|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Aurex 40||coated tablets; 40 mg; 20 tables||Sandoz||31.99||Check|
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
An antidepressant drug that belongs to the group of serotonin reuptake inhibitors.
The active substance is citalopram , a drug belonging to the group of selective serotonin reuptake inhibitors (the abbreviation SSRI from the English name of the selective serotonin reuptake inhibitor is also used). Serotonin is a neurotransmitter that plays an important role in the transmission of information between neurons in the central nervous system. The place of communication between two neurons is called a synapse. The cell transmitting the information in front of the synapse releases the neurotransmitter into the synaptic cleft, the chemical compound captured and recognized by the cell receiving information behind the synapse. Some molecules of the neurotransmitter, in this case serotonin, are captured back through the receptors of the neuron in front of the synapse. This phenomenon is called re-uptake. The effect of citalopram is to inhibit the process of reuptake of serotonin, and thus to extend the duration of serotonin in the synapse and the time of stimulation of the cell receiving the information. Nerve impulses are sent more often. Greater stimulation of serotonin-dependent cells is associated with antidepressant effects. Citalopram has no effect on reuptake other than serotonin mediators, as well as does not show affinity (or shows very weak) to non-serotonin receptors. Therefore, its operation is defined as selective.
Following oral administration, citalopram is well absorbed. There is no obvious relationship between plasma drug concentration and therapeutic response or side effects. Citalopram is metabolized in the liver to active metabolites, which are also inhibitors of serotonin reuptake but do not contribute to overall antidepressant effects. Excreted mainly in the bile (85%), in a smaller percentage (15%) also in the urine.
The preparation is indicated for use in the following cases:
• treatment of depression and prevention of recurrence of depressive disorders
• treatment of panic disorder with or without agoraphobia.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients.
Contraindication to the use of the preparation is:
• use of MAO inhibitors (monoamine oxidase inhibitors)
The preparation is contraindicated in the case of MAO inhibitors, including selegiline in a dose greater than 10 mg per day. The preparation can be started no earlier than 14 days after discontinuation of irreversible MAO inhibitors, and in the case of reversible MAO inhibitors, not earlier than after the time specified in the manufacturer's materials. MAO inhibitors may be instituted for treatment not earlier than 7 days after discontinuation of the preparation (citalopram).
• use of linezolid (unless close clinical observation and monitoring of blood pressure is possible)
• prolonged QT interval in ECG or congenital long QT interval
• use of other medicines that may prolong the QT interval.
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
Do not use the preparation in children and adolescents up to 18 years of age. In this group of patients, the use of the preparation may be associated with the occurrence of behavioral changes (aggression, hostility) and suicidal tendencies. However, if, in an individual case, the physician considers the use of the preparation in a patient of this age group to be strictly necessary, the patient should be closely monitored for suicidal behavior, including suicidal thoughts and attempts.
Data regarding the safety of long-term use of citalopram in children and adolescents are limited.
In patients with panic disorder, aggravation of anxiety symptoms may occur in the initial period of application. It is a paradoxical reaction, contrary to the intended effect, which usually disappears after about 2 weeks of using the preparation. To minimize the risk of anxiety symptoms, it is recommended to start treatment with a low initial dose.
Hyponatraemia (a decrease in blood sodium levels) is rare. It is probably the result of the syndrome of abnormal secretion of antidiuretic hormone (vasopressin); Elderly people are particularly vulnerable. This effect is transient and usually resolves after treatment.
Depression and other psychiatric conditions in which citalopram is prescribed can often be associated with an increased risk of suicidal behavior (suicidal thoughts and attempts). This risk persists until full recovery. Treatment is a long-term process, improvement can occur only after a few weeks of treatment, sometimes this time is longer. During the treatment period, the patient should be closely monitored. It should be emphasized that the risk of suicide may increase in the initial stages of the healing process.
People after suicide attempts, suicidal tendencies and those who had suicidal thoughts before starting treatment should be closely and carefully monitored during the treatment, especially at the beginning of the treatment and each time after the change of dosage. The group of special risks are people under the age of 25. Patients and those around them should pay attention to any clinical signs of disease severity, suicidal behavior or thoughts and changes in behavior, and contact their physician immediately if they occur.
The use of the preparation may be associated with the occurrence of anxiety, which is often accompanied by the inability to sit or stand still (akathisia). The occurrence of akathisia is most likely in the first weeks of treatment. In patients with akathisia, increasing the dose may be harmful.
In the case of bipolar disorder, the use of the preparation may be accompanied by the onset of the manic phase; if it occurs, your doctor will decide to stop using the product.
The use of antidepressants is associated with the risk of seizures. The occurrence of seizures usually requires discontinuation of the drug (this decision is made by the doctor). Avoid using citalopram in people with poorly controlled epilepsy. Patients with controlled epilepsy should be closely monitored. If the frequency of convulsive seizures increases, the physician will decide to discontinue use.
Diabetes should be used with caution. In diabetic patients, it may be necessary to change the dosage of insulin or oral antidiabetic agents (this decision is made by a physician).
If at the same time symptoms such as agitation, tremor, muscle clonic convulsions and elevated temperature occur, you should immediately consult a physician. The cause may be a so-called serotonin syndrome, a life-threatening condition. The serotonin syndrome requires immediate medical attention.
In parallel with citalopram, drugs affecting the activation of serotonin receptors (drugs with serotoninergic effect), such as: oxytryptan, Sumatriptan and other triptans, tramadol and tryptophan should not be used.
During the use of the preparation may occur prolonged or abnormal bleeding, including petechiae, vaginal bleeding, bleeding from the upper gastrointestinal tract, bleeding within the skin or mucous membranes. During treatment, patients should be under strict medical supervision if they are using medicines that affect platelet function or may increase the risk of bleeding, as well as if they have had blood clotting disorders in the past.
There is little data on parallel treatment with citalopram and the use of electroshock. For this reason, the treatment should be carried out with exceptional precautions. You should tell your doctor if you have used this method of treatment in the past.
In parallel with citalopram, herbal preparations containing St John's wort should not be used as this may contribute to side effects.
Do not stop the treatment suddenly because you may experience withdrawal symptoms, including dizziness, paresthesia (sensory disturbances such as tingling, numbness, sensation of electric shock), sleep disturbances (including insomnia and expressive dreams), agitation, anxiety, tremors muscular, nausea and / or vomiting, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and impaired vision. These symptoms usually disappear spontaneously within two weeks, but may persist for 2-3. months or longer. If discontinuation of the preparation is required, the dose should be gradually reduced over several weeks or months, following the doctor's instructions.
In patients with psychosis, the preparation may exacerbate psychotic symptoms; you should be under strict medical supervision.
Citalopram may cause dose-dependent QT interval prolongation in the ECG and ventricular arrhythmias (includingtorsade de pointes, life-threatening), mainly in women, patients with reduced levels of potassium in the blood (hypokalaemia), coexisting QT prolongation or other heart diseases.
Caution is advised in patients with severe bradycardia, recent heart attack or congestive heart failure .
In patients with stable cardiac disease, the doctor will prescribe ECG before using citalopram.
Electrolyte abnormalities such as hypokalaemia (decreased potassium in the blood) and hypomagnesaemia (reduced blood Magnesium levels) increase the risk of malignant arrhythmias. The electrolyte concentration should be evened before starting treatment with citalopram.
If cardiac arrhythmias develop during treatment with citalopram, please consult your doctor immediately.
Citalopram may cause dilation of the pupil of the eye, which may lead to increased intraocular pressure and glaucoma with a closed angle of perception. Caution should be exercised in patients with glaucoma.
Additional information about the other ingredients of the preparation:
• the product contains lactose; people with galactose intolerance, lactase deficiency or malabsorption of Glucose -galactose should not use this preparation.
Does this preparation affect the ability to drive vehicles?
The preparation may impair the psychomotor efficiency and limit the ability to drive vehicles and operate equipment / machines. Psychoactive drugs can interfere with the ability to assess the situation and respond quickly to emergencies.
The preparation is in the form of coated tablets for oral use. Do not exceed the recommended doses, because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts about the use of the preparation, consult your doctor.
Treatment of depression: 20 mg once daily. If necessary, your doctor may decide to increase the dose to a maximum of 40 mg a day.
Treatment of anxiety disorders with anxiety attacks: 10 mg once daily in the first week of treatment and then 20 mg once daily. If necessary, your doctor may decide to increase the dose to a maximum of 40 mg a day.
In elderly patients (after the age of 65): 10-20 mg once daily. The maximum dose is 20 mg per day.
Do not use the preparation in children and adolescents up to 18 years of age.
No dose adjustment is required in people with mild or moderate renal impairment.In people with severe renal impairment (creatinine clearance less than 20 ml / min), the use of the preparation is not recommended.
In subjects with mild or moderate hepatic impairment and in those who have been found to have a slow metabolism with CYP2C19, the initial dose for the first 2 weeks should be 10 mg daily. The maximum dose is 20 mg per day. People with severe hepatic impairment should be treated with extreme caution.
The way of taking the preparation:
The tablets should be swallowed whole (not chewed) with water; taken once daily, possibly at the same time of the day, regardless of the meal.
Duration of treatment:
The physician always decides about the time of application. The antidepressant effect is usually obtained after 2 -4. weeks of use. In the prevention of relapse, the use of the preparation should usually be continued for 6 months after the disappearance of depressive symptoms. In patients with recurrent depression, treatment may take several years. In patients with anxiety disorders, the first effects of the drug are usually seen after 2 -4. weeks of use and the maximum efficacy of citalopram is usually achieved after about 3 months and persists during further treatment.
Do not suddenly stop using the product. If it is necessary to stop using the product, the dose should be gradually reduced by following the doctor's instructions.
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that you consult a physician before taking any medicine during pregnancy or breastfeeding and explain beyond any doubt the potential risks and benefits of using the medicine. If you are pregnant or planning to become pregnant, please inform your prescribing physician about this medicine.
The preparation should not be used during pregnancy unless the physician considers the preparation to be strictly necessary. If the physician, considering the expected benefits and possible risks, considers using the preparation as absolutely necessary, he will also recommend appropriate precautions and necessary tests.
There are insufficient data on the safety of the preparation during breastfeeding. Consult a physician.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Taking the preparation is contraindicated when using:
• MAO inhibitors, due to the risk of serious side effects, including those leading to death;
The preparation can be started no earlier than 14 days after discontinuation of irreversible MAO inhibitors (eg selegiline), and in the case of reversible MAO inhibitors (eg moclobemide, linezolid), not earlier than after the time specified in the manufacturer's materials. MAO inhibitors may be instituted for treatment no earlier than 7 days after discontinuation of the preparation (citalopram);
• linezolid (unless close clinical observation and monitoring of blood pressure is possible)
• buspiron, due to the risk of serotonin syndrome
• drugs that prolong the QT interval in the ECG (possible strengthening of the QT prolonging effect leading to severe arrhythmia), such as class IA and III antiarrhythmics, antipsychotics (eg phenothiazine derivatives, pimozide, Haloperidol ), tricyclic antidepressants, some antibacterial agents (eg sparfloxacin, moxifloxacin, intravenous Erythromycin , pentamidine, medicines used to treat malaria, especially halofantrine), some antihistamines (astemizole, mizolastine).
If adequate precautions are taken by the physician, the product may be used with selegiline (a selective MAO inhibitor) at a dose of up to 10 mg per day. The use of the preparation with selegiline in a dose greater than 10 mg daily is contraindicated.
Caution should be exercised when using the preparation in combination:
• with lithium; risk of increased activity; control the concentration of lithium in the blood
• with drugs that increase the activation of serotonin receptors (e.g.tramadol or sumatriptan); in parallel with citalopram should not be used drugs with serotonergic effect, such as: oxytiptan, sumatriptan and other triptans, tramadol and tryptophan
• concomitant herbal preparations containing St. John's wort should not be used in parallel with citalopram, as this may contribute to side effects
• with anticoagulants that affect platelet function (eg NSAIDs , Acetylsalicylic acid , dipyridamole and ticlopidine) or other medicines (eg atypical antipsychotics, phenothiazine derivatives, tricyclic antidepressants) that may increase the risk of hemorrhage
• electroshock; there are no safety data or benefits associated with such combination treatment
• with medicines that may cause hypokalemia or hypomagnesaemia; the risk of serious arrhythmias increases
• with drugs that may lower the seizure threshold, such as for example: with neuroleptic drugs (derivatives of thioxanthene and butyrophenone derivatives), mefloquine, bupropion and tramadol, due to the possibility of pharmacodynamic interactions
• cimetidine or drugs that inhibit CYP2C19 activity (eg Omeprazole , esomeprazole, fluvoxamine, lansoprazole, ticlopidine) - your doctor may need to modify your dose of citalopram
• CYP2D6-mediated metabolisers (eg flecainide, propafenone, Metoprolol , antidepressants such as desipramine, clomipramine, nortriptyline, antipsychotics such as Risperidone , thioridazine and haloperidol may need to be adjusted by a physician)
Alcohol is not recommended during treatment.
Like all medicines, Aurex 20, -40 can cause side effects, although they will not occur in all patients using this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Side effects are usually mild and transient. They most often occur in the 1st and 2nd week of treatment and usually disappear as the patient improves.
Very often may occur: drowsiness, insomnia, headache, dizziness, nausea, dry mouth, excessive sweating.
Often or uncommon: weight gain or loss, increase or decrease in appetite, sleep disturbance, anxiety, agitation, nervousness, confusion, aggression, depersonalization, hallucinations, mania, tremors, paresthesia, dizziness, impaired concentration, fainting, visual impairment, mydriasis, tinnitus, increased or decreased heart rate (tachycardia or bradycardia), yawning, diarrhea, vomiting, constipation, hypersensitivity reactions (pruritus, rash, urticaria, purpura, photosensitivity, alopecia), muscle pain, joint pain, urinary retention, decreased sex drive, ejaculation problems, impotence, lack of orgasm in women, increased menstrual bleeding, bleeding from the genital tract, tiredness, edema.
Rarely or very rarely may occur: hyponatraemia (decrease in blood sodium), seizuresgrand mal, dyskinesias, dysgeusia, hepatitis, fever.
In addition, there may be side effects for which the frequency of occurrence has not been determined, such as: syndrome of abnormal secretion of antidiuretic hormone, thrombocytopenia, hypokalaemia (decrease in potassium in the blood), panic attacks (these symptoms may be related to the underlying disease), bruxism, anxiety, suicidal thoughts, suicidal behavior (including suicide attempts), convulsions, serotonin syndrome, extrapyramidal disorders, movement disorders, akathisia (anxiety, which may be accompanied by an inability to sit or stand still), visual disturbances, QT prolongation in the ECG, cardiac arrhythmias, including life-threatening type disorderstorsade de pointes, orthostatic hypotension, bleeding (eg, genital tract bleeding, gastrointestinal haemorrhage, including rectum, epistaxis, ecchymosis or other bleeding or bleeding within the skin or mucous membranes), abnormal liver function tests, priapism, galactorrhoea in men, hypersensitivity, angioneurotic edema , Anaphylactic reactions .
Do not suddenly stop using the product, which may be accompanied by withdrawal symptoms, including dizziness, paresthesia (sensory disturbances such as tingling, numbness, sensation of electric shock), sleep disorders (including insomnia and expressive dreams), agitation, anxiety , muscle tremors, nausea and / or vomiting, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability and impaired vision. These symptoms usually disappear spontaneously within two weeks, but may persist for 2-3. months or longer.
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