Buspirone Hydrochloride 10 mg Tablets

• 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Buspirone Hydrochloride is and what it is used for
2. What you need to know before your child takes Buspirone Hydrochloride
3. How to take Buspirone Hydrochloride
4. Possible side effects
5. How to store Buspirone Hydrochloride
6. Contents of the pack and other information

• are allergic (hypersensitive) to buspirone hydrochloride or any of the other ingredients in Buspirone Hydrochloride (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 Hydrochloride 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 You should be gradually withdrawn from these medicines before taking Buspirone Hydrochloride.
• acute narrow-angle glaucoma
• myasthenia gravis, a disorder characterised by muscle weakness, difficulty chewing or swallowing and slurred speech
• or have had drug dependence

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, 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)

Do not take Buspirone Hydrochloride if you are pregnant or are breast-feeding. Talk to your doctor before taking any medicine.

Buspirone Hydrochloride 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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Talk to your doctor before eating or drinking products containing grapefruit juice, whilst taking Buspirone Hydrochloride. You should not drink alcohol whilst taking Buspirone Hydrochloride.

Swallow the tablets with water, at the same time each day.

Buspirone Hydrochloride should be taken consistently with or without food. However, the medicine is taken on the day one should be continued thereafter.

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 (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).

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.

Talk to your doctor before you stop taking the tablets and follow their advice.

If your child gets 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is Buspirone Hydrochloride

Buspirone Hydrochloride 5 mg Tablets

Each tablet contains 5 mg Buspirone Hydrochloride

Buspirone Hydrochloride 10 mg Tablets

Each tablet contains 10 mg Buspirone Hydrochloride

The other ingredients are:

Lactose monohydrate

Cellulose, Microcrystalline (Grade -102)

Sodium Starch Glycolate (Type – A)

Silica colloidal anhydrous

Magnesium stearate

Buspirone Hydrochloride 5 mg Tablets

White to off-white, ovoid rectangular shaped, beveled edged, uncoated tablets debossed “B” and “5” separated by score line on one side and plain on other side.

Buspirone Hydrochloride 10 mg Tablets

White to off-white, ovoid rectangular shaped, beveled edged, uncoated tablets debossed “B” and “10” separated by score line on one side and plain on other side.

Pack sizes: 30 tablets.

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