Diane Diario 2 mg/0.035 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Diane Diario 2 mg / 0.035 mg coated tablets
cyproterone acetate/ethinylestradiol
Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.
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Contents of the leaflet
- What Diane Diario is and what it is used for
- What you need to know before taking Diane Diario
- How to take Diane Diario
- Possible side effects
- Storage of Diane Diario
- Contents of the pack and other information
1. What Diane Diario is and what it is used for
Diane Diario is used for the treatment of skin disorders such as acne, seborrheic skin, and excessive hair growth in women of reproductive age. Due to its contraceptive properties, your doctor should only prescribe this treatment if they consider hormonal contraception to be appropriate.
You should take Diane Diario only if your skin condition has not improved after using other anti-acne treatments, including topical treatments and antibiotics.
2. What you need to know before starting to take Diane Diario
Do not use Diane Diario
Inform your doctor if you are in any of the following conditions before taking Diane Diario. Your doctor may recommend a different treatment:
?? If you are using another hormonal contraceptive treatment.
?? If you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism), or in another part of your body.
?? If you have (or have ever had) a condition that may indicate a future heart attack (e.g., angina pectoris causing severe chest pain) or a transient ischemic attack (mini-stroke).
?? If you have had a heart attack or a stroke.
?? If you have a condition that may increase the risk of blood clots in your arteries. These conditions may include:
o Diabetes affecting your blood vessels
o High blood pressure
o Very high levels of blood lipids (cholesterol or triglycerides).
?? If you have blood clotting disorders (e.g., protein C deficiency).
?? If you or a close family member (parents or siblings) have had or have had venous thrombosis in the lower limbs that detached and affected other areas of the body, even if it occurred a long time ago. The detached clot may affect the lungs (pulmonary embolism).
?? If you have (or have ever had) migraine with visual disturbances.
?? If you have thrombogenic valvulopathies (heart valve diseases that may cause thrombosis).
?? If you have or have had severe liver disease or liver tumors.
?? If you have or are suspected of having malignant conditions of the genital organs or breast.
?? If you have meningioma or have ever been diagnosed with meningioma (a usually benign tumor of the tissue layer between the brain and the skull).
?? If you have vaginal bleeding of unknown cause.
?? If you are pregnant or suspect you might be pregnant.
?? If you are breastfeeding.
?? If you are allergic to the active substances or any of the other components of this medicine (listed in section 6).
Do not use Diane Diario if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking Diane Diario with other medicines”).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Diane Diario.
Diane Diario also has action as an oral contraceptive. You and your doctor should consider all factors normally affecting the safe use of hormonal oral contraceptives.
An increased risk of a benign brain tumor (meningioma) has been reported with high doses (25 mg or higher) of cyproterone acetate. If you are diagnosed with meningioma, your doctor will discontinue treatment with all medications containing cyproterone, including Diane Diario, as a precautionary measure (see section "Do not use Diane Diario").
Duration of use
Your doctor will indicate how long you should take Diane Diario.
Your doctor should periodically assess the need to continue treatment (see further below “How to take Diane Diario”).
If any of the conditions/risk factors mentioned below are present, your doctor should evaluate the benefits of using Diane Diario against the possible risks and discuss them with you before you decide to start using it.
When to contact your doctor
If any of the following conditions occur for the first time, worsen, or intensify, you must contact your doctor as soon as possible, as Diane Diario use should be discontinued.
- First occurrence or worsening of migraine-type headaches, or unusually frequent or severe headaches.
- Sudden changes in vision or hearing, or other sensory disturbances.
- First signs of thrombophlebitis or thromboembolic symptoms (such as unusual pain or swelling in the leg[s], chest pain, or unexplained shortness of breath or cough). Feeling of pain or tightness in the chest.
- Stop taking the tablets and contact your doctor immediately if you notice possible signs of a blood clot. Symptoms are described in section 2 “Blood clots (Thrombosis)”.
- Six weeks before any planned major surgery (abdominal, orthopedic), surgery on the legs, medical treatment for varicose veins, or periods of prolonged immobilization, such as after accidents or surgery. Treatment should not be resumed until two weeks after full mobility is restored. In case of emergency surgery, thromboprophylaxis (e.g., with subcutaneous heparin) is usually indicated.
- Appearance of jaundice (yellowing of the whites of the eyes and skin) or liver disorders or generalized itching.
- Epilepsy.
- Significant increase in blood pressure.
- Onset of severe depression.
- Severe abdominal pain or hepatomegaly (enlargement of the liver).
- Clear worsening of conditions known to worsen during use of hormonal contraceptives or during pregnancy.
- Pregnancy is a reason to stop treatment immediately.
Contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, along with difficulty breathing. Medications containing estrogens may induce or worsen symptoms of hereditary and acquired angioedema.
If you have diabetes, contact your doctor, who will assess whether treatment should be discontinued.
?? Blood clots (thrombosis)
Taking Diane Diario may slightly increase the risk of developing a blood clot (also known as thrombosis). Your chances of having a clot are only slightly higher when taking Diane Diario compared to women who do not take Diane Diario or who take another contraceptive. Recovery is not complete in all cases, and in 1-2% of cases, the outcome may be fatal.
Your doctor will check whether you have a higher risk of developing a blood clot due to a combination of risk factors or a single, more severe risk factor. This increased risk may be greater than the simple sum of individual risks. If the risk is too high, your doctor will not prescribe a combined oral contraceptive (COC) (see “What you need to know before starting to take Diane Diario”).
Blood clots in a vein
A blood clot in a vein (known as “venous thrombosis”) can block the vein. This can occur in veins of the leg, lung (pulmonary embolism), or in any other organ.
The use of combined contraceptives increases a woman’s risk of developing these clots compared to women who do not use combined contraceptives. The risk of developing a clot in a vein is higher during the first year a woman takes the contraceptive. The risk is not as high as the risk of developing a clot during pregnancy.
The risk of venous thrombosis in users of combined contraceptives increases:
?? with age
?? if you smoke
When using a hormonal contraceptive such as Diane Diario, it is strongly recommended to stop smoking, especially if you are over 35 years old.
?? if a close family member has had a blood clot in the leg, lung, or another organ at a young age
?? if you are overweight
?? if you are undergoing surgery, if you are immobilized for a prolonged period due to illness or injury, or if you have a leg immobilized in a cast
If this applies to you, it is important to inform your doctor that you are taking Diane Diario, as treatment may need to be interrupted. Your doctor may advise you to stop taking Diane Diario several weeks before surgery or when your mobility is reduced. Your doctor will also advise you when you can resume taking Diane Diario after regaining mobility.
Blood clots in an artery
A blood clot in an artery can cause serious problems. For example, a clot in an artery of the heart can cause a heart attack, or in the brain can cause a stroke.
The use of combined contraceptives has been associated with an increased risk of arterial clots. The risk increases:
?? with age
?? if you smoke
When using a hormonal contraceptive such as Diane Diario, it is strongly recommended to stop smoking, especially if you are over 35 years old.
?? if you are overweight
?? if you have high blood pressure
?? if a close family member has had a heart attack at a young age
?? if you have high levels of lipids in the blood (cholesterol or triglycerides)
?? if you suffer from migraines
?? if you have heart problems (valve disorders or cardiac rhythm disturbances)
Symptoms of blood clots
Stop taking this medicine and contact your doctor immediately if you notice possible signs of a blood clot, such as:
After a blood clot, recovery is not always complete. Permanent disability may rarely occur, or the blood clot may even be fatal. Shortly after childbirth, women have a higher risk of developing blood clots, so you should ask your doctor when you can restart treatment with Diane Diario after giving birth. |
??Blood pressure
If you have hypertension (high blood pressure) or any disease related to hypertension (including certain kidney diseases), it is preferable to use other contraceptive methods. If you decide to use oral contraceptives, your blood pressure should be monitored regularly; however, if your blood pressure increases and cannot be controlled with medication, you must discontinue treatment.
??Tumors
The most important risk factor for cervical cancer is persistent infection with human papillomavirus. Some studies have indicated that long-term use of combined oral contraceptives (COCs) may contribute to this increased risk, but controversy remains regarding the extent to which this finding is attributable to other factors, e.g., cervical screening and sexual behavior, including the use of barrier contraceptives.
Various studies have reported that women using COCs have a slight increase in the risk of being diagnosed with breast cancer compared to women who have never used them. This increased risk may be due to earlier diagnosis of breast cancer in COC users, resulting from more regular medical monitoring, to the biological effects of COCs, or to a combination of both. This increased frequency gradually decreases after stopping treatment. After ten years, the likelihood of developing breast cancer will be the same as in women who have never used oral contraceptives.
Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in users of COCs. In isolated cases, these tumors have caused life-threatening intra-abdominal hemorrhage. This may result in internal bleeding causing severe abdominal pain. If this occurs, you should contact your doctor immediately.
Malignant tumors can be life-threatening or fatal.
- Psychiatric disorders
Some women using hormonal contraceptives such as Diane Diario have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or depressive symptoms, contact your doctor for additional medical advice as soon as possible.
If a severe case of depression develops, discontinuation of treatment should be considered. Women with a history of depression should be closely monitored.
??Other conditions
In women with hypertriglyceridemia (elevated triglycerides in the blood) or a family history of the same, there may be an increased risk of pancreatitis during the use of Diane Diario.
During the use of COCs, many users have been observed to experience small increases in blood pressure, although clinically significant cases are rare. If persistent high blood pressure develops during your treatment with Diane Diario, you should consult your doctor.
In women with endometrial hyperplasia, the doctor must carefully evaluate the risk-benefit ratio before prescribing COCs and monitor the patient closely during treatment, performing periodic cervical cytology tests.
The following conditions may appear or worsen during pregnancy and with the use of COCs: jaundice (yellowing of the whites of the eyes and skin) and/or pruritus (itching) related to cholestasis (arrest or reduction of bile flow), gallstone formation, porphyria (inherited metabolic disorder), systemic lupus erythematosus (inflammatory skin disease), hemolytic uremic syndrome (kidney disease with blood abnormalities), Sydenham's chorea (involuntary movements), herpes gestationis (skin and mucosal lesions appearing during pregnancy), and hearing loss due to otosclerosis (a type of ear disease).
Acute or chronic disorders of liver function require discontinuation of Diane Diario until liver function markers return to normal. Recurrence of cholestatic jaundice that first appeared during pregnancy or during prior use of sex hormones requires discontinuation of Diane Diario.
COCs may alter peripheral insulin resistance and glucose tolerance, although it is generally not necessary to modify the therapeutic regimen in diabetic women using low-dose COCs (containing < 0.05 mg ethinylestradiol). Nevertheless, diabetic women should be carefully monitored while taking Diane Diario.
Occasionally, chloasma (brownish skin patches) may occur, especially in women with a history of chloasma gravidarum (during pregnancy). If you are prone to chloasma, you should avoid exposure to sunlight or ultraviolet radiation while taking Diane Diario.
If you have hirsutism (excessive hair growth), and symptoms have recently developed or worsened, you should consult your doctor, who should investigate possible underlying causes.
Medical examination and consultation
Before starting or resuming treatment with Diane Diario, your doctor must perform a complete medical history and physical examination to rule out contraindications and assess precautions. These evaluations should be repeated periodically during treatment.
Women should be advised that products such as Diane Diario do not protect against HIV (AIDS) infection or other sexually transmitted diseases.
Reduced efficacy
The effectiveness of Diane Diario may decrease if you forget to take an active tablet (see “What to do if you forget to take a tablet”), experience gastrointestinal disturbances during the intake of hormone-containing tablets (see “Recommendations in case of gastrointestinal disturbances”), or take other medications simultaneously (see “Taking Diane Diario with other medicines”).
You should not take herbal preparations containing St. John's wort (Hypericum perforatum) simultaneously with Diane Diario, as this may reduce its therapeutic effect and increase the risk of pregnancy and intermenstrual bleeding (see “Taking Diane Diario with other medicines”).
Irregularities in cycle control
During the use of Diane Diario, spotting or vaginal bleeding may occur, especially during the first months of use. If these bleeding irregularities persist or occur after previously regular cycles, you should consult your doctor so that appropriate diagnostic measures can be taken to exclude non-hormonal causes (malignant conditions, infections, or pregnancy).
In some women, withdrawal bleeding (period or menstruation) may not occur during the placebo tablet interval. If you have taken Diane Diario according to the instructions described in “How to take Diane Diario,” it is unlikely that you are pregnant. However, if you have not taken Diane Diario according to these instructions before the first missed withdrawal bleed, or if two withdrawal bleeds are missed, pregnancy should be ruled out before continuing treatment with Diane Diario.
Laboratory tests
The use of products such as Diane Diario may affect the results of certain laboratory tests. If you are scheduled for any laboratory test, inform your doctor that you are taking COCs.
Taking Diane Diario with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including over-the-counter drugs or herbal preparations. Also inform any other doctor or dentist who prescribes you a medicine (or your pharmacist) that you are taking Diane Diario. They may advise you whether you need to use additional contraceptive precautions (e.g., condoms), and if so, for how long, or whether you need to adjust the use of another medication.
Certain medicines may interact with each other, and in such cases, it may be necessary to change the dose or discontinue one of the treatments.
It is especially important that you inform your doctor if you are taking any of the following medicines, as they may prevent combined hormonal contraceptives from working properly, increase the incidence of intermenstrual bleeding and menstrual irregularities, and reduce the efficacy of Diane Diario by affecting its blood levels; if this occurs, you could become pregnant. These medicines are used to treat:
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Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, ethosuximide, topiramate, and felbamate).
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Tuberculosis (e.g., rifampicin, rifabutin).
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HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, and efavirenz).
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Fungal infections (e.g., griseofulvin, ketoconazole).
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Arthritis, osteoarthritis (etoricoxib).
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High blood pressure in the blood vessels of the lungs (bosentan).
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Antacids.
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Laxatives.
- Lansoprazole (used to treat digestive disorders such as ulcers).
- Modafinil (used to treat daytime sleep disorders).
- Atorvastatin (reduces triglyceride and cholesterol levels).
- Vitamin C and paracetamol (analgesic).
- Indinavir (for treatment of HIV (AIDS)).
- Troleandomycin (for treatment of bacterial infections).
- Hypericum perforatum or St. John's wort (herbal remedy for depression).
The herbal remedy St. John's wort (Hypericum perforatum) also reduces the effect of oral contraceptives, and cases of pregnancy have been reported in women taking oral contraceptives together with St. John's wort preparations. The reduced contraceptive effect lasts up to two weeks after stopping the St. John's wort preparation.
During treatment with any of these drugs, you should temporarily use a barrier method (condom) in addition to Diane Diario, or choose another contraceptive method. The barrier method should be used throughout the period of concomitant drug administration and for 28 days after its discontinuation. If the period during which the barrier method is used extends beyond the end of the hormone tablets in the Diane Diario pack, you should start the next pack immediately, discarding the placebo tablets in the current pack. Consult your doctor if you have any questions about this.
?? Diane Diario may alter the effect of other medicines:
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Medicines containing cyclosporine (used to prevent organ or bone marrow transplant rejection; increased risk of hepatotoxicity may occur).
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The antiepileptic lamotrigine (increased frequency of seizures may occur).
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Theophylline (for treatment of respiratory problems).
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Tizanidine (used to treat pain and/or muscle spasms).
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β-blockers (medicines used for heart conditions).
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Corticosteroids (prednisolone).
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Flunarizine (increasing the risk of galactorrhea, milk secretion).
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Analgesics (paracetamol and salicylates).
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Clofibrates (reduce triglyceride and cholesterol levels).
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Oral anticoagulants.
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Oral antidiabetics and insulin.
Do not take Diane Diario if you have Hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medications.
Diane Diario may be resumed approximately 2 weeks after completion of this treatment. See the section "Do not use Diane Diario".
Please consult the prescribing information of any concomitant medications to identify potential interactions.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Diane Diario is contraindicated during pregnancy. If pregnancy occurs, you must stop treatment immediately and consult your doctor.
Diane Diario is also contraindicated during breastfeeding. Small amounts of the oral contraceptive may be excreted in breast milk. Therefore, use of COCs is not recommended until after completion of the breastfeeding period.
Driving and using machines
The influence of Diane Diario on the ability to drive and use machines is negligible or none.
Diane Diario contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Diane Diario
Follow exactly the dosing instructions provided in this leaflet or those given by your doctor. If in doubt, consult your doctor again.
Diane Diario inhibits ovulation and therefore acts as a hormonal contraceptive. Consequently, if you are taking Diane Diario, you must not use an additional hormonal contraceptive, as you would be exposed to an excessive dose of hormones. You should discontinue the use of any previously used hormonal contraceptives (see section “What you need to know before starting to take Diane Diario”).
You must take Diane Diario regularly to achieve therapeutic efficacy and the required contraceptive protection. The dosing regimen for Diane Diario is similar to the standard regimen for most combined oral contraceptives. Therefore, you should follow the same administration rules. Irregular intake of Diane Diario may cause intermenstrual bleeding and could reduce its therapeutic and contraceptive effectiveness.
Inside the package, along with the reminder blister (which contains the tablets), there is a cardboard sheet with 7 adhesive strips (see Fig. 1). These strips display the days of the week. Each strip starts with a different day of the week. You must peel off the strip that starts with the day of the week on which you will take the first Diane Diario tablet (for example, if you are starting to take the tablets on a Thursday, peel off the strip starting with “THU”). Attach this strip to the rectangle located at the top of the blister containing the tablets. In this way, the first day will align with the beige tablet pointed to by the arrow marked with the number “1” (see Fig. 2).
START Peel off the strip starting with the day of the week
on which you will take the first tablet (e.g., if you
start on a Thursday, peel off the strip starting with
THU).
MON | TUE | WED | THU | FRI | SAT | SUN |
TUE | WED | THU | FRI | SAT | SUN | MON |
WED | THU | FRI | SAT | SUN | MON | TUE |
THU | FRI | SAT | SUN | MON | TUE | WED |
FRI | SAT | SUN | MON | TUE | WED | THU |
SAT | SUN | MON | TUE | WED | THU | FRI |
SUN | MON | TUE | WED | THU | FRI | SAT |
Figure 1
Figure 2
You should take the tablets in the order indicated on the pack, every day at approximately the same time, with a drink if necessary, until you have finished all 28 tablets in the blister pack. Thus, you will take one beige tablet (active) daily for the first 21 days, followed by one white tablet (placebo) daily for the next 7 days.
The treatment is continuous. This means that when you have finished one blister pack, you must start a new one the following day.
During the week of taking the placebo tablets, a withdrawal bleed similar to menstruation will normally occur. This usually begins 2–3 days after starting the placebo tablets and may not have finished before you start the next pack.
How to start taking Diane Diario
- No previous use of hormonal contraceptives (in the previous month)
Tablet-taking should begin on day 1 of the woman's natural cycle (i.e., the first day of her menstrual bleeding). It may also be started on days 2 to 5 of the cycle; however, in this case, it is recommended to use an additional barrier method (e.g., condom) during the first 7 days of tablet-taking.
- Switching from another combined oral contraceptive (COC), vaginal ring, or transdermal patch
You should preferably start taking Diane Diario the day after taking the last active (hormone-containing) tablet of your previous COC, but no later than the day after the usual hormone-free interval or placebo tablet period of your previous COC ends. This means that treatment with Diane Diario should be started no later than the day a new pack (blister) of your previous COC would have been started. If you have been using a vaginal ring or transdermal patch, you should preferably start taking Diane Diario on the day of removal of the last ring or patch of a cycle pack, or at the latest when the next application would have been due.
- Switching from a progestogen-only method (progestogen-only pill, injection, implant), or from a progestogen-releasing intrauterine system (IUS)
You may switch on any day from the progestogen-only pill (if using an implant or IUS, on the day of removal; if using an injectable, at the time the next injection would be due), but in all cases it is recommended to use an additional barrier method during the first 7 days of tablet-taking.
- After a first-trimester abortion
You may start immediately. In this case, no additional contraceptive measures are needed.
- After childbirth or second-trimester abortion
It is advisable to start on day 21 to 28 after childbirth or second-trimester abortion. If you start later, it is advisable to use an additional barrier method during the first 7 days of tablet-taking. However, if you have already had sexual intercourse, pregnancy must be ruled out before starting Diane Diario, or you must wait until your first menstrual period to begin treatment.
What to do if you forget to take a tablet
The white tablets are placebo tablets, and therefore forgetting them has no consequences, provided that no more than 7 days pass between taking the last beige tablet and the first beige tablet of the next pack. To maintain the regular dosing schedule, if you forget to take a white tablet, discard it. The following advice applies only to forgetting hormone-containing tablets (beige tablets).
If you are less than 12 hours late taking a beige tablet, contraceptive protection is not reduced. Take the tablet as soon as you remember and continue taking the following tablets at your usual time.
If you are more than 12 hours late taking a beige tablet, contraceptive protection may be reduced. The following two basic rules should be followed in case of missed tablets:
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You must never stop taking tablets for more than 7 days.
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You need to take tablets continuously for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.
Therefore, the following advice may be given in daily practice:
- Week 1
Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. In addition, use a barrier method (e.g., condom) for the next 7 days. If you had sexual intercourse in the previous 7 days, consider the possibility of pregnancy. The more tablets you miss and the closer you are to the placebo tablet phase, the higher the risk of pregnancy.
- Week 2
Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. If you have taken all tablets correctly in the 7 days before the first missed tablet, no additional contraceptive measures are necessary. However, if this is not the case, or if you have missed more than one tablet, it is advisable to take additional precautions for 7 days.
- Week 3
The risk of reduced contraceptive effectiveness is imminent due to the proximity of the placebo tablet phase. However, by adjusting the tablet-taking schedule, a reduction in contraceptive protection can still be prevented. Therefore, if you follow one of the two options below, you will not need to take additional contraceptive precautions, provided that you have taken all tablets correctly in the 7 days before the first missed tablet. If this is not the case, it is advisable to follow the first of these two options and also take additional contraceptive precautions for the following 7 days.
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Take the last missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time until you finish the hormone-containing tablets. Discard the 7 placebo tablets. Start the next pack immediately. It is unlikely that you will have a withdrawal bleed (period or menstruation) until you finish the hormone-containing tablets of the second pack, but you may experience spotting or intermenstrual bleeding during tablet-taking days.
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You may also stop taking tablets from the current pack. Then complete a tablet-free interval of up to 7 days (including the days on which you missed tablets) and then continue with the next pack.
If you miss tablets and do not have a withdrawal bleed (period or menstruation) during the placebo tablet phase, consider the possibility of pregnancy.
However, if in doubt, consult your doctor.
Recommendations in case of gastrointestinal disturbances
In case of severe gastrointestinal disturbances, absorption may be incomplete, and you should use additional contraceptive measures.
If you vomit within 3–4 hours after taking a tablet, follow the recommendations for missed tablets as described in the section “What to do if you forget to take a tablet.” If you do not wish to change your normal tablet-taking schedule, take the necessary additional tablet(s) from another spare blister pack.
Duration of use
Your doctor will tell you how long you should take Diane Diario.
Your doctor should periodically assess the need to continue treatment. If symptoms recur weeks or months after stopping the tablets, treatment with Diane Diario may be restarted. In case of restarting treatment with Diane Diario (after a tablet-free interval of at least one month), the increased risk of venous thromboembolism (VTE) should be considered (see “What you need to know before starting Diane Diario”).
Special populations
Patients with impaired hepatic function
Diane Diario is contraindicated in women with severe liver disease, as long as liver function values have not returned to normal.
Patients with impaired renal function
Diane Diario has not been specifically studied in patients with impaired renal function. There are no available data suggesting a need to modify treatment in this patient population.
If you take more Diane Diario than you should
In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
No serious adverse reactions have been reported due to overdose. Symptoms that may occur in case of overdose of hormone-containing tablets include: nausea, vomiting, or vaginal bleeding. This bleeding may occur even in girls who have not yet had their first menstrual period if they have accidentally taken this medication. There are no antidotes, and treatment should be symptomatic.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. If you suffer any adverse effect, especially if it is severe and persistent, or if you experience any change in your health that you think may be due to Diane Diario, consult your doctor.
All women who take combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Diane Diario”.
Serious adverse effects
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 with possible difficulty breathing (see also section “Warnings and precautions”).
In addition, the use of oral contraceptives has been associated with:
- Increased risk of cervical intraepithelial neoplasia and cervical cancer.
- Increased risk of diagnosis of breast cancer (see “What you need to know before starting to take Diane Diario”).
The following list of adverse effects has been reported with the use of Diane Diario. They are classified according to frequency in treated patients, based on the following criteria:
Very common: may affect more than 1 in 10 people
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
Very rare: may affect up to 1 in 10,000 people
Frequency not known: cannot be estimated from the available data
Infections and infestations
Common: vaginitis (inflammation of the vagina), including candidiasis (fungal infection in the vagina).
Immune system disorders
Rare: allergic-type reactions such as very rare cases of urticaria (itching) and severe reactions accompanied by difficulty breathing, dizziness, and even loss of consciousness.
Very rare: worsening of systemic lupus erythematosus.
Metabolism and nutrition disorders
Uncommon: changes in appetite (increase or decrease).
Rare: glucose intolerance.
Very rare: worsening of porphyria (a disorder of hemoglobin metabolism).
Psychiatric disorders
Common: mood changes, including depression; changes in libido (sexual desire).
Nervous system disorders
Very common: headaches, including migraines.
Common: nervousness, dizziness.
Very rare: worsening of chorea (a disease causing movement disorders).
Eye disorders
Rare: intolerance to contact lenses.
Very rare: eye abnormalities and visual disturbances (optic neuritis, retinal vascular thrombosis).
Vascular disorders
Rare: venous thrombosis.
Very rare: worsening of varicose veins.
Frequency not known: increased blood pressure.
Gastrointestinal disorders
Common: nausea, vomiting, abdominal pain.
Uncommon: colic, bloating.
Very rare: inflammation of the pancreas (pancreatitis), hepatic adenomas, hepatocellular carcinoma.
Hepatobiliary disorders
Rare: cholestatic jaundice.
Very rare: cholecystopathy (gallbladder disorders), including gallstones.
Skin and subcutaneous tissue disorders
Uncommon: rash (urticaria), chloasma which may persist.
Rare: erythema nodosum (a type of skin inflammation causing nodules on the legs).
Very rare: erythema multiforme (a type of skin inflammation).
Renal and urinary disorders
Very rare: haemolytic uraemic syndrome.
Reproductive and breast disorders
Very common: bleeding, spotting.
Common: breast pain, breast tenderness, breast enlargement, breast discharge, dysmenorrhoea (painful menstruation), changes in menstrual flow, changes in vaginal discharge, and cervical ectropion (alteration of the mucosa of the cervix), amenorrhoea (absence of menstruation).
General disorders and administration site conditions
Common: fluid retention, oedema (swelling), weight changes (gain or loss).
Investigations
Uncommon: changes in serum lipid levels, including hypertriglyceridaemia.
Rare: decrease in serum folate levels.
If any of these adverse effects occur, inform your doctor, who will advise you whether to discontinue treatment if it is considered to affect your well-being.
If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Diane Diario
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point 
at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Diane Diario
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Hormone tablets (beige-colored tablets): The active substances are cyproterone acetate and ethinylestradiol. Each tablet contains 2 mg of cyproterone acetate and 0.035 mg of ethinylestradiol. The other components are: monohydrate lactose, corn starch, povidone 25, magnesium stearate, talc, sucrose, povidone 700,000, macrogol 6000, calcium carbonate, glycerol 85% (E422), titanium dioxide (E171), yellow iron oxide (E172), and glycol montanic wax.
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Placebo tablets (white tablets): The tablet contains no active substances. The other components are: monohydrate lactose, corn starch, povidone 25, magnesium stearate, talc, sucrose, povidone 700,000, macrogol 6000, calcium carbonate, and glycol montanic wax.
Appearance of the product and contents of the pack
Pack containing a PVC/aluminum blister with 21 hormone tablets and 7 placebo tablets.
The hormone tablet is beige-colored and round.
The placebo tablet is white and round.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bayer Hispania, S.L.
Av. Baix Llobregat, 3 - 5
08970 Sant Joan Despí (Barcelona)
Spain
Manufacturer
Bayer AG
Müllerstrasse 178
13353 Berlin - Germany
or
Bayer Weimar GmbH und Co. KG
Döbereiner Str. 20
99427 Weimar - Germany
Date of the most recent revision of this leaflet: 10/2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.