The package insert of the medicine Diane 35

the package insert of the medicine Diane 35. Therapeutic class of the Control. Active principlesEthinyl estradiol and Acetate Cyproterone.

what For?

Diane 35 drágea is indicated for the treatment of diseases related to androgen hormones in women, such as acne, mainly in the forms of spoken and those that are accompanied by seborrhea, inflammation or formations of nodes (acne papulopustulosa, acne nodulocística); excessive loss of hair; mild cases of hirsutism (excess hair) and the syndrome of polycystic ovaries (PCOS).

adult Use – oral Use

Pharmacokinetics

How it works?

The acetate of ciproterona, administered orally, is rapidly and completely absorbed.

serum levels maximum of 15 ng/ml are reached in about 1.6 h after administration of a single dose.

The ethinyl estradiol, administered orally, is rapidly and completely absorbed.

serum Levels maximum of about 71 pg/ml are reached at 1.6 hours.

Dosage

How to use?

Diane 35 should be taken regularly in order to achieve the therapeutic efficacy and the contraceptive effect.

The intake irregular can lead to bleeding intermenstruais, in addition to reducing the effectiveness of the therapeutic and contraceptive effect of Diane 35.

The tablets should be taken in the order directed on the blister pack, for 21 consecutive days, remaining approximately the same time and, if necessary, with small amount of liquid.

Each new pack is started after a pause interval of 7 days without the intake of tablets, during which must occur bleeding by deprivation hormone (in 2-3 days after ingestion of the last drágea).

This bleeding could not be ceased before the start of a new pack.

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  • the Beginning of the use of Diane 35: when no hormonal contraceptive has been used in the previous month: in the case of the patient not having used hormonal contraceptive in the previous month, the intake should be started on the 1st day of the cycle (1st day of menstrual bleeding).
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  • Changing from another combined oral contraceptive, vaginal ring or transdermal patch (contraceptive) for Diane 35: The patient should start the use of Diane 35 preferably on the day after the intake of the last active tablet (the last tablet containing active substances) of contraceptive previously used, or, at most, on the day following the last day of break, or of taking inactive tablets. If you are moving from a vaginal ring or transdermal patch, you should begin preferably on the day of withdrawal or, at most, on the day envisaged for the next application.
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  • Changing a method of birth control containing only progestin (mini pill, injection, implant) or Intrauterine System (IUS) with release progestin for Diane 35: the patient may initiate the use of Diane 35 in any day in the case of the mini pill, or on the day of the withdrawal of the implant or IUS, or on the day scheduled for the next injection. In these three cases (the prior use of the mini pill, injection, implant or Intrauterine System with the release of progestin),it is recommended to use in addition to a barrier method in the first 7 days of intake of Diane 35.
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  • After the abortion of the first trimester: you can start the use of Diane 35 immediately, without need to take additional contraceptive measures.
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  • After delivery or abortion in the second trimester: for breast-feeding, see the item Diane 35 during pregnancy and lactation. After delivery or abortion in the second trimester, the user should be advised to start the use of Diane 35 in the period between the 21st and the 28th day after the procedure. If you start at a later time, you must advise the additional use of a barrier method for 7 days of initial intake. If it has already occurred sexual relationship, you should make sure that the woman is not pregnant before starting the use of Diane 35 or so, wait for the first menstruation.

Side Effects

What are the evils that can cause me?

The side effects associated with the use of Diane 35, as well as the related symptoms.

Read item Warnings and Precautions, and be sure to talk with your doctor in case of any doubts or immediately when it deems appropriate.

These side effects may arise in the first few months, and normally decrease with time use.

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  • common side Effects

Nausea, abdominal pain, increased body weight, headache, depressive moods, mood changes, pain and hypersensitivity to painful on the breasts.

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  • side Effects infrequent

Vomiting, diarrhea, fluid retention, migraine, decreased sexual desire (libido), the increase in the size of the breasts, rash and itching.

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  • side Effects rare

Intolerance to contact lenses, hypersensitivity, decreased body weight, increased sexual desire (libido), vaginal secretion, secretion of the breasts, erythema nodosum, and erythema multiforme.

Contraindications

When should I not use?

Medicines containing combinations of estrogen/progestin combinations should not be used in the presence of the following conditions:

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  • presence or history of processes thrombotic/thromboembolic arterial or venous, as, for example, deep vein thrombosis, pulmonary embolism, myocardial infarction or stroke;
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  • presence or history of symptoms and/or signs prodromal thrombosis (for example: episode transient ischemic, angina pectoris);
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  • history of migraine with focal neurological symptoms;
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  • diabetes melitus with changes vascular;
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  • the presence of one serious risk factor or multiple risk factors for venous or arterial thrombosis may also represent a contraindication;
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  • presence or history of pancreatitis associated with severe hypertriglyceridemia;
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  • presence or history of severe liver disease, while the values of liver function do not return to normal;
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  • presence or history of liver tumours (benign or malignant);
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  • diagnosis or suspicion of cancer is dependent on sex steroids (eg of the genital organs or the breasts);
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  • vaginal bleeding not diagnosed;
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  • hypersensitivity to the active substances or to any of the components of the product.

The administration of Diane 35 is also contraindicated during lactation.

Diane 35 during pregnancy: the administration of Diane 35 is contraindicated during pregnancy. If the user gets pregnant during the use of Diane 35, you should discontinue use.

If any of the conditions listed above occur for the first time during the use of medicines containing combinations of estrogen/progestin combinations, their use must be discontinued immediately.

Warnings and Precautions

what should I know before using?

clinical experience and epidemiological with medicines containing combinations of estrogen/progestin combinations, as in the case of Diane 35, is based, predominantly, on combined oral contraceptives (COCs).

Therefore, the following precautions related to the use of COC apply also to the product Diane 35.

In the event of the occurrence of any of the conditions or risk factors mentioned below, the benefits of the use of Diane 35 should be measured against the possible risks for each patient individually, and discussed with the same before you choose at the beginning of its use.

In case of aggravation, exacerbation or emergence for the first time any of these conditions or risk factors, the patient should contact your doctor.

in These cases, the continuation of the use of Diane 35 should be at the physician’s discretion.

epidemiological Studies suggest an association between the use of COCs and an increased risk of thromboembolic disorders and thrombotic arterial and venous, such as myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism.

The occurrence of these events is rare.

During the employment of any COCs can occur venous thromboembolism (VTE) manifest as deep vein thrombosis and/or pulmonary embolism.

The risk of occurrence of venous thromboembolism is highest during the first year of use in users of the first time of a COC.

In extremely rare cases, it has been observed the occurrence of thrombosis in other blood vessels such as, for example, in the veins and arteries of the liver mesentéricas, renal, cerebral or retinal in users of COCs.

Symptoms of processes thrombotic/ thromboembolic arterial or venous, or stroke, may include:

Pain and/or swelling unilateral on the lower limb; chest pain intense, acute, with or without irradiation to the left arm; dyspnea acute; cough of abrupt onset; headache is not unusual, intense and prolonged; sudden loss of vision, partial or total; diplopia; distortions in the speech or aphasia; vertigo; collapse with or without seizure focal; weakness, decrease of sensitivity or motor strength affecting, all of a sudden, a hand or a body part; motor disorders; abdomen acute.

The risk of processes thrombotic/ thromboembolic arterial or venous, or stroke increases with the following factors:

Age; smoking (with high consumption of cigarettes and increasing age, the risk becomes even greater, especially in women aged supo 35 years); positive family history (that is, arterial thromboembolism or venous detected in a(a) brother(a) or in one of the parents at relatively young age) – if it is suspected hereditary predisposition, the patient should be referred to a specialist before deciding for the use of any COC.

Obesity (body mass index greater than 30 Kg/m2); dyslipoproteinemia; hypertension; migraine; valvular heart disease; atrial fibrillation; prolonged immobilisation, major surgery, any surgical intervention in the lower limbs, or trauma extensive.

in These cases, it is advisable to discontinue COC use (in the case of scheduled surgery, it is advisable to discontinue COC use with at least four weeks in advance) and not restart it until at least two weeks after the establishment.

Other clinical conditions that have also been associated with adverse circulatory events are:

Diabetes melitus, polycystic ovary syndrome, systemic lupus erythematosus, hemolytic uremic syndrome, the pathology of chronic inflammatory bowel (Crohn’s disease or ulcerative colitis) and sickle cell anemia.

The increase in the frequency or intensity of migraine during use of COCs may be grounds for the immediate suspension of the same, given the possibility of this frame represent the beginning of an event stroke.

The most important risk factor for cervical cancer is persistent infection by HPV (the human papillomavirus).

Some epidemiological studies have indicated that the use of COCs for extended period may contribute to this increased risk.

have Been observed, in rare cases, liver tumors benign and, more rarely, malignant in users of COCs.

In isolated cases, these tumours led to bleeding in the intra-abdominal life-threatening for the patient.

The possibility of liver tumor should be considered in the differential diagnosis of users of COCs that are experiencing intense pain in the upper abdomen, increased size of the liver or signs of bleeding intra-abdominal.

Before starting or resuming treatment with Diane 35, it is necessary to obtain detailed medical history and perform complete clinical examination, considering the items outlined under the indications and Contra-indications; these follow-ups should be repeated periodically during therapy with Diane 35.

patients should be informed that medications of the type Diane 35 do not protect against infections caused by the HIV (AIDS) and other sexually transmitted diseases.

The contraceptive effect of Diane 35 may be reduced in case you have forgotten making tablets, gastrointestinal disorders, or concomitant treatment with other medicines.

As with all medicines containing combinations of estrogen/ progestin combinations may arise bleeding irregular (drip or breakthrough bleeding), especially during the first few months of use.

Therefore, evaluation of any irregular bleeding is only meaningful after a period of adaptation of about three cycles.

If the bleeding irregular persist or occur after previously regular cycles, should be considered non-hormonal causes and, in these cases, are indicated in diagnostic procedures appropriate for exclusion of neoplasia or pregnancy.

Warning: this medicine contains sugar, therefore should be used with caution in patients with diabetes.

Drug interactions

The use of some medications can affect the action of oral contraceptives, reducing their effectiveness.

This has been verified with the drugs used in the treatment of epilepsy (eg, primidone, phenytoin, barbiturates and carbamazepine), tuberculosis (eg, rifampin), and with some antibiotics (eg, penicillins, and tetracyclines), which are used in the treatment of other infectious diseases.

it Is possible that any interaction also with oxcarbazepina, topiramato, felbamato, medicines for the treatment of AIDS – Acquired immune Deficiency Syndrome (for example: ritonavir, nevirapine), the antibiotic griseofulvin, and medicines containing st John’s Wort (primarily used for the treatment of depressive states).

Medicine of the type of Diane 35 can also interfere with the effectiveness of other medications, for example, medicines containing cyclosporin, or the anti-epileptic lamotrigine.

Storage

Where how and for how long can I save?

The medicine should be kept at room temperature (15°C to 30°C).

Protect from moisture.

Overdose

what to do if someone use a larger amount than is recommended?

No effects were observed severe adverse after the ingestion of multiple tablets of Diane 35 at a single time.

if this is the Case, may appear nausea, vomiting, or vaginal bleeding.

If accidental ingestion occur with a child, see the doctor.

what should I do when I forget to use this medicine?

If there is a delay of less than 12 hours of the usual time, the contraceptive effect of Diane 35 is maintained.

Take the drágea forgotten as soon as you remember and take the next drágea at the usual time.

If there is a delay of more than 12 hours of the usual time, the contraceptive protection of Diane 35 may be reduced, especially if the oblivion of the outlet at the beginning or at the end of the cartouche.

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  • Forgetting 1 drágea in the first week of use

Take the drágea forgotten as soon as you remember (this includes the possibility of taking two tablets at once) and continue taking the next tablets at the usual time. Use additional contraceptive method (barrier method – for example, a condom) for the next 7 days. If you have had sexual intercourse in the week before forgetting the outlet of the drágea, there is a possibility of getting pregnant. Communicate the fact immediately to your doctor.

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  • Forgetting 1 drágea in the second week of use

Take the drágea forgotten as soon as you remember (this includes the possibility of taking two tablets at once) and continue taking the next tablets at the usual time. Protection contraceptive Diane 35 is maintained. It is not necessary to use additional contraceptive method.

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  • Forgetting 1 drágea in the third week of use

Choose one of the two options below, without the need to use additional contraceptive method:

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  1. Take the drágea forgotten as soon as you remember (this includes the possibility of taking two tablets at once) and continue taking the next tablets at the usual time. Start the new pack as soon as you finish the current one, without any break between one pack and another. It is possible that the bleeding occurs only after the end of the second cartouche. However, bleeding may occur-type drip or escape while you are taking the tablets.
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  3. stop taking the tablets from the current pack, take a break of 7 days or less, up to and including the day on which you forgot to take the drágea and start a new pack. If you want to keep the same day of the week to the beginning of the outlet, the pause may be shorter than 7 days. For example: if the pill was started on a Wednesday and you forgot to take the drágea on the Friday of the last week, you can start the new pack on Wednesday of the following week to oblivion, practicing in this way, a break of only 5 days.
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  • More than 1 drágea forgotten

If more than one drágea of the same cartouche is forgotten, consult your doctor. The more tablets sequential are forgotten, the lower the contraceptive effect.