Simescital

Leaflet accompanying the packaging: information for the user

Symescital, 5 mg, film-coated tablets

Symescital, 10 mg, film-coated tablets

Escitalopram

You should carefully read the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Symescital and what is it 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 packaging and other information

1. What is Symescital and what is it used for

Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the levels of serotonin. Disturbances in the serotonin system in the brain are thought to 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 the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• if the patient was born with a heart rhythm disorder or if the patient has had an episode of irregular heart rhythm (visible on an ECG, a test that assesses 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 and other medicines").

Warnings and precautions

Before starting to take Symescital, the patient should discuss it with their doctor or pharmacist.
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The patient should tell their doctor if they have any other disorders or diseases, as the doctor should take this information into account. In particular, the patient should inform their doctor:

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

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 antidepressant medicines, as these medicines usually start working only 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 medicines. If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital.

It may be helpful to inform relatives or friendsabout the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if their depression or anxiety worsens or if they notice any worrying changes in their behavior.
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Medicines like Symescital (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after the 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 taking medicines of this class, patients under 18 years of age are at increased risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (including aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Symescital to patients under 18 years of age if they consider it to be in their best interest. If the doctor prescribes Symescital to a patient under 18 years of age, and you have any doubts, please contact the doctor. If the above symptoms develop or worsen in patients under 18 years of age taking Symescital, the doctor should be informed. 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor if they are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting to take Symescital. After stopping Symescital, the patient should wait 7 days before taking any of these medicines;
• 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 medicines increase the risk of adverse reactions;
• the antibiotic linezolid;
• lithium (used to treat bipolar affective disorder) and tryptophan;
• imipramine and desipramine (used to treat depression);
• sumatriptan and similar medicines (used to treat migraine) and tramadol (used to treat severe pain). They may increase the risk of adverse reactions;
• 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 heart attack). These medicines may increase the levels of escitalopram in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression;
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used as painkillers or to 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). The doctor may order a blood clotting test 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 (medicines 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). A dose adjustment of Symescital may be required;

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• medicines 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 medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as anti-arrhythmic medicines of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine), and certain antihistamines (astemizole, mizolastine). The patient should consult their doctor if they 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 medicines, 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
The patient should not take Symescital during pregnancy and while breastfeeding, unless they have discussed the risks and benefits with their doctor.
If the patient takes Symescital during the last 3 months of pregnancy, they should be aware that the newborn may experience the following symptoms: difficulty breathing, blue skin, seizures, fluctuations in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflex excitability, tremors, tremors, irritability, lethargy, constant crying, and difficulty sleeping. If the newborn experiences any of these symptoms, the patient should immediately consult their doctor.
The patient should inform their doctor and/or midwife about taking Symescital. Taking medicines like Symescital during pregnancy, especially in the last three months, may increase the risk of the newborn developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN). It is characterized by rapid breathing and blue skin. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.
Taking Symescital at the end of pregnancy may increase the risk of severe postpartum hemorrhage, which occurs shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient takes Symescital, they should inform their doctor or midwife so that they can provide appropriate advice.
The patient 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

The patient should not drive or operate machinery until they know how Symescital affects them.

Symescital contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means that it is essentially "sodium-free".
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3. How to take Symescital

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their 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 the 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 the 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.
The doctor may reduce the dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on the patient's response to the medicine.
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 the 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 the 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. The 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. They should not be chewed, as they have a bitter taste.
If necessary, the tablets can be broken in half. To do this, the patient should place the tablet on a flat surface with the score line facing up and break it in half by pressing down on each end with their index fingers, as shown in the picture.

Duration of treatment

The patient may start to feel better only after a few weeks of treatment. Therefore, they should continue taking Symescital, even if it takes some time to feel better.
The patient should not change the dose without consulting their doctor.
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The medicine should be taken for as long as the doctor recommends. If the patient stops treatment too early, their symptoms may return. It is recommended to continue treatment for at least 6 months after feeling better.

Taking a higher dose of Symescital than recommended

If the patient takes a higher dose of Symescital than prescribed, they should immediately contact their doctor or go to the emergency room. They should do this even if they 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 the doctor or going to the hospital, the patient should take the Symescital packaging with them.

Missing a dose of Symescital

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take a dose and remembers before going to bed, they should take the missed dose immediately. They should take the next dose the following day. If the patient remembers that they missed a dose at night or the next day, they should skip the missed dose and take the next dose as usual.

Stopping treatment with Symescital

The patient should not stop taking Symescital unless their doctor recommends it. When the patient stops treatment, it is usually recommended to gradually reduce the dose of Symescital over a period of several weeks.
After stopping Symescital, especially if it is stopped abruptly, the patient may experience withdrawal symptoms. These symptoms are common when treatment with Symescital is stopped. The risk is higher when Symescital has been taken for a long time, in high doses, or when the dose has been reduced too quickly. In most patients, the symptoms are mild and resolve on their own within two weeks. However, in some patients, they may be more severe or last longer (2-3 months or longer). If the patient experiences severe withdrawal symptoms after stopping Symescital, they should contact their doctor. The doctor may recommend restarting the treatment 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), restlessness or agitation, tremors, confusion or disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or arrhythmias.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Symescital can cause side effects, although not everybody gets them.
Side effects usually resolve after a few weeks of treatment. It should be remembered that some of these side effects may also be symptoms of the disease and will resolve as the patient's condition improves.

The patient should contact their doctor if they experience any of the following side effects during treatment:

Uncommon (affecting 1 to 10 users in 1000):

• unusual bleeding, including gastrointestinal bleeding.

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Rare (affecting 1 to 10 users in 10,000):

• swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction); the patient should immediately contact their 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 these symptoms occur, the patient should contact their doctor.

The patient should contact their doctor or go to the hospital if they 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 or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes.

In addition to the above, the following side effects have also been reported:

Very common (affecting more than 1 user in 10):

• nausea;
• headache.

Common (affecting 1 to 10 users in 100):

• nasal congestion or sinusitis (sinus infection);
• decreased or increased appetite;
• restlessness, 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 (affecting 1 to 10 users in 1000):

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

Rare (affecting 1 to 10 users in 10,000):

• aggression, depersonalization, hallucinations;
• slow heartbeat.

Some patients have also 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 by 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 in 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 in non-breastfeeding women;
• mania;
• patients taking medicines of this class 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 assesses heart function);
• severe 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 medicines with a similar mechanism of action to escitalopram (the active substance of Symescital):

• psychomotor restlessness (akathisia);
• anorexia.

If any side effect worsens or if the patient experiences any side effects not listed in the leaflet, they should consult their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their 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 medicine.

5. How to store Symescital

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the blister or carton after: Expiry date. The expiry date refers to the last day of the month stated.
PVC/PE/PVDC/Aluminum blister: Do not store above 25°C.
OPA/Aluminum/PVC/Aluminum blister: No special storage precautions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.
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6. Contents of the packaging and other information

What Symescital contains

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

What Symescital looks like and contents of the pack

Symescital is a film-coated tablet 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.
Koszykowa 65
00-667 Warsaw
Importer
Symphar Sp. z o.o.
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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