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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 452 206
Medical Information e-mail: medicalinformationuk@merck.com
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Summary of Product Characteristics last updated on the eMC: 11/02/2010
SPC EMEND 80mg, 125mg hard Capsules

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 11/02/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   12-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update of SPC sections 4.8 and 5.1 based on the safety and efficacy data from a new clinical study (prevention of MEC-induced nausea and vomiting in a patient population with a variety of tumour types who were treated with a range of MEC agents).

Section 4.8

- the patient numbers have increased. The following additional side effects have been added:

Neutrophil count decreased, palpitations, cardiovascular disorder, lethargy, somnolence, abdominal distension, faeces hard, neutropenic colitis, rash pruritic, muscular weakness, malaise, chills, gait disturbance.

Section 5.1 -

details of the

clinical study have been added.

 
Updated on 03/09/2009 and displayed until 11/02/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   31-Jul-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 - Additional examples of relevant medicinal products have been added.

Section 4.5 - Section has been re-structured. Additional information on immunosuppressants has been added as follows.

"

Immunosuppressants:

 

 

During the 3 day CINV regimen, a transient moderate increase followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g. ciclosporin, tacrolimus, everolimus and sirolimus) is expected. Given the short duration of the 3-day regimen and the time-dependent limited changes in exposure, dose reduction of the immunosuppressants is not recommended during the 3 days of co-administration with EMEND."
Updated on 16/10/2008 and displayed until 03/09/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Removal of Black Triangle
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1 : It has been made clearer that the product is only for use in adults.

Section 4.2: Some clarification of the dosing regimen has been made.

Section 4.5: The following statement has been added- "Aprepitant does not seem to interact with P-glycoprotein transporter, as suggested by the lack of interaction of EMEND with digoxin".

Section 4.8: The percentage rates of the most common A/Es in patients treated with aprepitant have been compared to that of standard therapy.

The A/E categories have been re-ordered.

Additional A/Es in patients treated with the 40mg strength are listed.

The additional side effects of pruritis, rash, urticaria, and hypersensitivity have been added to a section headed " Additional A/Es reported during post-marketing experience.
Updated on 04/05/2007 and displayed until 16/10/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

Section 2 - inclusion of the quantity of sucrose in each strength

Section 4.1: Indication for 40mg strength added with footnote indicating this strength is not marketed

Section 4.2 - children's statement was modified according to standardised wording.

Section 4.5 - Addition of the statement regarding the effect of EMEND on the pharmacokinetics of orally and IV administered CYP3A4 substrates. Rewording of the interactions of EMEND with chemotherapeutic agents which includes information on vinorelbine. Where applicable, the abbreviation 'mcg' was changed to '¦Ìg'.  Addition of information from a clinical study with midazolam IV

Section 4.7: Rewording of statement on driving and use of machinery.

Section 4.8: Addition of side effects for the 40 mg strength (abdominal pain, bowel sounds, dysarthria, dyspnoea, hypoaethesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, visual acuity reduced, wheezing).

Section 4.8: Addition of two serious adverse experiences in PONV clinical studies in patients taking a higher dose of apprepitant - 1 case of constipation and 1 case of sub-ileus.

Section 4.8 - reference to 'events' was deleted in the first paragraph and the statement for frequencies was revised by updating the symbol '>' to '¡Ý'.

Section 6.1: Change to INN name to sodium laurilsulfate for the capsule content. Addition of sodium laurilsulphate and silica colloidal anhydrous to the capsule shell excipient list.

Section 6.4: Change in wording for storage conditions from 'No special precautions for storage' to 'Store in the original packaging to protect from moisture'.
Updated on 23/01/2006 and displayed until 04/05/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 17/05/2005 and displayed until 23/01/2006
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
Updated on 10/01/2005 and displayed until 17/05/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/12/2004 and displayed until 10/01/2005
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 05/08/2004 and displayed until 23/12/2004
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 20/01/2004 and displayed until 05/08/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  aprepitant


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