TEMAZE temazepam 10mg tablet bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

temazepam, Quantity: 10 mg

Disponível em:

Alphapharm Pty Ltd

Forma farmacêutica:

Tablet, uncoated

Composição:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; maize starch; magnesium stearate

Via de administração:

Oral

Unidades em pacote:

25 tablets, 50 tablets, 30 tablets

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Adjunctive therapy for the short term management of insomnia in adults.

Resumo do produto:

Visual Identification: 5.5 mm flat bevel edged white to off-white tablet, debossed TE over 10 on one side, alpha symbol on the reverse.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status de autorização:

Registered

Data de autorização:

1998-05-13

Folheto informativo - Bula

TEMAZE
_contains the active ingredient temazepam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Temaze.
It does not contain all 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 Temaze against
the benefits expected 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 TEMAZE IS USED
FOR
Temaze is used to treat sleeping
problems, also called insomnia.
Temaze belongs to a group of
medicines called benzodiazepines.
These medicines are thought to work
by acting on brain chemicals.
In general, benzodiazepines such as
Temaze should be taken for short
periods only (for example 2 to 4
weeks). Continuous long term use is
not recommended unless advised by
your doctor. The use of
benzodiazepines may lead to
dependence on the medicine.
Temaze is not recommended for use
in children under the age of 16, as its
safety and effectiveness have not
been established in this age group.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TEMAZE HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Temaze for another reason.
Temaze is available only with a
doctor's prescription.
BEFORE YOU TAKE
TEMAZE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TEMAZE IF YOU ARE
ALLERGIC TO:
•
temazepam or any other
benzodiazepine medicine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing;
wheezing or shortness of breath.
DO NOT TAKE TEMAZE IF YOU HAVE:
•
severe lung disease or breathing
difficulties
•
sleep apnoea, a condition where
you have breathing problems
when you sleep.
DO NOT TAKE TEMAZE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING I

Características técnicas

AUSTRALIAN PRODUCT INFORMATION
TEMAZE
_temazepam tablets _
1
NAME OF THE MEDICINE
Temazepam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Temaze tablet contains 10 mg of temazepam.
Excipients with known effect: Sugars (as lactose). Also contains
traces of galactose and sulfites.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Temazepam 10 mg tablet: 5.5 mm flat bevel edged white to off-white
tablet, debossed “TE” on one side and
"α" on the other. 10
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Temaze is indicated for:
•
Adjunctive therapy in the short term management of insomnia in adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage should be individualised for maximum beneficial effect. For use
as a hypnotic, the usual adult dose
is 10 to 30 mg, taken one-half hour before retiring. In elderly or
debilitated patients, 10 mg Temaze is the
initial recommended dosage (see Section 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE -
Elderly or debilitated patients).
The need for continued therapy with Temaze in patients who have been
taking medication for several weeks
should be evaluated periodically.
Temaze is not recommended for children.
4.3
CONTRAINDICATIONS
Temaze is contraindicated in:
•
Patients with a known hypersensitivity to benzodiazepines or to any of
the components of the
formulation.
•
Patients with chronic obstructive airways disease with incipient
respiratory failure.
•
Patients with sleep apnoea.
Temazepam should not be used as monotherapy to treat depression, or
symptoms of anxiety associated with
depression, due to a risk of suicide (see Section 4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
HYPOTENSION
Although hypotension has occurred rarely, Temaze should be
administered with caution to patients in whom
a drop in blood pressure might lead to cardiac or cerebral
complications. This is particularly important in
elderly patients.
TEMAZE – PRODUCT INFORMATION
2
AMNESIA
Transient amnesia or memo