TOPAMAX 50mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Topiramate

Available from:

Lexon (UK) Ltd

ATC code:

N03AX; N03AX11

INN (International Name):

Topiramate

Dosage:

50 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Other antiepileptics; topiramate

Authorization status:

Authorised

Authorization date:

2016-12-23

Patient Information leaflet

•
Aggression, abnormal behaviour
•
Difficulty falling or staying asleep
•
Feeling of unsteadiness when walking
•
Not feeling well
•
Decrease in potassium level in the blood
•
Showing and/or feeling no emotion
•
Watery eyes
•
Slow or irregular heartbeat
Other side effects that may occur in children are:
COMMON (MAY AFFECT UP TO 1 IN 10 PEOPLE)
•
Sensation of spinning (vertigo)
•
Vomiting
•
Fever
UNCOMMON (MAY AFFECT UP TO 1 IN 100 PEOPLE)
•
Increase in eosinophils (a type of white blood
cell) in the blood
•
Hyperactivity
•
Feeling warm
•
Learning disability
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via: HPRA Pharmacovigilance,
Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1
6764971; Fax: [phone]. Website:
www.hpra.ie; e-mail: [e-mail]. By
reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE TOPAMAX
•
Keep this medicine out of the sight and reach of
children.
•
Do not use this medicine after the expiry date
which is stated on the bottle/carton. The expiry
date refers to the last day of that month.
•
Do not store above 25°C. Store the tablets in
the original package (bottle) to protect
from moisture. Keep the bottle tightly closed to
protect the tablets from moisture.
•
Do not throw away any medicines via
wastewater or household waste.
Ask your pharmacist how to throw away
medicines you no longer use.
These measures will help protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT TOPAMAX CONTAINS
The active substance is topiramate.
- Each Topamax tablet contains 50, or 200 mg of
topiramate.
The other ingredients of Topamax are listed below.
Core tablet:
lactose monohydrate, microcrystalline cellulose,
sodium starch glycolate, pregelatinized starch,
magnesium stearate.
Film-coating:
OPADRY
®
light yellow, Pink
1
carnauba wax.
1
OP

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
TOPAMAX 50mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 50 mg of topiramate.
Excipients with known effect: also includes lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Greece_
Light yellow, round tablets, 7 mm in diameter, “TOP” on one side
and “50” on the other.
4 CLINICAL PARTICULARS
As per PA0748/012/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0748/012/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
CORE TABLET:
lactose monohydrate
microcrystalline cellulose
sodium starch glycolate
pregelatinized starch
magnesium Stearate
FILM-COATING:
carnauba wax
OPADRY Light Yellow which contains:
titanium dioxide E171
hypromellose
macrogol
polysorbate 80
yellow iron oxide (E172)
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
o
C. Store the tablets in the original package (bottle) to protect from
moisture. Keep the bottle
tightly closed to protect the tablets from moisture.
6.5 NATURE AND