País: Malta
Idioma: inglés
Fuente: Medicines Authority
DICLOFENAC SODIUM
Laboratoires THEA 12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France
S01BC03
DICLOFENAC SODIUM 1 mg/ml
EYE DROPS, SOLUTION
DICLOFENAC SODIUM 1 mg/ml
POM
OPHTHALMOLOGICALS
Withdrawn
2005-12-16
120x210 30/11/05 7936-6 Voltaren Malte VOLTAREN ® OPHTHA (diclofenac sodium) Please read this carefully before you start to use your eye drops. This leaflet provides a summary of the information available on the drops. If you have any questions or are not sure about anything ask your doctor or pharmacist. What you should know about Voltaren Ophtha The name of your eye drops is Voltaren Ophtha. The active ingredient is diclofenac sodium 0.1% w/v and they also contain benzalkonium chloride as preservative, disodium edetate, hydroxypropyl γ -cyclodextrin (HP γ -CD), hydrochloric acid, propylene glycol, trometamol, tyloxapol and water for injections. Voltaren Ophtha are eye drops available in 5ml bottles. This is one of a group of medicines called "non-ste- roidal anti- inflammatory drugs". Marketing Authorisation Holder: Laboratoires THEA 12 rue Louis Blériot 63017 Clermont-Ferrand Cedex 2 France Manufactured by: EXCELVISION Rue de la Lombardière 07100 Annonay Cedex France Voltaren Ophtha eye drops are used to treat: • Post-operative inflammation in cataract surgery and other surgical interventions. • Relief of pain and photophobia. • Post-traumatic inflammation in non-penetrating wounds. • Help keep the pupil open during eye surgery (after other drugs have been used to open the pupil initially). • Prevention of cystoid macular oedema after cataract extraction with lens implantation. Before you use the eye drops • Consult your doctor before the use of the drops if:- • You are allergic to any of the ingredients listed above. • You have had an allergic reaction, skin rash, blocked nose or wheezing after taking aspirin or any Leer el documento completo
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VOLTAREN ® OPHTHA, 0.1%, eye drops, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Voltaren ® Ophtha: one mL contains 1 mg of diclofenac sodium. For a full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Eye drops, solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Post-operative inflammation in cataract surgery and other surgical interventions. • Prevention of cystoid macular oedema after cataract extraction with lens implantation. • Post-traumatic inflammation in non-penetrating wounds. • Inhibition of miosis in cataract surgery. • Relief of pain and photophobia. 4.2 POSOLOGY 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) RELIEF OF PAIN AND PHOTOPHOBIA; POST-TRAUMATIC INFLAMMATION One drop 4 to 6 hourly. When pain is due to a surgical procedure (e.g. refractive surgery), 1 to 2 drops in the hour preceding surgery, 1 to 2 drops within the first 15 minutes after intervention and 1 drop 4 to 6 hourly for 3 days thereafter. ELDERLY: There is no indication that dosage needs to be modified for the elderly. PAEDIATRIC USE: Voltaren Ophtha is not indicated for use in children. Paediatric experience is limited to a few published clinical studies in strabismus surgery. Page 2 of 6 MULTIPLE DOSE UNIT (MDU): The dispenser remains sterile until the original closure Leer el documento completo