Страна: Израиль
Язык: английский
Источник: Ministry of Health
AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
N06BA01
TABLETS
AMPHETAMINE SULFATE 2.500 MG; DEXTROAMPHETAMINE SULFATE 2.500 MG; AMPHETAMINE ASPARTATE MONOHYDRATE 2.500 MG; DEXTROAMPHETAMINE SACCHARATE 2.500 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
AMFETAMINE
Treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
2020-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only ATTENT 10 MG TABLETS ATTENT 20 MG TABLETS ATTENT 30 MG TABLETS COMPOSITION 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 information on inactive and allergenic ingredients in the preparation, see in section 2 “Important information about some of the ingredients of the medicine” and section 6 – “Further information”. READ THE 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. Misuse of amphetamines may cause sudden death and severe cardiac side effects. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine contains a mix of amphetamine salts, which are central nervous system stimulants, and is in Прочитать полный документ
Attent FW 11-2023- Notification SUMMARY OF PRODUCT CHARACTERISTICS Attent 10 mg, 20 mg & 30 mg Tablets 1. NAME OF THE MEDICINAL PRODUCT Attent 10 mg Attent 20 mg Attent 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 Attent 10 mg Attent 20 mg Attent 30 mg Dextroamphetamine Saccharate 2.5 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate 2.5 mg 5 mg 7.5 mg Dextroamphetamine Sulfate 2.5 mg 5 mg 7.5 mg Amphetamine Sulfate 2.5 mg 5 mg 7.5 mg Total amphetamine base equivalence 6.3 mg 12.6 mg 18.8 mg Excipients with known effect: Saccharin sodium, compressible sugar, Attent 20 mg and 30 mg tablets contain FD & C Yellow No. 6 Aluminium lake (sunset yellow FCF). See section 4.4 "excipients with known effect". For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets for oral administration. 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 can be divided into equal parts. Attent FW 11-2023 Notification 2 WARNING: ABUSE, MISUSE, AND ADDICTION Attent tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Attent tablets, can result in overdose and Прочитать полный документ