Package leaflet: Information for the user

Mozarin Swift, 10 mg, orodispersible tablets
Mozarin Swift, 15 mg, orodispersible tablets
Mozarin Swift, 20 mg, orodispersible tablets
Escitalopram
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Mozarin Swift is and what it is used for

Mozarin Swift 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 an important factor in the development of depression and related disorders.
Mozarin Swift contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).

2. Important information before taking Mozarin Swift

When not to take Mozarin Swift:

if the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
if the patient is taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs), 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 congenital or a history of heart rhythm disorders (observed 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 Swift with other medicines").

Warnings and precautions
Before starting treatment with Mozarin Swift, discuss this with your doctor or pharmacist.
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 Swift 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 necessary;
the patient has diabetes; treatment with Mozarin Swift may disrupt blood glucose control (glycaemia); adjustment of insulin and/or oral glucose-lowering medicines may be required;
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 ischemic heart disease;
the patient has heart disease or a history of heart disease, 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 is taking diuretics;
the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disorders;
if the patient has eye problems, such as certain types of glaucoma or a history of glaucoma.
The patient is being treated with buprenorphine. Using this medicine together with Mozarin Swift may lead to serotonin syndrome, a potentially life-threatening condition (see section "Mozarin Swift with other medicines").
if there has been a history of bleeding disorders or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility")

Medicines such as Mozarin Swift (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Note
In some patients with bipolar affective disorder, a manic phase may occur. This is characterized 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 or standing still may also occur. If such symptoms appear, inform the doctor immediately.
Suicidal thoughts and worsening of depression or anxiety symptoms
People with depression and/or anxiety disorders may sometimes think about self-harm or suicide. These thoughts may be particularly intense when starting antidepressant treatment, as all these medicines take some time to work, usually about two weeks, although sometimes longer.
The likelihood of such thoughts is increased if:

the patient previously had suicidal or self-harming thoughts;
the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

If the patient ever experiences thoughts of self-harm or suicidal thoughts, the patient should contact their doctor immediately or go straight to hospital.
It may be helpful for the patient to tell a family member or friend that they have depression or an anxiety disorder, and ask these people to read this leaflet. The patient may ask them to inform them if they notice worsening of depression or anxiety, or concerning changes in their behaviour.
Children and adolescents
Mozarin Swift should not be used in children and adolescents under 18 years of age. It should also be noted that in patients under 18 years of age, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviour, and expressions of anger) when taking medicines of this class. Nevertheless, a doctor may prescribe Mozarin Swift to patients under 18 years of age if they consider it to be in their best interest. If Mozarin Swift has been prescribed to a patient under 18 years of age and you have any doubts, contact the doctor again. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Mozarin Swift, inform your doctor. Furthermore, there are currently no data on the long-term safety of Mozarin Swift in this age group regarding growth, maturation, cognitive development, and behavioural development.
Mozarin Swift with other medicines
Inform the doctor about all medicines currently or 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 Swift. After stopping treatment with Mozarin Swift, 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 reactions;
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 tramadol and buprenorphine (used for severe pain). These may increase the risk of adverse reactions. These medicines may interact with Mozarin Swift and cause symptoms such as involuntary, rhythmic muscle contractions, including those of the eye muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C. If such symptoms occur, contact the doctor;
cimetidine, lansoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase escitalopram blood levels;
St. John's wort (Hypericum perforatum) – an herbal remedy for depression;
acetylsalicylic acid and non-steroidal anti-inflammatory drugs (used as painkillers or blood thinners known as anticoagulants). 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 Swift, the doctor will likely check 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 Swift may be necessary;
medicines that reduce potassium or magnesium levels in the blood, due to an increased risk of life-threatening heart rhythm disorders.

Do not take Mozarin Swift 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 in doubt, consult the doctor.
Mozarin Swift with food, drink, and alcohol
Mozarin Swift can be taken during or between meals (see section 3 "How to take Mozarin Swift").
As with many medicines, it is not recommended to take Mozarin Swift together with alcohol, although interactions between Mozarin Swift and alcohol are not expected.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine. Do not take Mozarin Swift if the patient is pregnant or breastfeeding unless the benefits and risks of treatment have been discussed with the doctor.
If the patient takes Mozarin Swift during the last three months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, contact the doctor immediately.
During pregnancy, never abruptly stop taking Mozarin Swift.
Inform the doctor and/or midwife about taking Mozarin Swift. Taking medicines such as Mozarin Swift during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis and usually occurs within the first day after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
If Mozarin Swift is taken towards the end of pregnancy, there may be an increased risk of severe vaginal bleeding shortly after delivery, especially if there has been a history of bleeding disorders. Inform the doctor and/or midwife about taking Mozarin Swift.
Mozarin Swift is expected to pass into human milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. Theoretically, this may affect fertility, although no effect on human fertility has been observed so far.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Mozarin Swift affects them.
Mozarin Swift contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, consult the doctor before taking this medicine.
Mozarin Swift contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered sodium-free.

3. How to take Mozarin Swift

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Mozarin Swift orally disintegrating tablets should be taken daily as a single dose. Mozarin Swift may be taken during or between meals.
Mozarin Swift orally disintegrating tablets are fragile and should be handled with care. Do not touch the tablets with wet hands, as they may disintegrate. If a 5 mg dose is required, another medicinal product containing 5 mg of escitalopram should be used.

Holding the blister pack by the edges, gently separate one tablet from the rest of the strip along the perforation line.
Carefully peel back the backing foil.
Place the tablet on the tongue. The tablet will dissolve very quickly and can be swallowed without water.

Adults
Depression
The usual recommended dose of Mozarin Swift is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.
Panic disorder
The initial dose of Mozarin Swift is 5 mg once daily during the first week of treatment (use another medicinal product containing 5 mg escitalopram). The dose is then increased to 10 mg daily. Your doctor may subsequently increase the dose up to a maximum of 20 mg per day.
Social phobia
The usual recommended dose of Mozarin Swift is 10 mg taken once daily. Your doctor may then reduce the dose to 5 mg daily (use another medicinal product containing 5 mg escitalopram) or increase it up to a maximum of 20 mg per day, depending on the patient's response to treatment.
Generalized anxiety disorder
The usual recommended dose of Mozarin Swift is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of Mozarin Swift is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Mozarin Swift is 5 mg once daily (use another medicinal product containing 5 mg escitalopram). Your doctor may recommend increasing the dose to 10 mg per day.

Use in children and adolescents
Mozarin Swift is not generally recommended for use in children and adolescents. Additional information is provided in section 2, "Important information before taking Mozarin Swift".

Duration of treatment
It may take several weeks of treatment before the patient starts to feel better. Continue taking Mozarin Swift even if it takes some time before improvement is noticed.
Do not change the dose of this medicine without first consulting your doctor.
Mozarin Swift should be taken for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. It is recommended to continue therapy for at least 6 months after improvement occurs.

Taking more Mozarin Swift than recommended
If you take more Mozarin Swift than recommended, contact your doctor or go to hospital immediately, even if you do not have any symptoms. Some symptoms of overdose include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. When going to the doctor or hospital, bring the medicine packaging with you.

Missed dose of Mozarin Swift
Do not take a double dose to make up for a missed dose. If you forget to take your dose and remember before going to bed, take the missed dose immediately. Take your next dose the following day as usual. If you remember about the missed dose during the night or the next day, skip the missed dose and take the next dose as usual.

Stopping Mozarin Swift
Do not stop taking Mozarin Swift unless your doctor advises you to do so. When stopping treatment, it is recommended to gradually reduce the dose of Mozarin Swift over several weeks.
After stopping Mozarin Swift, particularly if stopped abruptly, withdrawal symptoms may occur. These are commonly observed after discontinuation of Mozarin Swift. The risk of withdrawal symptoms is increased with long-term use of Mozarin Swift, use of high doses, or too 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 longer). If severe withdrawal symptoms occur, 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, including 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 (loose stools), visual disturbances, palpitations or rapid heartbeat (palpitations).

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Side effects usually resolve within a few weeks of treatment. It should be noted that many
of them may also be symptoms of the condition being treated, and will subside as the patient's
condition improves.
If any of the following side effects occur,
contact your doctor:
Uncommon (occur in fewer than 1 in 100 people):

abnormal bleeding, including gastrointestinal bleeding

Rare (occur in fewer than 1 in 1000 people):

If swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing occurs (allergic reaction), contact your doctor immediately or go to hospital;
High fever, agitation, confusion, tremor, and sudden muscle spasms may be symptoms of a rare condition called serotonin syndrome. If these symptoms occur, contact your doctor.

If any of the following adverse events occur, contact your doctor immediately or go to hospital:

difficulty passing urine
seizures, see also section “When to be especially careful with Mozarin Swift”
yellowing of the skin or whites of the eyes, indicating liver dysfunction and/or hepatitis
rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as Torsades de Pointes

Some patients have reported (frequency cannot be estimated from available data):

heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); more information in section Pregnancy, breastfeeding and fertility

In addition to those listed above, the following side effects have also been reported:
Very common (occur in at least 1 in 10 people):

nausea
headache

Common (occur in fewer than 1 in 10 people):

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

Uncommon (occur in fewer than 1 in 100 people):

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

Rare (occur in fewer than 1 in 1000 people):

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

Some patients have reported (frequency cannot be estimated from available data):

thoughts of self-harm or suicide; see also section “Warnings and precautions”;
decreased sodium levels 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, prolonged 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 ADH – antidiuretic hormone – vasopressin secretion);
galactorrhoea (milk production) in women who are not breastfeeding;
mania;
increased risk of bone fractures has been observed in patients taking medicines in this class;
changes in heart rhythm on ECG (electrical activity of the heart) – so-called “QT interval prolongation”.

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

restlessness (akathisia)
loss of appetite

If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring 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 Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Mozarin Swift

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP
The expiry date refers to the last day of the mentioned month.
There are no special requirements regarding storage temperature. Store
in the original packaging to protect from moisture and light.
Medicines must not be disposed of via the sewage system or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Mozarin Swift contains

The active substance is escitalopram.
Mozarin Swift 10 mg: Each orodispersible tablet contains 10 mg escitalopram equivalent to 12.775 mg escitalopram oxalate.
Mozarin Swift 15 mg: Each orodispersible tablet contains 15 mg escitalopram equivalent to 19.1625 mg escitalopram oxalate.
Mozarin Swift 20 mg: Each orodispersible tablet contains 20 mg escitalopram equivalent to 25.55 mg escitalopram oxalate.
Other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, potassium polacrilin, potassium acesulfame, neohesperidin dihydrochalcone, magnesium stearate, peppermint flavour [containing maltodextrin (maize), modified starch (maize), peppermint oil].

What Mozarin Swift looks like and contents of the pack
Mozarin Swift 10 mg: white or almost white, flat, round tablet with bevelled edges and a diameter of 9 mm, engraved with the number "10" on one side.
Mozarin Swift 15 mg: white or almost white, flat, round tablet with bevelled edges and a diameter of 11 mm, engraved with the number "15" on one side.
Mozarin Swift 20 mg: white or almost white, flat, round tablet with bevelled edges and a diameter of 12 mm, engraved with the number "20" on one side.
Blister packs in cartons containing 28 orodispersible tablets.

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

Manufacturers:

Adamed Pharma S.A., ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland
Genepharm S.A., 18 km Marathon Avenue, 15351 Pallini Attikis, Greece
Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola, PLA 3000, Malta
Laboratorios Cinfa S.A., Olaz-Chipi, 10, Poligono Industrial Areta (Huarte-Pamplona (Navarra)) – 31620 – España
Pharmapath S.A., 28is Oktovriou 1, Agia Varvara, 123 51, Greece

10/2023

Mozarin swift