Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
ZUCLOPENTHIXOL DECANOATE
Lundbeck ( Ireland ) Limited
N05AF; N05AF05
ZUCLOPENTHIXOL DECANOATE
200 milligram(s)/millilitre
Solution for injection
Thioxanthene derivatives; zuclopenthixol
Marketed
1977-06-13
PACKAGE LEAFLET: INFORMATION FOR THE USER CLOPIXOL 200 MG/ML SOLUTION FOR INJECTION (zuclopenthixol decanoate) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Clopixol is and what it is used for 2. What you need to know before you use Clopixol 3. How to use Clopixol 4. Possible side effects 5. How to store Clopixol 6. Contents of the pack and other information 1. WHAT CLOPIXOL IS AND WHAT IT IS USED FOR Clopixol contains the active substance zuclopenthixol. Clopixol belongs 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. Clopixol is used for the treatment of schizophrenia and other related psychoses. Ask your doctor if you have any questions about why Clopixol has been prescribed for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLOPIXOL DO NOT USE CLOPIXOL • if you are allergic to zuclopenthixol or any of the other ingredients of this medicine (listed in section 6). Consult your doctor if you think you might be • if you have a reduced level of alertness due to the consumption of alcohol or drugs such as opiates (e.g. morphine) and barbiturates • if you are an older person who suffers from confusion • if you are receiving emergency treatment to support your blood circulation • if you are a child. WARNINGS AND PRECAUTIONS Talk to doctor or pharmacist before taking Clopixol if yo Lue koko asiakirja
Health Products Regulatory Authority 28 February 2023 CRN00DDXV Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clopixol 200 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 200 mg zuclopenthixol decanoate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear, yellowish oil, practically free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The management of schizophrenia and allied psychoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The dosage should be adjusted according to the severity of the patient's symptoms. The usual dose range is 200-400 mg every two to four weeks depending on the response of the individual patient. If volumes larger than 2-3 ml of the 200 mg/ml solution are required, the more concentrated solution (zuclopenthixol decanoate 500 mg/ml) should be preferred. The maximum recommended dose is 600 mg weekly. Patients who have not previously received depot neuroleptics are usually started on an initial dose of 100 mg. A few patients may need higher doses or shorter intervals between doses. Injection volumes exceeding 2 ml should be distributed between two injection sites (administration on both injection sites in total should not exceed 600mg). When changing the medication from oral zuclopenthixol or zuclopenthixol acetate i.m. to maintenance treatment with zuclopenthixol decanoate the following guidelines should be used: _1) Change from oral zuclopenthixol to zuclopenthixol decanoate_ x mg p.o. daily corresponds to 8x mg decanoate every two weeks. x mg p.o. daily corresponds to 16x mg decanoate every four weeks. Numerical example: 10 mg p.o. daily corresponds to 80 mg decanoate every two weeks. 10 mg p.o. daily corresponds to 160 mg decanoate every four weeks. Oral zuclopenthixol should be continued during the first week after the first injection but in diminishing dosage. _2) Change from zuclopenthixol acetate to zuclopenthixol decanoate_ C Lue koko asiakirja