Beacita 60 mg 84 hard capsules

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

BEACITA is indicated for weight loss in overweight adults (body mass index, BMI, ≥ 28 kg/m²) and must be taken in association with a moderately low-calorie, low-fat diet.

CONTRAINDICATIONS

- Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1; - Concomitant treatment with ciclosporin (see section 4.5); - Chronic malabsorption syndrome; - Cholestasis; - Pregnancy (see section 4.6); - Breastfeeding (see paragraph 4.6); - Concomitant treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8).

WARNINGS AND PRECAUTIONS FOR USE

Gastrointestinal symptoms Patients should be encouraged to adhere to the dietary recommendations received (see section 4.2). The risk of gastrointestinal symptoms (see section 4.8) may be increased 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 before bed. Antidiabetic medicines Because weight loss may be associated with improved metabolic control of diabetes, patients taking a diabetes medication should consult their doctor before starting treatment with BEACITA if it becomes necessary to adjust the dose of the antidiabetic drug. Medicines for hypertension and hypercholesterolemia Weight loss can be associated with an improvement in blood pressure and cholesterol levels. Patients taking a medication for hypertension or hypercholesterolemia should consult their doctor or pharmacist during treatment with BEACITA if it becomes necessary to adjust the dose of these medications. 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 receiving orlistat. If this occurs, the patient should consult a doctor. Oral contraceptives The use of an additional method of contraception is recommended to prevent possible failure of oral contraceptives which could occur in case of severe diarrhea (see section 4.5). Nephropathy Patients with kidney problems should consult a doctor before starting treatment with BEACITA, as the use of orlistat may be associated with hyperoxaluria and oxalate nephropathy which sometimes leads to kidney failure. This risk is increased in patients with latent chronic kidney disease and/or volume depletion. Levothyroxine When orlistat and levothyroxine are taken simultaneously, hypothyroidism and/or reduced control of hypothyroidism may occur (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 dose of levothyroxine. Antiepileptic medicines Patients taking an anti-epileptic drug should consult their doctor before starting treatment with BEACITA, as they should be monitored for changes in the frequency and intensity of seizures. If this occurs, consideration should be given to administering orlistat and anti-epileptic drugs at different times (see section 4.5). Antiretrovirals for HIV Patients should consult a doctor before taking orlistat concomitantly with antiretroviral medicines. Orlistat may potentially reduce the absorption of HIV antiretroviral medicinal products and may adversely affect the efficacy of HIV antiretroviral medicinal products (see section 4.5). Information on excipients Beacita Aurobindo 60 mg hard capsules contain less than 1 mmol (23 mg) sodium per capsule, i.e. it is essentially 'sodium-free'.

INTERACTIONS

Cyclosporine A decrease in plasma levels of ciclosporin was observed in a drug interaction study and has also been reported in many 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 Administration of warfarin or other oral anticoagulants concomitantly with orlistat may affect international normalized ratio values (International Normalized Ratio INR) (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 unwanted pregnancy. An additional method of contraception is recommended in case of severe diarrhea (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 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; for such cases a causal relationship due to an interaction cannot be excluded. Orlistat may decrease the absorption of anti-epileptic drugs, leading to seizures. Antiretroviral medicines Based on literature data and post-marketing experience, orlistat may potentially reduce the absorption of HIV antiretroviral medicinal products and may adversely affect the efficacy of HIV antiretroviral medicinal products (see section 4.4). Fat-soluble vitamins Orlistat therapy may 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 remained within the normal range in a large majority of subjects undergoing therapy with orlistat for up to 4 years. However, patients should be encouraged 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, was observed in a limited number of healthy volunteers treated concomitantly with orlistat. The clinical relevance of this effect in patients receiving 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 Some cases of reduced efficacy of antidepressants, antipsychotics (including lithium) and benzodiazepines have been reported in conjunction with initiation of orlistat treatment in previously well-controlled patients. Therefore treatment with orlistat should be initiated after careful evaluation of the possible impact in these patients.

SIDE EFFECTS

Safety profile summary Adverse reactions to orlistat mainly affect the gastrointestinal system and are related to the pharmacological effect of the medicine on the inhibition of the absorption of ingested fats. Gastrointestinal adverse reactions identified in clinical trials with orlistat 60 mg lasting 18 months to 2 years were generally mild and transient. They generally occurred in the early phase of treatment (within 3 months) and the majority of patients experienced only one episode. Consumption of a low-fat diet tends to decrease the likelihood of developing gastrointestinal adverse reactions (see section 4.4). Tabular 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 (which cannot be estimated from the available data). The frequencies of adverse reactions identified during the post-marketing phase of orlistat are unknown as these reactions were voluntarily reported from a population of unknown size. Within each frequency grouping, adverse reactions are reported in order of decreasing seriousness.

Classification by systems and organs | Adverse reaction

Infections and infestations

Very common: | Influence.

Pathologies of the blood and lymphatic 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

Municipality: | Anxiety¹.

Gastrointestinal disorders

Very common: | Oily discharge, Flatulence with stool, Urgent defecation, Oily fatty stool, Oily stool, Flatulence, Soft stool;

Municipality: | Abdominal pain, Fecal incontinence, Liquid stools, Increased defecation;

Not known: | Diverticulitis, Pancreatitis, Mild rectal bleeding (see section 4.4).

Hepatobiliary disorders

Not known: | Potentially serious hepatitis (some fatal cases or cases requiring liver transplantation have been reported), Cholelithiasis, Increased transaminases and alkaline phosphatase.

Pathologies of the skin and subcutaneous tissue

Not known: | Bullous eruption.

Renal and urinary disorders

Not known: | Oxalate nephropathy which can lead to kidney failure.

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