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BUSPIRONE HYDROCHLORIDE 10 MG TABLETS

Active substance(s): BUSPIRONE HYDROCHLORIDE / BUSPIRONE HYDROCHLORIDE / BUSPIRONE HYDROCHLORIDE

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BUSPIRONE
HYDROCHLORIDE
10 mg 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 effect, 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 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.

TBC
1122111

Warning 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withdrawn from these medicines before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.

• M
 edicines 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).
• B
 aclofen (a muscle relaxant).
• D
 igoxin 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 (use to aid drug withdrawal).
• W
 arfarin 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 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 5 mg (half of
a 1- mg 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
15 mg to 30 mg, divided up throughout the
day. The recommended maximum dose is
45 mg 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.

488075

Date: 22 Dec 2014
Description Buspirone Hydrochloride 10 mg All
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 488075

SAP No. N/A

Superceded Affiliate Item Code 10004799

Vendor Job No. 235805

TrackWise PR No. 488075

Proof No. 3

MA No. 04569/0369

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

TBC
1122111

Package leaflet: Information for
the patient

No. of colours
Colours

1

Time: 11:08
Page Count

Black

1/2

PMS
xxx

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480mm

Body Text Size 11pt

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

• s ecretion of breast milk in men, or in
women who are not breastfeeding.
• 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 25°C.
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
protect the environment.
6. Contents of the pack and other
information
What Buspirone contains
The active substance is 10 mg 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.
Buspirone is available in blister packs or
containers of 20, 28, 30, 50, 56, 84, 90, 100,
112, 120 or 168 tablets; or only in blister
packs of 180 tablets; or only in containers of
5, 7, 10, 15, 21, 25, 60, 250 or 500 tablets.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer
Generics [UK] Ltd, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle
Industrial Estate, Grange Road, Dublin 13,
Ireland.
Mylan Hungary Kft., H-2900, Komárom,
Mylan útca.1, Hungary.
This leaflet was last revised in 12/2014.

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.

488075

Date: 22 Dec 2014
Description Buspirone Hydrochloride 10 mg All
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 488075

SAP No. N/A

Superceded Affiliate Item Code 10004799

Vendor Job No. 235805

TrackWise PR No. 488075

Proof No. 3

MA No. 04569/0369

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

No. of colours
Colours

1

Time: 11:08
Page Count

Black

2/2

PMS
xxx

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480mm

Body Text Size 11pt

Expand Transcript

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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