Topamax 100 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Topiramate

Disponible depuis:

Lexon Pharmaceuticals (Ireland) Limited

Code ATC:

N03AX11

DCI (Dénomination commune internationale):

Topiramate

Dosage:

100 milligram(s)

forme pharmaceutique:

Film-coated tablet

Domaine thérapeutique:

topiramate

Date de l'autorisation:

2017-07-14

Notice patient

NOT KNOWN (FREQUENCY CANNOT BE ESTIMATED
FROM THE AVAILABLE DATA)
•
Maculopathy is a disease of the macula, the
small spot in the retina where vision is keenest.
You should call your doctor if you notice a
change or decrease in your vision.
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,
website: www.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 carton and bottle after
EXP. The expiry date refers to the last day of
that month.
•
Do not store above 25°C.
Store in the original package and 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 prot

Résumé des caractéristiques du produit

Health Products Regulatory Authority
21 November 2023
CRN00DYXY
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.
Excipient 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 and Greece _
Yellow, round tablets, 9 mm in diameter, TOP on one side and 100 on
the other.
4 CLINICAL PARTICULARS
As per PA22612/013/003.
5 PHARMACOLOGICAL PROPERTIES
As per PA22612/013/003.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Portugal _
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
_Product imported from Greece _
Core tablet:
Lactose Monohydrate
Pregelatinized Maize Starch
Microcrystalline Cellulose
Sodium Starch Glycolate (Type A)
Magnesium Stearate
Film-coating:
Health Products Regulatory Authority
21 November 2023
CRN00DYXY
Page 2 of 2
OPADRY Yellow
1
Carnauba Wax
1
OPADRY Yellow contains:
Hypromellose
Macrogol
Polysorbate 80
As a colourant, titanium dioxide E171 and iron oxide yellow E172
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the packaging of the product on the market in the country
of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Bottle: Store in the original package and keep the bottle tightly
closed to protect the tablets from moisture.
Blister: 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.
or
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