Diane - 35

Leaflet accompanying the packaging: information for the user

Diane-35, 2 mg + 0.035 mg, film-coated tablets

Cyproterone acetate + Ethinylestradiol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist.

Table of contents of the leaflet

• 1. What is Diane-35 and what is it used for
• 2. Important information before using Diane-35
• 3. How to use Diane-35
• 4. Possible side effects
• 5. How to store Diane-35
• 6. Contents of the packaging and other information

1. What is Diane-35 and what is it used for

Diane-35 is used to treat skin conditions such as acne, very oily skin, and excessive hair growth in women of childbearing age. Due to its contraceptive properties, this medicine should only be prescribed to a patient if the doctor considers that treatment with hormonal contraceptives is appropriate.
The patient should use Diane-35 to treat acne only if there has been no improvement in the skin condition after using other anti-acne therapies, including local treatment and antibiotic treatment.

2. Important information before using Diane-35

General notes

Before starting to use Diane-35, the doctor will ask the patient some questions about her health and that of her close relatives. The doctor will also measure the patient's blood pressure and, if necessary, perform other diagnostic tests.
This leaflet describes several situations in which Diane-35 should not be used, or in which the effectiveness of Diane-35 may be reduced. In such situations, sexual intercourse should not be maintained or additional non-hormonal methods of contraception, such as condoms or other mechanical methods, should be used.
You should always inform your doctor about the medications and herbal products you are taking. You should also inform the doctors or dentists who prescribe other medications (or pharmacists) about taking Diane-35. They will advise whether additional contraceptive measures (e.g., condoms) should be used, and if so, for how long, as well as whether the way other medications are used should be changed. You should not use the calendar method or the temperature measurement method. These methods may be unreliable because Diane-35 modifies the monthly changes in body temperature and cervical mucus.

Diane-35 does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

When not to use Diane-35:

You should inform your doctor if any of the following conditions are present before starting to use Diane-35. The doctor may then recommend using a different treatment:

• If the patient is allergicto ethinylestradiol, cyproterone acetate, or any of the other ingredients of this medicine (listed in section 6). May cause: itching, rash, or swelling.
• If the patient is taking another hormonal contraceptive.
• If the patient currently has (or has ever had) a blood clotin the leg (thrombophlebitis), a blood clot in the lungs (pulmonary embolism), or in any other part of the body.
• If the patient currently has (or has ever had) diseases that may indicate a previous heart attack (e.g., angina pectoris, which causes severe chest pain) or a "mini-stroke" (transient ischemic attack).
• If the patient currently has (or has ever had) a heart attack or stroke.
• If the patient has factors that may increase the risk of blood clots. These include:
• diabetes with vascular changes,
• very high blood pressure,
• very high levels of fat in the blood(cholesterol or triglycerides).
• If the patient has a blood clotting problem (e.g., protein C deficiency).
• If the patient currently has (or has ever had) migraine with visual disturbances.
• If the patient has had severe liver disease(which may cause yellowing of the skin or itching all over the body), and liver function is still abnormal.
• If the patient has had or currently has a malignant tumor that may grow under the influence of sex hormones(e.g., breast cancer or genital organ tumors).
• If the patient has had or currently has a benign or malignant liver tumor.
• If the patient has a meningiomaor has been diagnosed with a meningioma (usually a benign tumor of the tissue layer between the brain and the skull).
• If the patient experiences unexplained vaginal bleeding.
• If the patient is pregnant or thinks she may be pregnant.
• If the patient is breastfeeding.

Diane-35 should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Diane-35 and other medicines").
If any of the above symptoms occur for the first time while taking Diane-35, the medicine should be stopped immediately and a doctor consulted. During this time, non-hormonal methods of pregnancy prevention (see section "General notes") should be used.
Diane-35 should not be used in men.

Special patient groups

Children and adolescents
Diane-35 is not indicated for use in patients before the first menstrual period.
Elderly patients
Diane-35 is not intended for use in women after menopause.
Patients with liver function disorders
Diane-35 is contraindicated in women with severe liver function disorders until liver function parameters return to normal. See section "When not to use Diane-35" and "Warnings and precautions".
Patients with kidney function disorders
A doctor should be consulted. Available data do not indicate the need to change the way Diane-35 is used.

Warnings and precautions

When to consult a doctor.
You should stop taking the tablets and contact your doctor immediately if you notice symptoms that may indicate a blood clot, as described in section 2 "Blood clots".
Before starting to use Diane-35, you should discuss this with your doctor.
If you are using Diane-35, in any of the following situations, close medical supervision is necessary. Therefore, before starting to use Diane-35, you should inform your doctor if you:

• smoke (women over 35 years old should quit smoking if they decide to use combined oral contraception),
• have diabetes,
• are obese (body mass index over 30 kg/m²),
• have high blood pressure,
• have heart valve defects or atrial fibrillation,
• have superficial vein inflammation,
• have varicose veins,
• have a history of blood clots, heart attack, or stroke in close relatives,
• have migraines,
• have epilepsy,
• have high levels of cholesterol or triglycerides (fats) in the blood (also in the past or in close relatives),
• have breast cancer in the family,
• have liver or gallbladder disease,
• have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• have polycystic ovary syndrome,
• have systemic lupus erythematosus (SLE),
• have hemolytic-uremic syndrome (a blood clotting disorder that causes kidney failure),
• have sickle cell anemia,
• have diseases that occurred for the first time or worsened during pregnancy or previous use of steroid hormones (e.g., jaundice and/or itching associated with bile stasis, gallstone formation, hearing loss associated with otosclerosis, hemolytic-uremic syndrome, porphyria, herpes gestationis, Sydenham's chorea),
• have skin discoloration (brown-yellow pigment changes, so-called chloasma) currently or in the past; in this case, you should avoid excessive exposure to sunlight or ultraviolet radiation,
• have angioedema. You should contact your doctor if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing. Estrogen-containing medications may cause or worsen the symptoms of this disease,
• if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing, you should contact your doctor immediately. Estrogen-containing medications

may cause or worsen the symptoms of both hereditary and acquired angioedema.
If any of the above symptoms occur for the first time, recur, or worsen while taking Diane-35, you should contact your doctor.
In the case of hirsutism, if the symptoms of the disease have occurred recently or have worsened, you should immediately inform your doctor, who will make a proper diagnosis.
Diane-35 also acts as an oral contraceptive. The patient and doctor should consider all the rules for safe use of oral hormonal contraception.

Diane-35 and blood clots

Blood clots (thrombosis)
Using Diane-35 may slightly increase the risk of blood clots in the patient (so-called thrombosis). The likelihood of blood clots in patients using Diane-35 is only slightly increased compared to women who do not use Diane-35 or any oral contraceptive.
Blood clots in veins
A blood clot in a vein (known as venous thrombosis) can block a vein. This can happen in the veins of the legs, lungs (pulmonary embolism), or any other organ.
Using combined oral contraceptives increases the risk of such blood clots in women compared to women who do not take any combined oral contraceptives. The risk of forming a blood clot in the veins is highest during the first year of using an oral contraceptive by a woman. The risk is not as high as the risk of blood clots during pregnancy.
The risk of blood clots in the veins in patients using combined oral contraceptives is further increased:

• with age;
• if the patient smokes.

During the use of a hormonal contraceptive such as Diane-35, it is strongly recommended to quit smoking, especially if the patient is over 35 years old.

35 years old.

• if one of the patient's close relatives had a blood clot in the leg, lungs, or other organ at a young age;
• if the patient is overweight;
• if the patient needs to undergo surgery, is immobilized for a longer period due to injury or illness, or has a leg in a cast.

If the above conditions apply to the patient, it is essential to inform the doctor about using Diane-35, as treatment may need to be discontinued. The attending physician may order the patient to discontinue using Diane-35 for a few weeks before surgery or when the patient's mobility is limited. The attending physician will also inform the patient when they can resume using Diane-35 after regaining mobility.
Blood clots in arteries
Blood clots in arteries can cause severe disorders. For example, a blood clot in the coronary artery can cause a heart attack, and in the brain, it can cause a stroke.
Using combined oral contraceptives is associated with an increased risk of blood clots in arteries. This risk is further increased:

• with age;
• if the patient smokes.

During the use of a hormonal contraceptive such as Diane-35, it is strongly recommended to quit smoking, especially if the patient is over

35 years old;

• if the patient is overweight;
• if the patient has high blood pressure;
• if the patient has a close relative who had a heart attack or stroke at a young age;
• if the patient has high levels of fat in the blood (cholesterol or triglycerides);
• if the patient has migraines;
• if the patient has heart disease (valve damage, arrhythmias).

Symptoms caused by a blood clot

You should stop taking the tablets and contact your doctor immediately if you notice symptoms that may indicate a blood clot, such as:

• unusual sudden cough;
• severe chest pain that may radiate to the left arm;
• shortness of breath;
• any unusual, severe, or prolonged headache or worsening migraine;
• partial or complete loss of vision or double vision;
• slurred speech or loss of speech ability;
• sudden hearing, smell, or taste disorders;
• dizziness or fainting;
• numbness or paralysis of part of the body;
• severe abdominal pain;
• severe leg pain or swelling.

Not everyone recovers fully after a blood clot. Occasionally, thrombosis can cause permanent disability as well as death.
After childbirth, women are at increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Diane-35 after childbirth.
The doctor will assess whether there is an increased risk of thrombosis due to several risk factors or a single serious risk factor. If there are multiple risk factors, the risk of thrombosis may be higher than the sum of individual factors. If the risk is too high, the doctor will not recommend using Diane-35 (see also "When not to use Diane-35").

Diane-35 and cancer

In women who take hormonal contraceptives, breast cancer is slightly more common than in women of the same age who do not take them. It is not known whether this difference is caused solely by the use of combined oral contraceptives. The reason may also be that women who use hormonal contraception are more often examined and breast cancer is detected earlier in them.
The described difference in the incidence of breast cancer decreases gradually and disappears within 10 years after stopping the use of hormonal contraceptives.
In women using combined oral contraceptives, rare cases of benign or, even more rarely, malignant liver tumors have been reported, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, you should inform your doctor as soon as possible.
There have been reports of a more common occurrence of cervical cancer in women who have used hormonal contraceptives for a long time. However, this relationship may not be related to taking the tablets but to sexual behavior or other factors.
There have been reports of an increased risk of developing a benign brain tumor (meningioma) when using high doses (25 mg or higher) of cyproterone acetate. If a meningioma is detected in a patient, the doctor will discontinue treatment with products containing cyproterone, including Diane-35, as a precautionary measure (see section "When not to use Diane-35").
These tumors can be life-threatening or cause death.

Psychiatric disorders

Some women using hormonal contraceptives, including Diane-35, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Diane-35 and other medicines

You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the level of Diane-35 in the blood, reduce the effectiveness of contraception, or cause unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
• tuberculosis (e.g., rifampicin),
• HIV or hepatitis C virus infections (so-called protease inhibitors or non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
• fungal infections (e.g., griseofulvin, ketoconazole),
• arthritis, degenerative joint disease (etoricoxib),
• high blood pressure in the blood vessels of the lungs (bosentan),
• as well as products containing St. John's wort (Hypericum perforatum), used mainly to treat depressive moods.

Diane-35 may also affect the action of other medicines, such as:

• medicines containing cyclosporine,
• the antiepileptic drug lamotrigine (which may increase the frequency of seizures),
• theophylline (used to treat respiratory disorders),
• tizanidine (used to treat muscle pain and/or muscle spasms).

You should not use Diane-35 in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as they may cause abnormal liver function test results in the blood (increased liver enzyme activity).
Before starting to take these medicines, the doctor will prescribe a different type of contraception.
You can start taking Diane-35 again after about 2 weeks after finishing the above-mentioned treatment. See section "When not to use Diane-35".
You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you buy without a prescription.
Note: You should read the information about combined use of medicines to recognize possible interactions.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.
You should not take Diane-35 if you are pregnant or think you may be pregnant. If you suspect you are pregnant, you should consult your doctor as soon as possible.
You should not use Diane-35 during breastfeeding.

Driving and using machines

No effects of Diane-35 on the ability to drive and use machines have been observed.

Regular check-ups

While using Diane-35, your doctor will inform you about the need for regular medical check-ups.

The medicine contains lactose monohydrate and sucrose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to use Diane-35

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor.

How to use Diane-35

Regular intake of Diane-35 ensures effective therapeutic action and prevents pregnancy. Irregular intake of Diane-35 may lead to irregular bleeding and reduce the therapeutic and contraceptive properties of the medicine.

• When and how to take the tablets?

The blister packaging contains 21 film-coated tablets. On the packaging, each tablet is marked with the day of the week on which it should be taken. The tablets should be taken in the order indicated on the packaging, every day, at about the same time, with a small amount of liquid if necessary. For 21 consecutive days, 1 tablet should be taken per day. Each subsequent packaging should be started after a 7-day break, during which no tablets are taken and when withdrawal bleeding usually occurs. Bleeding usually starts within 2-3 days after taking the last tablet and may still occur after starting the next packaging.
This means that each subsequent packaging should always be started on the same day of the week, and bleeding will occur at about the same time every month.

• Using Diane-35 for the first time

If you have not used oral contraceptives in the last month
You should start taking the tablets on the 1st day of your natural menstrual cycle (i.e., on the 1st day of menstrual bleeding). You can also start taking the tablets between the 2nd and 5th day of your menstrual cycle; in this case, during the first cycle, you should use additional mechanical contraception for the first 7 days of taking the tablets.
If you have used another combined contraceptive or a vaginal ring or contraceptive patch
It is recommended to start taking Diane-35 on the 1st day after taking the last active tablet of the previous combined oral contraceptive, but no later than the 1st day after the usual break in taking active tablets or placebo tablets of the previous combined oral contraceptive. When using a vaginal ring or contraceptive patch, you should start taking Diane-35 on the day of removal, but no later than the day of planned re-application.
If you have used a progestin-only tablet (minipill)
You can stop taking the minipill at any time and start taking Diane-35 at the same time. If you have had sexual intercourse during the first 7 days of taking Diane-35, you should use additional contraceptive methods (mechanical methods).
If you have used injectable contraception, an implant, or an intrauterine therapeutic system releasing progestin
You should start taking Diane-35 on the day you were supposed to have the next injection or on the day the implant or intrauterine system is removed. If you have had sexual intercourse during the first 7 days of taking the tablets, you should use additional contraceptive methods (mechanical methods).
After childbirth, miscarriage, or abortion

• After a miscarriage in the first trimester of pregnancy, you can start taking Diane-35 immediately. In this case, there is no need to use additional contraceptive methods.
• After childbirth or miscarriage in the second trimester of pregnancy, your doctor should inform you that you should start taking the tablets between 21 and 28 days after childbirth or miscarriage in the second trimester of pregnancy. If you start taking the tablets later, your doctor should inform you about the need to use additional mechanical contraception for the first 7 days of taking the tablets. If you have had sexual intercourse before starting to use the combined oral contraceptive, you should make sure you are not pregnant or wait for your first menstrual period. If you feel that the action of Diane-35 is too strong or too weak, you should consult your doctor.

Using more than the recommended dose of Diane-35

Nausea, vomiting, or vaginal bleeding may occur. This type of bleeding may occur even in girls who have not started menstruating yet but have taken this medicine by mistake.
There have been no reports of severe side effects after taking multiple tablets of Diane-35 at the same time. If you have taken a higher dose of the medicine than recommended or someone else has taken it, you should inform your doctor.

Duration of treatment

Your doctor will inform you how long you should take Diane-35.

Missing a dose of Diane-35

If it has been less than 12 hourssince you missed a tablet, the contraceptive effectiveness of Diane-35 is maintained. You should take the missed tablet as soon as possible and take the next one at the usual time.
If it has been more than 12 hourssince you missed a tablet, the effectiveness of Diane-35 may be reduced. The more consecutive tablets you miss, the higher the risk of reduced contraceptive effectiveness. The risk of pregnancy is particularly high if you miss tablets at the beginning or end of the packaging. In this case, you should follow the rules below (see also the scheme below).

Missing more than 1 tablet from the packaging

You should consult your doctor.

Missing 1 tablet in the 1st week of taking Diane-35 from the current packaging

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. For the next 7 days, you should use additional contraceptive methods (mechanical methods).
If you had sexual intercourse during the week preceding the missed tablet, it is possible that you may become pregnant. You should consult your doctor immediately.

Missing 1 tablet in the 2nd week of taking Diane-35 from the current packaging

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. The contraceptive effectiveness of Diane-35 is maintained, and there is no need to use additional methods of pregnancy prevention. However, if you have made other mistakes in dosing or missed more than 1 tablet, you should use additional (mechanical) methods of contraception for 7 days.

Missing 1 tablet in the 3rd week of taking Diane-35 from the current packaging

You can choose one of the following options without the need for additional contraceptive methods, provided that you have been taking the tablets correctly for 7 days before missing the dose. Otherwise, you should follow the first of the two options below and use an additional method of contraception for 7 days.

• 1. Take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and take the next ones at the usual time. Start taking the tablets from the next packaging immediately after finishing the current one, i.e., without a 7-day break. Withdrawal bleeding will occur after finishing the second packaging, but you may experience spotting or bleeding during tablet intake.
• 2. You can also not take the remaining tablets from the current packaging, take a break (not more than 7 days, counting from the day you missed the tablet), and then continue taking the tablets from the next packaging.

If you forget to take a tablet and do not experience the expected withdrawal bleeding during the first break in taking the tablets, it is possible that you are pregnant. Before starting the next packaging of Diane-35, you should consult your doctor.

Scheme for missing a tablet

missed more than
1 tablet from the current
packaging
consult a doctor
Week 1.
had sexual intercourse in the week
before missing the tablet
did not have sexual intercourse

• take the missed tablet
• use additional contraception for 7 days
• finish the packaging

missed only
1 tablet
(delay of more
than 12 hours but
less than 24 hours)
Week 2.

• take the missed tablet
• finish the packaging
• take the missed tablet
• finish the packaging
• do not take a 7-day break
• continue with the next packaging

Week 3.

• stop taking the remaining tablets from the packaging
• take a break (not more than 7 days, counting from the day you missed the tablet)
• continue with the next packaging or

Procedure in case of:

• gastrointestinal disorders (vomiting)

If vomiting occurs, the active substances of Diane-35 may not be fully absorbed. If vomiting occurs within 3 to 4 hours after taking a tablet, you should follow the instructions for missing a tablet. If the woman does not want to change her normal tablet-taking schedule, she should take an additional tablet(s) from a new (additional) packaging.
In case of severe gastrointestinal disorders, additional contraceptive methods should be used.

• unexpected vaginal bleeding

While taking Diane-35, as with other hormonal contraceptives, irregular vaginal bleeding may occur in the first few months. Nevertheless, you should continue taking the tablets. Irregular vaginal bleeding usually disappears after 3 cycles of using Diane-35. If bleeding persists, becomes heavy, or recurs, you should consult your doctor.

Stopping the use of Diane-35

If you have any further questions about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diane-35 can cause side effects, although not everybody gets them.
You should inform your doctor about any side effects, especially if they are severe or prolonged, as well as any changes in your health that seem to be the result of taking Diane-35.

Severe side effects

Increased risk of blood clots in the veins (venous thromboembolic disease (VTE)) or arteries (arterial thromboembolic disease (ATE)) applies to all women taking combined hormonal contraceptives.
Severe side effects related to the use of Diane-35 and the accompanying symptoms have been described in the following sections of the leaflet: "Diane-35 and blood clots" and "Diane-35 and cancer".
You should read these sections to obtain additional information and consult your doctor immediately if necessary.
You should contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives that may cause difficulty breathing (see also section "Warnings and precautions").

Other possible side effects

Below are symptoms reported by patients taking Diane-35, although they may not have been caused by the medicine.
These symptoms may occur in the first few months of using Diane-35 and usually disappear over time.
The following side effects may occur when using Diane-35:

Frequent(less than 1 in 10 people):

• nausea,
• abdominal pain,
• weight gain,
• headache,
• breast pain,
• breast tenderness,
• depressive mood,
• mood changes.

Uncommon(less than 1 in 100 people):

• vomiting, diarrhea,
• fluid retention,
• migraine,
• decreased libido,
• rash, hives,
• breast enlargement.

Rare(less than 1 in 1000 people):

• intolerance to contact lenses,
• hypersensitivity,
• weight loss,
• increased libido,
• discharge, breast secretion,
• erythema nodosum, erythema multiforme,
• blood clot in a vein.

Frequency not known(cannot be estimated from the available data):

• increased blood pressure

Some people may experience other side effects when using Diane-35.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diane-35

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store at a temperature not exceeding 25°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Diane-35 contains

The active substances of Diane-35 are cyproterone acetate and ethinylestradiol.
The other ingredients are:

• tablet core: lactose monohydrate, cornstarch, povidone K25, talc, magnesium stearate.
• tablet coating: sucrose, povidone K90, macrogol 6000, calcium carbonate, talc, glycerol 85%, titanium dioxide (E171), yellow iron oxide (E172), montan glycerol wax.

What Diane-35 looks like and contents of the packaging

The packaging contains 1, 2, or 3 blisters of 21 film-coated tablets.
Blisters of PVC/Al foil in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer:

Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
To obtain more detailed information, you should contact the representative of the marketing authorization holder.
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
tel. (0-22) 572-35-00

Date of last revision of the leaflet: