Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flupentixol dihydrochloride
Lundbeck Ltd
N05AF01
Flupentixol dihydrochloride
3mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100; GTIN: 5702157122158
Package leaflet: Information for the user DEPIXOL ® 3 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 DEPIXOL TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEPIXOL TABLETS 3. HOW TO TAKE DEPIXOL TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DEPIXOL TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT DEPIXOL TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Depixol 3 mg film-coated tablets (called Depixol Tablets in this leaflet). Depixol Tablets contain the active substance flupentixol. Depixol Tablets belong to a group of medicines known as antipsychotics (also called neuroleptics). These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness. Depixol Tablets are used for the treatment of schizophrenia and other psychoses. Your doctor, however, may prescribe Depixol Tablets for another purpose. Ask your doctor if you have any questions about why Depixol Tablets have been prescribed for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEPIXOL TABLETS DO NOT TAKE DEPIXOL TABLETS: • If you are allergic (hypersensitive) to flupentixol, other thioxanthene drugs or antipsychotic drugs or 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 Lue koko asiakirja
OBJECT 1 DEPIXOL TABLETS 3MG Summary of Product Characteristics Updated 21-Apr-2021 | Lundbeck Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Depixol ® 3 mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 3 mg flupentixol (as 3.504 mg flupentixol dihydrochloride). Excipients with known effect: Lactose monohydrate Sunset yellow (E110) For the full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated tablet Round, slightly biconvex, ochre, film-coated tablet marked FI. 4. Clinical particulars 4.1 Therapeutic indications The treatment of schizophrenia and other psychoses. 4.2 Posology and method of administration Posology _Adults_ 1 - 3 tablets twice daily to a maximum of 18 mg (6 tablets) per day. It is recommended that commencement of treatment and increase in dosage should be carried out under close supervision. As with all antipsychotic drugs, the dose of Depixol should be titrated to the needs Lue koko asiakirja