ORLOS

Posology Adults The recommended dose of Orlistat is one 60 mg capsule to be taken three times daily. No more than three 60 mg capsules should be taken in 24 hours. Diet and exercise are important parts of a weight loss programme. It is recommended that a diet and exercise programme is started before beginning treatment with Orlistat.

g. in a 2,000 kcal/day diet, this equates to <67 g of fat). The daily intake of fat, carbohydrate and protein should be distributed over three main meals. The diet and exercise programme should continue to be followed when treatment with Orlistat is stopped.

Treatment should not exceed 6 months. If patients have been unable to lose weight after 12 weeks of treatment with Orlistat, they should consult their doctor or a pharmacist. It may be necessary to discontinue treatment. Special populations Elderly (>65 years old) There are limited data on the use of orlistat in the elderly.

However, as orlistat is minimally absorbed, no dose adjustment is necessary in the elderly. 4). However, as orlistat is minimally absorbed, no dose adjustment is necessary in individuals with hepatic and/or renal impairment. Paediatric population The safety and efficacy of Orlistat in children below 18 years of age has not been established.

No data are available. Method of administration The capsule should be taken with water immediately before, during or up to 1 hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.

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. 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) and 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.

5).

Immune system disorders Not known:

Hypersensitivity reactions including anaphylaxis, bronchospasm, angioedema, pruritus, rash, and urticaria. 4) Hepatobiliary disorders Not known: Hepatitis that may be serious. Some fatal cases or cases requiring liver transplantation have been reported.

Cholelithiasis Increase in transaminases and in alkaline phosphatase Skin and subcutaneous tissue disorders Not known: Bullous eruption Renal and urinary disorders Not known: Oxalate nephropathy that may lead to renal failure † it is plausible that treatment with orlistat can lead to anxiety in anticipation of or secondary to gastrointestinal adverse reactions.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

2). 8) may increase when orlistat is taken with an individual meal or a diet high in fat. 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 Orlistat, 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 Orlistat, in case it is necessary to adjust the dose of these medicinal products.

5). Rectal bleeding Cases of rectal bleeding have been reported in patients taking orlistat. If this occurs, the patient should consult a doctor. 5). 8) leading sometimes to renal failure. This risk is increased in patients with underlying chronic kidney disease and/or volume depletion.

5). Patients taking levothyroxine should consult a doctor before starting treatment with Orlistat, 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 Orlistat, as they should be monitored for possible changes in the frequency and severity of convulsions.

5). Antiretrovirals for HIV Patients should consult a physician before taking Orlistat concomitantly with antiretroviral medications. 5). Excipient This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

1. 5). Chronic malabsorption syndrome. Cholestasis. 6). 6). 8).