Oxycodone/Naloxone Stada

Oxycodone/Naloxone Stada is a prolonged-release tablet used for severe pain or severe restless legs syndrome, that slowly releases its active ingredients over 12 hours while helping to prevent constipation.

Form
depottabletti
Strength
10 mg / 5 mg
Active Ingredient
Oxycodone hydrochloride
Manufacturer
STADA Arzneimittel AG

How to Use

Dosage

Your doctor will decide your dose based on your condition. For pain, treatment usually starts with one 10 mg oxycodone hydrochloride / 5 mg naloxone hydrochloride prolonged-release tablet every 12 hours. For restless legs, treatment usually starts with one 5 mg oxycodone hydrochloride / 2.5 mg naloxone hydrochloride prolonged-release tablet every 12 hours.

Method

Swallow the tablet whole with about half a glass of water; do not break, chew, or crush it. Tablets of 10mg, 20mg, and 40mg can be divided into two equal doses, but must not be broken, chewed, or crushed. Take the tablet every 12 hours, for example, in the morning and evening at the same time. You can take it with or without food.

Important

For severe pain, the maximum daily dose 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
  • Nausea
  • Vomiting
  • Decreased appetite
  • Dizziness
  • Headache
  • Fatigue
  • Itching
  • Sweating
  • Drowsiness
  • Sleep problems
  • Hot flashes
  • Indigestion
RARE
  • Anxiety
  • Depression
  • Confusion
  • Withdrawal symptoms (like agitation)
  • Hallucinations
  • Seizures
  • Allergic reactions
  • Breathing difficulties
  • Swelling in hands or feet
  • Erectile dysfunction
  • Fainting
  • Chest tightness
  • Palpitations
  • High or low blood pressure
  • Blurred vision
  • Muscle cramps or pain
  • Urination problems
  • Drug dependence
  • Nightmares
  • Aggression

Important Warnings

  • Do not take this medicine if you are allergic to oxycodone, naloxone, or any other ingredients, or if you have severe breathing problems or serious lung diseases like severe asthma.
  • Avoid this medicine if you have moderate to severe liver problems or a bowel blockage (paralytic ileus) not caused by other opioids.
  • If you are taking this for restless legs syndrome and have a history of opioid abuse, or if you have kidney problems or mild liver problems, tell your doctor.
  • Never crush, chew, or inject these tablets, as it can release a dangerous dose and lead to serious harm, even death.
  • Do not drink alcohol or grapefruit juice while taking this medicine. It can make you drowsy or affect your ability to drive or use machines.
Show 4 more warnings
  • Long-term use can lead to physical and psychological dependence. Do not stop taking this medicine suddenly without talking to your doctor, as it can cause withdrawal symptoms.
  • Always tell your doctor or pharmacist about all other medicines you are taking, including over-the-counter drugs and herbal remedies, as they can affect how this medicine works.
  • This medicine is not recommended during pregnancy or breastfeeding. If you are pregnant, breastfeeding, or planning a pregnancy, consult your doctor.
  • Seek urgent medical help if you experience very slow or shallow breathing, as this is a serious overdose risk.

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)