Seronil – composition, action, indications, contraindications and dosage of the drug

Proven content

Seronil is a drug used in psychiatric treatment. It is used in adults and children to treat major depressive episodes and in adults to treat obsessive-compulsive disorder and bulimia nervosa. The active substance of the drug is fluoxetine, which is a selective serotonin reuptake inhibitor. The drug is available only with a prescription and the doctor decides to start the therapy with Seronil. What is the overall composition of this drug? What is the mechanism of action of Seronil? What are the indications and contraindications for its use? What side effects can its use cause? How to take the preparation and with what drugs not to combine it?

Seronil – general characteristics of the drug

Seronil, internationally known as Fluoxetinum, is a selective serotonin reuptake inhibitor, it does not significantly affect other receptors. It is a preparation belonging to the group antidepressants used in psychiatry and issued on a prescription issued by a doctor.

The active substance in the drug is fluoxetine hydrochloride, which increases the concentration of serotonin in the brain.

Seronil is available as film-coated tablets or hard capsules. The dose of fluoxetine in one film-coated tablet is 10 mg, and in 1 hard capsule is 20 mg.

Seronil film-coated tablets take the form of white, oblong, film-coated tablets of 5 × 10 mm, divided into two equal parts by a notch on the tablet.

While Seronil as a hard capsule It comes in the form of white opaque capsules filled with a white to almost white powder.

Both 10 mg and 20 mg Seronil tablets are sold in packs of 30 and 100 pieces. The price of the drug Seronil in the form of coated tablets depends on the size of the package and for a package with 30 tablets we have to pay about PLN 16, and for a package with 100 tablets about PLN 46.

The price of Seronil in the form of capsules for a package with 30 capsules is around PLN 23, and for a package with 100 capsules it is around PLN 60.

This preparation is free for patients over 75 years of age. In the case of handicapped and mentally ill people, the drug is reimbursed 30%.

Always keep the packaging with the drug out of the sight and reach of children, at a temperature below 25 ° C in the original packaging.

The distributor of Seronil in Poland is Orion Pharma Poland Sp. z o. o., a branch of the Finnish pharmaceutical company Orion Pharma with a 100-year tradition. The company’s products have been present on the Polish market since 2002. The company’s portfolio includes drugs for psychiatry, neurology, anesthesiology and intensive care, cardiology and pulmonology, as well as OTC products.

What are antidepressants and how do they work? Read: Antidepressants – types, indications and side effects [WE EXPLAIN]

Seronil – composition and action of the preparation

Action of the drug Seronil is closely related to the properties of the active substance of the preparation fluoxetine. One film-coated tablet of this medicine contains 11,2 mg of fluoxetine hydrochloride, corresponding to 10 mg of fluoxetine. However, each Seronil capsule contains 22,4 mg of fluoxetine hydrochloride, which is equivalent to 20 mg of fluoxetine.

Fluoxetine is an organic chemical compound used as an antidepressant, mainly in the treatment of depressive and obsessive-compulsive disorders.

The pharmacological action of fluoxetine it works by inhibiting the reuptake of serotonin by blocking the serotonin transporter (SERT). Serotonin is one of the neurotransmitters and plays an important role in communication between synaptic neurons.

The whole process is that at the synapse, the cell transmits information located in front of the synapse, releasing a mediator into the synaptic cleft, i.e. a substance that is captured and recognized by the cell receiving information from the synapse. The mediator is serotonin, the molecules of which are taken back by the receptors of the neuron that is in front of the synapse. This entire process is called reuptake.

Action of the active substance of Seronil it inhibits the reuptake of serotonin, causing the prolongation of the action of serotonin at the synapse and the duration of stimulation of the recipient cell.

Fluoxetine causes the nerve impulses to be sent more frequently, and the increased stimulation of serotonin-dependent cells is associated with an antidepressant effect.

The action of fluoxetine is said to be selective, as it has no effect on the reuptake of mediators other than serotonin, and has no affinity for receptors other than serotonin.

In addition to the active substance, Seronil also contains excipients that differ depending on the form of the preparation.

The core of the coated tablet additionally contains: mannitol (E 421), maize starch, povidone, microcrystalline cellulose, magnesium stearate, while the tablet coating consists of: hypromellose 6 cPs, sucrose, polysorbate 80, glycerol 85%, magnesium stearate, titanium dioxide (E 171).

In the case of Seronil in the form of capsules, the core consists of: microcrystalline cellulose, maize starch, magnesium stearate, as well as titanium dioxide (E 171) and gelatin, which form the drug coating.

How should antidepressants be used? Read: Drugs for depression – action, groups, rules of application

Seronil – indications

Seronil is a drug used mainly in psychiatry and the decision about its initiation into treatment is always made by the doctor. The use of this drug requires a detailed medical history and examination of the patient. The preparation is indicated for use in adults and children over 8 years of age, in the case of treatment of:

1. obsessive-compulsive disorder;
2. deep depression;
3. bulimia nervosa, as a method of supporting the basic treatment – psychotherapy, in order to reduce the willingness to overeat and return consumed food.

In addition, in children over 8 years of age, the use of Seronil is recommended for the treatment of severe or moderate depression. The drug is used when, after 4-6 therapeutic sessions, the treatment does not bring the expected improvement. In the case of this group of patients, the manufacturer of the drug stipulates that the preparation may only be administered as an adjunct to psychotherapy.

How to recognize and treat depression in children? Read on: Depression in children – causes, symptoms. How to help a child with depression?

Seronil – contraindications

The use of Seronil is often impossible despite the indications to start the therapy. There are contraindications that prevent the implementation of this preparation for treatment.

According to the manufacturer, this drug should not be used in people who are hypersensitive to any of the ingredients of the drug.

Moreover, among contraindications to the use of the drug Seronil it is suggested to be combined with a non-selective MAO inhibitor. Patients receiving SSRIs (Selcctive Serotonin Keuptake Inhibitor-selective serotonin reuptake inhibitors) in combination with an MAOI monoamine oxidase inhibitor, and in patients who discontinued an SSRI and started treatment with an MAOI, severe and sometimes even lethal reactions.

In many cases, symptoms similar to those in the serotonin syndrome appeared. The most common complications include: hypothermia, muscle stiffness, clonic muscle contractions, as well as vegetative disorders accompanied by disturbances in life functions, mental disorders, including irritability, disorientation or even extreme agitation, which even turned into delirium or coma.

The initiation of MAO inhibitor therapy should occur at least 5 weeks after discontinuing fluoxetine treatment, unless it has been used for long periods or in high doses. A longer break should then be considered.

Contraindications to the use of Seronil also include certain diseases, circumstances and mental states that may require the complete withdrawal of this drug during treatment or a change in the dosage of the preparation.

The use of Seronil sometimes requires specific follow-up tests.

Are antidepressants effective? Check: Antidepressants are effective. New study

Seronil – precautions when taking the drug

Seronil should be used with particular caution in cases of:

1. people prone to suicidal thoughts, mutilation and suicide related to depression (especially people under 25 years of age should be under close medical supervision);
2. children and adolescents under the age of 18;
3. people with untreated or untreated epilepsy;
4. people who have ever had a manic condition;
5. people with heart disease;
6. people taking medicines that affect the function of platelets in the blood or that may increase the risk of bleeding, or if you have a history of blood clotting problems;
7. Caution should be exercised in those with diabetes as often the dosage of insulin or oral antidiabetic medications may need to be changed.

In addition, the use of Seronil simultaneously with herbal preparations containing St. John’s wort (Hypericum perforator) may increase side effects such as, for example, serotonin syndrome. Contraindication to the use of Seronil may also be fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

How to recognize the symptoms of depression in a senior? Check: Depression in a senior. Characteristic symptoms of depression in the elderly

Seronil – method of taking and dosage of the drug

Seronil, a prescription-only medicine, should be used as directed by your doctor or pharmacist. In case of any doubts, a doctor or a pharmacist should be consulted, as the effect of the drug taken in the wrong doses may be harmful to health and life.

Seronil is a drug that is taken orally with or between meals. Dosage of Seronil is determined by the attending physician, who selects the appropriate dose depending on the disease and determines whether the drug is to be administered in a single daily dose or in divided doses.

Adults and elderly people who are using Seronil to treat depression are recommended initial dose of 20 mg dailywhich, if necessary, may be gradually increased after 3 weeks of treatment, up to a maximum of 60 mg daily.

Patients using this antidepressant should continue treatment for a period of at least 6 months and the first effects in terms of symptom relief should usually be noticed after a few weeks of treatment.

For the treatment of obsessive-compulsive disorders, the use of Seronil also begins with initial dose of 20 mg per day, which may be increased to a maximum of 2 mg per day after 60 weeks of treatment. Improvement in the patient’s condition should occur within 10 weeks of treatment, and in the absence of effects, continued use of Seronil should be considered.

During therapy with this drug, the patient should be under the constant supervision of a physician who should monitor his health and adjust the dose to his individual needs.

In the case of people using Seronil in the treatment of bulimia nervosa, it is recommended to take the drug in 60 mg daily. There are no data that would confirm the long-term (over 3 months) efficacy of therapy with this drug in the treatment of bulimia nervosa.

When taking Seronil, you should remember about caution and that fluoxetine remains in the body for several weeks after stopping taking the drug. Under no circumstances should the maximum dose of 60 mg per day be exceeded, while in the elderly special attention should be paid to the patient’s condition and reaction. The manufacturer of the drug notes that this age group should use a dose of no more than 40 mg a day.

Also in the case of people with impaired liver function, it is recommended to use lower doses of the drug or increase the time intervals between successive doses.

Seronil is not usually used in children and adolescents under 18 years of age. If the doctor determines that there is a need to include Seronil in a child over 8 years of age, it is recommended starting dose of 10 mg dailyby constantly monitoring the patient’s reactions. After a minimum of one week, your doctor may increase the dose to 20 mg a day, constantly monitoring the patient’s response to the drug. Seronil dose in childrenmay also depend on the patient’s body weight. Improvement of the condition should occur within 6 months of treatment with Seronil and the physician should evaluate the effectiveness of the therapy and decide on its termination.

How to take medication correctly? Check: How to take medications effectively?

Seronil – overdose or missed dose

Seronil dose should be determined by a physician who can individually increase or decrease the dose and decide to end therapy with this drug.

Discontinuation of the preparation should not be sudden, as withdrawal symptoms may occur, such as dizziness, tingling sensation, pricking sensations, sleep disturbances (vivid dreams, nightmares, insomnia), psychomotor restlessness or agitation, fatigue or weakness, anxiety, nausea or vomiting , tremor, headache.

When stopping treatment with Seronil, your doctor should advise you to gradually reduce the dose over a period of 1 to 2 weeks, until it is completely discontinued.

In case of accidental ingestion too much Seronil tell your doctor immediately and go to the nearest hospital. An overdose of the drug may lead to symptoms such as nausea, vomiting, seizures, cardiovascular disorders from asymptomatic arrhythmia to cardiac arrest, pulmonary dysfunction, central nervous system disorders – from the state of excitement to coma.

However, if one dose is missed, the missed tablet should not be taken or a double dose should not be taken. Take the next dose as soon as possible. It is important to consult your doctor or pharmacist about any dose changes or missed doses and never stop using the medicine yourself, even if you feel better.

Can blood tests show depressive disorder? Read on: A blood test will help detect depression

Side effects after taking Seronil

Like any other Seronil medicinal product, it may cause side effects which may not be experienced by every person using this medicine. After authorization of the medicinal product, it is important to report any suspected adverse reactions so that the benefit / risk balance of the medicinal product can be monitored.

The general classification of the frequency of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare ( ≥100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Side effects are dose dependent and often disappear with continued treatment. The occurrence of side effects may also be associated with the use of many preparations.

The most common side effects of Seronil are: insomnia (including initial, middle and early morning awakening), diarrhea, nausea, headache, fatigue (including asthenia).

Among the side effects that may occur during drug therapy with Seronil, the following are indicated:

1. very common (more than 1 in 10 patients): insomnia, headache, diarrhea, nausea, tiredness;
2. common (less than 1 in 10 patients): dry mouth, rash, hives, itching, excessive sweating, joint pain, frequent urination, vaginal bleeding, erectile dysfunction, ejaculation failure, feeling loose, chills, weight loss loss of appetite, anxiety, nervousness, restlessness, internal tension, libido disorder, sleep disturbance, abnormal dreams, disturbance in attention, dizziness, taste disturbance, lethargy, sleepiness, yawning, tremor, blurred vision, palpitations, stretch prolongation QT on the EKG, flushing, flushing, indigestion;
3. uncommon (affecting less than 1 in 100 patients): tinnitus, hypotension, dyspnoea, epistaxis and gastrointestinal bleeding, dysphagia, alopecia, increased bruising, cold sweat, muscle tics, difficulty urinating, sexual dysfunction , feeling unwell or abnormal, feeling cold, feeling hot, depersonalization, elevated mood, euphoria, abnormal thinking, abnormal orgasm, including no orgasm, involuntary jaw clenching and teeth grinding, suicidal thoughts and behavior, memory impairment, psychomotor hyperactivity, involuntary movements , impaired coordination, balance disorder, muscle spasms, dilation of the pupils;
4. Rare (less than 1 in 1 patients): dysthymia (depression caused by neurosis), aggression, convulsions, akathisia (agitation – need to be in constant motion), buccal-lingual syndrome, serotonin syndrome, ventricular arrhythmias, vasculitis, vasodilation, pharyngitis, lung disorders including inflammation, pulmonary fibrosis, pain in the esophagus, hepatitis, angioedema, ecchymosis, decreased number of platelets, neutrophils, leukocytes, anaphylactic reactions, serum sickness, abnormal hormone secretion antidiuretic effect, sodium decreased, manic reactions (hypomania, mania), hallucinations, agitation, panic attacks, confusion, stuttering, photosensitivity, purpura, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis-Lyell’s syndrome, pain muscle, urinary retention, urination disorder, galactorrhoea, hyperprolactinaemia (increased blood prolactin), painful erections in the penis, bleeding in the skin or mucous membranes, abnormal liver function tests
5. Not known: severe vaginal haemorrhage, increased risk of bone fragility.

Seronil, which has a psychoactive effect on the body, may disturb the assessment of abilities and skills. Therefore, while taking this drug, you should avoid driving or operating machinery. In the event of any of the above-mentioned side effects or other disturbing symptoms, stop taking Seronil and contact your doctor immediately.

When and what tests should be performed when depression is suspected? Read: Depression – How to Fight It? When is it worth getting laboratory tests for depression? [WE EXPLAIN]

Seronil and pregnancy and breastfeeding

The use of any drug during pregnancy or breastfeeding requires consultation with a physician in order to clarify all the potential risks and benefits associated with the use of the drug.

Research results show that fluoxetine is not teratogenic, i.e. it is not harmful to the fetus. Seronil can be used by pregnant women with caution. Particular caution should be exercised in the case of advanced pregnancy or before the term of delivery, as this drug may cause irritability, tremors, hypotonia, constant crying in the newborn, and difficulty in suckling and sleeping.

These symptoms may be related to the serotonergic effect of the drug or represent a withdrawal syndrome. These symptoms may appear or persist during the half-life of fluoxetine in the body (4 to 6 days) or during the half-life of its active metabolite (4 to 16 days).

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There may be times that taking Seronil during the first few months of pregnancy may increase the risk of birth defects to the heart, and there may be an increased risk of a serious complication in the newborn baby called persistent pulmonary hypertension of the newborn baby.

Therefore, before using Seronil, consult a doctor who will explain the potential risks and benefits associated with the use of a given drug.

Fluoxetine and its metabolite, norfluoxctin, passes into breast milk, therefore the use of Seronil is not recommended for lactating women. There have been side effects in babies who are breastfed by women taking Seronil. Therefore, breastfeeding women should only use the drug when the benefits of the treatment to the mother far outweigh the risk of side effects for the child.

If it is necessary to start treatment with this drug, weaning the baby should be considered and if breastfeeding is continued after starting therapy, special care should be taken and the baby’s response should be monitored. In such cases, it is recommended to use the lowest effective dose of the preparation.

What are the symptoms of depression during pregnancy? Check: Depression in pregnancy – symptoms, causes, treatment

Seronil – interactions with other drugs

The initiation of therapy with the use of Seronil requires a detailed history of all recently taken drugs, including over-the-counter drugs, and even additional examinations of the patient.

The use of certain medications at the same time as taking Seronil can cause serious side effects. The physician should be informed about the use of monoamine oxidase inhibitors, as there is a risk of serotonin syndrome.

In addition, Seronil must not be used simultaneously with metoprolol, as fluoxetine may increase its side effects. Seronil is not recommended for simultaneous use with:

1. tamoxifen as fluoxetine may reduce its effect;
2. reversible MAO inhibitors of type A e.g. linezolid, methylene blue as this may cause serotonin syndrome;
3. mequitazine, as fluoxetine may affect the blood levels of this medicine and increase the risk of side effects.

However, special care should be taken when using Seronil when taking drugs such as:

1. phenytoin, as Seronil may affect its blood levels;
2. lithium, tramadol, buprenorphines, triptans, tryptophan, selegiline, St. John’s wort, as the risk of serotonin syndrome increases;
3. drugs that may affect the heart rhythm, e.g. class IA and III antiarrhythmics, antipsychotics, tricyclic antidepressants, some antibacterial drugs, antimalarial drugs, especially halofantrine, some antihistamines (astemizole, mizolastine);
4. medicines that reduce blood clotting, such as warfarin, non-steroidal anti-inflammatory drugs, acetylsalicylic acid or other medicines that may thin the blood, as Seronil may affect their effect;
5. cyproheptadine, which may reduce the antidepressant effect of Seronil;
6. medicines that cause low sodium levels in the blood, e.g. diuretics, desmopressin, carbamazepine and oxcarbamazepine – simultaneous administration may reduce the level of sodium in the blood;
7. drugs that may lower the seizure threshold, e.g. tricyclic antidepressants, other selective serotonin reuptake inhibitors, phenothiazines, butyrophenone derivatives, mefloquine, chloroquine, bupropion, tramadol, as concomitant use may increase the risk of seizures;
8. flecainide, propafenone and nebivolol, atomoxetine, carbamazepine, tricyclic antidepressants, risperidone, as Seronil may change the blood levels of these drugs, so their doses may need to be reduced when used together.

Always tell your doctor or pharmacist what prescription medications, over-the-counter drugs, or herbal products, especially preparations containing St. John’s wort, are already being taken.

During therapy with Seronil, you should not consume both low-percentage and high-percentage drinks. The combination of an alcoholic product and a drug can lead to significant and harmful interactions. Drinking alcohol may cause excessive sleepiness, dizziness, impaired concentration and movement disorders.

Which drugs should never be combined with each other? Check: Dangerous interactions