Simescital

Package Leaflet: Information for the User

Symescital, 5 mg, Film-Coated Tablets

Symescital, 10 mg, Film-Coated Tablets

Escitalopram

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, please ask your doctor or pharmacist.
• This medication has been prescribed specifically 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, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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

Escitalopram belongs to a group of antidepressant medications called selective serotonin reuptake inhibitors (SSRIs). These medications work on the serotonin system in the brain by increasing serotonin levels. Disruptions in the serotonin system in the brain play a key role in the development of depression and related disorders.
Symescital contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).

2. Important information before taking Symescital

When Not to Take Symescital

• if you are allergic to escitalopram or any of the other ingredients of this medication (listed in section 6);
• if you are taking other medications belonging to the group called monoamine oxidase inhibitors (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 rhythm disorder or if you have had an episode of abnormal heart rhythm (visible on an ECG, a test that evaluates heart function);
• if you are taking medications used to treat heart rhythm disorders or medications that may affect heart rhythm (see section 2 "Symescital and other medications").

Warnings and Precautions

Before starting to take Symescital, you should discuss it with your doctor or pharmacist.
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You should tell your doctor if you have other disorders or diseases, as the doctor should consider this information. In particular, you should inform your doctor:

• if you have epilepsy. If you experience seizures for the first time or if their frequency increases, you should stop therapy with Symescital (see also section 4 "Possible side effects");
• if you have liver or kidney function disorders. Dose adjustment may be required by your doctor;
• if you have diabetes. Taking Symescital may affect blood glucose control. It may be necessary to adjust the dose of insulin and/or oral medications that lower blood glucose levels;
• if you have low sodium levels in the blood;
• if you have a history of bleeding disorders, if you have an increased tendency to bleed and bruise easily,
• if you are pregnant (see "Pregnancy, breastfeeding, and fertility");
• if you are being treated with electroconvulsive therapy;
• if you have ischemic heart disease;
• if you have had heart problems or have recently had a heart attack;
• if you have a slow resting heart rate and/or if you may have electrolyte deficiencies due to prolonged, severe diarrhea and vomiting or the use of diuretic medications;
• if you experience rapid or irregular heartbeat, fainting, collapse, dizziness when standing up, which may indicate heart rhythm disorders;
• if you currently have or have had narrow-angle glaucoma. Symescital may increase intraocular pressure and cause narrow-angle glaucoma, especially in patients who are predisposed.

Caution

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, you should consult your doctor.
In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, you should immediately inform your doctor.

Suicidal Thoughts and Worsening of Depression or Anxiety Disorder

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 antidepressant medications, as these medications usually start working after about 2 weeks, and sometimes later.
These symptoms are more likely to occur in:

• patients who have had suicidal thoughts or self-harm in the past;
• young adult patients.Clinical trial data show an increased risk of suicidal behavior in people under 25 years of age with mental disorders who were treated with antidepressant medications. If you experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the hospital.

It may be helpful to inform your relatives or friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may ask them to monitor you and inform you if they notice that your depression or anxiety has worsened or if there are any worrying changes in your behavior.
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Medications like Symescital (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.
Children and Adolescents
Symescital is not usually given to children and adolescents under 18 years of age. It should also be noted that in the case of medications of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (including aggression, rebellious behavior, and expressions of anger). Nevertheless, your doctor may prescribe Symescital to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Symescital to a patient under 18 years of age and you have any concerns, please contact the doctor. If the above symptoms develop or worsen in patients under 18 years of age taking Symescital, you should inform 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 Medications

You should tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
You should inform your doctor if you are taking any of the following medications:

• non-selective monoamine oxidase inhibitors (MAOIs) containing substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medications, you should wait 14 days before starting to take Symescital. After stopping Symescital, you should wait 7 days before taking any of these medications;
• reversible, selective monoamine oxidase A inhibitors (MAO-A) containing moclobemide (used to treat depression);
• irreversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used to treat Parkinson's disease). These medications increase the risk of side effects;
• the antibiotic linezolid;
• lithium (used to treat bipolar affective disorder) and tryptophan;
• imipramine and desipramine (used to treat depression);
• sumatriptan and similar medications (used to treat migraines) and tramadol (used to treat severe pain). They may increase the risk of side effects;
• cimetidine, lansoprazole, and omeprazole (medications used to treat stomach ulcers), fluconazole (a medication used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (a medication used to reduce the risk of heart attack). These medications may cause an increase in escitalopram levels in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal remedy used to treat depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory medications (used as painkillers or to thin the blood, known as anticoagulants). They may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (medications used to thin the blood, known as anticoagulants). Your doctor may order a blood test to check the blood clotting time at the start and after stopping Symescital to determine if the dose of the anticoagulant is still appropriate;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold;
• antipsychotics (medications used to treat schizophrenia, psychosis), due to the possible risk of lowering the seizure threshold and antidepressants;
• flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Symescital may be necessary;

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• medications that may decrease potassium or magnesium levels in the blood, such as diuretics, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Symescital at the same time as medications used to treat heart rhythm disorders or medications that may affect heart rhythm, such as anti-arrhythmic medications of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain anti-infective medications (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medications, especially halofantrine), and certain antihistamines (astemizole, mizolastine). You should consult your doctor if you have any further questions.

Taking Symescital with Food, Drink, and Alcohol

Symescital can be taken with or without food (see section 3 "How to take Symescital").
As with many medications, it is not recommended to take Symescital and drink alcohol at the same time, although interactions (effects) of Symescital with alcohol are not expected.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medication.
You should not take Symescital during pregnancy and breastfeeding, unless you have discussed the risks and benefits of treatment 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: breathing difficulties, blue skin, seizures, fluctuations in body temperature, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or flaccidity, increased reflex excitability, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur in the newborn, you should immediately consult your doctor.
You should inform your doctor and/or midwife about taking Symescital. Taking medications like Symescital, especially during the last 3 months of pregnancy, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and blue skin. These symptoms usually occur within the first day after birth. If such symptoms occur in the newborn, you should immediately contact your doctor and/or midwife.
Taking Symescital at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you take Symescital, you should inform your doctor or midwife so they can provide you with appropriate advice.
You should not stop taking Symescital abruptly during pregnancy.
Animal studies have shown that citalopram may affect sperm quality. So far, no effect on fertility has 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 medication contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".
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3. How to Take Symescital

This medication should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Adults
Depression
The recommended dose of Symescital is 10 mg, taken as a single dose once a 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 once a day for the first week of treatment, then the dose is increased to 10 mg per day. The dose may then be increased by your doctor to a maximum of 20 mg per day.
Social Phobia
The recommended dose of Symescital is 10 mg, taken as a single dose once a 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 medication.
Generalized Anxiety Disorder
The recommended dose of Symescital is 10 mg, taken as a single dose once a 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, taken as a single dose once a 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 once a day. Your doctor may recommend increasing the dose to 10 mg once a day.
Children and Adolescents (under 18 years of age)
Symescital is not usually given to children and adolescents. Additional information is provided in section 2 "Important information before taking 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 tablets can be broken into two halves. To do this, place the tablet on a flat surface with the score line facing up, and then break it in half by pressing down on each end with your index fingers, as shown in the picture.

Duration of Treatment

You may start to feel better after a few weeks of treatment. Therefore, you should continue taking Symescital, even if it takes some time before you notice an improvement in your condition.
Do not change the dose without consulting your doctor.
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You should take the medication 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.

Taking a Higher Dose of Symescital than Recommended

If you have taken a higher dose of Symescital than prescribed, you should immediately contact your doctor or go to the emergency room at the nearest hospital. You should do this even if you do not feel any discomfort. Symptoms of overdose include dizziness, tremors, restlessness, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. When visiting your doctor or the hospital, you should bring the packaging of Symescital with you.

Missing 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 bedtime, you should take the missed dose immediately. Take the next dose at the usual time the next day. If you remember that you 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 with Symescital

Do not stop taking Symescital unless your doctor recommends it. When you finish treatment, your doctor will usually recommend gradually reducing the dose of Symescital over a period of several weeks.
After stopping Symescital, especially if it is stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when treatment with Symescital is stopped. The risk is higher if Symescital has been taken for a long time, in high doses, or if the dose has been reduced too quickly. In most patients, the symptoms are mild and disappear on their own within two weeks. However, in some patients, they may be more severe or last longer (2-3 months or longer). If you experience severe withdrawal symptoms after stopping Symescital, you should contact your doctor. Your doctor may recommend restarting the medication and tapering it off more slowly.
Withdrawal symptoms include dizziness (unstable balance or lack of balance), tingling sensation, burning sensation, and (less commonly) a sensation of electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (nausea), sweating (including night sweats), psychomotor restlessness or agitation, tremors, confusion or disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, palpitations or irregular heartbeat.
If you have any further questions about taking this medication, you should consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Symescital can cause side effects, although not everyone gets them.
Side effects usually disappear after a few weeks of treatment. Remember that some of these side effects may also be symptoms of the disease and will disappear as your condition improves.

You Should Contact Your Doctor if You Experience Any of the Following Side Effects During Treatment:

Uncommon (occurring in 1 to 10 out of 1000 patients):

• unusual bleeding, including gastrointestinal bleeding.

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Rare (occurring in 1 to 10 out of 10,000 patients):

• swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction); you should immediately contact your doctor or go to the hospital,
• high fever, restlessness, confusion (disorientation), tremors, and sudden muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome. If they occur, you should contact your doctor.

You Should Contact Your Doctor or Go to the Hospital if You Experience Any of the Following Side Effects During Treatment:

• difficulty urinating;
• seizures, see also section "Warnings and precautions";
• yellowing of the skin and whites of the eyes, which is a sign of liver dysfunction/hepatitis;
• rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes.

Additionally, the Following Side Effects Have Been Reported:

Very common (occurring in more than 1 in 10 patients):

• nausea;
• headache.

Common (occurring in 1 to 10 out of 100 patients):

• nasal congestion or sinusitis (sinus infection);
• decreased or increased appetite;
• restlessness, psychomotor restlessness, vivid dreams, difficulty sleeping, drowsiness, 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 (occurring in 1 to 10 out of 1000 patients):

• hives, rash, itching;
• teeth grinding, restlessness, nervousness, panic attacks, confusion (disorientation);
• sleep disturbances, taste disorders, fainting;
• pupil dilation, vision disturbances, ringing in the ears (tinnitus);
• hair loss;
• vaginal bleeding;
• weight loss;
• rapid heartbeat;
• swelling of the upper or lower limbs;
• nosebleeds.

Rare (occurring in 1 to 10 out of 10,000 patients):

• aggression, depersonalization, hallucinations;
• slow heartbeat.

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

• suicidal thoughts or self-harm, see also section "Warnings and precautions";

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• decreased sodium levels in the blood (manifested as nausea and malaise with muscle weakness or confusion);
• dizziness when standing up due to low blood pressure (orthostatic hypotension);
• abnormal liver function test results (increased liver enzyme activity in the blood);
• movement disorders (involuntary muscle movements);
• painful erection of the penis (priapism);
• bleeding, including bruising and bleeding from the skin and mucous membranes, and decreased platelet count (thrombocytopenia);
• sudden onset of swelling of the skin or mucous membranes (angioedema);
• increased urine production (inappropriate secretion of antidiuretic hormone - vasopressin);
• galactorrhea (milk production) in non-breastfeeding women;
• mania;
• patients taking medications from this group have been observed to have an increased risk of fractures;
• changes in heart rhythm (called "QT interval prolongation" visible on an ECG, a test that evaluates heart function);
• severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.
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Additionally, the following side effects are known for medications with a similar mechanism of action to escitalopram (the active substance of Symescital):

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

If any of your side effects worsen or if you experience any side effects not listed in this leaflet, you should consult your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Symescital

The medication should be stored out of sight and reach of children.
Do not take this medication after the expiration date stated on the blister or carton after: Expiration Date. The expiration date refers to the last day of the specified month.
PVC/PE/PVDC/Aluminum Blister: Do not store above 25°C.
OPA/Aluminum/PVC/Aluminum Blister: No special storage precautions.
Medications should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.
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6. Contents of the Pack and Other Information

What Symescital Contains

• The active substance of Symescital is escitalopram. Each Symescital tablet contains 5 mg or 10 mg of escitalopram (in the form of oxalate).
• The other ingredients are: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate, talc, hypromellose 5 cP, macrogol 400, and titanium dioxide (E171).

What Symescital Looks Like and Contents of the Pack

Symescital is available in the form of film-coated tablets containing 5 mg or 10 mg of the active substance.
Below is a description of the tablets.
Symescital, 5 mg:
Round, white, biconvex film-coated tablets, marked with "B2" on one side of the tablet and smooth on the other side of the tablet.
Symescital, 10 mg:
Oval, white, biconvex film-coated tablets, with a score line and marked with "B" on one side and "3" 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 carton:
20, 28, 30, 50, 56, 84, 90, 98, and 100 tablets.
OPA/Aluminum/PVC/Aluminum Blister in a carton:
20, 28, 30, 50, 56, 84, 90, 98, and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Importer
Symphar Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
PSI SUPPLY N.V.
Axxes Business Park
Guldensporenpark 22, Block C
9820 Merelbeke
Belgium
Date of Last Revision of the Leaflet:December 2020
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