Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Phenobarbital
Clonmel Healthcare Ltd
N03AA; N03AA02
Phenobarbital
15 milligram(s)
Tablet
Product subject to prescription which may not be renewed (A)
Barbiturates and derivatives; phenobarbital
Marketed
1977-04-01
Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE USER PHENOBARBITAL 15MG TABLETS PHENOBARBITAL 30MG TABLETS PHENOBARBITAL READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Phenobarbital tablets are and what they are used for 2. What you need to know before you take Phenobarbital tablets 3. How to take Phenobarbital tablets 4. Possible side effects 5. How to store Phenobarbital tablets 6. Contents of the pack and other information 1. WHAT PHENOBARBITAL TABLETS ARE AND WHAT THEY ARE USED FOR Phenobarbital tablets belong to a group of medicines called barbiturates. These medicines reduce brain activity which would otherwise cause fits or seizures in epilepsy, except absence seizures (day dreaming). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENOBARBITAL TABLETS DO NOT TAKE Phenobarbital tablets and TELL your doctor if you are allergic to phenobarbital or any of the other ingredients of this medicine (listed in section 6) if you have PORPHYRIA (a genetic or inherited disorder of the red blood pigment haemoglobin) if you have SEVERE BREATHING DIFFICULTIES if you have SEVERE KIDNEY or LIVER disease if you have ADDISON’S DISEASE (a condition affecting the adrenal glands) A small number of people being treated with anti-epileptics such as phenobarbital have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor. Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) h Прочетете целия документ
Health Products Regulatory Authority 12 August 2021 CRN00CH7Y Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenobarbital 15 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg Phenobarbital as the active substance. Excipient(s) with known effect Each tablet contains 25 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Round, pale yellow, flat, beveled edge tablet, scored with a breakline on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As an anticonvulsant for the treatment of all forms of epilepsy except absence seizures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dose should be adjusted to the needs of the individual patient to achieve adequate control of seizures; this usually requires plasma concentrations of 10-40 µg/ml (40-160 µmol/litre). Adults: The recommended dose by mouth is 60-180 mg daily usually taken at night. Paediatric population: 5-8 mg/kg/day. Elderly The use of Phenobarbital must be the subject of a clinical risk/benefit assessment. Dose schedules may need to be reduced. Method of administration Oral. 4.3 CONTRAINDICATIONS 1. Acute intermittent porphyria. 2. Severe impairment of renal, hepatic or respiratory function. 3. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Warnings: Prolonged administration of barbiturates may induce psychic dependence and even addiction in some individuals. A severe withdrawal syndrome may occur. Withdrawal or transition to another type of anti-epileptic therapy should be gradual to avoid rebound seizures. Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal Health Products Regulatory Authority 12 August 2021 CRN00CH7Y Page 2 of 8 ideation and b Прочетете целия документ