Tapclob

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Clobazam 1 mg/mL

Available from:

Max Health Limited

Dosage:

5 mg/5mL

Pharmaceutical form:

Oral suspension

Composition:

Active: Clobazam 1 mg/mL Excipient: Acesulfame potassium Dibasic sodium phosphate dihydrate Monobasic sodium phosphate dihydrate Purified water Raspberry flavour R00287 Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Sorbitol Xanthan gum

Prescription type:

Class C5 Controlled Drug

Therapeutic indications:

Adjunctive therapy in partial or generalised epilepsy and monotherapy in certain forms of epilepsy such as Lennox-Gastaut and catamenial epilepsy.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, Type III amber with CR cap in cardboard carton with 30 mL dosing cup and 5 mL oral syringe - 150 mL - 24 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C - Bottle, glass, Type III amber with CR cap in cardboard carton with 30 mL dosing cup and 5 mL oral syringe - 250 mL - 24 months from date of manufacture stored at or below 25°C 28 days opened stored at or below 25°C

Authorization date:

2017-09-25

Patient Information leaflet

TAPCLOB
_Clobazam 5mg/5mL and 10mg/5mL Oral Suspension _
CONSUMER MEDICINE INFORMATION (CMI)
1
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Tapclob.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
this medicine against the benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT TAPCLOB IS USED
FOR
Tapclob is used to control certain
types of epilepsy. Epilepsy is a
neurological condition in which a
person may experience repeated
seizures (fits).
Tapclob belongs to a group of
medicines called
benzodiazepines. They are
thought to work by their action
on brain chemicals.
In general, benzodiazepines such
as Tapclob should be taken for
short periods only (up to one
month). Continuous long term
use is not recommended unless
advised by your doctor. The
prolonged use of benzodiazepines
may lead to dependence on the
medicine.
Your doctor, however, may
prescribe Tapclob for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
TAPCLOB
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TAPCLOB IF YOU HAVE:
•
severe or chronic lung
disease
•
a history of drug or alcohol
abuse
•
severe muscle weakness
known as myasthenia gravis
•
sleep apnoea syndrome
where you snore heavily and
stop breathing during the
night
•
severely reduced liver
function.
DO NOT TAKE TAPCLOB (CLOBAZAM)
IF YOU ARE ALLERGIC TO IT OR ANY
OTHER MEDICINE FROM THE
BENZODIAZEPINE GROUP OF
MEDICINES OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of
the face, lips or tongue, which
may cause difficulty in

Summary of Product characteristics

NEW ZEALAND DATA SHEET
1 PRODUCT NAME
Tapclob, 5mg/5ml Oral Suspension
Tapclob, 10mg/5ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tapclob 5mg/5ml Oral Suspension
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.
Tapclob 10mg/5ml Oral Suspension
Each 5ml of suspension contains 10mg of clobazam.
Each 5ml of suspension contains 1250mg of Sorbitol, 10.3mg of Sodium
Methyl Hydroxybenzoate and
1.12 mg of Sodium Propyl Hydroxybenzoate.
For the 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
Adjunctive therapy in partial or generalised epilepsy and monotherapy
in certain forms of
epilepsy such as Lennox-Gastaut and catamenial epilepsy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Small doses should be used initially, 5-15mg/day, gradually increasing
to a maximum daily dose of
60mg/day, as directed by the doctor. The possible interference with
alertness and reaction time must
be taken into account. After improvement of the symptoms, the dose may
be reduced. The
fundamental principle is to keep the dose as low as possible. Constant
doses, e.g. 20mg/day and
intermittent therapy, discontinuing clobazam and subsequently
prescribing it again, have proved
effective. If the daily dose is divided, the higher proportion should
be taken at night.
Daily doses up to 30mg may be taken as a single dose at night.
ADULTS:
20 - 30 mg daily in divided doses or as a single dose at night.
Maximum dose 60 mg.
CHILDREN AND ELDERLY PATIENTS:
Half the adult dose.
Page 2 of 15
Children over 3 years and elderly patients receive half the daily dose
recommended for adults.
Clobazam should not normally be given to children between the age of 6
months and 3 years, unless
it is strictly indicated.
In patients with impaired liver and kidney function, the dosage should