Leaflet OXICODONA/NALOXONA SANDOZ 30mg / 15mg prolonged-release tablets

Indicated for: moderate to severe pain

Route of administration: oral

Substance: oxycodone + naloxone (opioid analgesic + opioid antagonist)

ATC: N02AA55 (Nervous system | Opioids | Natural opium alkaloids)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Dependence / abuse
Dependence / abuse

This medicine may cause dependence or be misused.

Respiratory depression
Respiratory depression

May slow breathing, especially with alcohol or sedatives.

Avoid alcohol
Avoid alcohol

Avoid alcohol during treatment.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Elderly warning
Elderly warning

Older people may have an increased risk of side effects.

Withdrawal / do not stop abruptly
Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

The combination of oxycodone and naloxone is used for the treatment of severe pain requiring continuous opioid analgesic administration. Oxycodone is a potent opioid analgesic, while naloxone is an opioid antagonist that reduces the risk of opioid-induced constipation.

The medication is taken orally, usually as extended-release tablets, as directed by your doctor. It is important to follow the prescribed dosage to avoid the risk of dependence or other adverse effects.

Side effects may include nausea, drowsiness, dizziness, constipation, or, in rare cases, respiratory depression.

Patients should inform their doctor about any other medications being used or pre-existing conditions, such as respiratory or liver diseases, to ensure the safe use of this combination.

General data about OXICODONA/NALOXONA SANDOZ 30mg / 15mg

  • Substance: oxycodone + naloxone
  • Date of latest medicines list: 01-03-2026
  • Product code: W64204001
  • Concentration: 30mg / 15mg
  • Pharmaceutical form: prolonged-release tablets
  • Quantity: 10
  • Product type: Generic medicine
  • Prescription status: TAB2 - Medicines dispensed with a special medical prescription for narcotic substances, yellow in color.

Marketing authorisation

  • Manufacturer: SALUTAS PHARMA GMBH - GERMANIA
  • Holder: SANDOZ S.R.L. - ROMANIA
  • Number: 13621/2020/19
  • Shelf life: 2 years

Pharmaceutical forms available for oxycodone + naloxone

Concentrations available for oxycodone + naloxone

  • 10mg/5mg
  • 15mg/7.5mg
  • 2.5mg/1.25mg
  • 20mg/10mg
  • 30mg/15mg
  • 40mg/20mg
  • 5mg/2.5mg
  • 60mg/30mg
  • 80mg/40mg