Phenobarbital 15mg/5ml elixir

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Phenobarbital

Доступна з:

Thornton & Ross Ltd

Код атс:

N03AA02

ІПН (Міжнародна Ім'я):

Phenobarbital

Дозування:

3mg/1ml

Фармацевтична форма:

Oral solution

Адміністрація маршрут:

Oral

Клас:

Schedule 3 (CD No Register Phenobarbital)

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 04080100; GTIN: 5011309144918

інформаційний буклет

PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
B
gill.kennedy
628971
12618
Addition of 28 day in use shelf life.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
500ml
22822012
297mm x 210mm
1
25.01.2016
Process Black
Keyline (Does not print)
Phenobarbital Thornton & Ross
15mg/5ml Elixir
Helvetica Neue
Times
PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
B
gill.kennedy
628971
12618
Addition of 28 day in use shelf life.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
500ml
22822012
297mm x 210mm
1
25.01.2016
Process Black
Keyline (Does not print)
Phenobarbital Thornton & Ross
15mg/5ml Elixir
Helvetica Neue
Times
_Data Matrix:_
_ _
22822012 VERIFIED
PATIENT INFORMATION LEAFLET
PHENOBARBITAL THORNTON & ROSS 15MG/5ML ELIXIR
IMPORTANT THINGS YOU NEED TO KNOW:
•
Phenobarbital Elixir is prescribed to treat epilepsy.
•
Take Phenobarbital Elixir regularly to get the most benefit. Do not
stop
taking the medicine without talking to your doctor first. Stopping the
medicine abruptly can cause problems.
•
Phenobarbital can cause side effects, although most people do not have
serious problems - see section 4 for details. If you have fever, skin
rashes or
skin yellowing, mouth ulcers, bruising or bleeding, see your doctor
immediately.
•
Some side effects may occur early on in treatment. These often
disappear
after a few days as your body gets used to the drug.
•
Taking other medicines including other anti-epilepsy drugs may
sometimes
cause problems, see section 2 for details. Check with your doctor
before
taking any other medicines.
•
If you might become pregnant while taking Phenobarbital it is
important
that you talk to your doctor about this.
NOW READ THE REST OF THE LEAFLET BEFORE YOU USE THIS MEDICINE. IT
INCLUDE

Характеристики продукта

OBJECT 1
PHENOBARBITAL ELIXIR BP
Summary of Product Characteristics Updated 01-Feb-2016 | Thornton &
Ross Ltd
1. Name of the medicinal product
Phenobarbital Thornton & Ross 15mg/5ml Elixir
2. Qualitative and quantitative composition
Phenobarbital 0.3% w/v
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Elixir
4. Clinical particulars
4.1 Therapeutic indications
As an anticonvulsant in the treatment of all forms of epilepsy except
absence seizures
4.2 Posology and method of administration
Oral
RECOMMENDED DOSE AND DOSAGE SCHEDULE
Usual adult daily dose:
60-200mg phenobarbital taken in 2 or 3 divided portions.
Children:
initially 3-6mg per kg body weight per day taken in 2 or 3 divided
portions.
Label states:
for use as directed by the practitioner
4.3 Contraindications
Contra-indicated in patients with known hypersensitivity to
barbiturates or any other ingredient, with
severe respiratory depression, with severely impaired hepatic or renal
function, and in cases of acute
intermittent porphyria. Also in hyperkinetic children
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 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 Elixir.
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 behaviour emerge.
Barbiturates are frequently used in suicidal attempts. In the presence
of severe pain, barbiturates may fail
to exert their hypnotic action and may cause wakefulness, excitement
and delirium unless accompanied
by an analgesic. Phenobarbital should be used with c