Topamax 100 mg Film-coated Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-05-2020
Summary of Product characteristics
(SPC)
21-04-2020
Active ingredient:
Topiramate
Available from:
Lexon (UK) Ltd
ATC code:
N03AX; N03AX11
INN (International Name):
Topiramate
Dosage:
100 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:
2017-07-14
Patient Information leaflet
CHILDREN
The side effects in children are generally similar to
those seen in adults, but the following side effects
may be more common in children than adults:
•
Problems with concentration
•
Increased acid level in the blood
•
Having thoughts of serious self-harm
•
Tiredness
•
Decreased or increased appetite
•
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: +353 1 6762517. Website:
www.hpra.ie; e-mail: medsafety@hpra.ie. 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 blister/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 (blister) to protect
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.
The other ingredients of Topamax are listed below.
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
20 April 2020
CRN009PN0
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Topamax 100 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 100 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 Portugal_
Yellow, round tablets, 9 mm in diameter, TOP on one side and 100 on
the other.
4 CLINICAL PARTICULARS
As per _PA22612/013/003_
_ _
Lactose intolerance
Topamax tablets contain lactose. Patients with rare hereditary
problems of galactose intolerance,
Lapp lactase deficiency or glucose-galactose malabsorption should not
take this medication.
5 PHARMACOLOGICAL PROPERTIES
As per _PA22612/013/003_
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
CORE TABLET:
Lactose monohydrate
Pregelatinized maize starch
Microcrystalline cellulose
(Sodium) carboxymethyl starch (Type A)
Magnesium Stearate
FILM-COATING:
Opadry white
Opadry yellow
Opadry Pink
Carnauba wax
¹OPADRY contains hypromellose, macrogol, polysorbate 80 and contains
titanium dioxide E171, Iron oxide yellow E172
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
20 April 2020
CRN009PN0
Page 2 of 2
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister 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°C. Store the tablets in the original package
(blister) to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack of aluminium/aluminium foil in strips. Pack sizes of 60
tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Ltd
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1097/002/005
9 DATE O
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