Medicinal Products

DROSPIBEL Ge 0.02 mg / 3 mg

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

Coated tablet
Box of 3 Pads of 21
All forms

Indication

Oral contraception.

Dosage DROSPIBEL Ge 0.02 mg / 3 mg film-coated tablet Box of 3 packs of 21

Route of administration:

Oral way.

How to take DROSPIBEL 0.02 mg / 3 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 initiation of treatment with DROSPIBEL 0.02 mg / 3 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):

Begin treatment with DROSPIBEL 0.02 mg / 3 mg, film-coated tablet preferably on the day following the last active tablet (last tablet containing the active substances) of the previous COC, or at the latest on the day following the period usual stop of the tablets, or the day after taking the last placebo tablet from the previous COC. If a vaginal ring or transdermal patch is relayed, take the first tablet of DROSPIBEL 0.02 mg / 3 mg film-coated tablet preferably on the day of withdrawal, or at the latest on the day of 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 will be advised to use a complementary method of contraception during the first 7 days of taking DROSPIBEL 0.02 mg / 3 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 DROSPIBEL 0.02 mg / 3 mg film-coated tablets without interval compliance. The rules may be delayed until the end of the second wafer if necessary. During this period, bleeding or spotting may occur. DROSPIBEL 0.02 mg / 3 mg film-coated tablets 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

Do not use Combined Oral Contraception (COC) if a woman has any of the conditions listed below. If any of these conditions occur for the first time while taking oral contraception, stop treatment immediately:

· Venous thrombosis or history of venous thrombosis (deep vein thrombosis, pulmonary embolism).

· Arterial thrombosis or history of arterial thrombosis (eg myocardial infarction), or precursor signs of thrombosis (eg, angina and transient ischemic attack).

· Cerebrovascular accident (CVA) or history of stroke.

· Presence of a severe risk factor or several risk factors for arterial thrombosis:

o diabetes with vascular complications,

o severe hypertension,

o severe dyslipoproteinemia.

· Hereditary or acquired predisposition to venous or arterial thrombosis (resistance to activated protein C (APC)), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and anti-phospholipid antibodies (anti-cardiolipin antibody, lupus anticoagulant).

· 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.

· Liver tumor (benign or malignant) progressive or old.

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

· Vaginal bleeding of unknown origin.

· History of migraine with focused neurological signs.

· Hypersensitivity to any of the active ingredients or to any of the excipients of DROSPIBEL 0.02 mg / 3 mg film-coated tablets.

Adverse effects Drospibel GE

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

The following side effects have been reported during the use of DROSPIBEL 0.02 mg / 3 mg film-coated tablets:

On the basis of clinical trials, the table below 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 / 1, 000 to <1/100

Rare

≥1 / 10, 000 to < 1 / 1, 000

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, Decreased libido

Nervous system disorders

headaches

paresthesia,
Dizziness

Affections of the ear and labyrinth

Hearing Loss

Eye disorders

Abnormal vision

Heart conditions

Extrasystoles, Tachycardia

Vascular disorders

Pulmonary embolism, Hypertension, Hypotension,
Migraine,
Varicose veins

thromboembolism

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,
Pain in the extremities, muscle cramps

Renal and urinary disorders

Cystitis

Disorders of reproductive organs and breast

Breast pain, Breast enlargement, Dysmenorrhea, Metrorrhagia

Breast cancer,
Fibrocystic disease, Galactorrhea,
Ovarian Cyst,
Hot flashes, Menstrual disorders, Amenorrhea,
menorrhagia,
Vaginal candidiasis, Vaginitis,
Vaginal discharge, Vulvovaginal disorders, Vaginal dryness, Pelvic pain, Doubtful cervical smear (Pap smear test)

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.

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 .

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