Tuesday, October 25, 2016

Buspirone Tablets 5mg, 10mg






Buspirone 5mg and 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.



Index



  • 1 What Buspirone tablets are and what they are used for


  • 2 Before you take


  • 3 How to take


  • 4 Possible side effects


  • 5 How to store


  • 6 Further information




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 Buspirone



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 an inherited disorder of the red blood pigment haemoglobin causing skin blisters, abdominal pain and brain or nervous system disorders (porphyria).

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 You should be gradually withdrawn from these medicines before taking Buspirone tablets.


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 (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 (used 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 any other sedative or hypnotic medicine.



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.




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.




Taking Buspirone tablets with food and 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.





How to take Buspirone


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


Swallow the tablets with water.



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, slow heart beat, low blood pressure, fits and extrapyramidal symptoms (difficulty in speaking or swallowing, loss of balance control, lack of facial expression, 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, unless it is nearly time for your next dose. 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.





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 also taking selective serotonin re-uptake inhibitors (SSRIs) e.g. fluoxetine and paroxetine and experience:



  • Serotonin syndrome: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat.


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.



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



  • Nervous system: dizziness, headache, nervousness, light-headedness, excitement, tingling or pins and needles, disturbances in sleep, drowsiness, confusion, fits, dry mouth.


  • Ears: ringing or buzzing in the ears.


  • Heart: chest pain, racing heart beat, awareness of the heart beat.


  • Breathing: blocked nose.


  • Stomach: feeling sick.


  • Skin: sweating or clamminess.


  • Others: tiredness, sore throat.



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.




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




This leaflet was last revised in November 2009



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




Actavis

Barnstaple

EX32 8NS

UK


ALKPL000






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