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BUSPIRONE HYDROCHLORIDE 10MG TABLETS

Active substance(s): BUSPIRONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR
THE PATIENT

BUSPIRONE
HYDROCHLORIDE
10mg TABLETS
(buspirone hydrochloride)

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet
What is in this leaflet:
1. What Buspirone is and what it is used for
2. What you need to know before you take
Buspirone
3. How to take Buspirone
4. Possible side effects
5. How to store Buspirone
6. Contents of the pack and other information

1. WHAT BUSPIRONE IS AND WHAT IT IS
USED FOR
Buspirone contains the active ingredient
buspirone hydrochloride. Buspirone belongs to
a group of medicines called azapirones, used to
treat anxiety. These medicines work on the
central nervous system, altering levels of
chemicals in the brain which can help make you
feel anxious. It should only be taken for a short
time to relieve anxiety.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE BUSPIRONE
Do not take Buspirone:
if you are allergic to buspirone or to any of
the other ingredients in this medicine (listed
in section 6)
if you have severe liver or kidney problems
if you have epilepsy (suffer from fits)
if you have consumed high quantities of
alcohol, hypnotics, pain killers or
antipsychotic drugs (for mental illness) in the
last few days.
Warnings and precautions
Talk to your doctor or pharmacist before taking
buspirone:
if you have been prescribed a
benzodiazepine e.g. nitrazepam, temazepam,
or another common sedative or hypnotic
medicine (which may make you feel sleepy).
You should be gradually withdrawn from
these medicines before taking Buspirone
if you suffer from liver or kidney problems or
had them in the past
if you have a condition which causes your
muscles to become weak and tire easily
(myasthenia gravis)
if you suffer from addiction to drugs
if you suffer from high pressure in the eye
(glaucoma)
if you are suffering from depression and are
not feeling anxious, buspirone should not be
used alone to treat depression.
Other medicines and Buspirone
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, or the following:
medicines known as monoamine oxidase
inhibitors (MAOIs) to treat depression, such
as phenelzine or tranylcypromine should not
be taken with buspirone
other medicines to treat anxiety or
depression, or to help you sleep e.g.
nefazodone
medicine to treat mental illness
(antipsychotics) e.g. haloperidol and lithium
medicine for stomach ulcers e.g. cimetidine
antibiotics such as erythromycin, rifampicin,
linezolid
anti-fungal medicine such as itraconazole or
ketoconazole
certain antivirals which are used in treatment
of HIV disease
St John's wort, a herbal remedy
medicine to treat anxiety including those
containing benzodiazepine e.g. diazepam
calcium channel blocker medicines used to
treat heart conditions e.g. diltiazem,
verapamil

medicines used to treat depression, such as
selective serotonin re-uptake inhibitors
(e.g. fluoxetine, paroxetine, fluvoxamine),
trazodone and L-tryptophan
medicines called triptans, which are used for
migraines (e.g. sumatriptan)
tramadol (painkiller)
baclofen (a muscle relaxant)
digoxin which is used to treat heart
conditions
medicines used for epilepsy, such as
carbamazepine, phenytoin and phenobarbital
antihistamines (used to treat allergic
reactions)
nabilone (used to treat nausea and vomiting)
lofexidine (used to aid drug withdrawal)
warfarin which is used to prevent blood clots.
Buspirone with food, drink and alcohol
Do not take buspirone with large quantities of
grapefruit juice as this may increase the effect of
your medicine causing side effects. Do not drink
alcohol while taking buspirone.
Buspirone can be taken before, during or after
food, but make sure you take it the same way
each day.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Buspirone should not be given to a pregnant or
breast-feeding mother as it is not known if it
affects the growth of the unborn or breast-fed
baby. Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
Do not drive or operate machinery until you
know that Buspirone does not reduce your
reaction time by making you sleepy, dizzy or less
alert. You are more likely to suffer these side
effects at the start of treatment or when your
dose is changed.
Buspirone contains lactose if you have been
told by your doctor that you have an
intolerance to some sugars, such as lactose
contact your doctor before taking this medicine.

3. HOW TO TAKE BUSPIRONE
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The tablet can be divided into equal doses.
Buspirone can be taken before, during or after
food, but make sure you take it in the same way
each day. These tablets should not be chewed.
Swallow the tablet with a glass of water.
Adults (including older people)
The recommended starting dose is 5mg (half of
a 10mg tablet; the tablet can be divided into
equal doses) two or three times a day. After
several weeks your doctor may increase your
dose depending on how you respond to the
tablets. The recommended daily dose is 15mg to
30mg, divided up throughout the day. The
recommended maximum dose is 45mg a day in
divided doses.
Buspirone should not be taken for a long time
but it may take several weeks before you start to
feel better.
Use in children and adolescents
Buspirone tablets are not recommended for use
in children or adolescents under the age of 18.
Patients with liver or kidney problems
Your doctor may prescribe a lower dose if you
have liver or kidney problems.
If you take more Buspirone than you should
Contact your doctor or nearest hospital
emergency department immediately. Take the
container and any remaining tablets with you.
Symptoms of overdose include dizziness,
headache, ringing or buzzing in the ears,
restlessness, not reacting to light, stomach
problems, slow heartbeat, low blood pressure,
fits and symptoms such as difficulty in speaking
or swallowing, loss of balance control, shuffling
walk, stiffness of arms and legs, trembling or
shaking of hands or fingers, drowsiness, and
feeling or being sick.

(continued overleaf)

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

151215-XXXX-PIL-01
Buspirone PIL - Side 1
480 x 170mm
15 December 2015
14188/01 PIL S1.ai
Black

M2

If you forget to take Buspirone
Take the next dose as soon as you remember
unless it is almost time for your next dose. Do
not take a double dose to make up for a
forgotten dose.
If you stop taking Buspirone
Continue with buspirone until your doctor tells
you otherwise. If you are to stop buspirone
therapy you must follow your doctor's
instructions closely. It is especially important as
this type of medicine should not be stopped
suddenly. If you have any further questions on
the use of this medicine, ask your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects although not everybody gets them.
Stop taking Buspirone tablets and contact
your doctor immediately if you experience:
Very rare side effects
(may affect fewer than 1 in 10,000 people):
high fever, agitation, confusion, trembling and
abrupt contractions of muscles; these may be
signs of a condition called serotonin
syndrome
severe mental condition in which the person
loses contact with reality and is unable to
think and judge clearly (psychosis)
fits or seizures
restricted vision
unusual, uncontrollable movements including
trembling and shaking which may affect
hands, eyes, neck, body
uncontrollable twitching, jerking or writhing
movements.
Contact your doctor immediately if you notice
signs of an allergic reaction:
itchy skin rash, swelling of the face, lips, tongue
or throat, or difficulty breathing or swallowing.
The following side effects have also been
reported;

secretion of breast milk in men, or in women
who are not breast-feeding
a disorder of the central nervous system
(symptoms may include tremor, slurred
speech, involuntary movements, spasm in
muscle of face, shoulder, neck, trunk and
limbs, anxiety and distress).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. HOW TO STORE BUSPIRONE
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date
which is stated on the label or carton after 'EXP'.
The expiry date refers to the last day of that
month. Do not store above 25ÂșC.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you no
longer use. These measures will help to protect
the environment.

6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Buspirone contains
The active substance is 10mg of buspirone
hydrochloride. The other ingredients are lactose
monohydrate, microcrystalline cellulose, sodium
starch glycolate, colloidal anhydrous silica and
magnesium stearate.
What Buspirone looks like and contents of the
pack
Your medicine comes as a white capsule shaped
tablet. The tablets are marked 'BR 10' on one
side and 'G' on the reverse.

Very common side effects
(may affect more than 1 in 10 people)
dizziness
headache
drowsiness.

Buspirone is available in a blister pack 30
tablets.

Common side effects
(may affect up to 1 in 10 people)
feeling nervous or excited
inability to sleep or sleep disturbance
disturbance in attention
depression
blurred vision
confusion
anger
tingling or pins and needles
numbness
abnormal coordination, tremor
buzzing, hissing, whistling, ringing or other
persistent noise in the ears (tinnitus)
chest pain
fast heart beat, palpitations
blocked nose
sore throat
throat pain
being sick (vomiting)
feeling sick (nausea)
dry mouth
diarrhoea
constipation
stomach pain
cold sweats
rash
muscle, bone or joint pain
feeling weak or tired.

PL 14251/0042
Procured from within the EU

MA holder: Manx Healthcare Ltd,
Taylor Group House, Wedgnock Lane, Warwick,
CV34 5YA
POM

Manufacturer: Mylan BV, Dieselweg 25, 3725 LB
Bunschoten, The Netherlands
To request a copy of this leaflet in large print,
audio or Braille, please call 01926 482511.
This leaflet was last revised on 15/12/15
WIP URN: 151215-XXXX-PIL-01

Rare side effects
(may affect up to 1 in 1,000 people)
bruising
itchy skin
hives
loss of hair.
Very rare side effects
(may affect up to 1 in 10,000 people)
seeing, feeling or hearing things that are not
there (hallucination)
change in personality
mood swings
uncontrollable muscle spasms affecting the
eyes, head, neck and body
increased tension in muscles and joints
fainting
loss of memory
restless legs, difficulty standing still, lack of
coordination affecting balance and manner of
walking
difficulty passing urine

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

151215-XXXX-PIL-01
Buspirone PIL - Side 2
480 x 170mm
15 December 2015
14188/01 PIL S2.ai
Black

M2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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