Phenobarbitone (Noumed)
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
01-01-2024
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Active ingredient:
Phenobarbital 15mg; ; ; ;
Available from:
Noumed Pharmaceuticals Limited
INN (International Name):
Phenobarbital 15 mg
Dosage:
15 mg
Pharmaceutical form:
Tablet
Composition:
Active: Phenobarbital 15mg Excipient: Lactose monohydrate Magnesium stearate Purified talc Wheat starch
Units in package:
Blister pack, 90 tablets
Class:
Class C5 Controlled Drug
Prescription type:
Class C5 Controlled Drug
Manufactured by:
Harman Finochem Limited
Therapeutic indications:
Phenobarbitone is indicated for use as preoperative medication to help reduce anxiety and facilitate induction of anaesthesia. Phenobarbitone a long acting barbiturate is indicated as long term anticonvulsant therapy for the treatment of generalised tonic-clonic and simple partial (cortical focus) seizures. Seizures (prophylaxis and treatment) of febrile seizures.
Product summary:
Package - Contents - Shelf Life: Blister pack, - 90 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, - 500 tablets - 60 months from date of manufacture stored at or below 25°C
Authorization date:
1969-12-30
Summary of Product characteristics
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 1 of 16
1.
PRODUCT NAME
Phenobarbitone (Noumed), Tablet, 15mg
Phenobarbitone (Noumed), Tablets, 30mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Name and strength of the active substance
Phenobarbital 15mg
Phenobarbital 30mg
Excipient(s) with known effect
Contains gluten and sugars (as lactose).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral – tablet
Presentations
Phenobarbitone (Noumed) tablets 15 mg: A white, biconvex, circular
tablet.
Phenobarbitone (Noumed) tablets 30 mg: A white, biconvex, circular
tablet.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Phenobarbital is indicated for use as preoperative medication to help
reduce anxiety and
facilitate induction of anaesthesia.
Phenobarbital a long-acting barbiturate is indicated as long-term
anticonvulsant therapy for
the treatment of generalised tonic-clonic and simple partial (cortical
focus) seizures.
Seizures (prophylaxis and treatment) of febrile seizures.
4.2
Dose and method of administration
Phenobarbital is a barbiturate which may be used as an antiepileptic
agent to control tonic-
clonic (grand mal) and partial (focal) seizures.
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
to 40mcg per mL (43 to
NEW ZEALAND DATA SHEET
New Zealand Data Sheet
Page 2 of 16
172 micromoles per litre).
Up to 350 mg daily in divided doses may be taken.
4.3
Contraindications
Hypersensitivity to barbituric acid derivatives. Phenobarbital is
contraindicated in patients
with acute intermittent porphyria, severe respiratory depression or
pulmonary insufficiency,
renal impairment, hepatic impairment, sleep apnoea, uncontrolled
diabetes mellitus, severe
anaemia due to folate deficiency, hyperkinetic children, suicidal
potential, alcoholism, and
drug dependency. Phenobarbital is also contraindicated in those who
have a natural or
acquired idiosyncrasy to barbiturates.
Not to be admin
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