ALLI * 84CPS 60MG FL

ALLI * 84CPS 60MG FL

Therapeutic indications

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 AdultsThe 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, which contains approximately 30% of calories from fat (e.g. in a 2,000 kcal per day diet, this is equivalent to a Quantitative Special populations Elderly (≥65 years) There are only limited data on the use of orlistat in the elderly, however, as orlistat is only minimally absorbed, no dose adjustment is required in the elderly.Hepatic and renal insufficiencyThe 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 populationThe safety and efficacy of alli in children aged below 18 years have not been established. No data are available.Method of administrationThe 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.

Contraindications

• 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)

Side effects

Summary of the safety profileAdverse 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 reactionsAdverse reactions are listed below by system organ class and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100,

† It is plausible that treatment with orlistat may induce anticipatory anxiety or secondary to gastrointestinal adverse reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur 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.

Special warnings

Gastrointestinal symptomsPatients 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 vitaminsTreatment 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 bedtime.Anti-diabetic medicinesBecause 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 hypercholesterolemiaWeight 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.AmiodaronePatients taking amiodarone should consult their physician before starting treatment with alli (see section 4.5).Rectal bleedingThere have been reports of rectal bleeding in patients taking orlistat. Should this occur, the patient should consult a physician.Oral contraceptivesThe 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).NephropathyPatients 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.LevothyroxineHypothyroidism 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 adjust the levothyroxine dose.Anti-epileptic drugsPatients 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, 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 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 womenThe 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).PregnancyFor 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 timeSince it is not known whether orlistat is excreted in human milk, alli is contraindicated during lactation (see section 4.3).FertilityAnimal studies do not indicate 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

CyclosporineA 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 anticoagulantsAdministration of warfarin or other oral anticoagulants concomitantly with orlistat may affect the international normalized ratio values (International Normalized RatioINR) (see section 4.8). Concomitant use of alli and warfarin or other oral anticoagulants is therefore contraindicated (see section 4.3).Oral contraceptivesThe 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 contraceptive method is recommended in case of severe diarrhea (see section 4.4).LevothyroxineHypothyroidism 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 drugsCases of seizures 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 seizures.Antiretroviral drugsBased 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 vitaminsOrlistat 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).AcarboseIn the absence of pharmacokinetic interaction studies, alli is not recommended in patients treated with acarbose.AmiodaroneA decrease in plasma levels of amiodarone, given 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 benzodiazepinesThere 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.

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. 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, all systemic effects attributable to orlistat's lipase inhibiting properties are expected to be rapidly reversible.

Active principles

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

Excipients

Capsule contentsMicrocrystalline cellulose (E460) Sodium starch glycolate Povidone (E1201) Sodium lauryl sulfate TalcOperculumGelatin Indigo carmine (E132) Titanium dioxide (E171) Sodium lauryl sulfate Sorbitan monolaurateCapsule printing inkShellac Black iron oxide (E172) Propylene glycolBandGelatin Polysorbate 80 Indigo carmine (E132).