Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
levetiracetam, Quantity: 1000 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: povidone; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; maize starch; titanium dioxide; hypromellose; macrogol 6000
Oral
60, 10, 100
(S4) Prescription Only Medicine
Use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,Add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME), and,Add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).
Visual Identification: White, capsule shaped, biconvex film coated tablets plain on both sides; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-02-02
APO-LEVETIRACETAM _Levetiracetam_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about levetiracetam. 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 using this medicine against the benefits they expect it will 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Levetiracetam is 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 in nature. _HOW IT WORKS_ Levetiracetam belongs to a group of medicines called antiepileptics. It is thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. This medicine may be used alone, or in combination with other medicines, to treat your condition. Your doctor may prescribe levetiracetam in addition to your current therapy. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine in children under the age of 4 years. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • levetiracetam • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE AFTER T Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION – APO-LEVETIRACETAM (LEVETIRACETAM) TABLETS 1 NAME OF THE MEDICINE Levetiracetam. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg, 500 mg or 1000 mg levetiracetam as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 250 MG TABLETS: Light blue, capsule shaped, biconvex, film-coated tablets, plain on both sides. 500 MG TABLETS: Yellow, capsule shaped, biconvex, film-coated tablets, plain on both sides. 1000 MG TABLETS: White, capsule shaped, biconvex, film-coated tablets, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. • Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. • Add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME). • Add-on therapy in the treatment of primary generalised tonic-clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE). 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Levetiracetam tablets are intended for oral administration. The tablets must be taken orally, swallowed with liquid. It may be taken with or without food. The daily dose is administered in two equally divided doses. Therapy can be initiated with either intravenous or oral administration. Conversion to or from oral to intravenous can be done directly without titration. The total daily dose and frequency of administration should be maintained. After oral administration, the bitter taste of levetiracetam may be experienced. 2 Monotherapy The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two we Прочитајте комплетан документ