Summary of Product Characteristics
last updated on the eMC:
15/09/2010
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 15/09/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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| Date of revision of text on the SPC: 01-Jul-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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SPC
4.3 Contraindications: reorganisation and rewording of text and addition of new contraindications:
Hypersensitivity to epirubicin, other components of the product, other anthracyclines or anthracenediones
Lactation
Additional contraindications for intravenous use:
Severe hepatic impairment
Severe myocardial insufficiency
Recent myocardial infarction
Severe arrhythmias
Previous treatment with anthracenediones
Acute systemic infections
Unstable angina pectoris
Myocardiopathy
Additional contraindications for intravesical use:
Urinary tract infections
Bladder inflammation
Hematuria
Invasive tumours penetrating the bladder
Catheterisation problems
4.4 Warnings and precautions: addition of new warnings/precautions on the following topics:
Patients should recover from acute toxicities of prior cytotoxic treatment before beginning treatment with epirubicin
Adverse events associated with treatment with high doses of epirubicin
Cardiac function
Early (acute) cardiac events
Late (delayed) cardiac events
Risk of developing CHF
Assessment and monitoring of cardiac function before and during epirubicin therapy
Risk factors for cardiac toxicity
Haematologic toxicity
Secondary leukaemia
Gastrointestinal adverse events
Liver function
Renal function
Effects at site of injection
Extravasation
Thrombophlebitis and thromboembolic phenomena, including pulmonary embolism
Tumor-lysis syndrome
Immunosuppressant effects/increased susceptibility to infections
Reproductive system
Additional warnings and precautions for intravesical and intra-arterial route of administration
Adverse effects of excipients
4.5 Interactions (including interactions with other medicinal products) added, including the following topics:
Additive toxicity when epirubicin is used in combination with other cytotoxic/potentially cardiotoxic drugs, or other cardioactive compounds
Concomitant therapies that affect hepatic function
Vaccinations
Cimetidine to be discontinued during treatment with epirubicin
Prior use and coadministration (with epirubicin) of paclitaxel or docetaxel
Interaction with dexverapamil
Interaction with quinine
Coadministration of interferon alpha-2b
(Pre)treatment with medications that influence the bone marrow
4.6 Information added regarding fertility impairment and lactation, and information on pregnancy updated
4.8 Further undesirable effects added and section reorganised to include additional details of undesirable effects and their frequencies, in the following categories:
Infections and infestations
Neoplasms, benign, malignant and unspecified (incl cysts and polyps)
Blood and the lymphatic system disorders
Immune system disorders
Metabolism and nutrition disorders
Nervous system disorders
Eye disorders
Cardiac disorders
Vascular disorders
Gastrointestinal disorders
Skin and subcutaneous tissue disorders
Renal and urinary disorders
Reproductive system and breast disorders
General disorders and administration site conditions
Investigations
Injury, poisoning and procedural complications
Intravesical administration
4.9 Signs, symptoms and treatment of overdose updated to add new details, including gastrointestinal toxic effects, a longer latency period for cardiac failure after completion of treatment, and treatment of overdose.
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Updated on 25/08/2005 and displayed until 15/09/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/08/2005 and displayed until 25/08/2005
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/09/2004 and displayed until 22/08/2005
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Updated on 07/06/2004 and displayed until 30/09/2004
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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