País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Phenytoin sodium
Flynn Pharma Ltd
N03AB02
Phenytoin sodium
50mg
Oral capsule
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 04080100; GTIN: 5060106551269
EPANUTIN ® 50MG HARD CAPSULES (phenytoin sodium) Your medicine is known by the above name but will be referred to as Epanutin Hard Capsules throughout this: PATIENT INFORMATION LEAFLET WHAT IS IN THIS LEAFLET: 1) What Epanutin Hard Capsules are and what they are used for 2) What you need to know before you take Epanutin Hard Capsules 3) How to take Epanutin Hard Capsules 4) Possible side effects 5) How to store Epanutin Hard Capsules 6) Contents of the pack and other information 1) WHAT EPANUTIN HARD CAPSULES ARE AND WHAT THEY ARE USED FOR Epanutin Hard Capsules are one of a group of medicines called anti- epileptic drugs; these medicines are used to treat epilepsy. Epanutin Hard Capsules can be used to control a variety of epileptic conditions, to control or prevent seizures during or after brain surgery or severe head injury. Epanutin Hard Capsules 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 Epanutin Hard Capsules. 2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPANUTIN HARD CAPSULES DO NOT TAKE EPANUTIN HARD CAPSULES • if you are allergic to Phenytoin, or any of the other ingredients of this medicine (listed in section 6). • if you are allergic to other medicines with a similar chemical structure to Phenytoin (e.g. hydantoins). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Epanutin Hard Capsules. Medicines are not always suitable for everyone. Your doctor needs to know before you take Epanutin Hard Capsules if you suffer from or have suffered in the past from any of the following conditions: • Liver disease. • Kidney disease. • Porphyria (an inherited disease that affects haemoglobin biosynthesis). The following symptoms have been reported in some people treated with phenytoin at recommended doses: • shortness of breath, becoming unconscious, or unresponsive. All can be the symptoms of the sudden, unexpected stopping of the heart (known as cardiac arrest). If you or someone you know is Leia o documento completo
OBJECT 1 PHENYTOIN SODIUM FLYNN HARD CAPSULES 25MG Summary of Product Characteristics Updated 13-Mar-2018 | Flynn Pharma Ltd 1. Name of the medicinal product Phenytoin Sodium Flynn 25 mg Hard Capsules Phenytoin Sodium Flynn 50 mg Hard Capsules Phenytoin Sodium Flynn 100 mg Hard Capsules Phenytoin Sodium Flynn 300 mg Hard Capsules 2. Qualitative and quantitative composition Each capsule contains 25 mg phenytoin sodium. Each capsule also contains 66.857 mg lactose monohydrate Each capsule contains 50mg phenytoin sodium Each capsule also contains 90.71 mg lactose monohydrate Each capsule contains 100mg phenytoin sodium Each capsule also contains 96.15 mg lactose monohydrate Each capsule contains 300mg phenytoin sodium Each capsule also contains 61.88 mg lactose monohydrate For the full list of excipients, see Section 6.1. 3. Pharmaceutical form Capsules, hard Phenytoin Sodium Flynn 25 mg Hard Capsules A white powder in a No 4 hard gelatin capsule with a white opaque body and blue-violet cap, radially printed 'EPANUTIN 25'. Phenytoin Sodium Flynn 50 mg Hard Capsules A white powder in a No 4 hard gelatin capsule with a white opaque body and a flesh-coloured transparent cap, radially printed 'EPANUTIN 50' Phenytoin Sodium Flynn 100 mg Hard Capsules A white powder in a No 3 hard gelatin capsule with a white opaque body and orange cap, radially printed 'EPANUTIN 100' Phenytoin Sodium Flynn 300 mg Hard Capsules A white powder in a No 1 hard gelatin capsule with a white opaque body and green cap, radially printed 'EPANUTIN 300' 4. Clinical particulars 4.1 Therapeutic indications Phenytoin Sodium Flynn Hard Capsules are indicated for control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination of these, and for the prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury. Phenytoin Sodium Flynn Hard Capsules has also been employed in the treatment of trigeminal neuralgia but it should only be used as second line ther Leia o documento completo