Belara tablets are indicated for hormonal contraception.
Active ingredients: 1 coated tablet contains chlormadinone acetate 2 mg, ethinylestradiol 0.03 mg;
Excipients: lactose, corn starch, K-30, magnesium stearate;
Sheath: hypromellose, lactose, titanium dioxide (E 171), talc, polyethylene glycol (macrogol 6000), propylene glycol, iron oxide red (E 172).
Hypersensitivity to active ingredients or to any other component of the preparation.
Loss of control over diabetes.
Uncontrolled arterial hypertension or a significant increase in blood pressure (values constantly exceed 140/90 mm Hg).
The presence or risk of venous thromboembolism (VTE).
Presence or risk of arterial thromboembolism (ATE).
Hepatitis, jaundice, abnormal liver function (before normalization of liver function indicators).
Generalized pruritus, cholestasis, in particular during a previous pregnancy or estrogen therapy.
Dubin-Johnson syndrome, Rotor syndrome, impaired bile flow.
History of liver tumors or currently.
Severe epigastric pain, enlarged liver, or symptoms of intra-abdominal bleeding.
First-onset or recurrent porphyria (all three forms, especially acquired porphyria).
History or current malignant hormone-dependent tumors, such as tumors of the mammary glands or uterus.
Severe lipid metabolism disorders.
History or current pancreatitis, accompanied by severe hypertriglyceridemia.
Symptoms of migraine, which occurred for the first time, as well as frequent and very severe headache.
Acute sensory disorders, such as visual or hearing impairment.
Movement disorders (in particular paresis).
Strengthening epileptic seizures.
Severe depression.
Otosclerosis that has progressed during previous pregnancies.
Amenorrhea of unexplained etiology.
Endometrial hyperplasia.
Vaginal bleeding of unexplained etiology.
Concomitant use with preparations containing ombitasvir / paritaprevir / ritonavir and dazabuvir.
1 coated tablet should be taken daily at the same time (mainly in the evening) for 21 days in a row, then a seven-day break in taking the tablets should be taken; 2-4 days after taking the last coated tablet, withdrawal bleeding similar to menstrual bleeding will occur. After the end of the seven-day break, you should start taking Belara® from the next package, regardless of whether the bleeding has stopped or not.
The film-coated tablet noted on the package for the respective day of the week should be removed from the blister package and swallowed whole, with a little water if necessary. Film-coated tablets should be taken daily in the sequence indicated on the packaging by the direction of the arrow.
Pregnant
Contraindicated.
Children
Do not administer the preparation to children.
There is no information about the serious toxic effect of the preparation in case of an overdose. Symptoms include nausea, vomiting, and - especially in young girls - slight vaginal spotting. There is no specific antidote; carry out symptomatic therapy. In rare cases, it may be necessary to monitor indicators of water and electrolyte metabolism and liver function.
Clinical studies of tablet forms with the same combination of active substances showed that the most common side effects (> 20%) were breakthrough bleeding, minor spotting, headache and chest discomfort. The likelihood of irregular bleeding decreases with continued use of tablets with the same composition of active ingredients.
Note: in order to identify possible interactions, you should read the instructions for use of preparations taken simultaneously with this preparation.
Concomitant use with preparations containing ombitasvir / paritaprevir / ritonavir and dazabuvir is contraindicated.
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children!
Shelf life is 3 years.
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