Medicinal Products

DROSPIRENONE / ETHINYL MYLAN 3 mg / 0.03 mg

Generic drug of Jasmine
Therapeutic class: Contraception and termination of pregnancy
active ingredients: Ethinyl estradiol, Drospirenone
laboratory: Mylan

Coated tablet
Box of 3 Pads of 21
All forms

Indication

Oral contraception.

The decision to prescribe DROSPIRENONE / ETHINYLESTRADIOL MYLAN 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 DROSPIRENONE / ETHINYLESTRADIOL MYLAN in comparison other HCCs (see Contraindications and Warnings and Precautions ) sections.

Dosage DROSPIRENONE / ETHINYL MYLAN 3 mg / 0.03 mg Film-coated tablet Box of 3 packs of 21

Route of administration:

Oral way.

How to take DROSPIRENONE / ETHINYLESTRADIOL MYLAN 3 mg / 0.03 mg, film-coated tablet:

The tablets should be taken each day at about the same time, possibly with a little liquid, in the order indicated on the plate. Take one tablet daily for 21 consecutive days.

Start the next pack after a 7-day stop during which withdrawal bleeding usually occurs. This usually starts 2 or 3 days after the last tablet. It is possible that this deprivation haemorrhage is not complete when you start the next pack.

Procedures for initiating treatment with DROSPIRENONE / ETHINYLESTRADIOL MYLAN 3 mg / 0.03 mg film-coated tablets:

· Absence of previous hormonal contraception (the previous month):

Tablets should start on the first day of the cycle, the first day of menstruation.

· Relay of an estroprogestative contraceptive method (combined oral contraception / COC, vaginal ring or transdermal patch):

Start treatment with DROSPIRENONE / ETHINYLESTRADIOL MYLAN 3 mg / 0.03 mg, film-coated tablet preferably the day after taking the last active tablet (last tablet containing active substances) from the previous COC, or at the latest on the day follow the usual period of stopping the tablets, or the day after taking the last placebo tablet from the previous COC. In case of vaginal ring or transdermal patch relay, take the first tablet of DROSPIRENONE / ETHINYLESTRADIOL MYLAN 3 mg / 0.03 mg film-coated tablet preferably on the day of withdrawal, or at the latest on the scheduled day for the new pose.

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

In a woman, the relay can be done:

o at any point in the cycle if it is a progestin-only pill,

o the day of removal if it is an implant or an SIU,

o or the day scheduled for the next injection if it is an injectable form.

In any case, women should be advised to use a complementary method of contraception during the first 7 days of taking DROSPIRENONE / ETHINYLESTRADIOL MYLAN 3 mg / 0.03 mg film-coated tablets.

· After a pregnancy termination during the first trimester:

It is possible to start contraception immediately in these women. It is not necessary to use a complementary method of contraception.

· After a delivery or pregnancy termination during the second trimester:

Women will be advised to start contraception only after 21 to 28 days. If this contraception is started later, they will be advised to use a complementary method of contraception during the first 7 days of treatment. However, if sexual intercourse has already occurred, it should be ensured that there is no pregnancy before starting the oral contraceptive pill or waiting for the first period.

In case of breastfeeding, see section Pregnancy and breastfeeding .

What to do if you forget one or more tablets:

A delay of less than 12 hours in taking a tablet does not affect the contraceptive effectiveness. Women will be advised to take the forgotten tablet immediately as soon as this forgetfulness is noted; the following tablets are taken at the usual time.

If the delay is greater than 12 hours, contraceptive security may be decreased. 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 greater as the number of forgotten tablets is important or the date of forgetting is close to the beginning of the pack.

· 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 method of contraception 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; additional contraceptive measures must therefore be taken.

· If vomiting occurs within 3-4 hours of 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 guidelines as those given for tablet omissions should apply (see section 4.2) and how to take it in case of forgetting one or more tablets. ").

If the woman does not want to change the normal schedule of taking the tablets, she should take the extra tablet (s) from another pack.

How to delay the rules?

The onset of menses may be delayed by starting a new pack of DROSPIRENONE / ETHINYLESTRADIOL MYLAN 3 mg / 0.03 mg film-coated tablets without respite. The rules may be delayed until the end of the second wafer if necessary. During this period, bleeding or spotting may occur. DROSPIRENONE / ETHINYLESTRADIOL MYLAN 3 mg / 0.03 mg, film-coated tablet can then be resumed regularly after the usual free interval of 7 days.

It is possible to shift the occurrence of the rules to another day of the week by shortening the duration of the free interval by the number of days required.

As with a delay in menses, the shorter the interval between two platelets, the greater the risk of absence of withdrawal hemorrhage and the occurrence of metrorrhagia or spotting when taking tablets from the following pack.

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, stop treatment immediately:

· Presence or risk of venous thromboembolism (VTE):

o Venous thromboembolism - presence of VTE (patient treated with anticoagulants) or 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.

· Severe hepatic disease or a history of severe liver disease, in the absence of normalized liver function tests;

· Severe or acute renal insufficiency;

· Hepatic tumor (benign or malignant) progressive or old;

· Known or suspected hormonal-dependent malignant neoplasm (eg, genitals or breasts)

· Vaginal bleeding of unknown origin;

· Hypersensitivity to any of the active ingredients or to any of the excipients of DROSPIRENONE / ETHINYLESTRADIOL MYLAN listed under Composition .

Drospirenone / Ethinyl Mylan side effects

For serious adverse reactions in COC users, see Warnings and Precautions .

The following side effects have been reported during the use of the combination of ethinyl estradiol and drospirenone:

System-Organ Classification

Frequency of adverse effects

Frequent ³ 1/100 to <1/10

Uncommon ³ 1/1000 to <1/100,

Rare ³ 1/10 000 to <1/1000

Immune system disorders

Hypersensitivity, Asthma

Psychiatric disorders

Depressed mood

Nervous system disorders

headaches

Affections of the ear and labyrinth

Hearing Loss

Vascular system

Migraine

Hypertension,
hypotension

Venous Thromboembolism (VTE) and Arterial Thromboembolism (ATE)

Gastrointestinal disorders

Nausea

vomiting,

Diarrhea

Skin and subcutaneous tissue disorders

Acne,
eczema,
pruritus,

alopecia

Erythema nodosum

Erythema multiforme

Disorders of reproductive organs and breast

Menstrual disorders,
intermenstrual bleeding,
breast pain,
breast tenderness,
leucorrhea,
vaginal candidiasis

Increased breast volume,
changes in libido,
vaginitis

Breast secretion

investigations

Fluid retention,
change in weight

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 .

The following serious adverse reactions that have been reported in women using COCs are discussed under Warnings and Precautions for Use . :

Venous thromboembolic events,

· Arterial thromboembolic events,

· Hypertension,

· Liver tumors,

· Onset or aggravation of conditions that are not known to be associated with COCs: Crohn's disease, haemorrhagic colitis, epilepsy, migraine, uterine fibroids, 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 cessation of COC until hepatic function tests are normalized,

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

The frequency of breast cancer diagnosis is very slightly increased among COC users. Since breast cancer is rare in women under 40, this increase is small relative to the overall risk of breast cancer. The causal relationship with the use of COC remains unknown. For more information, refer to the sections Contraindications and Warnings and precautions for use .

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 must 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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