Medicinal Products

DESOBEL 150 μg / 30 μg

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

Compressed
Box of 3 Pads of 21
All forms

Indication

Oral contraception.

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

Dosage DESOBEL 150 μg / 30 μg Tablet Box of 3 Pads of 21

Take regularly and without forgetting 1 tablet per day at the same time of the day, for 21 consecutive days with a stop of 7 days between each plate.

· Start of oral contraception:
1st tablet to take the 1st day of the rules.

· Relay of another estroprogestatif:
1st tablet: after a 7-day stop if the previous pack contained 21 tablets (6 days if it contained 22 and no interval if it contained 28 tablets). If there is no withdrawal haemorrhage for 6 to 7 days after stopping the previous pill, make sure there is no pregnancy before starting treatment.

Case of forgetting one or more tablets

Forgetting a tablet puts you at risk for pregnancy.

If missed within 12 hours of the usual time of use, take the missed tablet immediately, and continue treatment normally by taking the next tablet at the usual time.

If forgetfulness is observed more than 12 hours after the normal time of taking, contraceptive security is no longer assured. Immediately take the last missed tablet and continue oral contraceptive treatment until the end of the pack, using simultaneously a method of contraceptive mechanical type (condoms, spermicides, ...) until the recovery of the next pack, including included during the rules.

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 .

Desobel side effects

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 .

Potentially related adverse reactions reported in users of DESOBEL 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 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.

A number of adverse reactions have been reported in users of combined hormonal 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. 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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