Patient Information Leaflet

Diane Diario 2 mg / 0.035 mg Coated Tablets

ciproterone acetate/ethinylestradiol

1.What Diane Diario is and what it is used for

2.What you need to know beforestartingto take Diane Diario

3.How to take Diane Diario

4.Possible side effects

5.Storage of Diane Diario

6.Contents of the pack and additional information

Diane Diario is used to treat skin conditions, such as acne, seborrheic skin, and excessive hair growth in fertile women. Due to its contraceptive properties, your doctor should only prescribe this treatment if they consider that hormonal contraceptive treatment is appropriate.

You should only take Diane Diario if your skin condition has not improved after using other anti-acne treatments, including topical treatments and antibiotics.

NouseDiane Diario

Inform your doctor if you have any of the following conditions before taking Diane Diario:

Your doctor may recommend a different treatment:

If you are using another hormonal contraceptive.anticonceptivo.

If you have (or have had at any time) a blood clot in your leg (thrombosis), lung (pulmonary embolism) or in another part of your body.

If you have (or have had at any time) a disease that may indicate a future heart attack (e.g. angina that causes a strong pain in your chest) or astroke (ictus leve)

(transient ischemic attack).

If you have (or have had at any time) a heart attack or a stroke.

If you have a condition that may increase your risk ofblood clotsin your arteries.

These conditions may include:

orDiabetes that affects your blood vessels

orHigh blood pressure

or High levels oflipids in your blood(cholesterol or triglycerides).

If you have a problem withblood coagulation(e.g. deficiency of protein C).

If you or a direct relative (parents and siblings) have or have had processes related to blood clots in the veins of your lower limbs that have detached and affected other

parts of your body, even if it happened a long time ago. The detached clot may affect your lungs (pulmonary embolism).

If you have (or have had at any time)migraines with visual disturbances

If you have valvulopathies (diseases of the heart valves that may

originate blood clots).

If you have or have had a severe liver disease or liver tumors.

If you have or suspect the presence of malignant diseases of the genital organs or breast.

If you have meningioma or have been diagnosed with meningioma (a generally benign tumor of the tissue layer located between the brain and the skull).

If you have unexplained vaginal bleeding.

If you are pregnant or suspect that you may be pregnant.

If you are breastfeeding.

If you are allergic to the active ingredients or any other components of this medication (listed in section 6).

Do not use Diane Diario if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Taking Diane Diario with other medications”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diane Diario.

Diane Diario also has an effect as an oral contraceptive. You and your doctor should consider all the factors that normally affect the safe use of oral contraceptives.

A higher risk of a benign brain tumor (meningioma) has been reported with high doses (25 mg and above) of ciproterone acetate. If you are diagnosed with meningioma, your doctor will interrupt treatment with all medications containing ciproterone, including Diane Diario, as a precaution (see section “Do not use Diane Diario”).

Duration of use

Your doctor will tell you for how long you need to take Diane Diario.

Your doctor should regularly assess the need to continue treatment (see also “How to take Diane Diario”).

If any of the processes/risk factors mentioned below are present, your doctor should assess 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 situations occur for the first time, worsen or become more severe, contact your doctor as soon as possible, as you should stop taking Diane Diario.

- First episode, or worsening, of migrainous headaches, or unusually frequent or severe headaches.

- Sudden changes in vision or hearing, or other changes in perception.

- First signs of thrombophlebitis or thromboembolic symptoms (such as unusual pain or inflammation in your legs, chest pain or cough without apparent cause).

-Stop taking the pills and contact your doctor immediately if you notice possible signs of a blood clot. The symptoms are described in section 2 “Blood clots (Trombosis)”.

- Six weeks before any scheduled major surgery (abdominal, orthopedic), any surgery on your legs, treatment of varicose veins or prolonged periods of immobility, such as after accidents or surgery. Do not resume treatment until you have fully recovered your mobility. In the case of emergency surgery, prophylactic anticoagulation is usually indicated, for example with subcutaneous heparin.

- Appearance of jaundice (yellowing of the whites of the eyes and skin) or liver or gallbladder disorders.

- Epilepsy.

- Significant increase in blood pressure.

- Appearance of severe depression.

- Intense abdominal pain or hepatomegaly (enlargement of the liver).

- Clear worsening of diseases that are known to worsen during the use of hormonal contraceptives or during pregnancy.

- Pregnancy is a reason to stop treatment immediately.

Consult your doctor immediately if you experience symptoms of angioedema such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing or urticaria, along with difficulty breathing. Medications containing estrogens can induce or worsen symptoms of hereditary and acquired angioedema.

If you have diabetes, contact your doctor, who will assess whether treatment should be interrupted.

Blood clots (Trombosis)

Taking Diane Diario may slightly increase the risk of developing a blood clot (also known as thrombosis). Your chances of having a blood clot are only slightly higher after taking Diane Diario compared to women who do not take Diane Diario or who take another contraceptive. There is no complete recovery in all cases, and in 1-2% of cases, the outcome can be fatal.

Your doctor will check if you have a higher risk of developing a blood clot caused by a combination of risk factors or a single risk factor of greater severity. This increased risk may be higher than the simple sum of individual risks. If the risk is too high, your doctor will not prescribe a combined oral contraceptive (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 “thrombosis venosa”) can block the vein. This can occur in veins in your leg, lung (pulmonary embolism) or in any other organ.

The use of combined contraceptives increases the risk of women developing those 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 that the woman takes the contraceptive. The risk is not as high as the risk of developing a clot during pregnancy.

The risk of thrombosis venosa in users of combined contraceptives increases:

??with age

??if you smoke

When using a hormonal contraceptive like Diane Diario, it is strongly recommended to quit smoking, especially if you are over 35 years old.

??if one of your close relatives has had a blood clot in their leg, lung or in another organ at a young age

??if you are overweight

??if you are about to undergo major surgery, if you are immobile for a prolonged period due to illness or injury, or if you have a leg immobilized with a cast

If this happens, it is essential to inform your doctor that you are taking Diane Diario, as treatment may need to be interrupted. Your doctor will advise you to stop taking Diane Diario several weeks before the surgery or when your mobility is reduced. Your doctor will also indicate when you can resume taking Diane Diario after recovering your 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 linked to an increased risk of blood clots in arteries. The risk increases:

??with age

??if you smoke

When using a hormonal contraceptive like Diane Diario, it is strongly recommended to quit smoking, especially if you are over 35 years old.

??if you are overweight

??if you have high blood pressure

??if one of your close relatives has had a heart attack at a young age

??if you have high levels of lipids in your blood (cholesterol or triglycerides)

??if you have migraines

??if you have heart problems (valve disorders or arrhythmia)

Signs of blood clots

??Blood pressure

If you have hypertension (high blood pressure) or any disease related to hypertension (including certain kidney diseases), it is recommended to use other contraceptive methods. If you decide to use oral contraceptives, you should monitor your blood pressure, but if it increases and cannot be controlled with medication, you should interrupt treatment.

??Tumors

The most important risk factor for cervical cancer is persistent infection with the human papillomavirus. Some studies have indicated that long-term use of combined oral contraceptives may contribute to this increased risk, but there is still controversy about the degree to which this finding is attributable to other factors, such as cervical examinations and sexual behavior, including the use of barrier contraceptives.

Various studies have reported that women taking combined oral contraceptives have a slight increase in the risk of being diagnosed with breast cancer, compared to women who have never taken them. The increase in this risk may be due to an earlier diagnosis of breast cancer in women taking combined oral contraceptives, due to regular medical check-ups, the biological effects of combined oral contraceptives, or a combination of both. This increase in frequency decreases gradually after stopping treatment. After ten years, the chances of having breast tumors will be the same as for women who have never used oral contraceptives.

Rarely, benign liver tumors have been reported in users of combined oral contraceptives, and even more rarely, malignant liver tumors. In isolated cases, these tumors have caused intra-abdominal hemorrhages that pose a threat to life. This can cause severe abdominal pain. If this happens, you should contact your doctor immediately.

Malignant tumors can pose a threat to life or have a fatal outcome.

• Mental health disorders

Some women who use hormonal contraceptives like Diane Diario have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

If a severe depression appears, treatment should be interrupted. 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 developing pancreatitis during the use of Diane Diario.

During the use of combined oral contraceptives, many users have reported small increases in blood pressure, although rare cases with clinical relevance have been reported. If high blood pressure appears during your treatment with Diane Diario, consult your doctor.

In women with endometrial hyperplasia, your doctor should carefully assess the risk-benefit relationship before prescribing combined oral contraceptives, and closely monitor the patient during treatment, performing periodic cervical cytology.

The following conditions may appear or worsen with pregnancy and with the use of combined oral contraceptives: jaundice (yellowing of the whites of the eyes and skin) and/or pruritus (itching) related to cholestasis (bile flow obstruction), gallstone formation, porphyria (a familial metabolic disorder), lupus erythematosus (inflammatory dermatitis), hemolytic-uremic syndrome (renal disease with blood alterations), Sydenham's chorea (involuntary movements), herpes gravidarum (skin and mucous membrane lesions that appear during pregnancy), and hearing loss due to otosclerosis (a type of ear disease).

Acute or chronic liver function disorders require suspension of Diane Diario treatment until liver function markers return to normal. Reappearance of cholestatic jaundice that first appeared during pregnancy, or during previous use of sex hormones, requires suspension of Diane Diario treatment.

Combined oral contraceptives can alter peripheral resistance to insulin and glucose tolerance, although it is not necessary to modify the therapeutic regimen in diabetic women taking low-dose combined oral contraceptives (with <0.05 mg of ethinylestradiol). However, diabetic women should be closely monitored while taking Diane Diario.

Occasionally, melasma (brown skin patches) may appear, especially in women with a history of melasma during pregnancy. If you are prone to melasma, avoid exposure to the sun or ultraviolet rays while taking Diane Diario.

If you have hirsutism (excessive hair growth), and recent symptoms have developed or increased, consult your doctor, who should clarify the possible causes.

Medical examination and consultation

Before starting or resuming treatment with Diane Diario, your doctor should perform a complete medical history and physical examination to rule out contraindications and observe precautions. These should be repeated periodically throughout treatment.

Women should be advised that preparations like Diane Diario do not protect against HIV (AIDS) infection or other sexually transmitted diseases.

Reduced efficacy

The efficacy of Diane Diario may decrease if you forget to take a hormone-containing pill (see “What to do if you forget to take a pill”), experience gastrointestinal disorders during hormone-containing pill use (see “Recommendations in case of gastrointestinal disorders”), or use other medications simultaneously (see “Taking Diane Diario with other medications”).

Do not take preparations based on St. John's Wort (Hypericum perforatum) simultaneously with Diane Diario, as it may reduce the therapeutic effect of Diane Diario and increase the risk of pregnancy and intermenstrual bleeding (see “Taking Diane Diario with other medications”).

Irregularities in menstrual control

During the use of Diane Diario, spotting or vaginal bleeding may appear, especially during the first months of use. If these irregularities of bleeding persist or occur after previously regular cycles, consult your doctor to take appropriate diagnostic measures to rule out possible non-hormonal causes (malignant processes, infections, or pregnancy).

In some women, menstruation may not occur during the placebo pill interval. If you have taken Diane Diario as instructed in “How to take Diane Diario,” it is unlikely that you are pregnant. However, if you have not taken Diane Diario as instructed before the first missed menstruation, or if two menstruations are missed, you should rule out pregnancy before continuing treatment with Diane Diario.

Laboratory tests

The use of preparations like Diane Diario may affect the results of certain laboratory tests. If you are instructed to undergo any laboratory test, inform your doctor that you are taking combined oral contraceptives.

Taking Diane Diario with other medications

Inform your doctor or pharmacist if you are using or have used other medications, including those purchased without a prescription or herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking Diane Diario. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or modify the use of another medication you need.

Certain medications may interact with each other, in which case it may be necessary to change the dose or interrupt treatment with one of the medications.

It is especially important to inform your doctor if you are using any of the medications listed below, as it may prevent combined oral contraceptives from working properly, may increase the incidence of intermenstrual bleeding and irregular menstrual bleeding, and reduce the efficacy of Diane Diario, as it may affect Diane Diario blood levels and, if this occurs, you may become pregnant.These medications are for the treatment of:

• Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, ethosuximide, topiramate, and felbamate).
• Tuberculosis (e.g., rifampicin, rifabutin).
• HIV and hepatitis C infections (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, and efavirenz).
• Fungal infections (e.g., griseofulvin, ketoconazole).
• Arthritis, osteoarthritis (etoricoxib).
• Pulmonary hypertension (bosentan).

- Antacids.

- 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 (used to treat HIV/AIDS).
• Troleandomycin (used to treat bacterial infections).
• Hypericum perforatumor St. John's Wort (herbal preparation for the treatment of depression).

The herbal preparation 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 and St. John's Wort simultaneously. The decrease in contraceptive effect lasts for up to two weeks after stopping St. John's Wort.

During treatment with any of these medications, use a barrier method (condom) temporarily in addition to Diane Diario, or choose another contraceptive method. The barrier method should be used while the concomitant medication is administered, and for 28 days after its suspension. If the period during which the barrier method is used exceeds the end of the hormone-containing pills in the current package of Diane Diario, start the next package directly, discarding the placebo pills in the current package. Consult your doctor if you have any doubts about this.

Diane Diario may modify the effect of other medications:

• Medications containing ciclosporin (a medication that prevents rejection in organ or bone marrow transplants, which may increase the risk of hepatotoxicity).
• Antiepileptic lamotrigine (which may increase the frequency of seizures).
• Theophylline (used to treat respiratory problems).
• Tizanidine (used to treat muscle pain and/or cramps).
• β-blockers (used to treat heart disorders).
• Corticosteroids (prednisolone).
• Flunarizine (which may increase the risk of galactorrhea, milk secretion).
• Analgesics (paracetamol and salicylates).
• Clofibrate (which reduces triglyceride and cholesterol levels).

- Oral anticoagulants.

- Oral antidiabetic medications and insulin.

Do not take Diane Diario if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated ALT levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Diane Diario can be restarted approximately 2 weeks after the end of this treatment. See the section “Do not use Diane Diario.”

You should consult the prescribing information for the medications you are taking concurrently to identify possible interactions.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or suspect that you may be pregnant, consult your doctor or pharmacist before using this medication.

Diane Diario is contraindicated during pregnancy. If this occurs, stop treatment immediately and consult your doctor.

Diane Diario is also contraindicated during breastfeeding. Small amounts of the contraceptive may be eliminated through breast milk. Therefore, it is not recommended to use combined oral contraceptives until the end of the breastfeeding period.

Driving and operating machinery

The influence of Diane Diario on your ability to drive and operate machinery is negligible or insignificant.

Diane Diario contains lactose and sucrose

If your doctor has told you that you have a intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor again.

Diane Diario inhibits ovulation and, therefore, acts as a hormonal contraceptive. Consequently, if you are taking Diane Diario, you should not use an additional hormonal contraceptive, as you would be exposed to an excessive dose of hormones.You must interrupt the use of previously used hormonal contraceptives (see section “What you need to know beforestarting totake Diane Diario”).

You must take Diane Diario regularly to achieve therapeutic efficacy and, in addition, the required contraceptive protection. The administration schedule of Diane Diario is similar to the usual schedule of most combined oral contraceptives. Therefore, you should follow the same administration rules. Irregular taking of Diane Diario may cause intermenstrual bleeding and could impair its therapeutic and contraceptive efficacy.

In the package, along with the blister reminder (which contains the tablets), there is a carton with 7 adhesive strips (see fig. 1). These strips show the days of the week. Each strip starts with a different day of the week. You must remove the strip that starts with the day of the week on which you will take the first Diane Diario tablet (for example, if you will start taking the tablets on a Thursday, you must remove the strip that starts with “THU”). You must stick the strip in the rectangle located at the top of the blister that contains the tablets. In this way, the first day is located over the beige tablet to which the arrow marked with the number “1” points (see fig. 2).

STARTRemove the strip that starts with the day of the week

on which you will take the first tablet (for example, if you start on a Thursday, remove the strip that starts with THU).

Figure 1

Figure 2

You must take the tablets in the order indicated in the package, each day, approximately at the same time, with something to drink if necessary, until you finish the 28 tablets in the blister. In this way, you will take a beige tablet (active) daily for the first 21 days and, subsequently, a white tablet (placebo) daily for the next 7 days.

The treatment is continuous. This means that when you have finished the blister, you must start a new one the next day.

During the week of taking placebo tablets, bleeding similar to menstrual bleeding will occur, normally starting 2-3 days after starting to take the placebo tablets, and may not have ended before starting the next package.

How to start taking Diane Diario

• Without previous use of hormonal contraceptives (in the past month)

The taking of tablets must start on day 1 of the woman's natural cycle (i.e., the first day of her menstrual bleeding). It can also start on days 2 to 5 of the cycle, but in that case, it is recommended to use an additional barrier method (condom) during the first 7 days of taking tablets.

• Switching from another combined oral contraceptive (COC), vaginal ring, or transdermal patch

You must start taking Diane Diario preferably the day after taking the last hormone-containing tablet of the COC you were previously taking, but no later than the day after the usual interval of no tablet-taking or no hormone-free tablet-taking of your previous COC. This means that, no later than, you must start treatment with Diane Diario on the same day that you should start a new package (blister) of your previous COC. In the case of use of a vaginal ring or transdermal patch, you must start taking Diane Diario preferably the day of the ring or patch removalfrom a package for a cycle, or no later than when the next application should have been made.

• Switching from a progestin-only method (progestin-only pill, injection, implant), or from a progestin-releasing intrauterine system (IUS)

You can switch any day of taking the progestin-only pill (if it is an implant or IUS, the same day of its removal; if it is an injectable, when the next injection is due), but in all cases, it is recommended to use an additional barrier method during the first 7 days of taking tablets.

• After a first-trimester abortion

You can start immediately. When you do, you do not need to take additional contraceptive measures.

• After a second-trimester abortion or delivery

It is recommended that you start on day 21 to 28 after the delivery or second-trimester abortion. If you do so later, it is recommended that you use an additional barrier method during the first 7 days of taking tablets. However, if you have already had sexual intercourse, you must rule out the possibility of pregnancy before starting treatment with Diane Diario, or wait until your first menstrual period.

What to do if you forget to take a tablet

The white tablets are placebo tablets and, therefore, forgetting to take them has no consequences, as long as between the last active tablet and the first active tablet of the next package, no more than 7 days have passed. To avoid altering the taking schedule, if you forget to take a white tablet, discard it. The following advice refers only to forgetting active tablets (beige tablets).

If you are lateless than 12 hoursin taking a tablet, the contraceptive protection will not be reduced. You must take the tablet as soon as you remember and continue taking the subsequent tablets at the usual time.

If you are latemore than 12 hoursin taking a tablet, the contraceptive protection may be reduced. The taking schedule to follow in case of forgetting tablets is governed by these two basic rules:

1. Never suspend taking tablets for more than 7 days.

1. It is necessary to take tablets uninterruptedly for 7 days to achieve adequate suppression of the hypothalamic-pituitary-ovarian axis.

Therefore, in daily practice, the following can be advised:

• Week 1

You must take the last forgotten tablet as soon as you remember, even if this means taking two tablets at once. Then, continue taking the tablets at your usual time. In addition, during the next 7 days, you must use a barrier method, such as a condom. If you have had sexual intercourse in the 7 days prior, you must consider the possibility of pregnancy. The more tablets you have forgotten and the closer you are to the placebo tablet-taking phase, the greater the risk of pregnancy.

• Week 2

You must take the last forgotten tablet as soon as you remember, even if this means taking two tablets at once. Then, continue taking the tablets at your usual time. As long as in the 7 days prior to the first forgotten tablet you have taken the tablets correctly, you do not need to take additional contraceptive measures. However, if this is not the case, or if you have forgotten more than one tablet, it is recommended that you take additional precautions for 7 days.

• Week 3

The risk of reduced efficacy is imminent due to the proximity of the placebo tablet-taking phase. However, by adjusting the taking schedule, it is still possible to prevent reduced contraceptive protection. Therefore, if you follow one of the two options below, you will not need to take additional contraceptive measures, as long as in the 7 days prior to the first forgotten tablet you have taken all the tablets correctly. If this is not the case, it is recommended that you follow the first of these two options, and also take additional contraceptive measures for the next 7 days.

1. You must take the last forgotten tablet as soon as you remember, even if this means taking two tablets at once. Then, continue taking the tablets at your usual time, until you finish the hormone-containing tablets. The 7 placebo tablets must be discarded. The next package must be started immediately. It is unlikely that you will experience withdrawal bleeding (period or menstruation) until you finish the hormone-containing tablets of the second package, but you may experience spotting or intermenstrual bleeding on tablet-taking days.

2. You can also stop taking the tablets in the current package. Then, you must complete a tablet-free interval of up to 7 days, including the days you forgot tablets, and then continue with the next package.

If you forget to take tablets and, subsequently, do not experience withdrawal bleeding (period or menstruation) during the placebo tablet-taking phase, you must consider the possibility of pregnancy.

However, in case of doubt, consult your doctor.

Recommendations in case of gastrointestinal disorders

In case of severe gastrointestinal disorders, absorption may not be complete, and you must take additional contraceptive measures.

If you experience vomiting in the 3-4 hours following tablet-taking, you must follow the recommendations for managing forgotten tablets, as described in the section “What to do if you forget to take a tablet”. If you do not want to change your usual tablet-taking schedule, take the additional tablets needed from another reserve blister package.

Duration of use

Your doctor will tell you for how long you must take Diane Diario.

Your doctor must periodically assess the need to continue treatment. If a recurrence occurs, weeks or months after stopping tablet-taking, treatment with Diane Diario can be resumed. In case of restarting treatment with Diane Diario (after an interval of at least one month without tablet-taking), you must consider the increased risk of venous thromboembolism (VTE) (see “What you need to know beforestarting totake Diane Diario”).

Special populations

Patients with liver dysfunction

Diane Diario is contraindicated in women with severe liver dysfunction, as long as liver function values have not returned to normal.

Patients with renal dysfunction

Diane Diario has not been specifically studied in patients with renal dysfunction. There are no available data to suggest a change in treatment in this population of patients.

If you take more Diane Diario than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or the Toxicology Information Service, telephone: 91 562 04 20, indicating the medication and the amount ingested.

No serious adverse reactions have been reported due to overdose. The symptoms that may appear in case of a hormone-containing tablet overdose are: nausea, vomiting, or vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.There are no antidotes, and treatment must be symptomatic.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be related to Diane Diario, consult your doctor.

All women taking combined hormonal contraceptives are at a higher 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 of taking combined hormonal contraceptives, see section2 “What you need to know before starting to take Diane Diario”.

Severe side effects

Contact your doctor immediately if you experience any of the following angioedema symptoms: facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing (also see section “Warnings and precautions”).

On the other hand, the use of oral contraceptives has been associated with:

• Increased risk of cervical intraepithelial neoplasia and cervical cancer.
• Increased risk of breast cancer diagnosis (see “What you need to know before starting to take Diane Diario”).

The following list of side effects has been related to the use of Diane Diario. They are classified according to their frequency in patients treated, according to the following criterion:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 peopleUncommon: 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 unknown: cannot be estimated from available data

Infections and infestations

Common: vaginitis (vaginal inflammation), including candidiasis (vaginal fungal infection).

Immune system disorders

Rare: allergic 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: intolerance to glucose.

Very rare: worsening of porphyria(a metabolic disorder of hemoglobin).

Mental disorders

Common: mood changes, including depression; changes in libido (sex drive).

Nervous system disorders

Very common: headaches, including migraines (headaches).

Common: nervousness, dizziness.

Very rare: worsening of chorea(a disorder that causes movement disorder).

Eye disorders

Rare: intolerance to contact lenses.

Very rare: eye abnormalities and visual disorders (optic neuritis, retinal vascular thrombosis).

Vascular disorders

Rare: venous thrombosis.

Very rare: worsening of varicose veins.

Frequency unknown: increased blood pressure.

Gastrointestinal disorders

Common: nausea, vomiting, abdominal pain.

Uncommon: cramps, bloating.

Very rare: pancreatitis (inflammation of the pancreas), hepatic adenomas, hepatocellular carcinoma.

Hepatobiliary disorders

Rare: cholestatic jaundice.

Very rare: cholecystopathy (bile duct disorders) including gallstones.

Skin and subcutaneous tissue disorders

Uncommon: rash (urticaria), melasma that may persist.

Rare: erythema nodosum (a type of skin inflammation with the appearance of nodules on the legs).

Very rare: erythema multiforme (a type of skin inflammation).

Renal and urinary disorders

Very rare: hemolytic-uremic syndrome.

Reproductive and mammary system disorders

Very common: bleeding, spotting.

Common: breast pain, breast tenderness, breast enlargement, nipple discharge, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal discharge, and cervical ectropion (alteration of the mucosa of the cervix), amenorrhea (absence of menstruation).

General disorders and administration site conditions

Common: fluid retention, edema (swelling), weight changes (gain or loss).

Investigations

Uncommon: changes in serum lipid levels, including hypertriglyceridemia.

Rare: decreased serum folate levels.

If any of these side effects occur, inform your doctor, who will instruct you to discontinue treatment if they consider it may affect your well-being.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Diane Diario

• Tablets with hormones (beige-colored tablets): The active principles are ciproterone acetate and ethinylestradiol. Each tablet contains 2 mg of ciproterone acetate and 0.035 mg of ethinylestradiol. The other components are: lactose monohydrate, cornstarch, povidone 25, magnesium stearate, talc, sucrose, povidone 700 000, macrogol 6000, calcium carbonate, 85% glycerol (E422), titanium dioxide (E171), yellow iron oxide (E172), and glycolated montan wax.

• Placebo tablets (white tablets): The tablet does not contain active principles. The other components are: lactose monohydrate, cornstarch, povidone 25, magnesium stearate, talc, sucrose, povidone 700 000, macrogol 6000, calcium carbonate, and glycolated montan wax.

Appearance of the product and content of the packaging

Packaging containing a PVC/aluminum blister with 21 tablets with hormones and 7 placebo tablets.

The tablet with hormones is beige-colored and round.

The placebo tablet is white and round.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bayer Hispania, S.L.

Av. Baix Llobregat, 3 - 5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Bayer AG

Müllerstrasse 178

13353 Berlin - Germany

or

Bayer Weimar GmbH und Co. KG,

Döbereiner Str. 20,

99427 Weimar - Germany

Last review date of this leaflet: 10/2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .