► Asertin 50 (sertraline) - Medycyna Praktyczna

Asertin 50 (sertraline) - coated tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Asertin 50 coated tablets; 50 mg; 30 tabl. Biofarm 13.48 0.00

Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:sertraline

The drug is available on prescription

What is Asertin?

An antidepressant drug that belongs to the group of serotonin reuptake inhibitors.

What does Asertin contain and how does it work?

The active substance is sertraline, 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. The effect of sertraline 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 receiving cell. Nerve impulses are sent more often. Greater stimulation of serotonin-dependent cells is associated with the pharmacological and clinical effects of sertraline. Sertraline also inhibits the uptake of serotonin by platelets. It does not show affinity for adrenergic (alpha 1, alpha 2, beta), cholinergic, GABA, Dopamine rgic, histaminergic, serotoninergic and benzodiazepine receptors. It does not work cardiotoxically, seductively and anticholinergically. Long-term administration of sertraline to animals leads to a reduction in the number and sensitivity of noradrenergic receptors in the brain. The drug has not been shown to be prone to abuse.

When to use Asertin?

The preparation is indicated for the treatment of:
· Episodes of major depression, as well as prevention of their recurrence
· Obsessive-compulsive disorder in adults and children over 6 years of age
· Panic disorder with or without agoraphobia
· Post-traumatic stress disorder
· Social anxiety 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.
Parallel use of sertraline with MAO inhibitors is contraindicated, may lead to the development of serotonin syndrome (with symptoms such as agitation, tremor, hyperthermia). Treatment with sertraline can be started no earlier than two weeks after the end of the MAO inhibitors; treatment with MAO inhibitors can be started one week after the end of the use of sertraline.
The use of MAO inhibitors pimozide is contraindicated in parallel with sertraline.

When should you take extra care with Asertin?

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.
If you need to replace your other antidepressant with sertraline, be careful, your doctor will carry out a thorough assessment of your health.
Persons suffering from mania should remain under close medical supervision during treatment (if the manic phase occurs, the use of the preparation will be discontinued).
In patients with schizophrenia, the sperm of psychotic symptoms may occur during treatment.
It is not recommended for people with epilepsy unless the doctor considers it necessary. If epileptic seizures occur during treatment, a doctor should be consulted; it will probably be necessary to stop using the product.
The effects of treatment with sertraline 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 preparation may be associated with a suicide attempt. High-risk group are people under the age of 25. Any noticeable disturbing behavioral changes should be immediately reported to the doctor.
The preparation should not be used in children and adolescents under 18 years of age (except for those over 6 years of age who suffer from obsessive-compulsive disorders). Lack of long-term data regarding safety of use regarding growth, maturation, as well as 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 (in this age group the risk of suicidal thoughts and behavior and hostility is greatest). If you notice any irregularities, please contact your pediatrician immediately.
Caution should be used if the patient is using oral anticoagulants, 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), as well as if it has a bleeding diathesis (prolonged or abnormal bleeding may occur during application).
There have been reports of hyponatraemia during the use of the preparation; this phenomenon is associated with disorders of antidiuretic hormone secretion. Caution should be exercised in the elderly, as well as in people with liver cirrhosis or those taking medications that may lead to hyponatraemia.
Do not stop treatment suddenly because withdrawal reactions may occur. The risk of their occurrence depends on several factors, including duration of treatment, dose size and rate of dose reduction. The most common symptoms are: dizziness, sensory disturbances (including paraesthesia), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremor and headache. Generally, these symptoms are mild or moderate, but may be severe in some people. They usually occur during the first few days after discontinuation of treatment, although sometimes it happened when the patient forgot to take one dose. To prevent their occurrence, it is recommended to gradually reduce the dose within a few weeks or months, strictly according to the doctor's instructions.
The use of the product may lead to akathisia in some people (unpleasant or troublesome restlessness and need for movement, often accompanied by an inability to sit or stand), especially in the first weeks of treatment. In this case, your doctor will probably not increase your dose.
In people with mild to moderate hepatic impairment, it is recommended to use lower doses of the preparation or to keep longer intervals between consecutive doses.
Due to the lack of clinical data, the preparation should not be used in people with severe hepatic impairment.
If you have diabetes, you may need to adjust your insulin dose and / or oral hypoglycemic agents.
There are no data on parallel treatment with sertraline and the use of electroconvulsants.

Information on additional components of the preparation:
The preparation contains lactose. Individuals with rare hereditary galactose intolerance, primary lactase deficiency and malabsorption of Glucose -galactose should not use it.
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 Asertin

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.

Depression, obsessive-compulsive disorder:
Usually 50 mg daily is used. If necessary, your doctor may decide to gradually (at least 7 days) increase the dose by 50 mg to a maximum of 200 mg a day.
In the maintenance treatment to prevent the recurrence of previous depressive states or the occurrence of new depressive disorders, it is recommended to use minimal, effective doses of the drug for at least 6 months. Your doctor will periodically evaluate the patient's response to treatment and adjust the dose if necessary.
Panic disorder, post-traumatic stress disorder and social anxiety disorder:
The starting dose is 25 mg a day. After one week, the dose should be increased to 50 mg daily (initiation of treatment from a lower dose counteracts the occurrence of paradoxical anxiety attacks at the beginning of the application). If necessary, your doctor may decide to gradually (at least 7 days) increase the dose by 50 mg to a maximum of 200 mg a day.
Children and adolescents from 6 to 12 years of age:
Obsessive-compulsive disorder:
The starting dose is 25 mg a day. If necessary, your doctor may decide to gradually (at least 7 days) increase the dose by 50 mg to a maximum of 200 mg a day.
Children and adolescents from 13 to 18:
Obsessive-compulsive disorder:
The starting dose is 50 mg a day. If necessary, the doctor may decide on a gradual (at least 7 days) dose increase depending on the needs up to a maximum of 200 mg per day.
The clinical effects of the medicine may occur after 7 days of treatment. Optimal treatment effects occur, as with other antidepressants, only for a longer time.

There is no need to adjust the dose in the elderly or in patients with impaired renal function.
Elderly caution should be used because of the risk of hyponatraemia.
In people with mild to moderate hepatic impairment, it is recommended to use lower doses of the preparation or to keep longer intervals between consecutive doses.
Due to the lack of clinical data, the preparation should not be used in people with severe hepatic impairment.
Due to the lack of tests, the preparation should not be used in children and adolescents under 18 years of age; this does not apply to people over 6 years of age with obsessive-compulsive disorder.
Method of administration:
The product should be used once a day in the morning or in the evening, regardless of the meal, with a sufficient amount of liquid.

Can you use Asertin 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.
During pregnancy and during breastfeeding, the preparation is used only in cases where the benefit for the mother outweighs the potential risk to the fetus (the risk is always assessed by the doctor individually).
It is not recommended to use the product during pregnancy and breastfeeding in other cases.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter.
The parallel use of sertraline with MAO inhibitors is contraindicated, may lead to the occurrence of serotonin syndrome (myoclonus and other involuntary movements, increased reflexes, stiffness, orthostatic hypotension, confusion, excitatory states). Treatment with sertraline can be started no earlier than two weeks after the end of the MAO inhibitors; treatment with MAO inhibitors can be started one week after the end of the use of sertraline.
The parallel use of pimozide with sertraline is contraindicated
Caution should be exercised when using the preparation in combination:
· With lithium, due to the serotonergic effect of sertraline; the plasma concentration of lithium should be monitored
· With phenytoin - its plasma concentration should be monitored at the beginning of treatment to optimize the dose; there may also be a decrease in sertraline plasma levels
· With Sumatriptan and other triptans, as may be weakened, excessive motor response, lack of coordination, confusion, anxiety and agitation
· With other drugs that potentiate the effect of serotoninergic neurotransmission (such as tryptophan, fenfluramine, 5-HT agonists) and herbal products containing St. John's Wort (Hypericum perforatum); the possibility of pharmacodynamic interactions
· With Warfarin , due to possible prolongation of prothrombin time
· With cimetidine, because the clearance of sertraline is reduced
· With medicines that affect platelet function or other medicines that may increase the risk of bleeding (eg acetylsalicylic acid, non-steroidal anti-inflammatory drugs, COX-2 inhibitors); prolonged or abnormal bleeding may occur
· With desipramine and other drugs metabolised by the cytochrome P450 CYP2D6 isoenzyme, especially those with a narrow therapeutic index, such as class 1C antiarrhythmics, tricyclic antidepressants, and typical antipsychotic drugs.
You should not drink alcohol during treatment.

What side effects can occur?

Like all medicines, Asertin can also cause side effects, although it 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.
Common: throat inflammation, anorexia, increased appetite, depression, depersonalization, nightmares, anxiety, agitation, nervousness, decreased libido, bruxism, paresthesia, tremor, hypertonia, taste disorders, concentration disorders, visual disturbances, tinnitus, palpitations , hot flushes, yawning, abdominal pain, vomiting, constipation, indigestion, bloating, rash, sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.
Uncommon: upper respiratory tract infections, rhinitis, hallucinations, euphoric moods, apathy, thinking disorders, seizures, involuntary muscle contractions, coordination disorders, hyperkinesia, amnesia, sensation impairment, speech disorders, postural headaches, MIG raine, earache , tachycardia, hypertension, sudden redness of the skin, bronchospasm, shortness of breath, nosebleeds, esophagitis,
dysphagia, haemorrhagic tumors, salivary gland hyperactivity, tongue disorders, gastrointestinal reflexes, periorbital edema, purpura, alopecia, cold sweats, dry skin, urticaria, osteoarthritis, muscle weakness, backache, muscle tics, nocturnal urination , urinary retention, polyuria, pollakiuria, urinary disorders, vaginal bleeding, sexual dysfunction in women, feeling unwell, chills, fever, asthenia, thirst, weight loss, weight gain.
Rarely can occur: diverticulitis, gastroenteritis, otitis media, tumors, lymphadenopathy, hypercholesterolemia, hypoglycaemia, conversion disorders, drug addiction, psychotic disorders, aggression, paranoia, suicidal ideation, cougar-somnolence, premature ejaculation, coma , choreoathetosis, dyskinesia, sensory disorders, hyperaesthesia, glaucoma,disorders of tear production, visual field defects, double vision, photophobia, bleeding in the anterior chamber of the eye, mydriasis, myocardial infarction, bradycardia, cardiac disorders, peripheral ischaemia, laryngeal spasm, hyperventilation, hypoxia, larynx, dysphonia, hiccups, tarry stools , presence of fresh blood in the stool, oral mucositis, tongue ulcer, tooth disorder, tongue inflammation, mouth ulcer, liver dysfunction, dermatitis, skin inflammation of the skin, follicular rash, abnormal hair structure, abnormal skin odor, bone disorders, oliguria, urinary incontinence, delayed urination, menorrhagia, atrophic vulvovaginitis, glans and foreskin inflammation, discharge, galactorrhea, painful erection of a member, hernia, swelling at the injection site, reduction of drug tolerance, gait disturbance, increased enzyme activity liver, abnormalities associated with semen, injuries.
In addition, leukopenia, thrombocytopenia, Anaphylactic reactions , allergic reactions, hyperprolactinemia, hypothyroidism and the syndrome of abnormal secretion of antidiuretic hormone, hyponatremia, nightmares, suicidal thoughts or behaviors, motor disorders (including extrapyramidal disorders) may occur with unknown frequency : hyperkinesia, hypertonia, gnashing of teeth, gait disturbances), syncope, symptoms of serotonin syndrome (agitation, confusion, profuse sweating, diarrhea, fever, hypertension, stiffness, tachycardia), akathisia / psychomotor restlessness, visual disturbances, abnormal bleeding, pancreatitis , severe liver disease (hepatitis, jaundice, hepatic failure), asymptomatic elevation of transaminase, Stevens and Johnson syndrome, epidermal necrolysis, angioedema, facial edema, sensitivity to light, skin reactions, pruritus, joint pain, muscle spasms, gynecomastia, irregular menstruation, peripheral edema, abnormal laboratory tests, platelet dysfunction, increased cholesterol.
Epidemiological studies have shown an increased risk of bone fractures among patients (mainly over 50 years of age) receiving drugs from this group; the mechanism of this action is unknown.

Children and adolescents from 6 to 18 years of age:
In pediatric patients treated with sertraline, the general characteristics of adverse reactions were similar to those seen in studies with adults.
The following side effects have been observed:
Very often there were: headache, insomnia, diarrhea, nausea.
Common: chest pain, mania, fever, vomiting, anorexia, emotional lability, aggression, agitation, nervousness, attention disorders, dizziness, hyperkinesia, migraine, drowsiness, tremors, blurred vision, dry mouth, indigestion, nightmares night, fatigue, incontinence, rash, acne, nosebleed, bloating.
Uncommon: ECG prolongation, suicide, convulsions, extrapyramidal disorder, paraesthesia, depression, hallucinations, purpura, hyperventilation, anemia, hepatic impairment, alanine aminotransferase increased, cystitis, herpes, external otitis, earache , eye pain, mydriasis, malaise, haematuria , pustular rash, rhinitis, injuries, weight loss, muscle twitching, abnormal dreams, apathy, albuminuria, pollakiuria, polyuria, breast pain, menstrual disorders, alopecia, dermatitis, abnormal skin smell, hives, bruxism, hot flushes.

Other preparations on the Polish market containing sertraline

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Asentra (coated tablets)
Asertin 100 (coated tablets)
Miravil (coated tablets)
Sastium (coated tablets)
Sertagen (coated tablets)
Sertralina Krka (coated tablets)
Sertraline Aurobindo (coated tablets)
Sertranorm (coated tablets)
Setaloft 50 mg (coated tablets)
Setaloft 100 mg (coated tablets)
Stimuloton (coated tablets)
Zoloft (coated tablets)
Zotral 50 mg (coated tablets)
Zotral 100 mg (coated tablets)