Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
pregabalin, Quantity: 100 mg
Pharmacor Pty Ltd
Capsule, hard
Excipient Ingredients: pregelatinised maize starch; purified talc; titanium dioxide; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
30
(S4) Prescription Only Medicine
AKM-PREGABALIN (pregabalin) is indicated for the treatment of neuropathic pain in adults.,AKM-PREGABALIN (pregabalin) is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Visual Identification: White to off- white powder filled in size 3 capsules,orange opaque cap imprinted A010 and orange opaque body imprinted PREG 100 with black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-06-05
Akm Pregabalin (Version- 04) Page 1 of 6 AKM PREGABALIN CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Akm Pregabalin. 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 Akm Pregabalin against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT AKM PREGABALIN IS USED FOR Akm Pregabalin is used to treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves. Akm Pregabalin 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. Akm Pregabalin 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. Akm Pregabalin also has pain relieving effects. Akm Pregabalin may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe Akm Pregabalin 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 AKM PREGABALIN 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 AKM PREGABALIN _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE AKM PREGABALIN IF YOU HAVE AN ALLERGY TO: • pregabalin, the active ingredient in Akm Pregabalin, or • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic r Read the complete document
AKM-PREGABALIN Ver 05 04 1 AUSTRALIAN PRODUCT INFORMATION- AKM-PREGABALIN (PREGABALIN) CAPSULES 1. NAME OF THE MEDICINE Pregabalin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AKM-PREGABALIN 75 MG CAPSULES: Each hard Gelatin capsule contains: Pregabalin 75 mg AKM-PREGABALIN 100 MG CAPSULES: Each hard Gelatin capsule contains: Pregabalin 100 mg AKM-PREGABALIN 150 MG CAPSULES: Each hard Gelatin capsule contains: Pregabalin 150 mg AKM-PREGABALIN 200 MG CAPSULES: Each hard Gelatin capsule contains: Pregabalin 200 mg AKM-PREGABALIN 225 MG CAPSULES: Each hard Gelatin capsule contains: Pregabalin 225 mg AKM-PREGABALIN 300 MG CAPSULES: Each hard Gelatin capsule contains: Pregabalin 300 mg For the full list of excipients, see SECTION 6.1- LIST OF EXCIPIENTS WARNINGS MISUSE, ABUSE POTENTIAL OR DEPENDENCE Pregabalin is a potential drug of misuse, abuse, and dependence. Pregabalin 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). AKM-PREGABALIN Ver 05 04 2 3. PHARMACEUTICAL FORM AKM-PREGABALIN 75 MG CAPSULES: Hard gelatin capsule, orange opaque cap imprinted with 'A009' with black ink and white opaque body imprinted with ‘PREG 75’ with black ink. AKM-PREGABALIN 100 MG CAPSULES: Hard gelatin capsule, orange opaque cap imprinted with 'A010' with black ink and orange opaque body imprinted with ‘PREG 100’ with black ink. AKM-PREGABALIN 150 MG CAPSULES: Hard gelatin capsule, white opaque cap imprinted with 'A011' with black ink and white opaque body imprinted with ‘PREG 150’ with black ink. AKM-PREGABALIN 200 MG CAPSULES: Hard gelatin capsule, light orange opaque cap imprinted with 'A012' with black ink and light or Read the complete document