Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buspirone hydrochloride
Mawdsley-Brooks & Company Ltd
N05BE01
Buspirone hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04010200
BUSPAR TM TABLETS 5MG AND 10MG Buspirone Hydrochloride Read all of this leaflet carefully before you start taking this medicine. . Keep this leaflet. You may need to read it again. . If you have any further questions, ask your doctor or pharmacist. . This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. In this leaflet: 1. What Buspar is and what it is used for 2. Before you take 3. How to take 4. Possible side effects 5. How to store 6. Further information 1. WHAT BUSPAR IS AND WHAT IT IS USED FOR Buspar belong to a group of medicines called anxiolytics. These medicines work on the central nervous system, altering levels of chemicals in the brain. Buspar may be used for the: short term management of anxiety disorders relief of symptoms of anxiety with or without symptoms of depression. 2. BEFORE YOU TAKE BUSPAR DO NOT TAKE BUSPAR AND TELL YOUR DOCTOR IF YOU: are ALLERGIC (hypersensitive) to buspirone hydrochloride or any of the other ingredients in Buspar (see section 6). are PREGNANT or BREAST-FEEDING. have EPILEPSY. have SEVERELY impaired LIVER or KIDNEY function. CHECK WITH YOUR DOCTOR OR PHARMACIST before taking Buspar if you have: had impaired LIVER or KIDNEY function in the past. been prescribed a BENZODIAZEPINE e.g. nitrazepam or temazepam or another common SEDATIVE or HYPNOTIC medicine. You should be gradually withdrawn from these medicines before taking Buspar. ACUTE NARROW-ANGLE GLAUCOMA MYASTHENIA GRAVIS, a disorder characterised by muscle weakness, difficulty chewing or swallowing and slurred speech or have had DRUG DEPENDENCE TAKING OTHER MEDICINES Please TELL YOUR DOCTOR OR PHARMACIST if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially: monoamine-oxidase inhibitors (MAOIs) such as phenelzine and tranylcypromine (for depression) St. John’s Wort, nefazodone and L-tryptophan, fluvoxamine, trazod Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buspar Tablets 5MG. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: buspirone hydrochloride 5mg. 3 PHARMACEUTICAL FORM Oral tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Buspar is indicated for the short-term management of anxiety disorders and the relief of symptoms of anxiety with or without accompanying depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _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 30mg daily in divided doses. The maximum recommended dose is 45mg 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. If buspirone is administered with a potent CYP3A4 inhibitor, the initial dose should be lowered and only increased gradually after medical evaluation (see section 4.5). Grapefruit juice increases the plasma concentrations of buspirone. Patients taking buspirone should avoid consuming large quantities of grapefruit juice. _ _ _Renal impairment _ After a single administration to patients with mild to moderate renal insufficiency (creatinin clearance 20-49 ml/min/1.72 m 2 ) 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. Buspirone should not be administered to patients with a cr Přečtěte si celý dokument