Држава: Израел
Језик: Енглески
Извор: Ministry of Health
OXYCODONE HYDROCHLORIDE; PARACETAMOL
TARO PHARMACEUTICAL INDUSTRIES LTD
N02BE71
TABLETS
PARACETAMOL 325 MG; OXYCODONE HYDROCHLORIDE 5 MG
PER OS
Required
TARO PHARMACEUTICAL INDUSTRIES LTD
PARACETAMOL, COMBINATIONS WITH PSYCHOLEPTICS
PARACETAMOL, COMBINATIONS WITH PSYCHOLEPTICS
For the relief of moderate to moderately severe pain.
2022-10-31
1 Percocet PIL – notification 12.2020 _ _ PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only PERCOCET ® 5 TABLETS PERCOCET ® 10 TABLETS Name and quantity of active ingredients: Name and quantity of active ingredients: Each tablet contains: Each tablet contains: oxycodone HCl 5 mg oxycodone HCl 10 mg paracetamol 325 mg paracetamol 325 mg Please see Section 6 for a list of the inactive ingredients. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, refer to your doctor or pharmacist; this medicine has been prescribed to treat you. Do not pass it on to others. It may harm them and even cause their death, even if it seems to you that their medical condition is similar to yours; this medicine is usually not recommended for children and babies; this medicine may cause addiction and substance abuse; this medicine may cause life-threatening respiratory depression; keep out of children’s reach. Unintentional exposure can be life- threatening; prolonged use during pregnancy may cause withdrawal symptoms in your newborn baby; this medicine contains paracetamol which may cause liver toxicity; using this medicine at the same time with other medicines may change the concentration of Percocet in your blood and cause side effects (see additional information in Section 2: 'Before using this medicine'). Taking this medicine with benzodiazepines, other medicines which suppress the central nervous system (including narcotic drugs), or alcohol may cause deep drowsiness, breathing difficulty (respiratory depression), coma and death. _ _ Opioid medicines may cause addiction, especially with prolonged use. It is also possible to abuse these medicines or overdose on them. An opioid overdose is often marked by slowed breathing and can cause death. Make sure you know the name of the medicine you are taking, your dosage, how oft Прочитајте комплетан документ
_PERCOCET 5MG AND 10 MG _ _ _ 1 _Percocet SPC 12.2020_ final PERCOCET ® TABLETS RX ONLY PRESCRIBING INFORMATION WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE PERCOCET EXPOSES PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S RISK PRIOR TO PRESCRIBING PERCOCET, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS]. LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF PERCOCET. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF PERCOCET OR FOLLOWING A DOSE INCREASE [SEE WARNINGS]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF PERCOCET, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF PERCOCET [SEE WARNINGS]. NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED USE OF PERCOCET DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE [SEE WARNINGS]. CYTOCHROME P450 3A4 INTERACTION THE CONCOMITANT USE OF PERCOCET WITH ALL CYTOCHROME P450 3A4 INHIBITORS MAY RESULT IN AN INCREASE IN OXYCODONE PLASMA CONCENTRATIONS, WHICH COULD INCREASE OR PROLONG ADVERSE REACTIONS AND MAY CAUSE POTENTIALLY FATAL RESPIRATORY DEPRESSION. IN ADDITION, DISCONTINUATION OF A CONCOMITANTLY USED CYTOCHROME P450 3A4 INDUCER MAY RESULT IN AN INCREASE IN OXYCODONE PLASMA CONCENTRATION. MONITOR PATIENTS RECEIVING PERCOCET AND ANY CYP3A4 INHIBI Прочитајте комплетан документ