Patient Leaflet Updated 28-Jul-2020 | Morningside Healthcare Ltd
Levomepromazine Maleate 6mg Tablets
Levomepromazine Maleate
6mg Tablets
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
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).
Talk to your doctor or pharmacist before taking Levomepromazine Maleate Tablets if you:
Additional tests will be done by your doctor at the start of treatment if you are taking Levomepromazine Maleate Tablets for a long period of time, or if you are taking other medicines at the same time such as heart drugs, antidepressants or drugs for mental health disorders.
These tests might include an ECG (electrocardiogram) to check your heart is working normally and/or blood tests. If you have to go to the dentist or hospital for any reason, tell them that you are taking Levomepromazine Maleate Tablets.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they may change the way Levomepromazine Maleate Tablets work.
These include:
Avoid alcohol while you are taking these tablets.
If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist before taking Levomepromazine Maleate Tablets or any other medicine.
The following symptoms may occur in newborn babies, of mothers that have used Levomepromazine Maleate Tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
Do not drive or operate machinery if taking Levomepromazine Maleate Tablets as they may make you feel drowsy, confused, dizzy or lightheaded.
This medicine contains lactose, which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The tablets should be swallowed with a glass of water.
The recommended dose is as follows:
Nausea in palliative care.
Your doctor will review your treatment on a daily basis.
Number of days of treatment Number of tablets
Initial (3 days) ½ to 1 tablet to be taken once at night for 3 days.
4 to 5 days Your dose may be increased up to maximum of 2 tablets on days 4-5. This may be achieved by taking 1 tablet twice a day.
6 to 14 days From day 6 the dose may then be switched to 2 tablets once daily at night, or as directed by your doctor. Your treatment may be extended to a maximum of 2 weeks, as needed.
No data are available. Levomepromazine tablets should not be used in children aged under 18 years.
For oral use only.
The tablet can be divided into equal doses.
If you accidentally swallow too many tablets, contact your doctor or nearest hospital casualty department immediately.
Symptoms of overdose include: drowsiness or loss of consciousness, convulsions, low blood pressure, irregular heartbeats, hypothermia (abnormally low body temperature) and severe extrapyramidal dyskinesias (involuntary movements).
If you miss a dose, just take your tablets as soon as you remember then carry on as before. Do not take a double dose to make up for the forgotten one. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Do not stop taking Levomepromazine Maleate Tablets unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
No formal reporting has been made about the undesirable effects of low-dose levomepromazine formulations; therefore, adverse effects cannot be ranked by frequency. Most available data on adverse effects are related to application of higher doses, i.e., ≥ 25 mg. Adverse effects that are more frequent and indicate the need for medical attention are as follows:
Hypotension is more frequent in the elderly and at the beginning of treatment, especially if high doses are used. Parkinsonian effects and tardive dyskinesia also occur more frequently in the elderly, whereas dystonia occurs more often in younger patients. Extrapyramidal effects may be dose-related and may decrease with a decrease in dosage. Ocular changes occur more frequently with high-dose or long-term use of phenothiazines.
Less frequent AEs include difficulty in urinating, photosensitivity (may cause severe sunburn), skin rash associated with contact dermatitis or cholestatic jaundice.
With rare incidence the following AEs may occur:
In the only double blind, randomised, controlled trial of low-dose levomepromazine (6.25mg once or twice daily), the most frequent side effects were
Additional side effects included dyspepsia, hypertension, diarrhoea, bruising (each 6.1%), dizziness, bowel colic, blurred vision (each 4.1%), confusion, sensitivity to light, palpitations, and jaundice (each 2.0%). Side effects worse than baseline were minimal, specifically those relating to extrapyramidal reactions.
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton or blister after ’EXP’.The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The tablets are 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.
They are supplied in blister packs of 7, 10, 14, 20, 24, 28, 30, 56, 60, 84, 90, 100 and 112 tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in March 2020.
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