Generic drug of the therapeutic class: Contraception and termination of pregnancy
active ingredients: Norgestimate + Ethinylestradiol
laboratory: Effik

© tablet
box of 3 wafers of 21
All forms

Indication

Oral contraception.

The decision to prescribe EFFIPREV should be made taking into account the risk factors of the patient, including her risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with EFFIPREV compared to other CHCs. (Combined Hormonal Contraceptives) (see sections Contraindications and Warnings and Precautions ).

Dosage EFFIPREV compressed box of 3 platelets of 21

Oral contraception.

The decision to prescribe EFFIPREV should be made taking into account the risk factors of the patient, including her risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with EFFIPREV 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 while taking oral contraception, discontinue the treatment immediately.

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

· 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 previous 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,

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 · Malignant neoplasms of the breast and uterus.

 · Severe or recent hemopathic conditions.

 · Pituitary tumors.

 · Undiagnosed genital bleedings.

· Connectivites.

· Porphyries.

· In combination with St. John's Wort.

This medicine is generally discouraged in the following situations:

· Smoking.

 · Metabolic disorders: uncomplicated diabetes, hyperlipidemia (hypertriglyceridia, hypercholesterolemia).

· Obesity (Body Mass Index = Weight / Height 2 > 30 kg / m 2 ).

 · Otosclà © rose.

 · Benign breast tumors and uterine dystrophies (hyperplasia, fibroma).

· Hyperprolactinemia with or without galactorrhea.

 · Renal insufficiency.

· Recurrent cholestasis or pruritus recurring during previous pregnancy.

· Herpes gestationis.

· In combination with enzyme inducers (see section Interactions with other medicinal products and other forms of interaction ).

· Breast-feeding (see section Pregnancy and breast-feeding ).

Adverse effects Effiprev

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 .

· Adverse effects that are relatively rare but need to stop treatment:

o Arterial thromboembolic accidents (especially myocardial infarction, stroke).

o Venous thromboembolic accidents (phlebotomy, pulmonary embolism).

o arterial hypertension, coronary artery disease.

o Hyperlipidemia (hypertriglyceridia and / or hypercholesterolemia), diabetes.

o Severe mastodynia, benign mastopathy.

o Pituitary adenoma to prolactin (possibly revealed by galactorrhea).

o Important and unusual episodes, migraines, vertigo, vision changes.

o Exacerbation of a comitiality.

o Hematologic adenoma, cholestatic jaundice.

o Chloasma.

· Untoward effects are more frequent, usually not preventing continuation of treatment but may lead to a change in the type of estrogen / progestogen:

o Nausea, mundane crap, weight gain, irritability, heavy legs.

o Mammary tension, intermenstrual bleeding, oligomorphic, ameliorated, modified libido.

o Eye irritation by contact lenses.

· Rarely:

o Acne, seborrhea, hypertrichosis.

· Other: cholelithiasis.

 · Effects at the end of treatment: post-therapeutic ameliorations.

Anovulatory disorders (more likely to occur in women with irregular cycles) may be observed when treatment is discontinued. They usually sell spontaneously. In case of prolongation, before any new prescription, the search for an eventual pituitary pathology is necessary.

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 Health and Medical Products Safety Authority (Ansm) and Network Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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