Medicinal Products

DESOBEL 150 micrograms / 20 micrograms

Generic drug from Mercilon
Therapeutic class: Contraception and termination of pregnancy
active ingredients: [Desogestrel + Ethinyl estradiol, 3885]
laboratory: Effik

© tablet
box of 1 plate of 21
All forms

Indication

Oral contraception.

The decision to prescribe DESOBEL 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 DESOBEL compared to other CHCs. (Combined Hormonal Contraceptives) (see sections Contraindications and Warnings and Precautions ).

Dosage DESOBEL 150 micrograms / 20 micrograms tablet box of 1 plate of 21

Oral contraception.

The decision to prescribe DESOBEL 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 DESOBEL compared to other CHCs. (Combined Hormonal Contraceptives) (see sections Contraindications and Warnings and Precautions ).

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 previous VTE (eg deep vein thrombosis [DVT] or pulmonary embolism [PE]).

o Known, inherited or acquired provision for venous thromboembolism, such as resistance to activated protein C (PCa) (including a factor V mutation in Leiden ), a defect in antithrombin III, a defect in protein C, a defect in protein 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 Warnings and Precautions section ).

 · 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 Cesarovascular condition - presence or history of cerebrovascular accident (CVA) or prodromes (eg transient ischemic attack [TIA]).

o Known, inherited or acquired provision for arterial thromboembolism, such as hyperhomocystemia or the presence of antiphospholipid antibodies (anti-cardiolipin antibody, anticoagulant lupus).

o Migraine antecedents with focal neurological signs.

o High risk of arterial thromboembolism due to the presence of multiple risk factors (see Warnings and Precautions ) or a serious risk factor. re such as:

Diabetes with vascular symptoms;

§ Severe arterial hypertension;

                                                                                           Â

· Pancreatitis or anterior pancreatitis associated with severe hypertriglyceridemia.

 · Presence or previous hematologic disorder is severe until the parameters of the hematology function are normalized.

· Hematologic tumor (benign or malignant), elective or old.

· Hormone-dependent malignant neoplasm known or suspected (eg, genitals or breasts).

· Endometrial hyperplasia.

 · Undiagnosed genital bleedings.

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

Desobel side effects

Description of some particular undesirable effects

Increased risk of arterial and venous thrombotic and thromboembolic events, including myocardial infarction, stroke, transient ischemic events, venous thrombosis, and pulmonary embolism, Has been observed in women using HCC; this is discussed in more detail under Warnings and Precautions .

Possible adverse effects reported for users of DESOBEL or CHC in general are listed in the table below 1 :

Class of organ systems

Frà © Quent

(> 1/100)

Not very frequent

(≥ 1/1000 and <1/100)

Rare

(<1/1000)

Immune system disorders

© HypersensibilitÃ

Vascular disorders

Venous thromboembolism and arterial thromboembolism

Metabolism and nutrition disorders

Water retention

Psychiatric disorders

Depressive mood, mood swings

Decreased libido

Increased libido

Nervous system disorders

Headache

Migraine

Eye disorders

Intolerance to contact lenses

Gastrointestinal disorders

Nausea, abdominal pain

Vomiting, diarrhea

Skin and subcutaneous tissue disorders

Rash, hives

Erytheme gnarly, polymorphic rhythms

Conditions of the genitals and breast

Mastodynia, breast tensions

Increased breast volume

Vaginal discharge, breast discharge

investigations

Weight gain

Weightloss

1 The most appropriate MeDRA (version 11.0) terms for describing certain actions have been taken over. Synonyms and related conditions are not mentioned but should also be taken into account.

A number of the undesirable effects reported in users of combined hormonal contraceptives are detailed in the Warnings and Precautions section . :

· Arterial hypertension,

· Hemostatic tumors,

 · onset or aggravation of conditions whose association with HCC is not certain: Crohn's disease, hemorrhagic colitis, epilepsy, migraine, uterine fibroids, porphyria, lupus erythematosus Minnesota, Herpes Pregnant, Sydenham's Chorea, Hemolytic Uremic Syndrome, Cholestatic jaundice,

· Chloasma,

· Chronic or severe disruption of the hepatic function that may require the discontinuation of a CHC until normalization of the liver function tests,

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

Declaration of suspected untoward effects

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

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