Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dorzolamide hydrochloride; Timolol maleate
Martindale Pharmaceuticals Ltd
S01ED51
Dorzolamide hydrochloride; Timolol maleate
20mg/1ml ; 5mg/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000; GTIN: 5026468744664
1 PACKAGE LEAFLET: INFORMATION FOR THE USER DORZOLAMIDE / TIMOLOL 20 MG/ML + 5 MG/ML EYE DROPS, SOLUTION (dorzolamide/timolol) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Dorzolamide / Timolol is and what it is used for 2. What you need to know before you use Dorzolamide / Timolol 3. How to use Dorzolamide / Timolol 4. Possible side effects 5. How to store Dorzolamide / Timolol 6. Contents of the pack and other information 1. WHAT DORZOLAMIDE / TIMOLOL IS AND WHAT IT IS USED FOR Dorzolamide / Timolol contains two medicines: dorzolamide and timolol. Dorzolamide belongs to a group of medicines called “carbonic anhydrase inhibitors”. Timolol belongs to a group of medicines called “beta blockers”. These medicines lower the pressure in the eye in different ways. Dorzolamide / Timolol is prescribed to lower raised pressure in the eye in the treatment of glaucoma when beta-blocker eye drop medicine used alone is not adequate. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE DORZOLAMIDE / TIMOLOL DO NOT USE DORZOLAMIDE / TIMOLOL if you are allergic (hypersensitive) to dorzolamide hydrochloride, timolol maleate or any of the other ingredients of Dorzolamide / Timolol (listed in section 6). if you have now or had in the past respiratory problems, such as asthma or severe chronic obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in breathing and/or long-standing cough) if you have a slow heart beat, heart failure or disorders of heart rhythm (irregular heart beat Baca dokumen lengkapnya
OBJECT 1 DORZOLAMIDE / TIMOLOL 20 MG/ML + 5 MG/ML EYE DROPS, SOLUTION Summary of Product Characteristics Updated 09-Dec-2016 | Martindale Pharma 1. Name of the medicinal product Dorzolamide / Timolol 20 mg/ml + 5 mg/ml eye drops, solution 2. Qualitative and quantitative composition Each ml contains 22.3 mg of dorzolamide hydrochloride corresponding to 20 mg dorzolamide and 6.84 mg of timolol maleate corresponding to 5 mg timolol. Excipients: benzalkonium chloride 0.075 mg/ml For a full list of excipients, see section 6.1. 3. Pharmaceutical form Eye drops, solution. Clear, colourless to nearly colourless, slightly viscous solution with a pH between 5.3-5.7 and an osmolality of 260-330 mOsm/kg. 4. Clinical particulars 4.1 Therapeutic indications Indicated in the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or pseudoexfoliative glaucoma when topical beta-blocker monotherapy is not sufficient. 4.2 Posology and method of administration The dose is one drop in the conjunctival sac of the affected eye(s) two times daily. If another topical ophthalmic agent is being used, Dorzolamide / Timolol and the other agent should be administered at least ten minutes apart. Patients should be instructed to wash their hands before use and avoid allowing the tip of the container to come into contact with the eye or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. _Paediatric population_ Efficacy in paediatric patients has not been established. Safety in paediatric patients below the age of two years has not been established (for information regarding safety in paediatr Baca dokumen lengkapnya