Stelazine 1mg/5ml Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Trifluoperazine

Available from:

Amdipharm Limited

ATC code:

N05AB; N05AB06

INN (International Name):

Trifluoperazine

Dosage:

1 mg/5ml

Pharmaceutical form:

Syrup

Therapeutic area:

Phenothiazines with piperazine structure; trifluoperazine

Authorization status:

Not marketed

Authorization date:

1997-04-01

Patient Information leaflet

• Swelling, discolouration or pain in your leg, arm or in your
chest, or breathing
problems, which may be caused by a blood clot.
• If you suffer from a sore throat, high fever, feel very tired,
become pale, develop
bruises and nose bleeds. These may indicate blood problems developing
as a
result of using this medicine.
If you stop taking this medicine regularly, you may suddenly feel
sick, be sick, sweat
and have difficulty in sleeping. Do not stop taking this medicine
without the advice of
your doctor.
Some
patients
may
experience
weakness,
drowsiness,
dizziness,
restlessness,
difficulty in sleeping, dry mouth, blurred vision, muscle weakness,
loss of appetite,
faintness on standing up, skin rashes (including increased sensitivity
to the sun),
weight gain, water retention causing swelling or confusion. These are
dependent on
the dose that you are taking, and tend to disappear when you have
finished taking the
medicine.
Your doctor should check your progress regularly to make sure no
unwanted effects
are developing.
If any of the side effects become serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. You can also report
side effects directly
via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel:
[phone];
Fax: [phone]. Website: www.hpra.ie. E-mail: [e-mail].
By reporting side effects you can help provide more information on the
safety of this
medicine.
5. HOW TO STORE STELAZINE SYRUP
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
label after “Exp”.
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package.
Do not throw away any medicines via wastewater or household waste. Ask
your
pharmacist how to throw away medicines

Summary of Product characteristics

Health Products Regulatory Authority
05 April 2019
CRN008RTX
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stelazine 1mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of syrup contains 1 mg of trifluoperazine as trifluoperazine
hydrochloride.
Excipients: Each 5ml of syrup contains 0.01mg sunset yellow (E110) and
1.76ml sorbitol liquid (E420).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
A clear, yellow, solution with a peach aroma.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of anxiety states, and psychoses, and as an
anti-emetic.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ORAL ADMINISTRATION:
LOW DOSAGE REQUIREMENTS
Adults:
The usual total daily dosage is 2 to 6mg in divided doses.
Children: Aged 6 to 12 years:
The usual total daily dosage is 1 to 4mg in divided doses.
HIGH DOSAGE REQUIREMENTS
Adults:
The usual total daily dosage is 5 to 25mg in divided doses.
Children: Aged 6 to 12 years:
The usual total daily dosage is 5mg in divided doses.
The Elderly:
Reduce the starting dose in elderly or frail patients by at least
half.
Health Products Regulatory Authority
05 April 2019
CRN008RTX
Page 2 of 6
4.3 CONTRAINDICATIONS
Do not use ‘Stelazine’ in patients with coma particularly if
associated with other central nervous system depressants. Do not
use ‘Stelazine’ in patients with existing blood dyscrasias, or
known liver damage, or in those hypersensitive to trifluoperazine,
related compounds, or any of the excipients. Patients with
uncontrolled cardiac decompensation should not be given
‘Stelazine’.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
‘Stelazine’ should be discontinued at the first sign of clinical
symptoms of tardive dyskinesia and Neuroleptic Malignant
Syndrome.
Patients on long-term phenothiazine therapy require regular and
careful surveillance with particular attention to tardive
dyskinesia and possible eye changes, blood dyscrasias, liver
dysfunction, and myocardial conduction defect