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.

Index

T| What Buspirone tablets are and what they are used for ” Before you take How to take Possible side effects How to store Further information

T| 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

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

Before you take

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

•    are allergic (hypersensitive) to buspirone 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.

•    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 You should be gradually withdrawn from these medicines before taking Buspirone tablets.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:

Continued top of next column AAAG9160

•    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, phenyton, 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 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.

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.

Continued over page

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 a 30mg a day in divided doses. The maximum daily dosage should not exceed 60mg per day.

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).

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

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

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

•    The active substance (the ingredient that makes the tablets work) is buspirone hydrochloride. Each tablet contains either 5mg or 10mg of the active substance.

•    The other ingredients are lactose monohydrate, 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

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, dystomia, anxiety, distress), muscle

Continued top of next column AAAG9160

This leaflet was last revised in November 2014.

If you would like a leaflet with larger text, please contact 01271 311257.

^actavis

Actavis, Barnstaple, EX32 8NS, UK