Leaflet AFLAMIL 15mg / g cream

Indicated for: pain and inflammation

Route of administration: cutaneous

Substance: aceclofenac (nonsteroidal anti-inflammatory drug)

ATC: M02AA25 (Musculo-skeletal system | Topical products for joint and muscular pain | Antiinflammatory preparations, non-steroids for topical use)

Precautions:
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.

Aceclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation associated with musculoskeletal and rheumatic conditions. It is indicated for conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Aceclofenac is a derivative of diclofenac, with improved gastrointestinal tolerability.

It works by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), thereby reducing the synthesis of prostaglandins, substances involved in inflammation, pain, and fever. This mechanism helps relieve pain and reduce inflammation.

The medication is taken orally, usually in the form of tablets, with a recommended dose of 100 mg twice daily, as directed by a doctor. It is important to take it after meals to minimize the risk of gastrointestinal irritation.

Common side effects include gastrointestinal disturbances such as nausea, abdominal pain, diarrhea, or constipation. Rarely, more severe reactions such as gastric ulcers, gastrointestinal bleeding, allergic reactions, or kidney and liver impairment may occur.

Aceclofenac should be used with caution in patients with a history of gastric ulcers, renal insufficiency, hypertension, or cardiovascular diseases. It is also important to avoid concurrent use with other NSAIDs or anticoagulants, as this may increase the risk of bleeding.

General data about AFLAMIL 15mg / g

  • Substance: aceclofenac
  • Date of latest medicines list: 01-07-2015
  • Product code: W61426001
  • Concentration: 15mg / g
  • Pharmaceutical form: cream
  • Quantity: 1
  • Product type: Original
  • Prescription status: OTC - Over the Counter = medicine that does not require a medical prescription.

Marketing authorisation

  • Manufacturer: GEDEON RICHTER PLC. - UNGARIA
  • Holder: GEDEON RICHTER ROMANIA S.A. - ROMANIA
  • Number: 12491/2019/01
  • Shelf life: 3 years-after packing for marketing;after openinga tubului-30 days

Pharmaceutical forms available for aceclofenac

Concentrations available for aceclofenac

  • 100mg
  • 15mg/g