Buspar 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buspirone hydrochloride

Available from:

Waymade Healthcare Plc

ATC code:

N05BE01

INN (International Name):

Buspirone hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200

Patient Information leaflet

BUSPAR
TM TABLETS 5MG AND 10MG
Buspirone Hydrochloride
Read all of this leaflet carefully before you start taking this
medicine.
. Keep this leaflet. You may need to read it again.
. If you have any further questions, ask your doctor or pharmacist.
. This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
In this leaflet:
1. What Buspar is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1.
WHAT BUSPAR IS AND WHAT IT IS USED FOR
Buspar belong to a group of medicines called anxiolytics. These
medicines work on the
central nervous system, altering levels of chemicals in the brain.
Buspar may be used for the:

short term management of anxiety disorders

relief of symptoms of anxiety with or without symptoms of depression.
2.
BEFORE YOU TAKE BUSPAR
DO NOT TAKE BUSPAR
AND TELL YOUR DOCTOR IF YOU:

are ALLERGIC (hypersensitive) to buspirone hydrochloride or any of the
other
ingredients in Buspar (see section 6).

are PREGNANT or BREAST-FEEDING.

have EPILEPSY.

have SEVERELY impaired LIVER or KIDNEY function.
CHECK WITH YOUR DOCTOR OR PHARMACIST before taking Buspar if you have:

had impaired LIVER or KIDNEY function in the past.

been prescribed a BENZODIAZEPINE e.g. nitrazepam or temazepam or
another common
SEDATIVE or HYPNOTIC medicine. You should be gradually withdrawn from
these medicines
before taking Buspar.

ACUTE NARROW-ANGLE GLAUCOMA

MYASTHENIA GRAVIS, a disorder characterised by muscle weakness,
difficulty chewing or
swallowing and slurred speech

or have had DRUG DEPENDENCE
TAKING OTHER MEDICINES
Please TELL YOUR DOCTOR OR PHARMACIST if you are taking or have
recently taken any other
medicines, including medicines obtained without a prescription.
Especially:

monoamine-oxidase inhibitors (MAOIs) such as phenelzine and
tranylcypromine (for
depression)

St. John’s Wort, nefazodone and L-tryptophan, fluvoxamine, trazod

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Buspar Tablets 10MG.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: buspirone hydrochloride 10mg.
3
PHARMACEUTICAL FORM
Oral tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Buspar is indicated for the short-term management of anxiety disorders
and
the relief of symptoms of anxiety with or without accompanying
depression.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The dosage should be individualized for each patient
_Adults (including the elderly): _the usual starting dosage is 5mg
given two to
three times per day. The dosage may be increased every 2-3 days. The
usual
therapeutic dosage is 15 to 30mg daily in divided doses. The maximum
recommended
dose
is
45mg
daily
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. If buspirone is
administered with a
potent
CYP3A4
inhibitor,
the
initial
dose
should
be
lowered
and
only
increased gradually after medical evaluation (see section 4.5).
Grapefruit juice increases the plasma concentrations of buspirone.
Patients
taking buspirone should avoid consuming large quantities of grapefruit
juice.
_ _
_Renal impairment _
After
a
single
administration
to
patients
with
mild
to
moderate
renal
insufficiency (creatinin clearance 20-49 ml/min/1.72 m
2
) a slight increase in
the buspirone blood levels was seen, without increase of the half-life
time. In
these patients buspirone should be administered with caution and a low
dosage, two-times daily, is advised. The response and the symptoms of
the
patients should be evaluated carefully, before an eventual increase of
the
dosage is made. A single administration to anuretic patients causes an
increase
in the blood levels of the metabolite 1-pyrimidine/piperazine (1-PP),
in which
dialysis did not prove to have any influence on the buspirone levels,
neither on
the 1-PP levels. Buspirone should not be administered to patients with
a