البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Reboxetine mesilate 2.612mg equivalent to 2 mg reboxetine free base
Pfizer New Zealand Limited
Reboxetine mesilate 2.612 mg (equivalent to 2 mg reboxetine free base)
2 mg
Tablet
Active: Reboxetine mesilate 2.612mg equivalent to 2 mg reboxetine free base Excipient: Calcium hydrogen phosphate dihydrate Crospovidone Hydrated silica Magnesium stearate Powdered cellulose
Blister pack, PVC/PVDC & alim,
Prescription
Prescription
Pfizer Cork Limited
Reboxetine is indicated for the treatment of depressive illness and for maintaining the clinical improvement in patients initially responding to treatment. The remission of the acute phase of the depressive illness is associated with an improvement in the patient's quality of life in terms of social adaptation.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC & alim - - 24 months from date of manufacture stored at or below 25°C - Bottle, glass, - - 24 months from date of manufacture stored at or below 25°C
1997-11-03
EDRONAX ® 1 EDRONAX ® _(ED-ROW-NACKS) _ _Reboxetine mesilate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Edronax. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Edronax against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EDRONAX IS USED FOR _WHAT IT DOES _ Edronax is used to treat depression. _HOW IT WORKS _ Depression is longer lasting and/or more severe than the 'low moods' everyone has from time to time due to the stress of everyday life. It is thought to be caused by a chemical imbalance in parts of the brain. Edronax may correct this chemical imbalance and help to relieve the symptoms of depression. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. There is no evidence that Edronax is addictive. This medicine is available only with a doctor's prescription. _USE IN CHILDREN _ There is not enough information to recommend the use of this medicine in children or adolescents younger than 18 years. BEFORE YOU TAKE EDRONAX _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE EDRONAX IF YOU HAVE AN ALLERGY TO: • any medicine containing reboxetine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction to Edronax may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE EDRONAX IF YOU ARE TAKING OTHER MEDICINES USED TO TREAT DEPRESSION SUCH AS MONOAMINE OXIDASE INHIBITORS (MAOIS). DO NOT TAKE EDRONAX IF YOU HAVE GLAUCOMA (HIGH PRESSURE IN THE EYE). DO NOT GIVE THIS MEDICI اقرأ الوثيقة كاملة
Version: pfdedrot10322 Supersedes: pfdedrot10219 Page 1 of 21 NEW ZEALAND DATA SHEET 1. PRODUCT NAME_ _ EDRONAX 2 mg, 4 mg Tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION EDRONAX tablets contain 2.6 mg or 5.2 mg reboxetine mesilate corresponding to 2 mg or 4 mg reboxetine free base respectively. Chemical name: (2RS, α RS)-2-[ α -(2-ethoxyphenoxy) benzyl] morpholine methanesulfonate. Reboxetine mesilate has the empirical formula C 19 H 23 NO 3 -CH 4 O 3 S, and a molecular weight of 409.50. Reboxetine mesilate is freely soluble in water (>20% w/v). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets 2 mg EDRONAX tablets: white, flat, capsule-shaped, 4mm x 8mm tablet with a breakline on both sides. 4 mg EDRONAX tablets: white, round, convex 8mm diameter tablet with a breakline on one side. A “P” is marked on the left side of the breakline. A “U” is marked on the right side of the breakline. The side opposite the breakline is marked with “7671”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reboxetine is indicated for the treatment of depressive illness and for maintaining the clinical improvement in patients initially responding to treatment. The remission of the acute phase of the depressive illness is associated with an improvement in the patient’s quality of life in terms of social adaptation. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE EDRONAX tablets are for oral administration. The onset of the clinical effect is generally seen after 14 days from treatment start. Version: pfdedrot10322 Supersedes: pfdedrot10219 Page 2 of 21 USE IN ADULTS The recommended therapeutic dose is 4mg twice daily (8mg/day) administered orally. The full therapeutic dose can be given upon starting treatment. After 3-4 weeks, this dose can be increased to 10mg/day in case of incomplete clinical response. USE IN THE ELDERLY (> 65 YEARS) As with other antidepressants, in elderly subjects and in elderly depressed patients, particularly in the presence of concomitant systemic illnesses اقرأ الوثيقة كاملة