Indications:
Oxycodone Sandoz contains the active substance oxycodone hydrochloride, which is a strong analgesic from the opioid group, with central action.
Oxycodone Sandoz is used in adults and adolescents over 12 years of age to treat severe pain that requires treatment with an opioid analgesic.

Contraindications:
Do not take Oxycodone Sandoz:
- if you are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine.

Precautions:
Talk to your doctor or pharmacist before taking Oxycodone Sandoz.

Pregnancy, lactation and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Task:
You should not use Oxycodone Sandoz during pregnancy. There is limited data on the use of oxycodone in pregnant women.
Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in newborns. Use of oxycodone during labor may cause breathing problems (respiratory depression) in the newborn.
Breastfeeding:
You should not use Oxycodone Sandoz while breastfeeding because the active substance oxycodone passes into breast milk and causes breathing problems (respiratory depression) in the infant.

Driving and using machines:
Oxycodone Sandoz may affect your ability to drive and use machines.
During maintenance treatment, it is not necessary to stop driving; the attending physician must assess the individual situation. Please consult your doctor to find out if and under what conditions you can drive a vehicle.

Method of administration:
Always take Oxycodone Sandoz exactly as your doctor has told you. Talk to your doctor or pharmacist if you are not sure.
For dose modifications, other strengths of this medicine are available.

The recommended dose is:
Adults and adolescents (over 12 years of age):
The usual starting dose is 10 mg of oxycodone hydrochloride every 12 hours. Your doctor will prescribe the recommended dose for the treatment of pain.
Other determinations of the daily dose, fractionation into single doses and any dose changes during treatment are made by the treating physician and depend on the previous dose.
Patients already using opioids may start treatment with higher doses taking into account previous opioid treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Composition:
- The active substance is oxycodone hydrochloride. Each prolonged-release tablet contains 40 mg/60 mg/80 mg of anhydrous oxycodone hydrochloride equivalent to 35.9 mg/53.9 mg/71.8 mg of oxycodone.
- The other ingredients are: Core: hydrogenated castor oil, copovidone, polyoxyglyceride behenoyl, lactose monohydrate, magnesium stearate, maize starch, colloidal anhydrous silica, medium chain triglycerides. Film-coating: microcrystalline cellulose, hypromellose, stearic acid, titanium dioxide (E 171).
Oxycodone Sandoz 40 mg prolonged-release tablets: yellow iron oxide (E 172);
Oxycodone Sandoz 60 mg prolonged-release tablets: red iron oxide (E 172);
Oxycodone Sandoz 80 mg prolonged-release tablets: black iron oxide (E 172),
hydrated aluminium oxide, indigotine (E 132); quinoline yellow (E 104).

Presentation:
20 extended-release tablets

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.