Land: Israël
Taal: Engels
Bron: Ministry of Health
LATANOPROST; TIMOLOL AS MALEATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
S01EX
EYE DROPS, SOLUTION
LATANOPROST 50 MCG/ML; TIMOLOL AS MALEATE 5 MG/ML
OCULAR
Required
PFIZER INC, USA
OTHER ANTIGLAUCOMA PREPARATIONS
Reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers.
2022-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only XALACOM ® EYE DROPS LATANOPROST 50 MCG/ML TIMOLOL (AS MALEATE) 5 MG/ML Inactive and allergenic ingredients in the preparation: see section 2 “Important information regarding some of the ingredients of the medicine” and section 6 “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? For reducing intraocular pressure in patients with open-angle glaucoma and intraocular hypertension that are not fully responsive to beta-blockers (intended for external use). THERAPEUTIC GROUP: LATANOPROST – a prostaglandin analog. It works by increasing the outflow of fluid from the eye into the bloodstream. TIMOLOL – a beta-blocker. It works by slowing the formation of fluid in the eye. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: x You are sensitive (allergic) to the active ingredients or to any of the other ingredients contained in the medicine (as listed in section 6). x You are sensitive (allergic) to preparations from the beta-blocker group. x You are suffering, or have suffered in the past, from respiratory system disturbances, such as: asthma, severe chronic obstructive bronchitis (a severe lung disease that may be manifested by wheezing, difficulty breathing and/or a prolonged cough). x You are suffering from severe heart problems or from heart rhythm disturbances. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH XALACOM, TELL THE DOCTOR IF: • You are suffering, or have suffered in the past, from coronary heart disease (the symptoms can include chest pain Lees het volledige document
Xalacom eye drops LPD WC 220922 1 2022-0077007 PS EYE DRO ® M ACO AL X 1. NAME OF THE MEDICINAL PRODUCT Xalacom ® eye drops. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1mL solution contains latanoprost 50 micrograms and timolol maleate 6.8 mg equivalent to 5 mg timolol. Excipients with known effect: Benzalkonium chloride 0.2 mg /ml Disodium phosphate, sodium dihydrogen phosphate monohydrate (containing total phosphate 6.3 mg/mL). For a 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 intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers. 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. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the effected eye(s) daily, since it has been shown that more frequent administration of latanoprost decreases the intraocular pressure lowering effect. _Paediatric population_ The safety and efficacy of Xalacom eye drops in children below 18 years of age has not been established. Method of administration Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. (see section 4.4) If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. 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. Xalacom eye drops LPD WC 220922 2 2022-0077007 4.3. CONTRAINDICATIONS Xalacom is contraindicated in patients with: • Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructi Lees het volledige document