LORAZEPAM VIATRIS lorazepam 2.5 mg tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

lorazepam, Quantity: 2.5 mg

Tilgjengelig fra:

Southern Cross Pharma Pty Ltd

Legemiddelform:

Tablet

Sammensetning:

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

Administreringsrute:

Oral

Enheter i pakken:

50 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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.

Produkt oppsummering:

Visual Identification: White, round, flat, beveled, scored 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

Autorisasjon status:

Registered

Autorisasjon dato:

2019-07-22

Informasjon til brukeren

LORAZEPAM MYLAN /072019/CMI-00
1
LORAZEPAM MYLAN
_contains the active ingredient lorazepam _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about LORAZEPAM
MYLAN.
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 LORAZEPAM
MYLAN 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 LORAZEPAM MYLAN is
used for
LORAZEPAM MYLAN 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.
LORAZEPAM MYLAN 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
LORAZEPAM MYLAN 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LORAZEPAM
MYLAN HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another purpose.
LORAZEPAM MYLAN is available
only with a doctor's prescription.
Before you use LORAZEPAM
MYLAN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LORAZEPAM MYLAN 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 when you
sleep
•
you are depressed with or
without anxiety problems
Lorazepam can increase thoughts
of death

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
LORAZEPAM MYLAN (LORAZEPAM) TABLETS
_ _
1. NAME OF THE MEDICINE
Lorazepam
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Lorazepam MYLAN immediate release tablets contain the active
ingredient lorazepam.
Each Lorazepam MYLAN 0.5 mg tablet contains 0.5 mg of lorazepam.
Each Lorazepam MYLAN 1 mg tablet contains 1 mg of lorazepam.
Each Lorazepam MYLAN 2.5 mg tablet contains 2.5 mg of lorazepam.
Lorazepam is a white or almost white crystalline powder.
Lorazepam MYLAN contains lactose, for the full list of excipients, see
Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Lorazepam MYLAN 0.5 mg immediate release tablets are white, round,
with rounded edge tablets.
Lorazepam MYLAN 1 mg immediate release tablets are white, round, flat,
beveled and scored with the
inscription “1.0” on one side.
Lorazepam MYLAN 2.5 mg i
mmediate 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
Lorazepam MYLAN 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
Lorazepam MYLAN 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
dail