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Package leaflet: Information for the patient

Buspirone hydrochloride 5 mg Tablets Buspirone hydrochloride 10 mg Tablets

Buspirone hydrochloride

The name of your medicine is ‘Buspirone hydrochloride 5/10 mg Tablets’ but it will be referred to as ‘Buspirone’ throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor, pharmacist or nurse.

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

What is in this leaflet

1.    What Buspirone is and what it is used for

2.    What you need to know before you take Buspirone

3.    How to take Buspirone

4.    Possible side effects

5.    How to store Buspirone

6.    Contents of the pack and other information

1.    What Buspirone is and what it is used for Buspirone contains the active ingredient buspirone hydrochloride, which belongs to a group of medicines called anxiolytics. These medicines work on the central nervous system, altering levels of chemicals in the brain. Buspirone may be used for the:

•    short term management of anxiety disorders;

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

2.    What you need to know before you take Buspirone

Do not take Buspirone and tell your doctor:

•    if you are allergic to buspirone hydrochloride or any of the other ingredients of this medicine (listed in section 6).

•    if you are pregnant or breast-feeding.

•    if you have epilepsy.

•    if you have severe problems with the way your liver or kidneys work (severely impaired liver or kidney function).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Buspirone:

•    if you have had problems with the way your liver or kidneys work (impaired liver or kidney function) in the past;

•    if you have been prescribed a benzodiazepine for example nitrazepam or temazepam or another common sedative or hypnotic medicine. You should be gradually withdrawn from these medicines before taking Buspirone.

•    if you have an eye disease called acute narrow-angle glaucoma;

•    if you have myasthenia gravis, a disorder characterised by muscle weakness, difficulty chewing or swallowing and slurred speech;

•    or if you have had drug dependence.

Other medicines and Buspirone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, 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) for example 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 medicines for example 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 for example 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).

Buspirone with food, drink and alcohol

Talk to your doctor before eating or drinking products containing grapefruit juice, while taking Buspirone.

You should not drink alcohol while taking Buspirone.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Buspirone may make you feel drowsy or dizzy. Make sure you are not affected before you drive or operate machinery.

Buspirone contains lactose

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.

3. How to take Buspirone

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets with water, at the same time each day. Buspirone should be taken consistently with or without food. The way the medicine is taken on the first day of treatment should be continued thereafter.

Doses

Adults (including the older people)

The starting dose is 5 mg two to three times a day, which may be increased every two to three days. The usual dose you will be maintained on is 15 mg to 30 mg a day in divided doses up to a maximum dose of 45 mg a day in divided doses. Use in children

This medicine is not recommended for use in children.

Use in patients with liver and kidney problems

If you have problems with the way your liver or kidneys work (impaired liver or kidney function), your doctor may prescribe you a lower dose.

If you take more Buspirone 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 (nausea or vomiting), headache, dizziness, drowsiness, ringing or buzzing in the ears, restlessness, restriction of the pupils, stomach problems, slow heart beat, low blood pressure, fits and difficulty in speaking or swallowing, loss of balance control, masklike face, shuffling walk, stiffness of arms and legs, trembling or shaking of hands or fingers (extrapyramidal symptoms).

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If you forget to take Buspirone

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. Do not take a double dose to make up for a forgotten dose.

If you stop taking Buspirone

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Buspirone and contact your doctor immediately if you experience: high fever, agitation, confusion, trembling and abrupt contractions of muscles; these may be signs of a rare condition called serotonin syndrome.

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.

Very common side effects (may affect more than 1 in 10 people):

•    dizziness

•    headache

•    drowsiness

•    feeling nervous or excited.

Common side effects (may affect up to 1 in 10 people):

nervousness inability to sleep disturbance in attention depression blurred vision confusion sleep disturbances anger

tingling or pins and needles abnormal coordination, tremor buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) chest pain fast heart beat blocked nose throat pain or soreness feeling sick (nausea) being sick (vomiting) dry mouth diarrhoea constipation abdominal pain cold sweat rash

muscle and bone pain tiredness.

Rare side effects (may affect up to 1 in 1,000 people):

•    symptoms such as wheezing, swelling of the face or tongue (angioedema)

•    bruising

•    hives.

Very rare side effects (may affect up to 1 in 10,000 people):

•    severe mental conditions in which the person loses contact with reality and is unable to think and judge clearly (psychosis)

•    seeing, feeling or hearing things that are not there (hallucination)

•    change in personality

•    mood swings

•    fits or seizures

•    unusual, uncontrollable movements such as twitching or spasms which may affect the hands, the eyes and the rest of the body resulting in for example increased hand tremor, muscle twitching, muscle cramp, irregular movement ofjaw muscles resulting in difficulty opening the mouth (ataxia)

•    fainting

•    loss of memory

•    restlessness or difficulty standing still

•    restricted vision

•    feeling of uneasiness and restlessness in the legs, especially after going to bed (restless legs syndrome)

•    difficulty passing urine

•    secretion of breast milk in men, or in women who are not breast-feeding.

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 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.

5.    How to store Buspirone

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Buspirone contains

•    The active substance is buspirone hydrochloride.

Each tablet contains either 5 mg or 10 mg buspirone (as hydrochloride).

•    The other ingredients are: lactose monohydrate, microcrystalline cellulose (Aavicel-PH-101),

sodium starch glycolate, microcrystalline cellulose (Aavicel-PH-200), colloidal silicon dioxide and magnesium stearate.

What Buspirone looks like and contents of the pack

The tablets are white ovoid rectangular uncoated tablets with a score line on one side and plain on the other side.

Blister pack sizes of 20, 30, 40, 50, 60, 90 and 100 tablets are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Strides Arcolab International Ltd.

Unit 4, Metro Centre, Tolpits Lane,

Watford, Hertfordshire, Wd18 9SS,

United Kingdom.

Manufacturer & Distributor:

Co-Pharma Limited

Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire WD18 9SS,

United Kingdom.

This leaflet was last revised in {08/2015}.

Dimension - 150 x 310 mm

Font: Times New Roman

Font size: 9 points

No. of Columns: 2 Columns

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ARTWORK DETAIL LABEL