Leaflet PALGOTAL 75mg / 650mg film-coated tablets


Indicated for: pain; fever

Route of administration: oral

Substance: tramadol + paracetamol (opioid analgesic + analgesic and antipyretic)

ATC: N02AJ13 (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.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

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 and paracetamol are medications used together to treat moderate to severe pain. Tramadol is an opioid analgesic that acts on the central nervous system to reduce the perception of pain, while paracetamol is a non-opioid analgesic and antipyretic that helps reduce pain and fever.

The tramadol/paracetamol combination provides a stronger analgesic effect than using either medication alone, making it effective in managing acute pain, including postoperative pain, musculoskeletal pain, and chronic pain. This combination is often used when weaker analgesics are insufficient to control pain.

Although effective, the use of tramadol and paracetamol may be associated with side effects such as nausea, dizziness, drowsiness, or gastrointestinal disturbances. It is essential to take these medications as prescribed by a doctor to minimize risks and ensure safe and effective treatment.

General data about PALGOTAL 75mg / 650mg

  • Substance: tramadol + paracetamol
  • Date of last drug list: 01-12-2021
  • Commercial code: W61588003
  • Concentration: 75mg / 650mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 30
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: ZENTIVA, K.S. - REPUBLICA CEHA
  • Holder: ZENTIVA, K.S. - REPUBLICA CEHA
  • Number: 12897/2020/03
  • Shelf life: 2 years

Pharmaceutical forms available for tramadol + paracetamol

Concentrations available for tramadol + paracetamol

  • 37.5m.g/325mg
  • 37.5mg/325mg
  • 75mg/650mg