Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Buspirone hydrochloride 5mg
Orion Pharma (NZ) Limited
Buspirone hydrochloride 5 mg
5 mg
Tablet
Active: Buspirone hydrochloride 5mg Excipient: Colloidal silicon dioxide Lactose monohydrate Magnesium stearate Microcrystalline cellulose Sodium starch glycolate
Prescription
Fermion Oy
Buspirone hydrochloride is indicated for the management of anxiety with or without accompanying depression in adults. Buspirone hydrochloride is indicated for the management of anxiety disorders or the short-term relief of symptoms of anxiety with or without accompanying depression.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil blister strips of 10 - 20 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 30 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 50 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 90 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC/Al foil blister strips of 10 - 100 tablets - 36 months from date of manufacture stored at or below 25°C protect from light
2015-07-15
Buspirone (Orion) 1 BUSPIRONE _Buspirone hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Buspirone. This leaflet answers some common questions about Buspirone. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Buspirone against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT BUSPIRONE IS USED FOR Buspirone is a medicine that is used for the symptomatic treatment of anxiety states of clinically relevant severity with the following cardinal symptoms: anxiety, agitation, tension. Your doctor may have prescribed Buspirone for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY BUSPIRONE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE BUSPIRONE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE BUSPIRONE IF: • you have ever had an allergy to buspirone or to any of the other ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE BUSPIRONE IF: • you suffer from acute angle- closure glaucoma (eye disease) • you suffer from myasthenia gravis (severe muscle weakness) • you if you suffer from any severe liver or kidney disease • you suffer from epilepsy • you suffer from acute intoxication with alcohol, hypnotics, analgesics, or antipsychotic drugs. If you are not sure whether any of the above conditions apply to you, your doctor can advise you. DO NOT TAKE BUSPIRONE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF T Lesen Sie das vollständige Dokument
Data sheet – Buspirone (Orion) Page 1 of 12 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Buspirone (Orion) 5 mg tablets Buspirone (Orion) 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg buspirone hydrochloride. Each tablet contains 10 mg buspirone hydrochloride. Excipient with known effect: contains sugars as lactose. _5 MG TABLET_: Each tablet contains 59.5 mg lactose (as monohydrate) _10 MG TABLET_: Each tablet contains 118.9 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 5 MG TABLET: White or almost white, oval tablets debossed with ‘ORN 30’ on one side and a score on the other side. The tablet can be divided into equal doses. 10 MG TABLET: White or almost white, oval tablets debossed with ‘ORN 31’ on one side and a score on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Buspirone hydrochloride is indicated for the management of anxiety with or without accompanying depression in adults. Buspirone hydrochloride is indicated for the management of anxiety disorders or the short- term relief of symptoms of anxiety with or without accompanying depression. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The usual starting dose is 5 mg given three times daily. This may be titrated according to the needs of the patient and the daily dose increased by 5 mg increments every two or three days depending upon the therapeutic response to a maximum daily dose of 60 mg. After dosage titration the usual daily dose will be 20 to 30 mg per day 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 (see Pharmacokinetics). If buspirone is given with a potent inhibitor of CYP3A4 such as itraconazole or nefazodone, the initial dose of buspirone should be reduced and titrated based on clinical assessment (see section 4.5). Data sheet – Buspirone (Orion) Page 2 of 12 Grapef Lesen Sie das vollständige Dokument