País: África do Sul
Língua: inglês
Origem: South African Health Products Regulatory Authority (SAHPRA)
iPharma (Pty) Ltd
Not Indicated
Ophthalmic solution
Each 1,0 ml contains LATANOPROST 50,0 ╡g and TIMOLOL MALEATE EQUIVALENT TO TIMOLOL 5,0 mg
Registered
2022-04-08
COMAREST PATIENT INFORMATION LEAFLET LATANOPROST 50 ΜG 49/15.4/0154 (REGISTERED) VERSION: 0000 OF 12 JULY 2022 PAGE | 1 SUBMITTED 20/05/2022 ECTD0001 REGISTRATION DATE & ORIGINAL APPROVAL: 12 JULY 2022 SCHEDULING STATUS: S4 COMAREST LATANOPROST 50 MICROGRAM/ML READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU USE COMAREST • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor, pharmacist, nurse or other healthcare provider. • Comarest has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What Comarest is and what it is used for 2. What you need to know before you use Comarest 3. How to use Comarest 4. Possible side effects 5. How to store Comarest 6. Contents of the pack and other information 1. WHAT COMAREST IS AND WHAT IT IS USED FOR Comarest belongs to a group of medicines known as prostaglandin analogues. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream. It lowers the pressure inside your eye. Comarest is used to treat conditions known as glaucoma and ocular hypertension in adults. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eye sight. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE COMAREST DO NOT USE COMAREST: • you are hypersensitive (allergic) to latanoprost, benzalkonium chloride or to any of the other ingredients of Comarest (listed in section 6). • If you are pregnant or breastfeeding your baby. COMAREST PATIENT INFORMATION LEAFLET LATANOPROST 50 ΜG 49/15.4/0154 (REGISTERED) VERSION: 0000 OF 12 JULY 2022 PAGE | 1 SUBMITTED 20/05/2022 ECTD0001 REGISTRATION DATE & ORIGINAL APPROVAL: 12 JULY 2022 WARNINGS AND PRECAUTIONS Take special care with Comarest: • If you are about to have or have had eye surgery (including cataract surgery) • If you have suffered or are currently suffering from a viral infection of t Leia o documento completo
COMAREST PROFESSIONAL INFORMATION LATANOPROST 50 ΜG 49/15.4/0154 (REGISTERED) VERSION: 0000 OF 12 JULY 2022 PAGE | 1 SUBMITTED 20/05/2022 ECTD0001 REGISTRATION DATE & ORIGINAL APPROVAL: 12 JULY 2022 SCHEDULING STATUS S4 1 NAME OF THE MEDICINE Comarest, 50 microgram/ ml, Ophthalmic Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each millilitre contains latanoprost 50 microgram. One drop contains approximately 1,5 microgram latanoprost. _Excipients with known effect: _ Each millilitre contains benzalkonium chloride 0,02 % m/v as preservative. Sodium dihydrogen phosphate monohydrate (E339i) 7,70 mg/ml. Disodium phosphate anhydrous (E339ii) 1,55 mg/ml. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ophthalmic Solution Sterile, colourless or pale yellow, clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in patients with open angle glaucoma, chronic angle closure glaucoma and ocular hypertension. In children less than 3 years of age, Comarest can be initiated prior to other corrective procedures and may be continued if therapeutic response is adequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Use in adults (including the elderly) _ One drop in the affected eye(s) once daily. Optimal effect is obtained if Comarest is administered in the evening. The dosage of Comarest should not exceed once daily since it has been shown that more frequent administration decreases the intra-ocular pressure lowering effect. If one dose is missed, treatment should continue with the next dose as normal. COMAREST PROFESSIONAL INFORMATION LATANOPROST 50 ΜG 49/15.4/0154 (REGISTERED) VERSION: 0000 OF 12 JULY 2022 PAGE | 2 SUBMITTED 20/05/2022 ECTD0001 REGISTRATION DATE & ORIGINAL APPROVAL: 12 JULY 2022 Reduction of the intraocular pressure starts about three to four hours after administration and maximum effect is reached after 8 to 12 hours. Pressure reduction is maintained for at least 24 hours. Comarest may be used concomitantly with other clas Leia o documento completo