LISTORA
(Orlistat)




COMPOSITION

A capsule contains:

Active ingredient: orlistat 60 mg or 120 mg.

Inactive ingredients: lactose monohydrate, povidone К30, sodium starch glycolate, sodium lauryl sulfate.

Composition of capsule: indigotine, titania, gelatine.

THERAPEUTIC INDICATIONS

Listora is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet for obese patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors. Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.

CONTRAINDICATIONS

- Hypersensitivity to the active substance or to any of the excipients.

- Chronic malabsorption syndrome.

- Cholestasis.

- Breast-feeding.

- Age under 18 years old.

ADVERSE EFFECTS

Adverse reactions to orlistat are largely gastrointestinal in nature. The incidence of adverse events decreased with prolonged use of orlistat.

Adverse events 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Nervous system disorders: very common: headache.

Respiratory, thoracic and mediastinal disorders : very common - upper respiratory infection; common - lower respiratory infection.

Gastrointestinal disorders: very common - abdominal pain/discomfort, oily spotting from the rectum, flatus with discharge, faecal urgency, fatty/oily stool, flatulence, liquid stools, oily evacuation, increased defecation; common - rectal pain/discomfort, soft stools, faecal incontinence, abdominal distension*, tooth disorder, gingival disorder.

Renal and urinary disorders: common - urinary tract infection.

Metabolism and nutrition disorders: very common - Hypoglycemia*.

Infections and infestations: very common - influenza.

General disorders: common - fatigue.

Reproductive system : common - menstrual irregularity.

Psychiatric disorders: common - anxiety.

* only unique treatment adverse events that occurred in obese type 2 diabetic patients..

The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown:

Investigations: increase in liver transaminases and in alkaline phosphatase. Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat.

Gastrointestinal disorders: rectal bleeding, diverticulitis, pancreatitis.

Skin and subcutaneous tissue disorders: bullous eruptions.

Immune system disorders: hypersensitivity (e.g. pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis).

Hepatobiliary disorders: cholelithiasis, hepatitis that may be serious. Some fatal cases or cases requiring liver transplantation have been reported.

Renal and urinary disorders: oxalate nephropathy that may lead to renal failure.

DOSAGE AND ADMINISTRATION

The recommended dose of orlistat is one capsule (60 mg or 120 mg) three times daily taken with water immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted. Doses of orlistat above 120 mg three times do not provide additional benefit.

Patients should follow the recommendations regarding the diet. They should receive well-balanced, moderate low caloric nutrition containing not more than 30 % of fats in daily food consumption. Daily fat consumption should be divided into 3 main food intakes.

SPECIAL INDICATIONS

Anti-diabetic medicinal product treatment may have to be closely monitored when taking orlistat. Co-administration of orlistat with cyclosporin is not recommended.

Patients should be advised to adhere to the dietary recommendations they are given. The possibility of experiencing gastrointestinal adverse reactions may increase when orlistat is taken with a diet or separate food intake high in fat.

Cases of rectal bleeding have been reported with orlistat. Prescribers should investigate further in case of severe and/or persistent symptoms.

The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.

Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants. The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy in patients with chronic renal diseases and/or dehydration symptoms.

Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur. The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine. Orlistat may unbalance anticonvulsant treatment by decreasing the absorption of anti-epileptic drugs, leading to convulsions.

Orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV.

PREGNANCY AND LACTATION

For orlistat no clinical data on exposed pregnancies are available.

Caution should be exercised when prescribing to pregnant women. As it is not known whether orlistat is secreted into human milk, orlistat is contra-indicated during breast-feeding.

MANUFACTURED FORM AND PACKAGE

Hard gelatin capsules.

14 capsules in a blister.

3 or 6 blisters with a leaflet in a carton box..

Alimentary Tract and Metabolism

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