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Package leaflet:
Information for the user

Buspirone 5mg and 10mg tablets
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• K
 eep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• T his 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 tablets are and what
they are used for
2 What you need to know before you
take Buspirone tablets
3 How to take Buspirone tablets
4 Possible side effects
5 How to store Buspirone tablets
6 Contents of the pack and other
 hat Buspirone tablets are and what
1 W
they are used for

Buspirone tablets belong to a group of medicines
called anxiolytics. These medicines work on the central
nervous system, altering levels of chemicals in the
Buspirone tablets may be used for the:
• short term management of anxiety disorders
• r elief of symptoms of anxiety with or without
symptoms of depression.

 hat you need to know before you
2 W
take Buspirone tablets
Do not take Buspirone tablets if you:

• a re allergic to buspirone hydrochloride or any of the

other ingredients of this medicine (listed in section 6).
• a re pregnant or breast-feeding.
 ave epilepsy.
 ave severely impaired liver or kidney function.

Warnings and precautions

Talk to your doctor or pharmacist before you take
Buspirone tablets if you have:
 ad impaired liver or kidney function in the past.
 een 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withdrawn from these medicines before taking
Buspirone tablets.
 cute narrow-angle glaucoma
 yasthenia gravis, a disorder characterised by
muscle weakness, difficulty chewing or swallowing
and slurred speech
 ave had drug dependence
Continued top of next column

Other medicines and Buspirone tablets

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. Especially:
 onoamine-oxidase inhibitors (MAOIs) such as
phenelzine and tranylcypromine (for depression)
• S t. John’s Wort, nefazodone and L-tryptophan,
fluvoxamine, trazodone (for depression)
• s elective serotonin re-uptake inhibitors (SSRIs) e.g.
fluoxetine and paroxetine (for depression)
 aloperidol and lithium (for mental illness)
• c alcium channel blockers such as diltiazem and
verapamil (to treat high blood pressure)
• r ifampicin (to treat tuberculosis)
• t riptan drugs e.g. sumatriptan (to treat migraine)
• t ramadol (a painkiller)
 aclofen (a muscle relaxant)
• lofexidine (to manage drug withdrawal)
 abilone (to treat nausea and vomiting)
• a ntihistamines (to treat allergic reactions)
• e rythromycin, itraconazole and linezolid (to treat
 enzodiazepines e.g. nitrazepam or temazepam or
another common sedative or hypnotic medicine
 iltiazem (to treat angina)
 igoxin (to treat heart failure)
 henobarbital, phenyton, carbamazepine (to treat
• c imetidine (to treat stomach ulcers)
 iazepam (to treat anxiety)
 arfarin (to treat blood clots)

Buspirone tablets with food or drink

Talk to your doctor before eating or drinking
products containing grapefruit juice, whilst taking
Buspirone tablets. You should not drink alcohol whilst
taking Buspirone tablets.
Pregnancy and breast-feeding
Do not take Buspirone tablets if you are pregnant or
are breast-feeding. Talk to your doctor before taking
any medicine.

Driving and using machines

Buspirone tablets may make you feel drowsy or dizzy.
Make sure you are not affected before you drive or
operate machinery.
The medicine can affect your ability to drive as it may
make you sleepy or dizzy.
• Do not drive while taking this medicine until you
know how it affects you.
• It is an offence to drive if this medicine affects your
ability to drive.
• However, you would not be committing an
offence if:
- The medicine has been prescribed to treat a
medical or dental problem and
 ou have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and • It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
Continued over page

Sugar intolerance

If you have been told you have an intolerance to
some sugars, contact your doctor before taking this
medicine, as it contains a sugar called lactose.

 ow to take Buspirone tablets
3 H

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are note sure.
Swallow the tablets with water, at the same time each
day. Buspirone should be taken consistently with or
without food. However, the medicine is taken on the
day one should be continued thereafter.
Adults (including the elderly)
The recommended starting dose is 5mg two to three
times a day, which may be increased every two to
three days. The usual dose you will be maintained on is
15mg to 30mg a day in divided doses. The maximum
daily dosage should not exceed 60mg per day.
Children: Not recommended.
If you have impaired liver or kidney function, your
doctor may prescribe you a lower dose.

If you take more than you should

If you (or someone else) swallow a lot of the
tablets at the same time, or if you think a child
has swallowed any, contact your nearest hospital
casualty department or tell your doctor immediately.
Symptoms of an overdose include feeling or being
sick, headache, dizziness, drowsiness, ringing or
buzzing in the ears, restlessness, restriction of the
pupils, stomach problems, slow heart beat, 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).

If you forget to take the tablets

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
you remember it and then take the next dose at the
right time.

If you stop taking the tablets

Talk to your doctor before you stop taking the tablets
and follow their advice.

 ossible side effects
4 P

Like all medicines, Buspirone tablets can cause side
effects although not everybody gets them.
Stop taking Buspirone tablets and contact your
doctor immediately if you have:
 erotonin syndrome, (feeling confused, feeling
restless, sweating, shaking, shivering, hallucinations
(strange visions or sounds), sudden jerks of the
muscles or a fast heartbeat).
 llergic reaction, itching, difficulty breathing or
swelling of the face, lips, throat or tongue, Allergic
conditions (causing itchy and swollen skin).

Very common: may affect more than 1 in 10 people
• Dizziness, headache, sleepiness

Common: may affect up to 1 in 10 people
 ervousness, Difficulty in sleeping, Disturbance
Nervousness, difficulty in sleeping, disturbance
in attention, depression, confused state, sleeping
problems, anger, pins and needles, tingling, blurred
vision, abnormal coordination, tremor, ringing or
buzzing in the ears, racing heart (abnormally fast
hear rhythm), chest pain, blocked nose, sore throat,
feeling and being sick, stomach pain, dry mouth,
Continued top of next column

diarrhoea, constipation, cold sweats, rash, pain in the
muscles, tendons, ligaments and bone, mental and
physical tiredness
Rare: may affect up to 1 in 1,000 people

• Bruising, itchy skin rash caused by allergic
reaction- pale or red irregular raised patches with
severe itching (hives)

Very rare: may affect up to 1 in 10, 000 people

• Psychosis, hallucinations, feeling of unreality to the
self, that the mind is separated from the body, effect
on your liability, fits, tunnel vision, extrapyramidal
disorder (tremor, slurred speech, restlessness
(akathisia), dystomia (affecting posture – muscle
spasm or the neck, shoulders or body), anxiety,
distress), muscle rigidity, difficulty controlling
movement/jerky movements, disorder affecting
posture (muscle spasm of neck, shoulders and body),
fainting or passing out, total or partial memory loss,
lack of muscle control, co-ordination, difficulty in
controlling movements, tremor, stiffness and
shuffling, restless leg syndrome, restlessness,
difficulty passing water, over production of
breast milk

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more
information on the safety of this medicine.

 ow to store Buspirone tablets
5 H

Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original
Do not use Buspirone tablets after the expiry date
stated on the label/carton/bottle. The expiry date
refers to the last day of that month.
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.

 ontents of the pack and other
6 C

What Buspirone tablets contain
• T he active substance is buspirone hydrochloride.
Each tablet contains either 5mg or 10mg of the
active substance.
• T he other ingredients are lactose monohydrate,
magnesium stearate, purified talc, polyvidone K-25
and potato starch.

What Buspirone tablets look like and contents
of the pack
Buspirone tablets are white, uncoated, flat bevelled
edge tablets.
Pack size is 30.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in June 2016

If you would like a
leaflet with larger
text, please contact
01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

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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.