Negara: Belanda
Bahasa: Belanda
Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ARIPIPRAZOL 30 mg/stuk
Zaklady Farmaceutyczne Polpharma SA Synthesis Section PS III, Pelplinska 19 83-200 STAROGARD GDANSKI (POLEN)
N05AX12
ARIPIPRAZOL 30 mg/stuk
Orodispergeerbare tablet
ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; BENZYLALCOHOL (E 1519) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; VANILLESMAAKSTOF, ARABISCHE GOM (E 414) ; ASPARTAAM (E 951) ; BENZYLALCOHOL (E 1519) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; PROPYLEENGLYCOL (E 1520) ; SILICIUMDIOXIDE (E 551) ; VANILLESMAAKSTOF,
Oraal gebruik
Aripiprazole
Hulpstoffen: ARABISCHE GOM (E 414); ASPARTAAM (E 951); BENZYLALCOHOL (E 1519); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; PROPYLEENGLYCOL (E 1520); SILICIUMDIOXIDE (E 551); VANILLESMAAKSTOF;
2015-09-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ARIBIT ODT 10 MG ORODISPERGEERBARE TABLETTEN ARIBIT ODT 15 MG ORODISPERGEERBARE TABLETTEN ARIBIT ODT 30 MG ORODISPERGEERBARE TABLETTEN Aripiprazole 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 Aribit ODT is and what it is used for 2. What you need to know before you take Aribit ODT 3. How to take Aribit ODT 4. Possible side effects 5 How to store Aribit ODT 6. Contents of the pack and other information 1. WHAT ARIBIT ODT IS AND WHAT IT IS USED FOR Aribit ODT 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. Aribit ODT 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 Aribit ODT. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIBIT ODT DO NOT TAKE ARIBIT ODT - if you are allergic to aripiprazole or any of the other ingredients of t Baca dokumen lengkapnya
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aribit ODT 10 mg orodispergeerbare tabletten Aribit ODT 15 mg orodispergeerbare tabletten Aribit ODT 30 mg orodispergeerbare tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aribit ODT 10 mg: Each orodispersible tablet contains 10 mg of aripiprazole. Aribit ODT 15 mg: Each orodispersible tablet contains 15 mg of aripiprazole. Aribit ODT 30 mg: Each orodispersible tablet contains 30 mg of aripiprazole. Excipients with known effect: Each 10 mg orodispersible tablet contains 90.30 mg lactose (as monohydrate), 1.00 mg aspartame (E951), 0.0036 mg benzyl alcohol and 0.86 mg (0,037 mmol) sodium. Each 15 mg orodispersible tablet contains 135.46 mg lactose (as monohydrate), 1.50 mg aspartame (E951), 0.0054 mg benzyl alcohol and 1.29 mg (0,056 mmol) sodium. Each 30 mg orodispersible tablet contains 270.90 mg lactose (as monohydrate), 3.00 mg aspartame (E951), 0.0108 mg benzyl alcohol and 2.58 mg (0,112 mmol) sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Orodispersible tablet Aribit ODT 10 mg: Round, flat, pink tablets, engraved with ‘10’ on one side and plain on the other with a diameter of 8.0 mm ± 0.1 mm. Aribit ODT 15 mg: Round, flat, yellow tablets, engraved with ‘15’ on one side and plain on the other with a diameter of 9.0 mm ± 0.1 mm. Aribit ODT 30 mg: Round, flat, pink tablets, engraved with ‘30’ on one side and plain on the other with a diameter of 10.0 mm ± 0.1 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aribit ODT is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aribit ODT 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 episodes responded to aripiprazole treatment (see section 5.1). Aribit ODT is indicated for the treatment up to 12 weeks of moderate to severe manic epi Baca dokumen lengkapnya