|The name of the preparation
||Character; dose; package
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|Arketis 20 mg
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:paroxetine
The drug is available on prescription
What is Arketis?
An antidepressant drug that belongs to the group of serotonin reuptake inhibitors.
What does Arketis contain and how does it work?
The active substance is paroxetine, belonging to the group of serotonin reuptake inhibitors (you can find the abbreviation SSRI for this group of drugs, derived from the English selective serotonin reuptake inhibitor). Serotonin is one of the neurotransmitters, substances that play an important role in communication between neurons. The place of connection of two neurons is called the synapse. The cell that transmits the information in front of the synapse releases a so-called mediator into the synaptic cleft, a substance that is captured and recognized by the cell receiving information behind the synapse. In this case, the mediator is serotonin. Some serotonin molecules are captured back by the neuron receptors in front of the synapse, what we call the reuptake. Paroxetine works by inhibiting the process of reuptake of serotonin, and thus by prolonging the duration of serotonin in the synapse and the time of stimulation of the receiving cell. Nerve impulses are sent more often. Higher stimulation of serotonin-dependent cells is associated with antidepressant effects, as well as with conditioning of treatment of obsessive-compulsive disorder, social phobia, generalized anxiety disorder, post-traumatic stress disorder and anxiety disorder with anxiety attacks. Paroxetine has little affinity for muscarinic receptors. Animal studies have shown its weak anticholinergic properties. Paroxetine has no inhibitory effect on the central nervous system and has no hypotensive properties. The use of paroxetine in the morning has no detrimental effect on the quality or length of sleep. What's more, people who respond to paroxetine are experiencing sleep improvement.
When to use Arketis?
The preparation is indicated for the treatment of:
· Severe episode of depression
· Obsessive-compulsive disorder
· Anxiety disorder with or without drug agoraphobia attacks
· Social phobia
· Generalized anxiety disorder
· Post-traumatic stress disorder.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the preparation if you are allergic (you are hypersensitive) to any of the ingredients.
The use of MAO inhibitors
in parallel with paroxetine is contraindicated.
Treatment with paroxetine may be started 14 days after discontinuation of irreversible MAO inhibitors and the day after discontinuing type A MAO reversible inhibitors. MAO inhibitors may be initiated 1 week after discontinuation of paroxetine.
Paroxetine should not be used in parallel with thioridazine, due to the possible prolongation of the QT interval and associated severe ventricular arrhythmiastorsades de pointes.
The product should not be used in parallel with pimozide.
Take special care with Arketis?
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.
Data regarding the safety of long-term use of paroxetine in children and adolescents up to 18 years of age are limited. Lack of long-term safety data regarding growth, maturation, cognitive development and behavioral development. If the physician decides about the need to treat the child with this preparation, the patient's development should be monitored as well as its behavior in relation to the occurrence of suicidal thoughts and behaviors. If you notice any irregularities, please contact your pediatrician immediately.
The effects of treatment with paroxetine are visible after a few weeks of its use, sometimes this time is longer. Especially people with a tendency to suicidal thoughts associated with depression should be under strict medical supervision during this period, because the use of the drug may be associated with a suicide attempt. Any noticeable disturbing behavioral changes should be immediately reported to the doctor.
The use of the preparation may lead to akathisia in some people (state of anxiety, inability to refrain from performing movements), especially in the first weeks of treatment. In this case, your doctor will probably not increase your dose.
If you experience symptoms such as:
· Muscle stiffness
· Muscle clonic convulsions
· Unstable autonomic system with possible rapid fluctuations in vital functions
· Changes in mental state (irritability, confusion, extreme psychomotor agitation going into delusion and coma)
you should immediately contact your doctor, because their cause may be dangerous for life so-called "serotonin syndrome".
In the following cases, during treatment, the patient should remain under close medical supervision:
· If you suffer from mania (if you have a manic phase, your doctor will probably stop the treatment)
· If you have kidney or liver failure
· If you suffer from epilepsy
· If you have heart problems
· If you are taking oral anticoagulants, medicines that affect your blood platelet function or other medicines that may increase the risk of bleeding (eg atypical antipsychotics such as clozapine, phenothiazine derivatives, most tricyclic antidepressants, Acetylsalicylic acid
, non-steroidal anti-inflammatory drugs, inhibitors COX-2), as well as if there have been blood coagulation disorders in the past (prolonged or abnormal bleeding may occur during treatment).
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 a convulsive attack occurs during treatment, the treatment should be discontinued (this decision should be taken by a doctor).
The experience in the treatment of paroxetine of people who have had electroconvulsive therapy is very low. For this reason, caution is recommended in this group of people.
Paroxetine, like other medicines in this group, may cause mydriasis; caution should be used in patients with narrow-angle glaucoma or glaucoma.
There are rare reports of hyponatremia with paroxetine, especially in older people. This phenomenon usually disappears spontaneously after discontinuation of the preparation.
Do not stop treatment suddenly because withdrawal reactions may occur. Typical symptoms include: dizziness, sensory disturbances (including paraesthesia), sleep disorders (including insomnia and intense dreams), weakness (asthenia), agitation or anxiety, nausea and / or vomiting, tremor and headache. If discontinuation of the preparation is required, the dose should be gradually reduced, strictly following the instructions of the physician.
Does this preparation affect the ability to drive vehicles?
The preparation may affect your ability to drive or use machines / machines.Psychoactive drugs can impair the ability to make decisions and reactions in emergency situations. Be careful!
Dosage of Arketis
The preparation is in the form of 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 regarding the use of the preparation, consult a physician.
Severe episode of depression, social phobia, generalized anxiety disorder, post-traumatic stress disorder:
Usually 20 mg daily is used. If necessary (after at least a few weeks) the doctor may decide to increase the dose by 10 mg to a maximum of 50 mg a day.
The improvement of the patient's condition becomes visible in the second week of treatment.
The use of the preparation should be continued for at least 6 months to ensure that the symptoms of depression disappear. The physician always decides about the time of application.
Typically, 40 mg / day is used, the starting dose should be 20 mg / day. If necessary, your doctor may decide to increase the dose to a maximum of 60 mg a day.
To ensure the effectiveness of treatment, the patient should use the preparation for at least several months. The physician always decides about the time of application.
Anxiety disorder with anxiety attacks:
Typically, 40 mg / day is used, the starting dose should be 10 mg / day.
Starting treatment with a low starting dose is recommended to reduce the risk of exacerbation of panic disorder symptoms, which sometimes occurs during the initial treatment period. If, after several weeks of using the recommended dose, the observed response to treatment is insufficient, your doctor may decide to increase the dose to a maximum of 60 mg a day.
People with anxiety disorder with anxiety attacks should be treated long enough to ensure relief of symptoms. This period can last several months or even longer. The physician always decides about the time of application.
Long-term treatment should be regularly evaluated.
In the elderly, the maximum dose is 40 mg per day.
In people with liver failure and severe renal insufficiency, it is recommended to use the smallest doses of the preparation.
Due to the lack of tests, the preparation is not used in children and adolescents under 18 years of age.
Method of administration:
The preparation should be used once a day in the morning, with a sufficient amount of liquid during a meal. Tablets should not be chewed.
Can you use Arketis during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or planning to become pregnant, consult your doctor before using the product.
The preparation should not be used in women planning pregnancy or during pregnancy, unless the doctor considers that the mother's condition necessarily requires it (after considering the possibility of using alternative therapy). Avoid sudden paroxetine treatment during pregnancy.
Paroxetine is excreted in breast milk to a small extent, therefore the doctor may consider using the product during breastfeeding.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Concomitant use of paroxetine with MAO inhibitors (risk of serotonin syndrome) and pimozide is contra-indicated (the possibility of QT interval prolongation).
As a potent CYP2D6 inhibitor, paroxetine may cause a decrease in the concentration of endoxifen, one of the most important active metabolites of Tamoxifen
. Therefore, if possible, use of paroxetine should be avoided during treatment with tamoxifen.
Caution should be exercised when using the preparation in combination:
· With procyclidine, because its plasma concentration is significantly increased and anticholinergic symptoms may occur; your doctor will reduce the dose of procyclidine in this case
· With serotonergic drugs (such as L-tryptophan, triptans, tramadol, linezolid, methylthionine chloride, SSRIs, lithium, pethidine and St. John's wort) due to the possibility of serotonin syndrome
· With fentanyl under general anesthesia or for the treatment of chronic pain
· Drugs metabolised by the CYP2D6 cytochrome P-450 isoenzyme; simultaneous use of paroxetine and Metoprolol
given in heart failure
is not recommended due to its narrow therapeutic index in this indication.
· With oral anticoagulants, as well as with medicines that affect platelet function or other medicines that may increase the risk of bleeding (eg atypical antipsychotics such as clozapine, phenothiazine derivatives, most tricyclic antidepressants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, COX-2 inhibitors), because it is possible to change their action (for example, increased bleeding)
· With St. John's wort, because the risk of side effects of paroxetine increases.
You should not drink alcohol during treatment.
What side effects can occur?
Like all medicines, also Arketis can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Very often may occur: nausea, sexual dysfunction.
Common: cholesterol-lowering, decreased appetite, drowsiness, insomnia, agitation, abnormal dreams (including nightmares), dizziness, tremor, headache, abnormal concentration, blurred vision, constipation, diarrhea, vomiting, dry mouth oral, sweating, weakness, weight gain.
Uncommon: unusual bleeding, mostly affecting the skin and mucous membranes - most often ecchymosis, confusion, hallucinations, extrapyramidal symptoms, mydriasis, sinus tachycardia, transient increase or decrease of blood pressure, orthostatic hypotension, rash, pruritus, urinary retention, incontinence urine.
Rarely may occur: hyponatremia, manic reactions, anxiety, depersonalization, panic attacks, akathisia, convulsions, restless legs syndrome, bradycardia, increased liver enzymes, hyperprolactinemia / galactorrhea, joint pain, muscle pain.
Very rarely may occur: thrombocytopenia, allergic reactions (including urticaria and angioneurotic edema
), syndrome of inappropriate secretion of antidiuretic hormone, serotonin syndrome (symptoms: agitation, confusion, sweating, hallucinations, hyperreflexia, myoclonus, chills, tachycardia and tremor), acute glaucoma, Gastrointestinal bleeding
, liver dysfunction, such as hepatitis, sometimes associated with jaundice and / or liver failure, severe skin reactions (including erythema multiforme, Stevens and Johnson syndrome, toxic epidermal necrolysis), photosensitivity, priapism (prolonged, painful erection without sexual arousal), peripheral edema.
In addition, suicidal thoughts, suicidal behavior, tinnitus may occur with an unknown frequency.
Cases of suicidal thoughts and suicidal behavior have been reported during treatment with paroxetine or shortly after discontinuation of treatment.
Epidemiological studies have shown an increased risk of bone fractures among patients taking drugs in this group, the mechanism of this action is not known.
Other preparations on the Polish market containing paroxetine
ParoGen (coated tablets)
Paroxetine Aurobindo (coated tablets)
Paroxinor (coated tablets)
Paxtin 20 (coated tablets)
Paxtin 40 (coated tablets)
Rexetin (coated tablets)
Seroxat (coated tablets)
Xetanor 20 mg (coated tablets)