Leaflet DELXORA 75mg / 25mg tablets


Indicated for: pain and inflammation

Route of administration: oral

Substance: tramadol + dexketoprofen (opioid analgesic + nonsteroidal anti-inflammatory drug)

ATC: N02AJ14 (Nervous system | Opioids | Opioids in combination with non-opioid analgesics)

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.

Photosensitivity
Photosensitivity

Avoid excessive exposure to sunlight or UV radiation.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Nephrotoxicity
Nephrotoxicity

This medicine may affect the kidneys.

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.

Seizure risk
Seizure risk

This medicine may increase the risk of seizures.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

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.

Ulcer / gastrointestinal bleeding
Ulcer / gastrointestinal bleeding

This medicine may increase the risk of ulcer or gastrointestinal bleeding.

Tramadol + dexketoprofen is a combination for the short-term treatment of moderate to severe acute pain in adults. Tramadol acts on the central nervous system and has opioid effects, while dexketoprofen is a non-steroidal anti-inflammatory medicine that reduces pain and inflammation. It is useful when the doctor considers that one painkiller alone is not enough.

It is taken by mouth according to the prescribed dose and duration, usually for only a few days. Do not exceed the recommended dose and do not combine it with alcohol, sedatives or other opioids unless a doctor agrees. Tell your doctor if you have stomach ulcers, digestive bleeding, liver or kidney disease, epilepsy, asthma, anticoagulant treatment or a history of dependence.

Side effects may include nausea, vomiting, sleepiness, dizziness, constipation, stomach pain, heartburn, diarrhoea, sweating, dry mouth and tiredness. More serious reactions can occur, such as slow breathing, confusion, seizures, allergic reactions, black stools, vomiting blood, worsening asthma or kidney problems. The risk is higher in older or frail patients.

Do not drive or use machines if you feel sleepy, dizzy or have blurred vision. Seek urgent medical advice if breathing difficulty, swelling of the face, severe abdominal pain, bleeding, widespread rash, fainting or confusion occur. This combination is not intended for unmanaged chronic pain and should not be used during pregnancy unless clearly advised by a doctor.

General data about DELXORA 75mg / 25mg

  • Substance: tramadol + dexketoprofen
  • Date of last drug list: 01-03-2026
  • Commercial code: W71181001
  • Concentration: 75mg / 25mg
  • Pharmaceutical form: tablets
  • Quantity: 10
  • Product type: generic
  • Prescription restrictions: TAB3 - Medicines that are issued with a special prescription (psychotropic) in green color.

Marketing authorisation

  • Manufacturer: KRKA, D.D., NOVO MESTO - SLOVENIA
  • Holder: KRKA, D.D., NOVO MESTO - SLOVENIA
  • Number: 16051/2025/01
  • Shelf life: 1 year

Pharmaceutical forms available for tramadol + dexketoprofen