Phenobarbital 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenobarbital

Available from:

Accord-UK Ltd

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; GTIN: 5012617009203

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 Accord 60mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenobarbital BP
60 mg
3
PHARMACEUTICAL FORM
Tablets for oral administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The treatment and control of all forms of epilepsy, except absence
seizures.
Phenobarbital should only be used in the treatment of febrile
convulsions in
exceptional circumstances.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _60-180mg at night
_Child: _ 5-8mg/kg daily
_Elderly: _Phenobarbital clearance diminishes in the elderly.
Therefore the
dose of phenobarbital is usually lower in elderly patients.
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).
_METHOD OF ADMINISTRATION _
_ _
For oral administration
4.3
CONTRAINDICATIONS
Phenobarbital should not be given to patients with:
•
Known hypersensitivity to phenobarbital, other barbiturates or other
ingredients in the tablet
•
Acute intermittent porphyia
•
Severe respiratory depression
•
Severe renal or hepatic impairment.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Suicidal ideation and behavior have been reported in patients treated
with anti-
epileptic agents in several indications. A meta-analysis of randomized
placebo
controlled trials of anti-epileptic drugs has also shown a small
increased risk
of suicidal ideation and behavior. 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 advice
should signs
of suicidal ideation or behavior emerge.
Steven-Johnson syndrome and toxic epidermal necrolysis
Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS)