Oxycodone/Naloxone Stada

Oxycodone/Naloxone Stada is a medicine for severe pain and severe restless legs syndrome, with naloxone included to prevent constipation.

Form
depottabletti
Strength
20 mg / 10 mg
Active Ingredient
Oxycodone hydrochloride
Manufacturer
STADA Arzneimittel AG

How to Use

Dosage

The usual starting dose is one tablet containing 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride every 12 hours. Your doctor will decide your exact dose.

Method

Swallow the tablet whole with enough water. Smaller tablets (5 mg/2.5 mg) must not be divided, broken, chewed, or crushed. Larger tablets can be divided in half, but not broken, chewed, or crushed. You can take the medicine with or without food, every 12 hours at the same times each day.

Important

The maximum daily dose for pain treatment is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride. For restless legs syndrome, the maximum daily dose is 60 mg oxycodone hydrochloride and 30 mg naloxone hydrochloride.

Possible Side Effects

COMMON
  • abdominal pain
  • constipation
  • diarrhea
  • dry mouth
  • indigestion
  • vomiting
  • nausea
  • flatulence (gas)
  • decreased appetite
  • dizziness
  • headache
  • hot flashes
  • unusual weakness
  • fatigue or tiredness
  • itching
  • skin reactions or rash
  • sweating
  • vertigo
  • sleep problems
  • drowsiness
RARE
  • abdominal swelling
  • anxiety
  • depression
  • low blood pressure
  • withdrawal symptoms (like restlessness)
  • fainting
  • palpitations
  • general discomfort
  • swelling of hands, ankles, or feet
  • concentration problems
  • tremor
  • breathing difficulties
  • high blood pressure
  • muscle cramps or twitches
  • blurred vision
  • seizures
  • drug dependence
  • erectile dysfunction
  • severe drowsiness or sudden sleep
  • changes in hormone levels

Important Warnings

  • Do not take if you are allergic to oxycodone hydrochloride, naloxone hydrochloride, or any other ingredient in this medicine.
  • Do not take if you have severe breathing problems, such as very slow and shallow breathing, severe lung disease, or severe asthma.
  • Never break, chew, or crush the tablets, as this can release a potentially fatal dose. Also, never dissolve and inject the tablets.
  • Do not consume alcohol or grapefruit juice with this medicine, as they can increase side effects.
  • Avoid use during pregnancy and breastfeeding. Talk to your doctor if you are pregnant, breastfeeding, or planning a pregnancy.
Show 2 more warnings
  • This medicine can cause drowsiness and sudden sleep. Do not drive or operate machinery if you experience these symptoms.
  • Long-term use can lead to dependence. Do not stop taking this medicine suddenly without talking to your doctor to avoid withdrawal symptoms.

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)