Medicinal Products

DROSPIRENONE / ETHINYL MYL PH CO 3 mg / 0.02 mg

Yaz Generic Drug
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 (24 pink + 4 white)
All forms

Indication

Oral contraception.

The decision to prescribe DROSPIRENONE / ETHINYLESTRADIOL MYLAN PHARMA CONTINUOUS must be made taking into account the risk factors of the patient, including its risk factors for venous thromboembolism (VTE), as well as the risk of VTE associated with DROSPIRENONE / ETHINYLESTRADIOL MYLAN PHARMA CONTINUOUS compared to other HCCs (see Contraindications and Warnings and Precautions ) sections.

Dosage DROSPIRENONE / ETHINYL MYL PH CO 3 mg / 0.02 mg Film-coated tablet Box of 1 blister of 28 film-coated tablets (24 pink + 4 white)

Route of administration: oral.

How to use DROPHINENONE / ETHINYLESTRADIOL MYLAN PHARMA CONTINUOUS 3 mg / 0.02 mg film-coated tablets

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 or 3 days after you start taking inactive tablets (located in the last row) and may not be complete when you start the next pack.

Procedures for initiation of treatment with DROSPIRENONE / ETHINYLESTRADIOL MYLAN PHARMA 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 estroprogestative contraceptive method (combined oral contraceptive / COC, vaginal ring or transdermal patch):

Take the first tablet of DROSPIRENONE / ETHINYLESTRADIOL MYLAN PHARMA CONTINUOUS 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 most late the day after the usual tablet-stop period, or the day after the last inactive tablet from the previous COC. If a vaginal ring or transdermal patch is used, take the first tablet of DROSPIRENONE / ETHINYLESTRADIOL MYLAN PHARMA 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 an intrauterine system (IUS) containing a progestin:

In a woman, the relay can be done: at any time of the cycle if it is a progestin-only pill; the day of removal if it is an implant or SIU; 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 administration of DROPHINENONE / ETHINYLESTRADIOL MYLAN PHARMA 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 taken place, it should be ensured that there is no pregnancy before starting the oral contraceptive pill or waiting for the return of the menses.

In case of breastfeeding, see section Pregnancy and breastfeeding .

What to do if you forget one or more tablets

The omission of the 4 white tablets in the last row of the pack corresponds to forgetting inactive tablets and therefore has 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.

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 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. Taking tablets should never be interrupted for more than 4 days;

2. 7 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.

· Day 1 to 7:

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 if the number of forgotten tablets is important or the date of forgetfulness is close to the beginning of the row of inactive tablets.

· Day 8 to 14:

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.

· Day 15 to 24:

The risk of a decrease in contraceptive activity is maximal because of the proximity of taking the 4 days of inactive tablets. However, it is possible to reduce the decrease in contraceptive effect by adjusting the dosage of the tablets as follows:

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 then possible to follow one of the 2 setting schemes described below.

If this is not the case, 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 4 tablets in the last row (inactive 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 have to take last-row tablets (inactive tablets) for up to 4 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 the inactive 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 and additional contraceptive measures should 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 instructions as those given for missed tablets should apply (see Dosage and administration section "What to do if you have missed one or more tablets"). .

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

How to delay the rules?

The onset of menses may be delayed by starting a new pack of DROPHINENONE / ETHINYLESTRADIOL MYLAN PHARMA CONTINUOUS 3 mg / 0.02 mg film-coated tablet without taking inactive 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.

DROPHINENONE / ETHINYLTRADIOL MYLAN PHARMA CONTINUOUS 3 mg / 0.02 mg film-coated tablets can then be resumed normally after taking inactive tablets.

It is possible to shift the onset of the rules to another day of the week by shortening the duration of taking the inactive tablets by 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

· Pancreatitis or history of pancreatitis associated with severe hypertriglyceridemia;

· 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 the active substances or to any of the excipients listed under Composition .

Adverse effects Drospirenone / Ethinyl Myl PH CO

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

Adverse reactions associated with the use of the combination drospirenone and ethinyl estradiol as a contraceptive or in the treatment of moderate acne according to MedDRA terminology and system-organ classification.

Class of organ systems
(MedDRA version 9.1)

Frequent
( ≥ 1/100 to <1/10)

Rare
( ≥ 1/1000 to <1/100)

Rare
( ≥1 / 10, 000 to <1/1000)

Unknown frequency (can not be estimated from available data)

Infections and infestations

candida

Blood and lymphatic system disorders

Anemia
thrombocythemia

Immune system disorders

Allergic reaction

hypersensitivity

Endocrine disorders

Endocrine disorders

Metabolism and nutrition disorders

Increased appetite
Anorexia
hyperkalemia
hyponatremia

Psychiatric disorders

Emotional lability

Depression
Nervousness
Drowsiness

anorgasmia
Insomnia

Nervous system disorders

Headache

Dizziness
paresthesia

Dizziness
tremors

Eye disorders

Conjunctivitis
Dry eye
Eye disorders

Heart conditions

tachycardia

Vascular disorders

Migraine
Varicose veins
Hypertension

Venous thromboembolism (VTE)

Arterial thromboembolism (ATE)

Phlebitis

Vascular disorders
Epistaxis
Syncope

Gastrointestinal disorders

nausea

Abdominal pain
vomiting
Dyspepsia
Flatulence
Gastritis
Diarrhea

Abdominal distention
Gastrointestinal disorders
Gastrointestinal replication
Hiatal hernia
Oral candidiasis
Constipation
Oral dryness

Hepatobiliary disorders

Biliary pain
cholecystitis

Skin and subcutaneous tissue disorders

Acne
itching
Skin rash

chloasma
Eczema
Alopecia
Acneiform dermatitis
Dryness of the skin
Erythema nodosum
hypertrichosis
Skin disorders
Stretch Marks
Contact dermatitis
Photosensitive dermatitis
Cutaneous nodule

Erythema multiforme

Musculoskeletal and systemic disorders

Back pain
Pain in the limbs
Muscle cramps

Disorders of reproductive organs and breast

Breast pain
metrorrhagia *
Amenorrhea

Vaginal candidiasis
Pelvic pain
Increased breast volume
Fibrocystic breast
Uterine / vaginal hemorrhage *
Genital losses
Hot flashes
vaginitis
Menstrual disorders
Dysmenorrhea
hypomenorrhea
menorrhagia
Vaginal dryness
Doubtful cervical smear
Decreased libido

dyspareunia
vulvovaginitis
Postcoital bleeding
Haemorrhage of deprivation
Breast cyst
Breast hyperplasia
Breast neoplasia
Cervical polyp
Endometrial atrophy
Ovarian Cyst
Increased volume of the uterus

General disorders and administration site conditions

Asthenia
Excessive sweating
edema
(generalized edema,
peripheral edema,
facial edema)

Discomfort

investigations

Weight gain

Weightloss

* Irregular bleeding usually disappears with continued treatment

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 combined oral contraceptives are also described in the Warnings and Precautions for Use section . :

Venous thromboembolic events;

· Arterial thromboembolic events;

· Hypertension;

· Liver tumors;

· Occurrence or aggravation of conditions that are not known to be associated with combined oral contraceptives: Crohn's disease, haemorrhagic colitis, epilepsy, uterine fibroma, porphyria, systemic lupus erythematosus, herpes simplex, Sydenham's chorea, hemolytic syndrome, and uremic, cholestatic jaundice;

· Chloasma;

· Chronic or severe disruption of liver function that may require discontinuation of combined 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 in users of 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 combined 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. Health professionals declare any suspected adverse reaction 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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