Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
Azure Pharmaceuticals Ltd 12 Hamilton Drive, The Rock Road, Blackrock, Co. Louth A91 T997, Ireland
N06AA16
DOSULEPIN HYDROCHLORIDE 75 mg
TABLET
DOSULEPIN HYDROCHLORIDE 75 mg
POM
PSYCHOANALEPTICS
Licence number in the source country: NOT APPLICAPABLE
Withdrawn
2023-02-24
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DOSULEPIN HYDROCHLORIDE AZURE 75 MG COATED TABLETS Dosulepin hydrochloride 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 sign 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 Dosulepin is and what it is used for 2. What you need to know before you take Dosulepin 3. How to take Dosulepin 4. Possible side effects 5. How to store Dosulepin 6. Contents of the pack and other information 1. WHAT DOSULEPIN IS AND WHAT IT IS USED FOR The name of your medicine is Dosulepin Hydrochloride Azure 75 mg Coated Tablets (called Dosulepin in this leaflet). The active ingredient in Dosulepin Hydrochloride is dosulepin. Dosulepin belongs to a group of medicines called antidepressants. Dosulepin is used to treat depression and can also help reduce feelings of anxiety. Please ask your doctor or pharmacist if you need more information. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOSULEPIN DO NOT TAKE DOSULEPIN: • If you are allergic to dosulepin hydrochloride or any of the other ingredients of this medicine (listed in section 6). • If you have the eye condition known as glaucoma. • If you are pregnant or planning to become pregnant, or are breast feeding. • If you have an irregular heartbeat, recent heart attack or any other heart problem. • If you have severe liver problems. • If you suffer from periods of exaggerated behaviour (mania). • If you are a child or adolescent under the age of 18 years. • If you are taking any of the following medicines: - A mono-amine oxidase inhibitor (MAOI), used to tr Perskaitykite visą dokumentą
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Dosulepin Hydrochloride Azure 75 mg Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each coated tablet contains 75 mg of dosulepin hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White circular, convex sugar-coated tablets plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dosulepin is indicated for the management of depression and associated anxiety. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ The usual total daily dose is 75 mg to 150 mg in divided doses or as a single night-time dose. Treatment should be initiated at the lower dose. In certain circumstances, _e.g. _ in hospital use, dosages up to 225 mg daily have been used. Suggested regimens: 25 or 50 mg three times daily or, alternatively, 75 or 150 mg as a single dose at night. Should the regimen of 150 mg as a single night-time dose be adopted, it is better to give a smaller dose for the first few days. _Elderly:_ 50 to 75 mg daily initially. As with any antidepressant, the initial dose should be increased with caution under close supervision. Half the normal adult dose may be sufficient to produce a satisfactory clinical response. _Children:_ Not recommended. Method of administration For oral administration. Page 2 of 7 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Dosulepin is contraindicated following recent myocardial infarction, and in patients with any degree of heart block or other cardiac arrhythmias. It is also contraindicated in mania, severe liver disease, narrow angle glaucoma or other causes of increased intraocular pressure. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE It may be two to four weeks from the start of treatment before there is an improvement in the patient's depression; the subject should be monitored closely during this period. The anxiolytic effect may be observed within a few days o Perskaitykite visą dokumentą