Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Triazolam
Pfizer Healthcare Ireland
N05CD; N05CD05
Triazolam
250 microgram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Benzodiazepine derivatives; triazolam
Marketed
1977-09-30
PACKAGE LEAFLET: INFORMATION FOR THE USER 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Halcion is and what it is used for 2. What you need to know before you take Halcion 3. How to take Halcion 4. Possible side effects 5. How to store Halcion 6. Contents of the pack and other information 1. What Halcion is and what it is used for Halcion contains the active ingredient triazolam. Triazolam belongs to a group of medicines called benzodiazepines. Halcion is used for the short-term treatment of severe insomnia (difficulty in falling asleep or sleeping properly). You must talk to a doctor if you do not feel better or if you feel worse. 2. What you need to know before you take Halcion Do not take Halcion if you: • are allergic to triazolam or other similar benzodiazepine medicines or any of the other ingredients of this medicine (listed in section 6) • suffer from an autoimmune disease called ‘myasthenia gravis’ where you suffer from very weak and tired muscles • have severe breathing difficulties • have ‘sleep apnea’- this is a condition where your breathing becomes irregular, even stopping for short periods, while you are asleep • have severe liver problems • are taking simultaneously • medicines for fungal infections containing ketoconazole or itraconazole, • medicines for depression containing nefazodone, • medicines for HIV infections containing efavirenz or HIV protease inhibitors (e.g. ritonavir), • or other medicines that strongly reduce the Прочитать полный документ
Health Products Regulatory Authority 14 November 2023 CRN00DWYN Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Halcion 250 microgram Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 micrograms of Triazolam. Excipients with known effect: This medicinal product contains 72 mg of lactose monohydrate and 0.15 mg of sodium benzoate in each tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Powder blue, elliptical, flat bevelled-edge tablet with the ‘UPJOHN’ logo and ‘17’ on one face and a single score on the other face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Insomnia Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage of triazolam should be individualised for a maximum beneficial effect and to help avoid significant adverse effects. It is recommended to find the lowest effective dose, particularly in geriatric or debilitated patients. The risk of dependence may increase with dose and duration of treatment; therefore, the lowest effective dose and duration should be used and the need for continued treatment reassessed frequently (see section 4.4.). Abrupt discontinuation or rapid dosage reduction of triazolam after continued use may precipitate withdrawal reactions, which can be life threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue triazolam or reduce the dosage (see section 4.4.). Duration of Treatment Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks with a maximum, including tapering-off process, of four weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient's status. Method of Administration Halcion should be taken just before going to bed. Posology Insomnia: The usual dose Прочитать полный документ