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Belara

Belara Side Effects

Manufacturer:

Gedeon Richter

Distributor:

Zuellig Pharma

Marketer:

Abbott
Full Prescribing Info
Side Effects
The frequencies with which side effects have been reported are defined as follows: Very Common (>1/10): Nausea, vaginal discharge, menstrual pain, absence of menstruation, breakthrough bleeding, spotting, headache, pain in the breasts.
Common (<1/10, >1/100): Ovarian cyst, benign tumours (fibroadenomas), feeling of tension in the breasts, depression, irritability, nervousness, dizziness, migraine (and/or aggravation), visual disorders, vomiting, acne, abdominal pain, tiredness, feeling of heaviness in the legs, accumulation of water, increase in weight and blood pressure.
Uncommon (<1/100, >1/1000): Stomachache, stomach and bowel problems, drug hypersensitivity including allergic skin reaction, rumbling in the bowels, diarrhoea, pigmentation problems, chloasma that becomes 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 (<1/1000, >1/10,000): Conjunctivitis, discomfort when wearing contact lenses, deafness, tinnitus, high blood pressure, low blood pressure, blood circulation collapse, varicose veins, venous thrombosis, hives, nettle-rash, eczema, dermatitis (inflamed skin), itching, fleeting acne, worsening of psoriasis, excessive hair on the body or in the face, enlargement of the breasts, 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 (<1/10,000 including isolated cases): Erythema nodosum.
Combined Oral Contraceptives have also been Linked with an Increase of Risk for Serious Diseases and Side Effects: Risk of blockage of the veins and arteries, diseases of the bile tract, tumours (eg, liver tumours, which in isolated cases cause life-threatening bleeding into the abdominal cavity, cancer of the neck, womb or breasts); aggravation of chronic inflammation of the bowels (Crohn's disease, ulcerative colitis).
Cycle Specific Spotting: Spotting may occur particularly during the first few intake cycles of Belara; in such cases, continue taking Belara. Consult a doctor if there is heavy spotting that is similar to the normal menstrual bleeding because such bleeding may have organic causes.
The same applies to spotting occurring at irregular intervals in several successive cycles, or for the first time after taking Belara for a long time. Such spotting may also occur as a result of interactions with other medicines taken at the same time (see Interactions).
Absence of Withdrawal Bleeding: If, in very rare cases, there is no withdrawal bleeding during the medication-free day, continue taking Belara 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, a physician should be consulted.
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 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, the blood sedimentation rate may rise even without illness. Increased levels of serum copper and iron or alkaline leukocyte phosphatase have been reported, in addition to change in other laboratory values.
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