Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BRIMONIDINE TARTRATE
ARMS PHARMA SDN. BHD.
BRIMONIDINE TARTRATE
5 ml
INDOCO REMEDIES LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ BRIMOGAN OPHTHALMIC SOLUTION Brimonidine tartrate (1.5 mg/ml) WHAT IS IN THIS LEAFLET 1. What BRIMOGAN is used for 2. How BRIMOGAN works 3. Before you use BRIMOGAN 4. How to use BRIMOGAN 5. While you are using it 6. Side effects 7. Storage and Disposal of BRIMOGAN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT BRIMOGAN IS USED FOR BRIMOGAN is used to lower pressure in the eye of people with glaucoma or high pressure in the eye. HOW BRIMOGAN WORKS BRIMOGAN is an eye drop solution that reduces the amount of fluid flowing into the eye and increases the amount of fluid flowing out of the eye. This reduces the pressure inside the eye. BEFORE YOU USE BRIMOGAN - _When you must not use it_ Do not use BRIMOGAN: - If you are allergic (hypersensitive to Brimonidine tartrate, or any of the other ingredients of BRIMOGAN. (For a full list of ingredients, see section “PRODUCT DESCRIPTION”). - If you are taking monoamine oxidase antidepressant medication (MAO) - For neonates and infants (children under the age of 2 years) If you are not sure whether you should start using BRIMOGAN, talk to your doctor. - _Pregnancy and lactation_ Discuss with your doctor the possible risks and benefits of using BRIMOGAN during pregnancy. Discuss with your doctor the possible risks and benefits of using BRIMOGAN when breast-feeding. - _Children_ The safe and effective use of BRIMOGAN in children under the age of 2 has not been established. - _Before you start use it_ Tell your doctor if: 1. You have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes. 2. You have or have had any medical conditions, especially the following: - Liver or kidney disease - Severe, uncontrolled heart disease, poor blood flow to the heart or recurring inflammation and clotting of small and medium blood vessels of the hands and feet. - Poor blood flow to the brain - Depression - Raynaud’s phenomenon. This is a condition Прочетете целия документ
to the foetus. LACTATION It is not known whether brimonidine is excreted in human milk, although in animal studies, Brimogan tartrate has been shown to be excreted in breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. PAEDIATRIC USE The safety and effectiveness have not been studied in paediatric patients below the age of 2 years. BRIMOGAN is not recommended for use in paediatric patients under the age of 2 years. GERIATRIC USE No overall differences in safety or effectiveness have been observed between elderly and other adult patients. UNDESIRABLE EFFECTS Side effects occurring are oral dryness, ocular hyperemia, burning and stinging, headache, blurring foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions and ocular pruritus. The following adverse reactions can be reported rarely: lid crusting, conjunctival hemorrhage, abnormal taste. insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope. Events occurring also included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms asthenia, conjunctival blanching, abnormal vision and muscular pain. The following events have been identified during post-marketing use of BRIMOGAN in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to BRIMOGAN or a combination of these factors, include: bradycardia; hypotension; iritis; miosis; skin reactions (including erythema, eyelid pruritus, rash, and vasodilation); and tachycardia. Apnea, bradycardia, hypotension, hypothermia, hypotonia, a Прочетете целия документ