Topamax 50mg sprinkle capsules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Topiramate

Tillgänglig från:

DE Pharmaceuticals

ATC-kod:

N03AX11

INN (International namn):

Topiramate

Dos:

50mg

Läkemedelsform:

Oral capsule

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 04080100

Bipacksedel

PATIENT INFORMATION LEAFLET
TOPAMAX
® SPRINKLE 50MG CAPSULES
(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.
•
The name of your medicine is Topamax
®
Sprinkle 50mg Capsules but
will be referred to as Topamax throughout the remainder of this
leaflet.
•
Topamax Sprinkle Capsules are also available in other strengths.
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 do

Produktens egenskaper

OBJECT 1
TOPAMAX 50MG SPRINKLE CAPSULES
Summary of Product Characteristics Updated 20-Nov-2019 | 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 Sprinkle 50 mg hard capsules
2. Qualitative and quantitative composition
One capsule contains 50 mg of topiramate.
Excipients with known effect: also includes sugar spheres containing
not less than 62.5% and not more than
91.5% of sucrose:
One 50 mg capsule contains between 93.7 and 137.2 mg sucrose
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
Small white to off-white spheres in Size 0 hard gelatin capsules with
white opaque body marked '50 mg' and
clear cap marked 'TOP'.
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, ado