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 packaging 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 social contacts), 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. Disorders of the serotonin system 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:

Do not take Escipram if you:

• are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6)
• are taking other medicines belonging to the group of MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic)
• have congenital or acquired heart rhythm disorders (as shown by an ECG - a test used to assess heart function)
• are taking medicines used to treat heart rhythm disorders or that may affect heart rhythm (see "Escipram and other medicines").

Warnings and precautions

Before starting to take Escipram, discuss it with your doctor or pharmacist. Inform your doctor about other diseases and conditions that may be important. In particular, inform your doctor if:

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

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 there are any doubts, the doctor should be consulted again. If the symptoms mentioned above worsen in patients under 18 years of age taking Escipram, the doctor should be informed.

Escipram and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
DO NOT TAKE ESCIPRAM if you are taking medicines to treat heart rhythm disorders or medicines that may affect heart function, such as anti-arrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines, especially halofantrine), and certain antihistamines (astemizole, mizolastine). In case of doubts, consult a doctor.

Using 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 found.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medicine.
If you are taking Escipram in the last 3 months of pregnancy, be aware that the newborn may experience the following symptoms: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiffness or flaccidity of muscles, increased reflexes, tremors, restlessness, irritability, lethargy, sleepiness, and difficulty sleeping. If the newborn experiences any of these symptoms, consult a doctor immediately.

Driving and using machines

Do not drive or operate machinery until you know how Escipram affects you.

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

Always take Escipram exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Adults

Depression
The recommended dose of Escipram is 10 mg taken as a single daily dose. Your doctor may suggest further increasing the dose to a maximum of 20 mg daily.
Panic disorder
The initial dose of Escipram is 5 mg daily for the first week, then the dose is increased to 10 mg daily. The dose may be further increased by your doctor to a maximum of 20 mg daily.
Social anxiety disorder
The recommended dose of Escipram is 10 mg taken as a single daily dose. The dose may be decreased by your doctor to 5 mg daily or increased to a maximum of 20 mg daily, depending on your response to the medicine.
Generalized anxiety disorder
The recommended dose is 10 mg taken as a single daily dose. The dose may be increased by your doctor to a maximum of 20 mg daily.
Obsessive-compulsive disorder
The recommended dose of Escipram is 10 mg taken as a single daily dose. The dose may be increased by your doctor to a maximum of 20 mg daily.

Children and adolescents

Escipram should not be used in 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. Do not chew them, as they have a bitter taste.
If necessary, the tablets can be broken into two equal halves by placing the tablet on a flat surface with the score line facing upwards and pressing both halves down with your fingers.

Elderly patients (over 65 years)

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

Duration of treatment

Improvement may occur only after a few weeks of treatment. Continue taking Escipram even if you do not feel better for some time.
Do not change the dose without consulting your doctor.
Take Escipram 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 after you have felt better.

Overdose of Escipram

If you have taken more than the prescribed dose of Escipram, contact your doctor or go to the emergency room immediately. Do this even if you do not feel any discomfort. Symptoms of overdose include dizziness, agitation, confusion, seizures, somnolence, nausea, vomiting, changes in heart rhythm, low blood pressure, and electrolyte imbalance. Bring the packaging of Escipram with you to the doctor or hospital.

Missed dose of Escipram

Do not take a double dose to make up for a missed dose. If you remember that you missed a dose before going to bed, take the missed dose as soon as possible. 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, skip the missed dose and take the next dose at the usual time.

Stopping treatment with Escipram

Do not stop taking Escipram without consulting your doctor. When you stop treatment, it is usually recommended to gradually reduce the dose of Escipram over a few weeks.
After stopping treatment with Escipram, especially if it is stopped abruptly, you 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 within two weeks. However, in some patients, they may be more severe or last longer (2-3 months or longer). If you experience severe withdrawal symptoms after stopping Escipram, consult your doctor. Your doctor may recommend restarting treatment with Escipram and reducing the dose more slowly.

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. Remember that some of these side effects may also be symptoms of the disease and will disappear as your condition improves.

If you experience any of the following symptoms during treatment, contact your doctor or go to the hospital immediately:

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 rash, swelling of the face, lips, tongue, or throat, or difficulty breathing (allergic reaction)
• high fever, agitation, confusion, tremors, and muscle stiffness, which can be symptoms of a rare disorder called serotonin syndrome (see section 2)

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

• difficulty urinating
• seizures, see also "When to be careful when taking Escipram"
• yellowing of the skin and whites of the eyes, which can be a sign of liver disease or inflammation
• rapid or irregular heartbeat, fainting, which can be symptoms of a life-threatening condition called torsades de pointes
• thoughts of self-harm or suicidal thoughts (reported in patients taking escitalopram or shortly after stopping treatment)
• severe bleeding from the uterus, which can occur shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility"

In addition, the following side effects have been reported:

• very common (affects more than 1 in 10 people):

nausea
headache

• common (affects up to 1 in 10 people):

nasal congestion or sinusitis (sinus infection)
decreased or increased appetite
anxiety, restlessness, unusual dreams, difficulty sleeping, sleepiness, dizziness, 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, and difficulty achieving orgasm in women)
feeling tired, fever
weight gain

• uncommon (affects up to 1 in 100 people):

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

• rare (affects up to 1 in 1,000 people):

aggression, depersonalization (feeling of loss of one's own identity), hallucinations
slow heartbeat

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

decreased sodium levels in the blood (manifested by nausea and malaise with muscle weakness or confusion)
dizziness when standing up due to low blood pressure (orthostatic hypotension)
abnormal liver function tests (increased liver enzyme activity in the blood)
movement disorders (involuntary muscle movements)
painful erection (priapism)
bleeding, including bruising and bleeding into the skin and mucous membranes, and decreased platelet count (thrombocytopenia)
sudden swelling of the skin or mucous membranes (angioedema)
increased urine production (inappropriate secretion of antidiuretic hormone - SIADH)
milky discharge from the breasts in women who are not breastfeeding
mania
increased risk of bone fractures in patients taking this type of medicine
heart rhythm disorders (prolonged QT interval observed in ECG)

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 you experience any side effects, including those not mentioned in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw, Poland
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escipram

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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).

• Excipients

The tablets contain:
Microcrystalline cellulose
Croscarmellose sodium
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 of about 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

For more information, contact your 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
e-mail: [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