Phenobarbital 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenobarbital

Available from:

Bristol Laboratories Ltd

ATC code:

N03AA02

INN (International Name):

Phenobarbital

Dosage:

30mg

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: 5060013943539

Patient Information leaflet

Phenobarbital Tablets
INSERT
SAME SIZE ARTWORK
240 x 120mm
Front
24 mm
240 mm
120 mm
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENOBARBITAL BRISTOL LABS 15MG TABLETS
PHENOBARBITAL BRISTOL LABS 30MG TABLETS
PHENOBARBITAL BRISTOL LABS 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. 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet.
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
The name of your medicine is Phenobarbital 15mg or
30mg or 60mg tablets. The active substance is
Phenobarbital.
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 (listed in section 6)
•
If you suffer from 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.
•
Potentially life-threatening skin rashes (Stevens-
Johnson syndrome, toxic epidermal necrolysis) have
been reported with the

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Phenobarbital Bristol Labs 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet containsPhenobarbital Ph Eur 30mg
Also contains Lactose Ph Eur 20.950mg
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet.
Smooth unmottled tablets showing no evidence of chipping or capping;
free from specks
and extraneous matter; odorless.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenobarbital is recommended for all forms of epilepsy (except absence
seizures).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of Administration
For oral administration.
_ _
Posology
Adults: The usual dose is 60 – 180mg daily taken at night.
Children: 5- 8mg/kg body weight 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 to
individual patients. This
usually
requires
plasma
concentration
of
15
to
40
micrograms/ml
(65
to
170
micromoles/litre).
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
Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS)
and toxic epidermal
necrolysis (TEN) have been reported with the use of Phenobarbital.
Patients should be
advised of the signs and symptoms and monitored closely for skin
reactions. The highest risk
for occurrence of SJS or TEN is within the first weeks of treatment.
If symptoms or signs of
SJS or TEN (e.g. progressive skin rash often with blisters or mucosal
lesions) are present,
Phenobarbital treatment should be discontinued. The best results in
managing SJS and TEN
come from early diagnosis and immediate discontinuation of any suspect
drug. Early
withdrawal is associated with a better progno