DIANE 2 mg /0,035 Mg Tabletka Powlekana

Treść ulotki

1. Diane 2 mg + 0.035 mg coated tablets
   1. What Diane is and what it is used for
   2. Cosa deve sapere prima di usare Diane
   3. How to use Diane
   4. Possible side effects
   5. How to store Diane
   6. Contents of the pack and other information

Diane 2 mg + 0.035 mg coated tablets

cyproterone acetate + ethinylestradiol

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful. If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

The use of Diane is reserved for cases where treatment of androgen-dependent
conditions described in the indications is necessary. Although due to its composition Diane
also has a contraceptive effect, it should not be used for this purpose.
Therefore, after complete resolution of the conditions for which the medicine has been
prescribed, it is recommended not to use Diane further for contraceptive purposes alone.
combined oral contraceptives.
Patients undergoing treatment with Diane should not use other hormonal contraceptives as
this would expose the patient to excessive doses of hormones without any need for
effective contraceptive treatment.
Contents of this leaflet

• 1. What Diane is and what it is used for
• 2. What you need to know before you use Diane
• 3. How to use Diane
• 4. Possible side effects
• 5. How to store Diane
• 6. Contents of the pack and other information

1. What Diane is and what it is used for

Diane is used for the treatment of skin conditions such as acne, very oily skin and excessive hair growth in women of childbearing potential. Due to its contraceptive properties, the medicine must only be prescribed if the doctor considers hormonal contraceptive (birth control pill) treatment to be appropriate.
You should only take Diane if the skin condition you suffer from has not improved with other acne treatments, including topical therapies and antibiotics.

Although Diane also has a contraceptive effect, it cannot be prescribed for this purpose; use should instead be reserved for cases where treatment of the androgen-dependent conditions described above is necessary.
It is recommended to discontinue treatment three to four cycles after complete resolution of the conditions for which the medicine was prescribed and that Diane is not further used solely for contraceptive purposes.
Further treatment cycles with Diane may be administered if the androgen-dependent pathological conditions should recur.

2. Cosa deve sapere prima di usare Diane

Note generali
Diane contains the progestin cyproterone acetate and the estrogen ethinylestradiol, and is
administered for twenty-one days in monthly cycles. Therefore, it is essentially analogous to a
combined oral contraceptive.
the intake of the medicine or in which a reduction in the effectiveness of the
medicine itself may occur. In such situations, the contraceptive action is also lacking; consequently, if you wish to avoid pregnancy, you must not have sexual intercourse or must adopt
additional non-hormonal contraceptive precautions such as the use of a condom or another barrier
method.
Do not use the rhythm and basal temperature methods, which may prove unreliable, as
estro-progestinic associations like Diane alter the normal variations in temperature
and cervical mucus that occur during the menstrual cycle.
Before starting or restarting Diane, it is recommended to undergo a thorough medical
examination. It is also advisable to undergo periodic check-up visits during the use of the
medicine. The frequency and type of visit will be established by the doctor and will be directed in particular
to the control of blood pressure, a breast examination, abdominal and gynecological
examination in general, including a Pap test and related blood tests.

As with all contraceptive pills, Diane does not protect against infection
from HIV (AIDS) or any other sexually transmitted disease.
Diane is prescribed for personal use and should not be available to multiple people
simultaneously.

Do not use Diane
Tell your doctor before starting to use Diane if any of the following conditions apply to
you. In such cases, your doctor may prescribe a different treatment:

• if you are using another hormonal contraceptive;
• if you have (or have had in the past) a blood clotin a leg (thrombosis), in the lungs (pulmonary embolism) or in another part of the body;
• if you have (or have had in the past) a disease that may suggest a future heart attack (e.g. angina pectoris, which causes severe chest pain) or a “mini-stroke” (transient ischemic attack);
• if you have (or have had in the past) a heart attack or stroke;
• if you have a disease that may increase the risk of a blood clotforming in the arteries. This happens in the following diseases: o diabetes with involvement of the blood vessels, o high blood pressure, o very high levels of fats (lipids) in the blood (cholesterol or triglycerides);
• if you have problems with blood coagulation(e.g. Protein C deficiency);
• if you have (or have had in the past) migraine with visual disturbances;
• if you are allergic to cyproterone acetate, ethinylestradiol or any of the other components of this medicine (listed in section 6);
• if you suffer from cardiovascular disorders: coronary heart disease, valvular heart disease, heart rhythm disorders that may originate thrombi;
• if you suffer from sickle cell anemia (an inherited red blood cell disease);
• if you have or have had jaundice (yellowing of the skin) or severe liver disease;
• if you have or have had cancer of the breast or genital organs;
• if you have or have had benign or malignant liver tumors;
• if you have vaginal bleeding of unknown origin;

• if you are or suspect you are pregnant;
• if you are breastfeeding (see “Pregnancy and breastfeeding”);
• if you have suffered from Herpes gestationis(an autoimmune skin disease that affects women during pregnancy or in the immediate postpartum period);
• if you have had hearing loss from otosclerosis during a pregnancy;
• if you are a young woman and have not yet stabilized your menstrual cycle;
• if you have eye problems of vascular origin;
• if you have or have had a meningioma (a generally benign tumor of the tissue layer located between the brain and the skull). If any of these conditions appear for the first time during the use of the medicine, stop taking it immediately and consult your doctor.

Diane must not be used in men.
Do not use Diane if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir (see also section “Other medicines and Diane”).

Warnings and precautions
Talk to your doctor or pharmacist before using Diane.
The effectiveness of Diane may be compromised if you forget to take tablets
or in case of vomiting and/or diarrhea (see “How to use Diane”), or in case of concomitant use of other medicines (see “Other medicines and Diane”).

When to contact your doctor
Stop taking the tablets and contact your doctor immediately if you notice any possible
signs of a blood clot. The symptoms are described in section 2 “Blood clots
(thrombosis)”.
Reasons requiring immediate discontinuation of treatment with Diane:

• 1. onset for the first time, or worsening, of migraines or increased frequency of headaches of unusual intensity;
• 2. sudden disturbances of vision or hearing or other disturbances of perception;
• 3. first symptoms of thrombophlebitis or thromboembolic symptoms (formation of blood clots in blood vessels) (e.g. unusual pain or swelling in the lower limbs, stabbing pain during breathing or unexplained cough). Feeling of pain and tightness in the chest;
• 4. six weeks before a major surgery (e.g. abdominal, orthopedic) including surgery on the lower limbs and sclerotherapy of varicose veins, and for the entire duration of a state of immobilization, such as in case of accidents or surgery. Treatment with Diane can be resumed two weeks after full recovery of mobility. In case of emergency surgery, prophylactic antithrombotic treatment will be indicated, such as subcutaneous administration of heparin;
• 5. onset of jaundice (yellowing of the skin, mucous membranes and whites of the eyes), hepatitis, generalized itching;
• 6. increased seizures;
• 7. significant increase in blood pressure;
• 8. onset of severe depression;
• 9. severe pain in the upper abdomen or enlargement of the liver;

• 10. worsening of conditions that are known to worsen during the use of oral contraceptives or during pregnancy;
• 11. pregnancy is a reason for immediate discontinuation of treatment, as a slight increase in the risk of fetal malformations cannot be ruled out.

In the presence of any of the conditions listed below, the use of Diane may require
close monitoring by the doctor. It is therefore necessary to inform the doctor of the possible
presence of any of the following conditions before starting to use Diane:

• smoking;
• diabetes;
• overweight;
• hypertension (high blood pressure);
• heart valve defects or some heart rhythm disorders;
• superficial phlebitis (venous inflammation);
• varicose veins;
• history of thrombosis, heart attack or stroke (also among close relatives);
• migraine (headache on one side only);
• depression;
• epilepsy;
• history of high levels of cholesterol and triglycerides (fats) in the blood (also in close relatives);
• breast nodules;
• family history (also among close relatives) of breast cancer;
• liver or gallbladder diseases;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have Systemic Lupus Erythematosus (SLE, a disease that affects the skin throughout the body);
• if you have Hemolytic Uremic Syndrome (HUS, a blood coagulation disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• porphyria (blood metabolic abnormality);
• if you suffer from or have suffered from chloasma (brownish-yellow pigmented patches on the skin, especially on the face). In this case, avoid prolonged exposure to the sun or ultraviolet rays;
• if you suffer from fluid retention
• if you have a reduction in folate levels
• if you have suffered from Herpes gestationis(an autoimmune skin disease that affects women during pregnancy or in the immediate postpartum period);
• some pathological conditions characterized by Activated Protein C resistance, hyperhomocysteinemia, Antithrombin III deficiency, Protein C deficiency, Protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant), which predispose to the onset of venous or arterial thrombosis;
• Sydenham's chorea (central nervous system disorder);
• hearing loss from otosclerosis;
• If you suffer from hereditary angioedema. Consult your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue or throat, and/or difficulty swallowing, or hives, along with difficulty breathing. Products containing estrogens may induce or worsen the symptoms of angioedema.

If any of the above conditions appear for the first time, recur or worsen
during the use of Diane, consult your doctor.

Do not take preparations based on St. John's wort (Hypericum perforatum) because the effectiveness of medicines
containing oral contraceptives may be decreased (see “Other medicines and Diane”).
The use of Diane may affect the results of some blood tests. Tell the doctor who
requested the tests that you are taking this medicine.

Psychiatric disorders
Some women who use hormonal contraceptives including Diane have reported depression or
depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you
experience changes in mood and depressive symptoms, see your doctor as soon as possible for
further medical advice.
Diane is also an oral contraceptive. Together with the doctor, you will need to consider all
aspects related to the safe use of oral hormonal contraceptives.

Blood clots (thrombosis)
Taking Diane may slightly increase the risk of forming a blood clot.
The probability of forming a blood clot is only slightly increased if you take Diane compared to women who do not take Diane or any other
contraceptive pill. Thrombosis does not always heal and in 1-2% of cases it can be fatal.
Blood clots in a vein
A blood clot in a vein (venous thrombosis) can block the vein. This can happen
in the veins of the legs, lungs (pulmonary embolism) or any other organ.
The use of a combined contraceptive pill increases the risk in women of developing a
clot compared to women who are not taking any combined contraceptive pill. The
risk of developing a blood clot in a vein is highest in the first year of use of the
pill. This risk is lower than the risk of developing a clot during pregnancy.
In users of a combined contraceptive pill, the risk of forming clots in
a vein is further increased:

• with increasing age;
• if you smoke. It is strongly recommended to stop smoking if you use a hormonal contraceptivelike Diane, especially if you are over 35 years old;
• if a family member has had a clot in the legs, lungs or elsewhere at a young age;
• if you are overweight;
• if you have to undergo surgery, if you have to stay in bed for a long time due to an accident or illness, or if you have a leg in a cast.

In these cases, it is important that you tell your doctor that you are using Diane, so that the
treatment can be stopped. Your doctor may tell you to stop using Diane
several weeks before surgery or during the period when you have reduced mobility. Your doctor will
also tell you when you can resume using Diane, once you are back on your feet.
Blood clots in an artery
A clot in an artery can cause serious problems. For example, a clot in an artery in the
heart can cause a heart attack, while in the brain it can cause a stroke.
The use of a combined contraceptive pill has been associated with an increased risk of
clots in the arteries. The risk is further increased:

• with increasing age;

• if you smoke. It is strongly recommended to stop smoking if you use a hormonal contraceptivelike Diane, especially if you are over 35 years old;
• if you are overweight;
• if you have high blood pressure;
• if a family member has had a heart attack or stroke at a young age;
• if you have high levels of fats (lipids) in the blood (cholesterol or triglycerides);
• if you suffer from migraine;
• if you have a heart problem (heart valve disease, heart rhythm disorders).

Arterial thromboembolic events can be life-threatening or fatal.
Symptoms of blood clots

Stop taking the tablets and consult your doctor immediately if you notice any
possible signs of a clot, such as:

• unusual, sudden cough;
• severe chest pain, which may radiate to the left arm;
• shortness of breath;
• any unusual, severe or persistent headache, or worsening of migraine;
• partial or total loss of vision, or double vision;
• difficulty or inability to speak;
• sudden changes in hearing, smell or taste;
• dizziness or fainting;
• weakness or numbness in any part of the body;
• severe abdominal pain;
• severe pain or swelling in a leg.

After a clot has formed, healing is not always complete. Rarely, serious and permanent disabilities may occur and the clot may also cause death.
Immediately after childbirth, the risk of forming clots is increased; therefore, you should ask
your doctor how long you should wait after childbirth before you can start taking Diane.
If you have a combination of risk factors or show a greater severity for a single
risk factor, there may be a greater potential risk of thrombosis than the simple
cumulative risk of the factors.
Diane should not be prescribed if the benefit/risk assessment
is negative (see “Do not use Diane”).

Tumors
Diagnoses of breast cancer are slightly more frequent in women who use
an oral estrogen-progestin combination than in those of the same age who do not use them. The
slight increase in the number of breast cancer diagnoses gradually disappears within ten years of stopping treatment. It is not known whether the difference is due to
the oral estrogen-progestin combination.

This increase may be due to earlier diagnosis, as women are visited
more frequently, to the biological effect of the oral estrogen-progestin combination or to both
factors. Breast cancer diagnosed in women treated with an estrogen-progestin
combination tends to be clinically less advanced than that diagnosed
in women who do not use it.

Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women treated with an estrogen-progestin combination. These tumors
can cause internal bleeding. Consult your doctor immediately if you experience severe abdominal pain. Tumors can be life-threatening or have fatal outcomes.
Cervical cancer has been reported to be more frequent in women treated with an estrogen-progestin combination for a long time. This may not
depend on the estrogen-progestin combination, but on sexual behavior and other
factors implicated in the development of tumors in general.
An increased risk of a benign brain tumor (meningioma) has been reported for high doses (equal to or greater than 25 mg) of cyproterone acetate. If you have been diagnosed with a
meningioma, your doctor will stop administering all medicines containing
cyproterone, including Diane, as a precaution (see section ‘Do not take Diane’).

Periodic checks
During the use of Diane, your doctor will ask you to attend periodic check-up visits.

Consult your doctor as soon as possible:
if you notice any change in your health status, especially regarding what is stated in “Precautions”;
if you feel a lump in your breast;
if you have to use other medicines (see also “Other medicines and Diane”);
if you are immobilized or have to undergo surgery (consult your doctor at least
four weeks before);
if you have heavy and unusual vaginal bleeding;
if you forgot to take the tablets in the first week of use and had
sexual intercourse in the seven days before the forgotten dose;
if you do not have your period for two consecutive cycles or suspect you are pregnant, do not start a
new pack without your doctor's authorization.

Children and adolescents
Diane is indicated only after menarche (the onset of the first menstrual period).

Elderly women
Diane is not indicated after menopause (cessation of menstruation).

Women with impaired liver function
Do not use Diane in case of severe liver disease. See also section “Warnings and
precautions”.

Women with impaired kidney function
Tell your doctor if you have kidney problems.

Other medicines and Diane
Always tell your doctor if you are taking any medicines or herbal products. Tell any
other doctor or dentist who prescribes you another medicine (or the pharmacist) that you are
taking Diane. They may tell you if you need to take additional contraceptive measures (for
example, a condom) and, if so, for how long, or if the use of another medicine
you may need should be modified.

Some medicines

• affect the levels of Diane in the blood and
• may make it less effective in preventing pregnancy, or
• may cause unexpected bleeding. These include:
• medicines for the treatment of: o epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) o tuberculosis (e.g. rifampicin) o HIV and Hepatitis C virus infection (ritonavir, nevirapine, efavirenz known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors) o fungal infections (e.g. griseofulvin, ketoconazole) o arthritis, osteoarthritis (etoricoxib) o high blood pressure in the pulmonary arteries (bosentan)
• St. John's wort, herbal remedy

Diane can affect the effect of other medicines, for example:

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this may lead to an increase in the frequency of seizures)
• Theophylline (used for the treatment of breathing problems)
• Tizanidine (used for the treatment of muscle pain and/or muscle cramps)

Do not use Diane if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function test results (increased liver enzyme ALT). Your doctor
will prescribe you another type of contraceptive before starting treatment with these
medicines. Diane can be resumed about 2 weeks after the end of this
treatment. See section “Do not use Diane”.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use Diane if you are pregnant or suspect you are pregnant.
Diane is not recommended during breastfeeding.

Driving and using machines
No effects on the ability to drive and use machines have been observed.

Diane contains lactose and sucrose
If you have been diagnosed with intolerance to certain sugars, contact your
doctor before taking this medicine.

3. How to use Diane

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
Having a composition similar to that of combined oral contraceptives, Diane inhibits
ovulation and therefore prevents conception. Therefore, you should not use other
hormonal contraceptives as this would expose you to excessive doses of hormones without any
need for effective contraceptive treatment. For the same reason, if you want to become
pregnant, you should not take Diane.
Diane should be taken regularly as irregular intake may result in intermenstrual bleeding and a loss of anticonceptional properties.
The tablets should be taken with some liquid, every day approximately at the
same time, according to the order indicated on the package.

Start of the first pack
Start taking Diane on the first day of your menstrual cycle with the tablet marked
with the corresponding day of the week; for example, a tablet marked Friday
if your period starts on Friday. Then follow the days in order, taking one
tablet without chewing, every day at the same time, preferably in the evening, until
exhaustion. The pack contains twenty-one tablets.

Subsequent treatment cycles
When the twenty-one tablets are finished, stop taking them for seven days during which
your period should begin. Resume treatment on the eighth day, even if
your period continues. This will start the new pack on the same
day of the week as the previous one.

Duration of use
Your doctor will tell you how long you should take Diane.
The duration of treatment depends on the severity of your condition; normally the treatment
should be continued for many months.
If a recurrence occurs after weeks or months from discontinuation, consult your
doctor who will have you resume treatment with Diane. If resuming treatment with
Diane (after an interval of 4 weeks or more without taking the pill), you should consider an increased risk of venous thromboembolism (see also “Warnings
and precautions”).

Particular situations
Switching from an oral contraceptive to Diane
Start taking Diane on the first day of the menstruation that occurs after the last
tablet of the previous oral contraceptive and then follow the above instructions.

Taking Diane after childbirth or after an abortion
Normally, after a childbirth or an abortion, Diane should be prescribed only after the
completion of the first normal menstrual cycle.
If, for medical reasons, immediate and reliable contraceptive effect is required, treatment
with Diane may be started within the twelfth (but not before the seventh) day after
childbirth or no later than the fifth day after abortion.
When oral estro-progestogenic combinations are administered in the period immediately
following a childbirth or abortion, it is necessary to assess the increased risk of thromboembolic disease.
If you are breastfeeding and want to take Diane, talk to your doctor first.

Absence of withdrawal bleeding (menstruation)
If, in exceptional cases, withdrawal bleeding does not occur, before continuing
to take Diane, the possibility of an ongoing pregnancy must be ruled out, which would
necessitate immediate discontinuation of treatment.

Measures in case of irregular bleeding
Sometimes mild bleeding (spotting) or intermenstrual bleeding is observed, particularly
during the first three months of use, which usually stops spontaneously. Continue taking
Diane even in case of irregular bleeding. If the bleeding persists or recurs, medical advice is recommended to exclude organic causes and the possible need for a curettage.
This also applies in the case of mild bleeding that recurs at irregular intervals in several
consecutive cycles or occurs for the first time after prolonged use of Diane.

In case of vomiting or diarrhea
In case of vomiting or diarrhea within 3 or 4 hours after taking the tablet, the active
ingredients may not be absorbed adequately. Continue your usual daily
intake, but adopt supplementary contraceptive measures for the rest of the cycle to avoid
the onset of a pregnancy that would necessitate immediate discontinuation of
treatment.

If you take more Diane than you should
There are no reports of serious adverse effects in case of taking more tablets
at the same time. In such case, nausea, vomiting or vaginal bleeding may occur.
Even girls who have not yet had their period, but who have accidentally taken
this medicine may experience such bleeding.
In case of accidental ingestion/intake of an excessive dose of Diane, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Diane
If you forget to take a Diane tablet at the usual time, you must take it
within the next twelve hours. If more than thirty-six hours have passed since taking the last
tablet, the contraceptive property of Diane is no longer guaranteed. Skip the forgotten
tablet and resume your normal daily intake, but adopt further contraceptive precautions for the rest of the cycle, to avoid
the onset of a pregnancy that would necessitate immediate discontinuation of the treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any side effect, especially if severe and persistent, or if you notice a
change in your health condition that you think may be caused by Diane,
inform your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or
blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who
take combined hormonal contraceptives. For more detailed information on the different risks
associated with taking combined hormonal contraceptives, see section 2 “What you need to
know before using Diane”.
The following is a list of side effects that have been associated with the use of Diane:

Common side effects:may affect up to 1 in 10 people
nausea, abdominal pain,
changes in body weight (weight gain)

headache
mood changes
breast pain

Uncommon side effects:may affect up to 1 in 100 people
vomiting, diarrhea,
fluid retention
breast hypertrophy (breast enlargement that can cause breast tension)
skin reactions, urticaria
migraine (headache on one side only)
decreased libido

Rare side effects:may affect up to 1 in 1000 people
intolerance to contact lenses
hypersensitivity reactions (allergy)
changes in body weight (weight loss)
increased libido
vaginal discharge
breast discharge
erythema nodosum, erythema multiforme or polymorphum
thromboembolism

Frequency not known
increased blood pressure

Serious side effects
The following serious side effects associated with the use of estrogen-progestin combinations, and
their symptoms, are described in the section “Warnings and precautions”: “Blood clots
(Thrombosis )” and “Tumors”:

• hypertension
• hypertriglyceridemia
• diabetes
• liver tumors (benign and malignant)
• liver problems
• chloasma
• angioedema
• jaundice and/or cholestatic pruritus, porphyria, systemic lupus erythematosus, hemolytic- uremic syndrome, Sydenham's chorea, Herpes gestationis, hearing loss from otosclerosis, Crohn's disease, ulcerative colitis, cervical cancer. For more information, read these paragraphs and consult your doctor immediately.

If you suffer from hereditary angioedema, medicines containing certain female sex hormones
(estrogens) may induce or worsen the symptoms of angioedema (see the section
“Warnings and precautions”).

Reporting of side effects

If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Diane

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the package after
“Exp.” The expiry date refers to the last day of that month. The date refers to the
product in intact packaging, correctly stored.
Do not use the medicine if you notice a change in color or crumbling of the tablet, or
in the presence of any other visible sign of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Diane contains

• The active ingredients are: cyproterone acetate and ethinylestradiol. Each coated tablet contains 2.0 mg of cyproterone acetate and 0.035 mg of ethinylestradiol.
• The other ingredients are: lactose, corn starch, povidone 25,000, talc, magnesium stearate, sucrose, povidone 700,000, macrogol 6,000, calcium carbonate, glycerol 85%, ethylene glycol monostearate, titanium dioxide, yellow iron oxide.

Description of the appearance of Diane and contents of the pack
Blisters with 21 coated tablets.

Marketing Authorisation Holder
Bayer S.p.A. - Viale Certosa, 130 - 20156 Milan (MI)

Manufacturer
Bayer AG, Muellerstrasse 170-178, D-13353, Berlin (Germany)
Bayer Weimar GmbH und Co. KG, Weimar Doebereinerstr. 20 99427 Weimar (Germany)