Simescital

Package Leaflet: Information for the User

Symescital, 5 mg, coated tablets

Symescital, 10 mg, coated tablets

Escitalopram

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

• 1. What is Symescital and what is it used for
• 2. Before you take 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 is Symescital and what is it used for

Symescital contains the active substance escitalopram. Symescital belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain.

Symescital is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take a few weeks before you start to feel better. You should continue to take Symescital even if you do not feel better immediately. If you do not feel better or feel worse, you should see your doctor.

2. Before you take Symescital

When not to take Symescital

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• if you are taking other medicines that belong to a group called MAOIs (including selegiline, used to treat Parkinson's disease, moclobemide, used to treat depression, and linezolid, an antibiotic);
• if you have been born with a heart condition or have had an episode of abnormal heart rhythm (seen on an ECG, a test that measures the activity of the heart);
• if you are taking medicines that can affect the heart rhythm (see section 2 "Symescital and other medicines").

Warnings and precautions

Before taking Symescital, you should tell your doctor or pharmacist if you have any other medical conditions or if you are taking any other medicines. In particular, you should tell your doctor:

• if you have epilepsy. If you have a seizure for the first time or if the frequency of seizures increases, you should stop taking Symescital (see also section 4 "Possible side effects");
• if you have liver or kidney disease. Your doctor may need to adjust your dose;
• if you have diabetes. Taking Symescital may affect your blood sugar levels. You may need to adjust your insulin dose or your oral hypoglycemic medication;
• if you have low sodium levels in your blood;
• if you have an increased risk of bleeding or bruising;
• if you are pregnant (see section "Pregnancy, breastfeeding, and fertility");
• if you are being treated with electroconvulsive therapy;
• if you have coronary heart disease;
• if you have had a recent heart attack or have heart problems;
• if you have a slow resting heart rate and/or if you may have low levels of potassium or magnesium in your blood due to prolonged, severe diarrhea and vomiting or the use of diuretics;
• if you have a fast or irregular heartbeat, fainting, or dizziness when standing up, which may indicate heart rhythm disorders;
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Caution

In some patients with bipolar disorder, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If you experience these symptoms, you should see your doctor.

In the first few weeks of treatment, you may also experience symptoms such as restlessness or difficulty sitting or standing still. If you experience these symptoms, you should see your doctor immediately.

Medicines like Symescital (SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms may worsen at the start of treatment with antidepressants, as these medicines start to work usually after about 2 weeks, and sometimes later.

These symptoms are more likely to occur in:

• patients who have had thoughts of self-harm or suicide before;
• young adults (under 25 years old). Clinical trials have shown an increased risk of suicidal behavior in young adults with mental health conditions who were treated with antidepressants.

If you experience thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately.

It may be helpful to tell your relatives or close friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may want to ask them to tell you if they notice any worsening of your depression or anxiety or any changes in your behavior.

Children and adolescents

Symescital should not be used in children and adolescents under 18 years of age. It is also important to note that in patients under 18 years of age, who are treated with this class of medicines, there is an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (especially aggression, rebelliousness, and anger).

However, your doctor may prescribe Symescital to patients under 18 years of age if they consider it necessary. If your doctor has prescribed Symescital to a patient under 18 years of age, and you have any concerns, you should talk to your doctor.

If these symptoms develop or worsen in patients under 18 years of age taking Symescital, you should tell your doctor. Additionally, there is currently no data on the long-term safety of Symescital in this age group regarding growth, maturation, and cognitive and behavioral development.

Symescital and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

You should tell your doctor if you are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) including phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take Symescital. After stopping treatment with Symescital, you should wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase inhibitors (RIMAs) including moclobemide (used to treat depression);
• irreversible monoamine oxidase inhibitors type B (MAO-B) containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects;
• the antibiotic linezolid;
• lithium (used to treat bipolar disorder) and tryptophan;
• imipramine and desipramine (used to treat depression);
• sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used to treat severe pain). They may increase the risk of side effects;
• cimetidine, lansoprazole, and omeprazole (medicines used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of stroke). These medicines may increase the levels of escitalopram in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal remedy used to treat depression;
• aspirin and non-steroidal anti-inflammatory medicines (used to treat pain or thin the blood, known as anticoagulants). They may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulants). Your doctor may need to monitor your blood clotting time when starting or stopping treatment with Symescital;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the risk of lowering the seizure threshold;
• antipsychotics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold;
• flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Your doctor may need to adjust the dose of Symescital;
• medicines that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders.

You should not take Symescital at the same time as medicines used to treat heart rhythm disorders or medicines that may affect the heart rhythm, such as:

anti-arrhythmic medicines class IA and class III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibiotics (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine).

Symescital with food, drinks, and alcohol

Symescital can be taken with or without food (see section 3 "How to take Symescital").

As with many medicines, it is not recommended to take Symescital with alcohol, although interactions between Symescital and alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take Symescital during pregnancy or while breastfeeding, unless your doctor considers it necessary. If you take Symescital during the last 3 months of pregnancy, you should be aware that the following symptoms may occur in the newborn: difficulty breathing, blue discoloration of the skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness of the muscles, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and difficulty sleeping.

If your baby experiences any of these symptoms, you should see your doctor immediately.

You should tell your doctor and/or midwife that you are taking Symescital. Taking medicines like Symescital during pregnancy, especially in the last 3 months, may increase the risk of the baby developing a condition called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue discoloration of the skin, and usually occurs in the first day after birth. If your baby experiences these symptoms, you should see your doctor and/or midwife immediately.

Taking Symescital at the end of pregnancy may increase the risk of severe bleeding from the vagina, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you take Symescital, you should tell your doctor or midwife so that they can give you appropriate advice.

You should not stop taking Symescital during pregnancy without talking to your doctor.

It is thought that Symescital passes into breast milk.

Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

You should not drive or operate machinery until you know how Symescital affects you.

Symescital contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Symescital

You should always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults

Depression

The recommended dose of Symescital is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder

The initial dose of Symescital is 5 mg once daily for the first week, then the dose is increased to 10 mg once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Social anxiety disorder

The recommended dose of Symescital is 10 mg, taken as a single dose once daily. Your doctor may reduce the dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on your response to the medicine.

Generalized anxiety disorder

The recommended dose of Symescital is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The recommended dose of Symescital is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)

The recommended initial dose of Symescital is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.

Children and adolescents

Symescital is not usually given to children and adolescents. For more information, see section 2 "Warnings and precautions".

Renal impairment

Caution should be exercised in patients with severe renal impairment. The medicine should be used as directed by your doctor.

Hepatic impairment

Patients with hepatic impairment should not take more than 10 mg per day. The medicine should be used as directed by your doctor.

Poor metabolizers of CYP2C19

Patients with this known genotype should not take more than 10 mg per day. The medicine should be used as directed by your doctor.

How to take Symescital

Symescital can be taken with or without food. The tablets should be swallowed with water. Do not chew them, as they have a bitter taste.

If necessary, the 10 mg tablets can be divided into two equal doses. To do this, place the tablet on a flat surface with the score line facing up, and press down on each end of the tablet with your index fingers, as shown in the picture.

Duration of treatment

You may start to feel better after a few weeks of treatment. You should continue to take Symescital even if you do not feel better immediately. Do not change your dose without talking to your doctor.

You should take the medicine for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you have recovered.

Overdose

If you take more Symescital than you should, you should contact your doctor or go to the emergency room immediately. This is even if you do not feel any symptoms. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. You should bring the package leaflet and any remaining tablets with you to the doctor or hospital.

Missed dose

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, you should take the missed dose immediately. Take the next dose at the usual time the next day. If you remember that you have missed a dose in the night or the next day, you should skip the missed dose and take the next dose as usual.

Stopping treatment

You should not stop taking Symescital without talking to your doctor. When you stop treatment, your doctor will usually recommend that you reduce the dose gradually over a few weeks.

After stopping treatment with Symescital, you may experience withdrawal symptoms. These symptoms are common when treatment with Symescital is stopped. The risk is higher if you have been taking Symescital for a long time, in high doses, or if you stop treatment suddenly. In most patients, the symptoms are mild and disappear within two weeks. However, in some patients, they may be more severe or longer-lasting (2-3 months or longer). If you experience severe withdrawal symptoms after stopping treatment with Symescital, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and taper it off more slowly.

Withdrawal symptoms include dizziness (unstable balance or lack of balance), tingling sensation, burning sensation, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea, sweating (including night sweats), agitation or restlessness, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Symescital can cause side effects, although not everybody gets them.

Side effects usually disappear after a few weeks of treatment. Remember that some of these side effects may also be symptoms of your illness and will disappear as you get better.

If you experience any of the following side effects during treatment, you should contact your doctor or go to the hospital immediately:

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

• unusual bleeding, including bleeding from the digestive tract.

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

• swelling of the skin, tongue, lips, throat, or face, hives, 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 (cannot be estimated from the available data):

• difficulty urinating;
• seizures, see also section 2 "Warnings and precautions";
• yellowing of the skin and whites of the eyes, which may be a sign of liver damage or hepatitis;
• fast or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes;
• suicidal thoughts and behaviors, see also section 2 "Warnings and precautions";
• sudden swelling of the skin or mucous membranes (angioedema).

Other side effects 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 sinusitis (sinus infection);
• decreased or increased appetite;
• restlessness, agitation, vivid dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensation;
• diarrhea, constipation, vomiting, dry mouth;
• increased sweating;
• muscle and joint pain;
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women);
• fatigue, fever;
• weight gain.

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

• hives, rash, itching;
• teeth grinding, agitation, nervousness, panic attacks, confusion;
• sleep disturbances, taste disturbances, fainting (syncope);
• dilated pupils, vision disturbances, ringing in the ears (tinnitus);
• hair loss;
• heavy menstrual bleeding;
• irregular menstrual periods;
• weight loss;
• fast heartbeat;
• swelling of the arms or legs;
• nosebleeds.

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

• aggression, depersonalization, hallucinations;
• slow heartbeat.

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

• low sodium levels in the blood (which may cause nausea and weakness with muscle weakness or confusion);
• dizziness when standing up due to low blood pressure (orthostatic hypotension);
• abnormal liver function tests (increased liver enzyme activity in the blood);
• movement disorders (involuntary muscle movements);
• painful erection (priapism);
• symptoms of unusual bleeding in the skin and mucous membranes (ecchymoses);
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, dilutional hyponatremia, and decreased sodium levels;
• galactorrhea (milk secretion) in men and women who are not breastfeeding;
• mania;
• patients taking this class of medicines have been observed to have an increased risk of fractures;
• changes in heart rhythm (called "QT interval prolongation" seen on an ECG, a test that measures the activity of the heart);
• severe bleeding from the vagina, which can occur shortly after delivery (postpartum hemorrhage), see additional information in section 2 "Pregnancy, breastfeeding, and fertility".

Other side effects have been reported with medicines that work in a similar way to escitalopram (the active substance of Symescital). These include:

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

Reporting side effects

If you experience any side effects, you should tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety, 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

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Symescital

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that 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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Symescital contains

• The active substance is escitalopram. Each Symescital tablet contains 5 mg or 10 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are: Tablet core: microcrystalline cellulose (type 101), croscarmellose sodium, 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, film-coated tablets, smooth on both sides.

Symescital 10 mg: white to off-white, oval, biconvex, film-coated tablets, with a score line and the marking "1" on one side and "0" on the other side of the score 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 packs:

PVC/PE/PVDC/Aluminum blister in a cardboard box

14, 28, 56, 98 film-coated tablets.

OPA/Aluminum/PVC/Aluminum blister in a cardboard box

14, 28, 56, 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Symescital

Date of last revision of the leaflet:May 2025