País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
LATANOPROST
Generics (UK) Limited
S01EE01
LATANOPROST
50 Microgram/ML
Eye Drops Solution
Product subject to prescription which may not be renewed (A)
latanoprost
Not Marketed
2014-07-04
18 PACKAGE LEAFLET 19 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LATANOPROST 50 MICROGRAMS/ML EYE DROPS, SOLUTION LATANOPROST 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 the doctor treating your child or your pharmacist. - This medicine has been prescribed for you or for your child 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 the doctor treating your child, or your pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Latanoprost is and what it is used for 2. What you need to know before you use Latanoprost 3. How to use Latanoprost 4. Possible side effects 5. How to store Latanoprost 6. Contents of the pack and other information 1. WHAT LATANOPROST IS AND WHAT IT IS USED FOR Latanoprost contains the active ingredient latanoprost which 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. Latanoprost is used to treat conditions known as open angle glaucoma and ocular hypertension. Both of these conditions are linked with an increase in the pressure within your eye, eventually affecting your eyesight. Latanoprost is also used to treat increased eye pressure and glaucoma in all ages of children and babies. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE LATANOPROST Latanoprost can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost has not been investigated in prematurely born infants (less than 36 weeks gestation). DO NOT USE LATANOPROST: - if you are allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your d Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Latanoprost 50 micrograms/ml Eye Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 50 micrograms of latanoprost. One drop of the solution contains approximately 1.5 micrograms of latanoprost. Excipients with known effect Each ml of solution contains 0.2 mg benzalkonium chloride and 6.34 mg phosphate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Eye drops, solution A clear, colourless, aqueous solution, pH between 6.5 – 6.9 and osmolality between 240 – 294 mOsmol/kg. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (including the elderly):_ Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Latanoprost is administered in the evening. The dosage of Latanoprost 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. _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 < 1 year (4 patients) are very limited (see section 5.1). Method of administration H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Leia o documento completo