Beacita 60 mg 84 hard capsules

Beacita 60 mg 84 hard capsules is a slimming drug based on orlistat , specifically formulated to promote weight loss in overweight adults with a BMI ≥ 28. This product acts directly on the absorption of dietary fats, partially blocking the action of intestinal lipases and thus reducing the assimilation of fats introduced with the diet. Beacita 60 mg is indicated as a support to a low-calorie, low-fat diet , proving particularly effective when combined with a healthy lifestyle and a regular physical activity program.

The hard capsules are easy to take and guarantee a precise dosage of the active ingredient orlistat , offering valid help for those who want to lose weight in a controlled and safe way. Beacita 60 mg is designed for adults who need treatment for excess weight and who cannot obtain satisfactory results with diet alone. The product is available in a pack of 84 capsules , ideal for a complete treatment cycle.

Thanks to its targeted action on blocking the absorption of fats , Beacita represents a valid ally for those who wish to reach and maintain their ideal weight in an effective and long-lasting way.

ACTIVE INGREDIENTS

Active ingredients contained in Beacita 60 mg 84 hard capsules - What is the active ingredient of Beacita 60 mg 84 hard capsules?

Each hard capsule contains 60 mg orlistat. For a full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Beacita 60 mg 84 hard capsules - What does Beacita 60 mg 84 hard capsules contain?

Capsule contents : Microcrystalline cellulose PH112, sodium starch glycolate (type A), hydrophobic colloidal silica, sodium lauryl sulphate. Capsule coating : Gelatin, indigo carmine (E132), titanium dioxide (E171).

DIRECTIONS

Therapeutic indications Beacita 60 mg 84 hard capsules - Why is Beacita 60 mg 84 hard capsules used? What is it used for?

BEACITA 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 AND SIDE EFFECTS

Contraindications Beacita 60 mg 84 hard capsules - When should Beacita 60 mg 84 hard capsules not be used?

- 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).

DOSAGE

Quantity and method of taking Beacita 60 mg 84 hard capsules - How to take Beacita 60 mg 84 hard capsules?

Dosage Adults The recommended dosage for treatment is one 60 mg capsule taken three times daily. No more than three 60 mg capsules should be taken in 24 hours. Diet and exercise are important components of a weight loss programme. It is recommended that a diet and exercise programme be started before starting treatment with BEACITA. During treatment with orlistat, the patient should follow a nutritionally balanced and moderately hypocaloric diet, containing approximately 30% of calories from fat (e.g. in a 2000 kcal/day diet, this equates to < 67 g fat). The daily intake of fat, carbohydrates and proteins should be distributed over three main meals. The diet and exercise programme should continue even when treatment with BEACITA is stopped. Treatment should not exceed 6 months. If patients are unable to lose weight after 12 weeks of treatment with BEACITA, they should consult their doctor or pharmacist. Treatment may need to be stopped. Diet and exercise are important components of a weight loss programme. It is recommended that a diet and exercise programme be started before starting treatment with BEACITA. During treatment with orlistat, the patient should follow a nutritionally balanced and moderately hypocaloric diet, containing approximately 30% of calories from fat (e.g. in a 2,000 kcal/day diet, this equates to < 67 g fat). The daily intake of fat, carbohydrates and proteins should be distributed over three main meals. The diet and exercise programme should be continued even when treatment with BEACITA is stopped. Special populations 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 minimally absorbed, no dose adjustment is necessary in the elderly. Hepatic and renal impairment 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. Paediatric population The safety and efficacy of BEACITA in children below 18 years of age have not yet been established. No data are available. Method of administration The capsule should be taken with water immediately before, during or up to one hour after main meals. If a meal is skipped or if it does not contain fat, the dose of orlistat should be omitted.

CONSERVATION

Storage Beacita 60 mg 84 hard capsules - How to store Beacita 60 mg 84 hard capsules?

Do not store above 25°C. Store in the original package in order to protect from light and moisture.

WARNINGS

Warnings Beacita 60 mg 84 hard capsules - About Beacita 60 mg 84 hard capsules it is important to know that:

Gastrointestinal symptoms Patients should be advised to adhere to the dietary recommendations received (see section 4.2). The possibility of gastrointestinal symptoms (see section 4.8) may increase if orlistat is taken with a single meal or with a high-fat diet. Fat-soluble vitamins Treatment with orlistat may impair the absorption of fat-soluble vitamins (A, D, E and K) (see section 4.5). For this reason, a multivitamin supplement should be taken at bedtime. Antidiabetic medicinal products Since weight loss may be associated with improved metabolic control of diabetes, patients taking a medicinal product for diabetes should consult their doctor before starting treatment with BEACITA, in case the dose of the antidiabetic medicinal product needs to be adjusted. Medicinal products for hypertension and hypercholesterolaemia Weight loss may be associated with improvement in blood pressure and cholesterol levels. Patients taking a medicine for hypertension or hypercholesterolaemia should consult their doctor or pharmacist during treatment with BEACITA, in case it is necessary to adjust the dose of these medicines. Amiodarone Patients taking amiodarone should consult their doctor or pharmacist before starting treatment with BEACITA (see section 4.5). Rectal bleeding Cases of rectal bleeding have been reported in patients treated with orlistat. If this occurs, the patient should consult a doctor. Oral contraceptives The use of an additional contraceptive method is recommended to prevent possible failure of oral contraceptives that could occur in case of severe diarrhoea (see section 4.5). Nephropathy Patients with kidney problems should consult a doctor before starting treatment with BEACITA, since the use of orlistat may be associated with hyperoxaluria and oxalate nephropathy sometimes leading to kidney failure. This risk is increased in patients with underlying chronic kidney disease and/or volume depletion. Levothyroxine Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are taken concomitantly (see section 4.5). Patients taking levothyroxine should consult their doctor before starting treatment with BEACITA as it may be necessary to take orlistat and levothyroxine at different times and to adjust the levothyroxine dose. Antiepileptic medicinal products Patients taking an antiepileptic medicinal product should consult their doctor before starting treatment with BEACITA as they should be monitored for changes in the frequency and severity of seizures. If this occurs, consideration should be given to administering orlistat and the antiepileptic medicinal products at different times (see section 4.5). Antiretrovirals for HIV Patients should consult a physician before taking orlistat concomitantly with antiretroviral medicinal products. Orlistat may potentially reduce the absorption of antiretroviral medicinal products for HIV and may negatively affect the efficacy of antiretroviral medicinal products for HIV (see section 4.5). Information on excipients Beacita Aurobindo 60 mg hard capsules contain less than 1 mmol sodium (23 mg) per capsule, i.e. essentially 'sodium-free'.

INTERACTIONS

Interactions Beacita 60 mg 84 hard capsules - Which medicines or foods can modify the effect of Beacita 60 mg 84 hard capsules?

Ciclosporin A decrease in plasma levels of ciclosporin was observed in a drug interaction study and has also been reported in several cases of concomitant administration with orlistat. This could lead to a decrease in the immunosuppressive efficacy of ciclosporin. The concomitant use of BEACITA and ciclosporin is therefore contraindicated (see section 4.3). Oral anticoagulants The concomitant administration of warfarin or other oral anticoagulants with orlistat may influence the International Normalised Ratio (INR) values ​​(see section 4.8). The concomitant use of BEACITA and warfarin or other oral anticoagulants is therefore contraindicated (see section 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 severe diarrhoea (see section 4.4). Levothyroxine When orlistat and levothyroxine are taken simultaneously, hypothyroidism and/or reduced control of hypothyroidism may occur (see section 4.4). These effects may be due to a reduced absorption of iodine salts and/or levothyroxine. Anti-epileptic drugs Cases of convulsions have been reported in patients treated concomitantly with orlistat and anti-epileptic drugs, e.g. valproate, lamotrigine; a causal relationship due to an interaction cannot be excluded in these cases. Orlistat may decrease the absorption of anti-epileptic drugs, leading to convulsions. Antiretroviral medicinal products Based on literature data and post-marketing experience, orlistat may potentially reduce the absorption of HIV antiretroviral medicinal products and may negatively affect the efficacy of HIV antiretroviral medicinal products (see section 4.4). Fat-soluble vitamins Treatment with orlistat may potentially reduce the absorption of fat-soluble vitamins (A, D, E and K). In clinical studies, vitamin A, D, E and K, and beta-carotene levels were maintained within the normal range in a large majority of subjects receiving orlistat therapy for up to 4 years. However, patients should be advised to take a multivitamin supplement at bedtime to help ensure adequate vitamin intake (see section 4.4). Acarbose In the absence of pharmacokinetic interaction studies, Beacita is not recommended in patients treated with acarbose. Amiodarone A decrease in plasma levels of amiodarone, administered as a single dose, has been observed in a limited number of healthy volunteers treated concomitantly with orlistat. The clinical relevance of this effect in patients treated with amiodarone is still unknown. Patients taking amiodarone should consult their doctor before starting treatment with BEACITA. Amiodarone dose adjustment may be necessary during treatment with BEACITA. Antidepressants, antipsychotics (including lithium) and benzodiazepines There have been reports of reduced efficacy of antidepressants, antipsychotics (including lithium) and benzodiazepines in association with the initiation of orlistat treatment in previously well-controlled patients. Therefore, treatment with orlistat should be initiated after careful consideration of the possible impact in these patients.

SIDE EFFECTS

Like all medicines, Beacita 60 mg 84 hard capsules can cause side effects - What are the side effects of Beacita 60 mg 84 hard capsules?

Summary of safety profile Adverse reactions to orlistat are predominantly gastrointestinal and are related to the pharmacological effect of the medicinal product on the inhibition of absorption of ingested fat. Gastrointestinal adverse reactions identified in clinical trials with orlistat 60 mg for 18 months to 2 years were generally mild and transient. They generally occurred early in treatment (within 3 months) and most patients experienced only a single episode. Consumption of a low-fat diet tends to decrease the likelihood of developing gastrointestinal adverse reactions (see section 4.4). Tabulated list of adverse reactions Adverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). The frequencies of adverse reactions identified during post-marketing experience with orlistat are not known as these reactions were reported voluntarily from a population of uncertain size. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Classification by systems and organs	Adverse reaction
Infections and infestations
Very common:	Influence.
Pathologies of the haemolymphopoietic system
Not known:	Decreased prothrombin and increased INR (see sections 4.3 and 4.5).
Immune system disorders
Not known:	Hypersensitivity reactions, including anaphylaxis, bronchospasm, angioedema, pruritus, erythema and urticaria.
Psychiatric disorders
Common:	Anxiety¹.
Gastrointestinal disorders
Very common:	Oily discharge, Flatulence with stool emission, Urgent defecation, Oily fatty stool, Oily evacuation, Flatulence, Soft stool;
Common:	Abdominal pain, Fecal incontinence, Loose stools, Increased defecation;
Not known:	Diverticulitis, Pancreatitis, Mild rectal bleeding (see section 4.4).
Hepatobiliary pathologies
Not known:	Potentially serious hepatitis (some fatal cases or cases requiring liver transplantation have been reported), Cholelithiasis, Increased transaminases and alkaline phosphatase.
Skin and subcutaneous tissue disorders
Not known:	Bullous eruption.
Kidney and urinary disorders
Not known:	Oxalate nephropathy which can lead to kidney failure.

¹ It is plausible that treatment with orlistat may induce anxiety in anticipation or secondary to gastrointestinal adverse reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Beacita 60 mg 84 hard capsules - What are the risks of Beacita 60 mg 84 hard capsules in case of overdose?

Single doses of 800 mg orlistat and multiple doses up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant clinical evidence. In addition, doses of 240 mg three times daily have been administered to obese patients for 6 months. The majority of post-marketing overdoses with orlistat have reported no adverse reactions or adverse reactions similar to those reported with the recommended dose of orlistat. In the event of an overdose, medical attention should be sought. If a significant overdose of orlistat occurs, it is recommended that the patient be observed for 24 hours. Based on clinical and animal studies, all systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Beacita 60 mg 84 hard capsules.

Women of childbearing potential/contraception in males and females The use of an additional method of contraception is recommended to prevent possible failure of oral contraception in case of severe diarrhoea (see sections 4.4 and 4.5). Pregnancy For orlistat, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). BEACITA is contraindicated during pregnancy (see section 4.3). Breastfeeding Since it is not known whether orlistat is excreted in human milk, BEACITA is contraindicated during breastfeeding (see section 4.3). Fertility Animal studies do not indicate harmful effects on fertility.

DRIVING AND USE OF MACHINERY

Take Beacita 60 mg 84 hard capsules before driving or using machines - Does Beacita 60 mg 84 hard capsules affect driving or using machines?

Orlistat has no or negligible influence on the ability to drive or use machines.