BUSPIRONE 10 MG TABLETS - Patient leaflet, side effects, dosage

1. what buspirone is and what it is used for

Buspirone tablets are used to relieve the symptoms of anxiety disorders such as anxiety, agitation and tension.

2. what you need to know before you take buspironedo not take buspirone:- if you are allergic to buspirone hydrochloride or any of the other ingredients of this medicine (listed in section 6)

• – if you suffer from acute angle closure glaucoma (increased pressure in the eye)

• – if you suffer from myasthenia gravis (severe muscle weakness)

• – if you suffer from any severe liver or kidney disease

• – if you suffer from epilepsy

• – if you suffer from acute intoxication with alcohol, hypnotics, analgesics, or antipsychotic drug­s.

Warnings and precautions

Talk to your doctor or pharmacist before taking Buspirone:

• – if you have taken a medicine with calming effect on the central nervous system for a long time. Before taking Buspirone, these medicines should be discontinued gradually

• – if you have a history of kidney or liver disease

• – if you have a history of seizures

• – if you have a history with drug dependence.

Children and adolescents

Buspirone should not be used in children and adolescents under 18 years of age (see “How to take Buspirone” below).

Other medicines and Buspirone

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

It is especially important to tell your doctor if you are taking any of the following:

• – medicines known as monoamine oxidase inhibitors (MAOIs), such as phenelzine or tranylcypromine (to treat depression and Parkinson’s di­sease). You should not take these medicines concomitantly with Buspirone.

• – medicines known as selective serotonin re-uptake inhibitors (SSRIs), such as fluoxetine, fluvoxamine and paroxetine (for depression and other psychiatric disorders)

• – Buprenorphine

• – antihypertensives (for high blood pressure)

• – antidiabetics (for diabetes)

• – anticoagulants such as warfarin (for stopping the blood from clotting)

• – contraceptives (for pregnancy prevention)

• – cardiac glycosides such as digoxin (for heart failure)

• – antihistamines (for allergy/hyper­sensitivity)

• – dexamethasone (for inflammatory and autoimmune conditions, such as rheumatoid arthritis)

• – phenytoin, phenobarbital, carbamazepine (for epilepsy)

• – nefazodone (for depression)

• – erythromycin (for various types of infections caused by bacteria)

• – linezolid (for severe infections caused by gram-positive bacteria)

• – itraconazole (for fungal infections)

• – diltiazem or verapamil (for high blood pressure, angina, heart failure, and as a preventive medication for migraine)

• – triptans (for migraine)

• – tramadol (for severe pain)

• – cimetidine (for heartburn and peptic ulcers)

• – rifampicin (for tuberculosis and other infections)

• – ketoconazole or ritonavir (to treat fungal or viral infections)

• – baclofen (for treatment of spasticity)

• – lofexidine (for opioid withdrawal)

• – nabilone (for control of nausea and vomiting)

• – haloperidol (for schizophrenia and for acute psychotic states and delirium)

• – trazodone (for depression)

• – lithium (for manic-depression)

• – st. John’s Wort (a herbal medicine for depression)

• – l-trytophan (nutritional supplement)

• – diazepam (for anxiety, sleep disorders, seizures, including epileptic seizures, muscle spasms, restless legs syndrome, alcohol withdrawal, benzodiazepine withdrawal, and Meniere’s disease.

A change in dose may need to be considered by your doctor.

Buspirone with food, drink and alcohol

Alcohol

You should not drinkalcohol while taking Buspirone.

Grapefruit juice

You should not eat or drink products containing large quantities of grapefruit juice 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.

Pregnancy

Buspirone should not be taken during pregnancy.

Breast-feeding

Breast-feeding is not recommended during treatment.

Driving and using machines

Do not drive or use any tools or machines until you know how Buspirone affects you. It cannot be excluded that Buspirone, especially at the beginning of treatment and after a change in dose, affects the capacity of reaction.

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Buspirone contains lactose

This medicine contains 59.5 mg lactose (as monohydrate) in a single 5 mg tablet and 118.9 mg lactose (as monohydrate) in a single 10 mg tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other excipients

This medicine contains less than 1 mmol (23 mg) sodium per tablet, that is to say essentially ‘sodium-free’.

3. how to take buspirone

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

Adults (over 18 years of age)

The recommended starting dose is 5 mg three times daily (corresponding to 15 mg buspirone hydrochloride daily). Your doctor may increase this dose gradually if necessary. The daily dose can be increased to 20–30 mg buspirone hydrochloride daily, divided into several individual doses. A single dose of 30 mg buspirone hydrochloride should not be exceeded. More than 60 mg buspirone hydrochloride per day should not be taken.

Patients with kidney and/or liver problems

These patients might need a lower dose. Your doctor will determine your individual dose.

Use in children and adolescents

Buspirone should not be used in children and adolescents under 18 years of age.

Method of administration

The tablets are scored and can be divided into equal doses.The whole tablets or, if needed, the divided halves should not be chewed or crushed but swallowed whole with some liquid. The tablets should always be taken at the same time of day, either always on an empty stomach or always after a meal.

Duration of treatment

It may take some time before you start to feel better. If the symptoms do not improve within 4–8 weeks, you should talk to your doctor. Your doctor will determine how long you should continue to take Buspirone. Ifa long-term medical treatment is necessary, it should be monitored intensively by your doctor and the need to continue treatment should be periodically reassessed.

If you take more Buspirone than you should

If you have taken too much of the medicine or if, for example, a child has taken the medicine by mistake, contact your doctor or hospital for an assessment of the risk and advice.

Take the medicine pack with you.

The typical symptoms ofan overdose include nausea, vomiting, dizziness, fatigue, constriction of the pupils and stomach pains.

If you forget to take Buspirone

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 possible. However, if it is almost time for your next dose, skip the missed dose and continue as before.

If you stop taking Buspirone

Continue with Buspirone until your doctor tells you otherwise. If you need a long-term medical treatment your doctor will monitor your use of this medicine on a regular basis.

If you are to stop Buspirone therapy you must follow your doctor’s instruc­tion closely. It is especially important as this type of medicine should not be stopped suddenly.

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

4. possible side effects

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

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Serious side effects:

• – suicidal thoughts

• – serotonin syndrome (fever, confusion, agitation, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat)

• – allergic reaction (itching, difficulty breathing or swelling of the face, lips, throat, tongue or skin)

• – serious heart problems such as heart failure and heart attack.

If you experience any of the above side effects, stop taking Buspirone and tell your doctor IMMEDIATELY or go to a casualty department at your nearest hospital.

The following side effects have also been reported:

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

• - nonspecific chest pain

• – nightmares, drowsiness, sleeplessness, dizziness, nervousness, light-headedness, impaired concentration, restlessness, anger, hostility, confusion, depression

• – blurred vision

• – ringing or buzzing in the ears (tinnitus)

• – sore throat, stuffy nose

• – nausea, dry mouth, gastrointestinal symptoms, diarrhoea

• – headache, weakness.

Uncommon (may affect up to 1 in 100people):

• – brief episodes of fainting, low or high blood pressure, exceedingly high heart rate/abnormality of heartbeat

• – depersonalisation, over-sensitivity to certain frequency ranges of sound, excitement, unpleasant mood (including symptoms such as sadness, irritability, restlessness), urge to move, anxiety, loss of interest, association disturbances, hallucinations, seizures

• – numbness, abnormal sensations (e.g. tingling, pricking sensation), loss of coordination, involuntary trembling

• – significantly increased breathing frequency, shortness of breath, chest pressure, altered sense of smell

• – redness of the eyes, itchy eyes, inflammation of the outermost layer of the eye and the inner surface of the eyelids

• – increased appetite, poor appetite, drooling, rectal bleeding, constipation, passing gas (flatulence), irritable colon, vomiting

• – lower urinary tract symptoms

• – oedema, nettle rash, flushing, tendency to bruising, hair loss, dry skin, eczema, vesicles, facial oedema

• – muscle cramps, muscle pain, muscle tension, joint pain

• – weight gain, fever, roaring in the head, weight loss, general feeling of being unwell, tiredness, altered taste, sweating, clammy hands

• – increased liver enzymes

• – menstrual disorders, decreased or increased sexual desire.

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

• – disorders in the blood supply to the brain, dysfunction of the heart muscle, slow resting heart rate

• – blood count changes signs of which include rash, tiredness, shortness of breath, bruising and prolonged bleeding. Types of blood count changes include increased number of certain white blood cells (eosinophilia), decreased number of certain blood cells (leukopenia), decreased number of platelets in the blood (thrombocytopenia)

• – mood swings, claustrophobia, cold intolerance, sleepiness which can cause immobility or unconsciousness, slurred speech, psychosis, transient memory gaps

• – movement disorders including involuntary movements of the body during or after treatment, involuntary movements of the body, face, mouth, or tongue and stiffness of the body, parkinsonism (e.g. symptoms such as slow movements and trembling), akathisia (e.g. symptoms such as restlessness, being unable to sit still), restless legs syndrome (e.g. symptoms such as burning, itching or tingling in the muscles), slowed reaction time

• – eye pain, sensitivity to light, sensation of pressure on the eyes, constricted circular tunnel-like field of vision

• – nosebleeds

• – inability to control urination, need to get up in the night to urinate

• – bruising, bleeding, acne, nail thinning

• – muscle weakness

• – milk secretion from the breast, breast enlargement in males, thyroid dysfunction

• – alcohol abuse, bleeding disorders, loss of voice, hiccups, burning tongue

• – absence of menstrual period, pelvic inflammatory disease, abnormal ejaculation, impotence.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

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 which is stated on the carton / tablet container / blister. The expiry date refers to the last day of that month.

This medicinal product does not require any special temperature storage conditions.

For blister additionally:

Keep the blister in the outer carton in order to protect from light.

HDPE tablet container additionally:

After first opening use within 1 year.

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 informationwhat buspirone contains- the active substance is buspirone hydrochloride.

• – 5 mg: Each tablet contains 5 mg buspirone hydrochloride.

• – 10 mg: Each tablet contains 10 mg buspirone hydrochloride.

• – The other ingredients are lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycolate (type A); magnesium stearate.

What Buspirone looks like and contents of the pack

• 5 mg: