Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flupentixol dihydrochloride
Lundbeck Ltd
N05AF01
Flupentixol dihydrochloride
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030400; GTIN: 5702157121854
Package leaflet: Information for the user FLUANXOL ® 0.5 MG AND 1 MG FILM-COATED TABLETS FLUPENTIXOL 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 FLUANXOL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUANXOL 3. HOW TO TAKE FLUANXOL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FLUANXOL 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT FLUANXOL IS AND WHAT IT IS USED FOR Fluanxol contains the active substance flupentixol. Fluanxol belongs to a group of medicines known as antidepressants. These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances that are causing the symptoms of your illness. Fluanxol is used to treat depression in patients who may, or may not, also be showing signs of anxiety. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUANXOL DO NOT TAKE FLUANXOL • If you are allergic (hypersensitive) to flupentixol, other thioxanthene drugs or antipsychotic drugs or to any of the other ingredients of this medicine (listed in section 6). • If you are feeling less alert than usual, or are drowsy or sleepy, or have serious problems with your blood circulation • If you suffer with severe depression, which needs you to stay in hospital or if you need electroconvulsive therapy (ECT) • If you suffer from periods of excitement, overactivity or mania. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Fluanxol if you: • have a heart condition (including an irregular heart beat) or se Read the complete document
OBJECT 1 FLUANXOL TABLETS Summary of Product Characteristics Updated 26-Jan-2017 | Lundbeck Limited 1. Name of the medicinal product Fluanxol ® 0.5 mg film-coated tablets Fluanxol ® 1 mg film-coated tablets 2. Qualitative and quantitative composition Each 0.5 mg film-coated tablet contains 0.5 mg flupentixol (as 0.5840 mg flupentixol dihydrochloride) Each 1 mg film-coated tablet contains 1 mg flupentixol (as 1.168 mg flupentixol dihydrochloride). Excipients with known effect: Lactose monohydrate For the full list of excipients, see section 6.1 3. Pharmaceutical form 0.5 mg Film-coated tablet Round, slightly biconvex, yellow, film-coated tablet marked FD. 1 mg Film-coated tablet Oval, slightly biconvex, yellow, film-coated tablet marked FF. 4. Clinical particulars 4.1 Therapeutic indications Symptomatic treatment of depression (with or without anxiety). 4.2 Posology and method of administration Posology _Adults_ The standard initial dosage is 1 mg as a single morning dose. After one week the dose may be increased to 2 mg if there is inadequate clinical response. Daily dosage of more than 2 mg should be in divided doses up to a maximum of 3 mg daily. _Older patients_ Older patients should receive half the recommended dosages. The standard initial dosage is 0.5 mg as a single morning dose. After one week, if response is inadequate, dosage may be increased to 1 mg once a day. Caution should be exercised in further increasing the dosage but occasional patients may require up to a maximum of 1.5 mg a day which should be given in divided doses. _Children_ Flupentixol is not recommended for use in children due to lack of clinical experience. _Patients with reduced renal function_ Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment (see section 4.4). _Patients with reduced hepatic function_ Flupentixol has not been studied in hepatic impairment. It is extensively metabolised by the liver and particular caution should be used in Read the complete document