البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
pregabalin, Quantity: 75 mg
Accord Healthcare Pty Ltd
Pregabalin
Capsule, hard
Excipient Ingredients: sodium lauryl sulfate; purified water; purified talc; iron oxide red; Gelatin; titanium dioxide; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
56 capsules in HDPE bottle, 200 capsules in HDPE bottle, 20 capsules in HDPE bottle, 30 capsules in HDPE bottle, 500 capsules in HDPE bottle, 60 capsules in HDPE bottle, 14 capsules in HDPE bottle
(S4) Prescription Only Medicine
LYZALON (pregabalin) is indicated for the treatment of neuropathic pain in adults.,LYZALON (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Visual Identification: Red opaque/White opaque, size 4 hard gelatin capsules imprinted with PG on cap and 75 on body containing white to off white powder.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2016-03-23
PRELINACCORD CONSUMER MEDICINE INFORMATION Version: 2.0 PRELINACCORD (PREGABALIN CAPSULES 25 MG, 75 MG, 150 MG AND 300 MG) _Pregabalin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Prelinaccord. 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 Prelinaccord against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING PRELINACCORD ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT PRELINACCORD IS USED FOR Prelinaccord is used to treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves. Prelinaccord is also used to control epilepsy. Epilepsy is a condition where you have repeated seizures (fits). There are many different types of seizures, ranging from mild to severe. Prelinaccord belongs to a group of medicines called anticonvulsants. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. Prelinaccord also has pain relieving effects. Prelinaccord _ _ may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe Prelinaccord _ _ in addition to your current therapy when your current treatment is no longer working as well as before. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PRELINACCORD_ _HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. _USE IN CHILDREN _ There is not enough information to recommend the use of this medicine in children under the age of 18 years. BEFORE YOU TAKE PRELINACCORD _WHEN YOU MUST NOT USE IT _ DO NOT USE PRELINACCORD_ _IF YOU HAVE AN ALLERGY TO: • pregabalin, the active ingredient in Prelinaccord or • any of the ingredients li اقرأ الوثيقة كاملة
1 v4 AUSTRALIAN PRODUCT INFORMATION – LYZALON (PREGABALIN) CAPSULES WARNINGS MISUSE, ABUSE POTENTIAL OR DEPENDENCE LYZALON is a potential drug of misuse, abuse, and dependence. LYZALON poses risks of misuse, abuse and dependence which can lead to overdose and death especially when used concomitantly with opioids and other CNS depressants. Assess the patient’s risk of misuse, abuse or dependence before prescribing and monitor the patient regularly during treatment, particularly amongst patients with current or past misuse, abuse or dependence of opioids and/or benzodiazepines (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 1 NAME OF THE MEDICINE Pregabalin. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LYZALON (Pregabalin Capsules 25 mg, 75 mg, 150 mg and 300 mg). LYZALON contains the active ingredient pregabalin. EXCIPIENTS: For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM LYZALON capsules 25 mg are white opaque/White opaque, size “4” hard gelatin capsules imprinted with ‘PG’ on cap and ‘25’ on body containing white to off white powder. LYZALON capsules 75 mg are red opaque/White opaque, size “4” hard gelatin capsules imprinted with ‘PG’ on cap and ‘75’ on body containing white to off white powder. LYZALON capsules 150 mg are white opaque/White opaque, size “2” hard gelatin capsules imprinted with ‘PG’ on cap and ‘150’ on body containing white to off white powder. LYZALON capsules 300 mg are red opaque/White opaque, size “0” hard gelatin capsules imprinted with ‘PG’ on cap and ‘300’ on body containing white to off white powder. 2 v4 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS LYZALON (pregabalin) is indicated for the treatment of neuropathic pain in adults. LYZALON (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The dose range is 150 to 600 mg per day given in two divided doses. LYZALON اقرأ الوثيقة كاملة