Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
DICLOFENAC SODIUM
BIOAVENIR LTD, ISRAEL
M02AA15
SOLUTION
DICLOFENAC SODIUM 0.1 %V/V
OCULAR
Required
FARMIGEA S.P.A., ITALY
DICLOFENAC
DICLOFENAC
Post-operative inflammation following cataract extraction. Control of ocular pain and discomfort associated with corneal epithelial defects after laser excimer PRK or accidental trauma.
2023-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only DICLOFTIL 0.1% EYE DROPS SINGLE DOSE CONTAINER PRESERVATIVE-FREE The active ingredient and its concentration: Each 1 ml contains 1 mg diclofenac sodium. Inactive ingredients and allergens: see section 2 "Important information about some of this medicine's ingredients" and section 6 "Additional information". READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. The use of Dicloftil 0.1% is prohibited in children below 14 years of age since there are no sufficient efficacy and safety data available in this age group. 1. WHAT IS THIS MEDICINE INTENDED FOR? • For the treatment of eye inflammation following cataract extraction surgery. • Relief of ocular pain and discomfort associated with corneal epithelial defects following laser surgery or accidental trauma in the eye. THERAPEUTIC GROUP: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 2. BEFORE USING THIS MEDICINE: DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (diclofenac sodium), to any of the other ingredients of this medicine (listed in section 6) or to other non-steroidal anti-inflammatory drugs (aspirin (acetylsalicylic acid), indomethacin etc.). • You have had an asthma attack, urticaria or acute rhinitis after taking aspirin (acetylsalicylic acid) or other prostaglandin-synthetase inhibitor drugs in the past. • You are under the age of 14. SPECIAL WARNINGS ABOUT USING THIS MEDICINE • Do not wear soft contact lenses during treatment with this medicine. Contact lenses should be removed before use of this medicine and should not be worn Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dicloftil 0.1% eye drops, solution – 30 single-dose containers 0.5 ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml contain 100 mg of diclofenac sodium (equal to 93.084 mg of diclofenac). One ml of Dicloftil 0.1% eye drops contains 1 mg of diclofenac sodium. Excipient(s) with known effect(s): boric acid. For a complete list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution in single-dose containers. 4. CLINICAL INFORMATION 4.1 THERAPEUTIC INDICATIONS • Post-operative inflammation following cataract extraction. • Control of ocular pain and discomfort associated with corneal epithelial defects after laser excimer PRK surgery or accidental trauma. 4.2 POSOLOGY, DOSAGE AND METHOD OF ADMINISTRATION ADULTS A) OCULAR SURGERY AND ITS COMPLICATIONS Preoperatively, up to 1 drop 5 times during the 3 hours before surgery. Postoperatively, 1 drop 3 times on the day of surgery, followed by 1 drop 3 to 5 times daily for as long as required. B) TREATMENT OF PAIN AND DISCOMFORT One drop 4 to 6 hourly. When pain is due to a surgical procedure (e.g. refractive surgery(. Instill 1 drop, 30-60 minutes prior to surgery, into the eye to be operated on. During the first 10 minutes following surgery, instill 1-2 doses of 1 drop each, followed by 1 drop 4 times daily for 2 days. ELDERLY: There is no indication that dosage needs to be modified for the elderly. PAEDIATRIC USE: Dicloftil 0.1% eye drops is not indicated for use in children. Paediatric experience is limited to a few published clinical studies in strabismus surgery. The dispenser remains sterile until the original closure is broken. Patients must be instructed to avoid allowing the tip of the dispensing container to to contact the eye or surrounding structures as this may contaminate the solution. If more than one medication needs to be instilled in the eye, an interval of at least 5 minutes between application of the different medicinal products must be allowed. Following in Aqra d-dokument sħiħ