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SPC: XENICAL Hard capsules (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Xenical 120 mg hard capsules.

Qualitative and quantitative composition

Each hard capsule contains 120 mg orlistat. For a full list of excipients, see 6.1.

Pharmaceutical form

Hard capsule. The capsule has a turquoise cap and turquoise body bearing the imprint of XENICAL 120.

Therapeutic indications

Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI >28 kg/m²) ...

Posology and method of administration

Adults The recommended dose of orlistat is one 120 mg capsule 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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Chronic malabsorption syndrome. Cholestasis. Breast-feeding.

Special warnings and precautions for use

In clinical trials, the decrease in bodyweight with orlistat treatment was less in type II diabetic patients than in non-diabetic patients. Antidiabetic medicinal product treatment may have to be closely ...

Interaction with other medicinal products and other forms of interaction

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 can lead to ...

Pregnancy and lactation

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 ...

Effects on ability to drive and use machines

Xenical has no influence on the ability to drive and use machines.

Undesirable 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 ...

Overdose

Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings. In addition, ...

Pharmacodynamic properties

Pharmaco-therapeutic group: Peripherally acting antiobesity agent ATC code: A08AB01 Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal lipases. It exerts its therapeutic activity ...

Pharmacokinetic properties

Absorption Studies in normal weight and obese volunteers have shown that the extent of absorption of orlistat was minimal. Plasma concentrations of intact orlistat were non-measurable (<5 ng/ml) eight ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. ...

List of excipients

Capsule filling: Microcrystalline cellulose (E460) Sodium starch glycolate (type A) Povidone (E1201) Sodium laurilsulfate Talc Capsule shell: gelatine Indigo carmine (E132) Titanium dioxide (E171) Edible ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Blisters: Do not store above 25°C. Store in original package and keep the blister in the outer carton in order to protect from light and moisture. Bottles: Do not store above 30°C. Keep the container tightly ...

Nature and contents of container

PVC/PVDC blisters containing 21, 42 and 84 hard capsules. Glass bottles with desiccant containing 21, 42 and 84 hard capsules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489, Greifswald, Germany

Marketing authorization number(s)

EU/1/98/071/001-006

Date of first authorization / renewal of the authorization

Date of first authorisation: 29 July 1998 Date of latest renewal: 17 June 2008

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