Descrizione Clinica
Weight loss Beacita 84cps 60mg
BEACITA 60 MG CAPSUDE
active ingredients
Each rigid capsule contains 60 mg of orlistat. For the full list of excipients, see paragraph 6.1.Excellent
Content of the capsule: Microcrystalline cellulose PH112, sodium starch (type A), hydrophobic colloidal silica, laurilsulfate sodium. Capsule coating: Gelatin, indigo carmine (E132), titanium dioxide (E171).Therapeutic indications
BEACITA It is indicated for weight loss in overweight adults (body mass index, BMI, ≥ 28 kg/m²) and should be taken in association with a moderately hypocaloric and low-fat diet.Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1;- Concomitant treatment with ciclosporin (see section 4.5);- Chronic malabsorption syndrome;- Cholestasis;- Pregnancy (see section 4.6);- Breastfeeding (see section 4.6);- Concomitant treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8).Population
Population Adults The recommended dosage for treatment is a 60 mg capsule to be taken three times a day. You should not take more than three 60 mg capsules in 24 hours. Diet and exercise are important components of a weight loss program. It is recommended to start a diet and exercise program before starting treatment with BEACITA. During treatment with orlistat, the patient must follow a diet balanced from the nutritional and moderately hypocaloric point of view, which contains about 30% of calories from fat (e.g. in a 2000 kcal diet per day, this is equivalent to a quantity Special popularity Paediatric population BEACITA should not be used in children and adolescents under 18 years of age due to insufficient data on safety and efficacy. Elderly (>65 years) Only limited data are available on the use of orlistat in the elderly. However, since orlistat is only absorbed in a small part, no dose adjustment is required in the elderly. Hepatic and renal comprogation The effects of orlistat in subjects with hepatic and/or renal impairment have not been studied (see section 4.4).However, since orlistat is minimally absorbed, no dose adjustment is necessary in subjects with hepatic and/or renal impairment. Pediatric population Security and effectiveness of BEACITA children under 18 years of age have not yet been established. There are no available data. Method of administration The capsule must be taken with water immediately before, during or within an hour after the main meals. If a meal is skipped or contains no fat, the dose of orlistat should be omitted.Conservation
Store in the original packaging to protect the medicine from light and moisture.Warnings
Gastrointestinal symptoms Patients should be invited to adhere to the dietary recommendations received (see paragraph 4.2). The possibility that gastrointestinal symptoms arise (see paragraph 4.8) may increase if orlistat is taken with a single meal or with a high-fat diet. Liposoluble vitamins Treatment with orlistat can compromise the absorption of fat-soluble vitamins (A, D, E and K) (see paragraph 4.5). For this reason, a multivitamin supplement must be taken before bedtime. Antidiabetic medicines Since weight loss can be associated with an improvement in metabolic control of diabetes, patients taking a drug for diabetes should consult your doctor before starting treatment with BEACITA, if the dose of the antidiabetic drug is to be adjusted. Medicines for hypertension and hypercholesterolemia Weight loss can be associated with an improvement in blood pressure and cholesterol levels. Patients taking a drug for hypertension or hypercolesterolemia should consult the doctor or pharmacist during treatment with BEACITA, if the dose of these drugs is to be adjusted. Amiodarone Patients taking amiodarone should consult the doctor or pharmacist before starting treatment with BEACITA (see paragraph 4.5). Straight bleeding Rectal bleeding cases have been reported in patients in treatment with orlistat. In case this occurs, the patient must consult a doctor. Oral contraceptives The use of an additional contraceptive method is recommended to prevent the possible failure of oral contraceptives which may occur in case of serious diarrhea (see paragraph 4.5). Nephropathy Patients with kidney problems should consult a doctor before starting treatment with BEACITA, since the use of orlistat can be associated with hyperoxluria and nephropathy from oxalates that sometimes leads to kidney failure. This risk has increased in patients with latent chronic kidney disease and/or volume depletion. Levotiroxin When orlistat and levotiroxin are taken simultaneously hypothyroidism and/or reduced control of hypothyroidism (see paragraph 4.5). Patients taking levotiroxin should consult your doctor before starting treatment with BEACITA as it may be necessary to take orlistat and levotiroxin at different times and correct the dose of levotiroxin. Anti-epileptic medicines Patients taking an anti-epileptic medication should consult your doctor before starting treatment with BEACITA, as such subjects must be monitored to detect any changes in frequency and intensity of seizures. If this happens, you should consider administering orlistat and anti-epileptic drugs at different times (see paragraph 4.5). Antiretrovirals for HIV Patients should consult a doctor before taking orlistat in conjunction with antiretroviral medicines. Orlistat can potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the effectiveness of antiretroviral medicines for HIV (see paragraph 4.5). Information on excipients Beacita Aurobindo 60 mg rigid capsules contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is essentially ‘without sodium’.Interactions
Ciclosporin A decrease in plasma levels of cyclosporin was observed in a pharmacological interaction study and was also reported in many cases of concomitant administration with orlistat. This could result in a decrease in the immunosuppressive effectiveness of cyclosporin. Concurrent use of BEACITA and cyclosporin is therefore contraindicated (see paragraph 4.3). Oral anticoagulants The administration of warfarin or other oral anticoagulants in conjunction with orlistat may affect the international normalized ratio values (International Normalised Ratio INR (see paragraph 4.8). Concurrent use of BEACITA and warfarin or other oral anticoagulants is therefore contraindicated (see paragraph 4.3). Oral contraceptives The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug interaction studies. However, orlistat, may indirectly reduce the availability of oral contraceptives and lead, in some individual cases, to an unwanted pregnancy. An additional contraceptive method is recommended in case of serious diarrhea (see paragraph 4.4). Levotiroxin When orlistat and levotiroxin are taken simultaneously hypothyroidism and/or reduced control of hypothyroidism (see paragraph 4.4) may occur. These effects may be due to a reduced absorption of iodine salts and/or levotiroxin. Anti-epileptic drugs Convulsions have been reported in patients treated simultaneously with orlistat and anti-epileptic drugs, such as valproate, lamotrigine; for such cases a causal relationship may not be excluded due to interaction. Orlistat can decrease the absorption of anti-epileptic drugs, leading to convulsions. Antiretroviral medicines Based on literature data and post-marketing experience, orlistat can potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the effectiveness of antiretroviral medicines for HIV (see paragraph 4.4). Liposoluble vitamins Orlistat therapy can potentially reduce the absorption of fat-soluble vitamins (A, D, E and K). In clinical studies the levels of vitamins A, D, E and K, and beta-carotene have been kept in the normal range in a wide majority of subjects subjected to orlistat therapy up to 4 years. However, patients should be invited to take a multivitamin supplement before bedtime, to help ensure proper vitamin intake (see paragraph 4.4). Acarbose In the absence of drug interaction studies, Beacita is not recommended in patients treated with acarbose. Amiodarone A decrease in plasma levels of amiodarone was observed, administered as a single dose, in a limited number of healthy volunteers treated simultaneously with orlistat. The clinical relevance of this effect in patients in amiodarone therapy is still unknown. Patients taking amiodarone should consult your doctor before starting treatment with BEACITA. A dose of amiodarone may be adjusted during treatment with BEACITA. . Antidepressants, antipsychotics (including lithium) and benzodiazepines Some cases have been reported of reduced effectiveness of antidepressants, antipsychotics (including lithium) and benzodiazepines in conjunction with the beginning of treatment with orlistat in previously well-controlled patients. Therefore treatment with orlistat must be started after careful assessment of the possible impact in these patients.Effects
Summary of security profile Adverse reactions to orlistat are mainly dependent on the gastrointestinal apparatus and are related to the pharmacological effect of the medicinal product on the inhibition of the absorption of ingested fats. Gastrointestinal adverse reactions identified in clinical studies with orlistat 60 mg of duration from 18 months to 2 years were generally mild and transitory. They have generally manifested early in treatment (within 3 months) and most patients have manifested only one episode. Consumption of a low-fat diet tends to decrease the likelihood of developing gastrointestinal adverse reactions (see paragraph 4.4). Tabular list of adverse reactions Adverse reactions are listed below by classification for systems and organs and frequency. The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100,Overdosing
Single doses of 800 mg of orlistat and multiple doses of up to 400 mg three times a day for 15 days in normopeous and obese subjects without significant clinical evidence were studied. In addition, doses of 240 mg three times a day were given to obese patients for 6 months. The majority of cases of overdose with orlistat received after marketing did not report adverse reactions or reported adverse reactions similar to those reported with the recommended dose of orlistat. In case of overdose, it is necessary to contact the doctor. If a significant overdose of orlistat occurs, it is recommended to keep the patient under observation for 24 hours. Based on clinical studies and animal studies, all systemic effects attributable to lipase inhibition properties by orlistat should be quickly reversible.Women potentially fertile/contraception in men and women
The use of an additional contraceptive method is recommended to prevent the possible ineffectiveness of oral contraception in case of severe diarrhea (see paragraph 4.4 and 4.5).Pregnancy
For orlistat there are no clinical data concerning the ongoing exposure of pregnancy. Animal studies indicate no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or post-natal development (see paragraph 5.3). BEACITA is contraindicated in pregnancy (see paragraph 4.3).Breastfeeding
Since it is not known whether orlistat is excreted in breast milk, BEACITA is contraindicated during breastfeeding (see paragraph 4.3).Fertility
Animal studies show no harmful effects on fertility.Source: Farmadati
