BUSPIRONE HYDROCHLORIDE

Posology The dosage should be individualized for each patient. Adults (including the elderly): the usual starting dosage is 5mg given two to three times per day. The dosage may be increased every 2-3 days. The usual therapeutic dosage is 15 to 30 mg daily in divided doses.

The maximum recommended dose is 60mg daily in divided doses. Food increases the bioavailability of buspirone. Buspirone should be taken at the same time each day and consistently with or without food. 5). Grapefruit juice increases the plasma concentrations of buspirone.

5). 72 m2) a slight increase in the buspirone blood levels was seen, without increase of the half-life time. In these patients buspirone should be administered with caution and a low dosage, two-times daily, is advised. The response and the symptoms of the patients should be evaluated carefully, before an eventual increase of the dosage is made.

A single administration to anuretic patients causes an increase in the blood levels of the metabolite 1-pyrimidine/piperazine (1-PP), in which dialysis did not prove to have any influence on the buspirone levels, neither on the 1-PP levels.

72 m2), especially not to anuretic patients, because of the fact that increased and untreated levels of buspirone and its metabolites may occur. Hepatic impairment As may be expected agents as buspirone used in patients with a reduced liver function show a reduced “first pass effect”.

After a single administration to patients with liver cirrhosis, higher maximum concentrations of unchanged buspirone are seen, with an increase in the half life time. In these patients buspirone should be used with caution and individual dosages should be titrated with care to reduce the chance of central undesirable effects, which may occur because of high maximum concentrations of buspirone.

Increased dosages should be considered carefully and only after 4-5 days experience with the prior dosage. Elderly Patients Current data do not support a change in dosage regimen based on age or sex of the patient.

Paediatric population:

Placebo-controlled trials, in which 334 patients were treated with buspirone for up to six weeks, have not shown buspirone at doses recommended for adults to be an effective treatment for generalized anxiety disorder in patients less than 18 years.

Side effects of buspirone, if they occur, are generally observed at the beginning of drug therapy and usually subside with use of the medication and/or decreased dosage. 10) in the buspirone group than in the placebo group. The list of undesirable effects shown below is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100 to <1/10), and very rare (<1/10,000).

ADVERSE DRUG EVENTS REPORTED DURING CLINICAL EXPERIENCE System Organ Class Frequency MedDRA Terms Psychiatric Disorders common nervousness, insomnia, disturbance in attention, depression, confusional state, sleep disorder, anger very rare psychotic disorder, hallucination, depersonalization, affect lability very common dizziness*, headache, somnolence common paraesthesia, vision blurred, coordination abnormal, tremor, tinnitus Nervous System Disorders very rare serotonin syndrome, convulsion, tunnel vision, extrapyramidaldisorder, cogwheel rigidity, dyskinesia, dystonia, syncope, amnesia, ataxias, Parkinsonism,akathisia, restless leg syndrome, restlessness common vision blurredEye disorders very rare tunnel vision Ear and labyrinth disorders common tinnitus Cardiac Disorders common tachycardia, chest pain Respiratory, Thoracic and Mediastinal Disorders common nasal congestion, pharyngolaryngeal pain Gastrointestinal Disorders common nausea, abdominal pain, dry mouth, diarrhoea, constipation, vomiting common cold sweat, rashSkin and Subcutaneous Tissue Disorders rare angioneurotic oedema, ecchymosis, urticaria Musculoskeletal and Connective Tissue Disorders common musculoskeletal pain Renal and Urinary Disorders very rare urinary retention Reproductive System and Breast Disorders very rare galactorrhoea General Disorders and Administration Site Conditions common fatigue * Dizziness includes light headedness.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The administration of buspirone to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone has been added to a regimen including a MAOI.

Therefore, it is recommended that buspirone not be used concomitantly with a MAOI. Buspirone should be used with care in the following situations. • acute narrow-angle glaucoma. • myasthenia gravis. • drug dependence. • patients with rare hereditary problems of galactose intolerance, the lapp • lactase deficiency or glucose – galactose malabsorption should not take this medicine.

• patients with a history of renal or hepatic impairment. • alcohol use should be avoided, although buspirone has not been reported to potentiate the psychomotor impairment produced by alcohol. No data are available on concomitant use of alcohol and single doses of buspirone greater than 20mg.

• buspirone does not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic agents. It will not block the withdrawal syndrome often seen with cessation of therapy with these agents. Patients should be gradually withdrawn from these agents before initiating buspirone treatment.

Buspirone should not be used alone to treat depression and may potentially mask the clinical signs of depression. Paediatric population The long-term safety and effectiveness of buspirone have not been determined in individuals below 18 years of age.

2). Drug abuse and dependence Buspirone is not a controlled substance. Buspirone has shown no potential for drug abuse and dependence based on human and animal studies Potential for withdrawal reactions in sedative/hypnotic/anxiolytic drug- dependent patients Because buspirone does not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs, it will not block the withdrawal syndrome often seen with cessation of therapy with these drugs.

1. • patients with severe renal (defined as creatinine clearance of 20 ml/min or below, or a plasma creatinine above 200 μmol/l) or severe hepatic impairment. • acute intoxication with alcohol, hypnotics, analgesics, or antipsychotic drugs.

• patients with epilepsy.