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BUSPIRONE HYDROCHLORIDE 5 MG TABLETS

Active substance(s): BUSPIRONE HYDROCHLORIDE

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Package leaflet: Information for the patient

Buspirone hydrochloride 5 mg tablets
Buspirone hydrochloride 10 mg tablets

Dimension - 150 x 310 mm

7220

Buspirone hydrochloride
The name of your medicine is ‘Buspirone
hydrochloride 5/10 mg Tablets’ but it will be
referred to as ‘Buspirone’ throughout this leaflet.
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, pharmacist or nurse.
− 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, pharmacist or nurse. 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, which belongs to a
group of medicines called anxiolytics. These
medicines work on the central nervous system,
altering levels of chemicals in the brain.
Buspirone may be used for the:
• short term management of anxiety disorders;
• relief of symptoms of anxiety with or without
symptoms of depression.
2. What you need to know before you take
Buspirone
Do not take Buspirone and tell your doctor:
• if you are allergic to buspirone hydrochloride
or any of the other ingredients of this
medicine (listed in section 6).
• if you are pregnant or breast-feeding.
• if you have epilepsy.
• if you have severe problems with the way
your liver or kidneys work (severely impaired
liver or kidney function).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Buspirone:
• if you have had problems with the way your
liver or kidneys work (impaired liver or
kidney function) in the past;
• if you have been prescribed a benzodiazepine
for example nitrazepam or temazepam or
another common sedative or hypnotic
medicine. You should be gradually withdrawn
from these medicines before taking Buspirone.
• if you have an eye disease called acute
narrow-angle glaucoma;
• if you have myasthenia gravis, a disorder
characterised by muscle weakness, difficulty
chewing or swallowing and slurred speech;
• if you have had drug dependence.
Other medicines and Buspirone
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, 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) for example 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 medicines for example 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 for example nitrazepam or
temazepam or another common sedative or
hypnotic medicine;
• diltiazem (to treat angina);
• digoxin (to treat heart failure);
• phenobarbital, phenyton, carbamazepine (to
treat epilepsy);
• cimetidine (to treat stomach ulcers);
• diazepam (to treat anxiety);
• warfarin (to treat blood clots).
Buspirone with food, drink and alcohol
Talk to your doctor before eating or drinking
products containing grapefruit juice, while taking
Buspirone.
You should not drink alcohol 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.
Driving and using machines
Buspirone 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.
Buspirone contains lactose
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.
3. How to take Buspirone
Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow the tablets with water, at the same time
each day. Buspirone should be taken consistently
with or without food. The way the medicine is
taken on the first day of treatment should be
continued thereafter.
Doses
Adults (including the older people)
The starting dose is 5 mg two to three times a
day, which may be increased every two to three
days. The usual dose you will be maintained on
is 15 mg to 30 mg a day in divided doses up to a
maximum dose of 45 mg a day in divided doses.
Use in children
This medicine is not recommended for use in
children.
Use in patients with liver and kidney problems
If you have problems with the way your liver or
kidneys work (impaired liver or kidney function),

Font: Times New Roman
Font size: 9 points
No. of Columns: 2 Columns

Front Side

Buspirone hydrochloride 5 mg & 10 mg Tablets
Strides Pharma UK Ltd.

Pack Insert
----

150 x 310 mm

1035069
BLACK
Record # 140092
Front & Back Side printing. To be supplied in the Unfolded size.
60 GSM Paper.
PRINTING CLARITY TO BE CLEAR AND SHARP.

1032647
1

4.0

Dimension - 150 x 310 mm

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This leaflet was last revised in {07/2017}.

Font: Times New Roman
Font size: 9 points
No. of Columns: 2 Columns

1035069

If you stop taking Buspirone
Talk to your doctor before you stop taking the
tablets and follow their advice.
If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Buspirone and contact your doctor
immediately if you experience: high fever,
agitation, confusion, trembling and abrupt
contractions of muscles; these may be signs of
a rare condition called serotonin syndrome.
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.
Very common side effects (may affect more
than 1 in 10 people):
• dizziness
• headache
• drowsiness
• feeling nervous or excited.
Common side effects (may affect up to 1 in 10
people):
• nervousness
• inability to sleep
• disturbance in attention
• depression
• blurred vision
• confusion
• sleep disturbances
• 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):
• symptoms such as wheezing, swelling of the
face or tongue (angioedema)
• bruising
• hives.
Very rare side effects (may affect up to 1 in
10,000 people):
• severe mental conditions in which the person

loses contact with reality and is unable to
think and judge clearly (psychosis)
• seeing, feeling or hearing things that are not
there (hallucination)
• change in personality
• mood swings
• fits or seizures
• unusual, uncontrollable movements such
as twitching or spasms which may affect
the hands, the eyes and the rest of the body
resulting in for example increased hand
tremor, muscle twitching, muscle cramp,
irregular movement of jaw muscles resulting
in difficulty opening the mouth (ataxia)
• fainting
• loss of memory
• restlessness or difficulty standing still
• restricted vision
• feeling of uneasiness and restlessness in the
legs, especially after going to bed (restless
legs syndrome)
• difficulty passing urine
• secretion of breast milk in men, or in women
who are not breast-feeding.
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 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
stated on the label after EXP. The expiry date
refers to the last day of that month.
This medicine does not require any special
storage conditions.
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.
Each tablet contains either 5 mg or 10 mg
buspirone (as hydrochloride).
• The other ingredients are: lactose
monohydrate, microcrystalline cellulose
(Aavicel-PH-101),
sodium starch glycolate, microcrystalline
cellulose (Aavicel-PH-200), colloidal silicon
dioxide and magnesium stearate.
What Buspirone looks like and contents of the
pack
The tablets are white ovoid rectangular uncoated
tablets with a score line on one side and plain on
the other side.
Blister pack sizes of 20, 30, 40, 50, 60, 90 and
100 tablets are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire, WD18 9SS,
United Kingdom.
Manufacturer:
Strides Pharma UK Ltd.
Unit 4, Metro Centre, Tolpits Lane, Watford,
Hertfordshire WD18 9SS,
United Kingdom.

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your doctor may prescribe you a lower dose.
If you take more Buspirone 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 (nausea or vomiting),
headache, dizziness, drowsiness, ringing or
buzzing in the ears, restlessness, restriction of the
pupils, stomach problems, slow heart beat, low
blood pressure, fits and difficulty in speaking
or swallowing, loss of balance control, masklike face, shuffling walk, stiffness of arms and
legs, trembling or shaking of hands or fingers
(extrapyramidal symptoms).
If you forget to take Buspirone
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. Do not take a double dose to make up
for a forgotten dose.

Back Side

Buspirone hydrochloride 5 mg & 10 mg Tablets
Strides Pharma UK Ltd.

Pack Insert
----

150 x 310 mm

1035069
BLACK
Record # 140092
Front & Back Side printing. To be supplied in the Unfolded size.
60 GSM Paper.
PRINTING CLARITY TO BE CLEAR AND SHARP.

1032647
1

4.0

+ 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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