness decreases and the risk of pregnancy increases. See the section “If you forget to take Zyrona”.
- If you miss your period and you have taken Zyrona as described in the “Dosage” section, it is unlikely that you are pregnant. Please note that it may take three months for the period to return to normal. If you miss your period twice in a row, you must contact your doctor before starting the next pack.
Other medicines and Zyrona
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can have an effect on blood levels and can make Zyrona less effective at preventing pregnancy, or can cause unexpected bleeding. These include the following:
- Medicines for epilepsy (eg phenytoin , barbiturates , primidone, carbamazepine, oxcarbazepine, topiramate, felbamate).
- Anti- tuberculosis medicines (eg rifampicin).
- Medicines for the treatment of HIV and hepatitis C virus infections (eg ritonavir, nevirapine, efavirenz) or other infections (griseofulvin, ketoconazole ).
- Products containing St. John’s wort (Hypericum perforatum). If you use products containing St. John’s wort at the same time as combined oral contraceptives , you must use a complementary method of contraception during the period and for another two weeks after you stop using the products containing St. John’s wort .
- Medicines for arthritis , arthrosis (etoricoxib).
Zyrona can affect the effect of other medicines, e.g.:
- Medicines used after transplantation (ciclosporin). This can affect your kidneys.
- Medicines for epilepsy (lamotrigine). Which can lead to an increase in the number of seizures.
- Medicines for the treatment of breathing problems (theophylline).
- Medicines for the treatment of muscle pain and/or muscle cramps (tizanidine).
Do not use Zyrona if you have hepatitis C and are being treated with medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir as this combination can increase your liver enzyme values (increases in the liver enzyme ALT ).
Your doctor will prescribe you another contraceptive method before starting such treatment.
Zyrona can be taken again about 2 weeks after finishing treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir. See section “Do not take Zyrona”.
Zyrona with food and drink
You can take Zyrona with food and drink.
Pregnancy and breastfeeding
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 using this medicine.
Pregnancy
You should not take Zyrona if you are pregnant or think you may be pregnant.
Breast-feeding
You should not take Zyrona if you are breast-feeding.
Driving ability and use of machinery
Zyrona does not affect your ability to drive or use machines.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Zyrona contains lactose and sucrose
This medicine contains lactose and sucrose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to take Zyrona
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Treatment time
The doctor will tell you how long you need to continue taking Zyrona.
Zyrona prevents ovulation and thereby prevents pregnancy. You should not take regular birth control pills while taking Zyrona.
If you want to become pregnant, you should not take Zyrona.
How to take Zyrona
The tablets must be taken in the order indicated on the package and at the same time each day. Take 1 tablet daily for 21 days. The next pack is started after a tablet-free break of 7 days. During the break, you will have menstrual-like bleeding. Bleeding usually starts on the second or third day after you take the last tablet and may not have stopped when you start the next pack.
If you have not taken any birth control pills in the last month:
You must start taking the tablets on the first day of bleeding (day 1 of a normal menstrual cycle).
You can start taking the tablets during days 2-5, but then you are advised to use a supplementary contraceptive method (eg condoms) during the first cycle, i.e. until the next bleeding.
If you change from another type of combined contraceptive ( birth control pill , vaginal ring or patch ):
You should ideally start Zyrona the day after the last active tablet (the last tablet containing the active substances) of your previous birth control pill , but no later than the day after the pill -free period with your previous pill (or after the last inactive tablet of your previous pill ). When changing from a vaginal ring or patch , you should preferably start Zyrona on the day the vaginal ring or patch is removed, but no later than the day a new ring or patchwould have been applied. Ask your doctor or pharmacist if you are unsure.
If you change from a progestogen product (tablets, injection or implant ) or intrauterine device that releases progestogen:
- You can switch from tablets to Zyrona at any time.
- If you have previously used a uterine insert or implant , treatment with Zyrona should begin on the same day as the implant or uterine insert is removed.
- If you have previously received an injection , you can switch to Zyrona on the same day you would have received your next injection .
- In all of the above cases, you are recommended to use a supplementary contraceptive method during the first 7 days that you take the tablets.
If you have had an abortion in the first trimester:
You can start taking Zyrona immediately after you have had an abortion in the first trimester. If you start taking the tablets immediately, it is not necessary to use any additional contraceptive method.
If you have just given birth or if you have had an abortion in the second trimester:
You should start taking Zyrona 21-28 days after the birth or after the abortion in the second trimester. If you start taking Zyrona later, you should use an additional method of contraception for the first 7 days after you start taking Zyrona.
If you have had intercourse before starting treatment with Zyrona, you should find out if you are pregnant or wait until the first day of your next period before starting the tablets.
If you are breast-feeding, see “Pregnancy and breast-feeding”.
If you have taken too much Zyrona
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Symptoms: nausea, vomiting or vaginal bleeding. Even girls who have not had their first period but accidentally used this medicine can experience this type of bleeding.
If you forget to take Zyrona
Less than 12 hours
If it has been less than 12 hours since you should have taken Zyrona, you are still protected against pregnancy. Take the tablet as soon as you remember. Take the next tablet as usual.
More than 12 hours
If it has been more than 12 hours since you should have taken Zyrona, the protection against pregnancy may have decreased, depending on where in your menstrual cycle you are when you forget to take a tablet.
The more tablets you forget to take, the greater the risk of pregnancy. Take the following precautions:
1 missed pill during week 1:
Take the tablet as soon as you remember, even if it means taking two tablets at the same time. Then continue as usual. You should also use a supplementary contraceptive method for 7 days. If you have had intercourse in the last 7 days, it is possible that you are pregnant.
Contact your doctor immediately.
1 missed pill during week 2:
Take the tablet as soon as you remember, even if it means taking two tablets at the same time.
If you took the tablets as directed before you missed a tablet, it is not necessary to use any additional contraception.
If you did not take the tablets as directed before you missed a tablet, or if you forgot to take more than one tablet, you are advised to use an additional method of contraception (eg condoms) for 7 days.
1 missed pill during week 3:
Protection against pregnancy is reduced due to the upcoming tablet-free break. This can be counteracted by adjusting your intake of the tablets. If you have taken the last 7 tablets according to the instructions, you can choose between two different options. If you don’t have it, you must use option 1 and also use an additional method of contraception for 7 days.
- Take the tablet as soon as you remember, even if it means taking two tablets at the same time. Continue taking the tablets as usual, but ignore the tablet-free break and instead continue with the next pack. You will probably not have a period until the second pack is finished, but spotting or breakthrough bleeding may occur while you are taking the tablets.
- Stop taking the tablets from the current pack. Make a break of 7 tablet-free days, including the days you forgot to take the tablets. Then start on a new package.
If you have forgotten to take a tablet and you do not get your period during the first normal tablet-free interval after you have forgotten the tablets, there is a risk that you are pregnant. Contact your doctor.
If you experience vomiting and severe diarrhea ( gastroenteritis ):
If you have severe gastroenteritis , the absorption of Zyrona may be impaired, reducing the protection against pregnancy. If you vomit within 3-4 hours of taking your pill , you must follow the missed pill instructions. If you do not want to change the schedule of your tablet intake, you must take additional tablets from a different pack.
If you want to postpone your period or change your bleeding day:
If you want to postpone your period, you can continue with a new pack of Zyrona without taking any tablet-free breaks. You can postpone your period for as many days as you want until the pack runs out. You may have spotting or breakthrough bleeding during the period when you are taking extra tablets. Start on the next pack of Zyrona after the normal tablet-free break of 7 days.
If you want to have your period on a different day of the week than usual, you can shorten the upcoming tablet-free break by as many days as you wish. The shorter the break, the greater the risk that you will not have a period but instead have spotting or breakthrough bleeding while taking the next pack.
How long should you take Zyrona?
The length of treatment varies depending on the type of illness you have and how serious it is. Most often, the treatment lasts for several months.
You are advised to take Zyrona for at least 3-4 menstrual cycles after the symptoms have disappeared. If you experience a relapse a few weeks or months after you stop taking the tablets, you can start taking Zyrona again.
If you have any further questions about this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
As with all women taking combined hormonal contraceptives, there is an increased risk of blood clots in your veins (venous thromboembolism , VTE) or blood clots in your arteries ( arterial thrombosis , ATE). More information about the different risks when using combined hormonal contraceptives can be found in section 2 “What you need to know before taking Zyrona”.
Serious side effects Rare
side effects (may affect up to 1 in 1,000 users):
- Dangerous blood clots in a vein or artery , e.g. in a leg or foot, in a lung, heart attack. Contact a doctor immediately.
Has been reported (occurring in an unknown number of users):
- Liver tumor that can cause pain under the ribs on the right side and jaundice. Contact a doctor immediately.
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives along with difficulty breathing (see also section “Warnings and precautions”).
Other side effect ar
Common side effects (may affect up to 1 in 10 users):
- Tenderness and pain in the breasts, breast enlargement, discharge from the breast.
- Headaches, migraines , altered sex drive, depression/mood swings.
- Skin problems (eg rash, painful red nodules (erythema nodosum), allergic reaction or infection (erythema multiforme)).
- Increased weight, fluid retention.
Uncommon side effects (may affect up to 1 in 100 users):
- Nausea, vomiting and other symptoms in the gastrointestinal tract.
- Hives ( urticaria ).
Rare side effects (may affect up to 1 in 1,000 users):
- Increased sensitivity when using contact lenses
- Changes in secretions from the vagina.
- Hypersensitivity reaction .
- Reduced weight.
Has been reported (occurring in an unknown number of users):
- Increased blood pressure .
- Fungal infections in the vagina.
- Patchy discoloration of the skin on the face.
If you have hereditary angioedema , medicines containing certain female sex hormones ( estrogens ) may induce or worsen the symptoms of angioedema (see the section “Take special care with Zyrona”).
How to store Zyrona
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 ºC.
Store in the original packaging.
Use before the expiry date stated on the packaging after EXP. Expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are: Cyproterone acetate 2 mg and ethinylestradiol 35 micrograms.
- Other ingredients are:Tablet core : lactose monohydrate , corn starch, povidone K25, talc and magnesium stearate.Tablet coating : sucrose, macrogol 6000, calcium carbonate , talc, glycerol 85%, povidone K90, montan glycol wax and the dyes titanium dioxide (E 171) and yellow iron oxide (E 172).
Appearance and package sizes of the medicine
Zyrona is a yellow, biconvex, round, coated tablet.
Blister pack (calendar blister): 1 x 21 and 3 x 21 tablets.
Not all pack sizes may be marketed.
Orifarm Generics A/S
Energivej 15
DK-5260 Odense S
Denmark
Local representative:
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com