国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Latanoprost
Zentiva Pharma UK Ltd
S01EE01
Latanoprost
50microgram/1ml
Eye drops
Ocular
No Controlled Drug Status
Valid as a prescribable product
BNF: 11060000; GTIN: 5000283655053
PACKAGE LEAFLET: INFORMATION FOR THE USER LATANOPROST 0.005% W/V EYE DROPS SOLUTION READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU (OR A CHILD IN YOUR CARE) START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. 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 only. 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 leafl et. See section 4. IN THE NEXT SECTIONS, THE WORD ‘YOU’ MEANS YOU OR A CHILD IN YOUR CARE. WHAT IS IN THIS LEAFL ET 1. What Latanoprost eye drops are and what they are used for 2. What do you need to know before you use Latanoprost eye drops 3. How to use Latanoprost eye drops 4. Possible side effects 5. How to store Latanoprost eye drops 6. Contents of the pack and other information 1 WHAT LATANOPROST EYE DROPS ARE AND WHAT THEY ARE USED FOR Latanoprost belongs to a group of medicines called prostaglandin analogues. Latanoprost eye drops lower the pressure within your eye by increasing the natural fl ow of fl uid from inside the eye into the blood stream. Latanoprost eye drops are used to treat open angle glaucoma and ocular hypertension. These conditions are caused by an increase in the pressure in your eye. If they are not treated they may affect your eyesight. Latanoprost eye drops can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost eye drops has not been investigated in prematurely born infants (less than 36 weeks gestation). 2 WHAT DO YOU NEED TO KNOW BEFORE YOU USE LATANOPROST EYE DROPS DO NOT USE LATANOPROST EYE DROPS - if you are ALLERGIC to the active substance latanoprost or any of the other ingredients of this medicine (listed in section 6). WARNING AND PRECAUTIONS Talk to your doctor or pharmacist be 阅读完整的文件
OBJECT 1 LATANOPROST 0.005% W/V EYE DROPS SOLUTION Summary of Product Characteristics Updated 23-May-2018 | Zentiva 1. Name of the medicinal product Latanoprost 0.005% w/v eye drops solution. 2. Qualitative and quantitative composition 1 ml eye drops solution contains 50 micrograms latanoprost. One drop contains approximately 1.5 micrograms latanoprost. Excipient with known effect: benzalkonium chloride 0.2 mg/ml. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Eye drops, solution. The solution is a clear colourless liquid. 4. Clinical particulars 4.1 Therapeutic indications Reduction of elevated intraocular pressure • in patients with open angle glaucoma and ocular hypertension. • in paediatric patients with elevated intraocular pressure and paediatric glaucoma. 4.2 Posology and method of administration Posology _Recommended dosage for adults (including the elderly):_ Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Latanoprost eye drops is administered in the evening. The dosage of Latanoprost eye drops should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect. If one dose is missed, treatment should continue with the next dose as normal. As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac is compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop. Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart. _Paediatric population_ Latanoprost eye drops may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group < 阅读完整的文件