Diclo-F^® (Drops) Instructions for Use

Marketing Authorization Holder

Sentiss Pharma, Pvt. Ltd. (India)

ATC Code

S01BC03 (Diclofenac)

Active Substance

Diclofenac (Rec.INN registered by WHO)

Dosage Form

Diclo-F®

Eye drops 0.1%: 5 ml dropper bottle

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent solution from colorless to light yellow.

Excipients : benzalkonium chloride – 0.1 mg, disodium edetate – 1 mg, boric acid – 15 mg, trometamol – 6 mg, polyoxyl 35 castor oil – 20 mg, povidone – 15 mg, sodium hydroxide or hydrochloric acid – to adjust pH to 7.7, purified water – up to 1 ml.

5 ml – plastic dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for topical use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; anti-inflammatory agents; nonsteroidal anti-inflammatory agents

Pharmacological Action

NSAID for topical use in ophthalmology. It has anti-inflammatory, analgesic, and antipyretic effects.

The mechanism of action is due to non-selective inhibition of COX-1 and COX-2 activity, which leads to suppression of prostaglandin synthesis at the site of inflammation.

When used as eye drops, Diclofenac sodium reduces eye inflammation resulting from infection, trauma, or surgery; reduces miosis during surgery, and reduces the synthesis of prostaglandins in the aqueous humor of the anterior chamber of the eye.

When instilled as eye drops, Diclofenac sodium is absorbed into the systemic circulation. However, the level of the active substance in the blood is significantly below the detection limit and has no clinical significance.

Indications

• Inhibition of miosis during cataract surgery;
• Treatment and prevention of inflammatory processes after surgical interventions on the eyeball;
• Prevention of cystoid macular edema after cataract surgery;
• Treatment of non-infectious conjunctivitis;
• Treatment and prevention of post-traumatic inflammatory process in penetrating and non-penetrating wounds of the eyeball (as an adjunct to local antibacterial therapy).

ICD codes

Dosage Regimen

The drug is intended for topical use.

For inhibition of intraoperative miosis, the drug is instilled into the conjunctival sac for 2 hours at 30-minute intervals (4 times in total) before surgery.

For prevention of cystoid macular edema, instill 1 drop 3-4 times/day for 2 weeks after surgery.

For other indications – 1 drop 3-4 times/day depending on the severity of the condition. The course of treatment can last from 1 to 2 weeks.

Adverse Reactions

From the organ of vision rarely – burning, blurred vision (immediately after instillation), corneal opacity, iritis.

Allergic reactions itching in the eyes, hyperemia, angioedema of the face, fever, chills, photosensitivity, skin rash (predominantly erythematous), urticaria, multiform exudative erythema.

Other nausea, vomiting.

Contraindications

• Hematopoietic disorders of unknown origin;
• Erosive and ulcerative processes in the gastrointestinal tract in the acute stage;
• Hypersensitivity to acetylsalicylic acid or other NSAIDs;
• Hypersensitivity to diclofenac or auxiliary components of the drug.

Use with caution in epithelial herpetic keratitis (including history), in diseases causing blood clotting disorders (including hemophilia, prolonged bleeding time, tendency to bleed), as well as in elderly patients.

Use in Pregnancy and Lactation

Currently, there are no data on the use of the drug Diclo-F^® during pregnancy and lactation.

When using NSAIDs in the third trimester of pregnancy, an increased risk of fetal circulation disorders is possible.

The use of the drug in pregnant women and during breastfeeding is possible only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus or breastfed infant.

Special Precautions

Patients using contact lenses should use the drug Diclo-F^® only with lenses removed. Lenses can be inserted 15 minutes after instillation of the drug. After removing contact lenses, instillation is performed after 5 minutes.

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

Use in pediatrics

There are no data on the use of Diclo-F^® in children. Prescription is possible only in cases where the expected benefit of therapy outweighs the risk of using the drug.

Effect on ability to drive vehicles and machinery

During treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

There are no data on overdose of the drug Diclo-F^®.

Drug Interactions

With simultaneous use of the drug with diflunisal and other NSAIDs (including acetylsalicylic acid in high doses of 3 g/day or more), sulfonylurea drugs, methotrexate, the development of gastrointestinal bleeding is possible.

Concomitant use with lithium preparations, digotoxin, indirect anticoagulants leads to an enhancement of their effect.

If necessary, simultaneous administration of other medicinal products in the form of eye drops (including corticosteroids) is possible, but the interval between instillations should be at least 5 minutes to prevent washing out of the active substances.

Storage Conditions

The drug should be stored in a light-protected place, out of the reach of children, at a temperature not exceeding 30°C (86°F); do not freeze.

Shelf Life

Shelf life – 2 years.

After opening the bottle, the drug should be used within 1 month.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.