Tapclob 5mg/5ml oral suspension
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
20-06-2018
Summary of Product characteristics
(SPC)
20-06-2018
Active ingredient:
Clobazam
Available from:
Martindale Pharmaceuticals Ltd
ATC code:
N05BA09
INN (International Name):
Clobazam
Dosage:
1mg/1ml
Pharmaceutical form:
Oral suspension
Administration route:
Oral
Class:
Schedule 4 (CD Benz)
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 04080100; GTIN: 5026468754052 5014124148949
Patient Information leaflet
5MG/5ML: DOSES
ADULTS AND ADOLESCENTS (OVER 15 YEARS)
• The usual dose is 20mg (20ml) to 30mg (30ml) each day.
This can be taken as two separate doses or as a single
dose at night.
• Your doctor may increase your dose to up to 60mg
(60ml) each day.
• Your doctor may lower the dose to suit you.
CHILDREN (OVER 6 YEARS)
• The usual starting dose is 5mg (5ml) each day.
• Your doctor will then adjust the dose according to your
child’s need.
ELDERLY
• The usual dose for anxiety is 10mg (10ml) to 20mg
(20ml) each day.
10MG/5ML: DOSES
ADULTS AND ADOLESCENTS (OVER 15 YEARS)
• The usual dose is 20mg (10ml) to 30mg (15ml) each day.
This can be taken as two separate doses or as a single
dose at night.
• Your doctor may increase your dose to up to 60mg
(30ml) each day.
• Your doctor may lower the dose to suit you.
CHILDREN (OVER 6 YEARS)
• The usual starting dose is 5mg (2.5ml) each day.
• Your doctor will then adjust the dose according to your
child’s need.
ELDERLY
• The usual dose for anxiety is 10mg (5ml) to 20mg (10ml)
each day.
METHOD OF ADMINISTRATION:
This product may settle during storage, PLEASE SHAKE WELL
BEFORE USE.
Your doctor, pharmacist or nurse will show you how
to administer this medicine. The box containing this
medicine will contain a 5ml dosing syringe, a dosing
adaptor and a 30ml dosing cup.
5ml syringe each numbered increment is 1ml equivalent
to 1mg of Tapclob 5mg/5ml Oral Suspension and 2mg
of Tapclob 10mg/5ml Oral Suspension . The smaller
increments are 0.2ml or 0.2mg of Tapclob 5mg/5ml
Oral Suspension and 0.4mg of Tapclob 10mg/5ml Oral
Suspension.
30ml dosing cup. Each numbered increment is 5ml -
equivalent to 5mg of Tapclob 5mg/5ml Oral Suspension
and 10mg of Tapclob 10mg/5ml Oral Suspension.
Instructions are provided overleaf for using the dosing
syringe. If you have any questions about the dose you
should use or how to use the syringe, you should ask your
pharmacist.
_Continued overleaf_
D03044
WHAT IS IN THIS LEAFLET
1.
What Tapclob® Oral Suspension is and what it is
u
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Summary of Product characteristics
OBJECT 1
TAPCLOB 5MG/5ML ORAL SUSPENSION
Summary of Product Characteristics Updated 20-Nov-2015 | Martindale
Pharma
1. Name of the medicinal product
Tapclob 5mg/5ml Oral Suspension
Clobazam Martindale Pharma 5mg/5ml Oral Suspension
2. Qualitative and quantitative composition
Each 5ml of suspension contains 5mg of Clobazam
Each 5ml of suspension contains 1250mg of Sorbitol, 10.3mg of Sodium
Methyl Hydroxybenzoate and
1.12mg of Sodium Propyl Hydroxybenzoate
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Oral Suspension
An off white viscous suspension with an odour of raspberry
4. Clinical particulars
4.1 Therapeutic indications
Clobazam is a 1,5-benzodiazepine indicated for the short-term relief
(2-4 weeks) only of anxiety that is
severe, disabling or subjecting the individual to unacceptable
distress, occurring alone or in association
with insomnia or short term psychosomatic, organic or psychotic
illness. The use of Clobazam to treat
short-term mild anxiety is inappropriate and unsuitable.
Before treatment of anxiety states associated with emotional
instability, it must first be determined
whether the patient suffers from a depressive disorder requiring
adjunctive or different treatment. Indeed,
in patients with anxiety associated with depression, Clobazam must be
used only in conjunction with
adequate concomitant treatment. Use of benzodiazepine (such as
Clobazam) alone, can precipitate suicide
in such patients.
In patients with schizophrenic or other psychotic illnesses, use of
benzodiazepines is recommended only
for adjunctive, i.e. not for primary treatment.
Clobazam may be used as adjunctive therapy in epilepsy.
4.2 Posology and method of administration
Posology
Treatment of anxiety
The usual anxiolytic dose for adults and adolescents over 15 years of
age is 20-30 mg daily in divided
doses or as a single dose given at night. Doses up to 60mg daily have
been used in the treatment of adult
in-patients with severe anxiety.
The lowest dose that can control symptoms should be used. Afte
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