Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
ZIPRASIDONE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N05AE04
ZIPRASIDONE 80 mg
HARD CAPSULE
ZIPRASIDONE 80 mg
POM
PSYCHOLEPTICS
Authorised
2013-06-13
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ZIPRASIDONE AUROBINDO 20 MG CAPSULES, HARD ZIPRASIDONE AUROBINDO 40 MG CAPSULES, HARD ZIPRASIDONE AUROBINDO 60 MG CAPSULES, HARD ZIPRASIDONE AUROBINDO 80 MG CAPSULES, HARD Ziprasidone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ziprasidone Aurobindo is and what it is used for 2. What you need to know before you take Ziprasidone Aurobindo 3. How to take Ziprasidone Aurobindo 4. Possible side effects 5. How to store Ziprasidone Aurobindo 6. Contents of the pack and other information 1. WHAT ZIPRASIDONE AUROBINDO IS AND WHAT IT IS USED FOR Ziprasidone Aurobindo belong to a group of medicines called antipsychotics. Ziprasidone Aurobindo is used for the treatment of schizophrenia in adults - a mental disorder characterised by the following symptoms: to hear, see and feel things that do not exist, to believe in something not true, to feel unusual suspicions, to be absent and have difficulty in establishing social relationships, nervousness, depression or anxiety. Ziprasidone Aurobindo is also used for the treatment of manic or mixed episodes of moderate severity in bipolar disorder in adults and children and adolescents aged 10-17 years - a mental disorder characterised by alternate stages of euphoric (mania) or depressed mood states. During mania episodes, the most characteristic symptoms are: elated behaviour, exaggerated self-esteem, increase in energy, decreased need for sleeping, lack of concentration or hyperactivity and repeated high risk Leggi il documento completo
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ziprasidone Aurobindo 20 mg capsules, hard Ziprasidone Aurobindo 40 mg capsules, hard Ziprasidone Aurobindo 60 mg capsules, hard Ziprasidone Aurobindo 80 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 20 mg of ziprasidone. Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 40 mg of ziprasidone. Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 60 mg of ziprasidone. Each hard capsule contains ziprasidone hydrochloride monohydrate equivalent to 80 mg of ziprasidone. Excipient(s) with known effect: lactose monohydrate Each 20 mg capsule contains 56.363 mg lactose monohydrate. Each 40 mg capsule contains 112.726 mg lactose monohydrate. Each 60 mg capsule contains 169.088 mg lactose monohydrate. Each 80 mg capsule contains 225.451 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Ziprasidone 20mg Capsules: Blue opaque cap/Off-white opaque body, size '5' hard gelatin capsules imprinted in black ink with ‘F’ on cap and '26' on body, filled with creamy to pale pinkish granular powder. Ziprasidone 40mg Capsules: Blue opaque cap/ Blue opaque body, size '3' hard gelatin capsules imprinted in black ink with ‘F’ on cap and '38' on body, filled with creamy to pale pinkish granular powder. Ziprasidone 60mg Capsules: Off-white opaque cap/ Off-white opaque body, size '2' hard gelatin capsules imprinted in black ink with ‘F’ on cap and '39' on body, filled with creamy to pale pinkish granular powder. Ziprasidone 80mg Capsules: Blue opaque cap/Off-white opaque body, size '1' hard gelatin capsules imprinted in black ink with ‘X’ on cap and '66' on body, filled with creamy to pale pinkish granular powder. Page 2 of 15 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziprasidone is indicated for the treatment of schizophrenia in Leggi il documento completo