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BUSPAR 5MG TABLETS

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

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PATIENT INFORMATION LEAFLET

Buspar® 5mg Tablets
(buspirone hydrochloride)

Your medicine is available using the name Buspar 5mg
Tablets, but will be referred to as Buspar throughout this
leaflet. Buspar 10mg Tablets are also available.

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

In this leaflet:

1.
2.
3.
4.
5.
6.

What Buspar is and what it is used for
Before you take Buspar
How to take Buspar
Possible side effects
How to store Buspar
Further information

1. What Buspar is and what it is used for
Buspar belong to a group of medicines called anxiolytics.
These medicines work on the central nervous system, altering
levels of chemicals in the brain.
Buspar may be used for the:

short term management of anxiety disorders

relief of symptoms of anxiety with or without symptoms
of depression.

2. Before you take Buspar
Do not take Buspar and tell your doctor if you:





are allergic (hypersensitive) to buspirone hydrochloride
or any of the other ingredients in Buspar (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
Buspar if you have:




had impaired liver or kidney function in the past.
been 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 You should be gradually withdrawn from these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 Buspar.






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:

monoamine-oxidase inhibitors (MAOIs) such as
phenelzine and tranylcypromine (for depression)

St. John’s Wort, nefazodone and L-tryptophan,
fluvoxamine, trazodone (for depression)

selective serotonin re-uptake inhibitors (SSRIs) e.g.
fluoxetine and paroxetine (for depression)

haloperidol and lithium (for mental illness)

calcium channel blockers such as diltiazem and
verapamil (to treat high blood pressure)

rifampicin (to treat tuberculosis)

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)

erythromycin, itraconazole and linezolid (to treat
infections)

benzodiazepines e.g. nitrazepam or temazepam or
another common sedative or hypnotic medicine

diltiazem (to treat angina)

digoxin (to treat heart failure)

phenobarbital, phenytoin, carbamazepine (to treat
epilepsy)

cimetidine (to treat stomach ulcers)

diazepam (to treat anxiety)

warfarin (to treat blood clots)

Pregnancy and breast-feeding

Do not take Buspar if you are pregnant or are breast-feeding.
Talk to your doctor before taking any medicine.

Driving and using machines

Buspar may make you feel drowsy or dizzy. Make sure you
are not affected before you drive or operate machinery.

Important information about some of the
ingredients of Buspar

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

Page 1 of 2

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

Taking Buspar with food or drink

Talk to your doctor before eating or drinking products
containing grapefruit juice, whilst taking Buspar. You should
not drink alcohol whilst taking Buspar.
Swallow the tablets with water, at the same time each day.
Buspar 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

5. How to store Buspar

Like all medicines, Buspar 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.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp) which is
marked on the carton and blister strips. This refers to the last
day of that month.
If your tablets appear discoloured, or show any other sign of
deterioration, take them to your pharmacist who will advise
you.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
any medicines you no longer use. These measures will help
protect the environment.

Stop taking Buspar 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).

Tell your doctor if you notice any of the following side
effects:













Psychiatric disorders: nervousness, insomnia,
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, dystonia, 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

6. Further information
What Buspar contains

The active substance is buspirone hydrochloride.
The other ingredients are lactose anhydrous,
magnesium stearate, microcrystalline cellulose,
silicon dioxide colloidal and sodium starch glycolate.

What Buspar looks like and contents of the pack
Buspar tablets are white, rounded, rectangular tablets
marked '5' on one side and plain on the reverse.

Buspar is available in blister packs of 60 and 90 tablets.
Manufactured by: Bristol-Myers Squibb, La Goualle, BP No. 6,
19250-Meymac, France.
Your medicine is procured from within the EU and repackaged
by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0306

POM

Leaflet Revision and Issue date (Ref): 26.09.16
Buspar® is a registered trademark of Bristol Myers Squibb
Pharm. Ltd.

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: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more
information on the safety of this medicine.

Page 2 of 2

PATIENT INFORMATION LEAFLET

Buspirone Hydrochloride 5mg Tablets
Your medicine is available using the name Buspirone
Hydrochloride 5mg Tablets, but will be referred to as
Buspirone Hydrochloride throughout this leaflet.
Buspirone Hydrochloride 10mg Tablets are also available.

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

In this leaflet:

1.
2.
3.
4.
5.
6.

What Buspirone Hydrochloride is and what it is used for
Before you take Buspirone Hydrochloride
How to take Buspirone Hydrochloride
Possible side effects
How to store Buspirone Hydrochloride
Further information

1. What Buspirone Hydrochloride is and what
it is used for
Buspirone Hydrochloride belong to a group of medicines
called anxiolytics. These medicines work on the central
nervous system, altering levels of chemicals in the brain.
Buspirone Hydrochloride may be used for the:

short term management of anxiety disorders

relief of symptoms of anxiety with or without symptoms
of depression.

2. Before you take Buspirone Hydrochloride
Do not take Buspirone Hydrochloride and tell your
doctor if you:





are allergic (hypersensitive) to buspirone hydrochloride
or any of the other ingredients in Buspirone
Hydrochloride (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 Hydrochloride if you have:









had impaired liver or kidney function in the past.
been 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 Hydrochloride.
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:

monoamine-oxidase inhibitors (MAOIs) such as
phenelzine and tranylcypromine (for depression)

St. John’s Wort, nefazodone and L-tryptophan,
fluvoxamine, trazodone (for depression)

selective serotonin re-uptake inhibitors (SSRIs) e.g.
fluoxetine and paroxetine (for depression)

haloperidol and lithium (for mental illness)

calcium channel blockers such as diltiazem and
verapamil (to treat high blood pressure)

rifampicin (to treat tuberculosis)

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)

erythromycin, itraconazole and linezolid (to treat
infections)

benzodiazepines e.g. nitrazepam or temazepam or
another common sedative or hypnotic medicine

diltiazem (to treat angina)

digoxin (to treat heart failure)

phenobarbital, phenytoin, carbamazepine (to treat
epilepsy)

cimetidine (to treat stomach ulcers)

diazepam (to treat anxiety)

warfarin (to treat blood clots)

Pregnancy and breast-feeding

Do not take Buspirone Hydrochloride if you are pregnant or
are breast-feeding. Talk to your doctor before taking any
medicine.

Driving and using machines

Buspirone Hydrochloride may make you feel drowsy or dizzy.
Make sure you are not affected before you drive or operate
machinery.

Important information about some of the
ingredients of Buspirone Hydrochloride

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

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

Taking Buspirone Hydrochloride with food or drink
Talk to your doctor before eating or drinking products
containing grapefruit juice, whilst taking Buspirone
Hydrochloride. You should not drink alcohol whilst taking
Buspirone Hydrochloride.

Swallow the tablets with water, at the same time each day.
Buspirone Hydrochloride 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.
Page 1 of 2

If you stop taking the tablets

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

4. Possible side effects

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: www.mhra.gov.uk/yellowcard.

Like all medicines, Buspirone Hydrochloride 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.

By reporting side effects, you can help provide more
information on the safety of this medicine.

Stop taking Buspirone Hydrochloride and contact your
doctor immediately if you are taking selective serotonin reuptake 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).

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (Exp) which is
marked on the carton and blister strips. This refers to the last
day of that month.
If your tablets appear discoloured, or show any other sign of
deterioration, take them to your pharmacist who will advise
you.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
any medicines you no longer use. These measures will help
protect the environment.

Tell your doctor if you notice any of the following side
effects:












Psychiatric disorders: nervousness, insomnia,
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, dystonia, 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 Buspirone Hydrochloride

6. Further information
What Buspirone Hydrochloride contains

The active substance is buspirone hydrochloride.
The other ingredients are lactose anhydrous,
magnesium stearate, microcrystalline cellulose,
silicon dioxide colloidal and sodium starch glycolate.

What Buspirone Hydrochloride looks like and
contents of the pack

Buspirone Hydrochloride tablets are white, rounded,
rectangular tablets marked '5' on one side and plain on the
reverse.
Buspirone Hydrochloride is available in blister packs of 30 and
60 tablets.
Manufactured by: Bristol-Myers Squibb, La Goualle, BP No. 6,
19250-Meymac, France.
Your medicine is procured from within the EU and repackaged
by: Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0306

POM

Leaflet Revision and Issue date (Ref): 26.09.16

Page 2 of 2

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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