BUSPIRONE

Posology The dosage depends on the individual circumstances of the patient. Adults (over 18 years of age) At the start of the treatment 5 mg buspirone hydrochloride three times daily and this may be increased every two to three days If necessary, the daily dose can be increased to 20-30 mg buspirone hydrochloride divided into several individual doses.

More than 60 mg buspirone hydrochloride per day should not be taken. A single dose of 30 mg buspirone hydrochloride should not be exceeded. 5). Grapefruit juice increases the plasma concentrations of buspirone. 5). Due to latency of effect patients should be advised not to expect immediate benefit.

If there is no improvement of symptoms within 4-8 weeks, treatment with buspirone should be reconsidered. 4). 72 m2) 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.

2). Hepatic impairment In patients with hepatic impairment 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.

2). 3). Age and gender Current data do not support any modification of the patient's dosage regimen based on age or gender. 2). Method of administration Buspirone tablets can be divided into equal doses and must be swallowed with liquid.

The bioavailability of buspirone is increased by food. Buspirone should be taken at the same time each day and consistently with or without food.

g. tingling, pricking sensation), loss of coordination, tremors, seizures, roaring in the head, altered taste, drooling Rare: extrapyramidal symptoms including early and late dyskinesia, dystonia and rigidity, parkinsonism, akathisia, restless legs syndrome, slowed reaction time, involuntary movements, stupor, slurred speech, transient memory gaps, serotonin syndrome, loss of voice Eye disorders Common: blurred vision Uncommon: redness of the eyes, itchy eyes, conjunctivitis Rare: eye pain, photophobia, sensation of pressure on the eyes, tunnel vision Ear and labyrinth disorders Common: tinnitus Uncommon: hyperacusis Cardiac disorders Common: nonspecific chest pain Uncommon: tachycardia/palpitations Rare: heart failure, heart attack, cardiomyopathy, bradycardia Vascular disorders Uncommon: brief episodes of fainting, hypo- or hypertension Rare: cerebral blood flow disorders Respiratory, thoracic and mediastinal disorders Common: sore throat, stuffy nose Uncommon: significantly increased breathing frequency, shortness of breath, chest pressure, altered sense of smell Rare: nosebleeds Gastrointestinal disorders Common: nausea, dry mouth, gastrointestinal symptoms, diarrhoea Uncommon: rectal bleeding, constipation, flatulence, irritable colon, vomiting Rare: burning tongue, hiccups Hepatobiliary disorders Uncommon: increased liver enzymes Skin and subcutaneous tissue disorders Uncommon: urticaria, flushing, tendency to bruising, hair loss, dry skin, eczema, vesicula Rare: small haemorrhages of the skin, acne, nail thinning Musculoskeletal and connective tissue disorders Uncommon: muscle cramps, muscle pain, muscle tension, joint pain Rare: muscle weakness Renal and urinary disorders Uncommon: lower urinary tract symptoms Rare: enuresis, nocturia Reproductive system and breast disorders Uncommon: menstrual disorders, decreased or increased libido Rare: amenorrhea, pelvic inflammatory disease, abnormal ejaculation, impotence, galactorrhoea, gynaecomastia General disorders and administration site conditions Common: weakness Uncommon: fever, malaise, fatigue, sweating, clammy hands, oedema, facial oedema Rare: cold intolerance Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Note Not all states of anxiety require medical treatment. They may also be a result of physical or mental illness and may sometimes be cured by targeted treatment of the underlying disease. In clinical and experimental studies, there has been no indication that buspirone causes the risk of developing habituation or addiction.

Nevertheless, until further clinical experience is gained, the administration should be monitored accordingly. Buspirone should be used with caution in patients with drug dependence. 2). Because buspirone has no cross-tolerance to benzodiazepines and other sedatives/hypnotics, it will not block the withdrawal symptoms that often occur at the discontinuation of these preparations.

Therefore, before starting treatment with buspirone, these medicinal products should be discontinued gradually. This has particular relevance to patients who have taken a medicinal product with calming effect on the CNS for a long time.

Careful observation is recommended for the use of buspirone in patients with a history of seizures. 5). 5). 5). If a long-term medical treatment is necessary, it should be monitored intensively. The need to continue treatment should be periodically reassessed by discontinuation of treatment after a longer period of time (several months).

Psycho- and sociotherapeutic measures should not be neglected during the treatment with buspirone. Since the mechanism of action of buspirone is not fully known, the long-term toxic effects on the central nervous system or other body systems cannot be predicted.

Controlled clinical studies with buspirone have only been performed over a period of six months. 2). Excipients Buspirone tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

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

72 m2).