Oxycodone Hydrochloride 10mg/ml Oral Solution

Riik: Suurbritannia

keel: inglise

Allikas: myHealthbox

Toimeaine:

Oxycodone Hydrochlorid

Saadav alates:

Ash Road North, Wrexham

ATC kood:

N02AA05

INN (Rahvusvaheline Nimetus):

Oxycodone Hydrochlorid

Annus:

10mg/ml

Ravimvorm:

Oral Solution

Manustamisviis:

Oral use

Ühikuid pakis:

125 ml bottle

Retsepti tüüp:

POM - Prescription Only Medicine

Valmistatud:

CP Pharmaceuticals Ltd

Terapeutiline rühm:

Natural opium alkaloids

Näidustused:

For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.

Volitamisolek:

Authorised

Loa andmise kuupäev:

2011-05-25

Infovoldik

MEASURE BAR SHOULD BE 150MM AT 100% SCALE 
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Wockhardt UK Lim
ited
Oxycodone 10mg
/m
l oral solution leaflet
105263-
4
148 x 210mm
uk
eng
lish
tom.robertson
2
19/05/2014
487228
5.5pt
Process Black
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•  have an enlarged prostate gland
•  have a severe headache or feel sick as this may indicate
 that the pressure in your skull is increased (have raised
 intracranial pressure)
•  have kidney or liver disease
•  are intoxicated with alcohol
•  are suffering from withdrawal symptoms of alcohol
SPECIAL CARE SHOULD BE TAKEN WITH ELDERLY, DEBILITATED AND 
WEAK PATIENTS AS WELL AS PATIENTS WITH A HISTORY OF DRUG OR 
ALCOHOL ABUSE. THIS MEDICINE CAN CAUSE DEPENDENCE, IF YOU 
HAVE ANY CONCERNS ABOUT WHETHER THIS MEDICINE IS SUITABLE 
FOR YOU SPEAK TO YOUR DOCTOR OR NURSE.
IF YOU ARE GOING TO HAVE AN OPERATION, PLEASE TELL THE DOCTOR 
AT THE HOSPITAL THAT YOU ARE TAKING THIS MEDICINE.
TAKING OTHER MEDICINES
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription. The following medicines can affect or be affected
by treatment with Oxycodone 10mg/ml Solution:
•  tranquilisers and sleeping tablets
•  anaesthetics
•  anti-depressants
•  phenothiazines (often used to treat severe mental illness)
•   neuroleptic drugs (often used to treat severe mental
illnesses such as psychosis and schizophrenia)
•  alcohol
•  other opioid painkillers
•  muscle relaxants
•  medicines to treat high blood pressure
•  quinid

Toote omadused

Oxycodone Hydrochloride 10mg/ml Oral Solution
Summary of Product Characteristics Updated 21­Oct­2014 | Wockhardt UK Ltd
1. Name of the medicinal product
Oxycodone Hydrochloride 10mg/ml Oral Solution
2. Qualitative and quantitative composition
Each 1ml contains oxycodone hydrochloride 10 mg (equivalent to 9 mg of oxycodone base).
This medicinal product contains approximately 0.85mg sodium per ml.
For full list of excipients, see Section 6.1.
3. Pharmaceutical form
A clear, orange oral solution.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of moderate to severe pain in patients with cancer and post­operative pain. For the treatment of
severe pain requiring the use of a strong opioid.
4.2 Posology and method of administration
_Route of administration:_
Oral use.
_Post­operative pain:_
In common with other strong opioids, the need for continued treatment should be assessed at regular intervals.
_Elderly and adults over 18 years:_
Oxycodone solution should be taken at 4­6 hourly intervals. The dosage is dependent on the severity of the pain, and
the patient's previous history of analgesic requirements.
Increasing severity of pain will require an increased dosage of Oxycodone solution. 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 naïve patients or patients presenting with severe pain uncontrolled by weaker opioids
is 5 mg, 4­6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve
pain relief. The majority of patients will not require a daily dose greater than 400 mg. However, a few