Beacita Orlistat Weight Loss Drug 84 Capsules 60 mg

Tablets based on orlistat.

Therapeutic indications

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

Dosage and Posology

The drug should be taken according to the following doses and methods: The recommended dosage of Beacita is one 60 mg capsule to be taken three times a day. No more than three 60 mg capsules should be taken in any 24 hours. Diet and exercise are important components of a weight loss program. It is recommended that a diet and exercise program be started before starting treatment with Beacita. During treatment with orlistat, the patient should follow a nutritionally balanced and moderately low-calorie diet, which contains approximately 30% of calories from fat (e.g. in a 2,000 kcal per day diet, this is equivalent to a quantity <67 g of fat). The daily intake of fats, carbohydrates and proteins should be distributed over the three main meals. The diet and exercise program should continue even when treatment with Beacita is stopped.

The treatment should not be longer than 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.

Only limited data are available on the use of orlistat in the elderly. However, since orlistat is only minimally absorbed, no dose adjustment is required in the elderly.

The effects of orlistat in subjects with hepatic and / or renal impairment have not been studied. However, as orlistat is only minimally absorbed, no dose adjustment is required in subjects with hepatic and / or renal impairment.

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 within one hour after the main meals. If a meal is skipped or contains no fat, the orlistat dose should be omitted.

Overdose

Single doses of 800 mg of orlistat and multiple doses of up to 400 mg three times daily for 15 days in normal weight and obese subjects were studied with no significant clinical evidence. In addition, doses of 240 mg three times a day were administered to obese patients for 6 months. The majority of post-marketing orlistat overdose cases reported no adverse reactions or reported adverse reactions similar to those reported with the recommended dose of orlistat. In the event of an overdose, medical attention should be sought. Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours. Based on clinical and animal studies, any systemic effects attributable to orlistat's lipase inhibiting properties are expected to be rapidly reversible.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• Concomitant treatment with cyclosporine
• Chronic malabsorption syndrome.
• Cholestasis.
• Pregnancy
• Feeding time
• Concomitant treatment with warfarin or other oral anticoagulants

Side effects

Adverse reactions to orlistat are predominantly affecting the gastrointestinal tract and are related to the pharmacological effect of the drug on inhibiting the absorption of ingested fats. Gastrointestinal adverse reactions identified in clinical studies with orlistat 60 mg lasting 18 months to 2 years were generally mild and transient. They generally occurred early in treatment (within 3 months) and most patients experienced only one episode. Consuming a low-fat diet tends to decrease the likelihood of developing gastrointestinal 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 to <1/10), uncommon (≥ 1 / 1,000 to <1/100), rare (≥ 1 / 10,000 , <1 / 1,000) and very rare (<1 / 10,000), not known (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 reported voluntarily from a population of undefined size. Within each frequency class, adverse reactions are reported in order of decreasing severity.

- Infections and infestations

• Very common: Influenza

- Disorders of the blood and lymphatic system

• Not known: Prothrombin decreased and INR increased

- Disorders of the immune system

• Not known: Hypersensitivity reactions including anaphylaxis, bronchospasm, angioedema, pruritus, erythema and urticaria

- Pathologies of metabolism and nutrition

• Very common: Hypoglycaemia

- Psychiatric disorders

• Common: Anxiety

- Nervous system disorders

• Very common: Headache

- Respiratory, thoracic and mediastinal disorders

• Very common: Oily discharge, Flatulence with passing stools, Urgent defecation, Fatty oily stools, Oily evacuation, Flatulence, Soft stools
• Common: Rectal pain / discomfort, Abdominal pain, Faecal incontinence, Liquid stools, Increased defecation, Abdominal distension, Dental disorders, Gum disease
• Not known: Diverticulitis, Pancreatitis, Mild rectal bleeding

- Hepatobiliary disorders

• Not known: Potentially serious hepatitis. Some fatal cases or cases requiring liver transplantation have been reported. Cholelithiasis. Increase in transaminases and alkaline phosphatase

- Skin and subcutaneous tissue disorders

• Not known: Bullous rash

- Renal and urinary disorders

• Common: Urinary tract infection
• Not known: Oxalate nephropathy which can lead to renal failure

- General disorders and administration site conditions

• Common: Fatigue

Pregnancy and breastfeeding

The use of an additional contraceptive method is recommended to prevent possible ineffectiveness of oral contraception in case of severe diarrhea. No clinical data on exposure during pregnancy are available for orlistat. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Beacita is contraindicated in pregnancy.

Since it is not known whether orlistat is excreted in human milk, Beacita is contraindicated during lactation.

Special warnings

Patients should be advised to adhere to received dietary recommendations. The chance of gastrointestinal symptoms may increase if orlistat is taken with a single meal or a high-fat diet.

Treatment with orlistat can impair the absorption of fat-soluble vitamins (A, D, E and K). For this reason, a multivitamin supplement should be taken before bedtime.

Since weight loss may be associated with improved metabolic control of their diabetes, patients taking a diabetes medicine should consult their doctor before starting treatment with Beacita if it becomes necessary to adjust the dose of the antidiabetic medicine. Weight loss can be associated with an improvement in blood pressure and cholesterol levels. Patients taking a medicine for hypertension or hypercholesterolemia should consult their doctor or pharmacist during treatment with Beacita, if the dose of these medicines needs to be adjusted.

Patients taking amiodarone should consult their doctor or pharmacist before starting treatment with Beacita. There have been reports of rectal bleeding in patients taking orlistat. Should this occur, the patient should consult a physician.

The use of an additional contraceptive method is recommended to prevent the possible failure of oral contraceptives which could occur in case of severe diarrhea. Patients with kidney problems should consult a doctor before starting treatment with Beacita, as the use of orlistat may in rare cases be associated with hyperoxaluria and oxalate nephropathy which sometimes leads to renal failure. This risk is increased in patients with latent and / or volume depleted chronic kidney disease.

Hypothyroidism and / or reduced control of hypothyroidism may occur when orlistat and levothyroxine are taken simultaneously. 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.

Patients taking an anti-epileptic medicine should consult their doctor before starting treatment with Beacita, as they should be monitored for any changes in the frequency and intensity of seizures. If this happens, the possibility of administering orlistat and anti-epileptic drugs at different times should be considered. Patients should consult a physician before taking orlistat concomitantly with antiretroviral drugs. Orlistat has the potential to reduce the absorption of HIV antiretroviral drugs and could adversely affect the efficacy of HIV antiretroviral drugs.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Do not store above 25 ° C. Store in the original package in order to protect from light and moisture.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

Each hard capsule of Beacita contains:

Active principle

60 mg of orlistat

Excipients

Capsule contents: Microcrystalline cellulose PH112, Sodium starch glycolate (type A), Colloidal anhydrous silicon, Sodium lauryl sulfate Capsule shell: Gelatin, Indigo carmine (E132), Titanium dioxide (E171)