Phenobarbital 30mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenobarbital

Available from:

Teva UK 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: 5017007031147

Patient Information leaflet

PATIENT INFORMATION LEAFLET
PHENOBARBITAL 30MG AND 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 OR PHARMACIST. THIS
INCLUDES ANY
POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
_PLEASE NOTE THAT PHENOBARBITAL 30MG AND 60MG TABLETS ARE REFERRED AS
PHENOBARBITAL _
_TABLETS 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
Phenobarbital belongs to a group of medicines called barbiturates.
These medicines reduce brain activity which would otherwise cause fits
or seizures
in epilepsy, except absence seizures (daydreaming or lapses in
attention).
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 KIDNEY or LIVER disease
•
SEVERE BREATHING DIFFICULTIES
IF YOU DEVELOP A RASH OR THE FOLLOWING SKIN SYMPTOMS, SEEK IMMEDIATE
ADVICE FROM A
DOCTOR AND TELL THEM 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 as reddish target

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenobarbital 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30mg phenobarbital Ph. Eur.
Excipient: Lactose monohydrate 18.8mg
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets for oral use
_Appearance_: White, circular, biconvex tablets
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 advice should signs of suicidal
ideation or
behavio