Updated on 15/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 08-Nov-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: The following sub-heading titles have been added "Posology", "Special Populations", "Method of administration" in line with the QRD template
Section 4.6: Section heading changed to "Fertility, pregnancy and lactation". Sub-heading title of "Breastfeeding" has been added. These changes are in line with the QRD template.
Section 4.7: The sentence "No studies on the effect of etoricoxib on the ability to drive or use machines have been performed" has now been deleted.
Section 4.8: Under the sub-heading "Skin and subcutaneous tissue disorders" the side effect "Fixed drug eruption" has been added against a frequency of "Not known". The sub-heading "Musculoskeletal, connective tissue and bone disorders" has been changed to "Musculoskeletal and connective tissue disorders" in line with QRD template. Other minor typographical changes have been made in line with QRD template.
Section 5.1: The sub-heading "Clinical efficacy and safety" has been added in line with the QRD template.
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Updated on 17/08/2011 and displayed until 15/11/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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| Date of revision of text on the SPC: 02-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 2 of the SmPC has been revised to declare the quantity of lactose monohydrate contained in the tablets, as lactose. ie
Excipient:
30 mg: lactose
1.4 1.3 mg
60 mg: lactose
2.8 2.7 mg
90 mg: lactose
4.2 4.0 mg
120 mg: lactose
5.6 5.3 mg
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Updated on 07/03/2011 and displayed until 17/08/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 23-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Resubmission of SPC uploaded on 3 March 2011- Change details clarified below
The changes made to the SmPC are as follows:
Section 4.8: New Side Effects are added as shown to the sub-headings "Psychiatric disorders", "Cardiac disorders" and text is deleted from subheading "Renal and urinary disorders":
Psychiatric disorders:
Uncommon: anxiety, depression, mental acuity decreased.
Very rare: confusion, hallucinations.
Not known: restlessness
Cardiac disorders:
Common: palpitations.
Uncommon: atrial fibrillation, congestive heart failure, non-specific ECG changes, angina pectoris, myocardial infarction*.
Not known: tachycardia, arrhythmia
Renal and urinary disorders:
Uncommon: proteinuria, serum creatinine increased.
Very rare: renal insufficiency, including renal failure, usually reversible upon discontinuation of treatment (see section 4.4).
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Updated on 03/03/2011 and displayed until 07/03/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 23-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.8: The following changes have been made under the sub-headings "Psychiatric disorders", "Cardiac disorders" and "Renal and urinary disorders":
Psychiatric disorders:
Uncommon: anxiety, depression, mental acuity decreased.
Very rare: confusion, hallucinations.
: confusion, hallucinations.
Not known: restlessness
Cardiac disorders:
Common: palpitations.
Uncommon: atrial fibrillation, congestive heart failure, non-specific ECG changes, angina pectoris, myocardial infarction*.
atrial fibrillation,congestive heart failure, non-specific ECG changes, angina pectoris, myocardial infarction*.
Not known: tachycardia
tachycardia
, arrhythmia.
Renal and urinary disorders:
Uncommon: proteinuria, serum creatinine increased.
Very rare: renal insufficiency, including renal failure
renal insufficiency, including renal failure
, usually reversible upon discontinuation of treatment (see section 4.4).
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Updated on 23/09/2009 and displayed until 03/03/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 17-Sep-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Changes to 4.8 Side effects include: addition of anaemia, leukopenia and thrombocytopenia under the additional heading "Blood and lymphatic system disorders".
Addition of angina pectoris and tachycardia under the heading " Cardiac disorders".
Pancreatitis and jaundice now captured under GI disorders and Hepatobiliary disorders respectively instead of in the paragraph with sides effects associated to NSAIDS.
Erythema moved from an incidence of not known to rare.
The following are deleted from Investigations: Haematocrit decreased, haemoglobin decreased, leukocytes decreased, platelets decreased.
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Updated on 23/10/2008 and displayed until 23/09/2009
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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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 5.1 - Pharmacodynamic Properties
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 16-Oct-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The SPC and PIL for Arcoxia have been updated following a European Referral Procedure which has resulted in updated safety advice for patients with hypertension together with approval of a new indication for Arcoxia in Ankylosing Spondylitis.
The SPC changes are:
Section 4.1: A new indication of ankylosing spondylitis (AS) is added.
Section 4.2: Dosage for AS added at 90mg once daily. Clarification that advice for hepatic insufficiency is regardless of indication.
Section 4.3: Contraindication for hypertension is further defined ie "Patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
Section 4.4: under heading of Fluid retention, oedema and hypertension, a new statement is added that all NSAIDs including etoricoxib can be associated with new onset or recurrent congestive heart failure. New advice is added that hypertension should be controlled before treatment with etoricoxib and that BP should be monitored within 2 weeks after initiation of treatment and periodically thereafter.
Section 5.1: A new paragraph describing the AS study is added.
Section 6.5: Additional pack sizes added for 30 mg dose although only 28 tablet pack is marketed in the UK.
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Updated on 22/01/2008 and displayed until 23/10/2008
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 10/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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SPC updated to include a new 30 mg tablet strength for use in osteoarthritis.
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Updated on 04/09/2007 and displayed until 22/01/2008
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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In section 2 of the SPC, the amount of lactose in each tablet has been added.
In section 4.8, 2 new side-effects have been added as follows:
Anaphylactoid reactions expanded to include shock, added as very rare under immune system disorder.
Gastritis added as uncommon under Gastro-intestinal disorders.
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Updated on 02/08/2007 and displayed until 04/09/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: sentence added to elderly section- "As with all drugs, caution should be exercised in elderly patients".
Section 4.3: History of hypersensitivity revised to Hypersensitivity.
Section 4.8: Reference added to the additional population from the MEDAL Programme. New AES added: conjunctivitis, vertigo, palpitations, atrial fibrillation, transient ischaemic attack, decrease in blood sodium.
Section 4.9: Additional information added from reports of acute overdosage reports- AEs consistent with safety profile of etoricoxib.
5.1: Description of the MEDAL programme studies and the safety results added.
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Updated on 23/02/2007 and displayed until 02/08/2007
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Reasons for adding or updating:
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Change to section 5.3 - Preclinical Safety Data
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| Date of revision of text on the SPC: 01/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 5.3 of the SPC has been updated with regard to the information on cardiovascular malformations and post-implantation loss in rabbits. A further study has been conducted confirming the earlier observations showing that exposure to Etoricoxib leads to increased incidences of cardiovascular malformations in rabbit embryos. The mechanism for the effect is unknown. Dose-related increases in post-implantation loss were observed in all three developmental toxicity studies conducted to date. This latter finding is considered to be a pharmacological effect of treatment due to the involvement of Cox-2 in embryonic implantation. Etoricoxib containing products are contraindicated during pregnancy and lactation therefore collectively the findings of these studies are not considered to impact on the risk/benefit profile of the the product. However prescribers need to be informed of the serious (and clinically relevant) toxicological/pharmacological properties of this active, and because the malformations occurred at systemic exposures that are lower than those achieved at therapeutic doses.
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Updated on 24/04/2006 and displayed until 23/02/2007
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 6. 3 - Shelf Life
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Updated on 05/01/2006 and displayed until 24/04/2006
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 01/06/2005 and displayed until 05/01/2006
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 18/02/2005 and displayed until 01/06/2005
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 21/01/2005 and displayed until 18/02/2005
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 23/07/2004 and displayed until 21/01/2005
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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Updated on 21/08/2002 and displayed until 23/07/2004
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Reasons for adding or updating:
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Change to section 3 - pharmaceutical form
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 6.1 - List of Excipients
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Updated on 17/04/2002 and displayed until 21/08/2002
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Correction of spelling/typing errors
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Updated on 15/04/2002 and displayed until 17/04/2002
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