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Ref: 1365/100114/1/F

Buspirone Hydrochloride 10mg Tablets
Patient Information Leaflet
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.
* If any side effect gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
Your medicine is called Buspirone hydrochloride 10mg Tablets but will be
referred to as Buspirone throughout this leaflet. Please note that the leaflet
also contains information about other strengths of the medicine.

Driving and using machines
Do not drive or operate machinery until you know that Buspirone does not
reduce your reaction time by making you sleepy or less alert. You are more
likely to suffer these side effects at the start of treatment or when your dose
is changed.
Important information about some of the ingredients of Buspirone
These tablets contain lactose. If your doctor has told you that you have an
intolerance to some sugars, such as lactose, contact your doctor before
taking this medicine.

In this leaflet:
1 What Buspirone is and what it is used for
2 Before you take Buspirone
3 How to take Buspirone
4 Possible side effects
5 How to store Buspirone
6 Further information


What Buspirone is and what it is used for

Buspirone contains the active ingredient buspirone hydrochloride.
Buspirone belong to a group of medicines called azapirones, used to treat
anxiety. It is not clear exactly how your medicine works. It is thought that it
changes the way in which some groups of nerves talk to each other, making
you feel less anxious. It should only be taken for a short time to relieve


Before you take Buspirone

Do not take Buspirone:
* if you are allergic (hypersensitive) to buspirone hydrochloride or any of the
other ingredients of these tablets.
* If you have severe liver or kidney problems
* If you have epilepsy.
* If you have taken painkillers, or medicines for anxiety or a mental illness
(e.g. Nefazodone), for a long time.
* If you have an alcohol problem
Take special care with Buspirone
Tell your doctor if any of the following applies to you:
* If you suffer from liver or kidney problems.
* If you have rare muscle disorder called myasthenia gravis
* If you have a history of drug or alcohol abuse
* if you have glaucoma
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 or
the following:
* medicines known as monoamine-oxidase inhibitors (MAOIs) to treat
depression, such as Phenelzine
* other medicines to treat anxiety or to help you sleep e.g. Trazadone,
* medicines to treat mental illness (antipsychotics) e.g. Haloperidol
* medicines for stomach ulcers e.g. Cimetidine
* antibiotics such as Erythromycin, Rifampicin
* anti-fungal medicines such as Itraconazole or Ketoconazole
* St John’s wort, a herbal remedy
* medicines to treat anxiety including those containing Benzodiazepine e.g.
* medicine to treat heart conditions e.g. Verapamil.
Taking Buspirone with food and drink
Do not take Buspirone with grapefruit juice as this may increase the effect of
your medicines causing side effects
Do not drink alcohol while taking Buspirone.
Pregnancy and breast-feeding
Buspirone should not be given to a pregnant or breast-feeding mother as it
is not known if it affects the growth of the unborn or breast-fed baby. Ask
your doctor or pharmacist for advice before taking any medicine.


How to take Buspirone

Buspirone can be taken before or after food. Always take Buspirone exactly
as your doctor has told you. You should check your doctor or pharmacist if
you are not sure.
* These tablets should not be chewed.
* Swallow the tablet with a glass of water before, during or after meals.
* Do not drink grapefruit juice at the same time as taking this medicine.
Adults (including the elderly) - The usual starting dose is 5mg two to three
times a day. After several weeks your doctor may increase your dose
depending on how you respond to the tablets. The usual daily dose is 15mg
to 30mg, divided up throughout the day. The maximum daily dose is 45mg.
Buspirone should not be taken for a long time but it may take several
weeks before you start to feel better.
Children: Do not give Buspirone to children or adolescents under 18 years.
Patients with liver or kidney problems - A lower does may be given twice
a day.
If you take more Buspirone than you should
Contact your doctor or nearest hospital emergency department immediately.
Take the container and any remaining tablets with you. Symptoms of over
dose include dizziness, drowsiness, and feeling or being sick.
If you forget to take Buspirone
Take the next does as soon as you remember unless it is almost time for
your next does. Do not take a double dose to make up for a forgotten dose.
If you suddenly stop taking the Buspirone
You may suffer from side effects. Do not stop taking your tablets unless your
doctor tells you to.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.


Possible side effects

Like all medicines, Buspirone can cause side effects although not everybody
gets them.
If any of the following happens, stop taking Buspirone and tell your doctor
immediately or go to your nearest hospital emergency department:
* skin rash
* allergic reactions, itchy red skin
* bruising/ bleeding under the skin
The following side effects are usually seen at the start of treatment and often
disapper on their own:
* dizziness
* headache
* feeling light-headed
* feeling sick
* feeling nervous or excited
* sweating/ clamminess
Common effects, seen in more than 1 in 100 patients include:
* a racing heart beat, palpitations
* chest pain
* feeling drowsy or unable to sleep
* difficulty concentrating
* confusion
* depression

Ref: 1365/100114/1/B

Buspirone ® Hydrochloride 10mg Tablets
Patient Information Leaflet (continued)
* feeling agitated or aggressive
* blurred vision
* sore throat
* blocked nose
* ringing in the ears
* stomach pain
* dry mouth
* diarrhoea or constipation
* being sick
* muscle or joint pain
* stiffness
* numbness or tingling
* loss of co-ordination
* shaking
* feeling unusually weak or tired
* impaired mental capacity
Rare side effects include:
* a sudden inability to perform normal activity
* a feeling of being detatched from yourself
* severe mental condition in which the person loses contact with reality and
is unable to think and judge clearly
* uncontrollable or sudden twitching or jerking movements
* lack of co-ordination affecting balance and manner or walking, limb or eye
movements and/ or speech
* becoming emotionally unstable
* a feeling of being detached from your surroundings
* hallucinations
* uncontrollable muscle spasms affecting the eyes, head, neck and body
* epileptic fits
Other rare side effects including fainting, tunnel vision, difficulty passing
urine, leaking of milk from the breasts, loss of hair and itching skin.
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.


How to store Buspirone

Do not store above 25°C. Store in the original package.
Do not take this medicine after the expiry date shown on the blister or carton
label. If your doctor tells you to stop taking the medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this medicine if
your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via water waste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.


Further information

What this medicine contains:
The active substance is Buspirone hydrochloride
Buspirone contains 10mg buspirone hydrochloride.
The other ingredients are: lactose monohydrate, microcrystalline cellulose,
sodium starch glycollate, magnesium stearate and colloidal anhydrous
What this medicine looks like and contents of the pack
Buspirone comes in blister packs containing 30 and 60 tablets.
Buspirone are a white, uncoated, capsule shaped with BR10 and a score
line on one side and G on the other side.
Manufacturer and Licence Holder
This medicine is manufactured by Mylan SAS, 117 Allee des Parcs,
Saint-Priest F-69800, France and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.


PL 15184/1365

Buspirone 10mg Tablets

Revision date: 10/01/14

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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.