Miniziston 20 femmes - instructions for use, dose, side effects, contraindications

auxiliary componentslactose monohydrate 35,190 mg, corn starch 9,900 mg, corn starch pregelatinized 6,600 mg, povidone 25 thousand 2,750 mg, magnesium stearate 0.440 mg, sucrose 19.374 mg, povidone 700 thousand 0.190 mg, macrogol 6000 2.148 mg, calcium carbonate 8.607 mg, talcum powder 4,198 mg, glycerol 85% 0.137 mg, titanium dioxide 0.274 mg, iron oxide oxide yellow 0.014 mg, iron oxide red oxide 0.008 mg, wax mountain glycol 0.050 mg.

Description:

The tablets are covered with a shell of pink color.

Pharmacotherapeutic group:Contraceptive agent combined (estrogen + progestogen)

ATX: & nbsp

G.03.A.B Progestogens and estrogens (combinations for sequential administration)

G.03.A.B.03 Levonorgestrel and ethinyl estradiol

Pharmacodynamics:

Miniziston 20 fem - a low-dose monophasic oral combined estrogen-progestational drug.

The contraceptive effect of the mini-zistone of 20 females is carried out by means of complementary mechanisms, the most important of which are suppression of ovulation and a change in the viscosity of cervical mucus, as a result of which it becomes impenetrable for spermatozoa.

When properly applied, the Perl index (the indicator that reflects the frequency of pregnancy in 100 women taking a contraceptive during the year) is less than 1. When missing tablets or improperly used, the Perl index may increase.

In women taking combined oral contraceptives, the cycle becomes more regular, the pain and intensity of menstrual bleeding decreases, which reduces the risk of iron deficiency anemia.

Indications:Oral contraception.

Contraindications:

Miniziston 20 fems is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions develop against the background of its administration, the drug should be immediately withdrawn.

- Thrombosis (venous and arterial) and thromboembolism now or in history (including deep vein thrombosis, pulmonary thromboembolism, myocardial infarction, stroke).

- Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) are currently or in the anamnesis.

- The presence of severe or multiple risk factors for venous or arterial thrombosis may also be a contraindication (see section "Special instructions").

- Migraine with focal neurologic symptoms in anamnesis.

- Diabetes mellitus with vascular complications.

- Pancreatitis with severe hypertriglyceridemia at present or in the anamnesis.

- Severe liver disease (prior to the normalization of "liver" samples) now or in the anamnesis.

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

- Revealed hormone-dependent malignant diseases (including genital organs or mammary glands) or suspected of them.

- Bleeding from the vagina of an unknown origin.

- Pregnancy or suspicion of it.

- Hypersensitivity to active substances or any of the components of Miniziston 20 fem.

- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Carefully:

Care should be taken to weigh the potential risk and the expected benefits of the application combined oral contraceptives in each individual case presence of the following diseases / conditions and risk factors:

- Risk factors for thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, heart valve flaws, prolonged immobilization, serious surgical interventions, extensive trauma, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebral infarction at a young age in whom or from the next of kin).

- Other diseases in which peripheral circulation disorders may be noted: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins.

- Hereditary angioedema.

- Hypertriglyceridemia.

- Diseases of the liver.

- Diseases that first appeared or worsened during pregnancy or on the background of previous reception of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes pregnant, Sydenham's chorea).

- Postpartum period.

- In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.

Pregnancy and lactation:

Miniziston 20 fems are contraindicated during pregnancy and lactation.

If pregnancy is detected during the treatment with Miniziston 20 femmes, the drug should be immediately discontinued. However, numerous epidemiological studies have not revealed an increased risk of developmental defects in children born to women who received sex hormones before pregnancy or teratogenicity when sex hormones were mistaken for early pregnancy.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore,their use is not recommended for lactation. A small amount of sex hormones and / or their metabolites can be excreted with milk.

Dosing and Administration:

When and how to take pills

The calendar pack contains 21 tablets. In the package, each tablet is marked with the day of the week in which it should be taken. Take the tablets inside at the same time each day, with a small amount of water. Follow the direction of the arrow until all 21 tablets are taken. During the next 7 days you do not take the drug. Menstruation (bleeding "cancellation") should begin within these 7 days. Usually it begins on day 2-3 after taking the last tablet of Miniziston 20 fem. After a 7-day break (on the 8th day), start taking the pills from the next package, even if the bleeding has not stopped. This means that you will always start a new package on the same day of the week, and that each month the withdrawal bleeding will occur approximately on the same day of the week.

Receiving the first package Miniziston 20 fems

- When no hormonal contraceptive was used in the previous month

Start taking Miniziston 20 frames on the first day of the cycle, that is, on the first day of menstrual bleeding. Take a tablet that is labeled with the appropriate day of the week. Then take the tablets in order. You can also start reception on the 2nd-5th day of the menstrual cycle, but in this case you must use the barrier method of contraception (condom) during the first 7 days of taking the tablets from the first package.

- When switching from other combined oral contraceptives, vaginal rings or contraceptive patches

You can start taking Miniziston 20 frames the next day after you take the last tablet of the current package of the combined oral contraceptive (i.e., without interruption of admission). If the current package contains 28 tablets, you can begin taking a Miniziston 20 fem on the day after receiving the last hormone-containing tablet of the contraceptive you are taking. If you are not sure which is the tablet, ask your doctor. You can also start taking it later, but in no case later than the next day after a normal break in taking (for drugs containing 21 tablets) or after taking the last inactive tablet (for preparations containing 28 tablets in the package).
Receiving Miniziston 20 femmes should begin on the day of removal of the vaginal ring or patch, but no later than the day when a new ring is to be inserted or a new patch is stuck.

- When switching from oral contraceptives containing only gestagen (mini-pili)

You can stop taking a mini-drank on any given day and start taking Miniziston 20 fems the next day, at the same time. During the first 7 days of taking the pill, it is also necessary to use the barrier method of contraception.

- When switching from an injectable contraceptive, an implant or an intrauterine contraceptive (IUD) progestogen-releasing progestogen,

Start taking Miniziston 20 fem on the day that the next injection is to be made, or on the day of removal of the implant or IUD. During the first 7 days of taking the pill, it is also necessary to use the barrier method of contraception.

- After childbirth

If you have just given birth to a child, the doctor may recommend that you wait until the end of the first normal menstrual cycle before starting taking Miniziston 20 fem. Sometimes, on the advice of a doctor, you can start taking the drug earlier.

- After a spontaneous miscarriage or abortion in the first trimester of pregnancy

Consult your physician. Usually, it is recommended that you start immediately.

Acceptance of missed tablets

- If the delay in taking the next tablet is less than 12 hours, the contraceptive effect of Miniziston 20 fems is preserved. Take the pill as soon as you remember it. The next tablet is taken at the usual time.

- If the delay in taking the tablet is more than 12 hours, the contraceptive protection may be reduced. The more pills in a row are missed, and the closer this pass to the beginning of admission or the end of admission, the higher the risk of pregnancy.

In doing so, you can follow the following rules:

- Forgotten more than one tablet from the packaging

Consult with your doctor.

- One tablet is missed in the first week of taking the drug

Take the missed tablet as soon as possible, as soon as remember (even if it means taking two pills at the same time). The next tablet is taken at the usual time. Additionally, use the barrier method of contraception for the next 7 days. If the sexual intercourse took place during the week before passing the pill, it is necessary to take into account the probability of pregnancy. Immediately consult a physician.

- One tablet is missed in the second week of taking the drug

Take the missed tablet as soon as possible, as soon as remember (even if it means taking two pills at the same time). The next tablet is taken at the usual time. If you took the tablets correctly for 7 days preceding the first missed pill, the contraceptive effect of Miniziston 20 fem is saved, and you do not need to use additional contraceptive measures. Otherwise, as well as when two or more tablets are missed, barrier methods of contraception must be used additionally within 7 days.

- One tablet was missed on the third week of taking the drug

If within 7 days preceding the first missed tablet, all tablets were taken correctly, there is no need to use additional contraceptive methods. You can follow any of the following two options:

1. Take the missed tablet as soon as possible, as soon as remember (even if it means taking two pills at the same time). The next tablet is taken at the usual time. Start the next package immediately after the end of taking the tablets from the current package, so there will be no break between the packages.Bleeding "cancellation" is unlikely until the tablets from the second package run out, but there may be spotting or breakthrough bleeding on the days of taking the drug.

2. Stop taking the pills from the current package, take a break for 7 or less days (including the day the tablet is missed) and then start taking the tablets from the new package.

Using this scheme, you can always start taking the tablets from the next package on the day of the week when you usually do it.

See figure

If, after a break in taking pills, there is no expected menstruation, you may be pregnant. Consult your doctor before you start taking the pills from the new package.

In situations where you are advised to stop taking a combined oral contraceptive, or when the reliability of the drug can be reduced, should refrain from having sex or use non-hormonal contraceptive methods (for example,, condom or other barrier methods). Do not use rhythm or temperature methods. These methods may be unreliable, since taking a combined oral contraceptive leads to changes in temperature and cervical mucus.

Recommendations in case of vomiting and diarrhea

If you were gastrointestinal disturbances (vomiting or diarrhea) within 4 hours after ingestion of tablets Miniziston FEM 20, the active substance may not be completely sucked. This situation is similar to skipping a drug. Therefore, follow the instructions for taking the missed tablets.

Postponement of menstrual bleeding

You can delay the onset of menstrualnopodobnoe bleeding if you start taking the pill from the next pack of themes Minizistona 20 immediately after the end of the current package. You can continue taking the pills from this package for as long as you want, or until the package is finished. If you want menstrual bleeding to start, stop taking the pills. During the reception of the Miniziston, 20 females from the second package may have spotting or breakthrough uterine bleeding on the days of taking the tablets. Start the next packing after an ordinary 7-day break.

Change in the day of menstrual bleeding

If you take the pill according to the recommendations, you will have menstrual bleeding about the same day every 4 weeks. If you want to change it, shorten (but do not extend) the time interval, free from taking the tablets.For example, if your cycle usually starts on Friday, and in the future you want it to start on Tuesday (3 days earlier), the next package should start 3 days earlier than usual. If the break from taking the pills will be very short (for example, 3 days or less), bleeding cancellation during the break may not occur. In this case, bleeding or spotting bleeding may occur during taking the tablets from the following package.

Additional information for individual groups of patients

Children and teens

Efficacy and safety of Miniziston 20 femme as a contraceptive was studied in women of reproductive age. It is assumed that in the post-pubertal period up to 18 years of efficacy and safety drugs are similar to those in women after 18 years. The use of the drug before menarche is not indicated.

Older patients

Not applicable. The drug Miniziston 20 females is not indicated after the onset of menopause.

Patients with hepatic impairment

The drug Miniziston 20 femmes is contraindicated in women with severe liver disease until the liver function test results are normal. See also "Contraindications".

Patients with impaired renal function

The drug Miniziston 20 fem. Has not been specifically studied in patients with impaired renal function. The available data do not suggest correction of the dosing regimen in such patients.

Side effects:

When taking Miniziston 20 femmes, as well as other combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) can occur, especially during the first months of use, and other undesirable effects, the relationship of which with taking the drug is not confirmed, but not disproved .

System of organs	Often (≥1 / 100)	Infrequently (≥1 / 1000 and <1/100)	Rarely (<1/1000)
Body of sight			intolerance to contact lenses (discomfort when wearing them)
Gastrointestinal tract	nausea, abdominal pain	vomiting, diarrhea	hypersensitivity
The immune system
General symptoms	weight gain		weight loss
Metabolism		fluid retention
Nervous system	headache	migraine
Mental disorders	decreased mood, swings moods	decreased libido	increased libido
Reproductive system and mammary glands	soreness of the mammary glands, breast engorgement	mammary gland hypertrophy	vaginal discharge, discharge from the mammary glands
Skin and subcutaneous tissue		rash, urticaria	erythema nodosum, multiform erythema

The following serious adverse events have been reported in women using combined oral contraceptives. These undesirable phenomena are discussed in the section "Special instructions":

Venous thromboembolic disorders
Arterial thromboembolic disorders
Cerebrovascular disorders
Increased blood pressure
Hypertriglyceridemia
Changes in glucose tolerance or effects on peripheral insulin resistance
Liver tumors (benign and malignant)
Impaired liver function
Chloasma
In women with hereditary angioedema, exogenous estrogens can cause or exacerbate symptoms of angioedema.
The onset or deterioration of conditions for which communication using combined oral contraceptives is not undeniable: jaundice and / or pruritus associated with cholestasis; formation of gallstones; porphyrin disease; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes pregnant; loss of hearing,associated with otosclerosis; Crohn's disease; ulcerative colitis; cervical cancer.

The frequency of diagnosing breast cancer in women using oral contraceptives is increased very slightly. Breast cancer is rarely seen in women under 40 years of age, exceeding the frequency is insignificant in relation to the overall risk of breast cancer. The causal relationship of the occurrence of breast cancer using combined oral contraceptives is not established. For more information, see "Contraindications" and "Special instructions".

Overdose:

About serious violations with a single intake of a large number of tablets Miniziston 20 femmes were not reported.

Symptoms that can be noted in an overdose: nausea, vomiting, spotting from the vagina.

In case of overdose, see a doctor.

Interaction:

Some drugs may reduce the effectiveness of Miniziston 20 fem. These include drugs used to treat epilepsy (for example, primidon, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (for example, rifampicin, rifabutin) and HIV infection (for example, ritonavir, nevirapine); antibiotics for the treatment of certain other infectious diseases (eg, penicillins, tetracyclines, griseofulvin), as well as medicines based on St. John's wort (used, mainly, in the treatment of reduced mood).

Oral combined contraceptives may affect the metabolism of other drugs (eg, cyclosporine and lamotrigine).

When taking combined oral contraceptives, you may also need to adjust the dosage regimen for hypoglycemic drugs and indirect anticoagulants.

Always tell the doctor who prescribes Miniziston 20 fem, what medications you are already taking. Also tell any doctor or dentist who prescribes other drugs, as well as a pharmacist who sells medicines to you at the pharmacy, that you are taking Miniziston 20 fem.

In some cases, the doctor may recommend that you also use the barrier method of contraception (condom).

Special instructions:

The following warnings regarding the use of other combined oral contraceptives should also be considered when using Miniziston 20 fem.

- Thrombosis

Thrombosis is the formation of a blood clot (thrombus) that can clog the blood vessel. When thrombus is broken off, thromboembolism develops. Sometimes thrombosis develops in the deep veins of the legs (deep vein thrombosis), cardiac vessels (myocardial infarction), the brain (stroke), and extremely rarely in the vessels of other organs.

The results of epidemiological studies indicate the existence of a relationship between the use of combined oral contraceptives and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders) when taking combined oral contraceptives. These diseases are rare.

The risk of developing venous thromboembolism (VTE) is maximal in the first year of taking such drugs. An increased risk is present after the initial use of combined oral contraceptives or the resumption of the use of the same or different combined oral contraceptives (after a break between doses of 4 weeks or more).Data from a large prospective study with 3 groups of patients show that this increased risk is present mainly during the first 3 months.

The overall risk of VTE in patients taking low-dose combined oral contraceptives (<50 mcg ethinyl estradiol) is two to three times higher than in non-pregnant patients who do not take COC, however, this risk remains lower compared with the risk of VTE in pregnancy and childbirth.

In very rare cases, venous or arterial thromboembolism can lead to serious functional impairment or to death.

VTE, manifested as deep vein thrombosis, or pulmonary embolism, can occur when using any combination oral contraceptives. Very rarely, when combined oral contraceptives are used, thrombosis of other blood vessels arises, for example, liver, mesenteric, renal, cerebral veins and arteries or retinal vessels.

The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:

-with age;

smokers (with increasing number of cigarettes or increasing age, the risk increases, especially in women over 35 years of age); in the presence of:

family history (for example, venous or arterial thromboembolism ever at close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, a woman should be examined by an appropriate specialist to decide on the possibility of taking combined oral contraceptives;
obesity (body mass index more than 30 kg / m²);
dyslipoproteinemia;
arterial hypertension;
migraine;
heart valve diseases;
atrial fibrillation;
prolonged immobilization, serious surgical intervention, any foot surgery or extensive trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of a planned operation at least four weeks before) and not to resume admission within two weeks after the end of immobilization.

- Tumors

The relationship between taking combined oral contraceptives and breast cancer has not been proven, although women,taking combined oral contraceptives, it is detected somewhat more often than in women of the same age who do not use them. Perhaps this difference is due to the fact that when taking the drug, women are examined more often and therefore breast cancer is detected at an early stage.

In rare cases, against the background of the use of sex steroids, there was a development of benign, and in extremely rare cases, malignant liver tumors that can lead to life-threatening intraabdominal hemorrhages. Communication with the use of drugs has not been proven. If there is a sudden appearance of severe pain in the abdomen, consult a doctor immediately.

The most significant risk factor for developing cervical cancer is persistent papillomavirus infection. Cervical cancer was detected more frequently in women using combined oral contraceptives for a long period of time. The connection with the use of combined oral contraceptives has not been proven. This may be due to more frequent gynecological examinations to detect cervical disease or with peculiarities of sexual behavior (a more rare use of barrier methods of contraception).

- Decreased efficiency

The effectiveness of combined oral contraceptive drugs can be reduced in the following cases: when missing tablets, with vomiting and diarrhea, or as a result of drug interactions.

- Women with a tendency to chloasma during the intake of combined oral contraceptives should avoid prolonged exposure to sunlight and exposure to ultraviolet radiation.

- In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen the symptoms of angioedema.

Frequency and severity of menstrual bleeding

As with the use of other combined oral contraceptives, occasional (acyclic) bleeding from the vagina (spotting spotting or "breakthrough" uterine bleeding) can occur during the first few months with the use of a Miniziston 20 fem. Use hygiene products and continue taking the pills as usual. Irregular bleeding usually stops as the body adapts to the Miniziston 20 fem (usually after 3 cycles of taking the pills). If they continue, get heavy or resume after stopping, see a doctor.

The absence of another menstrual bleeding

If you took all the pills correctly and you did not have vomiting or diarrhea while taking the pills or taking other medications at the same time, the probability of pregnancy is small. Continue taking Miniziston 20 fems, as usual. If there are no two menstrual bleeding in a row, consult a doctor immediately. Do not start taking the pills from the next package until the doctor excludes the pregnancy.

Laboratory Tests

Receiving COCs can affect the results of some laboratory tests including liver function, kidney, thyroid, adrenals, transport protein content in the plasma, carbohydrate metabolism, coagulation parameters and fibrinolysis. Changes usually do not go beyond the limits of normal values.

When to consult a doctor

See table

Regular inspections

If you are taking Miniziston 20 femmes, your doctor will tell you about the need for regular examinations, at least once every 6 months.

Miniziston 20 femmes do not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Miniziston 20 Fem is recommended by the doctor personally to you, do not pass the drug to others!

Effect on the ability to drive transp. cf. and fur:

Not found.

Form release / dosage:The coated tablets are 100 μg + 20 μg.

Packaging:

For 21 tablets in a blister of PVC and aluminum foil. For 1 or 3 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N015426 / 01

Date of registration:07.04.2009 / 23.01.2014

The owner of the registration certificate:Bayer Pharma AGBayer Pharma AG Germany

Manufacturer: & nbsp

BAYER WEIMAR, GmbH & Co. KG. KG Germany

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp31.05.2016

Illustrated instructions

Instructions

Miniziston® 20 fems (Minizistone® 20 fem)