OXYCOD 2 MGML SYRUP

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

OXYCODONE HYDROCHLORIDE

Tillgänglig från:

RAFA LABORATORIES LTD

ATC-kod:

N02AA05

Läkemedelsform:

SYRUP

Sammansättning:

OXYCODONE HYDROCHLORIDE 10 MG / 5 ML

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

RAFA LABORATORIES LTD, JERUSALEM

Terapeutisk grupp:

OXYCODONE

Terapiområde:

OXYCODONE

Terapeutiska indikationer:

For use in the relief of moderate to severe pain.

Tillstånd datum:

2022-09-30

Bipacksedel

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold with a doctor's prescription only
OXYCOD 2 MG/ML SYRUP
ACTIVE INGREDIENT:
Contains: Oxycodone hydrochloride 2 mg/ml.
For the list of the additional ingredients, see section 6.
See also ‘Important information about some of the medicine’s
ingredients’ in section 2.
CAREFULLY READ THE ENTIRE LEAFLET 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 it seems to you that 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_en.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 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 you received an explanation from the
doctor on the
duration of treatment with the medicine, when it is appropriate to

Produktens egenskaper

1
Oxycod Syrup 2mg/ml -DL-Nov 2022- 06
DOCTOR LEAFLET
1
NAME OF THE MEDICINAL PRODUCT
OXYCOD 2 MG/ML SYRUP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml Oxycod Syrup contains oxycodone HCl 2 mg.
For the full list of excipients see section 6.1
Excipients with known effect:
See section 4.4._ _
3
PHARMACEUTICAL FORM
Syrup for oral use.
Clear, pink solution.
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 sections _4.4, 4.5]_.
•
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 pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD of administration: _
Oxycod Syrup is for oral use.
_ _
_Post-operative pain: _
In common with other strong opioids, the need for continued treatment
should be assessed at
regular intervals.
_Elderly and adults over 18 years: _
Oxycod Syrup should be taken at 4-6 hourly intervals. The dosage is
dependent on the severity of
the pain, and the patient’s previous history of analgesic
requirements.
Generally, the lowest effective dose for analgesia should be selected.
2
Increasing severity of pain will require an increased dosage of Oxycod
Syrup. The correct dosage
for any individual patient is that which controls the pain and is well
tolerated throughout the dosing
period. Patients should be titrated to pain relief unless unmanageable
adverse drug reactions
prevent this.
The usual starting dose for opioid naive patients or patients
presenting with severe pain uncontrolled
by weaker opioids is 5 mg, 4-6 hourly. The dose should then be
carefully titrated, as