OXYCONTIN 5 MG

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

OXYCODONE HYDROCHLORIDE

Disponibil de la:

RAFA LABORATORIES LTD

Codul ATC:

N02AA05

Forma farmaceutică:

TABLETS CONTROLLED RELEASE

Compoziție:

OXYCODONE HYDROCHLORIDE 5 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

NAPP PHARMACEUTICALS LTD, UK

Grupul Terapeutică:

OXYCODONE

Zonă Terapeutică:

OXYCODONE

Indicații terapeutice:

For the relief of moderate to severe chronic pain.

Data de autorizare:

2014-10-31

Prospect

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
OXYCONTIN 5
CONTROLLED-RELEASE TABLETS.
ACTIVE INGREDIENT:
Each tablet contains: Oxycodone hydrochloride 5 mg
For the list of the additional ingredients, see section 6.
See also 'Important information about some of the medicine's
ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your condition. Do not pass
it on to others. It may
harm them, even if you think their medical condition is similar to
yours.
Medicines of the opioids group may cause addiction, especially with
prolonged use and they
have a potential for misuse and overdose. A reaction to an overdose
may be manifested by
slow breathing and may even cause death.
Make sure you know the name of the medicine, the dosage that you take,
how often you take it,
the duration of treatment, potential side effects and risks.
Additional information regarding the risk of dependence and addiction
can be found at the
following link:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/risk/DocLib/opioids_he.pdf
Taking this medicine along with medicines from the benzodiazepines
group, other medicines which
depress the central nervous system (including drugs) or alcohol may
cause a feeling of profound
drowsiness, breathing difficulties (respiratory depression), coma and
death.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the relief of long-term moderate to
severe pain.
THERAPEUTIC GROUP: Opioid analgesics
This medicine has been prescribed for you only and should not be given
to anyone else. Opioids
may cause addiction and you may experience withdrawal symptoms if you
stop taking them
suddenly. Make sure that you received an explanation from your doctor
on the duration of
treatment with the medicine

Caracteristicilor produsului

DL-OxyContin-SPC-Aug 2023-08
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_OXYCONTIN_
 10, 20, 40, 80 CONTROLLED RELEASE TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_OXYCONTIN 10_ contains 10 mg of oxycodone hydrochloride.
_OXYCONTIN 20_ contains 20 mg of oxycodone hydrochloride.
_OXYCONTIN 40_ contains 40 mg of oxycodone hydrochloride.
_OXYCONTIN 80_ contains 80 mg of oxycodone hydrochloride.
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Controlled release tablets.
The 10 mg tablets are white.
The 20 mg tablets are pink.
The 40 mg tablets are yellow.
The 80 mg tablets are green.
4.
CLINICAL PARTICULARS
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression, coma,
and death [see 'Drug Interactions'].
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative treatment
options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
4.1
THERAPEUTIC INDICATIONS
For the relief of moderate to severe chronic pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_OXYCONTIN _tablets must be swallowed whole, and not broken, chewed or
crushed.
_OXYCONTIN _tablets should be taken one tablet at a time. Take each
tablet with enough water to ensure
complete swallowing immediately after placing in the mouth. (see also
section 4.4).
_Adults over 18 years:_ _ _
_OXYCONTIN _tablets should be taken at 12-hourly intervals. The dosage
is dependent on the severity of
the pain, and the patient’s previous history of analgesic
requirements.
2
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a strategy
for ending treatment with oxycodone in order to minimise the risk of
addiction and drug withdrawal
syndrome (see section 4.4).
_OXY