Pays: Israël
Langue: anglais
Source: Ministry of Health
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
ABIC MARKETING LTD, ISRAEL
TABLETS
AMPHETAMINE SULFATE 1.250 MG; DEXTROAMPHETAMINE SULFATE 1.250 MG; AMPHETAMINE ASPARTATE MONOHYDRATE 1.250 MG; DEXTROAMPHETAMINE SACCHARATE 1.250 MG
PER OS
Required
BARR LABORATORIES INC.,
Treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
2015-07-12
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only ATTENT 5 MG TABLETS ATTENT 10 MG TABLETS ATTENT 20 MG TABLETS ATTENT 30 MG TABLETS COMPOSITION EACH ATTENT 5 MG TABLET CONTAINS 1.25 mg of each of the following ingredients: Dextroamphetamine Saccharate Amphetamine Aspartate Monohydrate Dextroamphetamine Sulfate Amphetamine Sulfate The total equivalent amount of amphetamine is 3.13 mg EACH ATTENT 10 MG TABLET CONTAINS 2.5 mg of each of the following ingredients: Dextroamphetamine Saccharate Amphetamine Aspartate Monohydrate Dextroamphetamine Sulfate Amphetamine Sulfate The total equivalent amount of amphetamine is 6.3 mg EACH ATTENT 20 MG TABLET CONTAINS 5 mg of each of the following ingredients: Dextroamphetamine Saccharate Amphetamine Aspartate Monohydrate Dextroamphetamine Sulfate Amphetamine Sulfate The total equivalent amount of amphetamine is 12.6 mg EACH ATTENT 30 MG TABLET CONTAINS 7.5 mg of each of the following ingredients: Dextroamphetamine Saccharate Amphetamine Aspartate Monohydrate Dextroamphetamine Sulfate Amphetamine Sulfate The total equivalent amount of amphetamine is 18.8 mg For the list of inactive ingredients in the preparation, see section 6 – “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. THIS MEDICINE HAS BEEN PRESCRIBED FOR THE TREATMENT OF YOUR AILMENT. DO NOT PASS IT ON TO OTHERS. IT MAY HARM THEM EVEN IF IT SEEMS TO YOU THAT THEIR MEDICAL CONDITION IS SIMILAR. THE MEDICINE CAN BE TAKEN BY ADULTS AND ALSO BY CHILDREN AND THEREFORE, THE INFORMATION IN THIS LEAFLET IS ALSO INTENDED FOR CHILDREN TAKING THIS MEDICINE. THE MEDICINE CONTAINS AMPHETAMINES, WHICH HAVE POTENTIAL TO BE MISUSED. TAKING FOR A LONG TIME MAY LEAD TO DEPENDENCE. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine contains a mix of amphet Lire le document complet
Attent tablets 03-2017 FW This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved on March 2017 PHYSICIANS’ PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT ATTENT 5 mg, 10 mg, 20 mg, 30 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION A single entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. EACH TABLET CONTAINS 5 MG 10 MG 20 MG 30 MG Dextroamphetamine Saccharate 1.25 mg 2.5 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate 1.25 mg 2.5 mg 5 mg 7.5 mg Dextroamphetamine Sulfate 1.25 mg 2.5 mg 5 mg 7.5 mg Amphetamine Sulfate 1.25 mg 2.5 mg 5 mg 7.5 mg Total amphetamine base equivalence 3.13 mg 6.3 mg 12.6 mg 18.8 mg For a full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM ATTENT 5 MG : Blue oval tablet, debossed with "b" over "971" between two horizontal lines on one side. On the other side, debossed with "5" above two lines perpendicular to each another. ATTENT 10 MG : Blue oval tablet, debossed with "b" over "972" between two horizontal lines on one side. On the other side, debossed with "1" and "0" on both sides of a bisect line [1│0] and between two horizontal lines. ATTENT 20 MG : Peach oval tablet, debossed with "b" over "973" between two horizontal lines on one side. On the other side, debossed with "2" and "0" on both sides of a bisect line [2 │ 0] and betweentwo horizontal lines. ATTENT 30 MG Peach oval tablet, debossed with "b" over "974" between two horizontal lines on one side. On the other side, debossed with "3" and "0" on both sides of a bisect line [3 │ 0] and between two horizontal lines. Attent tablets 03-2017 FW 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; Diagnostic and Statistical Manual Lire le document complet