Neulactil 10mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

periciazine, Quantity: 10 mg

Available from:

Clinect Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; wheat starch; magnesium stearate; colloidal anhydrous silica

Administration route:

Oral

Units in package:

100 x 10mg tablets

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Severe anxiety and tension states and the maintenance treatment of the psychotic patient. It is useful in controlling such symptoms as impulsiveness and aggression.

Product summary:

Visual Identification: VERY PALE LIME YELLOW COLOURED, BICONVEX TABLETS WITH A MATT FINISH, SOMETIMES SHOWING LIGHT YELLOW MOTTLING OR SPECKS. DEBOSSED WITH 10 ON ONE FACE, OPPOSITE FACE SCORED.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

1991-10-21

Patient Information leaflet

NEULACTIL
®
N
E
U
L
A
C
T
I
L
®
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 caref

Summary of Product characteristics

neulactil-ccdsv5-piv17-09may22
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION – NEULACTIL
(PERICIAZINE)
1
NAME OF THE MEDICINE
Periciazine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neulactil tablets contain periciazine (2.5 mg and 10 mg)
Excipients with known effect: contains sugars (as lactose) and wheat
starch.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablets
2.5 mg: yellow, scored, marked NEULACTIL
10 mg: yellow, scored, marked 10
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Severe anxiety and tension states and the maintenance treatment of the
psychotic patient. It is
useful in controlling such symptoms as impulsiveness and aggression.
4.2
DOSE AND METHOD OF ADMINISTRATION
In all cases, dosage may be progressively increased until the most
effective level is reached
after which the dosage should be adjusted to maintain control of
symptoms.
MILD TO MODERATE CONDITIONS IN GENERAL PRACTICE
_ADULTS _
The initial daily dosage is 15 to 30 mg divided into two portions with
the larger dose given in
the evening.
neulactil-ccdsv5-piv17-09may22
Page 2 of 17
_GERIATRIC PATIENTS _
The starting dose is 10 mg/day, increasing according to therapeutic
effect and patient
tolerance, to a maximum of about 30 mg daily in divided doses.
MODERATE TO SEVERE CONDITIONS
_HOSPITALISED ADULT PATIENTS _
Initial dosage is 25 to 75 mg/day orally, administered in divided
doses.
_CHILDREN _
The initial daily dosage should not exceed 0.5 mg per year of age. Use
in children below 1
year of age is contraindicated. In older children (16 years) the
twenty four hour dose should
be about 1 mg/year of age. Dosages up to 75 mg/day are used in
hospitals without any
untoward effects.
4.3
CONTRAINDICATIONS
Periciazine should never be used in the following circumstances:
•
Circulatory collapse.
•
Acute intoxication with central depression and coma.
•
Previous history of blood dyscrasias. or agranulocytosis.
•
Hypersensitivity to periciazine, other phenothiazines or to any of the
other ingredi