Topamax 25mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Topiramate

זמין מ:

Janssen-Cilag Ltd

קוד ATC:

N03AX11

INN (שם בינלאומי):

Topiramate

כמות:

25mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 04080100; GTIN: 5012946026063

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPAMAX 25 MG FILM-COATED TABLETS
TOPAMAX 50 MG FILM-COATED TABLETS
TOPAMAX 100 MG FILM-COATED TABLETS
TOPAMAX 200 MG FILM-COATED TABLETS
topiramate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Topamax is and what it is used for
2.
What you need to know before you take Topamax
3.
How to take Topamax
4.
Possible side effects
5.
How to store Topamax
6.
Contents of the pack and other information
1.
WHAT TOPAMAX IS AND WHAT IT IS USED FOR
Topamax belongs to a group of medicines called “anti-epileptic
medicines”. It is used:

alone to treat seizures in adults and children over age 6

with other medicines to treat seizures in adults and children aged 2
years and above

to prevent migraine headaches in adults
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TOPAMAX
DO NOT TAKE TOPAMAX

if you are allergic to topiramate or any of the other ingredients of
this medicine (listed in section 6).
-
for migraine prevention: if you are pregnant or if you are a woman of
childbearing potential unless
you are using effective contraception (see section ‘pregnancy and
breast-feeding’ for further
information). You should talk to your doctor about the best kind of
contraception to use while you are
taking Topamax.
If you are not sure if the above applies to you, talk to your doctor
or pharmacist before using Topamax.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Topamax if you:

have kidney problems, especially kidney ston

מאפייני מוצר

OBJECT 1
TOPAMAX 25 MG TABLETS
Summary of Product Characteristics Updated 28-Sep-2022 | Janssen-Cilag
Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Topamax 25 mg film-coated tablets
2. Qualitative and quantitative composition
One tablet contains 25 mg of topiramate.
Excipients with known effect: also includes lactose monohydrate:
One 25 mg tablet contains 30.85 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White round tablets, 6 mm in diameter, “TOP” on one side, “25”
on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Monotherapy in adults, adolescents and children over 6 years of age
with partial seizures with or without
secondary generalised seizures, and primary generalised tonic-clonic
seizures.
Adjunctive therapy in children aged 2 years and above, adolescents and
adults with partial onset seizures
with or without secondary generalisation or primary generalised
to