PERCOCET 10

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

OXYCODONE HYDROCHLORIDE; PARACETAMOL

Commercializzato da:

TARO PHARMACEUTICAL INDUSTRIES LTD

Codice ATC:

N02BE01

Forma farmaceutica:

TABLETS

Composizione:

OXYCODONE HYDROCHLORIDE 10 MG; PARACETAMOL 325 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

TARO PHARMACEUTICAL INDUSTRIES LTD

Gruppo terapeutico:

PARACETAMOL

Area terapeutica:

PARACETAMOL

Indicazioni terapeutiche:

For the relief of moderate to moderately severe pain.

Data dell'autorizzazione:

2022-10-31

Foglio illustrativo

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

Scheda tecnica

_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