Leaflet ACECLOFEN 500mg / 50mg suppositories

Indicated for: pain; fever

Route of administration: rectal

Substance: paracetamol + diclofenac (analgesic and antipyretic + nonsteroidal anti-inflammatory drug)

ATC: M01AB55 (Musculo-skeletal system | Antiinflammatory and antirheumatic products, non-steroids | Acetic acid derivatives and related substances)

Precautions:
Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Nephrotoxicity
Nephrotoxicity

This medicine may affect the kidneys.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

Ulcer / gastrointestinal bleeding
Ulcer / gastrointestinal bleeding

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

Paracetamol and diclofenac are active ingredients used in combination to treat moderate to severe pain and inflammation associated with various conditions, such as joint pain, muscle pain, back pain, or postoperative pain. This combination provides strong analgesic and anti-inflammatory effects.

Paracetamol is an analgesic and antipyretic that reduces pain and fever, being well-tolerated by most patients. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain by inhibiting the synthesis of prostaglandins, substances involved in the inflammatory process. Together, these substances offer more effective relief from pain and inflammation.

Although this combination is effective, its use should be approached with caution. Diclofenac may cause gastrointestinal side effects, such as stomach irritation, heartburn, or ulcers, especially with long-term use. Paracetamol, if overused, can harm the liver. It is important for patients to follow the recommended dosage and avoid alcohol consumption during treatment.

This combination is available only by prescription, and its use should be supervised by a doctor, especially in patients with gastrointestinal, liver, or kidney conditions. If pain or inflammation persists or worsens, further medical evaluation is necessary.

ACECLOFEN 500mg/50mg suppositories ANTIBIOTICE, paracetamol+diclofenac

General data about ACECLOFEN 500mg / 50mg

  • Substance: paracetamol + diclofenac
  • Date of latest medicines list: 01-06-2026
  • Product code: W14016001
  • Concentration: 500mg / 50mg
  • Pharmaceutical form: suppositories
  • Quantity: 6
  • Product type: Generic medicine
  • Price: 18.90 RON
  • 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.

Marketing authorisation

  • Manufacturer: ANTIBIOTICE S.A. - ROMANIA
  • Holder: ANTIBIOTICE S.A. - ROMANIA
  • Number: 7222/2014/01
  • Shelf life: 3 years

Pharmaceutical forms available for paracetamol + diclofenac

Compensation lists for ACECLOFEN 500mg / 50mg Antibiotice

C3 - Sublist C - section C3 (children, pregnant women and postpartum women) with 100% discount from the reference price

Price

Copayment

Patient

18.90 RON

18.90 RON

0.00 RON