Mozarin swift: detailed information

Package leaflet: Information for the user

Mozarin Swift, 10 mg, orodispersible tablets
Escitalopram
Please read carefully all the information in this leaflet before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Mozarin Swift is and what it is used for
Important information 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 serotonin system in the brain by increasing serotonin levels. Disturbances in the brain's serotonin system are considered an important factor in the development of depression and related disorders.
Mozarin Swift contains escitalopram and is used in the treatment of 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 check heart function);
if the patient is taking medicines for heart rhythm disorders or medicines affecting heart rhythm (see section 2 "Mozarin Swift and 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 ischaemic heart disease;
the patient has or has had heart disease or recently suffered a heart attack;
the patient has a low 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. Taking this medicine together with Mozarin Swift may lead to serotonin syndrome, a potentially life-threatening condition (see section "Mozarin Swift and other medicines").
if there has been a history of bleeding disorders or if you are 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. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
During 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 time to work, usually about two weeks, although sometimes longer.
The likelihood of such thoughts is increased if:

the patient has previously had thoughts about suicide or self-harm;
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 about self-harm or suicidal thoughts, the patient should contact a 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 to ask these people to read this leaflet. The patient may ask them to inform him or her if they notice worsening of depression or anxiety, or concerning changes in 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 the doctor. Furthermore, there are currently no data on the long-term safety of Mozarin Swift in this age group regarding growth, maturation, and cognitive and behavioural development.
Mozarin Swift and 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 taking these medicines, 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, 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 affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C. If the patient experiences such symptoms, contact a 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 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 blood potassium or magnesium levels, due to 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), certain antihistamines (astemizole, mizolastine). If in doubt, consult a 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 consume alcohol while taking Mozarin Swift, although interactions between Mozarin Swift and alcohol are not expected.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a 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 3 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, muscle stiffness or floppiness, increased reflex excitability, tremors, shivering, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek medical advice 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 sperm 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 a 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 as directed 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 therefore be handled with care. Do not touch the tablets with wet hands, as they may disintegrate. If a dose of 5 mg or 15 mg is required, another medicinal product containing 5 mg or 15 mg of escitalopram should be used.

Holding the blister pack by the edges, carefully separate one tablet from the rest of the strip by gently tearing along the perforation.
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 (another medicinal product containing 5 mg escitalopram should be used), then the dose is 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 (another medicinal product containing 5 mg escitalopram should be used) or increase it up to a maximum of 20 mg per day, depending on the patient's response to the medicine.
Generalised 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 taken once daily (another medicinal product containing 5 mg escitalopram should be used).
Your doctor may recommend increasing the dose to 10 mg per day.
Use in children and adolescents
Mozarin Swift is generally not recommended for use in children and adolescents. Further 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 feels better. Continue taking Mozarin Swift even if it takes some time before improvement is seen.
Do not change the dose of the medicine without first consulting your doctor.
Mozarin Swift 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 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 no symptoms are present. Some symptoms of overdose include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in fluid and electrolyte balance. When seeking medical help, bring the medicine packaging with you.
If you forget to take Mozarin Swift
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. Take the medicine as usual the next day. If you remember about the missed dose during the night or the following day, skip the missed dose and continue taking the medicine as usual.
Stopping Mozarin Swift
Do not stop taking Mozarin Swift unless your doctor advises you to do so. When stopping treatment is planned, 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 at high doses, or if the dose is reduced too quickly. 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 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 fluttering of the heart.
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 effects 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, you should
contact your doctor:
Not very common (occur in less than 1 in 100 people):

abnormal bleeding, including gastrointestinal bleeding

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

If swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing (an allergic reaction) occurs, seek immediate medical attention or go to hospital;
High fever, agitation, confusion, tremor, and sudden muscle contractions may be symptoms of a rare disorder known as 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 take special care when using Mozarin Swift”
yellowing of the skin and 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 determined 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 adverse effects have also been reported:
Very common (occur in at least 1 in 10 people):

nausea
headache

Common (occur in less 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, decreased libido, difficulty achieving orgasm in women)
fatigue, fever
weight gain

Not very common (occur in less 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 less than 1 in 1000 people):

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

Some patients have reported (frequency cannot be determined 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 hemorrhages (petechiae) and reduced platelet count (thrombocytopenia);
sudden swelling of the skin or mucous membranes (angioedema);
increased urine output (inappropriate antidiuretic hormone (ADH) - vasopressin - secretion);
galactorrhea 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”.

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

restlessness (akathisia)
loss of appetite

If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse 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 at 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 authorization holder.
Reporting adverse effects helps to gather more information on the safety of the 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 the storage temperature of this medicine. Store
in the original packaging to protect from moisture and light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These 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 orally disintegrating tablet contains 10 mg of escitalopram, equivalent to 12.775 mg of escitalopram oxalate.
Other ingredients: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, potassium polacriline, potassium acesulfame, neohesperidine dihydrochalcone, magnesium stearate, peppermint flavour [containing maltodextrin (maize), modified starch (maize), peppermint oil], concentrated hydrochloric acid.

What Mozarin Swift looks like and contents of the pack
Mozarin Swift 10 mg: white or almost white, flat, round tablet with bevelled edges, 9 mm in diameter, imprinted with the number "10" on one side.
Blister packs in cartons containing 28 orally disintegrating tablets.
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Genepharm S.A.
18 km Marathon Avenue
15351 Pallini Attikis
Greece
Laboratorios Cinfa S.A.
Olaz-Chipi, 10. Poligono Industrial Areta
(Huarte-Pamplona (Navarra)) –
31620 – Spain
Pharmapath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece