Epilim Chrono 200 Controlled Release

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

VALPROATE SODIUM

Dostępny od:

Sanofi Malta Limited

Kod ATC:

N03AG01

INN (International Nazwa):

VALPROATE SODIUM

Forma farmaceutyczna:

PROLONGED-RELEASE TABLET

Skład:

VALPROATE SODIUM 200 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

ANTIEPILEPTICS

Status autoryzacji:

Authorised

Data autoryzacji:

2007-03-02

Ulotka dla pacjenta

SANOFI
RIELLS PACKAGING TEAM
Format : 2 x 170 x 315 mm (DC)
Plant barcode :490
Colours : 2
- REFLEX BLUE - BLACK
Fonts : Ocean Sans Pro SAN (9pt)
Weight : 45 grms (+/- 5%)
Diametros : 600 (ext) / 70-76 (int)
Spot : 3 x 8 mm
Fonts : Ocean Sans Pro SAN (9pt)
Packaging line : UHLMANN 1040/1
Technical Data
Reason for change: R.Text
Code :
688535-G-688885
Update :
V2- 04/10/2017
VISTA folder : 3208398
Current item code: 688353
Product/Item type : EPILIM 200/500 MG
Country :UK
Artwork by : M.Pacho
Plant : Riells
GMID code : 502298/536983
For sanofi use only
PAG 4
UNWIND DIRECTION
170 x 315 mm
688535-G-688885
PAG 1
1
4
•
Fainting
•
Hearing loss
•
Skin
problems
such
as
rashes.
These
happen
rarely,
but
more
often
in
people
also
taking
lamotrigine
•
Acne
•
Hair loss which is usually temporary. When it
grows back it may be more curly than before
•
Hair, including body or facial hair grows more
than normal in women
•
Skin rash caused by narrow or blocked blood
vessels (vasculitis)
•
Changes in women’s periods and increased hair
growth in women
•
Breast enlargement in men
•
Swelling of the feet and legs (oedema)
•
Weight gain - as your appetite may be increased
•
Kidney problems, bedwetting or increased need
to pass urine
•
Headache
•
Aggression, agitation, disturbance in attention,
abnormal
behaviour,
restlessness/hyperactivity,
and learning disorder
•
Tingling or numbness in the hands and feet
BONE DISORDERS
There have been reports of bone disorders including
osteopenia
and
osteoporosis
(thinning
of
the
bone)
and fractures. Check with your doctor or pharmacist if
you are on long-term antiepileptic medication, have a
history of osteoporosis, or take steroids.
BLOOD TESTS
Epilim can change levels of liver enzymes, salts or
sugars shown up on blood and urine tests.
MALE FERTILITY
Taking Epilim can be a contributing factor in male
infertility.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side eff
ects not listed in thi

Charakterystyka produktu

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
_▼_
_ _This medicinal product is subject to additional monitoring. This
will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse reactions. See section 4.8 for how to report adverse
reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Epilim Chrono 200 Controlled Release
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents
Each tablet contains 133.2mg Sodium Valproate and 58.0mg Valproic Acid
equivalent to
200mg sodium valproate.
3.
PHARMACEUTICAL FORM
Prolonged Release Tablet
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of generalised, partial or other epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Chrono Controlled Release Tablets are for oral administration.
Epilim
Chrono
is
a
prolonged
release
formulation
of
Epilim
which
reduces
peak
concentration and ensures more even plasma concentrations throughout
the day.
Epilim Chrono may be given once or twice daily. The tablets should be
swallowed whole
and not crushed or chewed.
Daily dosage requirements vary according to age and body weight.
In patients where adequate control has been achieved Epilim Chrono
formulations are
interchangeable with other conventional or prolonged release
formulations on an equivalent
daily dosage basis.
_ _
_Dosage_
Usual requirements are as follows:
Adults
Dosage should start at 600mg daily increasing by 200mg at three-day
intervals until control
is achieved. This is generally within the dosage range 1000mg to
2000mg per day, ie 20-
30mg/kg/day body weight. Where adequate control is not achieved within
this range the
dose may be further increased to 2500mg per day.
Page 2 of 17
Children over 20kg
Initial dosage should be 400mg/day (irrespective of weight) with
spaced increases until
control is achieved; this is usually within the range 20-30mg/kg body
weight per day. Where
adequate control is not achieved within this range the dose may be
increased to 35mg/kg
body weight per day.
Children