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MSD Ireland (Human Health) Limited

Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 15/06/2017
SPC Temodal Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 15/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Jun-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to sections 4.4, 4.8, and 10 as a result of approval of Type IAIN variation EMEA/H/C/0229/IAIN/0078 - Signal of Meningoencephalitis herpetic
Updated on 12/06/2015 and displayed until 15/06/2017
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   27-May-2015
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



SPC Change Details: In section 4.4, updates on “Opportunistic infections and reactivation of infections” and “HBV” have been added. In section 4.8, uncommon side effects for “Infections and infestations” and “Endocrine disorders” have been added.

Updated on 04/07/2014 and displayed until 12/06/2015
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   22-May-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.8 Undesirable effects has been amended as follows:

Post-marketing experience:
Under System Organ Class 'Hepatobiliary disorders' all ADRs have had frequency realignment:
'liver enzymes elevations' has moved from unknown to common
'hyperbilirubinemia, cholestasis, hepatitis, hepatic injury, hepatic failure' have moved from unknown to uncommon.

Contact details for reporting suspected adverse reactions has been updated as follows:

HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Updated on 22/01/2014 and displayed until 04/07/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   18-Dec-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.4 Special warnings and precautions for use

-        This section has been updated to include information on severe liver injuries including those with fatal outcome (hepatocellular injury; hepatocellular failure) and the recommendation of carrying out a liver function test prior and depending on the length of treatment during treatment with temozolomide.

 

Section 4.8 - Undesirable Effects

 

-        The following frequency groupings have been added for this section-  Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000).

 

-        The text that falls under “Post-marketing experience” has been reformatted and summarised in a summary table to give a  much clearer overview of all important post marketing events with Temodal (Table 6 “Summary of events reported with termozolomide in the post-marketing setting”)

 

Antineoplastic agents, and notably alkylating agents, have been associated with a potential risk of myelodysplastic syndrome (MDS) and secondary malignancies, including leukaemia. Very rare cases of MDS and secondary malignancies, including myeloid leukaemia have been reported in patients treated with regimens that included TMZ. Prolonged pancytopenia, which may result in aplastic anaemia has been reported, and in some cases has resulted in a fatal outcome. Cases of toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported very rarely.

Cases of interstitial pneumonitis/pneumonitis, pulmonary fibrosis and fatal respiratory failure have been reported very rarely.

There have been reported cases of hepatotoxicity including elevations of liver enzymes, hyperbilirubinemia, cholestasis and hepatitis.

The following additional serious adverse reactions have been identified during post-marketing exposure:

 

Table 6. Summary of events reported with temozolomide in the post-marketing setting†*

Blood and lymphatic system disorders

Very rare:

prolonged pancytopenia, aplastic anaemia†

Neoplasm benign, malignant and unspecified

Very rare:

myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia

Respiratory, thoracic and mediastinal disorders

Very rare:

interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†

Hepatobiliary disorders

Not known:

liver enzymes elevations,  hyperbilirubinemia, cholestasis, hepatitis  hepatic injury, hepatic failure†

Skin and subcutaneous tissue disorders

Very rare:

toxic epidermal necrolysis, Stevens-Johnson syndrome

 

* † Events classified according to System Organ Class and post-marketing product usage

† Including cases with fatal outcome

 

-        The adverse event “Taste Perversion” was incorrectly listed under both common and uncommon in table 4 so it has now been deleted from the uncommon column.

 

-        The national reporting details for adverse events has been added to the end of the undesirable effects section.

 

 

Changes throughout the SmPC:

The SmPC has been updated to align better with the QRD template V.9.

Updated on 31/01/2013 and displayed until 22/01/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   13-Dec-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



We have received favorable CHMP opinion for a type II variation EMEA/H/C/0229/II/62 (to add information regarding pulmonary fibrosis to the SPC and PIL). The official date of adoption is 16-Jan-2013.

 

The changes made to the SPC are as follows:

Pneumocystis jirovecii pneumonia replaces Pneumocystis carinii pneumonia

 

Added to section 4.4:  Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.

 

Added to section 4.8: Cases of interstitial pneumonitis/pneumonitis, pulmonary fibrosis and fatal respiratory failure have been reported very rarely.

 

Updated on 22/08/2012 and displayed until 31/01/2013
Reasons for adding or updating:
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder
Date of revision of text on the SPC:   27-Jun-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


  • Minor formatting and editorial changes to bring the SmPC in line with current QRD template
  • Inclusion of statement in section 4.2 confirming safety and efficacy of Temodal in children under the age of 3 years is not established,
  • Wording added to section 4.5 confirming all interaction studies have only been performed in adults,
  • Section 4.6 has been amended to contain a statement advising women of childbearing potential are advised to use effective contraception while receiving Temodal,
  • Wording has been added to section 4.7 advising that Temodal has a minor influence on the ability to drive and use machines,
  • Updated section 4.4 and 4.8 regarding myelosuppression with possible fatal outcome,
  • Inclusion of adverse event frequency in paediatric patients in section 4.8 of the SmPC
Updated on 31/10/2011 and displayed until 22/08/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   13-Oct-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



In section 7 (Marketing Authorisation Holder) the address has been amended.

Updated on 17/10/2011 and displayed until 31/10/2011
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   14-Jun-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Shelf life changed from 4 years to 3 years.
Updated on 06/07/2011 and displayed until 17/10/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   14-Jun-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Paediatric patients has changed to paediatric populations in the following sections - 4.2, 4.4 and 5.1

In section 4.6, the word lactation has been replaced with breastfeeding

In section 4.8 the following text has been added:

There have been reported cases of hepatotoxicity including elevations of liver enzymes, hyperbilirubinemia, cholestasis and hepatitis.

Updated on 09/06/2011 and displayed until 06/07/2011
Reasons for adding or updating:
  • Improved electronic presentation
Date of revision of text on the SPC:   28-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Improved electronic version
Updated on 10/05/2011 and displayed until 09/06/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   14-Apr-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.8 – Now includes text on reported cases of hepatotoxicity including elevations of liver enzymes, hyperbilirubinemia, cholestasis and hepatitis.

Updated on 14/03/2011 and displayed until 10/05/2011
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   28-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Shelf life increased from 3 to 4 years
Updated on 23/07/2009 and displayed until 14/03/2011
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 11 - Dosimetry
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   24-Jun-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

6.5 Bottle presentation: "Not all pack sized may be marked" changed to "The carton contains one bottle"
8.0  024-25 added: Temodal 5 mg Capsules          :         EU/1/98/096/001-2, 024-25
9.0 "17 December 2008" changed to "26 January 2009"
10.0 "22 January 2009" changed to "24 June 2009"
11.0 1-09/15 changed to 06-09/16
Updated on 21/01/2009 and displayed until 23/07/2009
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.3 the following sentence has been removed from this section:
 
"Temodal is contraindicated in women who are pregnant (see section 4.6)"
 
Section 9 - date of renewal updated
Section 10 - date of revision of text updated
Updated on 08/12/2008 and displayed until 21/01/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8 changed as follows: 

Changed from:
 
Antineoplastic agents, and notably alkylating agents, have been associated with a potential risk of myelodysplastic syndrome (MDS) and secondary malignancies, including leukemia.Very rare cases of MDS and secondary malignancies, including myeloid leukemia have been reported in patients treated with regimens that included Temodal. Prolonged pancytopenia, which may result in aplastic anaemia has been reported very rarely.  Cases of toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported very rarely.

Changed to:

Post -Marketing Experience:

Antineoplastic agents, and notably alkylating agents, have been associated with a potential risk of myelodysplastic syndrome (MDS) and secondary malignancies, including leukemia.Very rare cases of MDS and secondary malignancies, including myeloid leukemia have been reported in patients treated with regimens that included Temodal. Prolonged pancytopenia, which may result in aplastic anaemia has been reported very rarely.  Cases of toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported very rarely.

Cases of interstitial pneumonitis/pneumonitis have been reported very rarely.

Section 10 - date of revision of text updated 

Updated on 04/07/2008 and displayed until 08/12/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4 - the following paragraph has been added:
 
 Very rare cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been observed.
 
Section 10 - updated date of revision of text
Updated on 22/08/2007 and displayed until 04/07/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.3

 

Changed from:

 

Temodal is contraindicated in women who are pregnant or breast feeding (see section 4.6).

 

To:

 

Temodal is contraindicated in women who are pregnant (see section 4.6).

 

Section 4.6, Lactation, changed from:

 

It is not known whether temozolomide is excreted in human milk; thus, Temodal must not be used by women who are breast-feeding.

 

To:

 

It is not known whether temozolomide is excreted in human milk; thus, breast-feeding must be discontinued while receiving treatment with Temodal.

 

The following has also been added to this section:

 

Male fertility and contraception

Temozolomide can have genotoxic effects. Therefore, men being treated with temozolomide are advised not to father a child during up to 6 months after treatment and to seek advice on cryoconservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with temozolomide.

 

Section 4.8, Table 5

 

Blood and lymphatic system disorders: changed to include “grade 3-4” in respect of thrombocytompenia

 

Section 10 – date of revision of text updated

Updated on 07/06/2007 and displayed until 22/08/2007
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 1

 

The following strengths have been added – 140mg & 180mg

 

Section 2

 

Changed from:

 

Each Temodal capsule contains 5 mg, 20 mg, 100 mg or 250 mg temozolomide.

 

Excipient:     5mg contains 132.8 mg of anhydrous lactose.

Excipient:   20mg contains 182.2 mg of anhydrous lactose.

Excipient: 100mg contains 175.7 mg of anhydrous lactose.

Excipient: 250mg contains 154.3 mg of anhydrous lactose.

 

Change to:

 

Each capsule contains 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg temozolomide.

 

Excipient:     5 mg contains 132.8 mg of anhydrous lactose.

                   20 mg contains 182.2 mg of anhydrous lactose.

                 100 mg contains 175.7 mg of anhydrous lactose.

                 140 mg contains 246 mg of anhydrous lactose.

                 180 mg contains 316.3 mg of anhydrous lactose.

                 250 mg contains 154.3 mg of anhydrous lactose.

 

 

Section 3

 

Changed from:

 

Hard capsule

The 5mg hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.

The 20mg hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink.

The 100mg hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.

The 250mg hard capsules have an opaque white body and cap and are imprinted with black ink.

 

Changed to:

 

Hard capsule

The 5 mg hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.  The cap is imprinted with “Temodal”.  The body is imprinted with “5 mg”, the Schering-Plough logo and two stripes.

The 20 mg hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink.  The cap is imprinted with “Temodal”.  The body is imprinted with “20 mg”, the Schering-Plough logo and two stripes.

The 100 mg hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.  The cap is imprinted with “Temodal”.  The body is imprinted with “100 mg”, the Schering-Plough logo and two stripes.

The 140 mg hard capsules have an opaque white body, a blue cap, and are imprinted with black ink.

The cap is imprinted with “Temodal”.  The body is imprinted with “140 mg”, the Schering-Plough logo and two stripes.

The 180 mg hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.  The cap is imprinted with “Temodal”.  The body is imprinted with “180 mg”, the Schering-Plough logo and two stripes.

The 250 mg hard capsules have an opaque white body and cap and are imprinted with black ink.

The cap is imprinted with “Temodal”.  The body is imprinted with “250 mg”, the Schering-Plough logo and two stripes.

 

Section 4.1

 

Changed from:

 

Temodal capsules are indicated for the treatment of patients with:

-                 newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment

-                 malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

 

Changed to:

 

Temodal is indicated for the treatment of patients with:

-                 newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment

-                 malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.

 

Section 4.2

 

“Concomitant phase” section, all references to “Temodal” changed to “temozolomide”

 

Table 1:  heading “(TMZ)” added at end of heading

              “TMZ = temozolomide; CTC = Common Toxicity Criteria.” Removed from end of table

 

Table 3:  “TMZ = temozolomide; CTC = Common Toxicity Criteria.” Removed from end of table

 

Penultimate paragraph of section 4.2 changed from:

 

Temodal capsules must be swallowed whole with a glass of water and must not be opened or chewed. The prescribed dose should be administered using the minimum number of capsules possible.

 

Changed to:

 

The capsules must be swallowed whole with a glass of water and must not be opened or chewed.

 

Section 4.4

 

Paragraph 1, second sentence, “pneumocystis carinii pneumonia” changed to “PCP”

 

Section headed: Patients with recurrent or progressive malignant glioma:, the following sentence has been removed:

 

This medicinal product contains lactose; thus, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

 

Section headed: Paediatric use: second sentence changed from:

 

Experience in older children is very limited (see section 4.2)

 

Changed to:

Experience in older children and adolescents is very limited (see section 4.2)

 

The following paragraph has been added at the end of Section 4.4:

 

Excipients

This medicinal product contains lactose; thus, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicines.

 

Section 4.5

 

The last word of paragraph 5 of this section has been changed from “medications” to “medicinal products”

 

Section 4.8

 

The following has been added at the start of Section 4.8:

 

In patients treated with temozolomide, whether in combination with radiotherapy for newly diagnosed glioblastoma multiforme, or monotherapy following radiotherapy for newly diagnosed glioblastoma multiforme, or alone in patients with recurrent or progressive glioma, the very common adverse reactions are similar as follows: nausea, vomiting, constipation, anorexia, headache and fatigue. Convulsions were reported very commonly in the newly diagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly diagnosed glioblastoma multiforme patients receiving temozolomide concurrent with radiotherapy and also as monotherapy, and commonly in recurrent glioma. Most of the haematologic parameters, as expected, were reported commonly or very commonly in both tables (4 and 5), with frequency of grade 3-4 laboratory findings to follow each table, below.

 

Under Table 4 the following sentence has been added: “Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.”

 

Within Table 4 side effects have been updated.

 

In the first paragraph after Table 4, “Temodal” has been changed to “temozolomide”.

 

Under Table 5 the following sentence has been added: “Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.”

 

Within Table 5 side effects have been updated.

 

Section 6.1

 

Changed from:

 

Capsule shells contain:

5mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate

yellow iron oxide (E 172),

indigotin (E 132),

 

20mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate,

yellow iron oxide (E 172)

 

100mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate,

red iron oxide (E172).

 

250mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate

 

and are imprinted with blackl ink which contains:

shellac,

propylene glycol,

water,

ammonium hydroxide,

potassium hydroxide

black iron oxide (E 172).

 

Changed to:

 

Capsule shells contain:

 

5 mg:

gelatine,

titanium dioxide (E 171),

sodium lauryl sulphate

yellow iron oxide (E 172),

indigo carmine (E 132),

 

20 mg:

gelatine,

titanium dioxide (E 171),

sodium lauryl sulphate,

yellow iron oxide (E 172)

 

100 mg:

gelatine,

titanium dioxide (E 171),

sodium lauryl sulphate,

red iron oxide (E172)

 

140 mg:

gelatine,

titanium dioxide (E 171),

sodium lauryl sulphate,

indigo carmine (E 132)


180 mg:

gelatine,

titanium dioxide (E 171),

sodium lauryl sulphate,

yellow iron oxide (E 172)

red iron oxide (E 172)

 

250 mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate

 

and are imprinted with black pharmaceutical ink which contains:

 

shellac,

propylene glycol,

purified water,

ammonium hydroxide,

potassium hydroxide

black iron oxide (E 172).

 

Section 6.5

 

The word “caps” has been changed to “closures”

 

Section 6.6

 

The following paragraph has been added to this section:

 

Any unused product or waste material should be disposed of in accordance with local requirements.”

 

Section 8

 

The following has been added:

 

Temodal 140 mg Capsules       :        EU/1/98/096/009-10

Temodal 180 mg Capsules       :        EU/1/98/096/011-12

 

Section 10

 

Date of revision of text updated.

 

Updated on 23/03/2007 and displayed until 07/06/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 2

 

Changed from:

 

Each Temodal capsule contains 5 mg, 20 mg, 100 mg or 250 mg temozolomide.

For excipients, see 6.1.

 

To:

 

Each Temodal capsule contains 5 mg, 20 mg, 100 mg or 250 mg temozolomide.

 

Excipient:     5mg contains 132.8 mg of anhydrous lactose.

Excipient:   20mg contains 182.2 mg of anhydrous lactose.

Excipient: 100mg contains 175.7 mg of anhydrous lactose.

Excipient: 250mg contains 154.3 mg of anhydrous lactose.

 

For a full list of excipients, see section 6.1.

 

 

Section 3

 

Changed from:

 

Hard capsule

The hard capsules are white, opaque and imprinted with a specific colour imprinting ink that is unique for each strength.

 

To:

 

Hard capsule

The 5mg hard capsules have an opaque white body, an opaque green cap, and are imprinted with black ink.

The 20mg hard capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink.

The 100mg hard capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink.

The 250mg hard capsules have an opaque white body and cap and are imprinted with black ink.

 

SECTION 4.2

 

Section headed Paediatric patients the following sentence has been added at the end of this section:

 

“There is no clinical experience with use of Temodal in children under the age of 3 years. Experience in older children is very limited (see section 4.4).”

 

SECTION 4.3

 

First sentence changed from:

 

“Temodal is contraindicated in patients who have a history of hypersensitivity to its components or to dacarbazine (DTIC).”

 

To:

 

“Hypersensitivity to the active substance, to any of the excipients or to dacarbazine (DTIC).”

 

SECTION 4.5

 

The following statement has been added at the beginning of the first paragraph:

 

“Interaction studies have only been performed in adults”

 

SECTION 4.7

 

The following statement has been added at the beginning of the paragraph:

 

“No studies on the effects on the ability to drive and use machines have been performed.”

 

SECTION 4.8

 

The following paragraph has been added before the final paragraph:

 

“In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169  male subjects for whom nadir neutrophil counts were available and 110 female and 174  male subjects for whom nadir platelet counts were available.  There were higher rates of Grade 4 neutropenia (ANC < 500 cells/µl), 12 % versus 5 %, and thrombocytopenia (< 20,000 cells/µl), 9 % versus 3 %, in women vs. men in the first cycle of therapy. In a 400  subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy. In a study of 288  subjects with newly diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3 % of female vs 0 % of male subjects and Grade 4 thrombocytopenia in 1 % of female vs 0 % of male subjects in the first cycle of therapy.”

 

The final paragraph has the following sentence added to the end:

 

“Cases of toxic epidermal necrolysis and Stevens-Johnson syndrome have been reported very rarely.”

 

SECTION 6.1

 

Changed from:

 

The capsule contains anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate, tartaric acid, stearic acid.  Capsule shells contain gelatine, titanium dioxide, sodium lauryl sulphate and are imprinted with pharmaceutical ink which contains:

5mg - green print – pharmaceutical grade shellac, propylene glycol, ammonium hydroxide, titanium dioxide (E 171), yellow iron oxide (E 172) and indigotin (E 132).

20mg - brown print – pharmaceutical grade shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, titanium dioxide (E 171), black iron oxide (E 172), yellow iron oxide (E 172), brown iron oxide (E 172) and red iron oxide (E 172).

100mg - blue print – pharmaceutical grade shellac, propylene glycol, titanium dioxide (E 171) and indigotin (E 132).

250mg - black print – pharmaceutical grade shellac, propylene glycol, ammonium hydroxide, potassium hydroxide and black iron oxide (E 172).

 

To:

 

The capsule contains:

anhydrous lactose,

colloidal anhydrous silica,

sodium starch glycolate,

tartaric acid,

stearic acid. 

 

Capsule shells contain:

5mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate

yellow iron oxide (E 172),

indigotin (E 132),

 

20mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate,

yellow iron oxide (E 172)

 

100mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate,

red iron oxide (E172).

 

250mg:

gelatine,

titanium dioxide,

sodium lauryl sulphate

 

and are imprinted with black ink which contains:

shellac,

propylene glycol,

water,

ammonium hydroxide,

potassium hydroxide

black iron oxide (E 172).

 

SECTION 10  Date of revision of text has been updated

Updated on 15/12/2005 and displayed until 23/03/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Updated on 19/07/2005 and displayed until 15/12/2005
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 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 05/07/2005 and displayed until 19/07/2005
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 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 16/04/2004 and displayed until 05/07/2005
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 18/08/2003 and displayed until 16/04/2004
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 03/06/2003 and displayed until 18/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Temozolomide