Trileptal 600 mg Film-coated Tablets

  • Company:

    Novartis Ireland Limited
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 06 July 2023

File name

Trileptal FCT REGPIL PF22-0126 Clean April 2023.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 05 July 2023

File name

Trileptal 600mg FCT REGSPC PF22-0126 clean April 2023.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 20 April 2023

File name

Trileptal 600mg FCT REGSPC PF22-0126 clean April 2023.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 01 December 2022

File name

Trileptal FCT REGPIL PF21-0305 clean 11-2022.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 09 April 2021

File name

Trileptal 600mg_REG SPC_PF 20-0173_March 2021_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 April 2021

File name

Trileptal FCT_REG PIL_PF 20-0173_March 2021_Clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects

Updated on 30 June 2020

File name

Trileptal_600mg_REG SPC_PF20-0087_June 2020_IPHA.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 January 2020

File name

Trileptal FCT_REG PIL_PF19-0272_Clean_IPHA.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 16 September 2019

File name

Trileptal FCT_REG PIL_PF19-0093_August 2019_IPHA.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 August 2019

File name

Trileptal FCT_REG PIL_PF19-0093_August 2019_IPHA.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 01 August 2019

File name

Trileptal 600mg_REG SPC_PF18-0191_July 2019_IPHA.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiepileptics, ATC code: N03A F 02

Pharmacodynamic effects

The pharmacological activity of oxcarbazepine is primarily exerted through the metabolite (MHD) (see section 5.2). The mechanism of action of oxcarbazepine and MHD is thought to be mainly based on the blockade of voltage-sensitive sodium channels, thus resulting in stabilisation of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminishment of propagation of synaptic impulses. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may also contribute to the anticonvulsant effects. No significant interactions with brain neurotransmitter or modulator receptor sites were found.

Oxcarbazepine and its active metabolite (MHD), are potent and efficacious anticonvulsants in animals. They protected rodents against generalised tonic-clonic and, to a lesser degree, clonic seizures, and abolished or reduced the frequency of chronically recurring partial seizures in Rhesus monkeys with aluminum implants. No tolerance (i.e. attenuation of anticonvulsive activity) against tonic-clonic seizures was observed when mice and rats were treated daily for 5 days or 4 weeks, respectively, with oxcarbazepine or MHD.

A prospective, open-label, multicentre, non-comparative, 24 week observational post marketing study has been conducted in India. Out of a study population of 816 patients, 256 pediatric patients (1 month to 19 years) with generalised tonic-clonic seizures (either secondary or primary) were treated with oxcarbazepine monotherapy. The initial oxcarbazepine dose for all patients > 6 years was 8-10 mg/kg/day given in 2 divided doses. For the 27 subjects aged 1 month to 6 years, the dose range for the initial dose was 4.62 – 27.27 mg/kg/day and 4.29 – 30.00 mg/kg/day maintenance dose. The primary endpoint was reduction in seizure frequency from baseline at week 24. In the age group 1 month to 6 years (n=27) the number of seizures changed from 1 [range] [1-12] to 0 [0-2], in the age group 7 years to 12 years (n=77) the frequency changed from 1 [1-22] to 0 [0-1] and in the age group 13-19 years (n=152), the frequency changed from 1 [1-32] to 0 [0-3]. No specific safety concerns in the pediatric patients were identified. Data supporting benefit/risk from the study regarding children under the age of 6 are inconclusive (see section 4.2).

Based on the data from the randomized controlled trials, the use of oxcarbazepine is not recommended in children below the age of 6 since safety and efficacy have not been adequately demonstrated (see section 4.2).

Updated on 22 January 2019

File name

Trileptal FCT 1231189_1231190_IE_TA_p2_LFT_X-4 RA approved 10.12.2018 IPHA.pdf

Reasons for updating

  • Change to marketing authorisation holder

Updated on 12 December 2018

File name

Trileptal 600mg FCT SPC PF 17-0139_Dec 2018 Clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 November 2018

File name

Trileptal 600mg FCT REGSPC_Nov 2018 Clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 December 2014

File name

PIL_10289_144.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 December 2014

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 17 October 2014

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 17 October 2014

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In Section 3     PHARMACEUTICAL form

Slightly biconvex has been added as part of the description of tablets

 

In Section  4.2 Posology and method of administration

Information has been added on Therapeutic drug monitoring and Method of Administration

Information on Paediatric and older people has been updated in this section

 

In Section 4.4  Special warnings and precautions for use

Additional information has been added on  

·         Allele frequencies

·         Risk of seizure aggravation

·         Hypothyroidism

·         Renal function

·         Monitoring of plasma levels

 

In Section 4.5  Interaction with other medicinal products and other forms of interaction

Information on interaction with Lamotrigine has been updated.

 

In Section 4.6  Fertility, pregnancy and lactation

This section has been completely updated.

 

In Section 4.7  Effects on ability to drive and use machines

This section has been completely updated.

 

In Section 4.8 Undesirable effects

The following “Unknown” side effects have been added

Hypothyroidism, Inappropriate ADH secretion like syndrome with signs and symptoms of lethargy, nausea, dizziness, decrease in serum (blood) osmolality, vomiting, headache, confusional state or other neurological signs and symptoms, Speech disorders (including dysarthria); more frequent during up titration of Trileptal dose, There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with Trileptal. The mechanism by which Trileptal affects bone metabolism has not been identified, and Fall.

 

Reporting of suspected adverse reactions has been updated to reflect name change to HPRA.

 

In Section 4.9  Overdose

Additional signs and symptoms of overdose has been added.

 

In Section 5.2  Pharmacokinetic properties

Additional information on absorbtion

 

In Section 5.3  Preclinical safety data

Information has been added on Mutagenicity, Reproductive toxicity and Carcinogenicity.

 

Updated on 13 June 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to name of manufacturer

Updated on 09 May 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.4 Special warnings and precautions for use; PhVWP required wording has been added.

In section 4.8 Undesirable effects;
information has been updated.

Updated on 22 September 2005

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 August 2005

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 11 August 2005

Reasons for updating

  • New PIL for medicines.ie
  • PIL retired pending re-submission