Symescital

Package leaflet: Information for the user

Symescital, 5 mg, film-coated tablets
Symescital, 10 mg, film-coated tablets
Escitalopram
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

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

Contents of the leaflet

1. What Symescital is and what it is used for
2. Important information before taking Symescital
3. How to take Symescital
4. Possible side effects
5. How to store Symescital
6. Contents of the pack and other information

1. What Symescital is and what it is used for

Symescital contains the active substance escitalopram. Symescital 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 the concentration of serotonin.
Symescital 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).
It may take several weeks of treatment before improvement begins. You should continue taking Symescital even if it takes some time for your condition to improve.
If no improvement occurs or if you feel worse, consult your doctor.

2. Important information before using Symescital

When not to use Symescital

• 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 MAO inhibitors, containing selegiline (used in the treatment of Parkinson's disease), moklobemide (used in the treatment of depression), or linezolid (an antibiotic);
• if the patient was born with a congenital abnormal heart rhythm or if the patient has experienced an episode of abnormal heart rhythm (visible on ECG, a test assessing heart function);
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Symescital with other medicines").

Warnings and precautions
Before starting treatment with Symescital, 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. If seizures occur for the first time or increase in frequency, treatment with Symescital should be discontinued (see also section 4 "Possible side effects");
• if the patient has impaired liver or kidney function. Dose adjustment by the doctor may be required;
• if the patient has diabetes. Treatment with Symescital may affect blood glucose control. Adjustment of insulin dose and/or oral glucose-lowering medicines may be necessary;
• if the patient has low sodium levels in the blood;
• if the patient has an increased tendency to bleed or bruise easily;
• if the patient is pregnant (see section "Pregnancy, breastfeeding and fertility");
• if the patient is undergoing electroconvulsive therapy;
• if the patient has ischemic heart disease;
• if the patient has heart problems or has recently had a heart attack;
• if the patient has a slow resting heart rate and/or may have electrolyte deficiency due to prolonged, severe diarrhoea and vomiting or use of diuretics;
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disorders;
• if the patient has had or currently has eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

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.
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.
Medicines such as Symescital (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety symptoms
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, or sometimes longer, to start working.
These symptoms are more likely in:

• patients who previously had thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behavior 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 medical advice immediately or go to hospital.

It may be helpful to inform relatives or close friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening of depression or anxiety, or concerning changes in behavior.
Children and adolescents
Symescital is not usually used in children and adolescents under 18 years of age. It should also be emphasized that when taking medicines of this class, patients under 18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behavior, and anger). Nevertheless, a doctor may prescribe Symescital to patients under 18 years of age if he/she considers it to be in their best interest. If the doctor has prescribed Symescital to a patient under 18 years of age and the patient has any doubts, contact the doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Symescital, inform the doctor. Furthermore, there are currently no data on the long-term safety of Symescital use in this age group regarding growth, maturation, cognitive development, and behavioral development.
Symescital with other medicines
Tell 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), including active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, a 14-day interval should be observed before starting Symescital. After stopping Symescital, wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase A inhibitors (MAO-A), including moklobemide (used in the treatment of depression);
• irreversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects;
• the antibiotic linezolid;
• lithium (used in the treatment of bipolar affective disorder) and tryptophan;
• imipramine and desipramine (used in the treatment of depression);
• sumatriptan and similar medicines (used in the treatment of migraine) and tramadol and similar medicines (opioids used in the treatment of severe pain). These may increase the risk of adverse effects;
• cimetidine, lansoprazole, and omeprazole (medicines 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 heart attack). These medicines may increase escitalopram blood levels;
• St. John's wort (Hypericum perforatum) — a herbal medicine used for depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines, known as anticoagulants). These may increase the tendency to bleed;
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). The doctor may order blood clotting time tests at the beginning and after stopping Symescital to determine whether the anticoagulant dose remains appropriate;
• mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold;
• neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to possible risk of lowering the seizure threshold;
• flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Symescital may be required;
• medicines that lower potassium or magnesium levels in the blood, due to increased risk of life-threatening heart rhythm disorders.

Do not take Symescital together with medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as: class IA and class III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine).
Consult your doctor if you have any further questions.
Symescital with food, drink, and alcohol
Symescital may be taken with or without food (see section 3 "How to take Symescital").
As with many medicines, it is not recommended to take Symescital together with alcohol, although interactions (effects) between Symescital and alcohol are not expected.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. The patient should not use Symescital during pregnancy or while breastfeeding unless she has discussed the risks and benefits of treatment with her doctor.
If the patient takes Symescital 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, 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, seek medical advice immediately.
Inform the doctor and/or midwife about the use of Symescital. Taking medicines such as Symescital 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. Symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
Taking Symescital late in pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Symescital, she should inform her doctor or midwife so they can provide appropriate advice.
Do not stop taking Symescital suddenly during pregnancy.
Symescital is expected to pass into human breast milk.
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 so far.
Driving and operating machinery
The patient should not drive or operate machinery until it is known how Symescital affects them.
Symescital contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Symescital

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Adults
Depression
The usual recommended dose of Symescital is 10 mg taken once daily.
Your doctor may increase the dose up to a maximum of 20 mg per day.
Panic disorder with agoraphobia
The initial dose of Symescital is 5 mg once daily during the first week of treatment,
after which the dose is increased to 10 mg per day. The dose may then be further increased by your doctor
up to a maximum of 20 mg per day.
Social phobia
The usual recommended dose of Symescital is 10 mg taken once daily.
Your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day,
depending on the patient's response to the medicine.
Generalized anxiety disorder
The usual recommended dose of Symescital 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 Symescital 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 starting dose of Symescital is 5 mg once daily. Your doctor may recommend increasing
the dose to 10 mg once daily.
Children and adolescents
Symescital should not usually be used in children and adolescents. Additional information
is provided in section 2 “Warnings and precautions”.
Renal impairment
Caution should be exercised in patients with severe renal impairment. The medicine should be used
according to your doctor's instructions.
Hepatic impairment
Patients with impaired liver function should not take more than 10 mg per day. The medicine should be used
according to your doctor's instructions.
Patients who are poor metabolizers of drugs via the CYP2C19 isoenzyme
Patients with this known genotype should not take more than 10 mg per day. The medicine should be used
according to your doctor's instructions.
How to take Symescital
Symescital can be taken with or without food. Swallow the tablets with water. Do not chew them, as they are
bitter in taste.
If necessary, the 10 mg tablets can be divided into two equal parts. To do this, place the tablet on a flat surface
with the score side facing up, then break it in half by pressing down with the index fingers of both hands on each end,
as shown in the figure.

Duration of treatment
Improvement in symptoms may take several weeks. Therefore, continue taking Symescital even if it takes some time
before you start feeling better. Do not change the dose without consulting your doctor.
Continue taking the medicine for as long as your doctor recommends. If treatment is stopped too early,
symptoms may return. It is therefore recommended to continue treatment for at least 6 months after recovery.
Taking more Symescital than prescribed
If you have taken more Symescital than prescribed, contact your doctor immediately or go to the nearest hospital emergency department.
This should be done even if you do not feel unwell. Symptoms of overdose include dizziness, tremor, agitation, seizures, coma, nausea,
vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. Bring the Symescital packaging
with you when visiting the doctor or going to hospital.
If you miss a dose of Symescital
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 and take the 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 at the usual time.
Stopping Symescital
Do not stop taking Symescital unless advised by your doctor. When ending treatment, your doctor will usually recommend
gradually reducing the dose of Symescital over a period of several weeks.
After stopping Symescital, especially if stopped abruptly, you may experience withdrawal symptoms. These symptoms are common
when treatment with Symescital is discontinued. The risk is higher if Symescital has been taken for a long time, at high doses,
or if the dose was reduced too quickly. In most patients, symptoms are mild and resolve spontaneously within two weeks.
However, in some patients, symptoms may be more severe or last longer (2–3 months or more). If you experience severe withdrawal
symptoms after stopping Symescital, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.
Withdrawal symptoms include dizziness (unstable balance or lack of balance), tingling sensations, burning sensations, and (less commonly)
an electric shock-like sensation, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety, headache,
nausea, sweating (including night sweats), psychomotor agitation or restlessness, tremor, feelings of confusion or disorientation, emotional
lability or irritability, diarrhea (loose stools), visual disturbances, palpitations or rapid heartbeat.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions usually resolve after a few weeks of treatment. It should be remembered that some
of these reactions may also be symptoms of the illness itself and will subside as the patient's condition improves.
If any of the following adverse reactions occur during treatment, you should
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, larynx or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction);
• high fever, agitation, confusion (disorientation), tremors, and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

Frequency not known (frequency cannot be estimated from available data):

• difficulty passing urine;
• seizures, see also section "Warnings and precautions";
• yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis;
• rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes;
• suicidal thoughts and behaviour, see also section "Warnings and precautions";
• sudden swelling of the skin or mucous membranes (angioedema).

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

• nausea;
• headache.

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

• nasal congestion or runny nose (sinusitis);
• decreased or increased appetite;
• anxiety, psychomotor agitation, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling;
• diarrhoea, constipation, vomiting, dry mouth;
• excessive sweating;
• muscle and joint pain;
• sexual disorders (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women);
• feeling of fatigue, fever;
• weight gain.

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

• urticaria, rash, itching;
• teeth grinding, agitation, nervousness, panic attack, confusion;
• sleep disturbances, taste disturbances, fainting (syncope);
• pupil dilation, visual disturbances, ringing in the ears (tinnitus);
• hair loss;
• heavy menstrual bleeding;
• irregular menstruation;
• weight loss;
• rapid heartbeat;
• swelling of upper or lower limbs;
• nosebleeds.

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

• aggression, depersonalization, hallucinations;
• slow heartbeat.

Frequency not known (frequency cannot be estimated from available data):

• decreased sodium concentration in blood (manifesting as nausea and malaise with muscle weakness or 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 penile erection (priapism);
• symptoms of unusual skin and mucous membrane bleeding (petechiae);
• increased secretion of antidiuretic hormone (ADH), causing water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate ADH secretion);
• galactorrhoea in men and women who are not breastfeeding;
• mania;
• in patients taking medicines of this class, an increased risk of bone fractures has been observed;
• changes in heart rhythm (called "QT interval prolongation" visible on ECG, a test assessing heart function);
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

Additionally, adverse reactions associated with drugs having a similar mechanism of action to escitalopram
(active substance in Symescital) are known. These include:

• psychomotor agitation (akathisia);
• loss of appetite.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions 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.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Symescital

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or carton after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

What the medicine Symescital contains

• The active substance is escitalopram. Each Symescital tablet contains 5 mg or 10 mg of escitalopram (as oxalate).
• The other ingredients are:
  Tablet core: microcrystalline cellulose (type 101), sodium croscarmellose, hypromellose, talc, colloidal anhydrous silica, magnesium stearate.
  Coating: hypromellose, macrogol 400, titanium dioxide (E171).

What Symescital looks like and contents of the pack
Symescital 5 mg: white to off-white, round, biconvex coated tablets, smooth on both sides.
Symescital 10 mg: white to off-white, oval, biconvex coated tablets, with a division line and the imprint “1” on one side and “0” on the other side of the line on one side of the tablet, and smooth on the other side of the tablet. The 10 mg tablets can be divided into equal doses.
Symescital is available in the following pack sizes:
PVC/PE/PVDC/Aluminium foil blister in a cardboard box:
14, 28, 56, 98 coated tablets.
OPA/Aluminium/PVC/Aluminium foil blister in a cardboard box:
14, 28, 56, 98 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: [email protected]

Manufacturer/Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Symescital