25 mg and 100 mg tablets of
levomepromazine
What Levomepromazine Orion is and what it is used for
The active substance levomepromazine is an antipsychotic, which is a medicine used mainly in the treatment of severe mental disorders (schizophrenia, psychosis ). It reduces the effect of certain substances in the brain and can thereby alleviate the symptoms of psychosis. The drug can also be used for severe pain conditions, either alone or in combination with painkillers to enhance the effect of these.
Levomepromazine contained in Levomepromazine Orion may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Levomepromazine Orion
Do not take Levomepromazine Orion
- if you are allergic to levomepromazine or any of the other ingredients of this medicine (listed in section 6).
- if you have an adrenal tumor (pheochromacytoma)
- if you have bone marrow disease
- if you have a brain injury
- if you have or have had neuroleptic malignant syndrome (NMS) – an unusual but serious reaction to certain medicines used to treat severe mental disorders
- if you suffer from myasthenia gravis (an unusual condition that causes muscle weakness)
- if you use alcohol
Warnings and cautions
Talk to your doctor or pharmacist before taking Levomepromazine Orion if you:
- have any disease of the central nervous system such as epilepsy , stroke and dementia
- have cardiovascular disease
- have liver or kidney disease
- have lung disease
- have hypothyroidism (lack of thyroid hormone)
- have diabetes
- have glaucoma ( glaucoma )
- have Parkinson’s disease
- or someone in your family has been diagnosed with a hereditary form of QT prolongation , which may increase the risk of irregular heartbeat
- or someone in your family has had a blood clot in the past, as medicines of this type have been associated with blood clots
- has a lower heart rate than normal
- has enlarged prostate
- have tardive dyskinesia (see section 4. “Possible side effects”)
- at the same time use other antipsychotic drugs or previously used other antipsychotic drugs of the phenothiazine type that did not suit you
This medicine may cause dry mouth, see section 4. “Possible side effects”.
Elderly
Dosage one to older patients is usually lower compared to other adults. This is because the elderly are more susceptible to side effects.
Children and adolescents The medicine is not recommended for children and adolescents.
Other medicines and Levomepromazine Orion
Other medicines and Levomepromazine Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Particular caution should be exercised when levomepromazine is co-administered with medicinal products known to affect the body’s salt balance or prolong the QT interval on the ECG (eg certain diuretics, antipsychotics, and antibiotics ).
Ask your doctor or pharmacist for advice before taking any other medicine with Levomepromazine Orion.
Concomitant use of certain medicines may affect the effect of Levomepromazine Orion or cause side effects. Examples of these drugs are:
- those that exert their effect in the central nervous system such as:
- other antipsychotics (eg thioridazine , sertindole )
- sedatives and hypnotics
- antidepressants (eg venlafaxine , paroxetine , fluoxetine and clomipramine )
- antiepileptics
- antihistamines or allergy medicines
- antihypertensive drugs
- opioids (eg codeine and methadone ) (painkillers)
- lithium (agents used to treat bipolar disorder )
- quinidine (drug used to treat irregular heartbeat)
- meflokin (antimalarial drug)
- cisapride (intestinal stimulant)
- bromocriptine, cabergoline and levodopa (medicines for Parkinson’s disease )
Levomepromazine Orion with food, drink and alcohol
The tablets can be taken with or without food.
Alcohol
Avoid drinking alcohol during treatment with Levomepromazine Orion. This may increase the risk of side effects from the medicine.
Pregnancy and Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. You should stop breastfeeding during treatment. Levomepromazine Orion is not recommended during pregnancy and lactation unless your doctor considers it necessary for maternal health. Ask your doctor or pharmacist for advice before taking any medicine.
The following symptoms may occur in newborns of mothers who have used Levomepromazine Orion during the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, anxiety, difficulty breathing, and difficulty eating. If your child has any of these symptoms, you may need to consult a doctor.
Driving and using machines
Levomepromazine Orion causes fatigue and may impair the ability to react. This should be taken into account when sharper attention is required e.g. when driving and handling machines. During the first weeks of treatment, it is recommended that you avoid driving and handling machines until you know how the medicine affects you.
You are always responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Levomepromazine Orion contains lactose
This medicine contains 43 mg and 171 mg of lactose (as monohydrate) in 25 mg and 100 mg tablets respectively. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Other ingredients
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Levomepromazine Orion
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The tablet can be divided into equal doses.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects at the beginning of treatment
You may experience dizziness and dizziness when you get up. They usually reduce the symptoms during continued treatment.
Contact a doctor immediately if you experience:
Levomepromazine may cause tardive dyskinesia with symptoms such as rhythmic, involuntary movements of the tongue, face, mouth, or jaws, sometimes associated with involuntary movements of the arm and leg.
Levomepromazine can also cause malignant neuroleptic syndrome, with symptoms such as fever, excessive sweating, muscle stiffness, mood swings, irregular heartbeat, and unstable blood pressure. This condition, if left untreated, can be life-threatening and can, in the worst case, lead to death.
Levomepromazine may cause fewer white blood cells and your resistance to infection may decrease. If you get an infection with symptoms such as fever and severe deterioration of your general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or difficulty urinating, you should see a doctor immediately. A blood sample will be taken to check if the white blood cells have decreased in number ( agranulocytosis ). It is important to inform your doctor about your medicine.
Levomepromazine may also cause anaphylactic shock, a severe allergic reaction with rapid onset. Symptoms may include itching or rash, swelling of the face, lips, tongue, and throat, difficulty breathing, and a rapid drop in blood pressure (which at first feels like dizziness, but may continue to collapse). If left untreated, anaphylactic shock is life-threatening and can, in the worst case, lead to death.
A dry mouth can affect your teeth
Levomepromazine Orion can cause dry mouth and can provide the long-term treatment of dental and oral mucosal changes. Teeth should be thoroughly cleaned with fluoride toothpaste twice daily. Use saliva stimulants if necessary. Go to the dentist regularly.
Very common (may affect more than 1 user in 10) or Common (may affect up to 1 user in 10):
- dizziness, fatigue, involuntary movements ( tardive dyskinesia ) and tremors around the mouth (during long-term treatment), Parkinson-like symptoms, such as tremors or stiffness, motor restlessness (inability to stand still)
- mild blood count
- increased heart rate
- drop in blood pressure
- dry mouth
- skin problems ( hives , rash, itching , photosensitivity or other skin problems)
Uncommon (may affect up to 1 in 100 people):
- impaired visual acuity
- constipation
- urinary incontinence
- menstrual disorders, swollen and sore mammary glands
Rare (may affect up to 1 in 1,000 people) or Very rare (may affect up to 1 in 10,000 users):
- strong blood image effect
- altered sensitivity to sugar, change in appetite, weight gain
- memory difficulties, sudden muscle movements or cramps, syndrome with cramps, fever, muscle stiffness and impaired consciousness
- aggravated narrow-angle glaucoma , cloudy lens or cornea
- irregular heartbeat, cardiac arrest
- jaundice
- malignant neuroleptic syndrome (disease with high fever, impaired consciousness and muscle stiffness)
- increased hair
- altered sex drive, delayed orgasm, impotence , painful prolonged erection
Has been reported (occurs in an unknown number of users):
- venous thromboembolism ( pulmonary embolism and deep vein thrombosis )
- anaphylactic shock (severe allergic reaction )
Among elderly people with dementia, a small increase in the number of deaths has been reported for patients treated with antipsychotics compared with those not treated with antipsychotics.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The Medical Products Agency
Box 26
751 03 Uppsala
Website: www.lakemedelsverket.se
By reporting side effects, you can help increase the safety of medicines.
How to store Levomepromazine Orion
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and package.
The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Sensitive to light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is levomepromazine. Each tablet contains 25 mg or 100 mg.
- The other ingredients are lactose monohydrate , corn starch, gelatin, glycerol (85%), talc, magnesium stearate and sodium starch glycolate (type C).
See section 2 “Levomepromazine Orion contains lactose”
What the medicine looks like and contents of the pack
25 mg tablets: white or almost white, plate with a beveled edge, breakable notch and marked ORN 16, diameter: 7 mm.
100 mg tablets: white or almost white, plate with beveled edge, notched, diameter: 12 mm
The tablet can be divided into equal doses.
Pack sizes:
25 mg: 30, 50, 84 and 100 tablets
100 mg: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionvägen 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation
Orionvägen 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com
This medicinal product is authorized by the EEA member countries under the following names:
| Finland: | Levomepromazine Orion 25 mg, 50 mg, 100 mg tablet / tablet |
| Germany: | Levomepromazine Orion 25 mg, 50 mg, 100 mg tablets |
| Norway: | Levomepromazine Orion 25 mg, 100 mg tablet |
| Sweden | Levomepromazine Orion 25 mg, 100 mg tablets |
| Estonia | Levomepromazine Orion 25 mg, 50 mg, 100 mg tabletid |