Package leaflet: Information for the user

Escitalopram Symphar, 5 mg, film-coated tablets
Escitalopram Symphar, 10 mg, film-coated tablets
Escitalopram Symphar, 20 mg, film-coated tablets
Escitalopramum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Table of contents of the leaflet

What Escitalopram Symphar is and what it is used for
What you need to know before taking Escitalopram Symphar
How to take Escitalopram Symphar
Possible side effects
How to store Escitalopram Symphar
Contents of the pack and other information

1. What Escitalopram Symphar is and what it is used for

Escitalopram Symphar contains the active substance escitalopram. Escitalopram Symphar
belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
These medicines act on the serotonergic system in the brain by increasing the concentration of serotonin.
Escitalopram Symphar is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take several weeks of treatment before improvement begins. You should continue taking Escitalopram Symphar even if it takes some time for your condition to improve.
If no improvement occurs or if you feel worse, consult your doctor.

2. Important information before using Escitalopram Symphar

When not to use Escitalopram Symphar

if the patient is allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
if the patient is taking other medicines belonging to a group called MAO inhibitors, containing selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic);
if the patient was born with a congenital abnormal heart rhythm or if the patient has experienced an episode of abnormal heart rhythm (visible on ECG, a test assessing heart function);
if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Escitalopram Symphar with other medicines").

Warnings and precautions
Before starting treatment with Escitalopram Symphar, discuss this with your doctor or
pharmacist. Inform your doctor if the patient has any other disorders or diseases,
as the doctor should take such information into account. In particular, inform
your doctor:

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

Note
In some patients with bipolar affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform the doctor immediately.
Medicines such as Escitalopram Symphar (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety symptoms
Patients with depression or anxiety disorders may sometimes have thoughts about self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually start to work only after about 2 weeks, sometimes later.
These symptoms are more likely in:

patients who previously had thoughts of self-harm or suicide;
young adult patients. Clinical trial data show an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who were treated with antidepressants. If the patient develops thoughts of self-harm or suicide, seek immediate medical advice from a doctor or go to hospital.

Informing family members or close friends about the depression or
anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask them to inform him or her if they notice worsening of depression or anxiety or concerning changes in behaviour.
Children and adolescents
Escitalopram Symphar is not usually used in children and adolescents under 18 years of age.
It should also be emphasized that when medicines of this class are used, patients under 18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and manifestations of anger). Nevertheless, a doctor may prescribe Escitalopram Symphar to patients under 18 years of age if he or she considers it to be in their best interest. If the doctor has prescribed Escitalopram Symphar to a patient under 18 years of age and the patient has any doubts, contact the doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram Symphar, inform the doctor. Furthermore, there are currently no data on the long-term safety of Escitalopram Symphar in this age group regarding growth, maturation, and cognitive and behavioural development.
Escitalopram Symphar with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to use.
Inform the doctor if the patient is taking any of the following medicines:

non-selective monoamine oxidase inhibitors (MAOIs) including active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, a 14-day interval should be observed before starting Escitalopram Symphar. After discontinuing Escitalopram Symphar, wait 7 days before taking any of these medicines;
reversible, selective monoamine oxidase A inhibitors (MAO-A) including moclobemide (used in the treatment of depression);
irreversible monoamine oxidase B inhibitors (MAO-B) containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects;
the antibiotic linezolid;
lithium (used in the treatment of bipolar affective disorder) and tryptophan;
imipramine and desipramine (used in the treatment of depression);
sumatriptan and similar medicines (used in the treatment of migraine) and tramadol and similar medicines (opioids, used in the treatment of severe pain). These may increase the risk of adverse effects;
cimetidine, lansoprazole, and omeprazole (medicines used in the treatment of peptic ulcer disease), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of heart attack). These medicines may increase the blood concentration of escitalopram;
St John's wort (Hypericum perforatum) – a herbal medicine used in depression;
acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines, known as anticoagulants). These may increase the tendency to bleed;
warfarin, dipyridamole, and phenprocoumon (blood-thinning medicines, known as anticoagulants). The doctor may order blood clotting time tests at the beginning and after discontinuation of Escitalopram Symphar to determine whether the anticoagulant dose remains appropriate;
mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold;
neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to possible risk of lowering the seizure threshold;
flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dosage adjustment of Escitalopram Symphar may be required;
medicines that lower blood potassium or magnesium levels, due to increased risk of life-threatening heart rhythm disturbances.

Do not take Escitalopram Symphar together with medicines used for
heart rhythm disorders or medicines that may affect heart rhythm, such as: class IA and class III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). Consult the doctor if you have any further questions.
Escitalopram Symphar with food, drink, and alcohol
Escitalopram Symphar can be taken with or without food (see section 3 "How to take Escitalopram Symphar").
As with many medicines, it is not recommended to consume alcohol while taking Escitalopram Symphar, although interactions (effects) between Escitalopram Symphar and alcohol are not expected.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The patient should not take Escitalopram Symphar during pregnancy or breastfeeding unless she has discussed the risks and benefits of treatment with her doctor.
If the patient takes Escitalopram Symphar during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek immediate medical advice.
Inform the doctor and/or midwife about the use of Escitalopram Symphar.
Taking medicines such as Escitalopram Symphar during pregnancy, especially during the last 3 months, 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 cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
Taking Escitalopram Symphar towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Escitalopram Symphar, she should inform her doctor or midwife so they can provide appropriate advice.
Do not abruptly stop taking Escitalopram Symphar during pregnancy.
Escitalopram Symphar is expected to pass into human milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This may theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
The patient should not drive or operate machinery until it is known how Escitalopram Symphar affects them.
Escitalopram Symphar contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Escitalopram Symphar

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Adults

Depression
The usual recommended dose of Escitalopram Symphar is 10 mg, taken as a single dose once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder with agoraphobia
The initial dose of Escitalopram Symphar is 5 mg once daily during the first week of treatment. The dose is then increased to 10 mg once daily. Your doctor may further increase the dose up to a maximum of 20 mg per day.

Social phobia
The usual recommended dose of Escitalopram Symphar is 10 mg, taken as a single dose once daily. Your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on the patient's response to the medicine.

Generalized anxiety disorder
The usual recommended dose of Escitalopram Symphar is 10 mg, taken as a single dose once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Symphar is 10 mg, taken as a single dose once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The recommended starting dose of Escitalopram Symphar is 5 mg once daily. Your doctor may recommend increasing the dose to 10 mg once daily.

Children and adolescents
Escitalopram Symphar should generally not be used in children and adolescents. Additional information is provided in section 2, "Warnings and precautions".

Renal impairment
Caution should be exercised in patients with severe renal impairment. The medicine should be used according to the doctor's instructions.

Hepatic impairment
Patients with impaired liver function should not take a dose exceeding 10 mg per day. The medicine should be used according to the doctor's instructions.

Patients who are poor metabolizers of drugs via the CYP2C19 isoenzyme
Patients with this known genotype should not take a dose exceeding 10 mg per day. The medicine should be used according to the doctor's instructions.

How to take Escitalopram Symphar
Escitalopram Symphar tablets may be taken with or without food. Swallow the tablets whole with water. Do not chew them, as they have a bitter taste.

If necessary, the 10 mg and 20 mg tablets may be divided into two equal parts. To do this, place the tablet on a flat surface with the groove facing upwards, then break it in half by pressing down with the index fingers of both hands on each end, as shown in the illustration.

Two pairs of hands pointing with index fingers at a round object placed centrally on a white background

Duration of treatment
You may not start to feel better until after several weeks of treatment. Therefore, continue taking Escitalopram Symphar even if it takes some time before you feel improvement in your well-being.
Do not change the dose without consulting your doctor.
Continue taking the medicine for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. It is therefore recommended to continue treatment for at least 6 months after regaining good well-being.

Taking more Escitalopram Symphar than prescribed
If you take more Escitalopram Symphar than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. This should be done even if you do not feel any symptoms. Symptoms of overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. Bring the medicine packaging with you when visiting the doctor or going to the hospital.

If you miss a dose of Escitalopram Symphar
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to bed, take the missed dose immediately and take the next dose the following day as usual. If you remember about the missed dose during the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping Escitalopram Symphar
Do not stop taking Escitalopram Symphar unless your doctor tells you to. When stopping treatment, your doctor will usually recommend gradually reducing the dose of Escitalopram Symphar over several weeks.

After stopping Escitalopram Symphar, especially if stopped abruptly, you may experience withdrawal symptoms. These symptoms are common when stopping treatment with Escitalopram Symphar. The risk is greater if the medicine has been taken for a long time, at high doses, or if the dose was reduced too quickly. In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some patients, symptoms may be more severe or last longer (2–3 months or more). If you experience severe withdrawal symptoms after stopping Escitalopram Symphar, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.

Withdrawal symptoms may include dizziness (unsteadiness or loss of balance), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head; sleep disturbances (vivid dreams, nightmares, insomnia); feelings of anxiety; headache; nausea; sweating (including night sweats); psychomotor agitation or restlessness; tremors; feelings of confusion or disorientation; emotional lability or irritability; diarrhoea (loose stools); visual disturbances; palpitations or rapid heartbeat.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions usually resolve within a few weeks of treatment. It should be remembered that some
of these reactions may also be symptoms of the underlying disease and will resolve as the patient's condition improves.
If any of the following adverse reactions occur during treatment, you should
contact your doctor or go to hospital immediately:
Uncommon (may occur in up to 1 in 100 people):

unusual bleeding, including gastrointestinal bleeding.

Rare (may occur in up to 1 in 1000 people):

swelling of the skin, tongue, lips, larynx or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction);
high fever, agitation, confusion (disorientation), tremors, and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

Frequency unknown (frequency cannot be estimated from the available data):

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

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

nausea;
headache.

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

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

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

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

Rare (may occur in up to 1 in 1000 people):

aggression, depersonalisation, hallucinations;
slow heartbeat.

Frequency unknown (frequency cannot be estimated from the available data):

decreased sodium concentration in blood (manifesting as nausea, malaise, muscle weakness or confusion);
dizziness upon standing due to low blood pressure (orthostatic hypotension);
abnormal liver function tests (increased liver enzyme activity in blood);
movement disorders (involuntary muscle movements);
painful penile erection (priapism);
signs of unusual bleeding in the skin and mucous membranes (petechiae);
increased secretion of antidiuretic hormone (ADH), leading to water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate ADH secretion);
galactorrhoea in men and women who are not breastfeeding;
mania;
in patients taking medicines of this class, an increased risk of bone fractures has been observed;
change in heart rhythm (called "QT interval prolongation" visible on ECG, a test assessing heart function);
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

Additionally, adverse reactions known for medicines with a similar mechanism of action to escitalopram
(active substance in Escitalopram Symphar) include:

psychomotor restlessness (akathisia);
loss of appetite.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Escitalopram Symphar

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or carton after EXP. The expiry date refers to the last day of the specified 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. Such measures will help protect the environment.

6. Contents of the package and other information

What Escitalopram Symphar contains

The active substance is escitalopram. Each tablet of Escitalopram Symphar contains 5 mg, 10 mg or 20 mg of escitalopram (as oxalate).
The other ingredients are:
Tablet core: microcrystalline cellulose (type 101), sodium croscarmellose, hypromellose, talc, colloidal anhydrous silica, magnesium stearate.
Coating: hypromellose, macrogol 400, titanium dioxide (E171).

What Escitalopram Symphar looks like and contents of the pack
Escitalopram Symphar 5 mg: white to off-white, round, biconvex coated tablets, smooth on both sides.
Escitalopram Symphar 10 mg: white to off-white, oval, biconvex coated tablets, with a division line and markings "1" on one side and "0" on the other side of the line on one side of the tablet, and smooth on the other side of the tablet. The 10 mg tablets can be divided into equal doses.
Escitalopram Symphar 20 mg: white to off-white, oval, biconvex coated tablets, with a division line on one side of the tablet and smooth on the other side of the tablet. The 20 mg tablets can be divided into equal doses.
Escitalopram Symphar is available in the following pack sizes:
Blister pack made of PVC/PE/PVDC/Aluminium in a cardboard box:
14, 28, 56, 98 coated tablets.
Blister pack made of OPA/Aluminium/PVC/Aluminium in a cardboard box:
14, 28, 56, 98 coated tablets.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised for sale in the European Economic Area under the following names:
Poland: Escitalopram Symphar

Escitalopram symphar