Updated on 14/02/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 31-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| 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 4.8
Updated ADR table
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
31 October 2011
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Updated on 12/05/2011 and displayed until 14/02/2012
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 05-May-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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The following paragrpah has been added to section 4.6:
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.
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Updated on 01/02/2011 and displayed until 12/05/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 24-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to section 2 - Qualitative and quantitative composition
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Tablets: Lactose amounts added
Capsules: Sucrose amounts added
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Change to section 3 - Pharmaceutical form
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Tablets: Product description revised to add dimensions
Capsules: Product description revised
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Change to section 6.1 - List of Excipients
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Tablets: Minor changes to highlight core tablet and film-coating excipients
Capsules: Minor changes to highlight capsule and printing ink excipients
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Change to section 6. 4 - Special Precautions for Storage
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Tablets: Addition of: “Store in the original package.” and “... in order to protect from moisture.”
Capsules: Addition of: “… in order to protect from moisture.”
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Change to section 6. 5 - Nature and Contents of Container
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Addition of non marketed presentations
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Change to section 10 - Date of revision of the text
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24 November 2010
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Updated on 08/07/2010 and displayed until 01/02/2011
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 05-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to section 6.1 - Excipients change
Change to section 10 - 05 July 2010
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Updated on 25/03/2010 and displayed until 08/07/2010
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5 - Pharmacological Properties
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Change to section 5.3 - Preclinical Safety Data
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to section 1 –Name of the medicinal product*
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Inclusion of pharmaceutical form
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Change to section 4 – Clinical Particulars
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 4.1 – Therapeutic Indications
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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.
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Change to section 4.2 – Posology and |Method of Administration
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 4.3 – Contra-indications
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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.
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Change to section 4.4 – Special Warnings and Precautions for Use
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 4.6 – Pregnancy and Lactation
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 4.8 – Undesirable effects
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Revised to include the latest data on ADRs in one consolidated table
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Change to section 4.9 - Overdose
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 5 – Pharmacological Properties
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 5.1 - Pharmacodynamic properties
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 5.2 - Pharmacokinetic properties
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 5.3 - Preclinical Safety Data
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Revised as per the EC Commission Decision on Article 30 Referral for Topamax
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Change to section 10 – Date of revision of the text
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12 March 2010
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Updated on 19/12/2008 and displayed until 25/03/2010
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 10-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.4 – Special Warnings and Precautions for Use
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Update to implement warnings on suicidal thoughts and behaviour associated with antiepileptic medicines
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Change to section 10 – Date of revision of the text
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10 Dec 2008
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Updated on 01/09/2008 and displayed until 19/12/2008
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 14-Aug-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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6.1
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List of excipients
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Change the excipient name of polyethylene glycol to Macrogol 400.
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10.
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DATE OF REVISION OF THE TEXT
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14 August 2008
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Updated on 10/07/2008 and displayed until 01/09/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 18-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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7.
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MARKETING AUTHORISATION HOLDER
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Change of address
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10.
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DATE OF REVISION OF THE TEXT
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June 2008
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Updated on 14/02/2008 and displayed until 10/07/2008
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 5.2 - Pharmacokinetic Properties
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
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Addition of – Lithium, glyburide, valproic acid, dilitiazem, venlafaxine
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Change to section 5.2 - Pharmacokinetic properties
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risperidone.
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Updated on 15/11/2006 and displayed until 14/02/2008
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Reasons for adding or updating:
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 11/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.7 - Updated - visual disturbances/blurred vision
Section 4.8 - Major update - post marketing data
Section 10 - Updated to 12.11.2006
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Updated on 13/07/2006 and displayed until 15/11/2006
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 6.1 - List of Excipients
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.4 -
Special Warnings and Precautions for Use - Providing more information on withdrawing treatment of Topamax to reduce the potential for drug withdrawal convulsions and
Change to section 6.1 -
List of Excipients - Hypromellose (excipient name change)
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Updated on 20/04/2006 and displayed until 13/07/2006
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 10 (date of (partial) revision of the text
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Updated on 14/11/2005 and displayed until 20/04/2006
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Reasons for adding or updating:
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Addition of Black Triangle
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Updated on 03/08/2005 and displayed until 14/11/2005
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic Indications
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Updated on 03/09/2004 and displayed until 03/08/2005
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/08/2004 and displayed until 03/09/2004
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 10 (date of (partial) revision of the text
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Updated on 30/07/2004 and displayed until 24/08/2004
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/02/2004 and displayed until 30/07/2004
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Reasons for adding or updating:
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/01/2004 and displayed until 24/02/2004
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 10/12/2003 and displayed until 22/01/2004
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 24/09/2003 and displayed until 10/12/2003
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 10 (date of (partial) revision of the text
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Updated on 14/05/2003 and displayed until 24/09/2003
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Reasons for adding or updating:
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Change to section 1 - trade name
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Change to section 2 - qualitative and quantitative composition
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Change to section 3 - pharmaceutical form
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 10 (date of (partial) revision of the text
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Updated on 19/06/2002 and displayed until 14/05/2003
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 18/06/2002 and displayed until 19/06/2002
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Updated on 10/10/2001 and displayed until 18/06/2002
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 28/08/2001 and displayed until 10/10/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 23/08/2001 and displayed until 28/08/2001
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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