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SPC: CAPECITABINE ACCORD Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Capecitabine Accord 150 mg film-coated tablets. Capecitabine Accord 300 mg film-coated tablets. Capecitabine Accord 500 mg film-coated tablets.

Qualitative and quantitative composition

Capecitabine Accord 150 mg film-coated tablets: Each film-coated tablet contains 150 mg of capecitabine. Capecitabine Accord 300 mg film-coated tablets: Each film-coated tablet contains 300 mg of capecitabine. ...

Pharmaceutical form

Film-coated tablet. Capecitabine Accord 150 mg film-coated tablets: The film-coated tablets are light peach colored, oblong shaped, biconvex, 11.4 mm in length and 5.3 mm in width, debossed with 150 on ...

Therapeutic indications

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

Posology and method of administration

Capecitabine Accord should only be prescribed by a qualified physician experienced in the utilisation of anti-neoplastic medicinal products. Careful monitoring during the first cycle of treatment is recommended ...

Contraindications

History of severe and unexpected reactions to fluoropyrimidine therapy, Hypersensitivity to capecitabine or to any of the excipients listed in section 6.1 or fluorouracil, In patients with known complete ...

Special warnings and precautions for use

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

Interaction with other medicinal products and other forms of interaction

Interaction studies have only been performed in adults. Interaction with other medicinal products Cytochrome P-450 2C9 substrates Other than warfarin, no formal interaction studies between capecitabine ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with capecitabine. If the patient ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile The overall safety profile of capecitabine is based on data from over 3,000 patients treated with capecitabine as monotherapy or capecitabine in combination with different ...

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: antineoplastic agents, antimetabolites, pyrimidine analogues ATC code: L01BC06 Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered ...

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

Capecitabine Accord 150 mg and 500 mg film-coated tablets Tablet core: Anhydrous lactose Microcrystalline cellulose (E460) Croscarmellose sodium Hypromellose (E5) Magnesium stearate Tablet coating: Hypromellose ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Aluminium/aluminium blisters: This medicinal product does not require any special storage conditions. PVC/PVdC/Aluminium blisters: Do not store above 30°C.

Nature and contents of container

Aluminium/aluminium or PVC/PVdC/Aluminium blister containing 30, 60 or 120 film-coated tablets. Each pack contains 30, 60 or 120 film-coated tablets. PVC/PVdC/Aluminium perforated unit dose blister containing ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Accord Healthcare Limited Sage house, 319, Pinner road North Harrow Middlesex HA1 4HF, United Kingdom

Marketing authorization number(s)

EU/1/12/762/001-003 EU/1/12/762/004-006 EU/1/12/762/019-021 EU/1/12/762/007-009 EU/1/12/762/010-012 EU/1/12/762/022-024 EU/1/12/762/013-015 EU/1/12/762/016-018 EU/1/12/762/025-027

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 April 2012 Date of latest renewal: 09<sup>th</sup> January 2017

Πηγαίο έγγραφο

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