LORAZE lorazepam 0.5 mg tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

lorazepam, Quantity: 0.5 mg

Предлага се от:

Southern XP IP Pty Ltd

Лекарствена форма:

Tablet

Композиция:

Excipient Ingredients: maize starch; microcrystalline cellulose; sodium starch glycollate type A; magnesium stearate; polacrilin potassium; lactose monohydrate; povidone; crospovidone

Начин на приложение:

Oral

Броя в опаковка:

100 tablets

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The physician should periodically reassess the usefulness of the drug for the individual patient. Pre-surgical medication taken the night before surgery and/or 1-2 hours prior to the surgical procedure.

Каталог на резюме:

Visual Identification: White, round, rounded edge tablets; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

2019-07-22

Листовка

1
LORAZE
_contains the active ingredient lorazepam _
_ _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about LORAZE.
It does not contain all of the
available information. It does not
take the place of talking to your
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LORAZE HAS
BEEN PRESCRIBED FOR YOU. Your
doctor may have prescribed it for
another purpose.
LORAZE is available only with a
doctor's prescription.
•
any other medicines,
•
any other substances, such as
foods, preservatives or dyes.
TELL YOUR DOCTOR OR PHARMACIST IF
YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
DO NOT TAKE LORAZE IF YOU ARE
doctor or pharmacist.
PREGNANT OR PLANNING TO BECOME
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking LORAZE 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 LORAZE is used for
LORAZE tablets contain the active
ingredient lorazepam, which
belongs to a group of medicines
called benzodiazepines. They are
thought to work by their action on
brain chemicals.
LORAZE is used to relieve anxiety.
However anxiety or tension
associated with the normal stress
of everyday life usually does not
require treatment with medicines.
It is also used before surgery to
help relax you.
In general, benzodiazepines such as
LORAZE should be taken for short
periods only (for example 2-4
weeks). Continuous long term use
is not recommended unless advised
by your doctor. The use of
benzodiazepines may lead to
dependence on the medicine.
Before you use LORAZE
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE LORAZE IF YOU HAVE:
•
you are allergic to lorazepam,
any of the ingredients at the end
of this leaflet or any other
medicine from the
benzodiazepine group of
medicines
•
you have severe and chronic lung
disease
•
you have sleep apnoea, a
condition where you have
breathing problems w

Данни за продукта

AUSTRALIAN PRODUCT INFORMATION
LORAZE (LORAZEPAM), TABLETS
1.
NAME OF THE MEDICINE
Lorazepam
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LORAZE immediate release tablets contain the active ingredient
lorazepam.
Each LORAZE 0.5 mg tablet contains 0.5 mg of lorazepam.
Each LORAZE 1 mg tablet contains 1 mg of lorazepam.
Each LORAZE 2.5 mg tablet contains 2.5 mg of lorazepam.
Excipients with known effect: sugars as lactose. For the full list of
excipients, see Section 6.1 LIST OF
EXCIPIENTS.
3.
PHARMACEUTICAL FORM
LORAZE 0.5 mg immediate release tablets are white, round, with rounded
edge tablets.
LORAZE 1 mg immediate release tablets are white, round, flat, beveled
and scored with the inscription “1.0”
on one side.
LORAZE 2.5 mg immediate release tablets are white, round, flat,
beveled and scored tablets.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Management of anxiety disorders or for the short-term relief of the
symptoms of anxiety or anxiety
associated with depressive symptoms.
Anxiety or tension associated with the stress of everyday life usually
does not require treatment with an
anxiolytic. The physician should periodically reassess the usefulness
of the drug for the individual patient.
Pre-surgical medication taken the night before surgery and/or 1-2
hours prior to the surgical procedure.
4.2. DOSE AND METHOD OF ADMINISTRATION
LORAZE is administered orally. For optimal results, dose, frequency of
administration and duration of therapy
should be individualised according to patient response. Dosage should
be individualised for maximum
beneficial effect. In patients previously treated with anxiolytic
agents, higher initial dosages of LORAZE may
be indicated.
The average daily dosage for treatment of anxiety is 2-3 mg
administered in divided doses, however, this may
range between 1 and 10 mg.
For insomnia due to anxiety or transient situational stress, a single
daily dose of 1-2 mg may be given, usually
at bedtime.
LORAZE – AUSTRALIAN PRODUCT INFORMATION
2
For patients with anxiety and/or insomnia