Medicinal Products

DESOGESTREL / ETHINYLESTRADIOL BIOGARANCONTINU 150 micrograms / 30 micrograms

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

Coated tablet
pack of 3 blister packs of 28 film-coated tablets (21 white + 7 green)
All forms

Indication

Oral contraception.

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

Dosage DESOGESTREL / ETHINYLESTRADIOL BIOGARANCONTINU 150 micrograms / 30 micrograms film-coated tablet box of 3 blister packs of 28 film-coated tablets (21 white + 7 green)

Oral contraception.

The decision to prescribe DESOGESTREL / ETHINYLESTRADIOL BIOGARANCONTINU should be made taking into account the risk factors of the patient, including its risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with DESOGESTREL / ETHINYLESTRADIOL BIOGARANCONTINU 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.

· Pregnancy known or suspected.

· Hypersensitivity to the active substances or to any of the excipients.

Undesirable effects Desogestrel / ethinyl Biog Con

As with all COCs, changes in vaginal bleeding can occur, especially during the first few months of use. They may include changes in their frequency (absent, more or less frequent, or continuous) their intensity (reduced or increased) or their duration.

For serious adverse reactions in COC users, see Warnings and Precautions for Use .

There is an increased risk of venous thromboembolism in all women who use HCC. For information on risk differences between HCCs, see Warnings and Precautions .

The potential adverse reactions reported in COC users containing 150 micrograms of desogestrel and 30 micrograms of ethinyl estradiol (such as DESOGESTREL / ETHINYLESTRADIOL BIOGARANCONTINU) or in COC users in general are listed in the table below 3 . All adverse reactions are classified by organ system and frequency; very common (> 1/10), common (> 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100), rare (<1/1000) and unknown (can not be estimated based on available data).

Class of organ systems

Very common (> 1/10)

Frequent (≥1 / 100; <1/10)

Uncommon (≥ 1/1000; <1/100

Rare (<1/1000)

Infections and infestations

Vaginal candidiasis

Immune system disorders

hypersensitivity

Metabolism and nutrition disorders

Water retention

Psychiatric disorders

Depressed mood

Altered mood

Decreased libido

Increased libido

Nervous system disorders

headaches

Dizziness

Nervousness

Migraine

Eye disorders

Contact lens intolerance

Ear and labyrinth disorders

otosclerosis

Vascular disorders

Hypertension

Venous or arterial thrombosis

Gastrointestinal disorders

nausea

Abdominal pain

Diarrhea Vomiting

Skin and subcutaneous tissue disorders

Acne

Skin rash

Urticaria

Erythema nodosum

Erythema multiforme

itching

Alopecia

Disorders of reproductive organs and breast

Irregular bleeding

Amenorrhea

Breast tension

Breast pain

metrorrhagia

Breast hypertrophy

Vaginal discharge

Breast flow

General disorders and administration site conditions

Weight gain

Weightloss

1 the most appropriate MeDRA (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.

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 .

The following serious side effects have been observed in women who use COC and are also listed under Warnings and Precautions for Use :

· Hypertension;

· Hormone-dependent tumors (eg liver tumors, breast cancer);

· Occurrence or worsening of conditions that are not known to be associated with HCC: Crohn's disease, ulcerative colitis, epilepsy, migraine, endometriosis, uterine myoma, porphyria, systemic lupus erythematosus, herpes simplex, Sydenham's chorea, syndrome hemolytic and uremic, cholestatic jaundice.

· Chloasma.

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 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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