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BUSPIRONE HYDROCHLORIDE 5MG TABLETS

Active substance(s): BUSPIRONE HYDROCHLORIDE

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Buspirone
Hydrochloride
5 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 effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.
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 less
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 hydrochloride
or any of the other ingredients of this
medicine (listed in section 6)
• if you have severe liver or kidney problems
• if you have consumed high quantities
of alcohol, hypnotics, pain killers or
antipsychotic drugs (for mental illness)in
the last few days
• if you have epilepsy (suffer from fits).

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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withdrawn from these medicines before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 high pressure in the
eye (glaucoma)
• 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 liver or kidney problems
or had them in the past
• if you are suffering from depression and
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 to help you sleep e.g. nefazodone
• antibiotics such as erythromycin,
rifampicin, linezolid
• anti-fungal medicine such as itraconazole
or ketoconazole
• certain medicines to treat for HIV infection
such as ritonavir, saquinavir, indinavir.
• 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), St John's Wort, trazodone
and L-tryptophan
• medicines for mental illness such as
haloperidol and lithium
• medicines used for migraines called
triptans such as 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
• cimetidine - used to treat certain
conditions caused by too much acid
being produced in the stomach
• warfarin - medicine used to prevent
blood clots
• antihistamines (used to treat
allergic reactions)
• nabilone (used to treat nausea and vomiting)
• lofexidine (use to aid drug withdrawal).
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 breastfed 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.
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.
The dosage will be adjusted to
individual requirement.
Adults (including older people)
The recommended starting dose is 5 mg
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 daily dose is 60 mg.
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 will prescribe a lower dose if
you have liver or kidney problems.
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Package leaflet: Information for the patient

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, slow heartbeat, low blood
pressure, fits and extrapyramidal symptoms
(difficulty in speaking or swallowing, loss
of balance control, mask-like face, shuffling
walk, stiffness of arms and legs, trembling
or shaking of hands or fingers) drowsiness,
constriction of the pupil, stomach upset
and feeling or being sick.
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 (affecting fewer than
1 in 10,000 people):
• high fever, agitation, confusion, trembling
and abrupt contractions of muscles; these
may be signs of a rare 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):
• nervousness
• feeling excited
• inability to sleep or sleep disturbances
• disturbance in attention
• depression
• blurred vision
• confusion
• anger
• tingling or pins and needles,
• abnormal coordination, tremor
• buzzing, hissing, whistling, ringing or
other persistent noise in the ears (tinnitus)
• chest pain
• fast heart beat
• blocked nose
• throat pain or soreness
• feeling sick (nausea)
• being sick (vomiting)
• dry mouth
• diarrhoea
• constipation
• abdominal pain
• cold sweat
• rash
• muscle and bone pain
• tiredness.

Rare side effects (may affect up to 1 in
1,000 people):
• bruising
• hives.
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
• secretion 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, pharmacist or nurse. This includes
any 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 5 mg of Buspirone
hydrochloride.
The other ingredients are lactose
monohydrate, cellulose, microcrystalline,
sodium starch glycolate, silica, colloidal
anhydrous silica and magnesium stearate.
What Buspirone looks like and contents of
the pack
Your medicine comes as a round white
tablet. The tablets are marked 'BR 5' on
one side and 'G' on the reverse. Buspirone
is available in blister packs or containers
of 20, 28, 30, 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, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100,
112, 120, 168, 250 or 500 tablets. Not all
pack sizes may be marketed.
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: April 2014

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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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