DIANE DAILY 2 mg/0.035 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Diane Diario 2 mg / 0.035 mg Film-Coated Tablets

cyproterone acetate/ethinylestradiol

Contents of the Package Leaflet

1. What is Diane Diario and what is it used for
2. What you need to know before you start taking Diane Diario
3. How to take Diane Diario
4. Possible side effects
5. Storing Diane Diario
6. Package Contents and Additional Information

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

Diane Diario is used to treat skin conditions such as acne, seborrhoeic skin, and excessive hair growth in women of childbearing age. Due to its contraceptive properties, your doctor should only prescribe this treatment if he/she considers that treatment with hormonal contraceptives is appropriate.

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

2. What you need to know before starting to take Diane Diario

DonotuseDiane Diario

Tell 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 contraceptivetreatment.

??If you have (or have ever had) a blood clotin your leg (thrombosis), lung (pulmonary embolism), or elsewhere in your body.

??If you have (or have ever had) a disease that may be indicative of a future heart attack (e.g., chest angina that causes severe chest pain) or a mild stroke(transient cerebral ischemia).

??If you have (or have ever had) a heart attack or stroke.

??If you have any condition that may increase the risk of blood clotsin your arteries.

These conditions may include:

o Diabetes that affects your blood vessels

o High blood pressure

o Very high levels of lipids in the blood(cholesterol or triglycerides).

??If you have blood coagulation problems(e.g., protein C deficiency).

??If you or a close relative (parents and siblings) have or have had processes related to blood clots in the veins of the lower limbs that have broken off and affected other areas of the body, even if it happened a long time ago. The broken-off clot can affect the lungs (pulmonary embolism).

??If you have (or have ever had) migraines with visual disturbances

??If you have thrombogenic valvulopathies (heart valve diseases that can cause blood clots).

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

??If you have or suspect the existence of malignant conditions of the genital organs or breast.

??If you have a meningioma or have been diagnosed with a 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 may be pregnant.

??If you are breastfeeding.

??If you are allergic to the active ingredients or any of the other components of this medication (included 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 action as an oral contraceptive. You and your doctor should consider all aspects that normally affect the safe use of hormonal oral contraceptives.

A increased risk of a benign brain tumor (meningioma) has been reported with high doses (25 mg and higher) of cyproterone acetate. If you are diagnosed with a meningioma, your doctor will interrupt treatment with all medications that contain 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 need to take Diane Diario.

The doctor must periodically assess the need to maintain treatment (see below "How to take Diane Diario").

If some of the processes/risk factors mentioned below are present, your doctor must 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

In case any of these situations appear for the first time, worsen, or become more severe, you should contact your doctor as soon as possible, as the use of Diane Diario should be interrupted.

• First episode, or worsening, of migraines, 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 of the leg, pain when breathing, or coughing without apparent reason). Feeling of pain or tension in the chest.
• 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 (Thrombosis)".
• Six weeks before any scheduled major surgery (abdominal, orthopedic), any leg surgery, medical treatment of varicose veins, or prolonged periods of immobilization, such as after accidents or surgery. Treatment should not be resumed until two weeks after complete mobility is recovered. In case of emergency surgery, thrombotic prophylaxis is usually indicated, for example, with subcutaneous heparin.
• Appearance of jaundice (yellowish color of the whites of the eyes and skin) or liver disorders or generalized itching.
• Epilepsy.
• Significant increase in blood pressure.
• Appearance of severe depression.
• Severe 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 swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria, along with difficulty breathing. Medications that contain estrogens can induce or worsen symptoms of hereditary and acquired angioedema.

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

??Blood clots

Taking Diane Diario may slightly increase the risk of having a blood clot (also called thrombosis). Your chances of having a clot are only slightly higher after taking Diane Diario compared to women who do not take Diane Diario or who take another contraceptive. Complete recovery does not occur 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 having a blood clot caused by a combination of risk factors or by a single risk factor of greater severity. 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 (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 happen in veins of the leg, lung (pulmonary embolism), or in any other organ.

The use of combined contraceptives increases the risk of women developing these clots compared to those who do not use combined contraceptives. The risk of developing a clot in a vein is higher during the first year that a woman takes the contraceptive. The risk is not as high as that 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 like Diane Diario, it is strongly recommended to

quit smoking, especially if you are over 35 years old.

??if any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age

??if you are overweight

??if you are going to have 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 happens, it is essential that you 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 indicate when you can take Diane Diario again after recovering mobility.

Blood clots in an artery

A blood clot in an artery can cause serious problems. For example, a clot in a coronary artery can cause a heart attack, or in the brain, it can cause a stroke.

The use of combined contraceptives has been linked to an increased risk of clotting in the 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 any of your close relatives have had a heart attack at a young age

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

??if you have migraines

??if you have heart problems (valve disorders or cardiac rhythm disturbances)

Symptoms of blood clots

??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, you should have your blood pressure monitored, 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 smears and sexual behavior, including the use of barrier contraceptives.

Various studies have reported that women taking combined oral contraceptives have a slightly increased risk of being diagnosed with breast cancer compared to those who have never taken them. This increased risk may be due to earlier diagnosis of breast cancer in users of combined oral contraceptives, as they are under more regular medical supervision, to the biological effects of combined oral contraceptives, or to a combination of both. This increased frequency decreases gradually after treatment is interrupted. After ten years, the chances of having breast tumors will be the same as for women who have never used oral contraceptives.

Rarely, benign and, even more rarely, malignant liver tumors have been reported in users of combined oral contraceptives. In isolated cases, these tumors have caused intra-abdominal bleeding, which poses a threat to life. This can cause internal bleeding that leads to 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.

• Psychiatric disorders

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

If a severe depression occurs, treatment should be interrupted. Women with a history of depression should be monitored.

??Other conditions

In women with hypertriglyceridemia (increased triglycerides in the blood) or with a family history of it, 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 been found to have small increases in blood pressure, although cases with clinical relevance are rare. If you develop sustained arterial hypertension during treatment with Diane Diario, you should consult your doctor.

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

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

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

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

Occasionally, chloasma (brown spots on the skin) may occur, especially in women with a history of chloasma during pregnancy. If you tend to have chloasma, you should avoid sun exposure or ultraviolet rays while taking Diane Diario.

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

Medical examination and consultation

Before starting or resuming treatment with Diane Diario, it is necessary for your doctor to perform a complete medical history and physical examination, aimed at ruling out contraindications and observing precautions. These should be repeated periodically throughout treatment.

Women should be warned 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 hormonal pill (see "What to do if you forget to take a pill"), have gastrointestinal disorders during the intake of hormonal pills (see "Recommendations in case of gastrointestinal disorders"), or use another medication simultaneously (see "Taking Diane Diario with other medications").

You should not take herbal preparations containing St. John's Wort (Hypericum perforatum) simultaneously with Diane Diario, as it may decrease the therapeutic effect of Diane Diario and increase the risk of pregnancy and intermenstrual bleeding (see "Taking Diane Diario with other medications").

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 to take appropriate diagnostic measures to rule out possible non-hormonal causes (malignant processes, infections, or pregnancy).

In some women, menstrual bleeding (menstruation) may not occur during the placebo pill interval. If you have taken Diane Diario following 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 menstrual bleeding, or if you miss two menstrual bleedings, you should rule out pregnancy before continuing treatment with Diane Diario.

Laboratory tests

The use of preparations like Diane Diario can affect the results of certain laboratory tests. If you are prescribed any laboratory test, inform your doctor that you are taking a combined oral contraceptive.

Taking Diane Diario with other medications

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

Certain medications may interact with Diane Diario, such as:

3. How to take Diane Diario

Follow the administration instructions of the medication contained in this prospectus or as 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 should stop taking previously used hormonal contraceptives (see section “What you need to know before starting to take Diane Diario”).

You should take Diane Diario regularly to achieve therapeutic efficacy and, additionally, the required contraceptive protection. The administration schedule of Diane Diario is similar to the usual schedule of most combined oral contraceptives. Therefore, you should take into account the same administration rules. Irregular intake of Diane Diario may cause intermenstrual bleeding and could deteriorate its therapeutic and contraceptive efficacy.

In the package, along with the reminder blister (which contains the tablets), there is a cardboard 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 should peel off the strip that starts with the day of the week on which you will take the first tablet of Diane Diario (for example, if you are going to start taking the tablets on a Thursday, you should peel off the strip that starts with “THU”). You should stick the strip on the rectangle located at the top of the blister that contains the tablets. In this way, the first day is found over the beige tablet to which the arrow marked with the number “1” points (see fig. 2).

STARTPeel off the strip that starts 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 that starts

with THU).

Figure 1

Figure 2

You should take the tablets in the order indicated in the package, every day, approximately at the same time, with some liquid if necessary, until you finish the 28 tablets of 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 should start a new one the next day.

During the week of taking the placebo tablets, you will normally experience a menstrual-like bleeding. This usually starts 2-3 days after starting 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 previous month)

Tablet intake must start on the first day of the woman's natural cycle (i.e., the first day of her menstrual bleeding). It can also be started on days 2 to 5 of the cycle, but in this case, it is recommended to use an additional barrier method (condom) during the first 7 days of tablet intake.

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

You should start taking Diane Diario preferably the day after taking the last hormone-containing tablet of the COC you were taking previously, but no later than the day after finishing the usual tablet-free interval or hormone-free tablet intake of your previous COC. This means that, at the latest, you should start treatment with Diane Diario on the same day you would start a new package (blister) of your previous COC. In the case of using a vaginal ring or transdermal patch, you should start taking Diane Diario preferably on the day of removal of the last ring or patch of a package for a cycle, or at the latest when the next application would be due.

• Change from a progestogen-only method (progestogen-only pill, injection, implant), or a progestogen intrauterine delivery system (IUS)

You can change any day of progestogen-only pill intake (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 tablet intake.

• After an abortion in the first trimester

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

• After childbirth or abortion in the second trimester

It is advisable to start on day 21 to 28 after childbirth or abortion in the second trimester. If you do so later, it is advisable to use an additional barrier method during the first 7 days of tablet intake. However, if you have already had sexual intercourse, you should rule out the possibility of pregnancy before starting the use of Diane Diario, or wait to start treatment until your first menstrual period.

Conduct to follow if you forget to take a tablet

The white tablets are placebo tablets, and therefore, forgetting them has no consequences, as long as between the intake of the last beige tablet and the intake of the first beige tablet of the next package, no more than 7 days have passed. To not alter the intake schedule, if you forget to take a white tablet, discard it. The following advice refers only to the forgetfulness of hormone-containing tablets (beige tablets).

If you delay less than 12 hoursin taking a beige tablet, contraceptive protection will not be reduced. You should take the tablet as soon as you remember and continue taking the following tablets at the usual time.

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

1. You should never stop taking tablets for more than 7 days.

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

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

• Week 1

You should take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Subsequently, you will continue taking the tablets at the usual time. Additionally, during the following 7 days, you should use a barrier method, such as a condom. If you have had sexual intercourse in the 7 days prior to the forgotten tablet, you should consider the possibility of pregnancy. The more tablets you have forgotten and the closer you are to the placebo tablet phase, the higher the risk of pregnancy.

• Week 2

You should take the last forgotten tablet as soon as you remember, even if this means taking two tablets at the same time. Subsequently, you will continue taking the tablets at the 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 use additional contraceptive measures. However, if this is not the case, or if you have forgotten more than one tablet, it is advisable to take additional precautions for 7 days.

• Week 3

The risk of reduced reliability is imminent due to the proximity of the placebo tablet phase. Nevertheless, by adjusting the tablet intake schedule, the reduction in contraceptive protection can still be prevented. Consequently, if you follow one of the two options below, you will not need to take additional contraceptive precautions, 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 advisable to follow the first of these two options and also take additional contraceptive precautions during the following 7 days.

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

1. You can also stop taking the tablets of the current package. Then you should complete a tablet-free interval of up to 7 days, including the days on which you forgot tablets, and subsequently continue with the next package.

If you forget to take tablets and subsequently do not experience withdrawal bleeding (menstruation) during the placebo tablet phase, you should 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 should take additional contraceptive measures.

If you experience vomiting within 3-4 hours after taking the tablet, you should follow the recommendations for managing forgotten tablets, as outlined in the section “Conduct to follow if you forget to take a tablet”. If you do not want to change your normal tablet intake schedule, take the necessary additional tablet(s) from another reserve blister package.

Duration of use

Your doctor will indicate how long you should take Diane Diario.

The doctor should periodically assess the need to maintain treatment. If a recurrence occurs, weeks or months after stopping tablet intake, treatment with Diane Diario can be resumed. 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 to take Diane Diario”).

Special populations

Patients with hepatic impairment

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

Patients with renal impairment

Diane Diario has not been specifically studied in patients with renal impairment. There are no available data suggesting a change in treatment for this patient population.

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, phone: 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 an overdose of hormone-containing tablets are: 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 can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or have any change in health that you think may be due to Diane Diario, consult your doctor.

All women who take 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 section 2 "What you need to know before taking Diane Diario".

Severe 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 urticaria with possible difficulty breathing (see also 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 taking Diane Diario").

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

Infections and Infestations

Common: vaginitis (inflammation of the vagina), including candidiasis (fungal infection in the vagina).

Disorders of the Immune System

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.

Metabolic and Nutrition Disorders

Uncommon: changes in appetite (increase or decrease).

Rare: glucose intolerance.

Very rare: worsening of porphyria (hemoglobin metabolism disorder).

Psychiatric Disorders

Common: mood changes, including depression; changes in libido (sexual desire).

Nervous System Disorders

Very common: headaches, including migraines.

Common: nervousness, vertigo.

Very rare: worsening of chorea (movement disorder).

Eye Disorders

Rare: intolerance to contact lenses.

Very rare: eye anomalies and visual disturbances (optic neuritis, vascular thrombosis in the retina).

Vascular Disorders

Rare: venous thrombosis.

Very rare: worsening of varices.

Frequency not known: increased blood pressure.

Gastrointestinal Disorders

Common: nausea, vomiting, abdominal pain.

Uncommon: colic, 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), chloasma 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 System and Breast Disorders

Very common: bleeding, spotting.

Common: breast pain, breast tension, breast enlargement, breast secretion, dysmenorrhea (painful menstruation), changes in menstrual flow, changes in vaginal secretion, and cervical ectropion (alteration of the cervical mucosa), 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: decrease in serum folate levels.

If any of these adverse effects occur, inform your doctor, who will indicate that you interrupt treatment if he considers that it may affect your well-being.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Adverse Effect Reporting

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

5. Conservation of Diane Diario

Keep this medicine out of sight and reach of children.

It does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Diane Diario

• Tablets with hormones (beige-colored tablets):The active ingredients are cyproterone acetate and ethinylestradiol. Each tablet contains 2 mg of cyproterone acetate and 0.035 mg of ethinylestradiol. The other components are: lactose monohydrate, cornstarch, povidone 25, magnesium stearate, talc, sucrose, povidone 700,000, macrogol 6,000, calcium carbonate, glycerol 85% (E422), titanium dioxide (E171), yellow iron oxide (E172), and montan wax glycolate.

• Placebo tablets (white tablets):The tablet does not contain active ingredients. The other components are: lactose monohydrate, cornstarch, povidone 25, magnesium stearate, talc, sucrose, povidone 700,000, macrogol 6,000, calcium carbonate, and montan wax glycolate.

Appearance of the Product and Packaging Contents

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

The tablet with hormones is beige 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 Last Revision of this Prospectus:10/2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.