Phenobarbital 30 mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Phenobarbital

Verfügbar ab:

Clonmel Healthcare Ltd

ATC-Code:

N03AA; N03AA02

INN (Internationale Bezeichnung):

Phenobarbital

Dosierung:

30 milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Barbiturates and derivatives; phenobarbital

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1977-04-01

Gebrauchsinformation

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENOBARBITAL 15MG TABLETS
PHENOBARBITAL 30MG TABLETS
PHENOBARBITAL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Phenobarbital tablets are and what they are used for
2.
What you need to know before you take Phenobarbital tablets
3.
How to take Phenobarbital tablets
4.
Possible side effects
5.
How to store Phenobarbital tablets
6.
Contents of the pack and other information
1.
WHAT PHENOBARBITAL TABLETS ARE AND WHAT THEY ARE USED FOR
Phenobarbital tablets belong to a group of medicines called
barbiturates. These medicines reduce brain
activity which would otherwise cause fits or seizures in epilepsy,
except absence seizures (day
dreaming).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENOBARBITAL TABLETS
DO NOT TAKE
Phenobarbital tablets and
TELL
your doctor

if you are allergic to phenobarbital or any of the other ingredients
of this medicine (listed in section
6)

if you have PORPHYRIA
(a genetic or inherited disorder of the red blood pigment haemoglobin)

if you have SEVERE BREATHING DIFFICULTIES

if you have SEVERE KIDNEY
or LIVER
disease

if you have ADDISON’S DISEASE
(a condition affecting the adrenal glands)
A small number of people being treated with anti-epileptics such as
phenobarbital have had thoughts of
harming or killing themselves. If at any time you have these thoughts,
immediately contact your
doctor.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome,
toxic epidermal necrolysis) h

Fachinformation

Health Products Regulatory Authority
12 August 2021
CRN00CH7Y
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenobarbital 30 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg Phenobarbital as the active substance.
Excipient(s) with known effect
Each tablet contains 18.8 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Round, white, biconvex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an anticonvulsant for the treatment of all forms of epilepsy except
absence seizures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose should be adjusted to the needs of the individual patient to
achieve adequate control of seizures; this usually requires
plasma concentrations of 10-40 µg/ml (40-160 µmol/litre).
Adults:
The recommended dose by mouth is 60-180mg daily usually taken at
night.
Paediatric population:
5-8 mg/kg/day.
Elderly
The use of Phenobarbital must be the subject of a clinical
risk/benefit assessment. Dose schedules may need to be reduced.
Method of administration
Oral.
4.3 CONTRAINDICATIONS
1. Acute intermittent porphyria.
2. Severe impairment of renal, hepatic or respiratory function.
3. Hypersensitivity to the active substance or to any of the
excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Warnings:
Prolonged administration of barbiturates may induce psychic dependence
and even addiction in some individuals. A severe
withdrawal syndrome may occur.
Withdrawal or transition to another type of anti-epileptic therapy
should be gradual to avoid rebound seizures.
Health Products Regulatory Authority
12 August 2021
CRN00CH7Y
Page 2 of 8
Suicidal ideation and behaviour have been reported in patients treated
with antiepileptic agents in several indications. A
meta-analysis of randomised placebo controlled trials of
anti-epileptic drugs has also shown a small increased risk of suicidal
ideation and behaviour. The mechanism of this risk is not known an