MINISTRY OF PUBLIC HEALTH OF THE REPUBLIC OF BELARUS

Stamp: AGREED

Ministry of Public Health

The Republic of Belarus

Order of the Ministry of Public Health

The Republic of Belarus 

of August 24, 2012 No. 954

INSTRUCTION

(information for patients)

on medical administration of medicinal preparation

DICLOFENAC

Trade name: Diclofenac.

International nonproprietary name: Diclofenac.

Description: Transparent colorless or light yellowish solution.

Composition: active substance – sodium diclofenac – 1.0 mg/ml;

aditives: sodium thiosulfate, disodium edentate, propylene glycol, boric acid, potassium chloride, sodium hydroxide, water for injections.

Drug formulation: solution (eye drops) 1 mg/ml.

Pharmacotherapeutic group: Drugs for ophthalmological administration. non-steroid anti-inflammatory drugs. Diclofenac.

ATC code: S01BC03.

 

Pharmacological action

Diclofenac has anti-inflammatory and analgesic effects. It reduces pain associated with inflammatory processes developed after operations, reduces the inflammatory edema developed on the wound site.

Indications

Miosis inhibition while operating for cataract; prevention of inflammatory processes associated with the cataract excision or a surgical interference on the eye anterior segment; pain and photophobia reduction during the first 24 hours after the operation.

Mode of administration and dosage

It is applied locally. For the intraoperation miosis inhibition 1 drop of the preparation is instilled into the conjunctival sac for 2 hours preceding the operation with 30 minutes intervals (4 times); 1 drop is instilled 3 times immediately after the operation followed by 1 drop 3 – 5 times a day until it is necessary. The therapy duration is specified by the attending physician.

For reducing pain and photophobia after keratectomy during the first 24 hours after the operation: 1 drop is instilled 1 – 2 times during the hour preceding the operation, 1 drop is instilled twice during the hour after the operation, followed by 1 drop 4 times during 24 hours after the operation.

Side effects

The tissues can be irritated locally (burning, reddening, blurred vision (immediately after the instillation), edema, colics, lachrymation), cornea opacification (leucoma), iritis; allergic reactions: eye itching, hyperemia, angioneurotic facial edema, fever, shivering, photosensitivity, skin eruption (mainly the erythematous rash, urticaria), multiform exudative erythema; nausea, vomiting can be observed while the preparation is being administered. Occasionally the cornea can get thinned or a cornea ulcer can develop especially in patients having factors of risk (prolonged administration of eye drops, concurrent administration of corticosteroids, rheumatoid arthritis). Patients having complications after the operation, corneal defects, diabetes mellitus, the lachrymal film composition changes (such as syndrome of dry eye), rheumatoid arthritis, those having survived ophthalmic re-operations are susceptible to a higher risk of side effects development in the cornea.

Contraindications

Hypersensitivity to diclofenac and other non-steroid anti-inflammatory drugs as well as to any additive, allergic reactions or bronchial asthma in the anamnesis caused by the diclofenac, acetyl salicylic acid or another non-steroid anti-inflammatory drug administration, pregnancy, period of lactation, infancy and childhood (up to 18 years).

With caution: epithelial herpetic keratitis (including that in the anamnesis); diseases associated with the blood coagulation changes (including hemophilia, prolonged bleedings, disposition to bleedings); elderly age.

Overdosing

No reports about overdosing have been found.

Specificity of administration

Wash your hands thoroughly before instilling the eye drops, avoid the bottle or the dropping tube contact with the eye or lid, close the bottle or the dropping tube tightly after using it. Application of diclofenac sodium the eye drops can mask the eye bacterial infection signs therefore one should consider the potential possibility of a sudden bacterial infection development on the background of the preparation instilling. When the drops have been instilled for a long time the eye should be inspected regularly and the intraocular pressure should be measured.

Contact lenses are not recommended to be worn. When it is not possible to give up contact lenses they should be removed at least 5 minutes before the drops instillation and re-put not earlier than in 15 minutes after the instillation. When a hypersensitivity reaction (itching, reddening, bronchial asthma attack or sudden edema of face and neck) has developed the treatment should be stopped and an urgent medical aid rendered. Patients suffering from bronchial asthma, chronic rhinitis, chronic sinusitis accompanied by nasal polyps or lacking them are at a higher risk of allergic reactions development when they take aspirin and/or non-steroid anti-inflammatory drugs.

Non-steroid anti-inflammatory drugs including diclofenac hinder the cornea re-epithelization even after a short time administration. Aftereffects of the cornea healing delay and the risk of infecting are not known.

The NSAIDs administration increases the risk of bleeding from the eye tissue during the operation. The preparation is recommended to be prescribed with caution to patients at a higher risk of bleeding or taking medicinal preparations that can prolong the bleeding.

When large doses of an NSAID have been administered for a long time keratitis can develop. The preparation prolonged administration can lead to the epithelial barrier damage, cornea thinning, cornea infiltrating, cornea erosion and ulcer formation, cornea perforation in patients particularly susceptible to the drug.

Administration during pregnancy and period of lactation is contraindicated.

Measures of precaution

Impact on driving capacity and managing potentially dangerous mechanisms. When the drops have been instilled the vision acuity can be disturbed for a short time, the person should refuse driving and managing mechanisms till the normal vision restores to the normal.

Interaction with other medicinal agents

The diclofenac sodium eye drops may be instilled in combination with antiviral and antibacterial eye drops and ointments, ophthalmic corticosteroids. The interval between the instillation should be not less than 15 minutes for preventing the active substances washing out by the next dose administration.

Storage conditions

Keep protected from light exposure at temperature not exceeding 25°C.

Keep away from children.

Shelf life

2 years.

Do not use after the shelf life specified on the pack has expired.

Keep the opened bottle protected from light exposure at temperature 15°C to 25°C for 4 weeks.

Packing

5 ml bottles. Each bottle accompanied by a dropping cover and an instruction on the drops administration are put into a cardboard box.

1 ml dropping tubes. 2 dropping tubes accompanied by an instruction on the drops administration are put into a cardboard box.

Terms of sale

On physician’s prescription.

Manufacturer:

Belmedpreparaty RUE

30 Fabritsius Str., 220007 Minsk, Republic of Belarus

Tel./Fax: (+375 17) 220 37 16

e-mail: medic@belmedpreparaty.com

http://www.belmedpreparaty.com

I hereby certify the authenticity of the translation with the original document. Translator G.F.Grigorieva.