দেশ: অস্ট্রেলিয়া
ভাষা: ইংরেজি
সূত্র: Department of Health (Therapeutic Goods Administration)
phenobarbital, Quantity: 30 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; magnesium stearate; Acacia; wheat starch
Oral
200 tablets
(S4) Prescription Only Medicine
Epilepsy; sedation
Visual Identification: A white, round biconvex tablet with a scoreline on one side and plain on the other side.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1991-10-14
PHENOBARB TABLETS Phenobarbital (phenobarbitone) 30 mg CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about the Phenobarb tablets. 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 taking Phenobarb tablets against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PHENOBARB TABLETS ARE USED FOR Phenobarb tablets contain the active ingredient Phenobarbital (phenobarbitone), which belongs to a group of medicines called barbiturates. Barbiturates act by inducing sleep and stopping convulsions. Phenobarb tablets are used for: • epileptic fits • sedation. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PHENOBARB TABLETS HAVE BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another purpose. It is available only with a doctor's prescription. The use of barbiturates may lead to dependence on the medicine. BEFORE YOU TAKE IT _When you must not take it _ Do not take Phenobarb tablets if you are allergic to: • Phenobarbital (phenobarbitone) • any other ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include red, itchy skin rashes, difficulty breathing, hayfever, swelling of the face or throat or faintness. PHENOBARB TABLETS SHOULD NOT BE USED IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • porphyria, a rare blood pigment disorder • anaemia, a disease of the blood with reduced number of red blood cells • uncontrolled severe asthma • uncontrolled diabetes mellitus or sugar diabetes • alcoholism or drug dependence • liver or kidney problems • severe depression or suicidal tendencies • or long term pain. PHENOBARB TABLETS SHOULD NOT BE GIVEN TO UNUSUALLY OVERACTIVE CHILDREN. সম্পূর্ণ নথি পড়ুন
1 AUSTRALIAN PRODUCT INFORMATION – PHENOBARB (PHENOBARBITAL (PHENOBARBITONE)) TABLETS 1 NAME OF THE MEDICINE Phenobarbital (phenobarbitone). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PHENOBARB tablets contain phenobarbital (phenobarbitone) 30 mg. Excipients with known effect: gluten and lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM PHENOBARB tablets are white, round uncoated biconvex tablets with a scoreline on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Epilepsy, sedation. 4.2 D OSE AND METHOD OF ADMINISTRATION ANTICONVULSANT _Adults _ 60 to 240 mg per day in 2 to 3 divided doses. _Paediatric _ 1 to 6 mg per kg per day in 2 to 3 divided doses. Phenobarbital (phenobarbitone) may be given as a single daily dose as it has a long half-life. Doses must be individualised. 2 SEDATIVE_ _ _Adults _ 30 to 120 mg per day in 2 to 3 divided doses. _Paediatric _ 1 to 2 mg per kg 2 to 3 times a day. Alternatively phenobarbital (phenobarbitone) may be given as a single daily dose. Geriatric and debilitated patients may exhibit excitement, confusion or depression with usual therapeutic doses. Lower doses are recommended. 4.3 C ONTRAINDICATIONS Phenobarbital (phenobarbitone) is not recommended in the presence of the following conditions: • a history of porphyria, either acute intermittent or variegata • hypersensitivity to barbiturates or the excipients in the tablets • severe anaemia (if it is due to folate deficiency) • severe asthma (if uncontrolled) • diabetes mellitus (if uncontrolled) • a history of drug abuse or dependence • severe hepatic or renal impairment • hyperkinetic children • severe depression or suicidal tendencies • acute or chronic pain (paradoxical excitement may result or other symptoms may be masked). 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE WOMEN OF CHILDBEARING POTENTIAL Phenobarbital may cause fetal harm when administered to a pregnant woman. Prenatal exposure to phen সম্পূর্ণ নথি পড়ুন