Medicinal Products

DESOGESTREL / ETHINYLESTRADIOL MYLAN 150 micrograms / 30 micrograms

Generic drug of Varnoline
Therapeutic class: Contraception and termination of pregnancy
active ingredients: Desogestrel + Ethinylestradiol
laboratory: Mylan

Compressed
box of 3 pads of 21
All forms

Indication

Oral contraception.

The decision to prescribe DESOGESTREL / ETHINYLESTRADIOL MYLAN should be made taking into account the risk factors of the patient, including risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with DESOGESTREL / ETHINYLESTRADIOL MYLAN in comparison other HCCs (see Contraindications and Warnings and Precautions ) sections.

Dosage DESOGESTREL / ETHINYLESTRADIOL MYLAN 150 micrograms / 30 micrograms tablet box of 3 platelets of 21

Oral contraception.

The decision to prescribe DESOGESTREL / ETHINYLESTRADIOL MYLAN should be made taking into account the risk factors of the patient, including risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with DESOGESTREL / ETHINYLESTRADIOL MYLAN in comparison other HCCs (see Contraindications and Warnings and Precautions ) sections.

Against indications

Combined hormonal contraceptives (HCC) should not be used in the following situations.

If any of these conditions occur for the first time when taking a CHC, stop the treatment immediately:

· Presence or risk of venous thromboembolism (VTE):

o Venous thromboembolism - presence of VTE (patient treated with anticoagulants) or a history of VTE (eg deep vein thrombosis [DVT] or pulmonary embolism [PE]).

o Known, inherited or acquired predisposition to venous thromboembolism, such as resistance to activated protein C (PCa) (including a factor V Leiden mutation), antithrombin III deficiency, protein deficiency C, a protein deficit S.

o Major surgery with prolonged immobilization (see section Warnings and Precautions ).

o High risk of venous thromboembolism due to the presence of multiple risk factors (see section Warnings and precautions for use ).

· Presence or risk of arterial thromboembolism (AME):

o Arterial thromboembolism - presence or history of arterial thromboembolism (eg, myocardial infarction [MI]) or prodromes (eg, angina pectoris).

o Cerebrovascular disease - presence or history of stroke or prodromes (eg transient ischemic attack [TIA]).

o Known, inherited or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinemia or the presence of anti-phospholipid antibodies (anticardiolipin antibodies, lupus anticoagulants).

o History of migraine with focal neurological signs.

o High risk of arterial thromboembolism due to the presence of multiple risk factors (see section Warnings and precautions for use ) or a severe risk factor such as:

§ diabetes with vascular symptoms,

§ severe hypertension,

§ severe dyslipoproteinemia,

· Pancreatitis or history of pancreatitis associated with severe hypertriglyceridemia.

· Presence or history of severe liver disease until hepatic function parameters are normalized.

· Liver tumor (benign or malignant) progressive or old.

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

· Endometrial hyperplasia.

· Undiagnosed genital haemorrhages.

· Hypersensitivity to the active substances or to any of the excipients listed under Composition .

DESOGESTREL / ETHINYLESTRADIOL MYLAN is contraindicated in combination with St. John's wort (see section Interactions with other medicinal products and other forms of interaction ).

Undesirable effects Desogestrel Ethinyl Mylan

Description of some specific adverse effects

An increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis, and pulmonary embolism, has been observed in women using HCCs ; this is discussed in more detail in the Warnings and Precautions section .

Possible undesirable effects reported in users of DESOGESTREL / ETHINYLESTRADIOL MYLAN or CHC in general are listed in the table below 1 :

Class of organ systems

Frequent

(> 1/100)

Rare

(≥ 1/1000 and <1/100)

Rare

(<1/1000)

Immune system disorders

hypersensitivity

Vascular disorders

Venous thromboembolism, arterial thromboembolism

Metabolism and nutrition disorders

Water retention

Psychiatric disorders

Depressed mood, change of mood

Decreased libido

Increased libido

Nervous system disorders

Headache

Migraine

Eye disorders

Contact lens intolerance

Gastrointestinal disorders

Nausea, abdominal pain

Vomiting, diarrhea

Skin and subcutaneous tissue disorders

Rash, hives

Erythema nodosum, erythema multiforme

Affections of the genitals and breast

Mastodynia, breast tensions

Increased breast volume

Vaginal discharge, breast discharge

investigations

Weight gain

Weightloss

1 the most appropriate MedDRA (version 11.0) terms to describe certain reactions have been taken up. Synonyms and related conditions are not mentioned but should also be taken into account.

A number of adverse reactions have been reported in users of combined oral contraceptives, and are detailed in the Warnings and Precautions for Use section . :

· High blood pressure,

· Liver tumors,

· Onset or aggravation of conditions that are not known to be associated with HCC: Crohn's disease, haemorrhagic colitis, epilepsy, migraine, uterine fibroma, porphyria, systemic lupus erythematosus, herpes simplex, Sydenham's chorea, hemolytic uremic syndrome cholestatic jaundice

· Chloasma,

· Chronic or severe changes in liver function that may require discontinuation of HCC until hepatic function tests are normalized.

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

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. Health professionals declare any suspected adverse reaction 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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