Leaflet SOLPADEINE DUO 500mg / 12.8mg film-coated tablets

Indicated for: pain; fever

Route of administration: oral

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

ATC: N02BE51 (Nervous system | Other analgesics and antipyretics | Anilides)

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.

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.

Paracetamol + codeine is a combination medication used to treat moderate to severe pain that cannot be managed with paracetamol alone. Paracetamol acts as an analgesic and antipyretic, reducing pain and fever, while codeine, a mild opioid, enhances the analgesic effect of paracetamol by acting on pain receptors in the central nervous system.

This combination is commonly used for severe headaches, dental pain, postoperative pain, or other types of acute or chronic pain. It is important to use this medication for short-term treatment, as codeine can cause dependency if taken for extended periods.

Side effects may include drowsiness, dizziness, constipation, nausea, or, in rare cases, allergic reactions. Overuse can lead to liver damage (due to paracetamol) or codeine dependency. It is essential to take this combination as prescribed by a doctor and avoid excessive use.

General data about SOLPADEINE DUO 500mg / 12.8mg

  • Substance: paracetamol + codeine
  • Date of latest medicines list: 01-04-2026
  • Product code: W63608002
  • Concentration: 500mg / 12.8mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 10
  • Product type: Generic medicine
  • Prescription status: OTC - Over the Counter = medicine that does not require a medical prescription.

Marketing authorisation

  • Manufacturer: SWISS CAPS GMBH - GERMANIA
  • Holder: HIPOCRATE 2000 S.R.L. - ROMANIA
  • Number: 9795/2017/02
  • Shelf life: 2 years

Pharmaceutical forms available for paracetamol + codeine

Concentrations available for paracetamol + codeine

  • 1000mg/60mg
  • 500mg/12.8mg
  • 500mg/30mg
  • 500mg/60mg