Oxycodone/Naloxone Ratiopharm

This medicine helps relieve strong pain and restless legs syndrome, and it also contains an ingredient to prevent constipation, a common side effect of strong pain medicines.

Form
depottabletti
Strength
5 mg / 2.5 mg
Active Ingredient
Oxycodone hydrochloride
Manufacturer
ratiopharm GmbH

How to Use

Dosage

Your doctor will determine the starting dose; it is typically one 10 mg/5 mg extended-release tablet every 12 hours for pain, or one 5 mg/2.5 mg extended-release tablet every 12 hours for restless legs syndrome.

Method

Swallow the tablets whole with enough water. Do not chew or crush any tablets. The 5 mg/2.5 mg tablets must not be split. The 10 mg/5 mg and 20 mg/10 mg tablets can be split in half, but not chewed or crushed. Take your dose every 12 hours, at the same times each day, with or without food.

Important

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

Possible Side Effects

COMMON
  • Abdominal pain
  • Constipation
  • Diarrhea
  • Dry mouth
  • Indigestion and gas
  • Nausea and vomiting
  • Decreased appetite
  • Dizziness or lightheadedness
  • Headache
  • Hot flashes
  • Unusual weakness or fatigue
  • Itching or skin rash
  • Sweating
  • Spinning sensation (vertigo)
  • Trouble sleeping or drowsiness
  • Depression
  • Difficulty concentrating
  • Tremor
  • Tingling in hands or feet
  • Impaired vision
  • Low or high blood pressure
  • Elevated liver enzymes
  • Chest pain
  • Chills
  • Pain
  • Thirst
RARE
  • Abdominal swelling
  • Anxiety
  • Confusion
  • Nervousness
  • Chest tightness
  • Withdrawal symptoms (e.g., agitation)
  • Fainting
  • Lack of energy
  • Changes in taste
  • Palpitations
  • Gallstone attack
  • General feeling of being unwell
  • Swelling of hands, ankles, or feet
  • Speech disorders
  • Restlessness
  • Decreased sex drive
  • Runny nose
  • Cough
  • Hypersensitivity or allergic reactions
  • Weight loss
  • Accidental injuries
  • Increased urge to urinate
  • Muscle spasms, twitches, or pain
  • Epileptic seizures
  • Increased heart rate
  • Drug dependence
  • Dental changes
  • Weight gain
  • Yawning
  • Hives (itchy rash)
  • Infections (like oral or genital herpes)
  • Increased appetite
  • Black, sticky stools
  • Gum bleeding
  • Episodes of sudden sleep onset
  • Erectile dysfunction

Important Warnings

  • Do not take if you are allergic to this medicine or its ingredients.
  • Do not use if you have very bad breathing problems or slow, shallow breathing.
  • Do not take if you have severe liver problems or a bowel blockage not caused by opioids.
  • This medicine can cause addiction. Do not take more than prescribed. Tell your doctor if you or a family member have misused drugs or alcohol.
  • Do not split, chew, or crush the 5 mg/2.5 mg tablets; this can be very dangerous. Other strengths can be split but not chewed or crushed.
Show 5 more warnings
  • Do not drink alcohol or grapefruit juice with this medicine, as it can cause serious side effects and make you very sleepy.
  • Avoid using this medicine if you are pregnant or breastfeeding, unless your doctor says it's absolutely necessary.
  • This medicine can make you sleepy or dizzy. Do not drive or use machines until you know how it affects you and feel fully awake.
  • Tell your doctor if you are taking or have recently taken MAO inhibitors (medicines for depression or Parkinson's disease).
  • Talk to your doctor if you have other health issues like kidney or mild liver problems, an enlarged prostate, blood pressure issues, heart problems, a head injury, epilepsy, or mental health problems with psychosis.

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)