Leitlinien & Arzneimittelsicherheit

HOS-094904 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Adverse reactions to orlistat are largely gastrointestinal in nature and related to the pharmacologic effect of the medicinal product on preventing the absorption of ingested fat. The gastrointestinal adverse reactions identified from clinical trials with orlistat 60 mg of 18 months to 2 years duration were generally mild and transient. They generally occurred early in treatment (within 3 months) and most patients experienced only one episode. Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal 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: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <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 use of 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. System organ class and frequency Adverse reaction Blood and lymphatic system disorders 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, rash, and urticaria Psychiatric disorders Common Anxiety† 5  System organ class and frequency Adverse reaction Gastrointestinal disorders Very common Oily spotting Flatus with discharge Faecal urgency Fatty oily stool Oily evacuation

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HOS-094900 · has-contraindication-information · PDF-Seite 2

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Concurrent treatment with ciclosporin (see section 4.5) 2 • Chronic malabsorption syndrome • Cholestasis • Pregnancy (see section 4.6) • Breast-feeding (see section 4.6) • Concurrent treatment with warfarin or other oral anticoagulants (see sections 4.5 and 4.8)

HOS-094899 · has-indication-information · PDF-Seite 2

alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.

HOS-094902 · has-interaction-information · PDF-Seite 4

Ciclosporin A decrease in ciclosporin plasma levels has been observed in a drug-drug interaction study and also reported in several cases, when orlistat was administered concomitantly. This could potentially lead to a decrease of immunosuppressive efficacy. Concurrent use of alli and ciclosporin is contraindicated (see section 4.3). Oral anticoagulants When warfarin or other oral anticoagulants are given in combination with orlistat, international normalised ratio (INR) values could be affected (see section 4.8). Concurrent use of alli and warfarin or other oral anticoagulants is contraindicated (see section 4.3). Oral contraceptives The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies. However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases. An additional contraceptive method is recommended in case of severe diarrhoea (see section 4.4). Levothyroxine Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are taken at the same time (see section 4.4). This could be due to a decreased absorption of iodine salts and/or levothyroxine. Antiepileptic medicinal products Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic medicinal products e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded. Orlistat may decrease the absorption of antiepileptic medicinal products, leading to convulsions. Antiretroviral medicinal products Based on reports from literature and post-marketing experience orlistat may potentially reduce the absorption of antiretroviral medicinal products for HIV and could negatively affect the efficacy of antiretroviral medicinal product for HIV (see section 4.4). Fat-soluble vitamins Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K). The vast majority of subjects receiving up to 4 full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range. However, patients should be advised to use 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 to be used by patients receiving acarbose. Amiod

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HOS-094903 · has-pregnancy-information · PDF-Seite 4

Women of childbearing potential / Contraception in males and females The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see sections 4.4 and 4.5). 4 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). alli is contraindicated in pregnancy (see section 4.3). Breast-feeding As it is not known whether orlistat is secreted into human milk, alli is contraindicated during breast-feeding (see section 4.3). Fertility Animal studies do not indicate harmful effects with respect to fertility.

HOS-094901 · has-warning-information · PDF-Seite 3

Gastrointestinal symptoms Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2). The possibility of experiencing gastrointestinal symptoms (see section 4.8) may increase when orlistat is taken with an individual meal or a diet high in fat. Fat-soluble vitamins Treatment with orlistat may potentially 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 As weight loss may be accompanied by improved metabolic control in diabetes, patients who are taking a medicinal product for diabetes should consult a doctor before starting treatment with alli, in case it is necessary to adjust the dose of the antidiabetic medicinal product. Medicinal products for hypertension or hypercholesterolaemia Weight loss may be accompanied by an improvement in blood pressure and cholesterol levels. Patients who are taking a medicinal product for hypertension or hypercholesterolaemia should consult a doctor or pharmacist when taking alli, in case it is necessary to adjust the dose of these medicinal products. Amiodarone Patients who are taking amiodarone should consult a doctor 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 doctor. Oral contraceptives The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see section 4.5). Kidney disease Patients with kidney disease should consult a doctor before starting treatment with alli, as the use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes 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 co-administered (see section 4.5). Patients taking levothyroxine should consult a doctor before starting treatment with alli, as orlistat and levothyroxine may need to be taken at different times and the dose of levothyroxine may need to be adjusted. Antiepileptic medicinal products Patients taking an antiepileptic medicinal product should consult a doctor before starting treatment with alli, as they

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