ROFENAC SUPPOSITORIES- Antirheumatic, anti-inflammatory, analgesic

Rofenac (Diclofenac) is a nonsteroidal compound with pronounced antirheumatic, anti-inflammatory, analgesic. and antipyretic properties. It inhibits prostaglandin biosynthesis which plays a major role in causing inflammation,  pain and fever.

Composition: (Diclofenac Sodium). Rofenac Suppositories of 12.5 mg,25 mg, 50 mg and 100 mg. 


Rofenac is indicated in the treatment of :

  1. Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis
  2. Non-articular rheumatism.
  3. Acute musculoskeletal disorders and back pain..
  4. Painful syndromes of the vertebral column. 
  5. Relief of pain in acute trauma and fractures.
  6. Control of pain and inflammation in orthopedic, dental and other surgeries. 
  7. Painful inflammatory conditions in gynaecology and primary dysmenorrhea.
  8. Renal colic and biliary colic (Diclofenac ampoules are recommended).
  9. Acute attacks of gout.
ROFENAC روفيناك تحاميل للاطفال
ROFENAC روفيناك تحاميل للاطفال

Adults dosage and Administration

Adults: The initial daily dose is usually 100 to150 mg. In milder cases, as well as in prolonged therapy 75 to100 mg daily is usually sufficient. The daily dosage is generally given in 2 to 3 divided doses. 

To prevent nocturnal pain and morning stiffness, treatment with tablets during the day can be supplemented by a suppository taken at bedtime (up to a maximum daily dose of 150 mg). 

In primary dysmenorrhea the daily dosage, which should be individually adapted, is generally 50 to 150 mg. The initial dose should be 50 to 100 mg and, if necessary this dose can be raised over a number of menstrual cycles to a maximum of 200 mg daily. Treatment should be started as soon as symptoms begin and continued for several days, depending on the symptomatology. 

Children dosage and Administration

  • Children: Children from the age of 1 year upwards should be given 0.5 to 2 mg/kg body weight daily, in 2 to 3 divided doses, depending on the severity of the condition. 
  • For the treatment of juvenile rheumatoid arthritis the daily dosage may be raised to a maximum of 3 mg/kg body weight, given in divided doses. 
  • Rofenac should not be given to children under 12 months of age. 
  • Owing to their high active substance content, Rofenac suppositories of 50 mg and 100 mg are not recommended for use in children.
  • For children, Rofenac Suppositories of 12.5 mg are recommended for use.
النشرة الداخلية لتحاميل روفيناك by pharmacia1
النشرة الداخلية لتحاميل روفيناك by pharmacia1


  • Hypersensitivity to Diclofenac.
  • Rofenac like other nonsteroidal anti-inflammatory drugs, should not be given to patients with peptic ulcer and to patients in whom aspirin induces asthma, acute rhinitis and urticaria. 


  • Rofenac (Diclofenac) should be used with caution in patients suffering from severe impairment of hepatic function. 
  • Owing to the importance of prostaglandins for maintaining renal blood flow, particular caution is called for when using Rofenac in cases of impaired cardiac or renal function, in patients being treated with diuretics and in those recovering from major surgical operations. 
  • Like other nonsteroidal anti-inflammatory drugs Rofenac (Diclofenac) may trigger allergic reactions including anaphylaxis events with patients receiving the product for the first time.
  • Rofenac (Diclofenac) should be used during pregnancy only if the benefits to the mother justify the potential risks to the fetus. Like other prostaglandin inhibiting drugs, use of Rofenac during late pregnancy should be avoided. 

Special Warnings- Cardiovascular Risk

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Special Warnings-Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms.Elderly patients are at greater risk for serious gastrointestinal events.

Side Effects

Rofenac (Diclofenac) is generally well tolerated. The most common side effects include:

  • gastrointestinal disturbances.
  • headache, and dizziness.
  • Fluid retention.
  • liver function disorders.
  • rash and pruritus.


  • Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels, making it necessary to monitor these levels.
  • Patients taking Diclofenac and are also receiving Digoxin, Methotrexate, Cyclosporine or Lithium, should be observed for potential development of the specific toxicities of these drugs.
  • Concomitant administration of other systemic nonsteroidal anti-inflammatory agents or glucocorticoids may increase the occurrence of side effects.
For Arabic Information
تحاميل روفيناك – معلومات لغة عربية

Patient Information Leaflet

ENG - Patient Information Leaflet
Rofenac Suppositories – Patient Information Leaflet
روفيناك تحاميل- نشرة معلومات المريض

Categories and Tags: #M01AB05, #Diclofenac Sodium, #NSAID, #acetic acid derivatives, #Suppositories, #Spimaco, #KSA, #R_letter, #حرف_ر.