Mozarin – composition, indications, contraindications, dosage. How does Mozarin work?

Proven content

MOZARIN is a prescription medicine that comes in the form of film-coated tablets. Due to the content of escitalopram, it belongs to the group of drugs with an antidepressant effect. It is intended primarily for adults – however, it is not recommended for use in adolescents under 18 years of age.

Mozarin – what is this drug?

MOZARIN is a drug that contains escitalopram. Escitalopram belongs to a group of antidepressants called Selective serotonin reuptake inhibitors (SSRIs). These drugs act on the serotonergic system in the brain by increasing serotonin levels.

Disturbances in the serotonergic system in the brain are considered to be an important factor in the development of depression and related diseases. MOZARIN is used to treat depression (major depressive episode) and anxiety disorders (such as panic attacks with or without agoraphobia, social anxiety disorder (social phobia).

Each MOZARIN tablet contains 10 mg, 15 mg, or 20 mg escitalopram (as oxalate). In addition, the drug contains:

Rdzeń: celuloza mikrokrystaliczna, kroskarmeloza sodowa, krzemionka koloidalna bezwodna, magnezu stearynian

Coating: Opadry White Y-1-7000: hypromellose 6 cP, titanium dioxide (E 171) and macrogol 400.

Do the test and see if you may be depressed

Mozarin – action

Escitalopram is a selective serotonin (5-HT) reuptake inhibitor with high affinity for its primary binding site. It also binds to the allosteric site on the serotonin transporter with 1000 times less affinity.

Escitalopram has no or very little affinity for many receptors, including 5-HT1A, 5-HT2, DA D1 and D2, α1-, α2-, β-adrenergic, histamine H1, muscarinic cholinergic, benzodiazepine and opioid receptors. The inhibition of 5-HT reuptake is the only likely mechanism of action explaining the pharmacological and clinical effects of escitalopram.

Mozarin – dosage

The dosage of MOZARIN depends on the medical condition it is being treated with. MOZARIN is given as a single daily dose and can be taken with or without food. The safety of a daily dose higher than 20 mg has not been demonstrated.

1. Dawkowanie leku Mozarin w przypadku występowania dużych epizodów depresji

The usual dose is 10 mg once a day. Depending on the individual patient’s response, the dose may be increased to a maximum of 20 mg daily. Usually, the antidepressant effect takes 2-4 weeks to appear. After symptoms have resolved, treatment should be continued for at least 6 months in order to consolidate the response.

1. Dosage of MOZARIN if you have panic disorder (panic disorder) with or without agoraphobia

An initial dose of 5 mg is recommended for the first week, followed by dose escalation to 10 mg daily. The dose may then be increased to a maximum of 20 mg daily, depending on individual patient response. The maximum effectiveness is achieved after about 3 months. Treatment lasts for several months.

1. Dosage of MOZARIN if you have social anxiety disorder

The usual dose is 10 mg once a day. Generally, improvement of symptoms is achieved after 2-4 weeks of treatment. Then, depending on the individual patient’s response, the dose may be reduced to 5 mg daily or increased to 20 mg daily.

Social anxiety disorder is a chronic disease and 12-week treatment is recommended to consolidate the response to treatment. Long-term treatment of responders has been studied for 6 months and can be considered on an individual basis to prevent relapse. The benefits of treatment should be assessed at regular intervals.

Social phobia is a well-defined disease entity and should not be confused with excessive shyness. Pharmacological treatment is indicated only when the disease significantly interferes with professional and social activity.

1. Dosage of MOZARIN in the presence of obsessive-compulsive disorder

The starting dose is 10 mg once a day. Depending on the individual patient’s response, the dose may be increased to a maximum of 20 mg daily. Obsessive Compulsive Disorder is a chronic disease and patients should be treated long enough to see that their symptoms have resolved.

1. Dosage of MOZARIN for the elderly

The starting dose is 5 mg once a day. Depending on the individual patient’s response, the dose may be increased to a maximum of 10 mg daily. The efficacy of MOZARIN in the treatment of social anxiety disorder in the elderly has not been studied.

Read: PANDAS syndrome – characteristics, symptoms, diagnosis and treatment

MOZARIN – when should you not use it?

MOZARIN is contraindicated in the following situations:

1. if you are hypersensitive to the active substance or any of the excipients of MOZARIN,
2. simultaneous treatment with non-selective, irreversible monoamine oxidase inhibitors (MAO inhibitors) due to the risk of serotonin syndrome associated with agitation, tremors, hyperthermia,
3. concomitant use of escitalopram with reversible MAO-A inhibitors (e.g. moclobemide) or a reversible non-selective MAO inhibitor – linezolid due to the risk of serotonin syndrome,
4. if you are born with or have had an episode of heart rhythm problems (found on an ECG image – a test that allows you to check how your heart is working),
5. if you are taking medicines to treat heart problems or medicines that affect the rhythm of the heart,
6. MOZARIN is contraindicated in patients with known prolongation of the QT interval or congenital long QT syndrome. Concomitant treatment with escitalopram and other drugs known to prolong the QT interval is contraindicated.

See: Stem cells to study serious heart disease

Mozarin – precautions

Talk to your doctor before using MOZARIN. Please tell your doctor if you have any other disorder or disease, as your doctor should take this into account.

It is especially important to tell your doctor if:

1. the patient has epilepsy. MOZARIN should be discontinued if seizures occur or increase in frequency,
2. you have impaired liver or kidney function. Your doctor may need to adjust your dosage.
3. you have diabetes. Treatment with MOZARIN may alter blood glucose (glycaemia) control. It may be necessary to adjust the dosage of insulin and / or oral medications to lower blood glucose levels.
4. the patient has a low sodium concentration in the blood,
5. you are prone to bleeding easily or bruise easily,
6. the patient is treated with electroconvulsive therapy,
7. the patient has ischemic heart disease,
8. you have or have suffered from heart disease or have recently had a heart attack
9. you have a low heart rate while at rest and / or may have salt depletion in your body as a result of prolonged, severe diarrhea and vomiting (feeling sick) or are taking diuretics (water tablets),
10. you have a fast or irregular heartbeat, fainting, collapse or dizziness when standing, which may be signs of heart rhythm disturbances
11. if you have or have had eye problems such as certain types of glaucoma (increased pressure inside the eye)
12. you are taking sumatriptan or other triptans, opioids (such as buprenorphine and tramadol) or tryptophan. Taking these medicines together with MOZARIN may lead to serotonin syndrome, a potentially life-threatening disease.
13. if you have a history of blood clotting disorders or if you are pregnant.

Medicines like MOZARIN (so-called SSRIs) can cause symptoms of sexual dysfunction.

In some patients with panic disorder, the symptoms of anxiety may worsen at the beginning of treatment with antidepressants. This paradoxical reaction usually disappears within 2 weeks of uninterrupted treatment. To reduce the likelihood of your anxiety symptoms getting worse, a low starting dose is recommended.

Also read: Thanks to ticks, we know more about blood clotting

Mozarin – thoughts of suicide

Depression is associated with an increased risk of suicidal thoughts, self harm or suicide (suicide-related events). This risk persists until significant improvement is achieved. As improvement may not occur during the first weeks or more of treatment, patients should be closely monitored until such improvement occurs.

It is general clinical experience that the risk of suicide is increased in the early stages of recovery. Other psychiatric disorders under which escitalopram is prescribed may be associated with an increased risk of suicide-related events.

Moreover, these disorders may coexist with major depressive disorders. Therefore, when treating people with other mental disorders, the same precautions should be taken as in the treatment of patients with major depressive disorders.

People with a history of suicide-related events or those who were highly suicidal prior to initiation of treatment are at high risk of suicide attempts. These patients require careful observation during therapy.

Treatment should be accompanied by close monitoring of patients, in particular those belonging to a high-risk group, especially in the early stages of treatment and after dose adjustments. Patients (and their caregivers) should be warned about the need to monitor the patient for any clinical worsening, suicidal ideation and behavior and unusual changes in behavior, and to seek medical advice immediately as soon as these symptoms occur.

Read also: Chronic pain may increase the risk of suicide

Mozarin – side effects

Like all medicines, MOZARIN can cause side effects, although not everybody gets them. The side effects usually disappear after a few weeks of treatment. It should be noted that many of them may also be symptoms of the disease being treated and will disappear as you feel better.

If you experience any of the following side effects, contact your doctor or go to the hospital straight away:

Uncommon (may affect up to 1 in 100 people):

1. unusual bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1000 people):

1. swelling of the skin, tongue, lips or face, or have difficulty breathing or swallowing (allergic reactions)
2. high fever, agitation, confusion, tremors and sudden muscle contractions may be symptoms of a rare condition called serotonin syndrome.

Not known (frequency cannot be estimated from the available data):

1. difficulty urinating
2. seizures
3. yellowing of the skin and whites of the eyes, which is a symptom of liver problems and / or hepatitis
4. fast, irregular heartbeat, fainting which could be symptoms of a life-threatening condition known as torsade de pointes
5. suicidal thoughts and behavior
6. heavy vaginal bleeding shortly after delivery (postpartum haemorrhage).

In addition to those listed above, the following side effects have also been reported very common, common and uncommon.

Very common (may affect more than 1 in 10 people):

1. feeling unwell (nausea)
2. headaches.

Common (may affect up to 1 in 10 people):

1. Blocked or runny nose (sinusitis)
2. decrease or increase in appetite,
3. anxiety, restlessness, abnormal dreams, difficulty falling asleep, sleepiness, dizziness, yawning, trembling, tingling
4. diarrhea, constipation, vomiting, dry mouth
5. increased sweating
6. muscle and joint pain (arthralgia, myalgia),
7. sexual problems (delayed ejaculation, erectile dysfunction, decreased sex drive, difficulty achieving orgasm in women),
8. fatigue, fever
9. weight gain.

Uncommon (may affect up to 1 in 100 people):

1. hives, other rashes, itching
2. teeth grinding, agitation, nervousness, panic attacks, confusion,
3. disturbances in sleep, taste, fainting
4. pupil dilation, visual disturbance, tinnitus
5. hair loss,
6. excessive vaginal bleeding
7. irregular menstrual bleeding
8. weight loss
9. fast heartbeat,
10. swelling of the arms and legs
11. epistaxis.

Rare (may affect up to 1 in 1000 people):

1. aggression,
2. depersonalization (feeling of losing one’s own identity), hallucinations,
3. slow heartbeat.

See: What is derealization?

Mozarin – overdose

The symptoms described in an overdose with MOZARIN mainly affect the central nervous system (from dizziness, tremors, agitation through rare cases of serotonin syndrome, convulsions to coma), the digestive system (nausea and / or vomiting) and the cardiovascular system (hypotension). blood pressure, tachycardia, QT prolongation and arrhythmias) and disturbances in the fluid and electrolyte balance (hypokalaemia, hyponatraemia).

There is no specific antidote. It is necessary to open the airways and maintain their patency, ensure a sufficient supply of oxygen and the proper functioning of the respiratory system. Gastric lavage and the administration of activated charcoal should be considered. Gastric lavage should be performed as soon as possible after oral ingestion. Monitoring of the heart rate and vital signs is recommended, as well as general symptomatic supportive measures.

See: The five most painful diseases

MOZARIN – stopping treatment

Do not stop taking MOZARIN until your doctor tells you to do so. If treatment is to be discontinued, it is recommended that the dose of MOZARIN be reduced gradually over several weeks.

When you stop taking MOZARIN, especially if it is abruptly, discontinuation symptoms may occur. These are often seen when treatment with MOZARIN is stopped. There is an increased risk of withdrawal symptoms with long term use or high doses of MOZARIN, and if the dose is reduced too quickly.

Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients, symptoms may be severe or last longer (2-3 months or more). Contact your doctor if you experience severe discontinuation symptoms when you stop taking MOZARIN. Your doctor may recommend that you start taking the medicine again and then stop it more slowly.

Withdrawal symptoms include: dizziness (vertigo), tingling, burning or (less commonly) electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), feeling anxious, headache, nausea, excessive sweating (including night sweats), restlessness or agitation, tremors, confusion or confusion, emotional lability or irritability, diarrhea, visual disturbances, palpitations.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

Mozarin – pregnancy and breastfeeding

MOZARIN should not be used during pregnancy or breastfeeding unless your doctor has told you so and you have discussed the risks and benefits of treatment with you.

If the patient has been taking MOZARIN in the last 3 months of pregnancy, be aware that the newborn may develop: breathing problems, cyanosis, seizures, fluctuations in body temperature, difficulty in feeding, vomiting, low blood glucose, muscle stiffness or laxity reflexes, tremors, shivering, irritability, lethargy, constant crying, sleepiness or difficulty falling asleep. If your newborn baby has any of these symptoms, please contact your doctor immediately. Należy się upewnić, że położna i (lub) lekarz wiedzą, że ciężarna przyjmuje lek Mozarin.

Mozarin – use in children and adolescents

MOZARIN should not be used in children and adolescents under 18 years of age. It should be remembered that in patients under 18 years of age, while taking this class of medicines, there is a greater risk of side effects such as suicide attempts and suicidal thoughts and hostility (especially aggression, oppositional behavior, anger).

Despite this, your doctor may prescribe MOZARIN for patients under 18 if considered essential. Należy poinformować lekarza o wystąpieniu lub nasileniu wymienionych wyżej objawów w trakcie stosowania leku Mozarin u chorego w wieku poniżej 18 lat. Ponadto, nie wykazano jeszcze bezpieczeństwa długoterminowego stosowania leku Mozarin w tej grupie wiekowej dotyczącego wzrostu, dojrzewania, rozwoju poznawczego i rozwoju zachowania.

Mozarin – interactions with other drugs

Tell the doctor or pharmacist about all the drugs the patient is taking or recently taking, and about the drugs that the patient is going to take.

Tell your doctor if you are taking any of the following medications:

1. “Non-selective monoamine oxidase inhibitors (MAOIs)” containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide and tranylcypromine. If you are taking these medicines, you must wait 14 days before starting treatment with MOZARIN. After stopping treatment with MOZARIN, you must wait 7 days before taking any of the above medicines.
2. “Reversible, selective MAO-A inhibitors” containing moclobemide (used to treat depression),
3. “Irreversible monoamine oxidase B (MAO-B) inhibitors” containing selegiline (used to treat Parkinson’s disease). They increase the risk of side effects,
4. linezolid antibiotic,
5. lithium (used to treat bipolar depression) and tryptophan
6. imipramine and desipramine (both used to treat depression)
7. sumatriptan and similar medicines (used to treat migraine) and opioids such as buprenorphine and tramadol (used for severe pain). They can increase the risk of side effects. These medicines can interact with MOZARIN and cause symptoms such as involuntary, rhythmic muscle contractions, including those responsible for eye movements, agitation, hallucinations, coma, hyperhidrosis, tremor, overactive reflexes, increased muscle tone, body temperature above 38 ° C. If a patient develops such symptoms, consult a physician,
8. cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). They may cause an increase in the blood levels of escitalopram.
9. St. John’s wort (Hypericum perforatum) – a herbal remedy for depression,
10. acetylsalicylic acid and non-steroidal anti-inflammatory drugs (used as painkillers or to thin the blood called anti-clotting drugs). These drugs can make you more likely to bleed.
11. warfaryna, dipirydamol i fenprokumon (leki przeciwzakrzepowe, stosowane w celu rozrzedzenia krwi). Na początku i po zakończeniu leczenia lekiem Mozarin lekarz prawdopodobnie sprawdzi czas krzepnięcia, w celu sprawdzenia, czy dawka leku przeciwzakrzepowego jest nadal odpowiednia,
12. mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) may lower the seizure threshold
13. neuroleptics (used in the treatment of schizophrenia, psychosis) may lower the seizure threshold, and antidepressants,
14. flecainide, propafenone, and metoprolol (used to treat cardiovascular disease), desipramine, clomipramine, and nortriptyline (antidepressants), risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of MOZARIN may need to be adjusted.
15. Medicines that lower the levels of potassium or magnesium in the blood increase the risk of life-threatening cardiac arrhythmias. 

Do not use MOZARIN if you are taking medicines for heart rhythm disorders or medicines that affect heart rhythm, such as class Ia and III antiarrhythmics, antipsychotics (e.g. phenothiazines, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial drugs (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial drugs – especially halofantrine), some antihistamines (astemizole, mizolastine). If you have any further questions, please ask your doctor.