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What is LEVID and what it is used
Levosulpiride belongs to a group of medicines called antipsychotics and psycholeptics It is used in:
• endogenous and reactive depression.
• somatoform disorders.
• Acute and chronic schizophrenia.
2. What you need to know before taking LEVID
Do not take LEVID:
• If you are allergic to levosulpiride or any of the other ingredients of this medicine (listed in section 6).
• If you have epilepsy
• If you are pregnant or may be pregnant or during lactation.
• If you are patient in a manic state or a manic phase of manic-depressive psychosis.
• If you have hypertension, which is supposed to be due to a pheochromocytoma, or if you have heart failure. In these cases require caution.
• If you have breast cancer.
Warnings and Precautions
Talk to your doctor or pharmacist before taking LEVID.
Levosulpiride should not be applied when the stimulation of gastrointestinal motility can be detrimental, for example in the presence of gastrointestinal bleeding, mechanical obstructions and perforations.
LEVID should be used with caution in patients with risk factors for stroke.
Levosulpiride should be used with caution in patients with cardiovascular disease or family history of QT prolongation.
Concurrent treatment with other neuroleptics should be avoided. During therapy with antipsychotic drugs is reported Disorder complex of symptoms called neuroleptic malignant syndrome. Clinical manifestations of this syndrome are hyperpyrexia, muscle rigidity, akinesia, vegetative disorders (irregular heartbeat or changes in blood pressure, sweating, tachycardia, arrhythmias), changes in consciousness, which may progress to stupor and coma. Treatment of Neuroleptic Malignant Syndrome consists of immediate discontinuation of antipsychotic drugs and other essential medicines and appointment of intensive symptomatic treatment (must be taken to reduce hyperthermia and correction of dehydration). In cases where antipsychotic treatment is deemed necessary, patients should be monitored carefully.
Caution patients that are known, even at the family level, history of clinical thrombosis, since the use of this drug is associated with thrombus formation.
Other medicines and LEVID
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Combining with other drugs require special attention and vigilance on the part of the physician to avoid unexpected effects from unwanted interaction.
The risk of cardiac arrhythmia is increased when antipsychotics are taken together with drugs that prolong the QT interval.
Levosulpiride should not be co-administered with drugs that cause electrolyte disturbances.
You should avoid joint alcohol intake.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
Do not take LEVID during pregnancy, probable pregnancy and while breastfeeding.
The following symptoms are observed in infants whose mothers were receiving conventional or atypical antipsychotics, including levosulpiride, in the last trimester (last three months of pregnancy): tremor, rigidity and / or muscle weakness, sleepiness, agitation, breathing problems and feeding problems . If your child is experiencing any of these symptoms, contact your doctor.
Driving and using machines
LEVID major influence on the ability to drive and use machines.
Patients undergoing therapy may experience numbness, dizziness or dyskinesia; therefore they should avoid driving or activities that require caution.
LEVID contains lactose.
If your doctor has told you suffer from an intolerance to some sugars, contact your doctor before taking this medicine.
How to take LEVID
Always take this medicine exactly as you have been told by your doctor or pharmacist. If you're not sure, ask your doctor or pharmacist.
The recommended dose is:
• Adults with Severe Mental Disorders: 2-3 tablets of 100 mg daily
• Maintenance: unless otherwise prescribed, 3 tablets of 50 mg daily
The dose may be decreased gradually.
Use in children and adolescents
This drug should not be taken by children and adolescents as there is no information available for this use.
In the treatment of elderly patients the dose will be determined by the practitioner who should carefully weigh the potential decreases in the above mentioned doses.
If you take more than the amount LEVID
If you accidentally swallow / accept overdose tell your doctor or visit the nearest hospital.
At very high doses and in patients sensitive to neuroleptic drugs may appear extrapyramidal effects and sleep disorders.
In this case dostatychno to stop treatment or reduce the dose you are taking, as decided by the physician.
If you forget to take LEVID
Do not take a double dose to make up the missed dose.
If you stop taking LEVID
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following adverse reactions:
Very rare (affects up to 1 in 10,000 people):
psychomotor agitation, neurovegetative disorders and extrapyramidal effects such as tremors, dystonia and parkinsonism. All these effects are moderate in intensity and were reversible.
Not known (frequency can not be established from the available data)
• Some disorders such as amenorrhea, gynecomastia, galactorrhea, hyperprolactinemia, and changes in libido occurred in special cases due to levosulpiride the normal function of the hypothalamic - pituitary - gonadal similar to that in many other neuroleptics
• Isolated cases of weight gain after prolonged treatment.
The following adverse reactions have been observed with other drugs of the same class:
Rare (affects up to 1 in 1000 people):
• cases of QT prolongation, ventricular arrhythmias such as polymorphic ventricular tachycardia (torsades de pointes), ventricular tachycardia, ventricular fibrillation and cardiac arrest.
Very rare (affects up to 1 in 10,000 people):
• cases of sudden death.
Not known (frequency can not be established from the available data):
• Cases of venous thromboembolism (VTE), including cases of pulmonary embolnzam (WAS) and deep vein thrombosis (DVT).
• withdrawal symptoms in the newborn, extrapyramidal symptoms (see section 2).
Particular care is required in patients where there is an even level of family history of thrombosis, since this drug is connects with thrombus formation
By reporting side effects, you can do your bit for getting more information on the safety of this medicine.
5. How to store LEVID
Keep out of reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer use. These measures will help to protect the environment.
Contents of the pack and other information What LEVID
- The active substance is levosulpiride (levosulpiride).
- The other ingredients are: microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycolate type A, magnesium stearate (E572).
LEVID looks like and contents of the pack
LEVID 50 mg tablets: White, round, convex tablets with 8 mm in diameter marked "50" on one side.
LEVID 100 mg tablets: White, round, convex tablets with a diameter of 10,3 mm.
Packs 20, 30, 60 and 100 tablets packaged in blisters (PVC / PVDC / Aluminium and PV C / PCTFE / aluminum). Each blister contains 10 tablets.
Not all pack sizes may be marketed.
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