Buspirone Viatris

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Buspirone hydrochloride 5mg;  

Tersedia dari:

Viatris Limited

INN (Nama Internasional):

Buspirone hydrochloride 5 mg

Dosis:

5 mg

Bentuk farmasi:

Tablet

Komposisi:

Active: Buspirone hydrochloride 5mg   Excipient: Colloidal anhydrous silica Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate

Unit dalam paket:

Blister pack, PVC/Al foil, 30 tablets

Kelas:

Prescription

Jenis Resep:

Prescription

Diproduksi oleh:

Excella GmbH & Co KG

Indikasi Terapi:

Buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression. The diagnosis of patients studied in controlled clinical trials of buspirone corresponds to the Generalised Anxiety Disorder of the WHO classification as described below: Generalised, persistent anxiety is manifested by symptoms from three of the following four categories: General tensions: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. Autonomic hyperactivity: sweating, heart pounding or racing, cold clammy hands, dry mouth, dizziness, lightheadedness, paraesthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhoea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. Apprehensive expectati

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al foil or PVC/AL foil - 30 tablets - 36 months unopened stored at or below 25°C protect from light - Blister pack, PVC/PVdC/Al foil or PVC/AL foil - 100 tablets - 36 months unopened stored at or below 25°C protect from light - Bottle, plastic, HDPE with pp cap - 100 tablets - 36 months unopened stored at or below 25°C protect from light

Tanggal Otorisasi:

2001-06-05

Selebaran informasi

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BUSPIRONE VIATRIS
_BUSPIRONE HYDROCHLORIDE TABLETS 5 MG & 10 MG _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking BUSPIRONE
VIATRIS.
This leaflet answers some common
questions about BUSPIRONE
VIATRIS.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking BUSPIRONE
VIATRIS against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT BUSPIRONE
VIATRIS IS USED FOR
BUSPIRONE VIATRIS is used to
treat anxiety over short periods of
time. The way it works is unknown.
It does not relax muscles or cause
drowsiness in most patients.
BUSPIRONE VIATRIS contains the
active ingredient buspirone
hydrochloride. It belongs to a group
of medicines called anxiolytics.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence BUSPIRONE
VIATRIS is addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
BUSPIRONE
VIATRIS
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE BUSPIRONE VIATRIS
IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
buspirone hydrochloride
•
any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO NOT GIVE THIS MEDICINE TO A
CHILD UNDER THE AGE OF 18 YEARS.
Safety and effectiveness in children
younger than 18 years have not
been established.
DO NOT BREAST-FEED IF YOU ARE
TAKING THIS MEDICINE.
The active ingredient in
BUSPIRONE VIATRIS passes into
breast milk and there is a p

Karakteristik produk

Page 1 of 13
NEW ZEALAND DATA SHEET
BUSPIRONE VIATRIS
1. PRODUCT NAME
BUSPIRONE VIATRIS, 5 mg and 10 mg, tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg or 10 mg of buspirone hydrochloride.
EXCIPIENT WITH KNOWN EFFECT:
Sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
5 mg tablets: white, round bevel edged tablet, 7 mm in diameter
embossed “BR 5” embossed on one
side and “G” on the other side.
10 mg tablets: white, 11 mm x 5.5 mm capsule shaped tablet embossed
“BR/10” on one side and
“G” on the other side.
Please note: "BR/10" is a written representation of the embossing "BR"
score line "10"
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
Buspirone hydrochloride is indicated for the management of anxiety
disorders or the short-term relief
of symptoms of anxiety with or without accompanying depression. The
diagnosis of patients studied
in controlled clinical trials of buspirone corresponds to the
Generalised Anxiety Disorder of the WHO
classification as described below:
Generalised, persistent anxiety is manifested by symptoms from three
of the following four
categories:
GENERAL TENSIONS: shakiness, jitteriness, jumpiness, trembling,
tension, muscle aches, fatigability,
inability to relax, eyelid twitch, furrowed brow, strained face,
fidgeting, restlessness, easy startle.
AUTONOMIC HYPERACTIVITY: sweating, heart pounding or racing, cold
clammy hands, dry mouth,
dizziness, lightheadedness, paraesthesias (tingling in hands or feet),
upset stomach, hot or cold
spells, frequent urination, diarrhoea, discomfort in the pit of the
stomach, lump in the throat, flushing,
pallor, high resting pulse and respiration rate.
APPREHENSIVE EXPECTATIONS: anxiety, worry, fear, rumination, and
anticipation of misfortune to self
or others.
VIGILANCE AND SCANNING: hypertensiveness resulting in distractibility,
difficulty in concentrating,
insomnia, feeling “on edge”, irritability, impatience.
Page 2 of 13
The anxious mood has been cont