Phenobarbital 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenobarbital

Available from:

Waymade Healthcare Plc

ATC code:

N03AA02

INN (International Name):

Phenobarbital

Dosage:

60mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 3 (CD No Register Phenobarbital)

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 04080100

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
PHENOBARBITAL ACCORD 30MG, 60MG TABLETS
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, 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
The active ingredient in this medicine is Phenobarbital. This is the
new name for Phenobarbitone. The
ingredient itself has not changed.
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 have:
•
an
ALLERGY
(hypersensitivity) to phenobarbital, other barbiturates or any of the
other ingredients (see
section 6).
•
PORPHYRIA
(a genetic or inherited disorder of the red blood pigment haemoglobin)
•
SEVERE BREATHING DIFFICULTIES
•
severe kidney or liver disease.
IF YOU DEVELOP A RASH OR THE FOLLOWING SKIN SYMPTOMS, SEEK IMMEDIATE
ADVICE FROM A DOCTOR AND TELL
THAT YOU ARE TAKING THIS MEDICINE:
•
potentially life-threatening skin rashes (Stevens-Johnson syndrome,
toxic epidermal necrolysis) have
been reported with the use of Phenobarbital tablets appearing
initially

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenobarbital 60mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60mg phenobarbital Ph.Eur.
Also contains excipients lactose monohydrate 22.0mg and sunset yellow
(E110)
0.05mg
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets for oral use
_Appearance_: Pale orange, circular, biconvex tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenobarbital tablets are indicated for the management of all forms of
epilepsy except
absence seizures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults and the elderly: _60 - 180mg daily at night.
Phenobarbital clearance diminishes in the elderly. Therefore the dose
of Phenobarbital
is usually lower in elderly patients.
_Children: _5 - 8mg per kg bodyweight daily.
The dose of Phenobarbital should be adjusted to meet the needs of
individual patients.
This usually requires plasma concentration of 15 to 40 micrograms/ml
(65 to 170
micromoles/litre).
_Administration: _Oral; the tablets should be swallowed with water.
4.3
CONTRAINDICATIONS
Phenobarbital should not be given to patients with:
• Known hypersensitivity to phenobarbital, other barbiturates or
other ingredients in the
tablet listed in section 6.1
• Acute intermittent porphyria
• Severe respiratory depression
• Severe renal or hepatic impairment
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Suicidal ideation and behaviour have been reported in patients treated
with anti-
epileptic
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 and the
available data do not exclude the possibility of an increased risk for
phenobarbital.
Therefore patients should be monitored for signs of suicidal ideation
and behaviours
and appropriate treatment should be considered. Patients (and
caregivers of patients)
should
be
advised
to
seek
medical