Medicinal Products

ALLI 60 mg

Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Orlistat
laboratory: Glaxo Group Ltd

capsule
Case of 1 bottle of 42
All forms

Indication

alli is indicated in combination with a moderately low-calorie and low-fat diet, in the treatment of overweight (Body Mass Index (BMI) ≥ 28 kg / m²) in adults,

Dosage ALLI 60 mg Capsule Case of 1 bottle of 42

adults

The recommended dosage for alli is one 60 mg capsule taken three times a day. The capsule should be taken with water immediately before, during or until one hour after each of the main meals. If a meal is skipped or contains no fat, orlistat intake should be discontinued. Do not take more than 3 capsules at 60 mg per 24 hours.

The treatment should not exceed 6 months.

Patients who have not lost weight after 12 weeks of treatment with alli should consult their physician or pharmacist. It may be necessary to stop the treatment.

Diet and exercise are important parts of a weight loss program. It is recommended that a diet and exercise program be in place before starting treatment with alli.

When orlistat is used, the patient should follow a nutritionally well-balanced, moderately low-calorie diet containing about 30% of calories from fat (eg, in a diet at 2, 000 kcal / day, this proportion is at <67 g of lipids). The daily intake of fat, carbohydrate and protein should be spread over the three main meals.

The patient should continue to follow the diet and exercise program after stopping alli therapy.

Special Populations

alli should not be used in children and adolescents under the age of 18, given the paucity of data regarding its effectiveness and tolerance.

There is limited data on the use of orlistat in elderly people.

The effect of orlistat has not been studied in patients with hepatic and / or renal impairment.

However, since orlistat absorption is minimal, no dose adjustment is necessary in the elderly or in patients with hepatic and / or renal impairment.

Against indications

• Hypersensitivity to the active substance or to any of the excipients

• Concomitant treatment with ciclosporin (see section 4.5 Interaction with other medicinal products and other forms of interaction )

• Chronic malabsorption syndrome

• Cholestasis

• Pregnancy (see section Pregnancy and lactation )

• Breastfeeding (see section on Pregnancy and lactation )

• Concomitant treatment with warfarin or other oral anticoagulants (see sections Interactions with other medicinal products and other forms of interaction and side effects )

Adverse effects Alli

The undesirable effects of orlistat are essentially gastrointestinal and related to the pharmacological effect of the drug, which opposes the absorption of ingested fats.

Gastrointestinal adverse events identified in clinical trials lasting 18 months to 2 years with orlistat 60 mg were generally moderate and transient. They usually occurred at the beginning of treatment (within the first three months) and the majority of patients presented only one episode. Monitoring a low-fat diet reduces the likelihood of gastrointestinal side effects (see section 4.4 ).

Undesirable events are listed below by organ system class and frequency. Frequencies are defined as follows: very common (≥1 / 10), common (≥1 / 100, <1/10), uncommon (≥1 / 1, 000, <1/100), rare (≥1 / 10, 000, <1 / 1, 000) and very rare (<1 / 10, 000), frequency unknown (can not be estimated based on available data).

The frequencies of post-marketing adverse effects of orlistat are unknown as these effects were reported spontaneously without knowledge of the size of the treated population.

Within each frequency category, adverse effects are presented in order of decreasing severity.

System organ class and frequency

Event / Adverse Effect

Hematological and systemic disorders

lymphatic

Frequency unknown:

Decreased prothrombin level and

increased INR (see sections Contraindications and Interactions with other drugs and other forms of interaction )

Immune system disorders

Frequency unknown:

Hypersensitivity reactions, including reaction

anaphylactic, bronchospasm, angioedema,

pruritus, rash, urticaria

Psychiatric disorders

Frequent:

Anxiety

Gastrointestinal disorders

Very common :

Oily stains

Flatulence with seepage

Driving seat

Oily and oily stools

Oily emission

Flatulence

Soft stools

Frequent

Abdominal pain

Fecal incontinence

Liquid stools

Frequent saddles

Frequency unknown:

diverticulitis

Moderate rectal haemorrhage (see section 4.4 Special warnings and precautions for use )

Hepatobiliary disorders

Frequency unknown:

Hepatitis

cholelithiasis

Increased transaminases and

alkaline phosphatase

Skin and subcutaneous tissue disorders

Frequency unknown:

Bullous eruption

Orlistat treatment may induce anxiety by anticipating or following digestive adverse reactions.

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