Topiramate Actavis 100

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Topiramate 100mg;  

Tilgængelig fra:

Teva Pharma (New Zealand) Limited

INN (International Name):

Topiramate 100 mg

Dosering:

100 mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Topiramate 100mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Opadry Yellow 85G32313 Magnesium stearate Mannitol Microcrystalline cellulose Pregelatinised maize starch

Recept type:

Prescription

Fremstillet af:

Hetero Drugs Limited

Terapeutiske indikationer:

Topiramate Actavis is indicated in adults and children. Topiramate Actavis tablet range is not suitable for any children weighing less than 25 Kg and is not suitable as monotherapy for children or adolescents weighing less than 50 kg. - as monotherapy in patients with newly diagnosed epilepsy - for conversion to monotherapy in patients with epilepsy - as add-on therapy in partial onset seizures, generalised tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, Alu/Alu bottom strip with Alu/PVC/PVDC blisters in printed carton - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu bottom strip with Alu/PVC/PVDC blisters in printed carton - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu bottom strip with Alu/PVC/PVDC blisters in printed carton - 200 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with HDPE twist off cap with integrated dessicant - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with HDPE twist off cap with integrated dessicant - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with HDPE twist off cap with integrated dessicant - 200 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

2013-06-05

Indlægsseddel

NEW ZEALAND CONSUMER MEDICINE INFORMATION
TOPIRAMATE ACTAVIS
TOPIRAMATE
TOPIRAMATE TABLETS 25 MG, 50 MG, 100 MG AND 200 MG
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about TOPIRAMATE - ACTAVIS
Tablets.
It does not contain all of the available information. It does not take
the place of talking to your
doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the
risks of you taking
TOPIRAMATE - ACTAVIS against the benefits they expect it will have for
you.
If you have any concerns about taking this medicine, talk to your
doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
WHAT TOPIRAMATE - ACTAVIS IS USED FOR
TOPIRAMATE, the active ingredient in TOPIRAMATE - ACTAVIS Tablets, is
used for the
treatment of various types of epilepsy in adults and children over 2
years of age**, and for the
prevention of migraine in adults. It prevents seizures and migraines
by acting on the nerves
and chemicals in the brain.
Your doctor may prescribe TOPIRAMATE - ACTAVIS on its own, or in
addition to another
medicine for controlling your seizures or migraines.
Your doctor may have prescribed TOPIRAMATE - ACTAVIS for another
reason. Ask your
doctor if you have any questions about why TOPIRAMATE - ACTAVIS has
been prescribed
for you.
There is no evidence that TOPIRAMATE - ACTAVIS is addictive.
TOPIRAMATE - ACTAVIS is available only with a doctor’s prescription.
_** Topiramate Actavis tablet range cannot deliver lower doses
required for younger paediatric _
_patients (See the data sheet for further information on this). _
BEFORE YOU TAKE TOPIRAMATE - ACTAVIS
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TOPIRAMATE - ACTAVIS IF YOU ARE ALLERGIC TO MEDICINES
CONTAINING
TOPIRAMATE, OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some of the symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

lumpy skin rash (“hives”),

Produktets egenskaber

Version 1.2
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Topiramate Actavis 25, film-coated tablets 25 mg
Topiramate Actavis 50, film-coated tablets, 50 mg
Topiramate Actavis 100, film-coated tablets, 100 mg
Topiramate Actavis 200, film-coated tablets, 200 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg, 50 mg, 100 mg or 200 mg
topiramate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
25 mg – White, round, biconvex, film coated tablet marked with
‘V1’.
50 mg – Light yellow, round biconvex, film coated tablet marked with
‘V3’.
100 mg – Yellow, round biconvex film, coated tablet marked with
‘V4’.
200 mg – Salmon, oval biconvex, film coated tablet marked with
‘V5’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EPILEPSY
Topiramate Actavis is indicated in adults and children 2 years and
over**:
•
as monotherapy in patients with newly diagnosed epilepsy
•
for conversion to monotherapy in patients with epilepsy
•
as add-on therapy in partial onset seizures, generalised tonic-clonic
seizures or seizures associated
with Lennox-Gastaut syndrome.
** Topiramate Actavis tablet range cannot deliver lower doses required
for younger paediatric
patients (See section 4.2
DOSE AND METHOD OF ADMINISTRATION
).
MIGRAINE
Topiramate Actavis is indicated in adults for the prophylaxis of
migraine headache. The usefulness of
Topiramate Actavis in the acute treatment of migraine headache has not
been studied.
4.2
DOSE AND METHOD OF ADMINISTRATION
Topiramate Actavis Tablets should be swallowed whole. Topiramate
Actavis Tablets can be taken
with or without food.
For optimum seizure control in both adults and children, it is
recommended that therapy should be
initiated at a low dose followed by slow titration to an effective
dose. Dose titration should be guided
by clinical outcome.
The recommended dosages of Topiramate Actavis in adults and children
with epilepsy are listed as
follows and summarised in Table 1.
EPILEPSY - MONOTHERAPY
In newly diag