Belare

Each tablet of Belare contains ethinyl oestradiol 0.03 mg and Chlormadinone (Belare) acetate 2 mg. It also contains the following excipients: Lactose monohydrate, maize starch, povidone K30, magnesium stearate, hypromellose, macrogol 6000, propylene glycol, talc, titanium dioxide (E171), iron oxide (E172).

indicated in the intimate, intended to be inserted into the vaginal cavity through cannula irrigation. Belare este un dispozitiv medical folosit in prevenirea proliferarii bacteriilor nedorite care mentine ph-ului vaginal in limite fiziologice, atenuand inflamatia vaginala si aducand microflora vaginala la valori normale. Belare is a device used to prevent proliferation of unwanted bacteria that maintain vaginal pH in the physiological limits, alleviating inflammation of the vagina and bringing normal vaginal microflora.

Recommended Dose: 1 tablet must be taken everyday at the same time (preferably in the evening) on 21 consecutive days, followed by a 7-day break in which no tablets are taken; menstruation-like withdrawal bleeding should occur 2-4 days after administration of the last tablet. After the 7-day medication-free interval, medication should be continued with the next pack of Belare, regardless of whether bleeding has ceased or not.

Administration: Before starting treatment with Belare, a thorough general and gynaecological examination should be carried out and pregnancy ruled out. Unless otherwise prescribed by the physician, the following dosage of Belare applies. The patient must follow the instructions, otherwise Belare will not be fully effective.

Start taking Belare on the 1st day of menstruation, even if the patient had previously been taking a different contraceptive ("pill").

Press out the 1st table at the position on the pack which is marked with the corresponding weekday (eg "Sun" for Sunday) and swallow without chewing. Then, continue taking 1 tablet everyday following the direction of the arrows, if possible at the same time of day, preferably in the evening of the arrows. It is essential to take Belare regularly in order to ensure its contraceptive reliability. The interval between taking 2 tablets should be 24 hrs as regularly as possible. The days printed on the pack allow the patient to check every day whether the tablet has already been taken for that particular day. After taking the last tablet, there is a 7-day medication-free interval during which bleeding occurs within 2-4 days after taking the last tablet. After the 7-day medication-free interval, the patient should continue taking Belare with the next pack, regardless of whether the bleeding has already stopped or is still present.

During the use of Belare, the patient should have a gynaecological check-up about every 6 months.

Contraception starts with the 1st day of intake and also continues during the 7-day medication-free intervals.

If the patient starts taking Belare very soon after childbirth or miscarriage, the patient must consult the physician whether additional protective measures are necessary during the 1st cycle.

As the acne treatment is only an additional beneficial effect of the hormonal contraception, the dosage regimen and the duration for use, and the posology for the acne treatment is the same as for the hormonal contraception.

Duration of Treatment: If the patient wishes to have hormonal contraception, Belare must be taken for years if the patient pays attention to the contraindications and the other information in the patient leaflet.

After the patient stop taking Belare, the reproductive glands rapidly resume their full function in most cases and the ability to conceive is restored. The 1st cycle is usually prolonged by about 1 week. If, however, a normal cycle does not develop within the first 2-3 months, the patient should consult a physician.

Hypersensitivity to Ethinylestradiol (Belare) or Chlormadinone (Belare) acetate or to any of the excipients of Belare. Patients suffering from or have history of blood clots in the veins or arteries (eg, deep vein thrombosis, pulmonary embolism, heart attack, stroke).

If the 1st stages of signs of a blood clot is noticed, inflammation of the veins or embolism eg, fleeting stabbing pain, chest pain or feeling of tightness in the chest; forced to rest for a long period of time (eg, on strict bed rest or due to a plaster cast) or is planning to have an operation (stop taking Belare at least 4 weeks before the scheduled date of the operation); diabetes and uncontrolled blood sugar fluctuations or have changes in the blood vessels; uncontrolled hypertension or blood pressure rises considerably (values constantly >140/90 mmHg); disturbance of blood clotting (eg, C-protein deficiency); suffering from inflammation of the liver (eg, due to a virus) or from jaundice and liver values have not yet returned to normal; itching all over the body or suffering from a bile flow disorder, particularly if this occurred in connection with a previous pregnancy or oestrogen treatment; increased bilirubin (a degradation production of blood pigment) in blood, eg, due to an inborn excretion disorder (Dubin-Johnson or Rotor syndrome); exisiting or history of liver tumour; severe stomachache, a liver enlargement or signs of abdominal bleeding; first occurrence or recurrence of porphyria (a disorder of blood pigment metabolism); suspected hormone-dependent malignant tumour eg, breast or uterine cancer; suffering from severe disorders of fat metabolism, inflammation of the pancreas associated with severely increased blood fats (triglycerides), migraine for the first time; severe, frequent or long-lasting headache, migraine accompanied by disorders of sensation, perception and/or movement (migraine accompagnee); sudden perception disorders (sight or hearing); movement disorders (in particular signs of paralysis); worsening of epileptic fits; suffering from severe depression, a certain type of deafness (otosclerosis) that worsen during previous pregnancies; no period for some unknown reason; abnormal overgrowth of the inner layer of the womb (endometrial hyperplasia); vaginal bleeding for some unknown reason.

If the one of these conditions occurs during administration of Belare, discontinue use immediately.

Belare should not be taken or discontinue abruptly, if patient has a serious or several risks of blood clotting disorders.

Listed as follows are the cases in which Belare should be taken under certain conditions and with caution: Heart and kidney diseases, migraine, epilepsy, history of asthma because these may be affected by fluid accumulation; history of inflammation of the veins (phlebitis); marked tendency towards varicose veins (varicosis); multiple sclerosis; St. Vitus' dance (chorea minor); muscle cramps (tetany); tendency of diabetes mellitus; history of liver disease; fat metabolism disorders; considerable overweight; elevated blood pressure; benign overgrowth of the mucous membranes of the womb (endometriosis); benign tumors of the womb (myomatous uterus); breast diseases (mastopathy); otosceloris (a certain form of middle-ear deafness).

The contraceptive effectiveness of Belare may be affected if substances that speed up the biological breakdown of steroid hormones eg, barbiturates, rifampicin, griseofulvin, phenylbutazone, antiepileptics (eg, barbexaclone, carbamazepine, phenytoin, primidone) and preparations containing St. John's wort and oral contraceptives at the same time spotting has been reported.

Reduced active substance levels have also been observed due to changes in the bowel flora when antibiotics eg, ampicillin or tetracyclines were taken at the same time, and also after taking activated charcoal. Also, increased rates of spotting and in isolated cases, pregnancy have been recorded. Requirements of insulin or antidiabetic medicines taken by mouth may be altered due to effects on glucose tolerance. The excretion of theophylline or caffeine is reduced during the use of oral contraceptives with the result that the effect of theophylline or caffeine may be increased and prolonged.

The frequencies with which adverse reactions have been reported are defined as follows: Very Common (Affecting >1 in 10 Users): Nausea, vaginal discharge, menstrual pain, amenorrhea, breakthrough bleeding, spotting, headache, pain in the breasts.

Common (Affecting <1 in 10, but >1 in 100 Users): Ovarian cyst, benign tumours (fibroadenomas), feeling of tension in the breasts, depression, irritability, nervousness, dizziness, migraine (and/or aggravation of these), visual disorders, vomiting, acne, pain in the belly, tiredness, feeling of heaviness in the legs, water retention; increased weight, blood pressure.

Uncommon (Affecting <1 in 100, but >1 in 1,000 Users): Stomachache, stomach and bowel problems, drug hypersensitivity including allergic skin reaction, rumbling in the bowels, diarrhoea, pigmentation problems, brown blotches on the face (chloasma) that become worse on long periods of sunbathing, hair loss, dry skin, back pain, muscle problems, secretion from the breasts, benign changes in the connective tissues of the breasts, fungal infection of the vagina, decrease in libido, tendency to sweat, changes in blood fats including increased triglycerides.

Rare (Affecting <1 in 1,000, but >1 in 10,000 Users): Conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high and low blood pressure, blood circulation collapse, varicose veins, venous thrombosis, hives, nettlerash, eczema, dermatitis (inflamed skin), itching, fleeting acne, worsening of psoriasis, excessive hair on the body or on the face, breast enlargement, inflammation of the vagina, longer and/or more intense menstruation, premenstrual syndrome (physical and emotional problems before the start of menstruation), increased appetite.

Very Rare (Affecting <1 in 10,000 Users) including isolated cases erythema nodosum.

Combined

Oral Contraceptives Have Also Been Linked With An Increase of Risks for Serious Diseases and Side-Effects:

Cycle-Specific Adverse Reactions: Spotting: Spotting may occur particularly during the 1st few intake cycles of Belare; in such cases, the patient should generally continue taking Belare. If heavy spotting that is similar to normal menstrual bleeding happened, the patient should seek medical help because such bleeding may have organic causes.

The same applies to spotting occurring at irregular intervals in several successive cycles, or for the 1st time after taking Belare for a long time. Such spotting may also occur as a result of interactions with other medicines taken at the same time.

Absence of Withdrawal Bleeding: If in very rare cases there is no withdrawal bleeding during the medication free day, the patient may continue taking Belare if pregnancy is ruled out within the first 10 days of the new medication cycle. If withdrawal bleeding does not occur in 2 successive cycles, the patient should seek medical help whether to continue taking Belare or not.

Effect on the Development of Breast Cancer: Sex hormones have an effect on breast tissue. Altering the hormone balance (eg, by taking hormonal contraceptives) may make the breast tissue more sensitive to other factors that encourage cancer, which in itself may encourage cancer. Analyses of the results of epidemiological studies on the possibility of a connection between taking hormonal contraceptives and cancer of the breast indicate that the occurrence of cancer of the breast in women up to middle age is more frequently associated with the long term use of oral contraceptives started at an early age. However, this is only of several possible risk factors. Breast secretion and enlargement have been observed in isolated cases.

Effect on Laboratory Tests: Normal laboratory values may be affected by hormonal contraceptive (eg, blood sedimentation rate may rise without illness). Increased levels of serum copper and iron or alkaline leukocyte phosphatase, have been reported, in addition to change in other values.