Simitsia - instructions for use, doses, side effects, contraindications

Excipients: lactose monohydrate 48.530 mg, corn starch 16,600 mg, corn pregelatinized starch 9,600 mg, macrogol and polyvinyl alcohol copolymer 1,450 mg, magnesium stearate 0,800 mg;

Film coat (Opadrai II white * 2,000 mg): polyvinyl alcohol 0,880 mg, titanium dioxide 0,403 mg, macrogol-3350 0,247 mg, talc 0,400 mg, lecithin soybean 0,070 mg.

* code 85 G18490

Description:

Round, biconcave tablets coated with a white or almost white film coating, marked "G73" on one side of the tablet, embossed. On the cross section, the nucleus is white or almost white in color.

Pharmacotherapeutic group:contraceptive combination (estrogen + progestogen)

ATX: & nbsp

G.03.A.A.12 Drospirenone and ethinylestradiol

Pharmacodynamics:

The contraceptive effect of Simicia® is based on the interaction various factors, the most important of which are the inhibition of ovulation and changes in the endometrium.

Simicia ® is a combined oral contraceptive containing ethinyl estradiol and drospirenone. In a therapeutic dose, drospirenone also has antiandrogenic and weak antimineralocorticoid properties. It is devoid of any estrogenic, glucocorticoid and antiglucocorticoid activity. This provides drospirenone pharmacological profile, similar to natural progesterone.

There is evidence of a reduced risk of developing endometrial and ovarian cancer when combined oral contraceptives are used.

Pharmacokinetics:

Drospirenone

Absorption

When ingested drospirenone quickly and almost completely absorbed. After a single oral intake, the maximum concentration of drospirenone in the serum, equal to 38 ng / ml, is achieved after 1-2 hours. Bioavailability ranges from 76 to 85%. Eating does not affect the bioavailability of drospirenone.

Distribution

After oral administration, the final half-life is 31 hours. Drospirenone binds to serum albumin, does not bind to sex hormone binding globulin (SHBG) or corticosteroid-binding globulin (CSG). 3-5% of the active substance in the blood serum is presented as a free steroid. An increase in SHBG induced by ethinyl estradiol does not affect the binding of drospirenone with serum proteins. The average apparent volume of distribution of drospirenone is 3.7 ± 1.2 l / kg.

Metabolism

Drospirenone is extensively metabolized after oral administration. The main metabolites in the plasma are acidic forms of drospirenone,derivatives with an open lactone ring and 4,5-dihydrodrospirenone-3-sulfate, which are formed without involvement of the cytochrome P450 system. An insignificant amount of drospirenone is metabolized by cytochrome P450 3A4. In vitro drospirenone inhibits cytochromes P450 3A4, P450 1A1 P450 2C9 and P450 2C19.

Elimination

The metabolic clearance rate of drospirenone in the serum is 1.5 ± 0.2 ml / min / kg. In unmodified form, drospirenone is excreted only in trace amounts. Metabolites of drospirenone are excreted by the kidneys and through the intestine in a ratio of approximately 1.2: 1.4. The half-life of metabolites by the kidneys and through the intestine is approximately 40 hours.

The equilibrium concentration

The maximum equilibrium concentration of drospirenone in the serum is reached by the 8th day of administration and is approximately 70 ng / ml.

With renal insufficiency

Equilibrium concentration of drospirenone in serum in women with mild and moderate renal insufficiency (creatinine clearance CLcr 30-80 ml / min) is comparable with the equilibrium concentration in women with normal renal function.

With hepatic insufficiency

Drospirenone is well tolerated in patients with mild or moderate hepatic impairment (Child-Pugh class B).Reduced clearance of drospirenone with moderate hepatic insufficiency does not lead to a clear change in the potassium concentration in the blood serum. With diabetes and concomitant treatment with spironolactone (two predisposing factors in the development of hyperkalemia), there was no increase in the serum potassium concentration above the upper limit of the norm.

Ethinylestradiol

Absorption

Ethinylestadiol is rapidly and completely absorbed. The maximum concentration of 80-100 pg / ml is achieved within 1-2 hours. After presystemic conjugation and presystemic metabolism in the small intestine and liver, the absolute bioavailability is 60%. Concomitant food intake reduces the bioavailability of ethinyl estradiol in about 25% of women.

Distribution

The concentration of ethinyl estradiol in the serum is reduced biphasic, the final pharmacokinetic phase is characterized by a half-life of about 24 hours. Ethinylestradiol strongly, but non-specifically binds to albumin (about 98.5%) and causes an increase in the concentration of SHBG and CRG in the serum. The apparent volume of distribution is approximately 5 l / kg.

Metabolism

Ethinyl estradiol undergoes presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinylestradiol Primarily metabolized by aromatic hydroxylation with the formation of both free metabolites and conjugates with glucuronic and sulfuric acids.

Ethinyl estradiol is completely metabolized. The metabolic clearance rate of ethinyl estradiol is 5 ml / min / kg.

Elimination

Ethinyl estradiol is practically not excreted unchanged. Metabolites of ethinyl estradiol are excreted by the kidneys and through the intestine in a ratio of 4: 6. The half-life of metabolites is approximately 1 day.

The equilibrium concentration

The state of equilibrium concentration is reached during the second half of the cycle of drug administration.

Indications:

Oral contraception.

Contraindications:

- The presence of vein thrombosis (deep vein thrombosis, pulmonary embolism, pulmonary embolism), including in anamnesis;

- the presence of thrombosis of the arteries (for example, myocardial infarction) or previous conditions (eg, angina and transient ischemic attack), including in the anamnesis;

- complicated heart valve disease, atrial fibrillation, uncontrolled hypertension;

- Serious surgical intervention with prolonged immobilization;

- smoking (over the age of 35 years);

- liver failure;

- cerebrovascular diseases, including in history;

- presence of severe or multiple risk factors for arterial thrombosis:

diabetes mellitus with vascular complications;
severe arterial hypertension;
severe dyslipoproteinemia;

- hereditary or acquired predisposition to venous or arterial thrombosis, such as resistance to APS (activated protein C), insufficiency of antithrombin III, protein C deficiency, protein S deficiency, hyperhomocysteinemia and the presence of antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);

- pancreatitis, including in the history, if there was a pronounced hypertriglyceridemia;

- severe liver disease (before the normalization of liver tests), including in history;

- severe chronic renal failure or acute renal failure failure;

- Liver tumors (benign or malignant) at present or in the anamnesis;

- hormone-dependent malignant diseases of the reproductive system (genitals, mammary glands) or suspicion of them;

bleeding from the vagina of unknown origin;

- a migraine with focal neurologic symptoms in the anamnesis;

- Pregnancy or suspicion of it;

- lactation period;

- hypersensitivity to the drug or any of its components;

- hereditary intolerance to galactose, lactase deficiency, glucose-galactose malabsorption.

Carefully:

Risk factors for thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve defects, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebral circulatory disturbances at a young age in someone from the next relatives); diseases in which there may be violations of peripheral circulation: diabetes, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia,phlebitis of superficial veins; hereditary angioedema, hypertriglyceridemia, liver disease; diseases that first appeared or worsened during pregnancy or on the background of previous reception of sex hormones (including jaundice and / or itching associated with cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy in the anamnesis, small chorea (Sydenham's disease), chloasma, postpartum period.

Pregnancy and lactation:

The drug Simizia® is contraindicated during pregnancy. If during the reception of the drug Simizia® the patient becomes pregnant, the drug should be stopped immediately. It is impossible to exclude unwanted effects on the course of pregnancy and fetal development due to the hormonal action of the active ingredients.

Combined oral contraceptives can reduce the amount and change the composition of breast milk. Small amounts of hormonal contraceptives or their metabolites are found in milk during hormonal contraception and can affect the baby. The use of combined oral contraceptives is possible after complete cessation of breastfeeding.

Dosing and Administration:

How to take Simizia®

Tablets are taken orally daily, at about the same time with a small amount of water in the order indicated on the blister pack. Take one tablet a day for 21 consecutive days. The intake of each next package begins after a 7-day break in taking the tablets, during which menstrual bleeding is usually observed. It usually starts 2-3 days after taking the last pill and may not end before the start of taking a new package.

How to start taking Simicia ®

- If there is no reception of any hormonal contraceptives (in the previous month) the first tablet from the first package should be taken on the first day of menstrual bleeding.

- When switching from another combined oral contraceptive a woman should start taking Simicia ® the day after the usual break in admission or after taking the last pill of the previous combined oral contraceptive.

- When switching from contraceptives containing only progesterone (mini-saws, injectable forms, implant) or progestogen-releasing intrauterine system a woman can switch from a mini-drank progestogen, an implant or a progestogen-releasing intrauterine system any day any day - on the day of removal, from the injection form - from the day the next injection is to be made. In this case, it is necessary to additionally use the barrier method of contraception during the first 7 days of admission.

- After a medical abortion in the first trimester of pregnancy The first pill can be taken as prescribed by the doctor on the day of termination of pregnancy. If this condition is met, the woman does not need additional contraception.

- After childbirth or abortion in the second trimester of pregnancy a woman should be recommended to start taking the drug on the 21-28th day after childbirth or abortion. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. With the onset of sexual activity, pregnancy should be excluded, or a woman should wait for the first menstruation.

Acceptance of missed tablets

If the delay in taking the pill was less than 12 hours, contraceptive protection is not reduced. A woman should take the pill as soon as possible, as soon as she remembers this, the next pill is taken at the usual time.

If the delay in taking the tablets was more than 12 hours, contraceptive protection can be reduced. Two rules should be observed:

1. The drug intake should never be interrupted for more than 7 days.

2. 7 days of continuous intake of tablets is required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system. Recommendations for admission:

Week 1

A woman should take the last missed pill as soon as possible, as soon as she remembers, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. In addition, the barrier method of contraception must be used during the next 7 days. If the sexual intercourse took place during the previous 7 days before passing the pill, it is necessary to take into account the probability of pregnancy. The more pills are missed and the closer this pass to the 7-day break in taking the drug, the higher the risk of pregnancy.

Week 2

A woman should take the last missed pill as soon as possible, as soon as she remembers, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. Provided that the woman correctly took the pill within 7 days preceding the skip of the first pill, there is no need to use additional methods of contraception.

If a woman misses more than 1 tablet, additional methods of contraception must be used within the next 7 days.

Week 3

The risk of a decrease in contraceptive effectiveness increases as the period of use of the placebo tablets approaches. However, if the admission scheme is adhered to, you can avoid reducing contraceptive protection. If one of the following options is followed, then there is no need to use additional contraceptive measures provided that the tablets are correctly taken 7 days before the first tablet is skipped. If this is not the case, it is recommended that you follow the first of the following options and use additional contraceptive methods within the next 7 days.

1.A woman should take the last missed pill as soon as possible, as soon as she remembers, even if it means taking two tablets at the same time. The next tablet is taken at the usual time. Receiving tablets from a new package should be started without interruption, as soon as the current packaging is finished. It is likely that the woman will not bleed "cancellation" to the end of the second package, but there may be spotting spotting or bleeding "cancellation" on the days of taking the drug from the second package.

2. You can also stop taking the tablets from the current package. In this case, a break in taking the drug can be up to 7 days, including the days of missing the tablets; then start taking the tablets from the next package.

If a woman missed taking the pills and then in the first normal drug-free interval, she does not have a bleeding "withdrawal", it is necessary to exclude pregnancy.

Use of the drug in case of gastrointestinal upset

In the case of severe gastrointestinal upset (vomiting or diarrhea), partial absorption of the drug is possible, therefore additional contraceptive means should be used.

If vomiting occurs within 3-4 hours after taking an active tablet, take an additional tablet as soon as possible from another package.

A new tablet should be taken within 12 hours of the usual pill.

If more than 12 hours have passed, the recommendations for missing tablets should be followed.

Reception of "missed tablets"

If a woman does not want to change the normal mode of taking the drug, she should take an additional tablet (or several tablets) from another package if necessary.

How to delay the bleeding of "cancellation"

To delay the onset of bleeding "cancellation", it is necessary to continue taking the tablets from a new package of the Simicia® preparation without interruption in admission. Delay is possible until the end of the tablets in the second package. During the lengthening of the cycle, spotting spotting from the vagina or breakthrough uterine bleeding can occur. Simycia ® from the new package should be resumed after an ordinary 7-day break.

To transfer the day of the onset of menstrual bleeding to the other day of the week of the usual schedule, you should shorten the immediate break in taking the pills for as many days as necessary.The shorter the interval, the higher the risk that there will be no "bleeding" of bleeding, and spotting spotting and breakthrough uterine bleeding (as in the case of a delay in the onset of bleeding "cancellation") will be noted during the taking of tablets from the second package.

Side effects:

During the simultaneous administration of drospirenone and ethinylestradiol, the following adverse reactions were reported:

Class of organ systems		Frequency
	Often ≥1 / 100 to <1/10	Infrequently ≥1 / 1,000 to <1/100	Rarely ≥1 / 10000 to <1/1000
Disturbances from the nervous system	headache, emotional lability / depression	decreased libido	gain libido
Disorders from the endocrine system	violations menstrual cycle, intermenstrual bleeding, soreness of mammary glands		discharge from the mammary glands
Impaired sensory organs			hearing loss, poor tolerance of contact lenses
Infringements from digestive system	nausea, abdominal pain	vomiting, diarrhea
Disturbances from the skin and subcutaneous tissue		acne, eczema, skin rash, urticaria, erythema nodosum, erythema multiforme, itching; Chloasma, especially if there is a history of chloasma of pregnant women
Disorders from the vascular system	migraine	increase or decrease in blood pressure	thromboses (venous and arterial), thromboembolism
Systemic disorders and complications at the site of administration	weight gain	fluid retention	weight loss
Immune system disorders			bronchospasm
Disorders from the reproductive system and breast	acyclic vaginal bleeding (spotting spotting or breakthrough uterine bleeding), engorgement, tenderness, enlargement of the mammary glands, candidiasis of the vagina	vaginitis	discharge from the mammary glands, increased secretions fromlagards

Overdose:

There is no information about an overdose. However, there may be nausea, vomiting, spotting spotting or bleeding from the vagina.

The specific antidote is unknown. Symptomatic treatment should be given.

Interaction:

The interaction between oral contraceptives and other medications can lead to breakthrough uterine bleeding and / or a decrease in contraceptive reliability.The following types of interactions are described:

Influence on metabolism in the liver

Some drugs due to the induction of microsomal enzymes can increase the clearance of sex hormones (phenytoin, barbiturates, primidon, carbamazepine and rifampicin; possibly the same effects of oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and herbal remedies based on St. John's wortHypericum perforatum).

The possible effect of HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and their combinations on liver metabolism has been reported.

Effect on intestinal hepatic recirculation

Clinical observations show that simultaneous use with certain antibiotics, such as penicillins and tetracyclines, reduces intestinal hepatic recycling of estrogens, which can lead to a decrease in the concentration of ethinylestradiol.

Women taking any of the aforementioned classes of medications should use the barrier method of contraception in addition to the Simizia drug or switch to any other method of contraception.

Women who receive constant treatment with drugs containing active substances that affect microsomal liver enzymes should additionally use a non-hormonal contraceptive method within 28 days after their withdrawal.

Women taking antibiotics (other than rifampicin or griseofulvin) should temporarily use the barrier method of contraception in addition to the combined oral contraceptive both at the time of taking the drug and within 7 days after its withdrawal.

If the concomitant use of the drug is initiated at the end of the reception of the packaging of the preparation Daila, the next package should be started without a normal interruption in admission.

The basic metabolism of drospirenone in human plasma is carried out without involvement of the cytochrome P450 system. Inhibitors of this enzyme system, therefore, do not affect the metabolism of drospirenone.

Effect of Simicia® on other drugs

Oral contraceptives can affect the metabolism of other medicines. In addition, their concentrations in plasma and tissues can vary - how to increase (for example, ciclosporin), and decrease (for example, lamotrigine).

Based on the results of inhibition studies in vitro and interaction studies in vivo among women volunteers omeprazole, simvastatin and midazolam as indicators-substrates, the effect of drospirenone in a dose of 3 mg on the metabolism of other active substances is unlikely.

Other interactions

There is a theoretical possibility of increasing serum potassium concentration in women receiving oral contraceptives concomitantly with other drugs that increase serum potassium concentration: angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, some non-steroidal anti-inflammatory drugs (for example, indomethacin), potassium-sparing diuretics and aldosterone antagonists. However, in a study evaluating the interaction of an ACE inhibitor with a combination drospirenone + ethinylestradiol in women with moderate arterial hypertension, there was no significant difference between serum potassium concentrations in women who received enalapril and placebo

Laboratory research

The intake of hormonal contraceptives can affect the results of individual laboratory tests, including biochemical indices of liver, thyroid, adrenal and kidney function, as well as the concentration of plasma transport proteins such as corticosteroid-binding globulin and lipid / lipoprotein fractions, carbohydrate metabolism, blood coagulation and fibrinolysis. Changes usually occur within laboratory norms.

Due to its small antimineralocorticoid activity, drospirenone increases the activity of renin and plasma aldosterone concentration.

Special instructions:

Precautionary measures

If any of the conditions of the risk factors listed below are currently available, the potential risk and expected benefit of using a combined oral contraceptive in each individual case should be weighed carefully and discussed with the woman before she decides to start taking the drug. In case of weighting, strengthening or the first manifestation of any of these conditions or risk factors, a woman should consult with her doctor who can decide whether to cancel the combined oral contraceptive.

Disorders of the circulatory system

The frequency of venous thromboembolism (VTE) when using a combined oral low-dose estrogen oral contraceptive (<50 μg ethinyl estradiol, such as Dailla®) is approximately 20 to 40 cases per 100,000 women per year, which is slightly higher than for women who do not using hormonal contraceptives (5 to 10 cases per 100,000 women), but lower than women during pregnancy (60 cases per 100,000 pregnancies).

An additional risk of VTE is noted during the first year of combined oral contraceptive use. VTE leads to a lethal outcome in 1-2% of cases.

There was also a correlation between the use of combined oral contraceptives and an increased risk of arterial thromboembolism. Very rare cases of thrombosis of other blood vessels, for example, liver, mesenteric, renal, cerebral and retinal arteries, as well as arteries and veins, in patients taking oral hormonal contraceptives have been described. The causal relationship between the occurrence of these side effects and the use of combined oral contraceptives has not been proven.

Symptoms of venous or arterial thrombosis / thromboembolism or cerebrovascular disease may include:

- unusual unilateral pain and / or swelling of the limb

- sudden severe pain in the chest with or without irradiation in the left arm;

- sudden shortness of breath;

- a sudden attack of coughing;

- Any unusual, strong, prolonged headache;

- sudden partial or complete loss of vision;

- Diplomacy;

- Inarticulate speech or aphasia;

- dizziness;

- loss of consciousness with or without convulsive seizure;

- weakness or very significant loss of sensitivity, suddenly

appeared in one half or in one part of the body;

- motor disorders;

- syndrome of "acute abdomen".

The risk of complications associated with VTE when taking a combined oral contraceptive increases:

- with age;

- in the presence of a family history (venous or arterial thromboembolism in close relatives or parents at a relatively young age); if hereditary predisposition is assumed, a woman needs specialist advice before prescribing a combined oral contraceptive;

- after prolonged immobilization, serious surgical intervention, any foot surgery or extensive trauma.In these situations, it is recommended that you stop taking the drug (in the case of a scheduled operation, at least four weeks before it) and do not resume taking it within two weeks of immobilization. Additionally, antiplatelet therapy may be prescribed if oral hormonal contraceptive use has not been discontinued at the recommended time;

- with obesity (body mass index more than 30 kg / m²);

The risk of arterial thrombosis and thromboembolism when taking a combined oral contraceptive increases:

- with age;

- for smokers (women over the age of 35 are strictly not recommended to smoke if they want to use combined oral contraceptives);

- with dyslipoproteinemia;

- with arterial hypertension;

- with migraine;

- with diseases of the heart valves;

- with atrial fibrillation.

The presence of one of the major risk factors or multiple risk factors for arterial or venous disease, respectively, may be a contraindication. Women who use combined oral contraceptives should immediately consult a doctor if symptoms of possible thrombosis occur.In cases of suspected thrombosis or confirmed thrombosis, the use of a combined oral contraceptive should be discontinued. It is necessary to choose an adequate method of contraception due to teratogenicity of anticoagulant therapy (coumarins). You should consider the increased risk of thromboembolism in the postpartum period.

Other diseases that are associated with severe vascular pathology include: diabetes mellitus, systemic lupus erythematosus, haemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraine attacks during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be the basis for the immediate discontinuation of these medications.

Tumors

The most significant risk factor for developing cervical cancer is infection with the human papillomavirus. Some epidemiological studies have reported an increased risk of developing cervical cancer with long-term use of combined oral contraceptives,but there remain conflicting opinions as to the extent to which these findings relate to confounding factors, such as the study of the presence of cervical cancer and the use of barrier methods of contraception.

It is believed that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are at the time of the study used combined oral contraceptives. The excess risk gradually decreases in treatment 10 years after discontinuation of combined oral contraceptives. Because breast cancer is rare in women younger than 40, the increase in breast cancer diagnosed in women who have taken or taken combined oral contraceptives in recent years is small relative to the overall risk of developing breast cancer. These studies do not support the causal relationship between the use of combined oral contraceptives and breast cancer. The observed increase in risk may be a consequence of an earlier diagnosis of breast cancer in women,using combined oral contraceptives, the biological effect of combined oral contraceptives, or a combination of both. Cancerous breast tumors in women who have ever taken combined oral contraceptives were clinically less pronounced than in women who never took them.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign liver tumors, and even more rare - malignant. In some cases, these tumors caused life-threatening abdominal bleeding. When differential diagnosis of liver tumors in women taking combined oral contraceptives, you must consider the occurrence of severe pain in the upper abdominal areas, an increase in the liver or symptoms of intra-abdominal bleeding.

Other states

The progesterone component in the preparation of Simicia® is an aldosterone antagonist having the property of retaining potassium. In most cases, there is no increase in potassium concentration. However, in some patients with mild or moderate renal failure and concomitantthe appointment of potassium-arresting drugs with the intake of drospirenone potassium concentration in the serum is insignificant, but increased. Thus, it is recommended to check the serum potassium concentration in the first cycle of the drug in patients with renal insufficiency and potassium concentration before treatment at the upper limit of the norm, and also with the simultaneous use of drugs that retard potassium in the body.

In women with hypertriglyceridemia or a family history of hypertriglyceridemia, an increased risk of developing pancreatitis during combined oral contraceptives can not be ruled out.

Although a small increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically relevant increases have been rare. Only in rare cases is it necessary to immediately stop taking combined oral contraceptives. If during the reception of combined oral contraceptives in patients with hypertension, the blood pressure values are constantly raised or not reduced with the use of antihypertensive drugs,the use of combined oral contraceptives should be discontinued. If necessary, the use of combined oral contraceptives can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.

The following conditions develop or worsen, both during pregnancy and when taking combined oral contraceptives, but their association with combined oral contraceptives has not been proven: jaundice and / or pruritus associated with cholestasis; formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy in anamnesis; hearing loss associated with otosclerosis.

In women with hereditary angioedema, exogenous estrogens can cause or exacerbate symptoms of angioedema.

In acute or chronic violations of liver function, it may be necessary to stop using combined oral contraceptives until the liver function returns to normal. Recurrent cholestatic jaundice and / or cholestasis-induced pruritus,which develop for the first time during pregnancy or previous reception of sex hormones, require discontinuation of combined oral contraceptives.

Although combined oral contraceptives may affect peripheral insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (containing <0.05 mg ethinyl estradiol). Nevertheless, women with diabetes should be carefully observed by a doctor, especially at the beginning of taking combined oral contraceptives.

Also reported was an increase in endogenous depression, epilepsy, Crohn's disease and ulcerative colitis with combined oral contraceptives.

Sometimes chloasma can develop, especially in women with chloasma during pregnancy in the anamnesis. Women with a tendency to chloasma when taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

The medicinal preparation Simicia® contains 48.53 mg of lactose in one tablet. Patients with hereditary intolerance to galactose, lactase deficiency, or glucose / galactose absorption disorders on a lactose-free diet should not take the drug.

Medical examination / consultation

Before starting the use of hormonal contraceptives it is necessary to consult with the treating gynecologist and undergo the appropriate medical examination. Further monitoring and frequency of medical examinations are carried out on an individual basis, but at least once every 6 months.

Simizia ®, like other combined oral contraceptives, does not protect against HIV infection and other sexually transmitted diseases.

Decreased efficiency

The effectiveness of combined oral contraceptives can be reduced in case of missing tablets, disorders of the gastrointestinal tract, or with the simultaneous administration of other medications.

Reduced cycle control

On the background of taking combined oral contraceptives, there may be irregular bleeding (spotting spotting or breakthrough uterine bleeding), especially during the first months of use.Therefore, the evaluation of any irregular bleeding is significant only after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, nonhormonal causes should be considered and adequate diagnostic measures taken to exclude malignant neoplasms or pregnancy, including diagnostic scraping, should be carried out.

In some women, bleeding "cancellation" may not develop during a break in taking combined oral contraceptives. If combined oral contraceptives are taken according to the rules for taking the drug specified in the instructions, pregnancy is unlikely. However, if before that, combined oral contraceptives were not taken regularly, or if there were no consecutive "bleeding" bleeds in a row, pregnancy should be ruled out before continuing with combined oral contraceptives.

Effect on the ability to drive transp. cf. and fur:The use of Simicia® does not affect the ability to drive vehicles and other mechanisms.

Form release / dosage:

Tablets, film-coated, 3 mg + 0.02 mg.

Packaging:

For 21 tablets in a blister of PVC / PE / PVDC - aluminum foil.

For 1 or 3 blisters in a cardboard box together with instructions for use.

In the cardboard box is enclosed a cardboard flat case for storing the blister.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:PL-000926

Date of registration:18.10.2011 / 11.09.2012

Date of cancellation:2018-05-11

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER, Ltd. Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp11.05.2018

Illustrated instructions

Instructions

Simicia® (Symicia®)