Simescital

Package Leaflet: Information for the User

Symescital, 5 mg, film-coated tablets

Symescital, 10 mg, film-coated tablets

Escitalopram

Read all of this leaflet carefully before taking this medicine.

• 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. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Symescital is and what it is 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 Symescital is and what it is 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 if your condition worsens, you should talk to your doctor.

2. Before you take Symescital

Do not take Symescital

• if you are allergic to escitalopram or any of the other ingredients of this medicine;
• if you are taking other medicines that belong to a group called MAOIs (including selegiline, moclobemide, and linezolid);
• if you have been born with a heart condition or have had an episode of abnormal heart rhythm;
• 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 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 experience seizures or an increase in seizure frequency, you should stop taking Symescital (see also section 4 "Possible side effects");
• if you have liver or kidney problems. Your doctor may need to adjust your dose;
• if you have diabetes. Taking Symescital may affect your blood sugar control. You may need to adjust your insulin dose or oral hypoglycemic medication;
• if you have low sodium levels in your blood;
• if you have a history of bleeding or bruising easily;
• if you are pregnant or breastfeeding (see section "Pregnancy, breastfeeding, and fertility");
• if you are receiving 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 low levels of potassium or magnesium in your blood;
• if you experience fast or irregular heartbeats, fainting, or dizziness when standing up;
• if you have eye problems, such as certain types of glaucoma.

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 contact 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 contact 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

Patients with depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide. These symptoms may worsen at the start of treatment with antidepressants, as these medicines may take about 2 weeks to start working, and sometimes longer.

These symptoms are more likely to occur in:

• patients who have previously experienced thoughts of self-harm or suicide;
• young adults. Clinical trial data suggest an increased risk of suicidal behavior in patients under 25 years of age with psychiatric disorders who are treated with antidepressant medication.

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 a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet.You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about 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 patients under 18 years of age who take this type of medicine are at increased risk of side effects, such as attempted suicide, suicidal thoughts, and hostility (especially aggression, oppositional behavior, and anger).

However, your doctor may prescribe Symescital to patients under 18 years of age if they think it is in their best interests. 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 occur in patients under 18 years of age who are taking Symescital, you should tell your doctor. Additionally, there is limited experience with the use of Symescital in this age group regarding long-term safety, 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, including those you have bought without a prescription.

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

• non-selective monoamine oxidase inhibitors (MAOIs) such as 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 Symescital, you should wait 7 days before taking any of these medicines;
• reversible, selective monoamine oxidase inhibitors A (RIMAs) such as moclobemide (used to treat depression);
• irreversible monoamine oxidase inhibitors B (MAO-B) such as 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). These medicines may increase the risk of side effects;
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the levels of escitalopram in your blood;
• St. John's Wort (Hypericum perforatum) - a herbal remedy used to treat depression;
• aspirin and non-steroidal anti-inflammatory drugs (used to treat pain or thin the blood, known as anticoagulants). These medicines may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulants). Your doctor may need to monitor your blood clotting;
• 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;
• neuroleptics (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 your dose;
• medicines that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders.

Do not take Symescital with 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 drugs, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine).

If you have any further questions, you should ask your doctor.

Symescital with food, drink, 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, you should ask your doctor or pharmacist for advice before taking this medicine.

You should not take Symescital if you are pregnant or breastfeeding unless you have discussed this with your doctor.

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, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, and sleepiness.

If your baby experiences any of these symptoms, you should contact 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 a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue discoloration of the skin.

Symescital may increase the risk of serious bleeding from the uterus after delivery, especially if you have a history of bleeding disorders.

Do 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 affect fertility, although this has not been observed in humans.

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 sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Symescital

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Depression

The recommended dose of Symescital is 10 mg per day. 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 per day for the first week, then increased to 10 mg per day. 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 per day. 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 per day. 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 per day. 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 per day. Your doctor may increase the dose to 10 mg per day.

Children and adolescents

Symescital should not be used in children and adolescents under 18 years of age. See section 2 "Before you take Symescital" for additional information.

Renal impairment

Caution should be exercised in patients with severe renal impairment. Your doctor may need to adjust your dose.

Hepatic impairment

Patients with hepatic impairment should not take more than 10 mg per day. Your doctor may need to adjust your dose.

Poor metabolizers of CYP2C19

Patients with this known genotype should not take more than 10 mg per day. Your doctor may need to adjust your dose.

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 Symescital for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended that you continue treatment for at least 6 months after you feel better.

Overdose

If you take more Symescital than you should, you should contact your doctor or go to the hospital immediately. This is even if you do not feel any symptoms. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, and changes in heart rhythm.

Take the Symescital packaging with you to the hospital or doctor.

Forgot to take Symescital

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before bedtime, you should take the missed dose immediately. Take the next dose at the usual time.

If you remember the missed dose in the night or the next day, you should skip the missed dose and take the next dose as usual.

Stopping treatment

Do 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, you may experience withdrawal symptoms. These symptoms are common when treatment with Symescital is stopped, especially if it is stopped suddenly. The risk is higher if you have been taking Symescital for a long time, in high doses, or if your dose is reduced too quickly. 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 Symescital, you should contact your doctor. Your doctor may recommend that you start taking Symescital again and reduce the dose more slowly.

Withdrawal symptoms include dizziness (unstable balance or lack of balance), tingling, burning sensations, 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 excitement, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), and changes in vision.

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, 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 "Before you take Symescital";
• yellowing of the skin and whites of the eyes, which may be a sign of liver damage or hepatitis;
• fast or irregular heartbeats, fainting, which may be symptoms of a life-threatening heart rhythm disorder called torsades de pointes;
• suicidal thoughts and behaviors, see also section 2 "Before you take Symescital";
• 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):

• blocked nose or sinusitis (inflammation of the sinuses);
• decreased or increased appetite;
• restlessness, agitation, vivid dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensations;
• diarrhea, constipation, vomiting, dry mouth;
• increased sweating;
• muscle and joint pain;
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty reaching orgasm in women);
• feeling tired, fever;
• weight gain.

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

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

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

• aggression, depersonalization, hallucinations;
• slow heart rate.

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 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 type of medicine have been observed to have an increased risk of fractures;
• changes in heart rhythm (called "QT interval prolongation" visible on an electrocardiogram);
• severe bleeding from the uterus after delivery, see also section 2 "Before you take Symescital".

Additionally, the following side effects have been reported with medicines that have a similar mechanism of action to escitalopram (the active substance of Symescital):

• restlessness (akathisia);
• loss of appetite.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Side effects can be reported 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

Side effects can also be reported 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 and carton after EXP. The expiry date refers to the last day of that month.

Store in a cool, dry place, below 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, croscarmellose sodium, hypromellose, talc, silicon dioxide, 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 "1" and "0" on either side of the score line on one side and smooth on the other side. 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: biuro@farmakinternational.pl

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