Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
reboxetinmesilat
Medartuum AB
N06AX18
reboxetinmesilat
4 mg
Tablett
reboxetinmesilat 5,224 mg Aktiv substans
Receptbelagt
Reboxetin
Avregistrerad
2011-01-13
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER EDRONAX 4 MG TABLETS reboxetine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Edronax is and what it is used for 2. What you need to know before you take Edronax 3. How to take Edronax 4. Possible side effects 5. How to store Edronax 6. Contents of the pack and other 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EDRONAX DO NOT TAKE EDRONAX - if you are allergic to reboxetine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Edronax, 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 a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) used for depression, or have taken an MAOI in the last 2 weeks. Your doctor may need to stop the MAOI at least 2 weeks before starting Edronax. • ever h Lue koko asiakirja
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT EDRONAX 4 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains 4 mg of reboxetine For the 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 Posology _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/day. The minimum effective dose has not yet been established. _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. _Paediatric population_ Reboxetine should not be used in the treatment of children and adolescents under the age of 18 years (see section 4.4). _Renal or hepatic impairment_ The starting dose in patients with renal or hepatic impairment should be 2 mg b.i.d which can be increased based on patient tolerance. 3 Method of administration Reboxetine is for oral use. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Paediatric population Rebox Lue koko asiakirja