Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
pregabalin, Quantity: 150 mg
Sandoz Pty Ltd
Pregabalin
Capsule
Excipient Ingredients: maize starch; Gelatin; titanium dioxide; pregelatinised maize starch; purified talc
Oral
56 capsules
(S4) Prescription Only Medicine
PREGABALIN SANDOZ is indicated for the treatment of neuropathic pain in adults. PREGABALIN SANDOZ is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Visual Identification: white hard gelatin capsule; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-12-01
PREGABALIN SANDOZ ® 1 PREGABALIN SANDOZ ® _pregabalin capsules _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Pregabalin Sandoz. 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 Pregabalin Sandoz 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 PREGABALIN SANDOZ IS USED FOR Pregabalin Sandoz is used to treat neuropathic pain, which is pain caused by an abnormality of, or damage to, the nerves. Pregabalin Sandoz 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 Sandoz 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 Sandoz also has analgesic effects (relieves pain). Pregabalin Sandoz may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe Pregabalin Sandoz 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 PREGABALIN SANDOZ 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 PREGABALIN SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PREGABALIN SANDOZ IF YOU HAVE AN ALLERGY TO: • pregabalin, the active ingredient in Pregabalin Sandoz or • any of the ingredients listed at Læs hele dokumentet
210809-pregabalin-sandoz-pi Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION PREGABALIN SANDOZ ® (PREGABALIN) 1 NAME OF THE MEDICINE Pregabalin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Pregabalin Sandoz ® 25 mg capsule contains 25 mg pregabalin. Each Pregabalin Sandoz ® 75 mg capsule contains 75 mg pregabalin. Each Pregabalin Sandoz ® 150 mg capsule contains 150 mg pregabalin. Each Pregabalin Sandoz ® 300 mg capsule contains 300 mg pregabalin. _Not all strengths may be marketed. _ For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Pregabalin Sandoz 25 mg capsules are skin coloured hard gelatin capsules. Pregabalin Sandoz 75 mg capsules are hard gelatin capsules with red cap and white body. Pregabalin Sandoz 150 mg capsules are white hard gelatin capsules. Pregabalin Sandoz 300 mg capsules are hard gelatin capsules with red cap and skin coloured body. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Pregabalin Sandoz is indicated for the treatment of neuropathic pain in adults. Pregabalin Sandoz is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. WARNINGS MISUSE, ABUSE POTENTIAL OR DEPENDENCE Pregabalin Sandoz is a potential drug of misuse, abuse and dependence. Pregabalin Sandoz 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). 210809-pregabalin-sandoz-pi Page 2 of 22 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE The dose range is 150 to 600 mg per day given in two divided doses. Pregabalin may be taken with or without food. _50, 100, 200 and 225 mg strength capsules are available in other brands. _ _NEUROP Læs hele dokumentet