Expiration date: 05/2026

The composition and form of issue: 

Eye drops 0.1%, 1 ml contains:

diclofenac sodium 1 mg

benzalkonium chloride 0 1 mg

excipients: disodium edetate boric acid tromethamine polyoxyl 35 castor oil water for injection — q.s. 

in dark glass bottles with dropper or in vials-droppers-plastic 5 ml in a cardboard pack 1 bottle.

Description pharmaceutical form:

Transparent solution from colorless to light yellow color.

Pharmacokinetics:

When instillation of eye drops diclofenac absorbed in the blood system. However, the concentration of drug achieved in the blood, significantly below the detection limit and has no clinical significance.

Description pharmacological action:

Has anti-inflammatory, analgesic and antipyretic activity. The mechanism of action is due to the indiscriminate inhibition of the activity of cyclooxygenase 1 and 2, which leads to the suppression of PG synthesis in inflammation.

Diclofenac reduces inflammation of the eyes, which can result from infection, injury, or surgery reduces miosis during surgery, reduces the synthesis of PG and their contents in the anterior chamber.

Indications:

• the inhibition of miosis during surgery for cataract
  
• treatment and prevention of inflammatory processes after surgical interventions on the eyeball
  
• prophylaxis of cystic edema of macula after surgery for cataract
  
• treatment of non-infectious conjunctivitis
  
• treatment and prevention of post-traumatic inflammatory process in penetrating and nonpenetrating wounds of the eyeball (as addition to the local anti-infective therapy).
  

Contraindications:

• hypersensitivity to the active substance or to any accessory ingredient that is included in the composition of the dosage form of the drug
  
• hypersensitivity to acetylsalicylic acid or other NSAIDs ("aspirin triad", a combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses and intolerance of acetylsalicylic acid).
  

With caution:

• epithelial herpetic keratitis (including in anamnesis)
  
• of disease, causing blood coagulation disorders (including hemophilia), prolonged bleeding time, bleeding tendency
  
• old age.
  

Application of pregnancy and breast-feeding:

There is no reliable data on drug use during pregnancy and breastfeeding, so the drug should be used in these categories of patients only if the expected benefit outweighs the potential risk.

Side effects:

In rare cases, burning of eyes, blurring of visual perception (immediately after instillation) corneal opacity (cataract), iritis.

Allergic reactions: itchy eyes, redness, angioedema of the face, fever, chills, photosensitivity, skin rash (predominantly erythematous, urticaria), multiform exudative erythema, nausea, vomiting.

Drug interactions:

The drug may increase the effect of indirect anticoagulants. Not recommended simultaneous application with diflunizalom (because the evolution of bleeding from the gastrointestinal tract) and other NSAIDs, including acetylsalicylic acid in large doses (3 g or more per day).

If necessary, you can use simultaneously with other eye drops, including that containing corticosteroids. The interval between applications should be at least 5 minutes to prevent washout of active substances and subsequent doses.

Method of application and dose:

Local.

For the inhibition of intraoperative miosis instilled into the conjunctival SAC during 2 hours with an interval of 30 min (4 times) before the operation.

For prophylaxis of cystic edema of the macula instill 1 drop 3-4 times a day for 2 weeks after surgery.

Other indications: 1 drop 3-4 times per day depending on the severity of the condition. The course of treatment may last from 1 to 2 weeks.

Overdose:

There is no data on overdose of the drug.

Precautions:

There is no reliable data on the use of the drug in children, so the drug should be used in these patients only if the expected benefit outweighs the potential risk.

Special instructions:

Patients who use contact lenses, you should apply Diklo-f only removing the lenses and wear them again after 15 minutes after instillation of the drug.

The bottle must be closed after each use. Do not touch the tip of the pipette to the eye.

During treatment should refrain from activities potentially hazardous activities, require high concentration and psychomotor speed reactions.

Expiration date:

After opening bottle - 1 month.