Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Reboxetine mesilate
Waymade Healthcare Plc
N06AX18
Reboxetine mesilate
4mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400
evening. You should swallow your tablet with a glass of water. The tablet can be divided into equal doses. Do not chew the tablet. To help you remember to take Edronax, you may fi nd it easier to take your tablets at the same time every day. Like other drugs Edronax will not relieve your symptoms immediately. You should start to feel better within a few weeks. It is important that you continue to take your tablets, even though you feel better, until your doctor advises you to stop. Please be patient, if you stop taking your tablets too early, your symptoms might come back. IF YOU TAKE MORE EDRONAX THAN YOU SHOULD You should never take more tablets than your doctor recommends. If you take too many tablets, contact your doctor or local hospital immediately. If you take more Edronax than you should, you may experience symptoms of overdose including low blood pressure, anxiety and hypertension. IF YOU FORGET TO TAKE EDRONAX If you forget to take Edronax, take your next dose at the normal time. Do not take a double dose to make up for a forgotten tablet. IF YOU STOP TAKING EDRONAX You should not stop your medicine without talking to your doctor, as your symptoms may come back. There have been a few reports of withdrawal symptoms including headache, dizziness, nervousness and nausea (feeling sick), when patients stopped treatment with Edronax. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. With Edronax most side effects are mild and usually go away after the fi rst few weeks of treatment. If any of the side effects below gets serious, or if you notice any side effects not listed in this leafl et, please tell your doctor or pharmacist. VERY COMMON SIDE EFFECTS (more than one in 10 patients) • Diffi culties to sleep (insomnia) • Dizziness • Dry mouth • Constipation • Nausea (feeling sick) • Sweating COMMON SIDE EFFECTS (less than one in 10 patients Прочетете целия документ
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 Прочетете целия документ