Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Levomepromazine maleate
Link Pharmaceuticals Ltd
N05AA02
Levomepromazine maleate
6mg
Oral tablet
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020100
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Levomepromazine Maleate 6mg Tablets Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • K eep 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 Levomepromazine Maleate Tablets are and what they are used for 2. What you need to know before you take Levomepromazine Maleate Tablets 3. How to take Levomepromazine Maleate Tablets 4. Possible side effects 5. How to store Levomepromazine Maleate Tablets 6. Contents of the pack and other information 1. What Levomepromazine Maleate Tablets are and what they are used for Levomepromazine is a phenothiazine used in palliative care and indicated for second or third line-treatment of adults with refractory nausea unassociated with chemotherapy, where other agents have failed to give adequate control (CCC System - B62.1 Nausea Care). 2. What you need to know before you take Levomepromazine Maleate Tablets Do not take Levomepromazine Maleate Tablets: • if you are allergic to levomepromazine maleate or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions: Talk to your doctor or pharmacist before taking Levomepromazine Maleate Tablets if you: • have liver problems • are elderly, frail or have heart disease as you may feel faint or light-headed when you take the tablets (if you have a large initial dose, you will have to stay in bed) • suffer from slow or irregular heartbeats/ palpitations (Torsades de Pointes), or have a family history of heart problems • or someone else in your family have a history of blood clots, as Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Levomepromazine Maleate 6mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 6mg levomepromazine maleate. _Excipient with known effect: _ Each tablet contains 85.74 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets. White to off white round shaped tablet with break line on one side and 'L4' debossing on another side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levomepromazine is a phenothiazine used in palliative care and indicated for second or third line-treatment of adults with refractory nausea unassociated with chemotherapy, where other agents have failed to give adequate control (CCC System - B62.1 Nausea Care). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ Nausea in palliative care. Patients will require daily physician review. TREATMENT DURATION DOSAGE Initial (3 days) Treatment is with 3-6mg once at night 4 to 5 days Dose may be up-titrated to a maximum of 12 mg per day in divided doses of 6 mg over days 4-5 6 to 14 days From day 6 the dose may then be switched to 12 mg once daily at night, or when steady state is achieved. Treatment may be extended to a maximum of 2 weeks, as needed _Paediatric population_ No data is available. Levomepromazine tablets should not be used in children aged under 18 years. Method of administration For oral use only. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Levomepromazine tablets is contraindicated in children aged under 18 years. Safety in pregnancy has not been established. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The drug should be avoided, or used with caution, in patients with liver dysfunction or cardiac disease. The hypotensive effects of levomepromazine should be taken into account when it is administered to patients with cardiac disease and the elderly or debilitated. Read the complete document