Diane-35

Package leaflet: Information for the user

Diane-35, 2 mg + 0,035 mg, coated tablets
Cyproteroni acetas + Ethinylestradiolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of the leaflet

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

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

Diane-35 is used in the treatment of skin disorders such as acne, very oily skin, and excessive
hirsutism in women of reproductive age. Due to its contraceptive properties, this medicine
should be prescribed to a patient only if the doctor considers that hormonal contraception
is appropriate.
The patient should use Diane-35 for the treatment of acne only when there has been no
improvement in the skin condition after using other anti-acne therapies, including topical
treatment and antibiotic therapy.

2. Important information before using Diane-35

General remarks
Before starting treatment with Diane-35, the doctor will ask several questions about the patient's health and that of her close relatives. The doctor will also measure blood pressure and, if necessary, perform other diagnostic tests.
This leaflet describes several situations in which you should stop using Diane-35 or in which the effectiveness of Diane-35 may be reduced. In such cases, sexual intercourse should be avoided or additional non-hormonal contraceptive methods (e.g. condoms or other mechanical methods) should be used. Always inform your doctor about any medications and herbal products you are taking. You should also inform doctors, dentists or pharmacists prescribing other medicines about your use of Diane-35. They will advise whether additional contraceptive measures (e.g. condoms) are needed, and if so, for how long, as well as whether any changes to other medications are required. Do not rely on the calendar method or temperature monitoring. These methods may be unreliable because Diane-35 modifies 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:
Inform your doctor if any of the following conditions apply to you before starting Diane-35. Your doctor may then recommend alternative treatment:

• If you have a hypersensitivity to ethinylestradiol, cyproterone acetate, or any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, rash or swelling.
• If you are already taking another hormonal contraceptive.
• If you currently have (or have ever had) a blood clot in the leg (thrombosis), in the lungs (pulmonary embolism), or in another part of the body.
• If you currently have (or have ever had) conditions indicating a previous heart attack (e.g. angina pectoris causing severe chest pain) or a "mini-stroke" (transient ischaemic attack).
• If you currently have (or have ever had) a heart attack or stroke.
• If you have factors that may increase the risk of blood clots, including:
  • Diabetes with vascular complications,
  • very high blood pressure,
  • very high levels of blood lipids (cholesterol or triglycerides).
• If you have a blood clotting disorder (e.g. protein C deficiency).
• If you currently have (or have ever had) migraine with visual disturbances.
• If you have had (or currently have) severe liver disease (which may present as yellowing of the skin or generalized itching), and liver function remains abnormal.
• If you have had (or currently have) a hormone-sensitive malignant tumour (e.g. breast cancer or genital organ cancers).
• If you have had (or currently have) a benign or malignant liver tumour.
• If you have meningioma or have ever been diagnosed with meningioma (usually a benign tumour of the membrane between the brain and skull).
• If you have unexplained vaginal bleeding.
• If you are pregnant or suspect you may be pregnant.
• If you are breastfeeding.

Do not use Diane-35 in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see also section "Diane-35 and other medicines").
If any of the symptoms listed above occur for the first time during treatment with Diane-35, the medicine should be stopped immediately and medical advice sought. During this time, use non-hormonal methods of contraception (see section "General remarks").
Diane-35 must not be used in men.
Special patient groups
Children and adolescents
Diane-35 is not indicated for use in patients before the onset of menstruation.
Elderly patients
Diane-35 is not intended for use in postmenopausal women.
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
Consult your doctor. Available data do not indicate the need to change the way Diane-35 is used.
Warnings and precautions
When to consult a doctor
Stop taking the tablets and contact your doctor immediately if you notice symptoms suggesting a possible blood clot. These symptoms are described in section 2 under "Blood clots (thrombosis)".
Before starting Diane-35, discuss this with your doctor.
If you are taking Diane-35, special and regular medical monitoring is required in any of the following situations. Therefore, inform your doctor before starting Diane-35 if you have:

• A history of smoking (women over 35 years of age should stop smoking if they decide to use combined oral contraception),
• Diabetes,
• Obesity (body mass index above 30 kg/m²),
• High blood pressure,
• Heart valve disease or atrial fibrillation,
• Superficial thrombophlebitis,
• Varicose veins,
• Personal or family history of thrombosis, heart attack or stroke,
• Migraine,
• Epilepsy,
• High cholesterol or triglyceride levels (fats) in the blood (either in the past or in family members),
• Family history of breast cancer,
• Liver or gallbladder disease,
• Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases),
• Polycystic ovary syndrome,
• Systemic lupus erythematosus (SLE),
• Haemolytic-uraemic syndrome (a blood clotting disorder causing kidney failure),
• Sickle cell anaemia,
• Diseases that first occurred or worsened during pregnancy or previous use of steroid hormones (e.g. jaundice and/or itching due to cholestasis, gallstone formation, hearing loss due to otosclerosis, haemolytic-uraemic syndrome, porphyria, herpes gestationis, Sydenham's chorea),
• Skin pigmentation disorders (yellow-brown pigmentation changes, so-called chloasma) currently or in the past; excessive exposure to sunlight or ultraviolet radiation should be avoided,
• Hereditary angioedema. Contact your doctor if symptoms of angioedema occur, such as swelling of the face, tongue or throat and/or difficulty swallowing, or urticaria associated with breathing difficulties. Medicinal products containing estrogens may induce or worsen symptoms of this condition,
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria that may cause breathing difficulties, contact your doctor immediately. Medicinal products containing estrogens

may cause or worsen symptoms of both hereditary and acquired angioedema.
If any of the symptoms listed above occur for the first time, recur or worsen during treatment with Diane-35, contact your doctor.
In cases of hirsutism, if symptoms have recently appeared or worsened, inform your doctor immediately for proper diagnosis.
Diane-35 also acts as an oral contraceptive. The patient and doctor should consider all principles of safe use of oral hormonal contraception.
Diane-35 and thrombosis
Blood clots (thrombosis)
Taking Diane-35 may slightly increase the risk of blood clots in the patient (so-called thrombosis). The likelihood of blood clots in patients taking Diane-35 is only slightly higher compared to women who do not take Diane-35 or any other oral contraceptive. Complete recovery is not always possible, and 1-2% of cases may be fatal.
Venous blood clots
A blood clot in a vein (known as venous thrombosis) may block the vein. This may occur in the leg veins, pulmonary arteries (pulmonary embolism), or any other organ.
Taking a combined oral contraceptive increases the risk of such venous blood clots compared to women who do not take any combined oral contraceptives. The risk of venous thrombosis is highest during the first year of taking an oral contraceptive. The risk is not as high as the risk of blood clots during pregnancy.
The risk of venous blood clots in patients taking combined oral contraceptives is further increased:

• with increasing age;
• if the patient smokes. When using a hormonal contraceptive such as Diane-35, it is strongly recommended to stop smoking, especially if the patient is over 35 years old.
• if a close relative had a blood clot in the leg, lungs or another organ at a young age;
• if the patient is overweight;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast.

If any of the above conditions apply, it is important to inform the doctor about taking Diane-35, as treatment may need to be discontinued. The treating doctor may instruct the patient to stop taking Diane-35 several weeks before surgery or when mobility is limited. The doctor will also inform the patient when she can resume taking Diane-35 after regaining mobility.
Arterial blood clots
Arterial blood clots may cause serious disorders. For example, a blood clot in an artery in the heart may cause a heart attack, and in the brain it may cause a stroke.
The use of combined oral contraceptives is associated with an increased risk of arterial blood clots. This risk is further increased:

• with increasing age;
• if the patient smokes. When using a hormonal contraceptive such as Diane-35, it is strongly recommended to stop smoking, especially if the patient is over 35 years old;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close relative had a heart attack or stroke at a young age;
• if the patient has high blood lipid levels (cholesterol or triglycerides);
• if the patient has migraines;
• if the patient has heart disease (valve damage, cardiac arrhythmias).

Symptoms caused by blood clots
Stop taking the tablets and contact your doctor immediately if you notice symptoms suggesting a possible blood clot, such as:

• unusual sudden cough;
• severe chest pain, possibly radiating 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;
• sudden hearing, smell or taste disturbances;
• dizziness or fainting;
• numbness or weakness of part of the body;
• severe abdominal pain;
• severe pain or swelling in the legs.

Complete recovery after a blood clot is not always possible. Occasionally, thrombosis may lead to permanent disability or death.
In the immediate postpartum period, women are at increased risk of blood clots. Consult your doctor for advice on how soon you can start taking Diane-35 after childbirth.
The doctor will assess whether there is an increased risk of thrombosis due to multiple risk factors or a single serious risk factor. When several factors are combined, the risk of thrombosis may be greater 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
Breast cancer occurs slightly more frequently in women taking hormonal contraceptives than in women of the same age who do not use them. It is not known whether this difference is solely due to the use of oral hormonal contraceptives. It may also be because women using hormonal contraception are examined more frequently, leading to earlier detection of breast cancer. The described difference in breast cancer incidence gradually decreases and disappears within 10 years after stopping hormonal contraceptives.
Rare cases of benign or, even more rarely, malignant liver tumours have been reported in women using combined oral contraceptives, which have caused life-threatening intra-abdominal bleeding. If you experience severe upper abdominal pain, inform your doctor as soon as possible.
There are reports of increased incidence of cervical cancer in women using hormonal contraceptives for a long time. However, this association may not be related to taking the tablets but rather to sexual behaviour or other factors.
An increased risk of developing a benign brain tumour (meningioma) has been reported with long-term use of high doses (25 mg or more) of cyproterone acetate. If a patient is diagnosed with meningioma, the doctor will discontinue treatment with products containing cyproterone, including Diane-35, as a precautionary measure (see section "When not to use Diane-35").
The cancers mentioned may be life-threatening or lead to 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 or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.
Diane-35 and other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect the blood concentration of Diane-35, reduce contraceptive effectiveness, or cause unexpected bleeding. This includes medicines used to treat:

• Epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
• Tuberculosis (e.g. rifampicin),
• HIV or hepatitis C virus infections (protease inhibitors or non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
• Fungal infections (e.g. griseofulvin, ketoconazole),
• Arthritis, osteoarthritis (etoricoxib),
• Pulmonary hypertension (bosentan),
• Herbal products containing St. John's wort (Hypericum perforatum), mainly used for treating depressive mood.

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

• Medicines containing cyclosporine,
• The antiepileptic lamotrigine (which may increase the frequency of seizures),
• Theophylline (used to treat breathing disorders),
• Tizanidine (used to treat muscle pain and/or muscle spasms).

Do not use Diane-35 in patients with hepatitis C who are taking medicinal products containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as they may cause abnormal liver function test results (increased liver enzyme AlAT activity).
Before starting these medicines, your doctor will prescribe another type of contraception.
You may restart taking Diane-35 approximately 2 weeks after completing the above treatment. See section "When not to use Diane-35".
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or are available without a prescription.
Warning: Read information about concomitant use of medicines to identify possible interactions.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Do not take Diane-35 during pregnancy or if pregnancy is suspected. If pregnancy is suspected, consult your doctor immediately.
Do not use Diane-35 during breastfeeding.
Driving and operating machinery
No effect of Diane-35 on the ability to drive and operate machinery has been observed.
Regular check-ups
While taking Diane-35, your doctor will inform you about the need for regular medical examinations.
The medicine contains monohydrate lactose and sucrose
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Diane-35

This medicine should always be used according to your doctor's instructions. If in doubt, consult your doctor.

How to take Diane-35

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

• When and how should the tablets be taken?

The blister pack contains 21 coated tablets. Each tablet is marked on the packaging with the day of the week on which it should be taken. The tablets must be taken in the order indicated on the pack, every day at approximately the same time, with a small amount of liquid if necessary. One tablet should be taken daily for 21 consecutive days. Each subsequent pack should be started after a 7-day break, during which no tablets are taken and withdrawal bleeding usually occurs. Bleeding usually begins 2–3 days after taking the last tablet and may continue into the start of the next pack. This means that each new pack should always be started on the same day of the week, and bleeding will occur approximately on the same days each month.

• Starting Diane-35 for the first time

If no oral contraceptives were used in the previous month
Start taking the tablets on day 1 of the natural menstrual cycle (i.e. the first day of menstrual bleeding). It is also possible to start between day 2 and day 5 of the cycle; in this case, during the first cycle, additional mechanical contraception is recommended for the first 7 days of tablet intake.

If previously using another combined oral contraceptive, vaginal ring, or contraceptive patch
It is recommended to start taking Diane-35 on the first day after taking the last active tablet of the previous combined oral contraceptive, but no later than the first day after the usual tablet-free or placebo interval of the previous combined oral contraceptive. If previously using a vaginal ring or contraceptive patch, start Diane-35 preferably on the day of removal, but no later than the day scheduled for reapplication.

If previously using a progestogen-only pill (mini-pill)
You may stop taking the mini-pill at any time and instead take Diane-35 at the same time. If sexual intercourse occurs during the first 7 days of taking Diane-35, additional contraceptive methods (mechanical methods) should be used simultaneously.

If previously using injectable contraception, implant, or intrauterine system releasing progestogen
Start taking Diane-35 on the day the next injection would have been administered, or on the day of removal of the implant or intrauterine system. If sexual intercourse occurs during the first 7 days of taking the tablets, additional contraceptive methods (mechanical methods) should be used simultaneously.

After childbirth, miscarriage, or abortion

• After first-trimester abortion
  Diane-35 may be started immediately. In this case, additional contraceptive methods are not required.

• After childbirth or second-trimester abortion
  Your doctor will advise you to start taking the tablets between 21 and 28 days after childbirth or second-trimester abortion. If tablet intake is started later, your doctor will advise using additional mechanical contraception for the first 7 days of tablet intake. If intercourse occurred before starting the combined oral contraceptive, ensure that pregnancy has not occurred, or wait until the first menstrual bleeding occurs. If you feel that the effect of Diane-35 is too strong or too weak, consult your doctor.

Taking more than the recommended dose of Diane-35

Nausea, vomiting, or vaginal bleeding may occur. Such bleeding may even occur in girls who have not yet started menstruating but have accidentally taken this medicine. There are no reports of severe adverse effects after taking multiple tablets of Diane-35 at once. If more than the recommended dose has been taken, or if someone else has taken the medicine, inform your doctor.

Duration of treatment

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

Missed dose of Diane-35

If less than 12 hours have passed since the missed tablet, the contraceptive effectiveness of Diane-35 is maintained. Take the missed tablet as soon as possible and take the next tablet at the usual time.

If more than 12 hours have passed since the missed tablet, the effectiveness of Diane-35 may be reduced. The more tablets missed consecutively, the greater the risk of reduced contraceptive protection. The risk of pregnancy is particularly high if tablets are missed at the beginning or end of the pack. In such cases, follow the rules below (see also the chart below).

More than 1 tablet missed from the pack
Consult your doctor.

1 tablet missed in week 1 of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and continue taking the following tablets at the usual time. Use additional contraceptive methods (mechanical methods) for the next 7 days.

If sexual intercourse occurred in the week before the missed tablet, pregnancy may have occurred. Inform your doctor immediately.

1 tablet missed in week 2 of the current pack
Take the missed tablet as soon as possible (even if this means taking two tablets at once), and continue taking the following tablets at the usual time. The contraceptive effectiveness of Diane-35 is maintained, and additional contraceptive methods are not required. However, if previous dosing errors occurred or more than one tablet was missed, use additional (mechanical) contraception for 7 days.

1 tablet missed in week 3 of the current pack
You may choose one of the following options without needing additional contraceptive methods, provided that correct dosing was maintained during the 7 days preceding the missed dose. Otherwise, apply the first of the two options below and use additional contraception for the next 7 days.

1. Take the missed tablet as soon as possible (even if this means taking two tablets at once), and continue taking the following tablets at the usual time. Start the next pack immediately after finishing the current one, i.e. without a 7-day break. Withdrawal bleeding will occur after finishing the second pack, but spotting or bleeding may occur during tablet intake.

2. Alternatively, stop taking tablets from the current pack, take a 7-day or shorter break (including the day the tablet was missed), then continue with the next pack.

If tablets are missed and no withdrawal bleeding occurs during the first tablet-free interval, pregnancy may have occurred. Contact your doctor before starting the next pack.

Missed tablet management chart

More than 1 tablet missed → Consult your doctor

Week 1
Missed only 1 tablet (more than 12 hours late but less than 24 hours)

• Take the missed tablet
• Use additional contraception for 7 days
• Finish the pack

Week 2
Missed only 1 tablet (more than 12 hours late but less than 24 hours)

• Take the missed tablet
• Finish the pack

Week 3
Missed only 1 tablet (more than 12 hours late but less than 24 hours)
Option 1:

• Take the missed tablet
• Finish the pack
• Do not take a 7-day break
• Continue with the next pack

Option 2:

• Discard remaining tablets in the pack
• Take a break (no longer than 7 days, including the day the tablet was missed)
• Continue with the next pack

Managing the following situations:

• Gastrointestinal disturbances (vomiting)

If vomiting occurs, the active ingredients of Diane-35 may not be fully absorbed. If vomiting occurs within 3 to 4 hours after taking the tablet, follow the recommendations for a missed tablet. If the woman does not wish to change her usual tablet-taking schedule, she should take an additional tablet(s) from a new (extra) pack.

In case of severe gastrointestinal disorders, use additional contraceptive methods.

• Unexpected bleeding

During treatment with Diane-35, as with other hormonal treatments, irregular vaginal bleeding (spotting or intermenstrual bleeding) may occur during the first few months. Despite this, continue taking the tablets as prescribed. Irregular vaginal bleeding usually resolves after 3 cycles of Diane-35. If bleeding persists, becomes heavy, or recurs, inform your doctor.

Stopping Diane-35

If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
You should inform your doctor about any adverse reactions, especially if they are severe or persistent, as well as about any changes in your health that seem to be caused by taking Diane-35.
Serious adverse reactions
Increased risk of venous thrombosis (venous thromboembolic disease, VTE) or arterial thrombosis (arterial thromboembolic disorders, ATE) occurs in all women taking combined hormonal contraceptives.
Serious adverse reactions associated with taking Diane-35 and their accompanying symptoms are described in the following sections of this leaflet: "Diane-35 and thrombosis" and "Diane-35 and cancer".
Please read these sections for 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 urticaria, which may cause breathing difficulties (see also section "Warnings and precautions").
Other possible adverse reactions
Below are symptoms reported by women taking Diane-35, although they may not necessarily have been caused by the medicine.
These symptoms may occur during the first few months of taking Diane-35 and usually resolve over time.
The following adverse reactions may occur during treatment:
Common (less than 1 in 10 people):

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

Uncommon (less than 1 in 100 people):

• vomiting, diarrhoea,
• fluid retention,
• migraine,
• decreased libido,
• rash, urticaria,
• breast enlargement.

Rare (less than 1 in 1,000 people):

• intolerance to contact lenses,
• hypersensitivity,
• weight loss,
• increased libido,
• vaginal discharge, galactorrhoea,
• nodular erythema, erythema multiforme,
• blood clots in veins.

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

• increased blood pressure

Other adverse reactions may occur in some individuals during treatment with Diane-35.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 . Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Diane-35

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store below 25 °C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

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

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

What Diane-35 looks like and contents of the pack
The pack contains 1, 2 or 3 blisters with 21 film-coated tablets each.
PVC/Al blister in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany
Manufacturer:
Bayer AG
Müllerstrasse 178
13353 Berlin
Germany
Bayer Weimar GmbH und Co. KG
Döbereinerstraße 20
99427 Weimar
Germany
For further information, please contact the representative of the Marketing Authorisation Holder.
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
tel. (0-22) 572-35-00