Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aripiprazole
Milpharm Ltd
N05AX12
Aripiprazole
5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100
PACKAGE LEAFLET: INFORMATION FOR THE USER ARIPIPRAZOLE 5 MG TABLETS ARIPIPRAZOLE 10 MG TABLETS ARIPIPRAZOLE 15 MG TABLETS ARIPIPRAZOLE 30 MG TABLETS aripiprazole P1518038 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 Aripiprazole is and what it is used for 2. What you need to know before you take Aripiprazole 3. How to take Aripiprazole 4. Possible side effects 5. How to store Aripiprazole 6. Contents of the pack and other information. 1. WHAT ARIPIPRAZOLE IS AND WHAT IT IS USED FOR Aripiprazole contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense. Aripiprazole is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with Aripiprazole. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE DO NOT TAKE ARIPIPRAZOLE • If you are allergic to aripiprazole or any of the other i Prečítajte si celý dokument
OBJECT 1 ARIPIPRAZOLE 5MG TABLETS Summary of Product Characteristics Updated 26-Oct-2018 | Aurobindo Pharma - Milpharm Ltd. • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Aripiprazole Milpharm 5 mg tablets 2. Qualitative and quantitative composition Each tablet contains 5 mg of aripiprazole. Excipient with known effect: 76 mg lactose monohydrate per tablet For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet Blue colored, modified rectangular shaped, uncoated tablets debossed with '62' on one side and 'H' on other side. The size is 8 mm × 4.5 mm. 4. Clinical particulars 4.1 Therapeutic indications Aripiprazole Milpharm is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episode Prečítajte si celý dokument