BUSPIRONE 10MG TABLETS

Active substance: BUSPIRONE HYDROCHLORIDE

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Buspirone 5mg and 10mg tablets
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it

again.
•  If you have any further questions, ask your

doctor or pharmacist.
•   his medicine has been prescribed for you.
T
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.

Index
1 What Buspirone tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information

1 What Buspirone tablets are and what
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 brain.
Buspirone tablets may be used for the:
• short term management of anxiety disorders
•  elief of symptoms of anxiety with or without
r
symptoms of depression.

2 Before you take

Do not take Buspirone tablets and tell your
doctor if you:

•  re allergic (hypersensitive) to buspirone
a
hydrochloride or any of the other ingredients in
Buspirone tablets (see section 6).
• are pregnant or breast-feeding.
• have epilepsy.
• have severely impaired liver or kidney function.

Check with your doctor or pharmacist
before taking Buspirone tablets if you have:

• had impaired liver or kidney function in the past.
•  een prescribed a benzodiazepine e.g.
b
nitrazepam or temazepam or another common
sedative or hypnotic medicine. You should be
gradually withdrawn from these medicines before
taking Buspirone tablets.
• acute narrow-angle glaucoma
• myasthenia gravis, a disorder characterised

by muscle weakness, difficulty chewing or
swallowing and slurred speech
• or have had drug dependence

Taking other medicines

Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without a

prescription. Especially:
•  onoamine-oxidase inhibitors (MAOIs) such as
m
phenelzine and tranylcypromine (for depression)
•  t. John’s Wort, nefazodone and L-tryptophan,
S
fluvoxamine, trazodone (for depression)
•  elective serotonin re-uptake inhibitors (SSRIs) e.g.
s
fluoxetine and paroxetine (for depression)
• haloperidol and lithium (for mental illness)
•  alcium channel blockers such as diltiazem and
c
verapamil (to treat high blood pressure)
•  ifampicin (to treat tuberculosis)
r
• triptan drugs e.g. sumatriptan (to treat migraine)
• tramadol (a painkiller)
• baclofen (a muscle relaxant)
• lofexidine (to manage drug withdrawal)
• nabilone (to treat nausea and vomiting)
• antihistamines (to treat allergic reactions)
•  rythromycin, itraconazole and linezolid (to treat
e
infections)
•  enzodiazepines e.g. nitrazepam or temazepam
b
or another common sedative or hypnotic
medicine
• diltiazem (to treat angina)
• digoxin (to treat heart failure)
•  henobarbital, phenyton, carbamazepine (to treat
p
epilepsy)
• cimetidine (to treat stomach ulcers)
• diazepam (to treat anxiety)
• warfarin (to treat blood clots)

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
• You 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 medicine.

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.

Continued top of next column
AAAG5855

Continued over page

Buspirone 5mg & 10mg tablets PIL - UK

colours/plates:
1. Black

item no: AAAG5855

dimensions: 120x210

print proof no: 2

pharmacode:

origination date: 25.02.14

min pt size: 7pts

3.
4.
5.
6.

originated by: dje
approved for print/date

2.

revision date: 01.04.14

Technical Approval

revised by: dje

date sent: 25.02.14

supplier: Alkaloida

technically app. date: 31.03.14

Non Printing Colours
1.
2.
3.

3 How to take

Always take Buspirone tablets exactly as your
doctor has told you. If you are not sure, check with
your doctor or pharmacist.

Taking 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.
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.
Doses:
Adults (including the elderly)
The 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 up to a maximum
dose of 45mg a day in divided doses.
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.

4 Possible side effects

Like all medicines, Buspirone tablets can cause side
effects although not everybody gets them. Please
tell your doctor or pharmacist if you notice any
of the following effects, they get worse or if you
notice any not listed.
Stop taking Buspirone tablets and contact
your doctor immediately if you are taking
selective serotonin re-uptake inhibitors (SSRIs) e.g.
fluoxetine and paroxetine and have: Serotonin
syndrome (feeling confused, feeling restless,
sweating, shaking, shivering, hallucinations
(strange visions or sounds), sudden jerks of the
muscles or a fast heartbeat).

problems concentrating, depression, confusion,
problems sleeping, anger
• Nervous system: dizziness, headache, sleepiness,

drowsiness, blurred vision, tingling or pins and
needles, co-ordination problems, involuntary
shakiness, ringing in the ears, fits, tunnel vision,
extrapyramidal disorder (tremor, slurred speech,
akathisia, dystomia, anxiety, distress), muscle
rigidity, with circular jerky movements, difficulty
controlling movement/jerky movements, muscle
spasm of neck, shoulders and body affecting
posture, fainting or passing out, memory loss,
Lack of muscle control or co-ordination, difficulty
in controlling movements, tremor, stiffness and
shuffling, restlessness, restless leg syndrome
• Cardiac disorders: racing heart beat, chest pain
• Respiratory, thoracic and mediastinal

disorders: blocked nose, sore throat
• Gastrointestinal disorders: feeling or being sick,

stomach pain, dry mouth, diarrhoea, constipation
• Skin and subcutaneous tissue disorders: cold

sweats, rash, bruising
• Musculoskeletal and connective tissue

disorders: pain in the muscles, tendons,
ligaments and bone
• Renal and urinary disorders: difficulty passing

water
• Reproductive system and breast disorders:

over production of breast milk
• General disorders and administration site

conditions: tiredness

5 How to store

Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original
container.
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.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.

6 Further information

What Buspirone tablets contain

•  he active substance (the ingredient that makes
T
the tablets work) is buspirone hydrochloride. Each
tablet contains either 5mg or 10mg of the active
substance.
•  he other ingredients are lactose monohydrate,
T
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 February 2014.

Tell your doctor if you notice any of the following
side effects:
• Psychiatirc disorders: nervousness, insomnia,


Continued top of next column
AAAG5855

Actavis, Barnstaple, EX32 8NS, UK

Buspirone 5mg & 10mg tablets PIL - UK

colours/plates:
1. Black

item no: AAAG5855

dimensions: 120x210

print proof no: 2

pharmacode:

origination date: 25.02.14

min pt size: 7pts

3.
4.
5.
6.

originated by: dje
approved for print/date

2.

revision date: 01.04.14

Technical Approval

revised by: dje

date sent: 25.02.14

supplier: Alkaloida

technically app. date: 31.03.14

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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