Idaman Pharma Phenobarbitone Tablet 30mg

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

PHENOBARBITONE

Предлага се от:

IDAMAN PHARMA MANUFACTURING SDN BHD

INN (Международно Name):

PHENOBARBITONE

Броя в опаковка:

50 Tablets

Произведено от:

IDAMAN PHARMA MANUFACTURING SDN BHD

Листовка

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
IDAMAN PHARMA PHENOBARBITONE
TABLET
Phenobarbitone (30 mg)
_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What
Phenobarbitone
Tablet
is
used for
2.
How Phenobarbitone Tablet works
3.
Before
you
use
Phenobarbitone
Tablet
4.
How to use Phenobarbitone Tablet
5.
While
you
are
using
Phenobarbitone Tablet
6.
Side effects
7.
Storage
and
disposal
of
Phenobarbitone Tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT PHENOBARBITONE TABLET IS USED
FOR
Phenobarbitone Tablet is used for:
•
short-term
treatment
of
insomnia
(difficulty falling or staying asleep)
•
as
a
sedation
to
relieve
anxiety,
tension and apprehension
•
treatments of seizures
•
treatment
of
hyperbilirubinaemia
(abnormally high level of bilirubin in
the blood) in neonates or chronic
intrahepatic
cholestasis
(decrease
the flow of bile from the liver).
HOW PHENOBARBITONE TABLET WORKS
Phenobarbitone Tablet belongs to a
group of medicines called long-acting
barbiturates. This
medicine
reduces
brain activities. It is widely used in
the treatment of seizures (epilepsy). It
also
has
sedative
effect
and
some
protective action against all varieties
of
human
partial
and
generalized
epilepsy.
BEFORE
YOU
USE
PHENOBARBITONE
TABLET
_-When you must not use it_
Do not take Phenobarbitone Tablet and
tell your doctor if you have:
•
an
allergy
(hypersensitivity)
to
phenobarbitone, other barbiturates
or any of the other ingredients
•
porphyria
(a
genetic
or
inherited
disorder of the red blood pigment
haemoglobin)
•
severe breathing difficulties
•
severe kidney or liver disease
_-Before you start to use it_
Tell your doctor or pharmacist before
taking this medicine if you:
•
have rare hereditary problems of
galactose
intolerance,
lactose
intolerance
(Lapp
lactase
intolerance)
or
galactose
malabsorption
•
have breathing difficulties
•
have kidney or liver problems
•
have acute chronic pain
•
or the person taking these tablets
are young, run down, senile or have
a

Данни за продукта

Corticosteroids
Phenobarbitone increases the rate of metabolism reducing serum
concentrations when
taking together with corticosteroids.
Cytotoxics
Phenobarbitone possibly reduces the plasma levels of etoposide or
irinotecan.
Diuretics
Concomitant use with eplerenone should be avoided.
Haloperidol
Serum levels are approximately halved by concurrent used with
phenobarbitone.
Hormone Antagonists
Phenobarbitone increases the rate of metabolism reducing serum
concentrations when
taking together with gestrinone and possibly toremifene.
Methadone
Levels can be reduced by concurrent use of phenobarbitone and
withdrawal symptoms
have been reported in patients maintained on methadone when
phenobarbitone has
been added. Increases in the methadone dosage may be necessary.
Montelukast
Phenobarbitone increases the rate of metabolism reducing serum
concentrations when
taking together with montelukast.
Oestrogens and Progestogens
Reduced contraceptive effect.
Sodium oxybate
Enhanced effects, avoid concomitant use.
Theophylline
May require an increase in theophylline dose.
Thyroid hormones
May increase requirements for thyroid hormones in hypothyroidism.
Tibolone
Phenobarbitone increases the rate of metabolism reducing serum
concentrations when
taking together with tibolone
Tropisetron
Phenobarbitone increases the rate of metabolism reducing serum
concentrations when
taking together with tropisetron.
Vitamins
Barbiturates possibly increase requirements for vitamin D.
PREGNANCY AND LACTATION
Pregnancy
Phenobarbitone therapy in epileptic pregnant women presents a risk to
the foetus in
terms of major and minor congenital defects such as congenital
craniofacial, digital
abnormalities and, less commonly, cleft lip and palate. The risk of
teratogenic effects
developing appears to be greater if more than one antiepileptic drug
is administered.
The risk to the mother, however is greater if phenobarbitone is
withheld and seizure
control is lost. The risk-benefit balance, in this case, favours
continued use of the drug
during pregnancy at