Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Reboxetine mesilate
Sigma Pharmaceuticals Plc
N06AX18
Reboxetine mesilate
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400
PACKAGE LEAFLET: INFORMATION FOR THE USER EDRONAX ® 4MG TABLETS (reboxetine methanesulphonate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Keep this leaflet. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Edronax is and what it is used for 2. Before you take Edronax 3. How to take Edronax 4. Possible side effects 5. How to store Edronax 6. Further information 1. WHAT EDRONAX IS AND WHAT IT IS USED FOR The active substance in Edronax is reboxetine which is part of a group of medicines called antidepressants. Edronax is used in acute treatment of depressive illness/major depression as well as for maintaining the improvement of your symptoms when you have initially responded to treatment with reboxetine. 2. BEFORE YOU TAKE EDRONAX DO NOT TAKE EDRONAX if you are allergic (hypersensitive) to reboxetine or any of the other ingredients of Edronax. For a full list of excipients, see section 6. TAKE SPECIAL CARE WITH EDRONAX Tell your doctor if you: suffer from convulsions or epilepsy. Treatment with reboxetine should be stopped if seizures occur. have any signs of urinary problems, enlarged prostate or a history of heart problems. are taking medicines to lower your blood pressure. have liver or kidney problems. Your doctor may need to adjust your dosage. are taking any other medicine for depression such as MAO inhibitors, tricyclics, nefazodone, SSRIs (such as fluvoxamine) or lithium. are taking other MAO inhibitors such as linezolid (an antibiotic) or methylene blue (see section “Taking other medicines”). ever had episodes of mania (overactive behaviour or thoughts). have eye problems, su Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT EDRONAX 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 4mg of reboxetine For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, convex 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 ‘7671’. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reboxetine is indicated for the acute treatment of depressive illness/major depression and for maintaining the clinical improvement in patients initially responding to treatment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Reboxetine is for oral use. Use in adults The recommended therapeutic dose is 4 mg twice a day (b.i.d.) i.e.8 mg/day administered orally. The full therapeutic dose can be given upon starting treatment. After 3-4 weeks, this dose can be increased to 10 mg/day in case of incomplete clinical response. The maximum daily dose should not exceed 12 mg. The minimum effective dose has not yet been established. Use in the elderly Elderly patients have been studied in clinical trials at doses of 2 mg b.i.d. However, safety and efficacy have not been evaluated in placebo-controlled conditions. Therefore, as for other antidepressants that have not been studied in placebo-controlled conditions, reboxetine cannot be recommended. Use in children and adolescents under the age of 18 years Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4). Use in patients with renal or hepatic insufficiency The starting dose in patients with renal or hepatic insufficiency should be 2 mg b.i.d which can be increased based on patient tolerance. 4.3 CONTRAINDICATIONS Known hypersensitivity to reboxetine or any of the components of the product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE USE IN CHILDREN AND ADOLESC Lire le document complet