BUSPIRONE 5 MG TABLETS

Active substance: BUSPIRONE HYDROCHLORIDE

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Package leaflet: Information for the patient
Buspirone 5 mg tablets
Buspirone 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 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 tablets are used to relieve the symptoms of anxiety
disorders such as anxiety, agitation and tension.
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 Buspirone (listed in section 6)

• suffer from acute angle closure glaucoma (increased pressure
in the eye)
• suffer from myasthenia gravis (severe muscle weakness)
• suffer from any severe liver or kidney disease
• suffer from epilepsy
• suffer from acute intoxication with alcohol, hypnotics,
analgesics, or antipsychotic drugs.
Warnings and precautions
Talk to your doctor or pharmacist before taking Buspirone, if you:
• have taken a medicine with calming effect on the central
nervous system for a long time. Before taking Buspirone, these
medicines should be discontinued gradually
• have a history of kidney or liver disease
• have a history of seizures
• have a history with drug dependence.
Children and adolescents:
Buspirone should not be used in children and adolescents under
18 years of age (see “How to take Buspirone” below).
Other medicines and Buspirone
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
It is especially important to tell your doctor if you are taking any
of the following:
• medicines known as monoamine oxidase inhibitors (MAOIs)
such as phenelzine or tranylcypromine (to treat depression
and Parkinson’s disease). You should not take these medicines
concomitantly with Buspirone.
• medicines known as selective serotonin re-uptake inhibitors
(SSRIs) such as fluoxetine, fluvoxamine and paroxetine (for
depression and other psychiatric disorders)
• antihypertensives (for high blood pressure)
• antidiabetics (for diabetes)

• anticoagulants such as Warfarin (for stopping the blood from
clotting)
• contraceptives (for pregnancy prevention)
• cardiac glycosides such as Digoxin (for heart failure)
• antihistamines (for allergy/hypersensitivity)

dexamethasone (for inflammatory and autoimmune
conditions, such as rheumatoid arthritis)
• phenytoin, phenobarbital, carbamazepine (for epilepsy)
• nefazodone (for depression)
• erythromycin (for various types of infections caused by
bacteria)
• linezolid (for severe infections caused by Gram-positive
bacteria)
• itraconazole (for fungal infections)
• diltiazem or verapamil (for high blood pressure, angina, heart
failure, and as a preventive medication for migraine)
• triptans (for migraine)
• tramadol (for severe pain)
• cimetidine (for heartburn and peptic ulcers)
• rifampicin (for tuberculosis and other infections)
• ketoconazole or ritonavir (to treat fungal or viral infections)
• baclofen (for treatment of spasticity)
• lofexidine (for opioid withdrawal)
• nabilone (for control of nausea and vomiting)
• haloperidol (for schizophrenia and for acute psychotic states
and delirium)
• trazodone (for depression)
• lithium (for manic-depression)
• st. John’s Wort (a herbal medicine for depression)
• l-tryptophan (nutritional supplement)
• diazepam (for anxiety, sleep disorders, seizures, including
epileptic seizures, muscle spasms, restless legs syndrome,
alcohol withdrawal, benzodiazepine withdrawal, and
Ménière’s disease)
A change in dose may need to be considered by your doctor.

Buspirone with food, drink and alcohol

The recommended dose is:

Alcohol
You should not drink alcohol while taking Buspirone.

Adults over 18 years of age:
The recommended starting dose is 5 mg three times daily
(corresponding to 15 mg buspirone hydrochloride daily).

Grapefruit juice
You should not eat or drink products containing large quantities
of grapefruit juice while taking Buspirone.
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.
Pregnancy:
Buspirone should not be taken during pregnancy.
Breast-feeding:
Breast-feeding is not recommended during treatment.
Driving and using machines
Do not drive or use any tools or machines until you know how
Buspirone affects you. It cannot be excluded that Buspirone,
especially at the beginning of treatment and after a change in
dose, affects the capacity of reaction.
Buspirone contains lactose
This medicine contains lactose. If you have been told by your
doctor that you have intolerance to some sugars, contact your
doctor before taking Buspirone.
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.

Your doctor may increase this dose gradually if necessary. The
daily dose can be increased to 20-30 mg buspirone hydrochloride
daily, divided into several individual doses. A single dose of 30
mg buspirone hydrochloride should not be exceeded. More than
60 mg buspirone hydrochloride per day should not be taken.
Patients with kidney and/or liver problems
These patients might need a lower dose. Your doctor will
determine your individual dose.
Use in children and adolescents:
Buspirone should not be used in children and adolescents under
18 years of age.
Method of administration
The tablets are scored and can be divided into equal doses. The
whole tablets or, if needed, the divided halves should not be
chewed or crushed but swallowed whole with some liquid. The
tablets should always be taken at the same time of day, either
always on an empty stomach or always after a meal.
Duration of treatment
It may take some time before you start to feel better. If the
symptoms do not improve within 4-8 weeks, you should talk to
your doctor. Your doctor will determine how long you should
continue to take Buspirone. If a long-term medical treatment
is necessary, it should be monitored intensively by your doctor
and the need to continue treatment should be periodically
reassessed.

If you take more Buspirone than you should
If you have taken too much of the medicine or if, for example, a
child has taken the medicine by mistake, contact your doctor or
hospital for an assessment of the risk and advice.
Take the medicine pack with you.
The typical symptoms of an overdose include nausea, vomiting,
dizziness, fatigue, constriction of the pupils and stomach pains.
If you forget to take Buspirone
Do not take a double dose to make up for a forgotten dose. If
you forget to take a dose, take it as soon as possible. However,
if it is almost time for your next dose, skip the missed dose and
continue as before.
If you stop taking Buspirone
Continue with Buspirone until your doctor tells you otherwise.
If you need a long-term medical treatment your doctor will
monitor your use of this medicine on a regular basis.
If you are to stop Buspirone therapy you must follow your
doctor’s instruction 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.
Serious side effects:
• suicidal thoughts
• serotonin syndrome (symptoms such as fever, stiffness,
trembling, confusion, nervousness, palpitations)
• serious heart problems such as heart failure and heart attack.

If you expereince any of the above side effects, tell your
doctor IMMEDIATELY or go to a casualty department at your
nearest hospital.
Common side effects (may affect up to 1 in 10 people):
• nonspecific chest pain
• nightmares, drowsiness, sleeplessness, dizziness, nervousness,
light-headedness, impaired concentration, restlessness, anger,
hostility, confusion, depression
• blurred vision
• ringing or buzzing in the ears (tinnitus)
• sore throat, stuffy nose
• nausea, dry mouth, gastrointestinal symptoms, diarrhoea
• headache, weakness.
Uncommon side effects (may affect up to 1 in 100 people):
• brief episodes of fainting, low or high blood pressure,
exceedingly high heart rate/abnormality of heartbeat
• depersonalisation, over-sensitivity to certain frequency
ranges of sound, excitement, unpleasant mood (including
symptoms such as sadness, irritability, restlessness), urge
to move, anxiety, loss of interest, association disturbances,
hallucinations, seizures
• numbness, abnormal sensations (e.g. tingling, pricking
sensation), loss of coordination, involuntary trembling
• significantly increased breathing frequency, shortness of
breath, chest pressure, altered sense of smell
• redness of the eyes, itchy eyes, inflammation of the outermost
layer of the eye and the inner surface of the eyelids
• increased appetite, poor appetite, drooling, rectal bleeding,
constipation, passing gas (flatulence), irritable colon, vomiting
• lower urinary tract symptoms
• oedema, nettle rash, flushing, tendency to bruising, hair loss,
dry skin, eczema, vesicles, facial oedema
• muscle cramps, muscle pain, muscle tension, joint pain
• weight gain, fever, roaring in the head, weight loss, general
feeling of being unwell, tiredness, altered taste, sweating,
clammy hands

• increased liver enzymes
• menstrual disorders, decreased or increased sexual desire.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

Rare side effects (may affect up to 1 in 10.000 people):
• disorders in the blood supply to the brain, dysfunction of the
heart muscle, slow resting heart rate
• blood count changes signs of which include rash, tiredness,
shortness of breath, bruising and prolonged bleeding. Types
of blood count changes include increased number of certain
white blood cells (eosinophilia), decreased number of certain
blood cells (leukopenia), decreased number of platelets in the
blood (thrombocytopenia)
• mood swings, claustrophobia, cold intolerance, sleepiness
which can cause immobility or unconsciousness, slurred
speech, psychosis, transient memory gaps
• movement disorders including involuntary movements of
the body during or after treatment, involuntary movements
of the body, face, mouth, or tongue and stiffness of the body,
parkinsonism (e.g. symptoms such as slow movements and
trembling), akathisia (e.g. symptoms such as restlessness,
being unable to sit still), restless legs syndrome (e.g. symptoms
such as burning, itching or tingling in the muscles), slowed
reaction time
• eye pain, sensitivity to light, sensation of pressure on the eyes,
constricted circular tunnel-like field of vision
• nosebleeds
• inability to control urination, need to get up in the night to
urinate
• allergic reactions, bruising, bleeding, acne, nail thinning
• muscle weakness
• milk secretion from the breast, breast enlargement in males,
thyroid dysfunction
• alcohol abuse, bleeding disorders, loss of voice, hiccups,
burning tongue
• absence of menstrual period, pelvic inflammatory disease,
abnormal ejaculation, impotence.

You can help to make sure that medicines remain as safe as
possible by reporting any unwanted side effects via the internet
at www.mhra.gov.uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m.
Mondays to Fridays) or fill in a paper form available from your
local pharmacy.
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 carton / tablet container / blister after EXP. The expiry date
refers to the last day of that month.

What Buspirone looks like and contents of the pack
Tablet.
5 mg:
Buspirone 5 mg tablets are 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:
Buspirone 10 mg tablets are 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.
Pack sizes:
Blister: 20, 30, 50, 60, 90 and 100 tablets

This medicinal product does not require any special temperature
storage conditions.

Tablet container: 250 tablets

For blister additionally:
Keep the blister in the outer carton in order to protect from light.

Marketing Authorisation Holder

HDPE tablet container additionally:
After first opening use within1 year.
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 buspirone hydrochloride.
• 5 mg: Each tablet contains 5 mg buspirone hydrochloride.
• 10 mg: Each tablet contains 10 mg buspirone hydrochloride.
• The other ingredients are: lactose monohydrate; silica,
colloidal anhydrous; cellulose microcrystalline; sodium starch
glycolate (type A); magnesium stearate.

Not all package sizes may be marketed.
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
This leaflet was last revised in
June 2013

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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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