Mozarin, 10 mg, film-coated tablets
Mozarin, 15 mg, film-coated tablets
Mozarin, 20 mg, film-coated tablets
Escitalopram
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Leaflet contents:

What Mozarin is and what it is used for
Important information before taking Mozarin
How to take Mozarin
Possible side effects
How to store Mozarin
Contents of the pack and other information

1. What Mozarin is and what it is used for

Mozarin contains escitalopram. Escitalopram belongs to a group of antidepressant medicines
called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing the concentration of serotonin. Disturbances in the brain's serotonergic system are considered to be a significant factor in the development of depression and related disorders.
Mozarin is used in the treatment of depression (major depressive episode) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder (social phobia)).

2. Important information before using Mozarin

When not to use Mozarin:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if the patient is taking other medicines belonging to a group known as MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic);
if the patient has a congenital heart rhythm disorder or has previously experienced such an episode (detected on ECG – a test used to assess heart function);
if the patient is taking medicines for heart rhythm disorders or medicines affecting heart rhythm (see section 2 “Mozarin with other medicines”).

Warnings and precautions
Before starting treatment with Mozarin, discuss this with your doctor.
Inform your doctor if the patient has any other disorders or diseases, as the doctor should take such information into account. In particular, inform the doctor if:

the patient has epilepsy. Treatment with Mozarin should be discontinued if seizures occur or increase in frequency (see also section 4 “Possible side effects”);
the patient has impaired liver or kidney function. Dose adjustment by the doctor may be required;
the patient has diabetes. Treatment with Mozarin may interfere with blood glucose control (glycaemia). A change in insulin dosage and/or oral glucose-lowering medicines may be necessary;
the patient has low sodium levels in the blood;
the patient has a tendency to bleed easily or develop bruises;
the patient is undergoing electroconvulsive therapy;
the patient has ischaemic heart disease;
the patient has had or currently has heart diseases or recently suffered a heart attack;
the patient has a slow resting heart rate and/or may have salt deficiency due to prolonged, severe diarrhoea and vomiting (nausea) or use of diuretics;
the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disturbances;
the patient has or has previously had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball);
the patient is 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 condition (see section “Mozarin with other medicines”);
if the patient has had or currently has blood clotting disorders or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”).

Medicines such as Mozarin (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Note
Some patients with bipolar affective disorder may experience a manic phase. This is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
In the first weeks of treatment, symptoms such as restlessness or difficulty sitting still or standing still may also occur. If such symptoms occur, inform the doctor immediately.
Suicidal thoughts and worsening of depression or anxiety disorders
People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
These symptoms are more likely in:

patients who previously had thoughts of suicide or self-harm;
young adult patients. Clinical trial data show an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who were treated with antidepressants.

If the patient develops thoughts of self-harm or suicide, seek immediate medical advice from a doctor or go to hospital.
It may be helpful to inform a relative or friend about the depression or anxiety disorder and to have them read this leaflet. The patient may ask them to inform him/her if they notice worsening of depression or anxiety or concerning changes in behaviour.
Children and adolescents
Mozarin should not be used in children and adolescents under 18 years of age. It should be noted that in patients under 18 years of age, treatment with medicines of this group is associated with a higher risk of adverse reactions such as suicide attempts and suicidal thoughts, as well as hostility (particularly aggression, oppositional behaviour, and anger).
Nevertheless, the doctor may prescribe Mozarin to a patient under 18 years of age if he/she considers it necessary. If the doctor has prescribed Mozarin to a patient in this age group and you have any doubts, consult the doctor again. Inform the doctor if any of the above-mentioned symptoms occur or worsen during treatment with Mozarin in patients under 18 years of age. Furthermore, the long-term safety of Mozarin in this age group with regard to growth, maturation, cognitive development, and behavioural development has not yet been established.
Mozarin with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

“non-selective monoamine oxidase inhibitors (MAOIs)” containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If these medicines are being taken, wait 14 days before starting treatment with Mozarin. After stopping treatment with Mozarin, wait 7 days before starting any of the above-mentioned medicines;
“reversible, selective MAO-A inhibitors” containing moclobemide (used in the treatment of depression);
“irreversible monoamine oxidase-B (MAO-B) inhibitors” containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of adverse effects;
the antibiotic linezolid;
lithium (used in the treatment of bipolar disorder) and tryptophan;
imipramine and desipramine (both used in the treatment of depression);
sumatriptan and similar medicines (used in the treatment of migraine) and opioids such as buprenorphine and tramadol (used for severe pain). These may increase the risk of adverse effects. These medicines may interact with Mozarin and cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If the patient experiences such symptoms, contact the doctor;
cimetidine, lanzoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase escitalopram blood levels;
St. John’s wort (Hypericum perforatum) – a herbal remedy for depression;
acetylsalicylic acid and non-steroidal anti-inflammatory drugs (used as painkillers or as blood thinners, known as anticoagulant medicines). These may increase the tendency to bleed;
warfarin, dipyridamole, and phenprocoumon (anticoagulant medicines used to thin the blood). At the beginning and after stopping treatment with Mozarin, the doctor will likely check the blood clotting time to ensure the anticoagulant dose remains appropriate;
mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used in the treatment of severe pain) may lower the seizure threshold;
neuroleptics (used in the treatment of schizophrenia, psychosis) may lower the seizure threshold, as well as antidepressants;
flecainide, propafenone, and metoprolol (used in the treatment of cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Mozarin may be necessary;
medicines that lower potassium or magnesium levels in the blood increase the risk of life-threatening heart rhythm disturbances.

Do not use Mozarin if the patient is taking medicines for heart rhythm disorders or medicines affecting heart rhythm, such as class Ia and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials – particularly halofantrine), or certain antihistamines (astemizole, mizolastine). If you have any further doubts, consult your doctor.
Mozarin with food, drink and alcohol
Mozarin can be taken with or without food (see section 3 “How to take Mozarin”).
As with many medicines, it is not recommended to consume alcohol while taking Mozarin, although an interaction between Mozarin and alcohol is not expected.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Mozarin should not be used during pregnancy or breastfeeding unless specifically advised by a doctor and after the patient has discussed the risks and benefits of treatment with the doctor.
If the patient takes Mozarin during the last three months of pregnancy, she should be aware that the newborn may experience: breathing difficulties, cyanosis, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, sleepiness, or difficulty sleeping. If any of these symptoms occur in the newborn, contact the doctor immediately.
Ensure that the midwife and/or doctor know that the patient is taking Mozarin.
Taking medicines such as Mozarin during pregnancy, particularly during the last three months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which is characterised by rapid breathing and bluish skin colouration. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur in the baby, contact the midwife and/or doctor immediately.
If Mozarin is taken towards the end of pregnancy, there may be an increased risk of severe vaginal bleeding shortly after delivery, especially if there have been previous blood clotting disorders. The doctor or midwife should be informed that the patient is taking Mozarin so they can provide appropriate advice.
If Mozarin is used during pregnancy, treatment should not be stopped abruptly.
Breastfeeding
Mozarin is expected to pass into breast milk.
Fertility
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans to date.
Driving and operating machinery
Do not drive or operate machinery until the patient knows how Mozarin affects him/her.
Mozarin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered to be essentially "sodium-free".

3. How to use Mozarin

Mozarin should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist again.
Adults
Depression
The usual recommended dose of Mozarin is 10 mg taken once daily. Your doctor may recommend increasing the dose up to the maximum dose of 20 mg per day.
Panic disorder
The initial dose of Mozarin is 5 mg once daily for the first week, then the dose is increased to 10 mg per day. Your doctor may recommend further increasing the dose up to the maximum dose of 20 mg per day.
Social anxiety disorder (Social phobia)
The usual recommended dose of Mozarin is 10 mg taken once daily. Depending on the patient's response to treatment, your doctor may reduce the dose to 5 mg once daily or increase it up to the maximum dose of 20 mg once daily.
Obsessive-compulsive disorder
The usual recommended dose of Mozarin is 10 mg taken once daily. Your doctor may increase the dose up to the maximum dose of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Mozarin is 5 mg taken once daily. Your doctor may increase the dose to 10 mg per day.
Children and adolescents (under 18 years of age)
Mozarin is generally not used in children and adolescents. For additional information – see section 2 “Important information before taking Mozarin”.
Mozarin can be taken with or without food. Swallow the tablet with water. Do not chew the tablets due to their bitter taste.
If necessary, the tablet can be divided. To do this, place the tablet on a flat, even surface with the score line facing upwards. The tablet can then be broken by pressing down on each end with the index fingers of both hands.
Duration of treatment
It may take several weeks of treatment before the patient starts to feel better. Continue taking the medicine even if it takes some time before improvement is noticed.
Do not change the dose of the medicine without first consulting your doctor.
Mozarin should be taken for as long as your doctor recommends. Stopping treatment too early may cause symptoms to return. It is recommended to continue therapy for at least 6 months after improvement is achieved.
Taking more Mozarin than prescribed
If you take more Mozarin than prescribed, contact your doctor or go to hospital immediately, even if you do not feel unwell. Some symptoms of overdose include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and disturbances in water and electrolyte balance. When seeking medical help, bring the Mozarin packaging with you.
Missing a dose of Mozarin
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to bed, take the missed dose immediately. The next day, continue taking the medicine as usual. If you remember about the missed dose during the night or the following day, skip the missed dose and take the next dose as usual.
Stopping Mozarin
Do not stop taking Mozarin unless your doctor tells you to. When stopping treatment is planned, it is recommended to gradually reduce the dose of Mozarin over several weeks.
After stopping Mozarin, especially if stopped abruptly, withdrawal symptoms may occur. These are commonly observed after discontinuation of Mozarin treatment. The risk of withdrawal symptoms is increased with long-term use of Mozarin, use at high doses, or rapid dose reduction. In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some patients, symptoms may be severe or persist longer (2–3 months or more). If you experience severe withdrawal symptoms, contact your doctor. Your doctor may recommend restarting the medicine and then tapering it more slowly.
Withdrawal symptoms include: dizziness (disturbances in balance), tingling, burning sensations, or (less commonly) electric shock-like sensations, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety, headache, nausea, excessive sweating (including night sweats), restlessness or agitation, tremor, confusion or disorientation, emotional instability or irritability, diarrhoea, visual disturbances, palpitations (rapid or irregular heartbeat).
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects usually resolve within a few weeks of treatment. It should be noted that many of
these may also be symptoms of the condition being treated and will subside as the patient's condition improves.
If any of the following adverse effects occur, contact your doctor or go to hospital immediately:
Uncommon (may affect up to 1 in 100 people):

unusual bleeding, including gastrointestinal bleeding

Rare (may affect up to 1 in 1,000 people):

swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing (allergic reactions)
high fever, agitation, confusion, tremor and sudden muscle spasms, which may be symptoms of a rare condition called serotonin syndrome;

Frequency unknown (frequency cannot be estimated from the available data):

difficulty passing urine
seizures, see also section “When to be especially careful with Mozarin”
yellowing of the skin and whites of the eyes, indicating impaired liver function and/or hepatitis
rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as torsade de pointes
suicidal thoughts and behaviour, see also section “Warnings and precautions”
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), more information in section 2 – Pregnancy, breastfeeding and fertility.

In addition to those listed above, the following adverse effects have also been reported:
Very common (may affect more than 1 in 10 people):

feeling unwell (nausea)
headache;

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

nasal congestion or runny nose (sinusitis)
decreased or increased appetite
anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling
diarrhoea, constipation, vomiting, dry mouth
increased sweating
muscle and joint pain (arthralgia, myalgia)
sexual disorders (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women)
fatigue, fever
weight gain;

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

hives, other rashes, itching
teeth grinding, agitation, nervousness, panic attacks, confusion
sleep disturbances, taste disturbances, fainting
dilated pupils, visual disturbances, tinnitus
hair loss
excessive vaginal bleeding
irregular menstrual bleeding
weight loss
rapid heartbeat
swelling of hands and feet
nosebleeds;

Rare (may affect up to 1 in 1,000 people):

aggression, depersonalisation (feeling of loss of self-identity), hallucinations
slow heartbeat;

Frequency unknown (frequency cannot be estimated from the available data):

decreased sodium concentration in serum (manifesting as nausea and malaise, muscle weakness and confusion);
dizziness upon standing due to low blood pressure (orthostatic hypotension);
abnormal liver function tests (increased liver enzyme activity in blood);
movement disorders (involuntary muscle movements)
painful persistent erection (priapism)
bleeding disorders, including development of skin and mucosal haemorrhages (petechiae) and reduced platelet count (thrombocytopenia)
sudden swelling of the skin or mucous membranes (angioedema)
increased urine output (inappropriate antidiuretic hormone (ADH) - vasopressin - secretion)
galactorrhoea in women who are not breastfeeding
mania
increased risk of bone fractures observed among patients taking this type of medicine
changes in heart rhythm on ECG (electrocardiogram) – so-called “QT interval prolongation”.

Furthermore, it is known that medicines with action similar to escitalopram (the active substance in Mozarin)
may cause adverse effects such as:

restlessness (akathisia)
loss of appetite.

Reporting of adverse effects
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Mozarin

Keep out of sight and reach of children.
Do not use Mozarin after the expiry date stated on the packaging following the abbreviation EXP. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Mozarin contains
The active substance is escitalopram. Each Mozarin tablet contains 10 mg, 15 mg, or 20 mg of escitalopram (as oxalate).
The other ingredients are:
Core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate
Coating: Opadry White Y-1-7000: hypromellose 6 cP, titanium dioxide (E 171), and macrogol 400.

What Mozarin looks like and contents of the pack
Mozarin is available as 10 mg, 15 mg, and 20 mg film-coated tablets. The tablets are described below.
Mozarin 10 mg (8.1 x 5.6 mm) – oval, white, film-coated tablets with a score line on one side. The tablets can be divided into two equal doses.
Mozarin 15 mg (10.4 x 5.6 mm) – oval, white, film-coated tablets with a score line on one side. The score line is intended to facilitate breaking the tablet for easier swallowing.
Mozarin 20 mg (11.6 x 7.1 mm) – oval, white, film-coated tablets with a score line on one side. The tablets can be divided into two equal doses.

Mozarin is available in the following pack sizes:
Mozarin 10 mg: 28, 30, 56, and 84 tablets
Mozarin 15 mg: 28 tablets
Mozarin 20 mg: 28 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia

This medicinal product is authorised for marketing in the European Economic Area under the following names:
{Poland} {Mozarin}
02.2021