দেশ: যুক্তরাজ্য
ভাষা: ইংরেজি
সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenytoin sodium
Accord-UK Ltd
N03AB02
Phenytoin sodium
100mg
Oral capsule
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 04080100; GTIN: 5060090471147
Phenytoin Sodium 100 mg capsules PIL - UK item no: print proof no: origination date: originated by: revision date: revised by: dimensions: pharmacode: colours/plates: approved for print/date Non Printing Colours 1. Black 2. 3. 4. 5. 6. 1. Pharmacode 2. 3. date sent: supplier: technically app. date: min pt size: TECHNICAL APPROVAL AAAI7813 6 25.02.16 DR 02.06.16 DR IL/Apex Laboratories Pvt Ltd 180 x 240 8.5pt 25.02.16 20.05.16 SPACE FOR PHARMA- CODE PHENYTOIN SODIUM NRIM 100MG CAPSULES PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Phenytoin Capsules are and what they are used for 2. Before you take Phenytoin Capsules 3. How to take Phenytoin Capsules 4. Possible side effects 5. How to store Phenytoin Capsules 6. Further Information 1. WHAT PHENYTOIN CAPSULES ARE AND WHAT THEY ARE USED FOR The name of your medicine is Phenytoin sodium NRIM 100mg Capsules (referred to as Phenytoin Capsules or as Phenytoin throughout this leaflet). Phenytoin belongs to a group of medicines called anti-epileptic drugs; these medicines are used to treat epilepsy. Phenytoin can be used to control a variety of epileptic conditions, to control or prevent seizures during or after brain surgery or severe head injury. Phenytoin can also be used to treat trigeminal neuralgia (facial nerve pain). You should ask your doctor if you are unsure why you have been given Phenytoin capsules. 2. BEFORE YOU TAKE PHENYTOIN CAPSULES You should not take Phenytoin until you are sure it is safe for you to do so. DO NOT TAKE PHENYTOIN - if you are allergic (hypersensitive) to phe সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Phenytoin Sodium NRIM 100mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100mg of phenytoin sodium. Each capsule also contains 85.50 mg of lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, Hard (capsules) Size “3” Hard gelatin capsule with orange transparent coloured cap printed with “146” and white coloured body, containing white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Phenytoin Sodium NRIM 100mg Capsules are indicated for the following: - Control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination of these - The prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury. Phenytoin Sodium NRIM 100mg Capsules have also been employed in the treatment of trigeminal neuralgia but should only be used as second line therapy if carbamazepine is ineffective or patients are intolerant to carbamazepine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Phenytoin Sodium NRIM Capsules contain phenytoin sodium. Although 100mg of phenytoin sodium is equivalent to 92mg of phenytoin on a molecular weight basis, these molecular equivalents are not necessarily biologically equivalent. Physicians should therefore exercise care in those situations where it is necessary to change the dosage form and serum level monitoring is advised. Posology Dosage should be individualised as there may be wide interpatient variability in phenytoin serum levels with equivalent dosage. Phenytoin should be introduced in small dosages with gradual increments until control is achieved or until toxic effects appear. In some cases serum level determinations may be necessary for optimal dosage adjustments - the clinically effective level is usually 10-20mg/l (40-80 micromoles/l) although some cases of tonic-clonic seizures may be controlled with lower serum levels of phenytoin. With rec সম্পূর্ণ নথি পড়ুন