Medicinal Products

DESOBEL 150 micrograms / 30 micrograms

Generic drug of Varnoline
Therapeutic class: Contraception and termination of pregnancy
active ingredients: [Désogestrel + Ethinylestradiol, 4593]
laboratory: Effik

ComprimÚ
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 with other CHCs. (Combined Hormonal Contraceptives) (see sections Contraindications and Warnings and Precautions for Use ).

Dosage DESOBEL 150 micrograms / 30 micrograms tablet pack 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 with other CHCs. (Combined Hormonal Contraceptives) (see sections Contraindications and Warnings and Precautions for Use ).

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:

At presence or risk of venous thromboembolism (VTE):

o Venous thromboembolism - presence of VTE (patient treated with anticoagulants) or prior 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), a deficit in antithrombin III, a deficit in protein C, a deficit 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 ).

At presence or risk of arterial thromboembolism (ATE):

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

o Cestrovascular affection - presence or antecedents of cerebrovascular accident (CVA) or prodromes (eg transient ischemic attack [TIA]).

o known, inherited or acquired predisposition to "arterial thromboembolism, such as hyperhomocysteinase or the presence of antiphospholipid antibodies (anti-cardiolipin, lupus anticoagulant).

o Migraine antecedents with focal neurological signs.

o Risk of arterial thromboembolism due to the presence of multiple risk factors (see Warnings and Precautions ) or serious risk factors such as:

Diabetes with vascular symptoms,

º high blood pressure,

º dyslipoprotÊinà © mie sèvÞre,

Pancreatitis or antecedent of pancreatitis associated with severe hypertriglyceridemia.

• Present or previous severe liver disease as long as the parameters of the hepatic function are not normalized.

Hepatic tumor (benign or malignant) scalable or old.

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

Endometrial hyperplasia.

To undiagnosed genital bleeding.

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

Desobel side effects

Description of certain undesirable effects

An 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 HCCs. ; this is discussed in more detail under Warnings and Precautions .

The possibly related undesirable effects reported in users of DESOBEL or CHC in general are listed in the table below 1 :

Class of organ systems

FrÚquent

(> 1/100)

Not very frequent

(≥ 1/1000 and <1/100)

Rare

(<1/1000)

Immune system disorders

HypersensibilitÚ

Vascular disorders

Venous thromboembolism, arterial thromboembolism

Metabolism and nutrition disorders

Water retention

Psychiatric disorders

Depressive mood, mood change

Decreased libido

Increased libido

Nervous System Affections

Headache

Migraine

Eye disorders

Intolerance with contact lenses

Gastrointestinal disorders

Nausea, abdominal pain

Vomiting, diarrhea

Skin and subcutaneous tissue disorders

Rash, hives

Erythenous gnarly, polymorphous šrythüme

Disorders of the genital organs and the breast

Mastodynia, breast tensions

Increased breast volume

Vaginal discharge, breast discharge

investigations

Weight gain

Weightloss

1 the most appropriate MeDRA (version 11.0) terms to describe some of the reactions have been taken up. 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,

Hepatic tumors,

The appearance or aggravation of conditions whose association with HCC is not certain: Crohn's disease, hemorrhagic colitis, epilepsy, migraine, fibroid uterine, porphyria, lupus erythematous dissemina, herpes, Sydenham's chorea, uremic syndrome hymolytic, cholestatic jaundice,

To chloasma,

Chronic or severe disruption of the hepatic function that may require the discontinuation of a CHC until the liver function tests are normalized.

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

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Health professionals report any suspected adverse effects 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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