Neulactil

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Periciazine 2.5mg;  ;  

Available from:

Clinect NZ Pty Limited

INN (International Name):

Periciazine 2.5 mg

Dosage:

2.5 mg

Pharmaceutical form:

Tablet

Composition:

Active: Periciazine 2.5mg     Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Wheat starch

Units in package:

Blister pack, 1 x 100, 100 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Katsura Chemical Co Ltd

Therapeutic indications:

In adults with schizophrenia or other psychoses, for the treatment of symptoms or prevention of relapse. In anxiety, psychomotor agitation, violent or dangerously impulsive behaviour. Neulactil is used as an adjunct to the short-term management of these conditions.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 25°C

Authorization date:

1969-12-31

Patient Information leaflet

NEULACTIL®
1
NEULACTIL
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NEULACTIL?
Neulactil contains the active ingredient periciazine. Neulactil is
used to treat patients who feel very anxious and/or tense. It is
used in patients to control symptoms such as impulsiveness and
aggression. It is also used in patients with severe mental
conditions when a person loses contact with reality and is unable to
think and judge clearly. Your doctor may have prescribed
Neulactil for another reason. For more information, see Section 1. Why
am I using Neulactil? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NEULACTIL?
Do not use if you have ever had an allergic reaction to Neulactil or
any of the ingredients listed at the end of the CMI. TALK TO YOUR
DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER
MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING. For more information, see Section 2. What should I know
before I use Neulactil? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Neulactil and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE NEULACTIL?
•
Swallow the tablets with a glass of water. Take Neulactil at about the
same time each day.
More instructions can be found in Section 4. How do I use Neulactil?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEULACTIL?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Neulactil.
•
Tell your doctor if you are pregnant, breastfeeding, or trying to
become pregnant.
THINGS YOU
SHOULD NOT DO
•
Do not take Neulactil to treat any other complaints unless your doctor
tells you to.
•
Do not stop taking Neulactil, or lower or raise the dosage, without
checking with your doctor.
DRIVING OR USING
MACHINES
•
Be careful driv

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
NEULACTIL TABLETS
Neulactil 2.5 mg tablets
Neulactil 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Periciazine 2.5mg
Periciazine 10mg
Excipients with known effect: contains sugars (as lactose) and wheat
starch
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Neulactil tablets
2.5 mg: yellow, scored, marked NEULACTIL
10 mg: yellow, scored, marked 10
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Periciazine is indicated:
1.
In adults with schizophrenia or other psychoses, for the treatment of
symptoms or prevention of
relapse.
2.
In anxiety, psychomotor agitation, violent or dangerously impulsive
behaviour. periciazine is used as
an adjunct to the short-term management of these conditions.
Periciazine tablets are not recommended for children (see Section 4.3
and 4.4).
4.2 DOSE AND METHOD OF ADMINISTRATION
Dosage requirements vary with the individual and the severity of the
condition being treated. Initial dosage
should be low with progressive increases until the desired response is
obtained, after which dosage should
be adjusted to maintain control of symptoms.
_SEVERE CONDITIONS (INDICATION 1) _
ADULTS
Initially 75 mg per day in divided doses. Dosage should be increased
by 25 mg per day at weekly intervals
until optimum effect is achieved. Maintenance therapy would not
normally be expected to exceed 300mg per
day.
ELDERLY
Initially 15-30 mg per day in divided doses. If this is well tolerated
the dosage may be increased if necessary
for optimum control of behaviour.
2
_MILD OR MODERATE CONDITIONS (INDICATION 2) _
ADULTS
Initially 15-30 mg daily, divided into two portions, with a larger
dose being given in the evening.
ELDERLY
5-10mg per day is suggested as a starting dose. It may be divided so
that a larger portion is given in the
evening. Half or quarter the normal adult dose may be sufficient for
maintenance therapy.
4.3 CONTRAINDICATIONS
Periciazine should not be used in the following circumstances:
•
Hypersensitivity to periciazine, other p