Phenobarbital 30mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Phenobarbital

Fáanlegur frá:

Accord-UK Ltd

ATC númer:

N03AA02

INN (Alþjóðlegt nafn):

Phenobarbital

Skammtar:

30mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

Schedule 3 (CD No Register Phenobarbital)

Gerð lyfseðils:

Caution - AMP level prescribing advised

Vörulýsing:

BNF: 04080100; GTIN: 5012617009197

Upplýsingar fylgiseðill

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Phenobarbital Tablets
30 & 60mg x 28’s (UK)
148x210 (Reel Fed)
50963817
Leaflet for Blisters
4182
R.Wrey
20/12/18
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FMD info
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Details
PHENOBARBITAL ACTAVIS 30MG & 60MG 28 TABLETS PIL - UK
Black
Profile
BBBA3673
R.Wrey
24/12/18
02/01/19
R.WRey
148 x 210
7pt
Actavis UK
n/a
n/a
2
Version 2
01.11.2017
PHENOBARBITAL ACCORD
30MG AND 60MG TABLETS
_Continued over page_
_Continued top of next column_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
• 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
symptoms are the same as yours.
INDEX
1
WHAT PHENOBARBITAL TABLETS ARE AND
WHAT THEY ARE USED FOR
2 BEFORE YOU TAKE
3 HOW TO TAKE
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE
6 FURTHER INFORMATION
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 BEFORE YOU TAKE
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 inh

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenobarbital Accord 30mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenobarbital BP
30 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