PROCALM prochlorperazine maleate 5 mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

prochlorperazine maleate, Quantity: 5 mg

Disponible des:

Arrotex Pharmaceuticals Pty Ltd

Designació comuna internacional (DCI):

Prochlorperazine maleate

formulario farmacéutico:

Tablet

Composición:

Excipient Ingredients: lactose monohydrate; maize starch; purified water; colloidal anhydrous silica; magnesium stearate

Vía de administración:

Oral

Unidades en paquete:

10, 100, 84, 25, 56, 14, 250, 28

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Nausea and vomiting due to various causes including migraine; vertigo due to Meniere's Syndrome, labyrinthitis and other causes.

Resumen del producto:

Visual Identification: White/off white, circular, uncoated tablets, '5' embossed on one side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Registered

Data d'autorització:

2010-04-19

Informació per a l'usuari

PROCALM- Consumer Medicine Information
Page 1 of 5
PROCALM
prochlorperazine maleate
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PROCALM. 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 benefits and
risks. Your doctor has weighed the
risks of you taking PROCALM
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
WHAT PROCALM IS USED
FOR
PROCALM belongs to a group of
medicines called phenothiazines. It
helps to correct chemical
imbalances in the brain, allowing it
to function correctly. These
chemicals may also affect the parts
of the brain which control nausea
(feeling sick) and vomiting.
PROCALM is used to treat nausea,
vomiting and dizziness due to
various causes, including migraine
(severe headache).
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS
BEEN PRESCRIBED FOR YOU.
PROCALM is available only with a
doctor's prescription.
This medicine is not recommended
for use in children (under the age of
2 years or children under 10 kg in
weight) because children may
develop unusual face and body
movements
BEFORE YOU TAKE IT
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE PROCALM IF YOU
HAVE AN ALLERGY TO:
•
prochlorperazine
•
the group of medicines called
phenothiazines
•
any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to
make sure you can use this
medicine
Symptoms of an allergic reaction to
PROCALM may include:
•
shortness of breath, wheezing or
difficulty in breathing
•
swelling of the face, lips, tongue or
other parts of the body
•
rash, itching or hives on the skin.
YOU SHOULD NOT TAKE PROCALM IF
YOU HAVE ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
shock
•
disease of the blood with

Fitxa tècnica

1
AUSTRALIAN PRODUCT INFORMATION – PROCALM
(PROCHLORPERAZINE MALEATE) TABLETS
1
NAME OF THE MEDICINE
Prochlorperazine maleate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Procalm tablets contain 5mg of prochlorperazine maleate.
Excipients with known effect: contains sugars (as lactose).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PROCALM: 5 mg prochlorperazine maleate, white to off-white, circular,
uncoated tablets with ‘5’
embossed on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Nausea and vomiting due to various causes including migraine; vertigo
due to Meniere’s Syndrome,
labyrinthitis and other causes.
4.2
D
OSE AND METHOD OF ADMINISTRATION
NAUSEA AND VOMITING
Adults:
Dosage should be adjusted to suit the
response of the individual, beginning with the lowest
recommended dosage.
Oral – 5 or 10 mg two or three times daily
Acute – 20 mg at once, followed, if necessary by 10 mg two hours
later
Children: (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE,
Paediatric Use)
If it is considered unavoidable to use prochlorperazine for a child,
the dosage is 250 micrograms/ kg
bodyweight two or three times a day.
Prochlorperazine has been associated with dystonic reactions
particularly after a cumulative dosage
of 500 micrograms/ kg. It should therefore be used cautiously in
children.
2
Prochlorperazine is not recommended for children weighing less than 10
kg.
VERTIGO IN MENIERE’S SYNDROME
Adults:
Oral – 5 to 10 mg three to four times daily. Dosage may be reduced
gradually after several weeks to a
maintenance dosage of 5 to 10 mg daily.
Children:
Oral – same as for nausea and vomiting.
Geriatric:
In general, dosages in the lower range are sufficient for most elderly
patients. Since they are especially
susceptible to hypotension and extrapyramidal reactions, such patients
should be observed closely.
Dosage should be increased more gradually in elderly patients.
IMPAIRED LIVER FUNCTION
Since prochlorperazine is extensively metabolized