Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buspirone hydrochloride
Viatris UK Healthcare Ltd
N05BE01
Buspirone hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04010200; GTIN: 5016695002309
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUSPIRONE HYDROCHLORIDE 5 MG TABLETS (buspirone hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Buspirone is and what it is used for. 2. What you need to know before you take Buspirone. 3. How to take Buspirone. 4. Possible side effects. 5. How to store Buspirone. 6. Contents of the pack and other information. 1. WHAT BUSPIRONE IS AND WHAT IT IS USED FOR Buspirone contains the active ingredient buspirone hydrochloride. Buspirone belongs to a group of medicines called azapirones, used to treat anxiety. These medicines work on the central nervous system, altering levels of chemicals in the brain which can help make you feel less anxious. It should only be taken for a short time to relieve anxiety. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUSPIRONE DO 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 have severe liver or kidney problems if you have consumed high quantities of alcohol, hypnotics, pain killers or antipsychotic drugs (for mental illness) in the last few days if you have epilepsy (suffer from fits) WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Buspirone: if you have been prescribed a benzodiazepine e.g. nitrazepam, temazepam or another common sedative or hypnotic medicine (which may make you feel sleepy). You should be gradually withdrawn from these medicines before taking Buspirone Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Buspirone Hydrochloride 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: buspirone hydrochloride 5 mg Excipient with known effect: Each tablet also contains 55.7 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Buspirone Hydrochloride 5 mg Tablets are white, round, bevelled edge tablets, embossed “BR 5” on one side, “G” on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Buspirone hydrochloride tablets are indicated for short-term use in cases of anxiety and to relieve the symptoms of anxiety with or without accompanying depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be individualised for each patient _Adults and older people_: Initially, a dose of 5 mg two to three times daily is given. After several weeks, to allow for a lag period, this may be increased in increments of 5 mg at 2 to 3 day intervals according to the therapeutic response. After dosage titration, the usual daily dose is 15 to 30 mg per day in divided doses. The maximum recommended daily dosage should not exceed 60 mg per day. Food increases the bioavailability of buspirone. 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 (see section 4.5). _Renal impairment _ After a single administration to patients with mild to moderate renal insufficiency (creatinine 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, befo Przeczytaj cały dokument