Serenace

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Haloperidol 5mg

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Haloperidol 5 mg

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Haloperidol 5mg Excipient: Acacia Calcium hydrogen phosphate dihydrate Lactose monohydrate Magnesium stearate Maize starch Ponceau 4R

Units in package:

Bottle, plastic, 50 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

RPG Life Sciences Ltd

Therapeutic indications:

The management of manifestations of psychotic disorders such as schizophrenia, psychosis due to organic brain damage or mental deficiency, the manic phase of manic depressive illness, Gilles de la Tourette syndrome.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, 30mL HDPE bottle with PP CR closure - 50 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 50 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, 30mL HDPE bottle with PP CR closure - 100 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 100 tablets - 24 months from date of manufacture stored at or below 30°C - Bottle, plastic, - 500 tablets - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1971-06-25

Patient Information leaflet

1
SERENACE TABLETS AND LIQUID
NEW ZEALAND CONSUMER MEDICINE INFORMATION
SERENACE
TABLETS AND LIQUID
HALOPERIDOL _(HAL OH PER I DOLL)_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SERENACE.
It does not contain all 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 SERENACE
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.
outbursts and body movements
(tics)
Your doctor may have prescribed
SERENACE for another reason.
Ask your doctor if you have any
questions about why SERENACE
has been prescribed for you.
SERENACE belongs to a group of
medicines called antipsychotics. It
helps to correct chemical
imbalances in the brain, which may
cause mental illness. _These _
_chemicals may also affect the parts _
_of the brain, which control nausea _
_and vomiting._
There is no evidence that
SERENACE is addictive or habit
forming.
This medicine is only available with
a doctor’s prescription.
•
Brain damage
•
Parkinson’s Disease
•
Severe depression
•
Alcohol or drug intoxication
•
Spasticity, where a group of
muscles are stiff and restricted
in movement
•
Parkinsonian-like symptoms
together with senility
•
Breast cancer
DO NOT GIVE SERENACE TO
ANYONE WHO IS UNCONSCIOUS OR IN
A COMA.
DO NOT GIVE SERENACE TO
CHILDREN UNDER 12 YEARS OF AGE,
UNLESS DIRECTED BY THE CHILD’S
DOCTOR.
SERENACE is not recommended
for use in children under 3 years of
age.
SERENACE is not recommended
DO NOT TAKE SERENACE AFTER THE
WHAT SERENACE IS USED FOR
SERENACE is used to treat mental
illnesses such as:
for use in children under the age of
3 years, as there is not enough
information on its effects in this age
group.
EXPIRY DATE _(EXP) _PRINTED ON THE
PACK.
DO NOT TAKE SERENACE IF THE
•
schizophrenia, an illness with
PACK

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SERENACE
Haloperidol tablets - 0.5mg; 1.5mg; 5mg
Haloperidol liquid – 2mg/mL
Haloperidol injection – 5mg/mL
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Serenace tablets contains 0.5mg, 1.5mg and 5mg haloperidol
respectively.
Serenace liquid contains 2mg/mL haloperidol
Serenace injection contains 5mg/mL haloperidol
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
SERENACE 0.5mg tablet: (1/4" diameter), green, biconvex, scored,
uncoated,
plain on one side, each containing haloperidol BP 0.5mg.
SERENACE 1.5mg tablet: (9/32" diameter), white, biconvex, scored,
uncoated,
plain on one side, each containing haloperidol BP 1.5mg.
SERENACE 5mg tablet: (5/16" diameter), red, biconvex, scored,
uncoated,
plain on one side, each containing haloperidol BP 5mg.
Liquid
Clear, colourless liquid containing 2mg haloperidol BP per ml, in a
bottle.
Injection Ampoule
1ml amber coloured ampoule containing 5mg haloperidol BP per ml.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Chronic Therapy
The management of manifestations of psychotic disorders such as
schizophrenia, psychosis due to organic brain damage or mental
deficiency, the manic phase of manic depressive illness, Gilles de la
Tourette syndrome.
Short Term Therapy
The treatment of acute alcoholism for the relief of delusions,
hallucinations and confused states, and for the control of
accompanying
tremulousness and aggressive behaviour.
In the treatment of intractable nausea and vomiting associated with
radiation or malignancy and not responding to other therapy.
Neuroleptanalgesia.
2
4.2
DOSAGE AND METHOD OF ADMINISTRATION
Higher doses and intravenous administration of haloperidol appear to
be associated
with a higher risk of QT prolongation and Torsades de Pointes (See
PRECAUTIONS and ADVERSE REACTIONS). Haloperidol solution for injection
is
recommended for intramuscular administration only. However, if
administered
intravenously, continuous ECG monitoring must be performed for QTc
interval
prolongation and