Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
pregabalin, Quantity: 150 mg
Southern Cross Pharma Pty Ltd
Pregabalin
Capsule, hard
Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; titanium dioxide; iron oxide black; purified talc; Gelatin; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; Shellac; strong ammonia solution; ethanol absolute; potassium hydroxide
Oral
60 capsules, 20 capsules, 14 capsules, 56 capsules
(S4) Prescription Only Medicine
PREGABALIN APOTEX is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation PREGABALIN APOTEX is indicated for the treatment of neuropathic pain in adults.
Visual Identification: Size: 2 Hard gelatin capsule, cap: light grey, body: light grey with "150" printed in black ink; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-02-14
PREGABALIN APOTEX/MAY2021/CMI-2 WARNING: Before taking PREGABALIN APOTEX, tell your doctor if you have a history of drug abuse. PREGABALIN APOTEX poses risks of misuse, abuse and dependence. Using PREGABALIN APOTEX with other medicines that can make you feel drowsy such as sleeping tablets and other pain relievers (e.g. benzodiazepines and opioids), antihistamines, antidepressants, antipsychotics, cannabis, and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. If you have any concern about taking this medicine, speak to your doctor. PREGABALIN APOTEX _contains the active ingredient pregabalin _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about PREGABALIN APOTEX. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking PREGABALIN APOTEX against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet. You may need to read it again. What PREGABALIN APOTEX is used for PREGABALIN APOTEX is used to treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves. PREGABALIN APOTEX 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. PREGABALIN APOTEX 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. PREGABALIN APOTEX also has pain relieving effects. PREGABALIN APOTEX may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe PREGABALIN APOTEX in addition to your current therapy when your current treatment is no longer working as well as before. Y Lire le document complet
AUSTRALIAN PRODUCT INFORMATION PREGABALIN APOTEX (PREGABALIN) CAPSULES 1. NAME OF THE MEDICINE Pregabalin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PREGABALIN APOTEX capsules contain the active ingredient pregabalin. Excipients with known effect: - Sugars as Lactose monohydrate (25 and 50 mg strengths); - Lactose monohydrate (all other strengths) For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM PREGABALIN APOTEX 25 mg capsules: Size: 4 Hard gelatin capsule, cap: light grey, body: light grey with “25” printed in black ink PREGABALIN APOTEX 50 mg capsules*: Size: 3 Hard gelatin capsule, cap: light grey, body: light grey with “50” and a black line printed in black ink PREGABALIN APOTEX 75 mg capsules: Size: 4 Hard gelatin capsule, cap: light red, body: light grey with “75” printed in black ink PREGABALIN APOTEX 100 mg capsules*: Size: 3 Hard gelatin capsule, cap: red, body: red with “100” printed in black ink PREGABALIN APOTEX 150 mg capsules: Size: 2 Hard gelatin capsule, cap: light grey, body: light grey with “150” printed in black ink PREGABALIN APOTEX 200 mg capsules*: Size: 1 Hard gelatin capsule, cap: red, body: red with “200” printed in black ink PREGABALIN APOTEX 225 mg capsules*: Size: 1 Hard gelatin capsule, cap: red, body: light grey with “225” printed in black ink PREGABALIN APOTEX 300 mg capsules: Size: 0 Hard gelatin capsule, cap: red, body: light grey with “300” printed in black ink *non-marketed presentations WARNINGS MISUSE, ABUSE POTENTIAL OR DEPENDENCE PREGABALIN APOTEX is a potential drug of misuse, abuse, and dependence. PREGABALIN APOTEX 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 benzo Lire le document complet