Medicinal Products

DROPHENENONE / ETHINYL MYLAN CON 3 mg / 0.02 mg

Generic drug of Jasminellcontinu
Therapeutic class: Contraception and termination of pregnancy
active ingredients: Active tablet (pink): Ethinylestradiol, Drospirenone
laboratory: Mylan

Coated tablet
Box of 1 blister pack of 28 film-coated tablets (21 pink + 7 white)
All forms

Indication

Oral contraception.

The decision to prescribe DROSPIRENONE / ETHINYLESTRADIOL MYLAN CONTINUOUS 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 DROSPIRENONE / ETHINYLESTRADIOL MYLAN CONTINU compared to other HCCs (see Contraindications and Warnings and Precautions ) sections.

Dosage DROSPIRENONE / ETHINYL MYLAN CON 3 mg / 0.02 mg Film-coated tablet Box of 1 blister of 28 film-coated tablets (21 pink + 7 white)

Route of administration:

Oral way.

How to take DROPHINENONE / ETHINYLESTRADIOL CONTINUOUS MYLAN 3 mg / 0.02 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.

The tablets should be taken continuously. Take one tablet each day for 28 consecutive days.

Begin the next pack the day after taking the last tablet from the previous pack. A withdrawal hemorrhage usually starts 2-3 days after starting the row of placebo tablets (last row) and may not be complete when you start the next pack.

Procedures for initiating treatment with DROSPIRENONE / ETHINYLESTRADIOL MYLAN CONTINUOUS 3 mg / 0.02 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 DROPHINENONE / ETHINYLESTRADIOL CONTINUOUS MYLAN 3 mg / 0.02 mg, film-coated tablet preferably the day after taking the last active tablet (last tablet containing the active substances) of the previous COC, or at the latest the day which follows the usual period of stopping the tablets, or the day after taking the last placebo tablet from the previous COC.

In the case of a vaginal ring or transdermal patch, take the first tablet of DROSPIRENONE / ETHINYLESTRADIOL MYLAN CONTINUOUS 3 mg / 0.02 mg film-coated tablet preferably on the day of withdrawal, or at the latest planned 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 all cases, women should be advised to use a complementary method of contraception during the first 7 days of taking DROPHIRENONE / ETHINYLESTRADIOL MYLAN CONTINUOUS 3 mg / 0.02 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:

The omission of tablets from the last row of the wafer corresponds to the omission of placebo tablets and is therefore of no real importance. However, forgotten tablets should be discarded to prevent unintentional prolongation of the placebo period.

The following tips apply only if you forget active tablets (ie tablets in rows 1 to 3 of the pack).

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 higher as the number of forgotten tablets is important or the date of oblivion is close to the beginning of the row of placebo tablets.

· 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 a decrease in contraceptive activity is greatest because of the proximity of taking 7 days of placebo tablets.

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 are then taken at the usual time until you have finished the active tablet tablets. The seven tablets in the last row (placebo tablets) should not be taken. The following plate must be started immediately. A withdrawal hemorrhage is unlikely before the end of the active tablets of the second platelet, but "spottings" or metrorrhagia can be observed during the duration of taking tablets.

Figure 2:

Alternatively, the woman may be advised to discontinue active tablet active tablets. She will then need to take last-resort tablets (placebo tablets) for up to 7 days, including the number of days that tablets have been missed, and she will then start the next pack.

In a woman who has forgotten to take a tablet (s), the absence of withdrawal hemorrhage during the taking of placebo tablets should make look for 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 after taking an active 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 occurrence of menses may be delayed by starting a new pack of DROPHINENONE / ETHINYLESTRADIOL MYLAN CONTINUOUS 3mg / 0.02mg, film-coated tablet without taking placebo tablets from the current pack.

The rules may be delayed until the end of the active tablets of the second pack if necessary.

During this period, metrorrhagia or spottings may occur.

DROSPIRENONE / ETHINYLESTRADIOL MYLAN CONTINUOUS 3 mg / 0.02 mg, film-coated tablet can then be resumed after taking placebos tablets.

It is possible to shift the onset of the rules to another day of the week by shortening the duration of taking tablets placebos the number of days needed.

As for a delay of menses, the shorter the interval, the greater the risk of absence of withdrawal bleeding and the occurrence of metrorrhagia or "spottings" when taking tablets of the following wafer.

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,

· 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 CONTINUOUS listed under Composition .

Adverse effects Drospirenone / Ethinyl Mylan Con

See also Warnings and Precautions for Serious Adverse Reactions in CHC Users.

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

Based on clinical trials, the following table describes by frequency the adverse effects according to the MedDRA system-organ classification.

Classification
System Organ

Frequency of adverse effects

Frequent
≥1 / 100 to <1/10

Rare
≥1 / 1000 to <1/100

Rare
≥1 / 10000 to <1/1000

Infections and infestations

Candidiasis, Herpes simplex

Immune system disorders

Allergic reaction

Asthma

Metabolism and nutrition disorders

Increased appetite

Psychiatric disorders

Emotional lability

Depression, Nervousness, Sleep Disorders

Nervous system disorders

headaches

Paresthesia, Dizziness

Affections of the ear and labyrinth

Hearing Loss

Eye disorders

Abnormal vision

Heart conditions

Extrasystoles, Tachycardia

Vascular disorders

Hypertension, Hypotension, Migraine, Varicose veins

Venous thromboembolism (VTE)

Arterial thromboembolism (ATE)

Respiratory, thoracic and mediastinal disorders

Pharyngitis

Gastrointestinal disorders

Abdominal pain

Nausea, Vomiting, Gastroenteritis, Diarrhea, Constipation, Gastrointestinal disorders

Skin and subcutaneous tissue disorders

Acne

Angioedema, Alopecia, Eczema, Pruritus, Rash, Dry Skin, Seborrhea, Skin Disorders

Erythema nodosum
Erythema multiforme

Musculoskeletal and systemic disorders

Neck pain, extremity pain, muscle cramps

Renal and urinary disorders

Cystitis

Disorders of reproductive organs and breast

Breast pain, Breast enlargement, Breast tenderness, Dysmenorrhea, Metrorrhagia

Breast cancer, Fibrocystic disease, Galactorrhoea, Ovarian cyst, Hot flashes, Menstrual disorders, Amenorrhea, Menorrhagia, Vaginal candidiasis, Vaginitis, Vaginal discharge, Vulvovaginal disorders, Vaginal dryness, Pelvic pain, Doubtful cervical smear (Pap smear), Decrease libido

General disorders and administration site conditions

Edema, Asthenia, Pain, Excessive thirst, Hypersudation

investigations

Weight gain

Weightloss

The term most appropriate MedDRA is used to describe a certain type of reaction as well as its synonyms and related pathologies.

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 side effects seen in women who use oral contraceptives are also described in the Warnings and Precautions for Use section .

Venous thromboembolic events;

· Arterial thromboembolic events;

· Hypertension;

· Liver tumors;

· Occurrence or worsening of conditions whose association with oral contraceptives is uncertain: Crohn's disease, haemorrhagic colitis, epilepsy, migraine, uterine fibroma, porphyria, systemic lupus erythematosus, herpes simplex, Sydenham's chorea, uremic syndrome hemolytic, cholestatic jaundice;

· Chloasma;

· Chronic or severe disruption of liver function that may require discontinuation of oral contraception until normal liver function tests are normalized;

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

The frequency of diagnosis of breast cancer is very slightly increased among users of combined oral contraceptives. Because breast cancer is rare in women under 40, this increase is small relative to the overall risk of breast cancer. The causal relationship with oral contraceptive use 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 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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