Belara

Belara

Manufacturer:

Gedeon Richter

Distributor:

Zuellig Pharma

Marketer:

Abbott
Full Prescribing Info
Contents
Chlormadinone acetate, ethinyl oestradiol.
Description
Each tablet contains chlormadinone acetate 2 mg and ethinyl oestradiol 0.03 mg.
It also contains the following excipients: Lactose monohydrate, maize starch, povidone K30, magnesium stearate, hypromellose, macrogol 6000, propylene glycol, talc, titanium dioxide (E171) and iron oxide (E172).
Indications/Uses
Belara is a hormonal contraceptive.
It should be used as an alternative treatment of moderate papulopustular acne in women for whom hormonal contraception with ethinylestradiol/chlormadinone acetate is indicated. Acne treatment in unresponsive women to standard treatment or in women who have signs/symptoms of endocrine disorder (endocrine acne).
Dosage/Direction for Use
Before starting treatment with Belara, a thorough general and gynaecological examination should be carried out and pregnancy ruled out. Unless otherwise prescribed by the doctor, the following dosage of Belara applies.
Take the 1st tab on the 1st day of menstruation, even if a different contraceptive (pill) has been used previously.
Press out the 1st tab 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 tab everyday following the direction of the arrows, if possible at the same time of the day (preferably in the evening). It is essential to take Belara regularly in order to ensure its contraceptive reliability. The interval between taking 2 tabs should be 24 hrs as regularly as possible. The days printed on the pack allows the patient to check everyday whether the tab has been taken for that particular day. After taking the last tab, 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, continue taking Belara with the next pack regardless of whether the bleeding has already stopped or is still present.
During the use of Belara, a gynaecological check-up should be done every 6 months.
Contraception starts with the 1st day of intake and also continues during the 7-day medication-free intervals.
If Belara is taken soon after childbirth or miscarriage, consult a doctor whether additional protective measures are necessary during the 1st cycle.
Belara may be taken for years.
After discontinuing Belara, 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. However, if a normal cycle does not develop within the first 2-3 months, consult a doctor.
Intake errors, vomiting or intestinal diseases accompanied by diarrhoea, long-term use of certain medicines at the same time (see Interactions) and very rare individual metabolic disorders may affect contraceptive effectiveness. Mild laxatives do not reduce reliability.
In the Event of Vomiting or Diarrhoea While Taking Belara: The hormones contained in Belara are usually rapidly absorbed by the body. If vomiting or diarrhoea occurs shortly after taking Belara (up to 4 hrs afterwards), immediately take the next tablet in order to ensure continued contraceptive protection. The cycle will then be shortened by 1 day.
If vomiting occurs several times or complaints persist for >12 hrs, continue taking the tablets for the cycle but additional mechanical methods of contraception (eg, condoms) should be used.
Missed Dose: Take the tablet within the next 12 hrs at the latest. If the usual intake interval is exceeded by >12 hrs, effective contraception is no longer guaranteed during the cycle. In such cases, continue taking pills from the current calendar pack as scheduled but leaving out the missed tablet in order to prevent premature bleeding. Mechanical protective measures should also be taken.
Overdosage
Acute poisoning due to taking a large number of tablets at once is unlikely, except in extreme cases, and is not life-threatening. Possible symptoms are mainly stomach or bowel complaints, disorders of liver function and the water and electrolyte balance, and withdrawal bleeding in women. Preventive measures or countermeasures are only necessary in rare cases following an overdose.
Contraindications
Hypersensitivity to chlormadinone acetate, ethinyl oestradiol or any of the excipients of Belara; history or current blood clots in the veins or arteries (eg, deep vein thrombosis, pulmonary embolism, heart attack, stroke); 1st stages or signs of a blood clot, inflammation of the veins or embolism eg, fleeting, stabbing pain, chest pain or feeling of tightness in the chest; immobilization for long periods of time (eg, on strict bed-rest or due to a plaster cast) or scheduled surgery (discontinue Belara at least 4 weeks before the operation); diabetes, uncontrollable blood sugar or changes in the blood vessels; high blood pressure which is difficult to control or if blood pressure rises considerably (values constantly >140/90 mmHg); blood clotting disturbance (eg, protein C deficiency); inflammation of the liver (eg, due to a virus) or from jaundice or if liver values have not yet returned to normal; itching all over the body or bile flow disorder particularly if this occurred in connection with a previous pregnancy or oestrogen treatment; increased bilirubin eg, due to an in-born excretion disorder (Dubin-Johnson or Rotor syndrome); history of or current liver tumour; severe stomachache, enlarged liver or signs of bleeding in the belly; 1st time or recurrent porphyria; history of or suspected hormone-dependent malignant tumour eg, cancer of the breast or womb; severe disorders of fat metabolism; history or current inflammation of the pancreas associated with severe increase in triglycerides; migraine or migraine accompanied by disorders of sensation, perception and/or movement (migraine accompagnee); unusually severe, frequent or long-lasting headache; sudden perception disorders (sight or hearing); movement disorders (in particular signs of paralysis); worsening of epileptic fits; severe depression; otosclerosis that became worse during previous pregnancies; absence of menstrual period for some unknown reason; endometrial hyperplasia; vaginal bleeding of unknown origin.
If one of these conditions occurs during administration of Belara, it should be discontinued immediately.
Do not take Belara or discontinue immediately if there is a serious risk or several risks of blood clotting disorders.
Warnings
Serious effects on health may occur due to thromboembolic events (see Side Effects). Therefore, predisposing factors (eg, varicose veins, previous inflammation of the veins, thrombosis, heart disease, considerable overweight, blood-clotting disorders) and thromboembolism of the veins occurring in close relatives at an early age should be determined and taken into account when deciding whether to use Belara.
Smokers taking hormone preparations for contraception are at an increased risk of suffering from, in some cases, serious consequences of changes in the vessels (eg, heart attack, stroke). The risk increases with age and rising cigarette consumption.
In particular, women >30 years should therefore refrain from smoking when taking hormone preparations for contraception. If smoking cannot be stopped, other methods of contraception should be used. Surveillance studies have shown that the incidence of thromboembolic diseases may decrease when taking preparations with low oestrogen dosage (≤0.05 mg), which led to the development of contraceptives containing smaller amounts of hormones. It is still not certain that women taking such low-dose preparations will in fact suffer less frequently from thrombotic or thromboembolic blockage of the vessels.
Therefore, even when taking low-dose hormonal contraceptives, patients should be examined for factors promoting the formation of blood clots and the risks should be weighed against the potential benefits of this method of contraception.
The occurrence of thromboembolic diseases in relatives at an early age may be evidence of disorder of the blood clotting system. Such diseases include deep vein thrombosis, pulmonary embolism, stroke, sudden disorders of sensation and perception, speech and motion disorders, in particular paralysis, heart attack and angina pectoris. If there is a family history of such diseases, blood clotting must be examined carefully before prescribing Belara (including eg, ATIII, protein C and S).
Women >40 years require special supervision because the tendency towards thrombosis increases with age.
The risk of thromboembolism is higher with combined oral contraceptives (COC). The additional risk is highest during the first year of first taking a COC. This increased risk on the use of a COC is lower than the risk of thrombosis during pregnancy which is estimated to be 60 cases/100,000 pregnancies. In 1-2% of the cases, thromboembolism is fatal.
Consult a doctor as soon as symptoms of thrombosis or pulmonary embolism eg, pain and swelling in the arms and/or legs, shortness of breath and stabbing pain in the chest occur. The effect of Belara on the risk of thromboembolism, in comparison with other COCs, is not known.
Special Precautions
Belara should be taken only under certain conditions and with special care for the following cases: Heart and kidney diseases, migraine, epilepsy, asthma because these may be affected by the possible accumulation of fluid; history of phlebitis; marked tendency towards varicose veins (varicosis); multiple sclerosis; St. Vitus' dance (chorea minor); muscle cramps (tetany); diabetes mellitus and a tendency towards it; history of liver disease; disorders of fat metabolism; considerable overweight; raised blood pressure; endometriosis; myomatous uterus; mastopathy; otosclerosis.
Use in Pregnancy: Belara is not indicated during pregnancy. Discontinue immediately if a patient becomes pregnant while taking Belara. However, previous use of Belara does not justify an abortion. Chlormadinone acetate has exhibited embryolethal effects in rabbits, rats and mice. Moreover, teratogenicity was observed at embryotoxic doses in rabbits and already at lowest dose tested (1 mg/kg/day). The significance of these findings for human administration is unclear.
Use in Lactation: Milk production may be reduced and its quality affected with the use of Belara. Very small amounts of the active substances pass into the milk. Oral contraceptives eg, Belara should only be taken after breastfeeding has been stopped.
In general, however, contraception is only indicated if breastfeeding for a long time because usually, the patient will not have a cycle during a short period of breastfeeding. If possible, nonhormonal methods of contraception should be used until the baby has been fully weaned.
Use In Pregnancy & Lactation
Use in Pregnancy: Belara is not indicated during pregnancy. Discontinue immediately if a patient becomes pregnant while taking Belara. However, previous use of Belara does not justify an abortion. Chlormadinone acetate has exhibited embryolethal effects in rabbits, rats and mice. Moreover, teratogenicity was observed at embryotoxic doses in rabbits and already at lowest dose tested (1 mg/kg/day). The significance of these findings for human administration is unclear.
Use in Lactation: Milk production may be reduced and its quality affected with the use of Belara. Very small amounts of the active substances pass into the milk. Oral contraceptives eg, Belara should only be taken after breastfeeding has been stopped.
In general, however, contraception is only indicated if breastfeeding for a long time because usually, the patient will not have a cycle during a short period of breastfeeding. If possible, nonhormonal methods of contraception should be used until the baby has been fully weaned.
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.
Drug Interactions
The contraceptive effectiveness of Belara 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 has 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.
Storage
Do not store above 30°C.
MIMS Class
ATC Classification
G03AA15 - chlormadinone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
FC tab 1 x 21's.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in