Zonegran 25 mg hard capsules
- Name:
Zonegran 25 mg hard capsules
- Company:
Eisai Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/01/21

XPIL
Package leaflet: Information for the user
Package leaflet: Information for the user
1. What Zonegran is and what it is used for
1. What Zonegran is and what it is used for
2. What you need to know before you take Zonegran
2. What you need to know before you take Zonegran
3. How to take Zonegran
3. How to take Zonegran
4. Possible side effects
4. Possible side effects
5. How to store Zonegran
5. How to store Zonegran
6. Contents of the pack and other information
6. Contents of the pack and other information
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Eisai Ltd

Company Products
When a pharmaceutical company changes any document, 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 26 January 2021 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 26 January 2021 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to Section 4.4: Update to “Metabolic acidosis” warning: additional data stating: “Metabolic acidosis has the potential to lead to hyperammonaemia, which has been reported with or without encephalopathy during zonisamide treatment…”
Updated on 2 July 2020 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 2 July 2020 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
- Change from joint to individual SPCs
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to an individual SPC (was previously inlcuded in a joint SPC)
SPC Section affected |
Change |
Section 7 Marketing Authorisation Holder |
Change of MAH address details:
From :
Eisai GmbH Lyoner Straße 36 60528 Frankfurt am Main Germany
Amended to:
Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany
|
Section 10 Date of Revision of the Text |
Amended to 26 May 2020 |
Updated on 22 January 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 22 January 2019 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 18 January 2019 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 22 January 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 22 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 22 January 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
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
The following text has been added under Women of childbearing potential:
Zonegran must not be used in women of childbearing potential not using effective contraception unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus. Specialist advice should be given to women who are of childbearing potential regarding the possible effects of Zonegran on the foetus and these risks should be discussed with the patient in relation to the benefits before starting treatment. Women planning a pregnancy should meet with their specialists to reassess treatment with Zonegran and to consider other therapeutic options.
The following paragraph has been amended:
Physicians treating patients with Zonegran should ensure that patients are fully informed about the need to use appropriate effective contraception, and should use clinical judgement when assessing whether oral contraceptives (OCs), or the doses of the OC components, are adequate based on the individual patient’s clinical situation.
In Section 4.6 Fertility, pregnancy and lactation
The following text has been added under Women of childbearing potential
Zonegran must not be used in women of childbearing potential not using effective contraception unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus. Specialist medical advice should be given to women treated with zonisamide who are of childbearing potential. Women planning a pregnancy should meet with their specialists to reassess treatment with zonisamide and to consider other therapeutic options.
As with all antiepileptic medicines, sudden discontinuation of zonisamide should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child. The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medicinal product. The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect. Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy.
The following changes have been made under Pregnancy
The following paragraph has been deleted
Specialist advice should be given to women who are likely to become pregnant in order to consider the optimal treatment during pregnancy. Women of childbearing potential should be given specialist advice regarding possible effects of Zonegran on the foetus and the risk should be discussed with the patient in relation to the benefits before starting treatment. The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medicinal product. The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect. Multiple antiepileptic medicinal product therapy may be associated with a higher risk of congenital malformations than monotherapy.
No sudden discontinuation of anti-epileptic therapy should be undertaken as this may lead to breakthrough seizures, which could have serious consequences for both mother and child.
New text added
Data from a registry study suggest an increase in the proportion of babies born at a low birth weight (LBW), pre-term or small for gestational age (SGA). These increases are from about 5% to 8% for LBW, from about 8% to 10% for pre-term birth and from about 7% to 12% for SGA, all compared with mothers treated with lamotrigine monotherapy.
The text in the following paragraph has been amended
Zonegran must not be used during pregnancy unless clearly necessary and only if the potential benefit is considered to justify the risk to the foetus. If Zonegran is prescribed during pregnancy, patients should be fully informed of the potential harm to the foetus and use of the minimal effective dose is advised along with careful monitoring.
ISection 10. Date of revision of the text has been updated to 01/2018
Updated on 22 January 2018 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 27 November 2017 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to MA holder contact details
Updated on 26 January 2017 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Documented changes |
|
Sections of the SPC |
Changes/updates |
2. Qualitative and quantitative composition
|
Addition of new information: 25 mg: “Excipient with known effect: Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from soyabean)”
50 mg: “Excipient with known effect: Each hard capsule contains 1.5 mg hydrogenated vegetable oil (from soyabean)”
100 mg: “Excipient with known effect: Each hard capsule contains 3 mg hydrogenated vegetable oil (from soyabean)”
|
4.3 Contraindications |
Addition of new information: “Zonegran contains Hydrogenated vegetable oil (from soyabean). Patients must not take this medicinal product if they are allergic to peanut or soya.” |
4.4 Special warnings and precautions for use
|
Addition of new information:
“Acute myopia and secondary angle closure glaucoma
A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide. Symptoms include acute onset of decreased visual acuity and/or ocular pain. Ophthalmologic findings can include myopia, anterior chamber shallowing, and ocular hyperaemia (redness) and increased intraocular pressure. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma. Symptoms may occur within hours to weeks of initiating therapy. Treatment includes discontinuation of zonisamide, as rapidly as possible in the judgment of the treating physician, and appropriate measures to reduce intraocular pressure. Elevated intraocular pressure of any aetiology, if left untreated, can lead to serious sequelae including permanent vision loss. Caution should be used when treating patients with history of eye disorders with zonisamide.”
|
6.1 List of excipients
|
Addition of ‘from soyabean’ to the following excipient: Hydrogenated vegetable oil (from soyabean)
|
Section 10 Date of Revision of the text
|
01/ 2017
|
Updated on 25 January 2017 PIL
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 8 July 2016 SPC
Reasons for 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 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of text:
It is not always possible to precisely achieve the calculated dose with the commercially available capsule strengths of Zonegran. In these cases it is therefore recommended that the Zonegran total dose should be rounded up or down to the nearest available dose that can be achieved with commercially available capsule strengths of Zonegran (25 mg, 50 mg and 100 mg).In Section 4.4 Special warnings and precautions of use:
Change in text:
From: Women of childbearing potential must use adequate contraception during treatment with Zonegran and for one month after discontinuation (see section 4.6).
To: Women of childbearing potential have to use effective contraception during treatment with Zonegran and for one month after discontinuation (see section 4.6).In Section 4.6 Fertility, pregnancy and lactation:
Change in text:
From: Women of childbearing potential must use adequate contraception during treatment with Zonegran and for one month after discontinuation.
To: Women of childbearing potential have to use effective contraception during treatment with Zonegran and for one month after discontinuation.
Change in text:
From: There are no adequate data from the use of Zonegran in pregnant women.
To: There are limited data from the use of Zonegran in pregnant women.In Section 9 Date of first authorisation/ renewal:
Date of latest renewal: 21/12/2009
In Section 10 Date of revision of the text:
06/2016
List excludes sections with minor formatting or editorial change
Updated on 6 July 2016 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
Updated on 8 October 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
- Changes to therapeutic indications
- Change of special precautions for disposal
- Addition of information on reporting a side effect.
Updated on 8 October 2013 SPC
Reasons for 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 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.1: Addition of paediatric indication as adjunctive therapy.
Section 4.2: Addition of paediatric dosing information.
Section 4.4: Addition of warnings and precautions specifically related to the paediatric
Section 4.5: Addition of clarification of co-medication in the paediatric population.
Section 4.8: Addition of paediatric undesirable effects profile and information regarding reporting of suspected adverse reactions.
Section 5.1: Addition of paediatric pivotal study.
Section 10: Date of revision of text amended to 2nd October 2013.
Updated on 26 February 2013 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 25 February 2013 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 30 January 2013 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 8 August 2012 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 10 July 2012 SPC
Reasons for 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 4.8 - Undesirable effects
- Change to section 5 - Pharmacological properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The monotherapy indication was approved as a Type II line extension variation (addition of a new indication) to Zonegran SmPC Sections updated: 4.1, 4.4, 4.8 and 5.1.
Also section 1 and 3 of the PIL for the capsule were updated as well.
Updated on 29 June 2012 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 15 May 2012 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Zonegran SPC
Change in section 4.8 ‘Undesirable effect’ of pruritis from very rare to common; oedema peripheral added as common undesirable effect.
Additional information on special populations in section 4.8:
A pooled analysis of safety data on 95 elderly subjects has shown a relatively higher reporting frequency of oedema peripheral and pruritus compared to the adult population
Updated on 3 February 2012 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Two additional very rare undesirable effects have been added to section 4.8 -
Drug-induced hypersensitivity syndrome and drug rash with eosinophilia and systemic symptoms.
Updated on 7 July 2011 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 20 August 2010 PIL
Reasons for updating
- Change of contraindications
- Change to MA holder contact details
Updated on 17 August 2010 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 15 April 2010 SPC
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Children and Adolescents (5
Updated on 12 January 2010 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to dosage and administration
- Change to MA holder contact details
Updated on 11 January 2010 SPC
Reasons for updating
- 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 4.4 - 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 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In addition to minor formatting changes, please see below a summary of changes:
Section 2: Qualitative and quantitative composition
The following sentence has been added:
“100mg: Excipients: 0.002 mg of sunset yellow FCF (E110) and 0.147 mg of allura red AC (E129).”
Section 4.2: Posology and method of administration
Children and adolescents
The wording has been amended to read:
“Zonegran is not recommended for use in children below 18 due to insufficient data on safety and efficacy.”
Section 4.3: Contraindications
The word “zonisamide has been changed to “the active substance”
Section 4.4: Special warnings and precautions for use
In the second paragraph, the word “medications” has been changed to “medicines”
In the fifth and eighth paragraphs, the word “drugs” has been changed to “medicinal products”
Section 4.5: Interaction with other medicinal products and other forms of interaction
In the second paragraph, the word “drugs” has been changed to “medicinal products”
Carbonic anhydrase inhibitors
The wording has been amended to read:
“Zonegran should be used with caution in patients treated concomitantly with carbonic anhydrase inhibitors such as topiramate, as there are insufficient data to rule out a possible pharmacodynamic interaction (see section 4.4).”
In the fifth paragraph, the first mention of the word “drugs” has been changed to “substances” and the second mention to “medicinal products”
Section 4.6: Pregnancy and lactation
In the third paragraph, the word “drug” has been changed to “medicinal product”
Section 4.7: Effects on ability to drive and use machines
The wording has been amended to read:
“No studies on the effects on the ability to drive and use machines have been performed. However, given that some patients may experience drowsiness or difficulty with concentration, particularly early in treatment or after a dose increase, patients must be advised to exercise caution during activities requiring a high degree of alertness, e.g., driving or operating machines.”
The date of renewal of the authorisation and revision of text has been updated to 21 December 2009
Updated on 21 July 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 20 July 2009 SPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Change to section 4.8 - Undesirable effects
- Change to section 4.4 - Special warnings and precautions for use
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
Addition of the following information:
Hyperchloraemic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with Zonegran treatment. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of zonisamide on carbonic anhydrase. Such electrolyte imbalance has been observed with the use of Zonegran in placebo-controlled clinical trials and in the post-marketing period. Generally, zonisamide-induced metabolic acidosis occurs early in treatment although cases can occur at any time during treatment. The amounts by which bicarbonate is decreased are usually small – moderate (average decrease of approximately 3.5 mEq/ L at daily doses of 300 mg in adults); rarely patients can experience more severe decreases. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of zonisamide.
The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in younger patients. Appropriate evaluation and monitoring of serum bicarbonate levels should be carried out in patients taking zonisamide who have underlying conditions which might increase the risk of acidosis, in patients who are at an increased risk of adverse consequences of metabolic acidosis and in patients with symptoms suggestive of metabolic acidosis. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Zonegran (by gradual discontinuation or reduction of a therapeutic dose). If the decision is made to continue patients on Zonegran in the face of persistent acidosis, alkali treatment should be considered.
Section 4.8 Undesirable effects
Addition of 'Renal tubular acidosis' as a 'very rare' metabolism and nutrition disorders.
Section 6.5 - Nature of packaging
The composition of the immediate packaging materials of the finished product is being changed from a PVC/PCTFE/Aluminium to PVC/PVDC/Aluminium foil blister. This section of the SmPC now states:
25 mg: PVC/PVDC/Aluminium foil blisters, packs of 14, 28, 56 and 84 hard capsules.
50 mg: PVC/PVDC/Aluminium foil blisters, packs of 14, 28, 56 and 84 hard capsules.
100 mg: PVC/PVDC/aluminium foil blisters, packs of 28, 56, 84, 98 and 196 hard capsules.
Section 10 Date of revision of text
Updated to: July 2009
Updated on 14 April 2009 SPC
Reasons for updating
- Change to marketing authorisation holder address
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 7: Marketing authorisation
The MA address has been updated to:
Eisai Limited, European Knowledge Centre,
Section 10: Date of revision of text
The date of revision of text has been updated to March 2009
Updated on 9 April 2009 PIL
Reasons for updating
- Addition of marketing authorisation holder
- Change to date of revision
Updated on 19 February 2009 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of the following statement regarding suicide ideation and behaviour:
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Zonegran.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Section 4.7 - Undesirable effects
Addition of Toxic epidermal necrolysis as a very rare side effect to the skin and subcutaneous tissue disorders section of the undesirable effects.
Section 10 Date of revision of text
Date of revision updated to 02/2009
Updated on 19 February 2009 PIL
Reasons for updating
- Change to further information section
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 9 July 2008 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 8 July 2008 SPC
Reasons for 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Zonegran SmPC changes ¨C March 2008
4.4 Special warnings and precautions for use
There has been additional text added to the warning regarding immune based adverse reactions associated with medicinal products containing a sulphonamide:
Zonegran is a benzisoxazole derivative, which contains a sulphonamide group. Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal.
4.8 Undesirable effects
Addition of information regarding Zonegran being a benzisoxazole derivative:
It should be noted that Zonegran is a benzisoxazole derivative, which contains a sulphonamide group. Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal (see Section 4.4).
Change from > to ¡Ý in the definition of frequencies of adverse event for very common, common, uncommon and rare
very common |
¡Ý1/10 |
common |
¡Ý 1/100 < 1/10 |
uncommon |
¡Ý 1/1,000 < 1/100 |
rare |
¡Ý 1/10,000 < 1/1,000 |
very rare |
< 1/10,000 including isolated reports |
|
|
There have been the following changes to the adverse event table:
Addition of ecchymosis as a common blood and lymphatic system disorder.
Deletion of insomnia and psychotic disorder as uncommon psychiatric disorders.
Addition of affect lability, anxiety, insomnia, psychotic disorder as common sychiatric Disorders.
Addition of bradyphrenia, nystagmus, paraesthesia and tremor as common nervous system disorders.
Addition of status epilepticus as a very rare nervous system disorder.
Addition of constipation and dyspepsia as common gastrointestinal disorders.
Addition of nephrolithiasis as a common renal and urinary disorder.
Deletion of nephrolithiasis as an uncommon renal and urinary disorder.
Renal failure insufficiency changed to renal failure as a very rare renal and urinary disorders.
Addition of fatigue and influenza-like illness as common general disorders and administration site conditions.
Addition of decreased bicarbonate as a very common investigations adverse reaction.
Addition of blood creatinine increased as a very rare investigations adverse reaction.
Addition of information on special populations:
Additional information on special populations:
Review of post-marketing data suggests that patients aged 65 years or older report a higher frequency than the general population of the following events: Stevens-Johnson syndrome (SJS) and Drug Induced Hypersensitivity syndrome (DIHS).
10. DATE OF REVISION OF THE TEXT
Date of revision of text changed to:
31 March 08
Updated on 1 February 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to information about driving or using machinery
- Change to information about pregnancy or lactation
- Change to dosage and administration
- Change to date of revision
- Change to further information section
Updated on 1 February 2008 SPC
Reasons for 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
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
Minor textual changes
Section 4.5 - Interaction with other medicinal products and other forms interactions
Effect of Zonegran on cytochrome P450 enzymes
2B6, 2C8, added
New information on interaction studies of zonisamide with drugs that are P-gp substrates:
P-gp substrate An in vitro study shows that zonisamide is a weak inhibitor of P-gp (MDR1) with an IC50 of 267 µmol/L and there is the theoretical potential for zonisamide to affect the pharmacokinetics of drugs which are P-gp substrates. Caution is advised when starting or stopping zonisamide treatment or changing the zonisamide dose in patients who are also receiving drugs which are P-gp substrates (e.g. digoxin, quinidine).
Updated on 23 May 2007 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
- Change due to harmonisation of patient information leaflet
Updated on 18 May 2007 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.6 - Pregnancy and lactation
- 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 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 - QUALITATIVE AND QUANTITATIVE COMPOSITION
Changed to: For a full list of excipients, see section 6.1.
Section 4.4 - Special warnings and precautions for use
The following statement: “Serious rashes have occurred in association with Zonegran therapy, including cases of Stevens‑Johnson syndrome” has been moved from the 4th paragraph to the start of this section in bold type in a box. Also the word ‘isolated’ has been removed.
Section 4.6- Pregnancy and lactation
This section now reads: (new information in bold)
Zonegran must not be used during pregnancy unless clearly necessary, in the opinion of the physician, and only if the potential benefit is considered to justify the risk to the foetus…
Specialist advice should be given to women who are likely to become pregnant in order to consider the optimal treatment during pregnancy. Women of childbearing potential should be given specialist advice regarding possible effects of Zonegran on the foetus and the risk should be discussed with the patient in relation to the benefits before starting treatment. The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medication. The most frequently reported are cleft lip, cardiovascular malformations and neural tube defect. Multiple antiepileptic drug therapy may be associated with a higher risk of congenital malformations than monotherapy.
Women of childbearing potential must use adequate contraception during treatment with Zonegran, and for one month after discontinuation.
Section 4.8- Undesirable effects
“Suicidal ideation” has moved from “very rare” to “uncommon”
The following have been added to the “uncommon” section:
“Anger”, “Aggression” & “Suicidal attempt”
“Abnormal pain” is now “abdominal pain”
Section 6 - PHARMACEUTICAL PARTICULARS
Section 6.5 - Nature and contents of container:
An 84 pack size has been added to each strength
The title has changed to the following:
Section 6.6 - Special precautions for disposal
Section 10: Date of revision of the text
This has changed to the 29th March 2007
Updated on 27 July 2006 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 June 2005 PIL
Reasons for updating
- New PIL for new product
Updated on 29 June 2005 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)