Clonazepam 2mg/5ml oral solution sugar free

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Clonazepam

Dostupno od:

Rosemont Pharmaceuticals Ltd

ATC koda:

N03AE01

INN (International ime):

Clonazepam

Doziranje:

400microgram/1ml

Farmaceutski oblik:

Oral solution

Administracija rute:

Oral

Razred:

Schedule 4 (CD Benz)

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04080100; GTIN: 5016119150890

Uputa o lijeku

0
10
20
30
40
50
60
70
80
90
100
JOB INFORMATION
Product Name:
Strength:
Keyline Ref:
Font Type:
Font Size:
Pharmacode:
Dimensions:
EAN Code:
Folded Size:
No. of Colours:
Tabbed:
Pack Size:
Bottle Size:
Design Icon:
Print
Colours:
Non-print
Colours:
New Item Code:
Previous Item Code:
Supplier Code:
Page Number:
COLOURS
ARTWORK
VERSION:
Date:
Date:
Operator:
Operator:
PREFLIGHT
VERSION:
JOB SPECIFICATION
MAIN BODY TEXT
Univers LTD Std 55 Roman
UNIVERS LTD STD 65 BOLD
2mg/5ml
BLACK
CUTTER
UKL445
337
300 x 330mm
N/A
150 x 37mm
1
9pt
No
150ml
150ml
N/A
H3MD1RBJ1
P0760
N/A
1 of 2
Clonazepam Rosemont 2mg/5ml Oral Solution
15/06/17
-
DH
-
4
-
APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
SEXUAL
n
loss of sex drive
n
difficulty getting or keeping an erection (erectile dysfunction).
WITHDRAWAL SYMPTOMS
Using benzodiazepines like Clonazepam may make you dependent on the
medicine. This means that if you stop treatment quickly, or reduce the
dose too
quickly, you may get withdrawal symptoms. The most common symptoms can
include:
n
problems sleeping
n
muscle pain, shaking (tremor) or feeling restless
n
feeling very anxious, tense, confused, irritable or agitated, or
changes in
your mood
n
increased sweating
n
headache.
Less common withdrawal symptoms can include:
n
feeling sensitive to light, noise or physical contact
n
seeing or hearing things that are not really there (hallucinations)
n
tingling and feeling numb in your arms and legs
n
a feeling of losing contact with reality.
INJURY
n
Patients taking benzodiazepine medicines are at risk of falling and
breaking bones. This risk is
increased in the elderly and those taking other sedatives (including
alcohol).
If any of the side effects gets serious, or if you notice any side
effects not mentioned in this leaflet,
please tell your doctor or pharmacist.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharma

Svojstava lijeka

OBJECT 1
CLONAZEPAM ROSEMONT 2MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 21-Sep-2017 | Rosemont
Pharmaceuticals Limited
1. Name of the medicinal product
Clonazepam Rosemont 2mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml contains 2mg Clonazepam
Excipients with known effects: Ethanol – 100mg/5ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution
A clear, pale straw coloured oily solution
4. Clinical particulars
4.1 Therapeutic indications
Clonazepam Rosemont Oral Solution is indicated in all clinical forms
of epileptic disease and seizures in
adults, especially absence seizures (petit mal) including atypical
absence; primary or secondarily
generalised tonic-clonic (grand mal), tonic or clonic seizures;
partial (focal) seizures with elementary or
complex symptomatology; various forms of myoclonic seizures, myoclonus
and associated abnormal
movements.
4.2 Posology and method of administration
Posology
The 0.5mg/5ml oral solution may facilitate the administration of lower
daily doses in the initial stages of
treatment or treatment for the elderly.
The 2mg/5ml oral solution should be used for maintenance and maximum
dosage regimens.
_Adults_
Initial dosage should not exceed 1mg/day. The maintenance dosage for
adults normally falls within the
range 4 to 8mg.
_Elderly_
The elderly are particularly sensitive to the effects of centrally
depressant drugs and may experience
confusion. It is recommended that the initial dosage of clonazepam
should not exceed 0.5mg/day.
These are total daily dosages which should be divided into 4 doses
taken at intervals throughout the day.
If necessary, larger doses may be given at the discretion of the
physician, up to a maximum of 20mg
daily. The maintenance dose should be attained after 2 to 4 weeks of
treatment.
_Paediatric Population_
Due to the presence of ethanol in the formulation, this product is not
indicated for paediatric use.
METHOD OF ADMINISTRATION
A 2.5ml/ 5ml double ended spoon with a furth