Oxcarbazepine 150mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Oxcarbazepine

Доступна з:

A A H Pharmaceuticals Ltd

Код атс:

N03AF02

ІПН (Міжнародна Ім'я):

Oxcarbazepine

Дозування:

150mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04080100; GTIN: 5025903006749

інформаційний буклет

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Non-Print
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9 pt
9 pt
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1
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1/2
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SAP No.
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Keyline/Drawing No.
Barcode Info
Description
Component Type
Superceded Affiliate Item Code
TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
1691300
PL 04569/0779-0781
Medis International
(Bolatice - CZ)
11300271 MI-03
2008
N/A
1
United Kingdom
101546372/0020
N/A
10:39
16 Nov 18
170 x 620 mm
Affiliate Item Code
v3/Jul 2017
Oxcarbazepine_600mg_300mg_150mg_50
Leaflet
1691300
741222
3D Render ID
N/A
Black
N/A
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.
Package leaflet: Information for the patient
OXCARBAZEPINE MYLAN
150/300/600 MG
FILM-COATED TABLETS
oxcarbazepine
WHAT IS IN THIS LEAFLET:
1. What Oxcarbazepine Mylan is and what it is
used for.
2. What you need to know before you take
Oxcarbazepine Mylan.
3. How to take Oxcarbazepine Mylan.
4. Possible side effects.
5. How to store Oxcarbazepine Mylan.
6. Contents of the pack and other information.
1. WHAT OXCARBAZEPINE MYLAN IS AND
WHAT IT IS USED FOR
Oxcarbazepine Mylan contains the active ingredient
oxcarbazepine. Oxcarbazepine Mylan belongs to
a group of medicines called anticonvulsants or
antiepileptics which are used in the treatment
of epilepsy.
Oxcarbazepine Mylan is used to help control seizures
or fits in patients that have epilepsy. People with
epilepsy are prone to having periods of uncontrolled
electrical activit

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Oxcarbazepine Mylan 150 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg oxcarbazepine.
Excipient with known effect
Each 150 mg tablet contains 1.23 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Buff, oblong, normal convex film-coated tablet debossed “OX|150”
on one side and
“G|G” on the other side. The tablet has a score line to facilitate
breaking for ease of
swallowing and not to divide into equal doses.
4
CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Oxcarbazepine Mylan is indicated for the treatment of partial seizures
with or without
secondarily generalised tonic-clonic seizures.
Oxcarbazepine Mylan is indicated for use as monotherapy or adjunctive
therapy in
adults and in children of 6 years of age and above.
_4.2 _
_POSOLOGY AND METHOD OF ADMINISTRATION _
Posology:
In mono- and adjunctive therapy, treatment with Oxcarbazepine Mylan is
initiated
with a clinically effective dose given in two divided doses. The dose
may be
increased depending on the clinical response of the patient. When
other antiepileptic
medicinal products are replaced by Oxcarbazepine Mylan, the dose of
the
concomitant antiepileptic medicinal products(s) should be reduced
gradually on
initiation of Oxcarbazepine Mylan therapy. In adjunctive therapy, as
the total
antiepileptic medicinal product load of the patient is increased, the
dose of
concomitant antiepileptic medicinal product(s) may need to be reduced
and/or the
Oxcarbazepine Mylan dose increased more slowly (see section 4.5).
THERAPEUTIC DRUG MONITORING
The therapeutic effect of oxcarbazepine is primarily exerted through
the active
metabolite 10-monohydroxy derivative (MHD) of oxcarbazepine (see
section 5).
Plasma level monitoring of oxcarbazepine or MHD is not routinely
warranted.
However, it may be useful in situations where an alteration in MHD
clearance is to be
expected