Leaflet TRAMADOL KALCEKS 50mg / ml solution for injection / infusion

Indicated for: moderate to severe pain

Route of administration: injectable / infusion

Substance: tramadol (opioid analgesic)

ATC: N02AX02 (Nervous system | Opioids | Other opioids)

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.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

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.

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.

Tramadol is an opioid analgesic used to treat moderate to severe pain. It works by binding to opioid receptors in the central nervous system and inhibiting the reuptake of serotonin and norepinephrine, which helps reduce the perception of pain. It is commonly used for managing acute pain (such as post-surgical pain) or chronic pain associated with conditions like osteoarthritis or neuropathic pain.

Tramadol is available in the form of tablets, capsules, injectable solutions, or oral drops. The dosage and frequency of administration are determined by a doctor based on the severity of the pain and the patient's response to treatment.

Common side effects include nausea, dizziness, drowsiness, constipation, dry mouth, and excessive sweating. In rare cases, tramadol may cause seizures, respiratory depression, or severe allergic reactions. Prolonged use can lead to physical and psychological dependence, and abrupt discontinuation may result in withdrawal symptoms.

Tramadol is contraindicated in patients with severe respiratory depression, acute intoxication with alcohol or other central nervous system depressants. It should also be used with caution in patients with a history of seizures or those taking medications that affect serotonin levels, due to the risk of serotonin syndrome.

General data about TRAMADOL KALCEKS 50mg / ml

  • Substance: tramadol
  • Date of latest medicines list: 01-06-2026
  • Product code: W64091003
  • Concentration: 50mg / ml
  • Pharmaceutical form: solution for injection / infusion
  • Quantity: 10
  • Product type: Generic medicine
  • Price: 24.03 RON
  • Prescription status: TAB3 - Medicines dispensed with a special medical prescription for psychotropic substances, green in color.

Marketing authorisation

  • Manufacturer: AS KALCEKS - LETONIA
  • Holder: AS KALCEKS - LETONIA
  • Number: 13654/2021/04
  • Shelf life: 4 years-after packing for marketing;after opening it is used immediately

Concentrations available for tramadol

  • 100mg
  • 100mg/2ml
  • 100mg/ml
  • 150mg
  • 200mg
  • 300mg
  • 50mg
  • 50mg/ml

Combinations with other substances

Compensation lists for TRAMADOL KALCEKS 50mg / ml Kalceks

A - Sublist A with 90% discount from the reference price

Price

Copayment

Patient

24.03 RON

21.63 RON

2.40 RON

G10 (C1) - Leukemias, lymphomas and bone marrow aplasia, tumors

Price

Copayment

Patient

24.03 RON

24.03 RON

0.00 RON

GX (C1) - GENERIC (used in compensation list, C1, for another diagnosis)

Price

Copayment

Patient

24.03 RON

24.03 RON

0.00 RON

NHP 9.1 (C2) - Spinal cord transplant

Price

Copayment

Patient

24.03 RON

24.03 RON

0.00 RON

NHP 9.6 (C2) - Lung transplant

Price

Copayment

Patient

24.03 RON

24.03 RON

0.00 RON