TOPITRIM 50 MG

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

TOPIRAMATE

Beschikbaar vanaf:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD

ATC-code:

N03AX11

farmaceutische vorm:

TABLETS

Samenstelling:

TOPIRAMATE 50 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Therapeutische categorie:

TOPIRAMATE

Therapeutisch gebied:

TOPIRAMATE

therapeutische indicaties:

In adjunctive therapy of adults and children (from 2 years) with partial seizures and generalized tonic-clonic seizures. In adjunctive therapy of seizures with Lennox-Gastaut syndrome in adults and children. Topitim is indicated as monotherapy in patients with newly diagnosed epilepsy in children aged 7 years and above or for conversion to monotherapy in patients with epilepsy. Topitrim is indicated in adults for the prevention of migraines. The use of Topitrim in the acute treatment of migraine has not been studied.

Autorisatie datum:

2022-04-30

Bijsluiter

PIL-0621-08
0421I
P00001236
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
TOPITRIM 25 MG, 50 MG, 100 MG, 200 MG TABLETS
Each tablet contains: topiramate 25 mg, 50 mg, 100 mg, 200 mg
For inactive ingredients and allergens: See section 2 “Important
information
about some of this medicine’s ingredients” and section 6
“Additional information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It
may harm them, even if it seems to you that their medical condition is
similar.
This medicine is not intended for infants and for children under 2
years of age
and as a monotherapy in children under 7 years of age.
1.
WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for:
Treatment of seizures as combination therapy with other medicines in
adults
and children aged two years and above, or as monotherapy in adult
patients
and children aged 7 years and above.
Prevention of migraines in adults. The medicine is not intended for
pain relief
during a migraine attack.
THERAPEUTIC GROUP: Antiepileptics
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to the active ingredient or any of the
additional
ingredients contained in the medicine, listed in section 6.
To prevent migraine if you are pregnant or think you are pregnant or
if
you are of child-bearing age and you do not use effective
contraception.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
DO
NOT
USE
THE
MEDICINE
WITHOUT
CONSULTING
THE
DOCTOR
BEFORE
COMMENCING TREATMENT IF YOU HAVE:
Kidney problems, especially kidney stones or if you are a patient
undergoing
dialysis.
A history of problems related to blood and body fluids (metabolic
acidosis).
Liver problems.
Eye problems (especially if yo