Oxycodone/Naloxone Ratiopharm

This medicine treats severe pain or restless legs syndrome in adults by releasing its ingredients slowly over 12 hours, using oxycodone for relief and naloxone to prevent constipation.

Form
depottabletti
Strength
10 mg / 5 mg
Active Ingredient
Oxycodone hydrochloride
Manufacturer
ratiopharm GmbH

How to Use

Dosage

The usual starting dose is 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride as extended-release tablets every 12 hours.

Method

Take tablets whole with half a glass of water, with or without food, at the same times every 12 hours (e.g., 8 AM and 8 PM). Do not split, break, chew, or crush the 5mg/2.5mg tablets. The 10mg/5mg and 20mg/10mg tablets can be split into equal halves, but do not chew or crush them. Crushing or chewing can release a deadly amount of oxycodone.

Important

The maximum daily dose is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride.

Possible Side Effects

COMMON
  • Stomach pain
  • Constipation
  • Diarrhea
  • Nausea
  • Vomiting
  • Dry mouth
  • Dizziness or light-headedness
  • Headache
  • Sweating
  • Tiredness
RARE
  • Anxiety
  • Depression
  • Chest pain or tightness
  • Fainting
  • Tremors or shaking
  • Breathing difficulties
  • Muscle spasms or pain
  • Blurred vision
  • Skin rash or itching
  • Increased heart rate

Important Warnings

  • Do not take if you are allergic to oxycodone, naloxone, or any other ingredients.
  • Do not take if you have severe breathing problems, such as very slow or shallow breathing, severe lung disease, or severe asthma.
  • Do not take if you have a blocked bowel (paralytic ileus) not caused by opioids.
  • Do not take if you have moderate to severe liver problems.
  • If taking for restless legs, do not use if you have a history of misusing opioids.
Show 5 more warnings
  • This medicine contains oxycodone, which is an opioid and can cause addiction.
  • Do not drink alcohol or grapefruit juice while taking this medicine.
  • Avoid use during pregnancy and breastfeeding unless your doctor says it's absolutely necessary.
  • Do not drive or use machines if this medicine makes you drowsy or dizzy.
  • Do not split, chew, or crush the tablets as this can lead to a potentially deadly dose.

Use in Elderly Patients

Category C

Suitable for older adults, with specific precautions. Sedative. Reduce the dose already in mild renal impairment. Increases the risk of confusion and falling. Need for laxative is often necessary. Consider potential interactions. Avoid grapefruit. (updated 24.3.2025)