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Xeloda 150mg and 500mg Film-coated Tablets (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Roche Products Limited
Διεύθυνση Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Name of the medicinal product

Xeloda 150 mg and 500 mg film-coated tablets.

Qualitative and quantitative composition

150 mg or 500 mg capecitabine. Excipient: 15.6 mg anhydrous lactose (150 mg tablet). Excipient: 52 mg anhydrous lactose (500 mg tablet). For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Light peach film-coated tablet of biconvex, oblong shape with the marking 150 on the one side and 'Xeloda' on the other side. Peach film-coated tablet of biconvex, oblong shape with ...

Therapeutic indications

Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer (see section 5.1). Xeloda is indicated for the treatment of metastatic colorectal ...

Posology and method of administration

Xeloda should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic agents. Xeloda tablets should be swallowed with water within 30 minutes after a meal. Treatment ...

Contraindications

History of severe and unexpected reactions to fluoropyrimidine therapy, Hypersensitivity to capecitabine or to any of the excipients or fluorouracil, In patients with known dihydropyrimidine dehydrogenase ...

Special warnings and precautions for use

Dose limiting toxicities include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia). Most adverse reactions are reversible ...

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Interaction with other medicinal products Coumarin-derivative anticoagulants: altered coagulation parameters and/or bleeding have been reported in ...

Fertility, pregnancy and lactation

Women of childbearing potential Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Xeloda. If the patient becomes pregnant while receiving Xeloda ...

Effects on ability to drive and use machines

Xeloda has minor or moderate influence on the ability to drive and use machines. Xeloda may cause dizziness, fatigue and nausea.

Undesirable effects

a. Summary of the safety profile The overall safety profile of Xeloda is based on data from over 3000 patients treated with Xeloda as monotherapy or Xeloda in combination with different chemotherapy regimens ...

Overdose

The manifestations of acute overdose include nausea, vomiting, diarrhoea, mucositis, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include ...

Pharmacodynamic properties

Pharmacotherapeutic group: cytostatic (antimetabolite) ATC code: L01BC06 Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic ...

Pharmacokinetic properties

The pharmacokinetics of capecitabine have been evaluated over a dose range of 502-3514 mg/m²/day. The parameters of capecitabine, 5'-deoxy-5-fluorocytidine (5'-DFCR) and 5'-deoxy-5-fluorouridine (5'-DFUR) ...

Preclinical safety data

In repeat-dose toxicity studies, daily oral administration of capecitabine to cynomolgus monkeys and mice produced toxic effects on the gastrointestinal, lymphoid and haemopoietic systems, typical for ...

List of excipients

Tablet core: Anhydrous lactose Croscarmellose sodium Hypromellose Microcrystalline cellulose Magnesium stearate Tablet coating: Hypromellose Titanium dioxide (E171) Yellow and red iron oxide (E172) Talc ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Nature: PVC/PVDC blisters Content: 150 mg: 60 film-coated tablets (6 blisters of 10 tablets) 500 mg: 120 film-coated tablets (12 blisters of 10 tablets)

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom

Marketing authorization number(s)

EU/1/00/163/001 – 150 mg film-coated tablets EU/1/00/163/002 – 500 mg film-coated tablets

Date of first authorization / renewal of the authorization

Date of first authorisation: 02 February 2001 Date of first renewal: 02 February 2006

Date of revision of the text

17 June 2011
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