Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenobarbital
Arrow Generics Ltd
N03AA02
Phenobarbital
60mg
Oral tablet
Oral
Schedule 3 (CD No Register Phenobarbital)
Caution - AMP level prescribing advised
BNF: 04080100
1 PATIENT INFORMATION LEAFLET PHENOBARBITAL ACCORD 30MG, 60MG TABLETS 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, 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 The active ingredient in this medicine is Phenobarbital. This is the new name for Phenobarbitone. The ingredient itself has not changed. 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 have: • an ALLERGY (hypersensitivity) to phenobarbital, other barbiturates or any of the other ingredients (see section 6). • PORPHYRIA (a genetic or inherited disorder of the red blood pigment haemoglobin) • SEVERE BREATHING DIFFICULTIES • severe kidney or liver disease. IF YOU DEVELOP A RASH OR THE FOLLOWING SKIN SYMPTOMS, SEEK IMMEDIATE ADVICE FROM A DOCTOR AND TELL THAT YOU ARE TAKING THIS MEDICINE: • potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Phenobarbital tablets appearing initially Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenobarbital Accord 60mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Phenobarbital BP 60 mg 3 PHARMACEUTICAL FORM Tablets for oral administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment and control of all forms of epilepsy, except absence seizures. Phenobarbital should only be used in the treatment of febrile convulsions in exceptional circumstances. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults: _60-180mg at night _Child: _ 5-8mg/kg daily _Elderly: _Phenobarbital clearance diminishes in the elderly. Therefore the dose of phenobarbital is usually lower in elderly patients. The dose of phenobarbital should be adjusted to meet the needs of individual patients. This usually requires plasma concentration of 15 to 40 micrograms/ml (65 to 170 micromoles/litre). _METHOD OF ADMINISTRATION _ _ _ For oral administration 4.3 CONTRAINDICATIONS Phenobarbital should not be given to patients with: • Known hypersensitivity to phenobarbital, other barbiturates or other ingredients in the tablet • Acute intermittent porphyia • Severe respiratory depression • Severe renal or hepatic impairment. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Suicidal ideation and behavior have been reported in patients treated with anti- epileptic agents in several indications. A meta-analysis of randomized placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behavior. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for phenobarbital. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. Steven-Johnson syndrome and toxic epidermal necrolysis Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) Прочитајте комплетан документ