Jess Plus, 28 pcs.
€39.03 €32.52
Jes Plus is a low-dose monophasic oral combined estrogen-gestogen contraceptive including the active pills and auxiliary vitamin tablets containing calcium levomepolate.
The contraceptive effect of the drug Jes Plus is mainly due to suppression of ovulation and increased viscosity of cervical mucus.
Women taking combined oral contraceptives (OCs) have more regular cycles, less pain, intensity and duration of menstrual bleeding, and as a result the risk of iron deficiency anemia decreases. There is also evidence of a decreased risk of endometrial and ovarian cancer.
Drospirenone, contained in the drug Jes Plus, has antimineralocorticoid action and contributes to the prevention of hormone-dependent fluid retention, which may manifest as a decrease in body weight and reduce the likelihood of peripheral edema. Drospirenone also has anti-androgenic activity and helps to reduce acne (acne), oily skin and hair. Such effect of drospirenone is similar to the effect of natural progesterone produced in the female body. This should be considered when choosing a contraceptive, especially for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. When used correctly, the Perl Index (a measure of the number of pregnancies in 100 women using the contraceptive in a year) is less than 1. If the pill is missed or used incorrectly, the Perl Index may increase.
The acidic form of calcium levomepholate, is identical in structure to naturally occurring L-5-methyltetrahydrofolate (L-5-methyl-TGF), the major folate form found in food. The average plasma concentration in people who do not use foods fortified with folic acid is about 15 nmol/L.
Levomefolate, in contrast to folic acid, is a biologically active form of folate. Because of this, it is absorbed better than folic acid. Levomefolate is indicated to meet the increased need and to ensure the necessary content of folate in women during pregnancy and while breastfeeding. Injection of calcium levomepholate into an oral contraceptive reduces the risk of fetal neural tube defects if a woman becomes pregnant unexpectedly, immediately after discontinuation of contraception (or in very rare cases, when oral contraception is used).
Pharmacokinetics
Drospirenone
Absorption. When taken orally, drospirenone is quickly and almost completely absorbed. After a single oral administration, the Cmax of drospirenone in blood plasma, equal to 35 ng/ml, is reached after 1-2 hours. Bioavailability ranges from 76 to 85%. Compared with taking drospirenone on an empty stomach, food intake does not affect its bioavailability.
Distribution. After oral administration, there is a biphasic decrease in serum levels of the drug with T1/2 respectively (1.6±0.7) h and (27.0±7.5) h. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (hsBG) or corticosteroid-binding globulin (CRB). Only 3-5% of the total serum concentration of the substance is present as free hormone. Ethinylestradiol-induced increases in hGH do not affect the binding of drospirenone by plasma proteins. Mean apparent Vd is (3.7±1.2) L/kg.
Metabolism. After oral administration drospirenone is extensively metabolized. Most metabolites in plasma are represented by acidic forms of drospirenone, which are formed without involvement of the cytochrome P450 system. The cytochrome P4503A4 isoenzyme is minimally involved in metabolism of drospirenone; drospirenone is able to decrease the concentration of the enzyme in blood plasma and the activity of cytochrome P4501A1, P4502C9 and P4502C19 isoenzymes in vitro.
Elimination. The metabolic clearance rate of drospirenone in blood plasma is (1.5±0.2) ml/min/kg. Unchanged drospirenone is excreted only in trace amounts. Drospirenone metabolites are excreted through the gastrointestinal tract and kidneys in a ratio of approximately 1.2:1.4. The T1/2 for excretion of metabolites is about 40 h.
The equilibrium concentration. During the first course of use, Css of drospirenone in plasma about 60 ng/mL is reached from the 7th to the 14th day of use of the drug. There was an increase in plasma concentration of drospirenone by about 2-3 times (due to cumulation), which was due to the ratio of T1/2 in the terminal phase and the dosing interval. A further increase in plasma concentration of drospirenone was noted after 1-6 courses of the drug, after which no increase in concentration was observed.
Kidney function impairment. Plasma concentration of drospirenone at equilibrium was comparable in women with mild renal dysfunction (creatinine Cl 50-80 ml/min) and in women with preserved renal function (creatinine Cl >80 ml/min). However, in women with moderate renal impairment (creatinine Cl – 30-50 ml/min), the average plasma concentration of drospirenone was 37% higher than in patients with preserved renal function. No change in plasma potassium concentrations was noted with drospirenone.
Hepatic impairment. In women with moderate hepatic impairment (Child-Pugh class B) AUC is comparable to that of healthy women with similar Cmax values in absorption and distribution phases. The T1/2 of drospirenone in patients with moderate liver function impairment was 1.8 times higher than in healthy volunteers with preserved liver function.
In patients with moderate hepatic impairment a decrease in drospirenone clearance of about 50% compared to women with preserved liver function was noted, and no differences in plasma potassium concentration in the study groups were noted. No changes in potassium concentration were noted even in the case of a combination of factors predisposing to its increase (concomitant diabetes mellitus or treatment with spironolactone).
Ethinylestradiol
Absorption. After oral administration, ethinylestradiol is quickly and completely absorbed. Cmax – about 33 pg/mL – is reached within 1-2 hours. The drug undergoes presystemic metabolism in the liver, its bioavailability when taken orally is on average about 60%. Simultaneous intake of food in some cases is accompanied by a decrease in bioavailability of ethinylestradiol by 25%.
Distribution. The concentration of ethinylestradiol in blood plasma decreases in 2 phases, T1/2 ethinylestradiol in the second phase is about 24 hours. Ethinylestradiol has a nonspecific but strong binding to plasma albumin (about 98.5%) and induces an increase in plasma HGH concentration. The estimated Vd is about 5 L/kg.
Metabolism. Ethinylestradiol undergoes presystemic conjugation in the liver and small intestinal mucosa. The main route of metabolism of ethinylestradiol is aromatic hydroxylation with formation of numerous metabolites, which are in both bound and unbound states. The excretion rate of ethinylestradiol is about 5 ml/min/kg.
Excretion. Ethinylestradiol is excreted only as metabolites by the kidneys and through the GI tract at a ratio of 4:6 with a T1/2 of about 24 hours.
The equilibrium concentration. The equilibrium state is reached in the second half of the treatment course, the plasma concentration of ethinylestradiol increases about 1.4-2.1-fold.
Ethnicity. The effect of ethnicity on pharmacokinetic parameters was studied in studies of single and multiple dosing of drospirenone and ethinylestradiol in healthy Caucasian women as well as in Japanese women. No effect of ethnicity on the pharmacokinetic parameters of drospirenone and ethinylestradiol was found.
Calcium levomepolate
Absorption. After oral administration, calcium levomepholate is rapidly absorbed and incorporated into the body’s folate pool. After a single oral intake of 0.451 mg of calcium levomepholate in 0.5-1.5 hours, Cmax becomes 50 nmol/L above the initial concentration.
Distribution. The pharmacokinetics of folate is biphasic: a pool of folate with rapid and slow metabolism is defined. Pool with fast metabolism, probably, represents newly ingested folate, that agrees with T1/2 calcium levomepolate, which is about 4-5 h after its single oral dose of 0.451 mg. The slow metabolism pool reflects the conversion of polyglutamate folate, whose T1/2 is about 100 days. Externally supplied folate and folate passing through the intestinal-hepatic cycle ensure that a constant concentration of L-5-methyl-THF is maintained in the body.
L-5-methyl-THF represents the main form of existence of folate in the body, in which it is delivered to peripheral tissues to participate in cellular folate metabolism.
Metabolism. L-5-methyl-THF represents the major folate transported form in plasma. When comparing 0.451 mg of calcium levomepholate and 0.4 mg of folic acid, similar metabolic mechanisms were established for other significant folates. Folate coenzymes are involved in 3 major conjugated cycles of metabolism in the cell cytoplasm. These cycles are required for the synthesis of thymidine and purines, precursors of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), as well as for the synthesis of methionine from homocysteine and the conversion of serine to glycine.
Excretion. L-5-methyl-THF is excreted by the kidneys unchanged and as metabolites, as well as through the gastrointestinal tract.
The equilibrium concentration. The equilibrium state of L-5-methyl-THF in plasma after oral administration of 0.451 mg of calcium levomepolate is reached after 8-16 weeks and depends on its initial concentration. In erythrocytes, Css is reached at a later time because of the life span of erythrocytes, which is about 120 days.
Indications
Composition
1 active combination tablet contains:
the active ingredients:
drospirenone (micronized) 3 mg,
ethinylestradiol betadex clathrate,
micronized (in terms of ethinylestradiol) 0.02 mg,
calcium levomepholate (micronized) 0.451 mg;
excipients:
Lactose monohydrate, 45.329 mg;
MCC, 24.8 mg;
croscarmellose sodium, 3.2 mg;
Hyprolose (5 cP) – 1.6 mg;
Magnesium stearate – 1.6 mg
coat film:
Pink varnish – 2 mg or (alternatively): hypromellose (5 cP) – 1.0112 mg, macrogol 6000 – 0.2024 mg; talc – 0.2024 mg; titanium dioxide – 0.5580 mg; iron oxide red dye – 0.026 mg.
1 auxiliary vitamin tablet contains:
the active ingredient:
calcium levomepholate (micronized) 0.451 mg,
excipients:
Lactose monohydrate, 48.349 mg;
MCC, 24.8 mg;
croscarmellose sodium, 3.2 mg;
Hyprolose (5 cP) – 1.6 mg;
magnesium stearate – 1.6 mg,
coated film:
Light orange varnish – 2 mg or (alternatively): Hypromellose (5 cP) – 1.0112 mg, macrogol 6000 – 0.2024 mg; talc – 0.2024 mg; titanium dioxide – 0.5723 mg; iron oxide yellow dye – 0.0089 mg; iron oxide red dye – 0.0028 mg.
How to take, the dosage
To be taken orally, in the order shown on the package, at approximately the same time each day, without chewing, drinking a small amount of water.
Take 1 tablet daily, continuously, for 28 days. The next tablet in the pack should be taken after the previous one is finished.
The beginning of taking Jes Plus
The intake of Jes Plus starts on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding).
Recommendations in case of vomiting and diarrhea
In case of vomiting or diarrhea up to 4 hours after taking the pills, absorption may not be complete, and additional precautions should be taken to prevent unwanted pregnancy.
The use in selected groups of patients
Children: The efficacy and safety of Jes Plus as a contraceptive has been studied in women of reproductive age. It is assumed that efficacy and safety of the drug in postpubertal age less than 18 years old are similar to those in women after 18 years old. The use of the drug before the onset of menarche is not indicated.
Elderly patients. The drug Jes Plus is not used after menopause.
Liver function disorders. The drug is contraindicated in women with severe liver function disorders.
Kidney function abnormalities. The drug is contraindicated in women with severe renal dysfunction and in acute renal failure.
Interaction
The interaction of oral contraceptives with other drugs may lead to breakthrough uterine bleeding and/or decreased contraceptive reliability.
Interactions leading to decreased effectiveness of the drug Jes® Plus
Impacts on hepatic metabolism. The use of drugs that induce microsomal liver enzymes may lead to increased clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John’s wort. HIV protease inhibitors (e.g. ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and their combinations can also potentially affect metabolism in the liver.
Impacts on intestinal-hepatic recirculation. According to individual studies, some antibiotics (e.g., penicillins and tetracyclines) may reduce intestinal hepatic estrogen recirculation. thereby decreasing ethinyl estradiol concentrations.
When taking drugs that affect microsomal liver enzymes and for 28 days after their withdrawal, an additional barrier method of contraception should be used.
When taking antibiotics (except rifampicin and griseofulvin) and for 7 days after their withdrawal, an additional barrier method of contraception should be used. If the period of barrier method of contraception ends later than the hormone-containing pink tablets in the package, you should skip taking the remaining supporting light orange tablets and start taking Ges® Plus from a new package without interruption of the pills.
Interactions that reduce the effectiveness of calcium levomepolate
Impacts on folate metabolism. Certain medications reduce the blood folate concentration or decrease the effectiveness of calcium levomepolate by inhibiting the dihydrofolate reductase enzyme (e.g. methotrexate, trimethoprim, sulfasalazine and triamterene) or by reducing folate absorption (e.g. cholestyramine) or by unknown mechanisms (e.g. antiepileptic drugs: carbamazepine, phenytoin, phenobarbital, primidone, and valproic acid).
The effect on metabolism of PDAs (enzyme inhibitors). The main metabolites of drospirenone are formed in the plasma without the participation of the cytochrome P450 system. Therefore, the effect of cytochrome P450 system inhibitors on drospirenone metabolism is unlikely.
The effect of PDAs or calcium levomepolate on the activity of other drugs
PDAs can affect the metabolism of other drugs, resulting in an increase (e.g. cyclosporine) or decrease (e.g. lamotrigine) in their plasma and tissue concentrations.
Based on interaction studies as well as studies with female volunteers taking omeprazole, simvastatin, and midazolam as study substrates, it is unlikely that drospirenone at 3 mg will affect metabolism of other drugs.
Folates can change the pharmacokinetics or pharmacodynamics of some drugs that affect folate metabolism, such as antiepileptic drugs (phenytoin), methotrexate or pyrimethamine, and this can be accompanied by a reduction (generally reversible with increasing doses of the folate-affecting drugs) in their therapeutic effects. Administration of folate against the background of treatment with these drugs is recommended mainly to reduce the toxicity of the latter.
Special Instructions
If any of the conditions, diseases, and risk factors listed below are present, the potential risks and expected benefits of using Ges® Plus should be carefully weighed on an individual basis and discussed with the woman before she decides to start taking this medication.
Cardiovascular disease
Indications. Epidemiologic studies suggest an association between MTCT use and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, and cerebrovascular events) with combined oral contraceptive use. These diseases are rare.
The risk of venous thromboembolism (VTE) is highest in the first year of taking these drugs. An increased risk is present after initial use of combined oral contraceptives or renewed use of the same or different combined oral contraceptives (after a break of 4 weeks or more between doses). Data from a large prospective study involving 3 groups of patients show that this increased risk is predominantly present during the first 3 months.
The overall risk of venous VTE thromboembolism in patients taking low-dose combination oral contraceptives (< 50 mcg ethinylestradiol) is 2 to 3 times higher than in nonpregnant patients who are not taking the PDA, yet this risk remains lower compared with the risk of VTE in pregnancy and childbirth.
VTE can be life-threatening or fatal (1-2% of cases).
VTE, manifesting as deep vein thrombosis, or pulmonary embolism, can occur with any combination oral contraceptive.
It is extremely rare for thrombosis of other blood vessels, such as hepatic, mesenteric, renal, cerebral veins and arteries, or retinal vessels, to occur with the use of combined oral contraceptives. There is no consensus on the association between the occurrence of these events and the use of combined oral contraceptives.
The symptoms of deep vein thrombosis (DVT) include unilateral swelling of the lower extremity or along the vein of the lower extremity, pain or discomfort in the lower extremity only when upright or walking, localized temperature rise in the affected lower extremity, redness or discoloration of the skin on the lower extremity.
The symptoms of pulmonary artery thromboembolism (TELA) include difficulty or rapid breathing; sudden cough, including coughing with hemoptysis; sharp chest pain, which may increase with deep breaths; anxiety; severe dizziness; and rapid or irregular heartbeat. Some of these symptoms (e.g., shortness of breath, coughing) are nonspecific and may be misinterpreted as signs of other more or less severe events (e.g., respiratory tract infection).
Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction.
Stroke symptoms: Sudden weakness or loss of sensation in the face, upper or lower extremities, especially on one side of the body, sudden confusion, problems with speech and comprehension; sudden one- or two-sided loss of vision; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure.
Other signs of vascular occlusion: sudden pain, swelling and mild bruising of the extremities, acute abdomen.
Symptoms of myocardial infarction: pain, discomfort, pressure, heaviness, compression or distention in the chest, arm or behind the sternum; discomfort radiating to the back, cheekbone, throat, arm, stomach; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; palpitations or irregularities.
Arterial thromboembolism can be life-threatening or fatal.
The risk of thrombosis (venous and/or arterial) and thromboembolism is increased:
– with age;
– in smokers (the risk increases with more cigarettes or greater age, especially in women over 35);
when:
– obesity (body mass index greater than 30 kg/m2);
– family history (e.g., venous or arterial thromboembolism ever in a close relative or parent at a relatively young age). If there is an inherited or acquired predisposition, the woman should be seen by an appropriate specialist to decide whether she can take Ges® Plus;
– prolonged immobilization, major surgery, any surgery on the lower extremities or extensive trauma. In these situations, it is advisable to discontinue use of Ges® Plus (if surgery is planned, at least four weeks before) and not resume for two weeks after the end of immobilization;
– dyslipoproteinemia;
– arterial hypertension;
– migraine;
– heart valve disease;
– atrial fibrillation.
The possible role of varicose veins and superficial thrombophlebitis in venous thromboembolism remains controversial.
The increased risk of thromboembolism in the postpartum period should be considered.
Peripheral circulatory disorders may also be seen in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn’s disease or nonspecific ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine headaches during use of the drug Jes® Plus (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of this drug.
The biochemical indicators indicating an inherited or acquired predisposition to venous or arterial thrombosis include: activated protein C resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When evaluating the risk-benefit ratio, it should be considered that adequate treatment of the condition in question can reduce the associated risk of thrombosis. It should also be considered that the risk of thrombosis and thromboembolism in pregnancy is higher than with low-dose oral contraceptives (< 50 mcg ethinylestradiol).
Tumors
The most significant risk factor for cervical cancer is persistent papillomavirus infection. There have been reports of some increased risk of cervical cancer with long-term use of CRPS. However, the association with PDA intake has not been proven. The possibility of a correlation between these data and cervical disease screening and patterns of sexual behavior (less frequent use of barrier methods of contraception) is being discussed.
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of breast cancer diagnosed in women currently taking CRC (relative risk 1.24). The increased risk gradually disappears within 10 years after stopping these drugs. Because breast cancer is rare in women under 40 years of age, the increase in breast cancer diagnoses in women currently or recently taking CRPs is small relative to their overall risk of the disease. It has not been shown to be associated with taking CRPS. The increased risk observed may be a result of close monitoring and earlier diagnosis of breast cancer in women taking CRPS. Women who have ever used PDAs are found to have earlier stages of breast cancer than women who have never used them.
In rare cases, there have been benign and, in extremely rare cases, malignant liver tumors that have led to life-threatening intra-abdominal bleeding in some patients.
If severe abdominal pain, liver enlargement, or signs of intra-abdominal bleeding occur, this should be considered when making a differential diagnosis.
Tumors can be life-threatening or fatal.
Other conditions
Clinical studies have shown no effect of drospirenone on plasma potassium concentrations in patients with mild to moderate renal impairment. However, in patients with impaired renal function and baseline potassium concentration at the upper limit of normal, the risk of hyperkalemia with potassium retention medications cannot be excluded.
Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of pancreatitis while taking CRP.
While small increases in BP have been described in many women taking CRP, clinically significant increases have been rare. However, if a persistent, clinically significant increase in BP develops while taking Ges® Plus, the drug should be stopped and treatment for arterial hypertension should be initiated. The drug may be continued if normal BP values are achieved with hypotensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking PDA, but their association with taking PDA has not been proven: Jaundice and/or pruritus associated with cholestasis; gallstone formation; porphyria; systemic lupus erythematosus: hemolytic-uremic syndrome; Sydenham’s chorea; pregnancy herpes; hearing loss associated with otosclerosis. Cases of Crohn’s disease and ulcerative colitis have also been described with PDA.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of Jes® Plus until liver function returns to normal. Recurrent cholestatic jaundice that develops for the first time during pregnancy or previous use of sex hormones requires discontinuation of Jes® Plus.
While PDAs may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using Jes® Plus. However, women with diabetes mellitus should be closely monitored while taking this drug.
Chloasma may sometimes develop, especially in women with a history of pregnancy chloasma. Women who are prone to chloasma should avoid prolonged sun exposure and exposure to ultraviolet radiation while taking Ges® Plus.
The folate may mask vitamin B12 deficiency.
Preclinical safety data
Preclinical data from standard studies for multiple-dose toxicity, genotoxicity, carcinogenic potential, and reproductive toxicity indicate no particular risk to humans. However, we should keep in mind that sex hormones can promote the growth of some hormone-dependent tissues and tumors.
Preclinical data from standard studies of calcium levomepholate for multiple-dose toxicity and genotoxicity and reproductive toxicity do not indicate a particular risk to humans.
Laboratory tests
The administration of Jes® Plus may affect the results of some laboratory tests, including liver, kidney, thyroid, and adrenal function, plasma transport protein concentrations, carbohydrate metabolism, and clotting and fibrinolysis parameters. The changes usually do not go beyond the normal values. Drospirenone increases plasma renin activity and aldosterone concentration, which is associated with its anti-mineralocorticoid effect.
There is a theoretical possibility of increased plasma potassium concentrations in women receiving the drug Jes® Plus simultaneously with other drugs that can increase plasma potassium levels. These drugs include angiotensin II receptor antagonists, potassium-saving diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or indomethacin, no significant difference was found between plasma potassium concentrations compared to placebo.
The efficacy of the drug Jes® Plus may be reduced in the following cases: skipping pills, vomiting and diarrhea, or as a result of drug interaction.
The frequency and severity of menstrual bleeding
In the course of taking the drug Jes® Plus irregular (acyclical) bleeding and vaginal bleeding (spotting or uterine breakthrough bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should be evaluated after an adjustment period of approximately 3 cycles.
If irregular bleeding recurs or develops after previous regular cycles, a thorough evaluation should be performed to rule out malignancy or pregnancy.
Some women may not develop “withdrawal” bleeding during a break in the pill. If Jes® Plus was taken as recommended, it is unlikely that a woman is pregnant. However, if you do not use Ges® Plus regularly and do not have two consecutive abortion bleeds, you should not continue taking the drug until pregnancy is ruled out.
Medical examinations
Before starting or resuming use of the drug, a woman’s medical history, family history, a thorough physical examination (including BP, HR, BMI, breast examinations), a gynecologic examination, cervical cytology (Papanicolae test), and pregnancy should be performed. When resuming use of Ges ® Plus, the volume of additional examinations and the frequency of follow-up examinations are determined individually, but at least once every 6 months.
A woman should be warned that Ges® Plus does not protect against HIV infection or other sexually transmitted diseases.
Influence on driving and operating ability
There have been no reports of adverse effects of Jes® Plus on psychomotor reaction speed; no studies have been done to study the effect of the drug on psychomotor reaction speed.
Contraindications
Side effects
The most common adverse reactions reported in relation to the use of the drug Jes are as follows:
– nausea, mammary gland pain, irregular uterine bleeding, and unspecified genital bleeding (in more than 3% of women using the drug for “Contraception’ and “Contraception and treatment of moderate acne /acne vulgaris/”);
Nausea, mammary gland pain, and irregular uterine bleeding (in more than 10% of women using the drug for the indication “Contraception and treatment of severe premenstrual syndrome”).
Serious adverse reactions are arterial and venous thromboembolism. Below is the frequency of adverse reactions reported in clinical trials of Ges and Ges Plus for the indication “Contraception” as well as for the indications “Contraception and treatment of moderate acne (acne vulgaris)” (n=3565) and “Contraception and treatment of severe premenstrual syndrome” (n=289) for the drug Ges. Within each group, separated according to frequency of occurrence, adverse reactions are presented in decreasing order of severity. The frequency of adverse events was classified as follows: frequent (â¥1/100 and
CNS side: frequent – migraine.
Mental disorders: frequent – mood swings, depression/depressed mood; infrequent – reduction or loss of libido.
Cardiovascular system: rare – venous or arterial thromboembolism (approximate frequency according to the results of epidemiological studies covering the group of combined oral contraceptives. The frequency bordered on the very rare. The term includes the following nosological units: peripheral deep vein occlusion, thrombosis and pulmonary embolism/occlusion, thrombosis, embolism and infarction, myocardial infarction, cerebral infarction and hemorrhagic stroke).
Digestive system disorders: frequently – nausea.
Skin disorders: frequency is unknown – erythema multiforme.
Reproductive system and mammary glands: often – pain in the mammary glands, irregular uterine bleeding, uterine bleeding of unspecified genesis.
The adverse events were classified using the MedDRA (Medical Dictionary of Regulatory Activity) dictionary. Different MedDRA terms reflecting the same symptom were grouped together and presented as a single adverse reaction to avoid diluting or blurring the true effect.
Overdose
There have been no reported cases of overdose of the drug Jes Plus.
Symptoms: nausea, vomiting, mucous bloody vaginal discharge or metrorrhagia (more common in young women).
Treatment: there is no specific antidote, symptomatic treatment should be carried out. Calcium levomepholate and its metabolites are identical to folate contained in natural products, the daily consumption of which is not harmful to the body. Calcium levomepholate at a dose of 17 mg per day (37 times the dose contained in 1 tablet of the drug Jes Plus) for 12 weeks was well tolerated.
Weight | 0.032 kg |
---|---|
Shelf life | 3 years |
Conditions of storage | The drug should be kept out of reach of children at a temperature not exceeding 25 ° C. |
Manufacturer | Bayer Weimar GmbH & Co. KG, Germany |
Medication form | pills |
Brand | Bayer Weimar GmbH & Co. KG |
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