Leaflet FASCONAL P 200mg / 200mg / 25mg / 10mg / 25mg tablets

Indicated for: cold and flu symptoms

Route of administration: oral

Substance: acetylsalicylic acid + paracetamol + caffeine + codeine + phenobarbital (nonsteroidal anti-inflammatory drug + analgesic and antipyretic + xanthine stimulant + opioid analgesic + antiepileptic barbiturate)

ATC: N02BA71 (Nervous system | Other analgesics and antipyretics | Salicylic acid and derivatives)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

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.

Narrow therapeutic index
Narrow therapeutic index

The dose must be followed strictly.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

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.

Pediatric warning
Pediatric warning

Use in children only as recommended in the leaflet or by a doctor.

Elderly warning
Elderly warning

Older people may have an increased risk of side effects.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Seizure risk
Seizure risk

This medicine may increase the risk of seizures.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

Suicidal ideation / mental changes
Suicidal ideation / mental changes

Seek medical help if suicidal thoughts or major behavior changes occur.

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.

The combination of acetylsalicylic acid, paracetamol, caffeine, codeine, and phenobarbital is used for the relief of moderate to severe pain, particularly in cases of migraines, severe headaches, or other types of pain that do not respond to simple analgesics. This combination combines analgesic, sedative, and stimulant effects to provide effective pain relief and symptom management.

- Acetylsalicylic acid is an analgesic and anti-inflammatory agent that reduces pain, inflammation, and fever.
- Paracetamol is an analgesic and antipyretic that complements the effect of acetylsalicylic acid, providing additional pain and fever reduction.
- Caffeine enhances the absorption of analgesics and has a stimulating effect, reducing fatigue associated with pain.
- Codeine is a mild opioid that enhances the analgesic effect of the other components, making it effective for more intense pain.
- Phenobarbital is a sedative that calms the central nervous system, providing relaxation and reducing tension associated with pain.

This combination should be used with caution, as codeine and phenobarbital can cause dependency, and prolonged use may lead to serious side effects such as excessive drowsiness, respiratory depression, or liver damage. It is important to take it only as prescribed by a doctor and avoid long-term use without medical supervision.

General data about FASCONAL P 200mg / 200mg / 25mg / 10mg / 25mg

  • Substance: acetylsalicylic acid + paracetamol + caffeine + codeine + phenobarbital
  • Date of latest medicines list: 01-07-2013
  • Product code: W13992001
  • Concentration: 200mg / 200mg / 25mg / 10mg / 25mg
  • Pharmaceutical form: tablets
  • Quantity: 20
  • Product type: Generic medicine
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.