Servenon

Leaflet accompanying the packaging: patient information

Servenon, 10 mg, coated tablets

Servenon, 15 mg, coated tablets

Servenon, 20 mg, coated tablets

Escitalopram

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 packaging 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 antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the levels of serotonin. Disruption of the serotonin system is thought to be a major factor in the development of depression and related diseases.

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 the patient feels better. The patient should continue to take Servenon, even if it takes some time to improve their condition.

If there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Servenon

When not to take Servenon:

• 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 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 the patient has or has ever had an irregular heart rhythm (visible on an ECG, a test that evaluates heart function),
• if the patient is taking medicines used to treat irregular heart rhythms or medicines that may affect the heart rhythm (see section 2 "Servenon and other medicines").

Warnings and precautions

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

Particularly, the patient should inform their doctor if:

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

Caution

In some patients with bipolar affective disorder, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If such 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.

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 stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorders

If the patient has depression and/or anxiety disorders, they may sometimes have thoughts of self-harm or suicide. These thoughts may increase at the start of treatment with antidepressant medicines, as these medicines usually start to work after about 2 weeks, and sometimes later.

The risk of such thoughts is higher if:

• the patient has had thoughts of suicide or self-harm in the past.
• the patient is an adult in their 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 antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm at any time, they should immediately contact their doctor or go to the hospital.

It may be helpful if the patient informs someone from their family or a friend about their depression or anxiety disorder and asks them to read this leaflet. The patient may ask them to monitor them and inform them if they notice that their symptoms of depression or anxiety disorder have worsened or if they notice any worrying changes in their behavior.

Use in children and adolescents under 18 years of age

Servenon should not normally be used in children and adolescents under 18 years of age. It should also be noted that in patients under 18 years of age treated with medicines of this class, there is an increased risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). However, the doctor may prescribe Servenon to patients under 18 years of age if they consider it necessary. If the doctor has prescribed Servenon to a patient under 18 years of age and the patient has any doubts, they should consult their doctor again. The patient should contact their 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 influence on growth, maturation, and cognitive and behavioral development in this age group has not yet been established.

Servenon 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 phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If the patient has taken any of these medicines, they should wait 14 days before starting to take escitalopram. After stopping escitalopram, they should wait 7 days before starting to take 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 adverse reactions.
• 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 migraine) and tramadol (used to treat severe pain). These medicines increase the risk of adverse reactions.
• buprenorphine (an opioid medicine). This medicine may interact with Servenon and increase the risk of serotonin syndrome, a potentially life-threatening condition. The patient 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 the patient experiences such symptoms, they should contact their 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 the levels of escitalopram in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal preparation used to treat depression.
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines (medicines used to treat pain or to thin the blood, so-called anticoagulants). These medicines may increase the tendency to bleed.
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). The doctor will probably check the blood clotting time before starting and after stopping treatment with escitalopram to check if the dose of the anticoagulant medicine 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.
• neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressant medicines (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold.
• flecainide, propafenone, metoprolol (used to treat cardiovascular diseases), clomipramine and nortriptyline (antidepressant medicines), risperidone, thioridazine, and haloperidol (antipsychotic medicines). It may be necessary 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 irregular heart rhythms.

The patient should not take Servenon if they are taking medicines used to treat irregular heart rhythms or medicines that affect the heart rhythm, such as anti-arrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, medicines used to treat malaria, especially halofantrine), or certain antihistamine medicines (astemizole, hydroxyzine, mizolastine). In case of further doubts, the patient should consult their doctor.

Servenon with food, drinks, 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 no interaction with alcohol is expected.

Pregnancy, breastfeeding, and fertility

The patient should inform their doctor if they are pregnant or planning to become pregnant. Escitalopram should not be taken during pregnancy or breastfeeding unless the doctor has discussed the risks and benefits with the patient.

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

The patient should ensure that their midwife and/or doctor know that they are taking escitalopram.

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

Taking Servenon towards the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Servenon, they should inform their doctor or midwife so that they can provide appropriate advice.

The patient should not stop taking Servenon during pregnancy unless their doctor advises them to do so.

It is assumed that Servenon passes into breast milk.

Animal studies have 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

The patient should not drive or operate machinery until they are sure how Servenon affects them.

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

The patient should always take this medicine exactly as their doctor has told them. If they are unsure, they should consult their doctor or pharmacist.

Adults

Depression

The recommended dose of Servenon is 10 mg once daily. The doctor may increase the dose 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. The doctor may recommend further increases in the dose to a maximum of 20 mg daily.

Social anxiety disorder

The recommended dose of Servenon is 10 mg once daily. The doctor may decrease the dose to 5 mg daily or increase the dose to a maximum of 20 mg daily, depending on the patient's response to the medicine.

Generalized anxiety disorder

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

Obsessive-compulsive disorder

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

Children and adolescents (under 18 years of age)

Servenon is not normally given to children and adolescents.

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

Renal impairment

Care should be taken 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. The patient should swallow the tablet with water. The tablets should not be chewed, as they have a bitter taste.

If necessary, the tablets can be broken into two pieces. To do this, the patient should place the tablet on a flat surface with the break line (score) facing upwards. The tablet can then be broken by pressing each end downwards with the index fingers of both hands.

Duration of treatment

It may take a few weeks of treatment before the patient feels better. The patient should continue to take Servenon, even if they do not feel better at first.

The patient should not change the dose of the medicine without consulting their doctor.

Servenon should be taken for as long as the doctor has prescribed it. If the patient stops treatment too early, their symptoms may return. It is recommended that treatment be continued for at least 6 months after the patient's condition has improved.

Overdose of Servenon

If the patient has taken more than the prescribed dose of Servenon, they should immediately contact their doctor or go to the emergency department of the nearest hospital. They should do this even if they do not feel any symptoms. Some of the symptoms of overdose are: dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, irregular heart rhythm, low blood pressure, and disturbances in the body's water and electrolyte balance. When visiting the doctor or hospital, the patient should take the packaging (box) of Servenon with them.

Missed dose of Servenon

The patient should not take a double dose of the medicine to make up for a missed dose. If the patient has forgotten to take a dose and remembers before going to bed, they should take the missed dose immediately. They should take the next dose at the usual time the next day. If the patient remembers that they have missed a dose in the night or the next day, they should omit the missed dose and take the next dose at the usual time.

Stopping treatment with Servenon

The patient should not stop taking escitalopram unless their doctor tells them to do so. If the patient is to stop taking Servenon, their doctor will usually recommend that the dose be gradually reduced over a few weeks.

If the patient stops taking Servenon, they may experience withdrawal symptoms. This happens quite often when Servenon is stopped, especially if the patient has been taking it for a long time or in high doses, or if the dose is 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 severe or persist for longer (2 to 3 months or longer). If the patient experiences severe withdrawal symptoms after stopping Servenon, they should contact their doctor. The doctor may recommend that the patient start taking the medicine again and then stop it more slowly.

Withdrawal symptoms include: dizziness (unsteady gait, balance disturbances), feelings of tingling and numbness, feelings of burning, and (less commonly) sensations of electric shock, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headaches, nausea (nausea), sweating (including night sweats), feelings of restlessness or agitation, tremors, confusion and disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, and 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, Servenon can cause side effects, although not everybody gets them.

Side effects usually disappear after a few weeks of treatment. The patient should be aware that many of these side effects may also be symptoms of the disease being treated and will disappear as the patient feels better.

If the patient experiences any of the following side effects, they should contact their 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 symptom 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 vagina, 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 agitation, unusual dreams, sleep disturbances, drowsiness, dizziness, yawning, tremors, feeling of tingling in the skin,
• diarrhea, constipation, vomiting, dry mouth,
• increased sweating,
• muscle and joint pain,
• sexual disturbances (delayed ejaculation, erectile dysfunction, decreased libido, difficulty reaching orgasm in women),
• feeling tired, fever,
• weight gain.

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

• hives, rash, itching,
• grinding of the teeth, 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 being a stranger to oneself), hallucinations,
• slow heartbeat.

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

• low sodium levels in the blood (symptoms may include nausea and weakness, and muscle weakness; or disorientation),
• 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 and persistent 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),
• galactorrhoea (milk secretion) in men and women who are not breastfeeding,
• mania,
• increased risk of bone fractures observed in patients taking medicines of this class,
• 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 the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Servenon

The medicine should be kept 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 month stated.

There are no special precautions for storing the medicine.

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 need. This will help protect the environment.

6. Contents of the packaging 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, film-coated tablets with "E9CM" embossed on one side and a break line and the number "10" embossed on either side of the break line on the other side.

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

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

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

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

Servenon 20 mg is available in blisters packaged 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, the patient 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