Medicinal Products

DESOGESTREL ETHINYL BIOGARAN 150 μg / 20 μg

Generic drug from Mercilon
Therapeutic class: Contraception and termination of pregnancy
active ingredients: Desogestrel, Ethinylestradiol
laboratory: Biogaran

Coated tablet
Box of 1 Plate of 21
All forms

Indication

Oral hormonal contraception.

The decision to prescribe DESOGESTREL ETHINYLESTRADIOL BIOGARAN must 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 DESOGESTREL ETHINYLESTRADIOL BIOGARAN in comparison to other CHC (Combined Hormonal Contraceptives) (see sections Contraindications and Warnings and Precautions for Use ).

Dosage DESOGESTREL ETHINYL BIOGARAN 150 μg / 20 μg Coated Tablet Box of 1 Plate of 21

The tablets should be taken in the order indicated on the plate, each day at the same time of the day (possibly with a little water). One tablet should be taken daily for 21 consecutive days followed by a 7 day break between each pack. A withdrawal hemorrhage usually begins 2-3 days after the last tablet is taken and may continue after the beginning of the next pack.

Methods of initiation of treatment with DESOGESTREL ETHINYLESTRADIOL BIOGARAN:

· Absence of hormonal contraception the previous month :

Take the first tablet on the first day of menstruation.

· Relay of another estrogen / progestogen contraceptive method (combined hormonal contraceptive (CHC), vaginal ring or transdermal system (patch)) :

Preferably take the first tablet of DESOGESTREL ETHINYLESTRADIOL BIOGARAN the day after taking the last active tablet of the previous contraceptive or at the latest one day after the usual period of stopping tablets or taking placebo tablets. In reliance on a vaginal ring or patch, take the first tablet of DESOGESTREL ETHINYLESTRADIOL BIOGARAN preferably on the day of withdrawal or at the latest on the day scheduled for the new pose.

· Relay of progestin-only contraception (microdose pill, injectable form, implant) or intrauterine system (IUS) containing a progestin :

The relay of a microdosed contraception can be done at any time of the cycle and DESOGESTREL ETHINYLESTRADIOL BIOGARAN should be started the day after the stop. The relay of an implant or a SIU containing a progestin is done on the day of withdrawal, or the day scheduled for the new injection if it is the relay of an injectable contraceptive. In all cases, it is recommended to use a complementary method of non-hormonal contraception during the first 7 days of treatment.

· After a first trimester pregnancy termination :

It is possible to start DESOGESTREL ETHINYLESTRADIOL BIOGARAN immediately. It is not necessary to use a complementary method of contraception.

· After a delivery or after a second trimester miscarriage :

Since immediate postpartum is associated with an increased risk of thromboembolism, oral contraceptives should not be started less than 21 to 28 days after delivery or second trimester abortion.

If treatment is started more than 28 days after a second trimester delivery or abortion, it is recommended that a complementary method of mechanical contraception be used for the first 7 days of treatment. However, if sexual intercourse has already occurred, it should be ensured that there is no pregnancy before the start of estrogen / progestin oral contraceptive or waiting for the first period.

In case of breastfeeding: see section Pregnancy and breastfeeding .

Case of forgetting one or more tablets

Forgetting a tablet puts you at risk for pregnancy.

Contraceptive security may be diminished in case of forgetting especially if this forgetfulness increases the time interval between the last tablet of the current wafer and the first tablet of the following wafer.

If you miss a tablet within 12 hours of the usual time, take the missed tablet immediately and continue taking CHC normally by taking the next tablet at the usual time.

If a tablet is missed more than 12 hours after the normal time, contraceptive effectiveness may be reduced. In case of forgetting tablets, the following two rules must be known as necessary to choose the behavior to take:

1. The interval between 2 platelets must never exceed 7 days;

2. Seven days of uninterrupted treatment are required to achieve correct inhibition of the hypothalamic-pituitary-ovarian axis.

As a result, the following tips may be given as part of daily practice:

· Week 1

Women should be asked to take the last forgotten tablet as soon as they forget it, even if it means taking two tablets at the same time.

The following tablets should be taken at the usual time. Additional mechanical contraception (condoms for example) is necessary for the next 7 days. If sexual intercourse took place during the 7 days preceding the forgetfulness, there is a risk of pregnancy.

The risk of pregnancy is all the higher as the number of forgotten tablets is important or the date of forgetting is close to the usual interval without taking a tablet.

· Week 2

Women should be advised to take the last missed tablet as soon as they forget it, even if it means taking two tablets at the same time.

The following tablets should be taken at the usual time.

If the tablets were taken correctly within 7 days of the first missed tablet, no additional contraceptive measures are necessary. However, if multiple tablets are missed, women should be advised to take additional precautions for 7 days.

· Week 3

The risk of decreased contraceptive activity is highest due to the proximity of the 7-day stop. However, it is possible to prevent a decrease in the contraceptive effect by adjusting the dosage of the tablets as follows:

o If the woman has taken all the tablets correctly during the 7 days prior to a missed pill, no additional contraceptive measures are necessary. It is possible to follow one of the 2 setting schemes described below.

o Otherwise, women should be advised to follow the first regimen and use a complementary contraceptive method for the next 7 days:

Figure 1:

It will be advisable for women to take the last forgotten tablet as soon as this forgetfulness is noticed, even if two tablets should be taken at the same time. The following tablets will then be taken at the usual time. The following plate must be started at the end of the previous one, that is to say without stopping between the two plates. A withdrawal bleed is unlikely before the end of the second wafer, but spottings or bleeding may be observed while the tablets are in use.

Figure 2:

A stop of taking tablets of the current wafer may alternatively be advised to women in this situation. In this case, a break of up to 7 days, including the number of days that tablets have been missed, must be respected before starting the next pack.

In a woman who has forgotten to take a tablet (s), the absence of withdrawal hemorrhage between the two platelets will have to seek a possible pregnancy.

What to do in case of gastrointestinal disorders:

In severe gastrointestinal disorders (eg, vomiting or diarrhea), tablet absorption may not be complete and additional contraceptive measures should be taken.

If vomiting occurs within 3-4 hours after taking the tablet, a new tablet should be taken as a replacement as soon as possible. The new tablet should be taken, if possible, within 12 hours after the usual dose. If more than 12 hours have elapsed, the same instructions as for missed tablets should apply (see section 4.2 ).

In the case of prolonged episodes, another reliable method of contraception should be considered (condoms, spermicides, etc.) until the next pack is taken again, including during menses.

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 S deficiency;

o Major surgery with prolonged immobilization (see Warnings and Precautions section );

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 (anti-cardiolipin antibody, lupus anticoagulant);

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.

DESOGESTREL ETHINYLESTRADIOL BIOGARAN is contraindicated in combination with St. John's Wort (see section Interactions with other medicinal products and other forms of interaction ).

Undesirable effects Desogestrel Ethinyl Biogaran

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 .

Possible undesirable effects reported in users of DESOGESTREL ETHINYLESTRADIOL BIOGARAN 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 and 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 disruption of 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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