Microlut 35 tablets

Microlut 30 mcg

35 coated tablets

Composition:

1 coated tablet contains: 

Levonorgestrel 30 mcg

Inactive ingredients:

Lactose monohydrate, maize starch, polyvidone 25,000, talcum, magnesium stearate (Ph.Eur.), sucrose (saccharose), povidone 90,000, macrogol 6,000, calcium carbonate, montanglycol, wax

Properties:

•Synthetic gestagen with contraceptive action. Emergency contraceptive action is realized due to pronounced gestagenic and antiestrogenic effects. The main mechanism of action is the inhibition and / or delay of ovulation as a result of the suppression of the LH peak.

When used as a means of emergency contraception, levonorgestrel suppresses ovulation and fertilization if sexual act occurs in the preovulatory phase, when the possibility of fertilization is greatest. •Levonorgestrel is not effective if implantation of a fertilized egg has already occurred.

Indications:

-Emergency (postcoital) contraception within 72 hours after unprotected sexual  or if the contraceptive method used is unreliable;

-Intrauterine contraception

Dosage and administration:

-The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosing regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

-As for emergency contraception, it is used orally at a dose of 0.75-1.5 mg according to a special scheme.

-When used in the form of an intrauterine contraceptive, the dose depends on the drug used.

Side effects:

-From the immune system: very rarely - an allergic reaction (skin rash, urticaria, itching, swelling of the face). If any of these signs occur, you should immediately seek medical attention.

-From the nervous system: very often - headache; often - dizziness.

-From the gastrointestinal tract: very often - nausea, pain in the lower abdomen; often - diarrhea, vomiting; very rarely - abdominal pain.

-On the part of the genital organs and the mammary gland: very often - bleeding not associated with menstruation; often - a delay in menstruation for more than 7 days, irregular menstrual bleeding, engorgement of the mammary glands; very rarely - pain in the pelvis, dysmenorrhea.

-General disorders and disorders at the injection site: very often - increased fatigue, swelling of the face.

-On the part of the skin and subcutaneous tissues: very rarely - skin rash, urticaria, itching.

Contraindications:

-Hypersensitivity to levonorgestrel; pregnancy (including intended); established or suspected malignant neoplasms of the genital organs and breast; 

-uterine bleeding of unknown etiology; 

-a history of inflammatory diseases of the pelvic organs or ectopic pregnancy; 

severe liver failure, acute liver disease, liver tumors; 

-thromboembolic disorders, thrombophlebitis, cerebrovascular diseases, coronary artery diseases; 

-age up to 16 years (for dosage forms for emergency contraception).

-For an intrauterine contraceptive device - infections of the external genital organs; -postpartum endometritis, septic abortion within the last 3 months, cervicitis, cervical dysplasia, congenital or acquired anomalies of the uterus, incl. fibromyomas leading to deformation of the uterine cavity.

Warnings and precautions:

•Levonorgestrel should be used in patients with diseases of the liver and biliary tract, jaundice (including history), Crohn's disease, with a hereditary or acquired predisposition to thrombosis, with congenital heart disease or heart valve disease (due to the risk of developing septic endocarditis), diabetes mellitus.

•When using an intrauterine contraceptive, you should consult your doctor if you have or first experience any of the following conditions: migraine, focal migraine with asymmetric loss of vision or other symptoms indicating transient cerebral ischemia; unusually severe headache; jaundice; severe arterial hypertension; severe circulatory disorders, incl. stroke and myocardial infarction.

•In patients who are overweight, the contraceptive effect of levonorgestrel is less effective.

•If, against the background of the action of levonorgestrel, the expected menstruation did not occur within 6 weeks from the beginning of the previous menstruation or menstrual-like reaction, it is necessary to exclude the presence of pregnancy.

•With prolonged and persistent intermenstrual bleeding, an additional examination is necessary to verify the diagnosis.

Drug interactions:

•With simultaneous use with rifampicin, phenytoin, primidone, barbiturates, the contraceptive effect of levonorgestrel decreases due to an increase in steroid metabolism due to the induction of microsomal liver enzymes.With simultaneous use with ampicillin, sulfamethoxypyridazine, chloramphenicol, nitrofurantoin, phenoxymethipenicillin and neomycin, intermenstrual bleeding may increase. This is due to the inhibition of enterohepatic recirculation of sex steroids, which is associated with a change in the intestinal flora.

•The following drugs may reduce the effectiveness of levonorgestrel: amprenavir, lansoprazole, nevirapine, oxcarbazepine. tacrolimus, topiramate, tretinoin, barbiturates (including primidone), phenytoin and carbamazepine; preparations containing St. John's wort (Hypericum perforatum); as well as rifampicin, ritonavir, ampicillin, tetracycline, rifabutin, griseofulvin.

•Levonorgestrel reduces the effectiveness of oral anticoagulants, antihypertensives, anticonvulsants and hypoglycemic agents. Increases plasma concentrations of corticosteroids. Women taking these drugs should consult their doctor for advice.

•Levonorgestrel can disrupt the processes of oxidative metabolism of diazepam and chlordiazepoxide, which leads to accumulation in the plasma of the latter.

•Preparations containing levonorgestrel may increase the risk of cyclosporine toxicity due to suppression of its metabolism.

•Levonorgestrel can reduce the effectiveness of ulipristal by competitive action on the progesterone receptor, and therefore their simultaneous use is not recommended.

Storage:

Store at a temperature not exceeding 30°C.

Package:

Carton box holds a calendar blister of 35 tablets and paper instructions.