Buspirone Hydrochloride 10mg Tablets
BUSPIRONE HYDROCHLORIDE 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.
■ 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Buspirone Hydrochloride 10mg Tablets but will be referred to as Buspirone throughout this leaflet.
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
1. What Buspirone is and what it is used for
Buspirone contains the active ingredient buspirone hydrochloride. Buspirone belongs 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 anxiety.
2. 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 medicine 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 a 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, Nefazodone
■ medicine to treat mental illness (antipsychotics) e.g. Haloperidol
■ medicines for stomach ulcers e.g. Cimetidine
■ antibiotics such as Erythromycin, Rifampicin
■ anti-fungal medicine such as Itraconazole or Ketoconazole
■ St John's wort, a herbal remedy
■ medicines to treat anxiety including those containing Benzodiazepine e.g. Diazepam
■ medicines 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 medicine 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.
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 monohydrate. If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.
3. 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 with 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 or 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 dose 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 overdose include dizziness, drowsiness, and feeling or being sick.
If you forget to take Buspirone
Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you suddenly stop taking 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.
4. Possible side effects
Like all medicines, Buspirone can cause side effects, although not everybody gets them.
If any of the following happen, 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 disappear 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
■ 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 detached 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 of 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 include fainting, tunnel vision, difficulty passing urine, leaking of milk from the breasts, loss of hair and itchy skin.
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly via: Yellow Card Scheme Website: 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 OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Do not store above 25°C.
■ Do not use after the expiry date printed on the pack.
■ If your doctor decides to stop your treatment, take any leftover tablets back to the pharmacy.
■ If your tablets appear discoloured, or show any other signs of deterioration, take them to your pharmacist who will advise you.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.
6. Further information
What Buspirone contains
Each tablet contains lOmg of buspirone hydrochloride.
Also contains: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, colloidal anhydrous silica and magnesium stearate.
What Buspirone looks like and contents of the pack
Buspirone are white, capsule shaped tablets with a score line on one side ('BR' embossed on one side of the score line and '10' on the other) and 'G' embossed on the other side.
Buspirone comes in blister packs of 20 and 30 tablets.
Manufacturer
Manufactured by: Mylan S.A.S., 117 Allee des Parcs, 69800 Saint-Priest, France.
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.
POM
PL No: 21828/0535
Leaflet issue and revision date: 26.01.15
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