Busansil, tablets, 10 mg

NAME OF THE MEDICAL PRODUCT
Busansil

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance (per tablet):

Buspirone hydrochloride ……………………………………… 10 mg

PHARMACEUTICAL FORM AND CONTENT
Packages with 20 and 60 tablets.

PHARMACOTHERAPEUTIC CLASS
Pharmacotherapeutic group: II-8a Psychopharmacs, Anxiolytics, sedatives and hypnotics

ATC code: N05BE01 Anxyolitics, Derivatives from azaspirodecanodione.

MARKETING AUTHORIZATION HOLDER
Rega Farma – Promoção de Produtos Farmacêuticos, S. A.
Rua João Chagas 53, Piso 3,
1495-764 Cruz Quebrada - Dafundo

THERAPEUTIC INDICATIONS
Short-term treatment of anxious disorders.

CONTRAINDICATIONS
Patients hypersensitive to hydrochloride buspirone.
Severe renal and/or hepatic impairment. Patients below 18 years.

SIDE EFFECTS
Studies demonstrate than buspirone hydrochloride in therapeutic doses causes less sedation than other anxyolitics and they do not cause any significant functional decrease. However, their effects in the CNS of some patients may not be predictible and at the beginning of treatment it may occur vertigo sensations, headaches, nauseas, sweating and gastralgias, which decrease or disappear with the continuation of the treatment and/or the decrease of posology.

DRUG INTERACTIONS AND OTHER FORMS OF INTERACTION
The simultaneous administration of buspirone hydrochloride and MAOI may constitute a risk of increase of blood pressure. It is recommended that buspirone hydrochloride and non selective MAOI are not administered simultaneously and that there is an interval of at least 10 days between the end of MAOI administration and the beginning of the administration of buspirone hydrochloride.

In controlled studies no interaction was seen between buspirone hydrochloride and alcohol; there were no different psychomotor limitations than those caused by alcohol itself, however caution should be exercised in its concomitant administration with alcohol.

The simultaneous administration of buspirone hydrochloride with food can delay its gastrointestinal absorption, thus increasing the quantity of substance in systemic circulation.

Buspirone hydrochloride in therapeutic doses does not potentiate the sedative effect of central action antidepressants.

WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In the depression, buspirone hydrochloride acts mainly over its anxious component. The single administration of buspirone hydrochloride does not constitute any treatment for depression and can even eventually mask the signs of depression.

The effects of buspirone hydrochloride were not evaluated in patients with history of convulsive disorders.

In animals, buspirone hydrochloride did not reveal any anticonvulsionant activity. Therefore, it is not recommended for patients with convulsive attacks. It should not be used in replacement of a antipsychotic treatment, since no antipsychotic activity is established for Buspirone hydrochloride.

It is not described the potential effect of dependence. The suspension of the treatment with buspirone, can be quick and it is not expected the occurrence of withdrawal symptoms which occur after the discontinuation of a therapy with benzodiazepines or other sedative or hypnotic medicines. In case the treatment with benzodiapines is replaced by the treatment with buspirone hydrochloride, the latter should be administered 15 days after the end of the treatment with benzodiazepines.

It is also convenient to carry out a progressive decrease of the posology of benzodiazepines fully respecting usual rules. Buspirone does not prevent or treat the withdrawal syndrome of benzodiazepines.

EFFECTS ON PREGNANT WOMEN, BREAST-FEEDING WOMEN, CHILDREN, ELDERLY PATIENTS AND PATIENTS WITH SPECIAL PATHOLOGIES
In the absence of adequate and controlled studies in humans, it is not recommended the use of the drug during pregnancy.

In the same way, it is not advisable the administration of buspirone hydrochloride during lactation due to the absence of data on the passage of the substance and its metabolites into mother milk.

Buspirone hydrochloride was evaluated in elderly patients and in the clinical studies performed no specific geriatric problems were observed that might jeopardize its administration in elderly patients.

However, these patients may have an age-related renal impairment that may demand the decrease of the posology to be administered.

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
The effect of buspirone hydrochloride may interfere with the capacity to drive and use machines due to the vertigo sensation that may eventually occur.

These symptoms may decrease or disappear with the continuation of the treatment and/or the reduction of the posology.

LIST OF EXCIPIENTS
Lactose, sodium Carboxymethylamide, microcrystalline cellulose, precipitated silica and magnesium stearate.

WARNING: Contains lactose.
If you were informed by your doctor that you are intolerant to some sugars, contact him before taking this medicine.

POSOLOGY AND ADMINISTRATION MODE
The recommended posology is 1 tablet, 2 to 3 times a day.
Maximum daily dose should not exceed 60 mg.

This medicine should not be administered to patients younger than 18 years.

INDICATION OF THE MOST FAVOURABLE MOMENT FOR THE ADMINISTRATION OF THE MEDICINE
The medicine can be taken before and after meals.
The administration with food can delay the gastrointestinal absorption of Buspirone hydrochloride, thus increasing the quantity of substance in the systemic circulation.

DURATION OF THE AVERAGE TREATMENT WHEN IT SHOULD BE LIMITED
The duration of the treatment should be established by the family doctor and according to the type and degree of anxiety of the patient.

INSTRUCTIONS ABOUT WHAT TO DO IF YOU FORGET TO TAKE ONE OR MORE DOSES
If you forgot to take the medicine, take it as soon as possible, but do not duplicate the dose. The omission of several doses should be communicated to the family doctor.

INDICATION OF HOW TO DISCONTINUE THE TREATMENT WHEN ITS DISCONTINUATION CAUSES WITHDRAWAL EFFECTS
It is not described the potential effect of dependence. The suspension of the treatment with buspirone, can be quick and it is not expected the occurrence of withdrawal symptoms which occur after the discontinuation of a therapy with benzodiazepines or other sedative or hypnotic medicines. In case the treatment with benzodiapines is replaced by the treatment with buspirone hydrochloride, the latter should be administered 15 days after the end of the treatment with benzodiazepines.

It is also convenient to carry out a progressive decrease of the posology of benzodiazepines fully respecting usual rules. Buspirone does not prevent or treat the withdrawal syndrome of benzodiazepines.

MEASURES TO ADOPT IN CASE OF OVERDOSAGE AND/OR INTOXICATION, EMERGENCY SYMPTOMS AND ANTIDOTES
In case of overdosage there is no specific antidote. It is recommended gastric lavage, the monitorization of the patient and, if necessary, the application of support measures and symptomatic treatment.

Buspirone hydrochloride is not removed by dialysis.

ADVICE TO THE PATIENT
If you notice any side effects not mentioned in this Patient Leaflet, please inform your doctor or pharmacist.

Keep the medicine out of reach and sight of children.

Before taking the medicine, check if the product is within the expiry date mentioned in the package.

SPECIAL PRECAUTIONS FOR STORAGE AND INDICATION OF VISIBLE SIGNS OF DETERIORATION IF THEY EXIST

Keep the package protected from light, humidity and heat.

DATE OF THE REVISION OF THE LEAFLET: September 2005.

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