Buspirone

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Buspirone hydrochloride 5mg

Available from:

Orion Pharma (NZ) Limited

INN (International Name):

Buspirone hydrochloride 5 mg

Dosage:

5 mg

Pharmaceutical form:

Tablet

Composition:

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

Prescription type:

Prescription

Manufactured by:

Fermion Oy

Therapeutic indications:

Buspirone hydrochloride is indicated for the management of anxiety with or without accompanying depression in adults. Buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil blister strips of 10 - 20 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 50 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2015-07-15

Patient Information leaflet

Buspirone (Orion)
1
BUSPIRONE
_Buspirone hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using Buspirone.
This leaflet answers some common
questions about Buspirone. 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 using Buspirone
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT BUSPIRONE IS
USED FOR
Buspirone is a medicine that is used
for the symptomatic treatment of
anxiety states of clinically relevant
severity with the following cardinal
symptoms: anxiety, agitation,
tension.
Your doctor may have prescribed
Buspirone for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BUSPIRONE HAS
BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
BUSPIRONE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE BUSPIRONE IF:
•
you have ever had an allergy to
buspirone or to any of the other
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 TAKE BUSPIRONE IF:
•
you suffer from acute angle-
closure glaucoma (eye disease)
•
you suffer from myasthenia
gravis (severe muscle weakness)
•
you if you suffer from any severe
liver or kidney disease
•
you suffer from epilepsy
•
you suffer from acute intoxication
with alcohol, hypnotics,
analgesics, or antipsychotic
drugs.
If you are not sure whether any of the
above conditions apply to you, your
doctor can advise you.
DO NOT TAKE BUSPIRONE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF T

Summary of Product characteristics

Data sheet – Buspirone (Orion)
Page 1 of 12
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Buspirone (Orion) 5 mg tablets
Buspirone (Orion) 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg buspirone hydrochloride. Each tablet
contains 10 mg buspirone
hydrochloride.
Excipient with known effect: contains sugars as lactose.
_5 MG TABLET_: Each tablet contains 59.5 mg lactose (as monohydrate)
_10 MG TABLET_: Each tablet contains 118.9 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
5 MG TABLET:
White or almost white, oval tablets debossed with ‘ORN 30’ on one
side and a score on the
other side.
The tablet can be divided into equal doses.
10 MG TABLET:
White or almost white, oval tablets debossed with ‘ORN 31’ on one
side and a score on the
other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Buspirone
hydrochloride
is indicated for the management of anxiety with or without
accompanying depression in adults.
Buspirone hydrochloride is indicated for the management of anxiety
disorders or the short-
term relief of symptoms of anxiety with or without accompanying
depression.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The usual starting dose is 5 mg given three times daily. This may be
titrated according to the
needs of the patient and the daily dose increased by 5 mg increments
every two or three
days depending upon the therapeutic response to a maximum daily dose
of 60 mg. After
dosage titration the usual daily dose will be 20 to 30 mg per day in
divided doses.
Food increases the bioavailability of buspirone. Buspirone should be
taken at the same time
each day and consistently with or without food (see Pharmacokinetics).
If buspirone is given with a potent inhibitor of CYP3A4 such as
itraconazole or nefazodone,
the initial dose of buspirone should be reduced and titrated based on
clinical assessment
(see section 4.5).
Data sheet – Buspirone (Orion)
Page 2 of 12
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