Servenon

Package Leaflet: Information for the Patient

Servenon, 10 mg, coated tablets

Servenon, 15 mg, coated tablets

Servenon, 20 mg, coated tablets

Escitalopram

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Servenon and what is it used for
• 2. Important information before taking Servenon
• 3. How to take Servenon
• 4. Possible side effects
• 5. How to store Servenon
• 6. Contents of the pack and other information

1. What is Servenon and what is it used for

Servenon contains the active substance escitalopram. Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing serotonin levels. Disruption of the serotonin system is thought to be a major factor in the development of depression and related disorders.

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

It may take a few weeks before you feel better. You should continue to take Servenon even if it takes some time for your condition to improve.

If you do not feel better or feel worse, you should consult your doctor.

2. Important information before taking Servenon

When not to take Servenon:

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6),
• if you are taking other medicines that belong to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic),
• if you have or have ever had an abnormal heart rhythm (visible on an ECG, a test that evaluates heart function),
• if you are taking medicines used to treat irregular heartbeats or medicines that may affect heart rhythm (see section 2 "Servenon and other medicines").

Warnings and precautions

Before starting Servenon, you should discuss it with your doctor or pharmacist. You should tell your doctor if you have any other conditions or diseases, as your doctor should take this information into account.

Especially, you should inform your doctor if:

• you have epilepsy. You should stop taking Servenon if you experience or have an increased frequency of seizures (see also section 4 "Possible side effects"),
• you have liver or kidney disease. Your doctor may need to adjust the dose,
• you have diabetes. Treatment with Servenon may affect blood sugar control. You may need to adjust the dose of insulin and/or oral antidiabetic medicines,
• you have low sodium levels in the blood,
• you have an increased tendency to bleed or bruise,
• you are undergoing electroconvulsive therapy,
• you have coronary heart disease,
• you have or have had heart disease, or if you have recently had a heart attack,
• you have low resting heart rate and/or electrolyte disturbances due to prolonged, persistent diarrhea and vomiting or the use of diuretics,
• you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate abnormal heart function.
• you have or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball)
• you have or have had bleeding disorders or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").

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 such 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 occur, you should immediately inform your doctor.

Medicines like Servenon (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety disorders

If you have depression and/or anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after about 2 weeks, and sometimes later.

The likelihood of such thoughts is higher if:

• you have had suicidal thoughts or self-harm in the past.
• you are an adult in young age. Information from clinical trials indicates an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressants.

If you experience suicidal thoughts or self-harm at any time, you should contact your doctor or go to the hospital immediately.

It may be helpful if you inform someone from your family or a friendabout your depression or anxiety disorder and ask them to read this leaflet. You may ask them to tell you if they notice that your symptoms of depression or anxiety disorder have worsened or if you have worrying changes in your behavior.

Use in children and adolescents under 18 years of age

Servenon should not be used in children and adolescents under 18 years of age. You should also remember that in patients under 18 years of age taking medicines of this group, there is an increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, your doctor may prescribe Servenon to patients under 18 years of age if they consider it necessary. If your doctor has prescribed Servenon to a patient under 18 years of age and you have concerns, you should consult your doctor again. You should contact your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Servenon. The long-term safety of Servenon regarding its impact on growth, maturation, and cognitive and behavioral development in this age group has not been established yet.

Servenon and other medicines

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

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

• non-selective monoamine oxidase inhibitors (IMAOs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting escitalopram. After stopping escitalopram, you should wait 7 days before starting any of these medicines.
• reversible, selective monoamine oxidase A inhibitors (RIMAs), including moclobemide (used to treat depression).
• irreversible monoamine oxidase B inhibitors (MAO-B inhibitors), including selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.
• the antibiotic linezolid.
• lithium (used to treat manic-depressive disorder) and tryptophan.
• imipramine and desipramine (used to treat depression).
• sumatriptan and similar medicines (used to treat migraines) and tramadol (used to treat severe pain). These medicines increase the risk of side effects.
• buprenorphine (an opioid medicine). This medicine may interact with Servenon and increase the risk of serotonin syndrome, a life-threatening condition. You may experience symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, body temperature above 38°C. If you experience such symptoms, you should contact your doctor.
• cimetidine and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal preparation used to treat depression.
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used to treat pain or to thin the blood, so-called anticoagulants). These medicines may increase the risk of bleeding.
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely monitor your blood clotting time before and after stopping escitalopram to check if the dose of anticoagulant is still appropriate.
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the risk of lowering the seizure threshold.
• antipsychotics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold.
• flecainide, propafenone, metoprolol (used to treat cardiovascular diseases), clomipramine and nortriptyline (antidepressants), risperidone, thioridazine, and haloperidol (antipsychotics). Your doctor may need to adjust the dose of escitalopram.
• medicines that lower potassium or magnesium levels in the blood, as these disorders increase the risk of life-threatening heart rhythm disorders.

Do not take Servenon if you are taking medicines used to treat irregular heartbeats or medicines that 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, medicines used to treat malaria, especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If you have any further questions, consult your doctor.

Servenon with food, drink, and alcohol

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

As with many other medicines, it is not recommended to drink alcohol while taking Servenon, although you should not expect an interaction with alcohol.

Pregnancy, breastfeeding, and fertility

You should inform your doctor if you are pregnant or planning to become pregnant. You should not take escitalopram if you are pregnant or breastfeeding, unless your doctor has discussed the risks and benefits with you.

If you take Servenon during the last 3 months of pregnancy, you should be aware that your newborn may experience the following symptoms: difficulty breathing, blue discoloration of the skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness of the muscles, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If your newborn experiences any of these symptoms, you should contact your doctor immediately.

You should ensure that your midwife and/or doctor know that you are taking escitalopram.

Taking Servenon during pregnancy, especially in the last three months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). This condition causes rapid breathing and blue discoloration of the skin in the newborn. These symptoms usually appear within the first 24 hours after birth. If you notice these symptoms in your baby, you should contact your midwife and/or doctor immediately.

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

You should not stop taking Servenon during pregnancy.

It is assumed that Servenon passes into breast milk.

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

Driving and using machines

You should not drive or operate machinery until you are sure how Servenon affects you.

Servenon contains sodium

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

3. How to take Servenon

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

Adults

Depression

The recommended dose of Servenon is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg daily.

Panic disorder

The initial dose of Servenon is 5 mg once daily for the first week, which is then increased to 10 mg daily. Your doctor may recommend further dose increases up to a maximum of 20 mg daily.

Social anxiety disorder

The recommended dose of Servenon is 10 mg once daily. Your doctor may reduce the dose to 5 mg daily or increase the dose up to a maximum of 20 mg daily, depending on your response to the medicine.

Generalized anxiety disorder

The recommended dose of Servenon is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg daily.

Obsessive-compulsive disorder

The recommended dose of Servenon is 10 mg once daily. Your doctor may increase the dose up to a maximum of 20 mg daily.

Elderly patients (over 65 years of age)

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

Children and adolescents (under 18 years of age)

Servenon should not be used in children and adolescents.

For more information, see section 2 "Warnings and precautions".

Renal impairment

Caution should be exercised in patients with severe renal impairment, and the dose should be adjusted according to the doctor's instructions.

Hepatic impairment

Patients with liver disease should not receive more than 10 mg daily. The dose should be adjusted according to the doctor's instructions.

Patients known to be poor metabolizers of CYP2C19

Patients known to have this genotype should not receive more than 10 mg daily. The dose should be adjusted according to the doctor's instructions.

Servenon can be taken with or without food. You should swallow the tablet with water. Do not chew the tablets, as they have a bitter taste.

If necessary, the tablets can be broken into two parts. To do this, place the tablet on a flat surface with the score line (groove) facing up. You can then break the tablet by pressing each end down with your index fingers.

Duration of treatment

It may take a few weeks of treatment before you feel better. You should continue to take Servenon even if you do not feel better at first.

Do not change the dose of the medicine without consulting your doctor.

You should take Servenon 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 from the time you start to feel better.

Overdose of Servenon

If you have taken more than the prescribed dose of Servenon, you should contact your doctor or go to the emergency room immediately. You should do this even if you do not feel any discomfort. Some of the symptoms of overdose are dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbances, low blood pressure, and electrolyte disturbances in the body. You should bring the package (box) of Servenon with you to the doctor's visit or hospital.

Missed dose of Servenon

Do not take a double dose of the medicine to make up for a missed dose. If you forget to take a dose and remember before going to bed, you should take the missed dose immediately. You should 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 at the usual time.

Stopping Servenon treatment

You should not stop taking escitalopram unless your doctor tells you to. If you are stopping treatment, your doctor will usually recommend gradually reducing the dose of Servenon over a few weeks.

If you stop taking Servenon, especially suddenly, you may experience withdrawal symptoms. This happens often when stopping treatment with Servenon. The risk is higher if you have taken Servenon for a long time or in high doses, or if the dose of the medicine has been reduced too quickly. In most patients, the symptoms are mild and go away on their own within two weeks. However, in some patients, they may be severe or last longer (2 to 3 months or longer). If you experience severe withdrawal symptoms after stopping Servenon, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and then stop it more slowly.

Withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling and numbness, burning sensations, and (less often) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headaches, nausea (nausea), sweating (including night sweats), restlessness or agitation, tremors, confusion and disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, palpitations or pounding heart.

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

4. Possible side effects

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

Side effects usually go away after a few weeks of treatment. You should be aware that many of these side effects may also be symptoms of the disease being treated and will go away as you start to feel 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):

• abnormal bleeding, including gastrointestinal bleeding.

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

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

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

• difficulty urinating,
• seizures, see also section 2 "Warnings and precautions",
• yellowing of the skin and whites of the eyes, which is a sign of liver dysfunction and/or hepatitis,
• rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes,
• thoughts of self-harm or suicide, see also section 2 "Warnings and precautions",
• severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection Pregnancy, breastfeeding, and fertility in section 2.

The following 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):

• stuffy or runny nose or sinusitis (sinus infection),
• decreased or increased appetite,
• anxiety, restlessness, especially motor restlessness, unusual dreams, sleep disturbances, drowsiness, yawning, tremors, tingling sensation in the skin,
• diarrhea, constipation, vomiting, dry mouth,
• increased sweating,
• muscle and joint pain,
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women),
• fatigue, fever,
• weight gain.

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

• hives, rash, itching,
• grinding of the teeth, agitation, nervousness, panic attacks, disorientation,
• sleep disturbances, taste disturbances, fainting,
• dilated pupils, vision disturbances, ringing in the ears (tinnitus),
• hair loss,
• heavy menstrual bleeding,
• irregular menstrual periods,
• weight loss,
• rapid heartbeat,
• swelling of the hands or feet,
• nosebleeds.

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

• aggression, depersonalization (feeling of strangeness of one's own person), hallucinations,
• slow heartbeat.

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

• low sodium levels in the blood (symptoms may include nausea and malaise with muscle weakness; or disorientation),
• dizziness when standing up due to low blood pressure (orthostatic hypotension),
• abnormal liver function test results (elevated liver enzyme activity in the blood),
• movement disorders (involuntary muscle movements),
• painful, prolonged erection (priapism),
• symptoms of abnormal bleeding, such as bleeding into the skin and mucous membranes (ecchymoses),
• sudden swelling of the skin and mucous membranes (angioedema),
• increased urine production (inappropriate secretion of antidiuretic hormone - SIADH),
• galactorrhea in men and women who are not breastfeeding,
• mania,
• increased risk of fractures observed in patients taking medicines of this group,
• changes in heart rhythm (called "QT interval prolongation", visible on an ECG, a test that evaluates the electrical activity of the heart).

The following side effects are also known to occur with medicines with a similar mechanism of action to escitalopram (the active substance of Servenon):

• restlessness (akathisia),
• loss of appetite.

Reporting side effects

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

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

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

5. How to store Servenon

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

Do not use this medicine after the expiry date stated on the carton after "EXP" or on the blister after "EXP". The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the specified month.

There are no special precautions for storing the medicine.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Servenon contains

• The active substance of Servenon is escitalopram. Each Servenon 10 mg tablet contains 10 mg of escitalopram as escitalopram oxalate. Each Servenon 15 mg tablet contains 15 mg of escitalopram as escitalopram oxalate. Each Servenon 20 mg tablet contains 20 mg of escitalopram as escitalopram oxalate.
• The other ingredients are: tablet core: microcrystalline cellulose, anhydrous colloidal silica, talc, sodium croscarmellose, and magnesium stearate, tablet coating: hypromellose, macrogol 400, and titanium dioxide (E171).

What Servenon looks like and contents of the pack

Servenon 10 mg: white, oval, coated tablets with "E9CM" embossed on one side and a score line and the number 10 embossed on either side of the score line on the other side of the tablet.

Servenon 15 mg: white, oval, coated tablets with "E9CM" embossed on one side and a score line and the number 15 embossed on either side of the score line on the other side of the tablet.

Servenon 20 mg: white, oval, coated tablets with "E9CM" embossed on one side and a score line and the number 20 embossed on either side of the score line on the other side of the tablet.

Servenon 10 mg is available in blisters packed in a carton containing 28 or 56 tablets.

Servenon 15 mg is available in blisters packed in a carton containing 28 or 56 tablets.

Servenon 20 mg is available in blisters packed in a carton containing 28 or 56 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b

140 78 Prague 4

Czech Republic

Manufacturer

Synthon BV

Microweg 22

6545CM Nijmegen

Netherlands

Synthon Hispania SL

Castelló 1, Polígono Las Salinas

08830 Sant Boi de Llobregat

Spain

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

566 17 Vysoké Mýto

Czech Republic

For more information about this medicine and its names in other EU countries, you should contact the representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.

ul. Osmańska 14

02-823 Warsaw

Date of last revision of the leaflet:May 2021