Escipram

Leaflet included in the packaging: patient information

Escipram, 5 mg, film-coated tablets
Escipram, 10 mg, film-coated tablets
Escipram, 15 mg, film-coated tablets
Escipram, 20 mg, film-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 for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Escipram and what is it used for

Escipram contains the active substance escitalopram, which is used to treat depression (severe depressive episodes) and anxiety disorders, such as panic disorder with or without agoraphobia (fear of open spaces), social anxiety disorder (fear of contact with people), generalized anxiety disorder, and obsessive-compulsive disorder.
Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRI). These medicines work on the serotonin system in the brain by increasing the level of serotonin. Serotonin system disorders are considered a serious factor influencing the development of depression and related diseases.
The patient may start feeling better only after a few weeks of therapy. The patient should continue taking Escipram even if they do not feel better for some time.

2. Important information before taking Escipram

When not to take Escipram:

Escipram should not be taken in the following cases:

• hypersensitivity to escitalopram or any of the other ingredients of this medicine (listed in section 6)
• concomitant use of monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic)
• congenital or acquired heart rhythm disorders (as shown by an ECG - a test used to evaluate heart function)
• concomitant use of medicines that affect heart rhythm or may affect heart rhythm (see "Escipram and other medicines").

Warnings and precautions

Before starting to take Escipram, the patient should discuss it with their doctor or pharmacist. The patient should inform their doctor about any other diseases or conditions that may be important. In particular, the patient should inform their doctor if:

• they have had a seizure for the first time or if their seizures have worsened; treatment with Escipram should be discontinued (see also section 4 "Possible side effects")
• they have liver or kidney function disorders; the doctor may consider it necessary to adjust the dose
• they have diabetes; treatment with Escipram may affect blood sugar levels; 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 a tendency to bleed or bruise easily or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility");
• they are undergoing electroconvulsive therapy;
• they have coronary heart disease;
• they have heart rhythm disorders or have recently had a heart attack;
• they have low resting blood pressure and/or low sodium levels due to prolonged diarrhea and vomiting or the use of diuretics;
• they have rapid or irregular heartbeat, fainting, dizziness, or lightheadedness when standing up, which may indicate heart rhythm disorders;
• they have a history of eye disorders, such as glaucoma (increased pressure in the eye).

Caution

As with other medicines used to treat depression or related diseases, improvement in health does not occur immediately after starting treatment, but only after a few weeks. In the case of anxiety disorders, improvement usually occurs after 2-4 weeks. At the beginning of treatment, some patients may experience increased anxiety, which disappears during treatment. Therefore, it is very important to follow the doctor's instructions carefully and not to stop treatment without consulting a doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

Depression and/or anxiety disorders may be accompanied by thoughtsof self-harmor suicidalthoughts.
These symptoms may worsen during the initial phase of therapy with antidepressant medicines, as these medicines usually start working only after about two weeks. Sometimes this period is longer.
People who have had suicidal thoughts or self-harm thoughts before are more likely to experience this type of symptom.

• people who have had suicidal thoughts or self-harm thoughts before
• younger adult patients. Information obtained during clinical trials indicates an increased risk of suicidal behavior in adult patients under 25 years of age with mental disorders treated with antidepressant medicines.

In case of suicidal thoughts or self-harm thoughts, the patient should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient can ask them to provide the necessary information if they notice that depression or anxiety has worsened or if there are any worrying changes in behavior.
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 occur, the patient should immediately inform their doctor.
Medicines such as Escipram (so-called SSRI or SNRI) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after the treatment was discontinued.
Sometimes the patient may not be aware of the occurrence of the above symptoms, and therefore it may be advisable to ask someone from their acquaintances or family to pay attention to whether there are any changes in the patient's behavior.
If the patient has worrying thoughts or experiences or if any of the above symptoms occur during treatment, they should immediately consult their doctor or go to the hospital.

Children and adolescents

Escipram should not be used in children and adolescents under 18 years of age. Additional information is provided in section 2 "Important information before taking Escipram".
If the doctor has prescribed Escipram to a patient under 18 years of age, and if any doubts arise, the patient should consult their doctor again. If the symptoms mentioned above worsen in patients under 18 years of age taking Escipram, the patient should inform their doctor.
Furthermore, there is currently no data on the long-term safety of using Escipram in this age group regarding growth, maturation, and cognitive and behavioral development.

Escipram 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 about medicines they plan to take.
DO NOT TAKE ESCIPRAM IF YOU ARE TAKING MEDICINES FOR HEART RHYTHM DISORDERS OR MEDICINES THAT MAY AFFECT HEART FUNCTION, SUCH AS:
antiarrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines, especially halofantrine), certain antihistamine medicines (astemizole, mizolastine). In case of doubts, the patient should consult their doctor.
The patient should inform their doctor if they are taking any of the following medicines:

• non-selective monoamine oxidase inhibitors (MAOIs) containing active 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 Escipram. After stopping Escipram, the patient should wait 7 days before taking any of these medicines.
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (used to treat depression);
• irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects;
• linezolid (an antibiotic);
• lithium (used to treat bipolar affective 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 may increase the risk of side effects;
• buprenorphine (used to treat chronic moderate to severe pain), as this may increase the risk of developing a potentially life-threatening condition called serotonin syndrome.
• cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood;
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression;
• acetylsalicylic acid and nonsteroidal anti-inflammatory medicines (used to relieve pain or thin the blood, known as anticoagulant medicines - may increase the tendency to bleed);
• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, known as anticoagulant medicines). The doctor may order a blood clotting test at the beginning and after stopping Escipram to determine if the anticoagulant dose is still appropriate;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the potential risk of lowering the seizure threshold;
• antipsychotic medicines (used to treat schizophrenia, psychosis) due to the potential risk of lowering the seizure threshold, as well as antidepressant medicines;
• flecainide, propafenone, and metoprolol (used to treat heart diseases), desipramine, clomipramine, and nortriptyline (antidepressant medicines), as well as risperidone, tiordiazine, and haloperidol (antipsychotic medicines). A dose adjustment of Escipram may be necessary;
• medicines that lower potassium or magnesium levels in the blood, as this may lead to life-threatening heart rhythm disorders.

Taking Escipram with food, drinks, and alcohol

Escipram can be taken with or without food (see section 3 "How to take Escipram").
As with other medicines, it is not recommended to take Escipram and drink alcohol at the same time, although no interaction (effect) of Escipram with alcohol has been demonstrated.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.
If the patient is taking Escipram in the last 3 months of pregnancy, they should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, tremors, restlessness, irritability, lethargy, sleepiness, and difficulty sleeping. If any of these symptoms occur in the newborn, the patient should immediately consult their doctor.
The patient should make sure that their doctor and/or midwife know that they are taking Escipram. If the patient has taken medicines like Escipram during the last 3 months of pregnancy, the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN) may be increased in the child, which causes rapid breathing and blue skin in the child. These symptoms usually occur in the first day of life. If this happens, the patient should immediately consult their midwife and/or doctor.
Taking Escipram at the end of pregnancy may increase the risk of severe vaginal bleeding occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Escipram, they should inform their doctor or midwife so that they can provide the necessary advice.
The patient should not stop taking Escipram during pregnancy.
Escipram is excreted into human milk. If the patient is breastfeeding, they should not take Escipram without discussing the risks and benefits of treatment with their doctor.
In animal studies, it has been shown that citalopram, a medicine with a similar mechanism of action to escitalopram, affects sperm quality. This may theoretically affect fertility; however, no effect on fertility has been observed in humans.
The patient should consult their doctor or pharmacist before taking any medicine.

Driving and using machines

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

Escipram contains sodium

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

3. How to take Escipram

Escipram should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist again.

Adults

Depression
The recommended dose of Escipram is 10 mg, taken as a single dose once daily. The doctor may recommend further increasing the dose to a maximum of 20 mg per day.
Panic disorder
The initial dose of Escipram is 5 mg per day for the first week of treatment, then the dose is increased to 10 mg per day. The dose may be further increased by the doctor to a maximum of 20 mg per day.
Social anxiety disorder
The recommended dose of Escipram is 10 mg, taken as a single dose once daily. The dose may be decreased by the doctor to 5 mg per day or increased to a maximum of 20 mg per day, depending on the patient's response to the medicine.
Generalized anxiety disorder
The recommended dose is usually 10 mg of Escipram per day. The dose may be increased by the doctor to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The recommended dose of Escipram is 10 mg, taken as a single dose once daily. The dose may be increased by the doctor to a maximum of 20 mg per day.

Children and adolescents

Escipram is not usually recommended for children and adolescents. Additional information is provided in section 2 "Important information before taking Escipram".
Escipram can be taken with or without food. The tablets should be swallowed with water. The patient should not chew them, as they have a bitter taste.
If necessary, the tablets can be broken into two halves by placing the tablet on a flat surface with the score line facing up. The tablet can then be broken into two halves by pressing down on each end with the index fingers.
The tablet can be divided into equal doses.

Elderly patients (over 65 years of age)

The recommended initial dose of Escipram is 5 mg, taken as a single dose once daily. The doctor may increase the dose to 10 mg per day.

Duration of treatment

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

Overdose of Escipram

In case of overdose, the patient should immediately consult their doctor or go to the hospital. The patient should do this even if they do not feel any discomfort. Symptoms of overdose include dizziness, tremors, agitation, seizures, somnolence, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. When visiting the doctor or hospital, the patient should take the Escipram packaging with them.

Missed dose of Escipram

The patient should not take a double dose to make up for a missed dose. If the patient has forgotten to take a dose and remembers before bedtime, they should take the missed dose immediately. The patient should take the next dose at the usual time the next day. If the patient remembers the missed dose at night or the next day, they should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Escipram

The patient should not stop taking Escipram without consulting their doctor. When the patient stops treatment, it is usually recommended to gradually reduce the dose of Escipram over a period of several weeks.
After stopping Escipram, especially if it is stopped abruptly, the patient may experience withdrawal symptoms. These symptoms are common, and the risk is higher if Escipram has been taken for a long time, in high doses, or if the dose has been reduced too quickly. In most patients, the symptoms are mild and disappear on their own within two weeks. However, in some patients, they may be more severe or last longer (2-3 months or longer). If the patient experiences severe withdrawal symptoms after stopping Escipram, they should consult their doctor. The doctor may recommend restarting the treatment and tapering it off more slowly.
Withdrawal symptoms include dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less commonly) a sensation of being struck by an electric current, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (feeling sick), sweating (including night sweats), agitation or excitement, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, palpitations or rapid heartbeat.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Escipram can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. The patient should remember that some of these side effects may also be symptoms of the disease and will disappear as their condition improves.

In case of the following symptoms during treatment, the patient should immediately consult their doctor or go to the hospital:

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

• unusual bleeding, including gastrointestinal bleeding.

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

• skin swelling, tongue, lip, or face swelling, 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 (see section 2).

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

• urination difficulties
• seizures, see also "When to be cautious when taking Escipram"
• yellowing of the skin and whites of the eyes, which may be a sign of liver dysfunction or hepatitis
• rapid or irregular heartbeat, fainting, which may be a sign of a life-threatening condition called torsades de pointes
• thoughts of self-harm or suicidal thoughts (there have been reports of suicidal thoughts or behaviors during treatment with escitalopram or shortly after stopping treatment)
• severe vaginal bleeding occurring shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility"

In addition, the following side effects are known for medicines with a similar mechanism of action to escitalopram (the active substance of Escipram):

• restlessness (akathisia)
• loss of appetite (anorexia)

Reporting side effects

If the patient experiences any side effects, including any side effects not mentioned 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 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Reporting side effects helps to gather more information on the safety of the medicine.

5. How to store Escipram

This medicine should be stored out of the sight and reach of children.
The patient should not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
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 pack and other information

What Escipram contains

• The active substance is escitalopram. Escipram, 5 mg: Each tablet contains 5 mg of escitalopram (as escitalopram oxalate). Escipram, 10 mg: Each tablet contains 10 mg of escitalopram (as escitalopram oxalate).

Escipram, 15 mg: Each tablet contains 15 mg of escitalopram (as escitalopram oxalate).
Escipram, 20 mg: Each tablet contains 20 mg of escitalopram (as escitalopram oxalate).

• Other ingredients

The tablets contain:
microcrystalline cellulose
sodium carboxymethylcellulose
colloidal anhydrous silica
magnesium stearate
Coating:
Opadry White Y-1-7000
hypromellose 6cP
titanium dioxide (E171)
macrogol 400
What Escipram looks like and contents of the pack:
Escipram, 5 mg
White or almost white, round (diameter approximately 5.1 mm), biconvex, film-coated tablets.
Escipram, 10 mg
White or almost white, oval (8.1 x 5.6 mm) film-coated tablets with a score line on one side.
Escipram, 15 mg
White or almost white, oval (10.4 x 5.6 mm) film-coated tablets with a score line on one side.
Escipram, 20 mg
White or almost white, oval (11.6 x 7.1 mm) film-coated tablets with a score line on one side.
The film-coated tablets are packaged in OPA/Aluminum/PVC/Aluminum blisters.
7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria

Manufacturers

G.L. Pharma GmbH
Schloßplatz 1
8502 Lannach
Austria
HBM Pharma s.r.o.
Sklabinská 30
036 80 Martin
Slovakia
Delorbis Pharmaceuticals LTD.,
17 Athinon Street Ergates Industrial Area,
2643 Lefkosia,
Cyprus
To obtain more detailed information, the patient should contact their local representative of the Marketing Authorization Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
[email protected]

This medicinal product is authorized in the Member States of the European Union under the following names:

Austria
Escitalopram G.L. 5/10/15/20 mg film-coated tablets
Bulgaria
Escipram 10/20 mg
Czech Republic
Depresinal 10 mg film-coated tablets
Poland
Escipram (5/10/15/20 film-coated tablets)

Date of last revision of the leaflet: 27.02.2025