Medicinal Products

DIANE 35 micrograms 2 mg / 0.035 mg

Generic drug of the therapeutic class: Dermatology
active ingredients: Cyproterone acetate, Ethinyl estradiol
laboratory: Bayer Healthcare

Coated tablet
Case of 1 Pack of 21
All forms

Indication

Treatment of moderate to severe acne associated with androgen sensitivity (with or without seborrhea) and / or hirsutism in women of childbearing age.

For the treatment of acne, DIANE 35 micrograms, coated tablet should be used only after failure of a topical treatment or systemic antibiotic treatment.

Since DIANE 35 micrograms, coated tablet is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section 4.3 ).

Dosage DIANE 35 micrograms 2 mg / 0.035 mg Tablet coated 1 pack of 21

Oral way.

· DIANE 35 micrograms, coated tablet: in initial treatment should be initiated as follows:

o 1st cycle: daily intake at the same time of a tablet starting on the first day of the cycle for 21 days.

o Following cycles: after a 7-day therapeutic break, take the next pack for 21 days.

· DIANE 35 micrograms, coated tablet: in relay of an oral estrogen / progestin contraceptive, must be initiated in the following way:

Take the first tablet preferably the day after taking the last active tablet of oral estrogen / progestogen, or at the latest one day after the usual period of stopping tablets, or the day after taking the last placebo tablet contraceptive oral contraceptive.

Duration of the treatment

At least three months are required to improve symptoms. The need for further treatment should be regularly assessed by the attending physician.

Stopping treatment with DIANE 35 micrograms, coated tablet should discuss with the patient the need for contraception.

Case of forgetting one or more tablets:

Forgetting a tablet puts you at risk for pregnancy. If missed within 12 hours of the usual time of use, take the missed tablet immediately, and continue treatment normally by taking the next tablet at the usual time.

If forgetfulness is noted more than 12 hours after the normal time of taking, the contraceptive effect is no longer assured. Immediately take the last missed tablet and continue treatment until the end of the pack, using simultaneously a contraceptive method of mechanical type (condoms, spermicides, ...) until the recovery of the next pack, including during the rules.

What to do in case of gastrointestinal disorders:

In severe gastrointestinal disorders (eg, vomiting or diarrhea), tablet absorption may not be complete; additional contraceptive measures must therefore be taken.

If vomiting occurs within 3-4 hours of taking a tablet, the same guidelines as for tablet forgetfulness should apply (see above). several tablets ").

Against indications

Do not use this medicine in the conditions and / or situations described below:

· Concomitant use of another hormonal contraceptive (see section Therapeutic indications ),

· In combination with St. John's Wort (see section Interactions with other medicinal products and other forms of interaction ),

· Presence or history of venous thrombosis (deep vein thrombosis, pulmonary embolism),

· Presence or history of arterial thrombosis (eg myocardial infarction) or prodromes (such as angina and transient ischemic attack),

· Presence or history of stroke,

· Presence of a severe risk factor or multiple risk factors for venous or arterial thrombosis (see section Warnings and Precautions for Use ) such as:

o diabetes with vascular symptoms,

o severe hypertension,

o severe dyslipoproteinemia.

· Hereditary or acquired predisposition to venous or arterial thrombosis, such as resistance to activated protein C (PCa), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia or the presence of anti-phospholipid antibody (anti-cardiolipin antibody, lupus anticoagulant);

· Pancreatitis or history of pancreatitis associated with severe hypertriglyceridemia;

· Severe hepatic disease or a history of severe liver disease, in the absence of normalized liver function tests;

· Hepatic tumor (benign or malignant) progressive or old;

· Known or suspected hormonal-dependent malignant neoplasm (eg, genitals or breasts)

· Vaginal bleeding of unknown origin;

· History of migraine with focal neurological signs;

· Hypersensitivity to any of the active ingredients or to any of the excipients of DIANE 35 micrograms, coated tablet.

Adverse effects Diane 35 Micrograms

There is an increased risk of thromboembolism in all women using DIANE 35 micrograms, coated tablets (see Warnings and Precautions ).

Adverse reactions reported with DIANE 35 micrograms, coated tablet are listed below by System Organ Class and by frequency. Frequencies are defined according to the following categories: rare (≥ 1/10 000 to <1/1000) and indeterminate frequency (can not be estimated based on available data).

Immune system disorders

Not known: Hypersensitivity

Metabolism and nutrition disorders

Not known: Water retention

Psychiatric disorders

Not known: depressed mood

Mood change

Decreased libido

Increased libido

Nervous system disorders

Not known: Headache

Migraine

Eye disorders

Not known: Eye irritation by contact lenses

Vascular disorders

Rare: Thromboembolic events

Gastrointestinal disorders

Not known: Nausea, Vomiting

Abdominal pain

Diarrhea

Skin and subcutaneous tissue disorders

Not known: Rash

Urticaria

Erythema nodosum

Erythema multiforme

Disorders of reproductive organs and breast

Not known: Breast pain

Breast tension

Breast hypertrophy

Vaginal discharge

Breast flow

investigations

Not known: Weight gain

Weightloss.

The following serious adverse reactions, described in the Warnings and Precautions for Use section, have been reported in women using DIANE 35 micrograms, coated tablets:

  • Venous thromboembolic events (phlebitis, deep vein thrombosis, pulmonary embolism).
  • Arterial thromboembolic events (in particular myocardial infarction, cerebrovascular accident).

Effects at discontinuation of treatment : post-treatment amenorrhea.

Amenorrhea with anovulation (more likely to occur in women with a history of irregular cycles) may be observed upon discontinuation of treatment. They usually disappear spontaneously. In case of prolongation, before any new prescription, the search for a possible pituitary pathology is necessary.

The following serious side effects seen in women who use oral iron-additive combinations are also described in the Warnings and Precautions for Use section .

Venous thromboembolic events (deep vein thrombosis, pulmonary embolism);

Arterial thromboembolic events (in particular myocardial infarction, stroke);

· High blood pressure

· Hyperlipidemia (hypertriglyceridaemia and / or hypercholesterolemia), diabetes;

· Intermenstrual bleeding, oligomenorrhea, amenorrhea;

· Pituitary adenoma with prolactin (possibly revealed by galactorrhea);

· Dizziness, change in vision

· Chronic or severe disruption of liver function that may require discontinuation of oral estrogen / progestin combination until normal liver function tests are normalized;

· Liver tumors (benign or malignant);

· Chloasma;

· Occurrence or worsening of the symptoms of angioedema by estrogens in women with hereditary angioedema;

· Occurrence or aggravation of conditions whose association with oral estrogen / progestogen combinations is not certain: Crohn's disease, haemorrhagic colitis, epilepsy, migraine, endometriosis, uterine fibroids, porphyria, systemic lupus erythematosus, herpes simplex, Sydenham's chorea hemolytic uremic syndrome, cholestatic jaundice, cholelithiasis.

The frequency of diagnosis of breast cancer is very slightly increased in users of oral estrogen / progestogen combinations. Because breast cancer is rare in women under 40, this increase is small relative to the overall risk of breast cancer. The causal relationship with the use of oral estrogen / progestin combination is unknown (see sections Contraindications and Warnings and Precautions for Use ).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals must report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. Website: www.ansm.sante.fr.

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