OXYCOD FORTE 10 MGML SYRUP

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

OXYCODONE HYDROCHLORIDE

Prieinama:

RAFA LABORATORIES LTD

ATC kodas:

N02AA05

Vaisto forma:

SYRUP

Sudėtis:

OXYCODONE HYDROCHLORIDE 10 MG/ML

Vartojimo būdas:

PER OS

Recepto tipas:

Required

Pagaminta:

RAFA LABORATORIES LTD, JERUSALEM

Farmakoterapinė grupė:

OXYCODONE

Gydymo sritis:

OXYCODONE

Terapinės indikacijos:

For the relief of moderate to severe pain.

Leidimo data:

2017-01-31

Pakuotės lapelis

Patient Leaflet According to the Pharmacists' Regulations (Preparations) – 1986
This medicine is sold with a doctor's prescription only
Oxycod Forte 10 mg/ml Syrup
Active ingredient:
Contains : Oxycodone hydrochloride 10 mg/ml .
For the list of the addit ional ingredients, see section 6.
See also ‘Important information about some of the medicine’s ingredients’ in section 2.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information about the medicine. I f 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 .
This medicine is not intended for children and adolescents under 18 years of age .
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 manif ested 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 depen dence 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 th e 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 m ay experience withdrawal symptoms if you stop
taking them suddenly. Make sure you recei

Prekės savybės

1
Oxycod Forte -DL -Aug 2022 _ 05
Doctor Leaflet
1 NAME OF THE MEDICINAL PRODUCT
Oxycod Forte 10 mg/ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml Oxycod F orte S yrup contains oxycodone HC l 10 mg.
Excipient s with known effect:
Each 1 ml Oxycod Forte Syrup contains 1 mg sodium benzoate .
Each 1 ml Oxycod Forte Syrup contains 0.1 mg sunset yellow (E 110), which may cause allergic
reactions .
See section 4.4.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Syrup for oral use .
Clear, orange 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 section s 4.4, 4.5] .
• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment
options are ina dequate.
• 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 Forte Syrup is for oral use.
Adults over 18 years:
Oxycod Forte 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 .