País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Naftidrofuryl oxalate
Mawdsley-Brooks & Company Ltd
C04AX21
Naftidrofuryl oxalate
100mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060400
PAGE 1 PRAXILENE ® 100 MG CAPSULES Naftidrofuryl oxalate PACKAGE LEAFLET: INFORMATION FOR THE USER The name of your medicine is Praxilene 100 mg capsules, which will be referred to as Praxilene throughout this leaflet. 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 or nurse. • 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Praxilene is and what it is used for 2. What you need to know before you take Praxilene 3. How to take Praxilene 4. Possible side effects 5. How to store Praxilene 6. Contents of the pack and other information 1. WHAT PRAXILENE IS AND WHAT IT IS USED FOR Praxilene belongs to a group of medicines known as ‘metabolic activators’. These are used to treat different types of blood circulation problems. Praxilene allows your body to make better use of the oxygen in your blood. Praxilene is used to treat peripheral vascular disorders (blood circulation problems outside the brain and heart). Praxilene is used to treat the following symptoms of these disorders: • cramp-like pains, usually in your calves when you walk (intermittent claudication) • cramps in your legs at night • severe pain in your legs when you are resting (rest pain) • pale or blue fingers or toes which get worse when it is cold • numbness, tingling or burning feelings in your fingers or toes (Raynaud’s syndrome or acrocyanosis) • open sores on the legs or feet (trophic ulcers) • poor circulation caused by diabetes (diabetic arteriopathy) Praxilene is also used to treat gangrene. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAXILENE DO NOT T Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Praxilene 100mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 100mg naftidrofuryl oxalate equivalent to 81.0 mg naftidrofuryl and 19.0 mg oxalate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Peripheral vascular disorders - intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud’s Syndrome, diabetic arteriopathy and acrocyanosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: One or two capsules three times daily for a minimum of three months, or at the discretion of the physician. Method of administration: For oral administration. The capsules should be swallowed whole during meals with a sufficient amount of water (minimum) of one glass. _Paediatric population_ The safety and efficacy of Praxilene in the paediatric population have not been established. This drug is not indicated for use in children. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with a history of hyperoxaluria or recurrent calcium-containing kidney stones. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The administration of Praxilene may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones (the oxalate content is 19 mg per 100 mg of active ingredient). A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis. The administration of Praxilene without liquid before going to bed may cause local oesophagitis. Therefore, it is essential to always take the capsule with a sufficient amount of water. Cases of liver damage have been reported. In the event of symptoms suggesting liver damage, Praxilene must be discontinued. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 FERTILITY, PREGNANCY AND LACTATION Pregnancy In the absen Leia o documento completo