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Topamax Sprinkle 15, 25 and 50 mg hard capsules

  • Name:

    Topamax Sprinkle 15, 25 and 50 mg hard capsules

  • Company:
    info
  • Active Ingredients:

    Topiramate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 23/10/19

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Summary of Product Characteristics last updated on medicines.ie: 23/10/2019

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Janssen Sciences Ireland

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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 23 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 23 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 23 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 23 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 21 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.4 - Special precautions for storage

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

Updated on 21 October 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.4 - Special precautions for storage

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

Updated on 21 October 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - what the product looks like and pack contents

Updated on 12 April 2019 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 April 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Updated on 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 20 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 20 December 2017 SmPC

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 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

4.4          Special warnings and precautions for use

Women of childbearing potential

Topiramate may cause fetal harm and fetal growth restriction (small for gestational age and low birth weight) when administered to a pregnant woman. The North American Antiepileptic Drug pregnancy registry data for topiramate monotherapy showed an approximate 3‑fold higher prevalence of major congenital malformations (4.3%), compared with a reference group not taking AEDs (1.4%). In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy.

Before the initiation of treatment with topiramate in a woman of childbearing potential, pregnancy testing should be performed and a highly effective contraceptive method advised (see section 4.5).  The patient should be fully informed of the risks related to the use of topiramate during pregnancy (see sections 4.3 and 4.6).

 

4.6           Fertility, pregnancy and lactation

 

Pregnancy

Risk related to epilepsy and AEDs in general

Specialist advice should be given to women who are of childbearing potential. The need for treatment with AEDs should be reviewed when a woman is planning to become pregnant. In women being treated for epilepsy, sudden discontinuation of AED therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.

Monotherapy should be preferred whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.

Risk related to topiramate

Topiramate was teratogenic in mice, rats and rabbits (see section 5.3). In rats, topiramate crosses the placental barrier.

In humans, topiramate crosses the placenta and similar concentrations have been reported in the umbilical cord and maternal blood.

Clinical data from pregnancy registries indicate that infants exposed to topiramate monotherapy have:

 

·                     An increased risk of congenital malformations (particularly cleft lip/palate, hypospadias, and anomalies involving various body systems) following exposure during the first trimester. The North American Antiepileptic Drug pregnancy registry data for topiramate monotherapy showed an approximate 3-fold higher incidenceprevalence of major congenital malformations (4.3%), compared with a reference group not taking AEDs (1.4%). In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy. The risk has been reported to be dose dependent; effects were observed in all doses.  In women treated with topiramate who have had a child with a congenital malformation, there appears to be an increased risk of malformations in subsequent pregnancies when exposed to topiramate.

·                     A higher prevalence of low birth weight (<2500 grams) compared with a reference group.

·                     An increased prevalence of being small for gestational age (SGA; defined as birth weight below the 10th percentile corrected for their gestational age, stratified by sex). The long term consequences of the SGA findings could not be determined.

It is recommended that women of child bearing potential use highly effective contraception (see section 4.5) and consider alternative therapeutic options.

Indication epilepsy

It is recommended to consider alternative therapeutic options in women of child bearing potential. If topirmate is used in women of child bearing potential, it is recommended that highly effective contraception be used (see section 4.5), and that the woman is fully informed of the known risks of uncontrolled epilepsy to the pregnancy and the potential risks of the medicinal product to the foetus. If a woman plans a pregnancy, a preconceptional visit is recommended in order to reassess the treatment, and to consider other therapeutic options. In case of administration during the first trimester, careful prenatal monitoring should be performed.

Indication migraine prophylaxis

Topiramate is contraindicated in pregnancy and in women of childbearing potential if a highly effective method of contraception is not used (see sections 4.3 and 4.5).

Brest-feeding

Animal studies have shown excretion of topiramate in milk. The excretion of topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive excretion of topiramate into breast milk. Effects that have been observed in breastfed newborns/infants of treated mothers, include diarrhea, drowsiness, irritability and inadequate weight gain. Therefore,Since many medicinal products are excreted into human milk, a decision must be made whether to suspend breast-feeding or to discontinue/ abstain from topiramate therapy taking into account the importance of the medicinal product to the mother (see section 4.4).

Fertility

Animal studies did not reveal impairment of fertility by topiramate (see section 5.3). The effect of topiramate on human fertility has not been established.

4.8           Undesirable effects

 

Congenital malformations and fetal growth restrictions (see section 4.4 and section 4.6).

 

 

Updated on 19 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 December 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 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 27 April 2017 SmPC

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
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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

4.4     Special warnings and precautions for use

Hyperammonemia and encephalopathy

 

Hyperammonemia with or without encephalopathy has been reported with topiramate treatment (see section 4.8). The risk for hyperammonemia with topiramate appears dose-related. Hyperammonemia has been reported more frequently when topiramate is used concomitantly with valproic acid (see section 4.5).

 

In patients who develop unexplained lethargy or changes in mental status associated with topiramate monotherapy or adjunctive therapy, it is recommended to consider hyperammonemic encephalopathy and measuring ammonia levels.

 

4.5     Interaction with other medicinal products and other forms of interaction

 

Valproic acid

 

Concomitant administration of topiramate and valproic acid has been associated with hyperammonemia with or without encephalopathy in patients who have tolerated either medicinal product alone. In most cases, symptoms and signs abated with discontinuation of either medicinal product (see section 4.4 and section 4.8). This adverse reaction is not due to a pharmacokinetic interaction. An association of hyperammonemia with topiramate monotherapy or concomitant treatment with other AEDs has not been established.

 

 

4.8     Undesirable effects

 

Addition of hyperammonemia and hyperammonemic encephalopathy as adverse reactions with rare frequency into Table 1 under 'Metabolism and nutrition disorders', notes at the bottom of Table 1 are also revised to state ‘* identified as an adverse reaction from postmarketing spontaneous reports. Its frequency was calculated based on the incidence in clinical trials, or was calculated if the event did not occur in clinical trials data.

Updated on 24 April 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 17 November 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • 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

2. Qualitative and Quantative Composition

Excipients with known effect:

aAlso includes lactose monohydrate:

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

Migraine prophylaxis in pregnancy and in women of childbearing potential if not using a highly effective methods of contraception.

4.6 Fertility, pregnancy and lactation

Pregnancy

Risk related to epilepsy and AEDs in general

Specialist advice should be given to women who are of childbearing potential. The need for treatment with AEDs should be reviewed when a woman is planning to become pregnant. In women being treated for epilepsy, sudden discontinuation of AED therapy should be avoided as this may lead to breakthrough seizures that could have serious consequences for the woman and the unborn child.
Monotherapy should be preferred whenever possible because therapy with multiple AEDs could be associated with a higher risk of congenital malformations than monotherapy, depending on the associated antiepileptics.

Risk related to topiramate

Topiramate was teratogenic in mice, rats and rabbits (see section 5.3). In rats, topiramate crosses the placental barrier.

Data from the U.K. pregnancy register and the North American Antiepileptic Drug (NAAED) pregnancy registryClinical data from pregnancy registries indicate that infants exposed to topiramate monotherapy in the first trimester have an increased risk of have:

• An increased risk of congenital malformations (e.g., craniofacial defects, such asparticularly cleft lip/palate, hypospadias, and anomalies involving various body systems) following exposure during the first trimester. The NAAED North American Antiepileptic Drug pregnancy registry data for topiramate monotherapy showed an approximate 3-fold higher incidence of major congenital malformations, compared with a reference group not taking AEDs. In addition, data from other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy.
• Furthermore, there was aA higher prevalence of low birth weight (<2500 grams) following topiramate treatment than in thecompared with a reference group.
• An increased prevalence of being small for gestational age (SGA; defined as birth weight below the 10th percentile corrected for their gestational age, stratified by sex). The long term consequences of the SGA findings could not be determined.

In addition, data from these registries and other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of AEDs in combination therapy.

It is recommended that women of child bearing potential use adequate highly effective contraception (see section 4.5) and consider alternative therapeutic options and consider alternative therapeutic options.

Indication epilepsy

During pregnancy, topiramate should be prescribed after fully informing the woman of the known risks of uncontrolled epilepsy to the pregnancy and the potential risks of the medicinal product to the foetus. It is recommended to consider alternative therapeutic options in women of child bearing potential. If topirmate is used in women of child bearing potential, it is recommended that highly effective contraception be used (see section 4.5), and that the woman is fully informed of the known risks of uncontrolled epilepsy to the pregnancy and the potential risks of the medicinal product to the foetus. If a woman plans a pregnancy, a preconceptional visit is recommended in order to reassess the treatment, and to consider other therapeutic options. In case of administration during the first trimester, careful prenatal monitoring should be performed.

Indication migraine prophylaxis

Topiramate is contraindicated in pregnancy, and in women of childbearing potential if an a highly effective method of contraception is not used (see sections 4.3 and 4.5).

Breast-feeding

Animal studies have shown excretion of topiramate in milk. The excretion of topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive excretion of topiramate into breast milk. Since many medicinal products are excreted into human milk, a decision must be made whether to suspend breast-feeding or to discontinue/ abstain from topiramate therapy taking into account the importance of the medicinal product to the mother (see section 4.4).

Fertility

Animal studies did not reveal impairment of fertility by topiramate (see section 5.3). The effect of topiramate on human fertility has not been established.


Updated on 16 November 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 19 August 2015 PIL

Reasons for updating

  • Change to further information section

Updated on 24 November 2014 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 24 November 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 24 November 2014 SmPC

Reasons for updating

  • 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 4.8 – Undesirable effects - how to report a side effect
  • 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 4.2: Addition of 'method of administration' section
Section 4.3: 'listed in section 6.1' added
Section 4.4: visual field defects paragraph added
4.5: Minor editorial changes
4.6: Addition of 'Fertility' paragraph
4.8: Table 1-conjunctival oedema moved from section 'immune system disorders' to 'eye disorders'.
Reporting of suspected adverse reactions section added.
5.2: Sub-headings added
10: 20 November 2014

Updated on 26 July 2013 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 26 July 2013 SmPC

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

Section 4.8:

To add ADR cough under frequency “common”.

Updated on 10 June 2013 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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

Tablets: addition of a new pack size of 200 (2 x 100)

Updated on 11 October 2012 PIL

Reasons for updating

  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to improve clarity and readability

Updated on 10 October 2012 SmPC

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 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Amendments following Article 45 approval.

Updated on 19 June 2012 SmPC

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
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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

Change to section 4.4 - Addition of statement regarding patients with decreased renal function
Change to section 4.5 - Addition of information regarding hypothermia associated with Topamax use with concomitant valproic acid
Change to section 4.7 - Deletion of statement “No studies on the effect on the ability to drive and use machines have been performed”
Change to section 10 - 13 June 2012

Updated on 23 December 2011 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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

Change to section 3 -

Description of the product.

15 mg - small white to off-white spheres in Size 2 hard gelatin capsules with white opaque body marked '15 mg’ and clear cap marked 'TOP'.

25 mg - small white to off-white spheres in Size 1 hard gelatin capsules with white opaque body marked '25 mg’ and clear cap marked 'TOP'.


Change to section 4.2

In patients with impaired renal function (CLCR  ≤ 70 mL/min) topiramate should be administered with caution as the plasma and renal clearance of topiramate are decreased. Subjects with known renal impairment may require a longer time to reach steady-state at each dose. Half of the usual starting and maintenance dose is recommended (see section 5.2).

 

In patients with end-stage renal failure, since topiramate is removed from plasma by haemodialysis, a supplemental dose of Topamax equal to approximately one-half the daily dose should be administered on haemodialysis days. The supplemental dose should be administered in divided doses at the beginning and completion of the haemodialysis procedure. The supplemental dose may differ based on the characteristics of the dialysis equipment being used (see section 5.2).


Change to section 4.6

Topiramate was teratogenic in mice, rats and rabbits. In rats, topiramate crosses the placental barrier.

 

Data from the U.K. pregnancy register and the North American Antiepileptic Drug (NAAED) pregnancy registry indicate that infants exposed to topiramate monotherapy in the first trimester have an increased risk of congenital malformations (e.g., craniofacial defects, such as cleft lip/palate, hypospadias, and anomalies involving various body systems

 

The NAAED pregnancy registry data for topiramate monotherapy showed an approximate 3-fold higher incidence of major congenital malformations, compared with a reference group not taking antiepileptic drugs. Furthermore, there was a higher prevalence of low birth weight (<2500 grams) following topiramate treatment than in the reference group.

 

In addition, data from these registries and other studies indicate that, compared with monotherapy, there is an increased risk of teratogenic effects associated with the use of anti-epileptic drugs in combination therapy.

 

It is recommended that women of child bearing potential use adequate contraception and consider alternative therapeutic options.

 

Animal studies have shown excretion of topiramate in milk. The excretion of topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive excretion of topiramate into breast milk. Since many medicinal products are excreted into human milk, a decision must be made whether to suspend breast-feeding or to discontinue/ abstain from topiramate therapy taking into account the importance of the medicinal product to the mother (see section 4.4).

Change to section 4.7
Topamax has minor or moderate influence on the ability to drive and use machines.

Change to section 5.1

Pharmacotherapeutic group: antiepileptics, other antiepileptics, antimigraine preparations, ATC code: N03AX11.


Change to section 5.2

The plasma and renal clearance of topiramate are decreased in patients with moderate and severe impaired renal function (CLCR ≤ 70 ml/min). As a result, higher steady-state topiramate plasma concentrations are expected for a given dose in renal-impaired patients as compared to those with normal renal function. In addition, patients with renal impairment will require a longer time to reach steady-state at each dose. In patients with moderate and severe renal impairment, half of the usual starting and maintenance dose is recommended.

 

Topiramate is effectively removed from plasma by haemodialysis. A prolonged period of hemodialysis may cause topiramate concentration to fall below levels that are required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.

 

Plasma clearance of topiramate decreased a mean of 26% in patients with moderate to severe hepatic impairment. Therefore, topiramate should be administered with caution in patients with hepatic impairment.

Change to section 6.1

Film-coated tablets:

 

Core tablet:

Lactose Monohydrate

Pregelatinized Maize Starch

Microcrystalline Cellulose

Sodium Starch Glycolate (Type A)

Magnesium Stearate

Film-coating:

OPADRYÒ White, Yellow, Pink1, Carnauba Wax

1OPADRYÒ contains:

Hypromellose, Macrogol, Polysorbate 80 and as colourants Titanium Dioxide E171 (all strengths) and Iron Oxide yellow E172 (50 and 100 mg) iron oxide red E172 (200 mg)

 

Hard capsules:

 

Sugar spheres (maize starch, sucrose)

Povidone

Cellulose acetate

Capsule:

Gelatin

Titanium dioxide (E171)

Printing ink:

Iron oxide black (E172)

Shellac

Propylene glycol


Change to section 6.4

Film-coated tablets:  

Do not store above 25°C. Store the tablets in the original package (blister or bottle) to protect from moisture. Keep the bottle tightly closed to protect the tablets from moisture.

 

Hard capsules:

Do not store above 25°C. Keep the bottle tightly closed to protect from moisture.


Change to section 9

Film-coated tablets: 13 June 1997 / 30 June 2010

Hard capsules: 25 June 1999 / 30 June 2010

Change to section 10
December 2011

Updated on 20 December 2011 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 further information section
  • Change to date of revision

Updated on 3 March 2011 SmPC

Reasons for updating

  • 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

Change to section 4.6 - Pregnancy and lactation

Compared with a reference group not taking antiepileptic drugs, registry data for Topamax monotherapy showed a higher prevalence of low birth weight (<2500 grams). A causal relationship has not been established.

 

Change to section 10 - Date of revision of the text

25 February 2011

Updated on 26 January 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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

Change to section 2 - Qualitative and quantitative composition

Tablets: Minor wording revisions

Capsules: Sucrose amounts revised

Change to section 3 - Pharmaceutical form

Tablets: Product description revised to add dimensions

Capsules: Product description revised

Change to section 6.1 - List of excipients

Tablets: Minor changes to highlight core tablet and film-coating excipients

Capsules: Minor changes to highlight capsule and printing ink excipients

Change to section 6.4 - Special precautions for storage

Capsules: Deletion of store in the original package

 

Change to section 6.5 - Nature and contents of container

Addition of non marketed presentations

 

Change to section 10 - Date of revision of the text

20 January 2011

Updated on 24 January 2011 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Change to improve clarity and readability
  • Change of special precautions for disposal
  • Introduction of new pack/pack size

Updated on 8 July 2010 SmPC

Reasons for updating

  • 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

Change to section 6.1 - Excipients change
Change to section 10 - 05 July 2010

Updated on 6 July 2010 PIL

Reasons for updating

  • Change of inactive ingredient
  • Change of manufacturer
  • Change to date of revision

Updated on 16 June 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 25 May 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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

Change to section 1 - Name of medicinal product

Inclusion of pharmaceutical form

Change to section 3 - Pharmaceutical form

Rephrased

Change to section 4 - Clinical particulars

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.1 - Therapeutic indications

Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.

 

Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome.

 

Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment.

 

Change to section 4.2 - Posology and method of administration

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.3 - Contraindications

Hypersensitivity to the active substance or to any of the excipients.

 

Migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective methods of contraception.

 

Change to section 4.4 - Special warnings and precautions for use

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.6 - Pregnancy and lactation

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.7 - Effects on ability to drive and use machines

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.8 - Undesirable effects

Revised to include the latest data on ADRs in one consolidated table

Change to section 4.9 - Overdose

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 5 - Pharmacological properties

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 5.1 - Pharmacodynamic properties

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 5.2 - Pharmacokinetic properties

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 5.3 - Preclinical safety data

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 6.2 - Incompatibilities

Rephrased

Change to section 6.4 - Special precautions for storage

Addition of “Store in the original package.”

Change to section 10 - Date of revision of the text

05 May 2010

Updated on 14 May 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 30 January 2009 SmPC

Reasons for updating

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

 

4.4

Special Warnings and Precautions for Use

Warnings on suicidal thoughts and behaviour associated with antiepileptic medicines

10.

DATE OF REVISION OF THE TEXT

20 January 2009

Updated on 28 January 2009 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 12 January 2009 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 23 December 2008 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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

 
4.1
Therapeutic Indications
Updated to allow General Practitioners to initiate Topamax for migraine prophylaxis
 
 

10.

DATE OF REVISION OF THE TEXT

 

Changed to 16 December 2008

 

Updated on 23 December 2008 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 12 August 2008 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 – Undesirable effects

Complete reformat of the entire section.  A new ADR table added

Change to section 5.3 - Preclinical Safety Data

Addition of juvenile rat data

Updated on 24 June 2008 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder address

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

Free text change information supplied by the pharmaceutical company

Change to section 10 – Date of revision of text

 

Change to Marketing Authorisation Holder address

 

Updated on 24 June 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder address

Updated on 25 February 2008 PIL

Reasons for updating

  • Change to storage instructions

Updated on 17 May 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about driving or using machinery

Updated on 16 May 2007 SmPC

Reasons for updating

  • 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 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

4.5

Interaction with other medicinal products and other forms of interaction

Deletion of Laboratory tests paragraph (relocated to section 4.8)

4.7

Effects of ability to drive and use machines

Addition of visual disturbances and blurred vision.

4.8

Undesirable effects

Addition of 4.8.3 Laboratory test.  Addition of wording to 4.8.4.  Addition of liver function test information.  Adverse Events added to table.

10.

DATE OF REVISION OF THE TEXT

April 2007

Updated on 22 November 2006 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 3 August 2006 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

4.5
Interaction with other medicinal products and other forms of interaction
 
Glyburide name changed to glibenclamide (EU name)
 

10.

DATE OF REVISION OF THE TEXT

Change to 16th March 2006
 

Updated on 12 July 2006 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 12 July 2006 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 12 April 2006 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to side-effects

Updated on 11 April 2006 SmPC

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
  • 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)

Updated on 7 March 2006 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 30 March 2005 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 25 February 2005 SmPC

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
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

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

Updated on 6 September 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 September 2004 SmPC

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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 6 August 2004 SmPC

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
  • 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)

Updated on 6 August 2004 SmPC

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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

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

Updated on 26 June 2003 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects

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

Updated on 5 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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