ALLI * 84CPS 60MG FL
alli 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 method of use
Dosage Adults The recommended dosage of alli 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 alli. During treatment with orlistat, the patient should follow a nutritionally balanced and moderately low-calorie diet, containing approximately 30 % of calories from fat (e.g. in a 2,000 kcal per day diet, this equates to a large amount Special populations Elderly (≥65 years) Only limited data is available on the use of orlistat in the elderly. However, since orlistat is only minimally absorbed, no dose adjustment is required in the elderly. Hepatic and renal insufficiency The effects of orlistat in subjects with hepatic and / or renal insufficiency have not been studied (see section 4.4). However, as orlistat is only minimally absorbed, no dose adjustment is required in subjects with hepatic and / or renal insufficiency. Pediatric population The safety and efficacy of alli in children aged below 18 years have not been established. No data are available. Method of administration The capsule should be taken 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.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Concomitant treatment with cyclosporine (see section 4.5) • Chronic malabsorption syndrome • Cholestasis • Pregnancy (see section 4.6) • Lactation (see section 4.6) • Concomitant treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8)
Summary of the safety profile 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. Consumption of a low fat diet tends to decrease the likelihood of developing gastrointestinal adverse reactions (see section 4.4). Table with 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,
| Classification by systems and organs and by frequency || Adverse reaction |
|Disorders of the blood and lymphatic system || |
| Not known || Decreased prothrombin and increased INR (see sections 4.3 and 4.5) |
|Disorders of the immune system || |
| Not known ||Hypersensitivity reactions, including anaphylaxis, bronchospasm, angioedema, pruritus, erythema and urticaria |
|Psychiatric disorders || |
| Common ||Anxiety† |
|Gastrointestinal disorders || |
| Very common ||Oily leaks |
|Flatulence with stool emission |
|Urgent defecation |
|Fat oily stools |
|Oily evacuation |
|Soft stools |
| Common || Abdominal pain |
|Faecal incontinence |
|Liquid stools |
|Increased defecation |
| Not known ||Diverticulitis |
|Mild rectal bleeding (see section 4.4) |
|Renal and urinary disorders || |
| Not known ||Oxalate nephropathy sometimes resulting in renal failure |
|Hepatobiliary disorders || |
| Not known || Hepatitis which can be severe. Some fatal cases or cases requiring liver transplantation have been reported. |
|Increased transaminases and alkaline phosphatase |
|Skin and subcutaneous tissue disorders || |
| Not known ||Bullous rash |
† It is plausible that treatment with orlistat may induce anticipatory anxiety or secondary to gastrointestinal adverse reactions. Reporting of suspected adverse reactions The reporting of suspected adverse reactions occurring after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Gastrointestinal symptoms Patients should be advised to adhere to received dietary recommendations (see section 4.2). The possibility of developing gastrointestinal symptoms (see section 4.8) may be increased if orlistat is taken with a single meal or 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 must be taken before bedtime. Anti-diabetic medicines Because weight loss may be associated with improved metabolic control of diabetes, patients taking a diabetes medicine should consult with their doctor before starting treatment with alli, should it become necessary to adjust the dose of the antidiabetic drug. Medicines for hypertension or hypercholesterolemia 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 alli, if it becomes necessary to adjust the dose of these medicines. Amiodarone Patients taking amiodarone should consult their physician before starting treatment with alli (see section 4.5).Rectal bleeding Cases of rectal bleeding have been reported in patients taking orlistat. If this occurs, the patient should consult a physician. Oral contraceptives 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 (see section 4.5). Nephropathy Patients with nephropathy should consult their physician before starting treatment with alli, as the use of orlistat may be associated with hyperoxaluria and oxalate nephropathy which sometimes lead to renal 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 simultaneously (see section 4.5). Patients taking levothyroxine should consult their doctor before starting treatment with alli, as it may be necessary to take orlistat and levothyroxine at different times and to adjust the levothyroxine dose. Anti-epileptic drugs Patients taking an anti-epileptic drug should consult their physician before starting treatment with alli, as such individuals should be monitored for any changes in the frequency and intensity of seizures. If this occurs, the possibility of administering orlistat and anti-epileptic drugs at different times should be considered (see section 4.5). Antiretrovirals for HIV Patients should consult a physician before taking alli 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 (see section 4.5).
Pregnancy and breastfeeding
Women of childbearing potential / Contraception in men and women The use of an additional contraceptive method is recommended to prevent possible ineffectiveness of oral contraception in case of severe diarrhea (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 / fetal development, parturition or postnatal development (see section 5.3). alli is contraindicated in pregnancy (see section 4.3). Feeding time Since it is not known whether orlistat is excreted in human milk, alli is contraindicated during lactation (see section 4.3). Fertility Animal studies do not show harmful effects on fertility.
Expiration and retention
Do not store above 25 ° C. Keep the bottle tightly closed in order to protect from moisture.
Interactions with other drugs
Cyclosporine A decrease in plasma levels of cyclosporine was observed in a drug interaction study and was also reported in many cases of concomitant administration with orlistat. This could lead to a decrease in the immunosuppressive efficacy of cyclosporine. Concomitant use of alli and cyclosporine is therefore contraindicated (see section 4.3). Oral anticoagulants Administration of warfarin or other oral anticoagulants concomitantly with orlistat may affect the international normalized ratio values (International Normalized Ratio INR) (see section 4.8). Concomitant use of alli 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 can indirectly reduce the availability of oral contraceptives and lead, in some individual cases, to unwanted pregnancy. An additional contraceptive method is recommended in case of severe diarrhea (see section 4.4). Levothyroxine Hypothyroidism and / or reduced control of hypothyroidism may occur when orlistat and levothyroxine are taken simultaneously (see section 4.4). These effects may be due to a reduced absorption of iodine and / or levothyroxine salts. Anti-epileptic drugs Cases of convulsions have been reported in patients treated concomitantly with orlistat and anti-epileptic drugs, such as eg. valproate, lamotrigine; for such cases a causal relationship due to an interaction cannot be excluded. Orlistat can decrease the absorption of anti-epileptic drugs, leading to convulsions. Antiretroviral drugs Based on reports from literature and post-marketing experience, orlistat has the potential to reduce the absorption of HIV antiretroviral drugs and may adversely affect the efficacy of HIV antiretroviral drugs (see section 4.4). Fat-soluble vitamins Orlistat therapy has the potential to reduce the absorption of fat-soluble vitamins (A, D, E and K). In clinical studies, plasma levels of vitamins A, D, E and K, and beta-carotene remained within the normal range in a large majority of subjects receiving orlistat 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, alli 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 alli. Amiodarone dose adjustment may be required during treatment with alli. Antidepressants, antipsychotics (including lithium) and benzodiazepines There have been some reports of decreased efficacy of antidepressants, antipsychotics (including lithium) and benzodiazepines in conjunction with initiation of orlistat in previously well-controlled patients. Therefore, treatment with orlistat should only be initiated after careful consideration of the possible effects in these patients.
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 daily 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. In case of overdose, it is necessary to seek medical attention. Should a significant overdose of orlistat occur, it is recommended that the patient be observed for 24 hours. Based on clinical and animal studies, all systemic effects attributable to orlistat's lipase inhibiting properties are expected to be rapidly reversible.
Each hard capsule contains 60 mg of orlistat. For the full list of excipients, see section 6.1.
Capsule contents Microcrystalline cellulose (E460) Sodium starch glycolate Povidone (E1201) Sodium lauryl sulfate Talc Operculum Gelatin Indigo carmine (E132) Titanium dioxide (E171) Sodium lauryl sulfate Sorbitan monolaurate Capsule printing ink Shellac Black iron oxide (E172) Propylene glycol Band Gelatin Polysorbate 80 Indigo carmine (E132).