Topiramate 50mg capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Topiramate

Prieinama:

Teva UK Ltd

ATC kodas:

N03AX11

INN (Tarptautinis Pavadinimas):

Topiramate

Dozė:

50mg

Vaisto forma:

Oral capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 04080100; GTIN: 5017007059851

Pakuotės lapelis

260x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Topiramate Hard Capsules 15,
25mg x 14, 20, 28, 56, 60’s (UK)
260x210 (Reel Fed)
50975615
Leaflet for Bottle
1456
T. Hull
07/08/19
page 1
page 4
* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
[e-mail]
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
FMD info
NA (not a carton)

No

Yes

Details
TOPIRAMATE 50 MG CAPSULES PIL - UNITED KINGDOM
Black
Profile
BBBA5903
NM
16/08/2019
260 x 210
9 ts
Accord Barnstaple
NA
1
Version 2
01.11.2017
•
Unusual feeling or sensation that may precede a migraine
or a certain type of seizure (aura)
•
Problems with handwriting
•
Feeling of movement under the skin
•
Eye problems including dry eyes, light sensitivity,
involuntary twitching, tearing and decreased vision
•
Decreased or loss of hearing
•
Irregular heartbeat or slowness of the heartbeat, feeling
your heart beating in your chest
•
Low blood pressure or decrease in blood pressure that
occurs when you stand up
•
Hot flushing
•
Hoarseness of the voice
•
Inflammation of the pancreas
•
Gas, heartburn, fullness or bloating
•
Loss of sensitivity to touch in the mouth, painful or burning
sensations in the mouth, bleeding gums, breath odour
•
Increased saliva
•
Skin discolouration, localised swelling in the skin
•
Swelling of the joints, musculoskeletal stiffness, pain in side
•
Crystals in the urine, blood in urine, leakage of urine and/or
stools, urgent desire to urinate, pain in the kidney area and/
or bladder caused by kidney stones
•
Disturbances in sexual function (erectile dys

Prekės savybės

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Topiramate Accord 50mg Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50mg of topiramate.
Each capsule also contains 138 mg of sucrose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
White opaque body and white opaque cap. The body has ‘50’ printed
in black and the
cap has ‘>’ over ‘Ti’ printed in black.
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 generalization or
primary generalized
tonic-clonic seizures and for the treatment of seizures associated
with Lennox-Gastaut
syndrome.
Topiramate is indicated in adults for the prophylaxis of migraine
headache after
careful evaluation of possible alternative treatment options.
Topiramate is not
intended for acute treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
General
It is recommended that therapy be initiated at a low dose followed by
titration to an
effective dose. Dose and titration rate should be guided by clinical
response.
Topiramate is available in film-coated tablet and a hard capsule
formulations. It is
recommended that film-coated tablets not be broken. The hard capsule
formulation is
provided for those patients who cannot swallow tablets, e.g.
paediatric and the
elderly.
Topiramate Capsules may be swallowed whole or may be administered by
carefully
opening the capsule and sprinkling the entire contents on a small
amount (teaspoon)
of soft food. This medicinal product/food mixture is to be swallowed
immediately
and not chewed. It must not be stored for future use.
It is not necessary to monitor topiramate plasma concentrations to
optimize therapy
with topiramate. On rare occasions