Escipram

Leaflet included in the packaging: patient information

Escipram, 5 mg, coated tablets
Escipram, 10 mg, coated tablets
Escipram, 15 mg, coated tablets
Escipram, 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 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 contact), 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 major factor influencing the development of depression and related diseases.
The patient may start feeling better only after a few weeks of treatment. 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), if you 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), if you have congenital or acquired heart rhythm disorders (as shown in an ECG), or if you are taking medicines for 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 any other diseases or 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; the treatment with Escipram should be discontinued (see also section 4 "Possible side effects").

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 subsides 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 in 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. Additionally, it should be noted that in patients under 18 years of age taking this type of medicine, there is an increased risk of undesirable effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). However, the doctor may prescribe Escipram to patients under 18 years of age if they consider it to be in the best interest of the patient.

Escipram and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 anti-arrhythmic 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), or certain antihistamines (astemizole, mizolastine). In case of doubts, consult a doctor.

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 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, muscle stiffness or flaccidity, 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 per day, taken as a single dose. The doctor may recommend 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, 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.

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.

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

In case of overdose, consult a doctor or go to the emergency room immediately. Do this even if you do not feel any discomfort. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, and changes in the water and electrolyte balance.

Missed dose

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 immediately. 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 period of a few weeks.
After stopping treatment with Escipram, especially if it is sudden, 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 subside within two weeks. In some patients, they may be more severe or last longer (2-3 months or longer). If you experience severe withdrawal symptoms after stopping treatment with Escipram, consult your doctor. The 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 subside after a few weeks of treatment. Remember that some of these side effects may also be symptoms of the disease and will subside as your condition improves.

If you experience any of the following symptoms during treatment, consult a doctor or go to the emergency room 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):

• Swelling of the skin, lips, tongue, or face, or difficulty breathing or swallowing (allergic reaction)
• High fever, agitation, confusion, 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):

• Difficulty urinating
• Seizures, see also "When to be careful 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, which occurs shortly after delivery (postpartum hemorrhage), (see section "Pregnancy, breastfeeding, and fertility")

Additional side effects have also 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 inflammation)
• Decreased or increased appetite
• Anxiety, restlessness, unusual dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensation
• 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
• Teeth grinding, agitation, nervousness, panic attacks, confusion
• Sleep disturbances, taste disturbances, fainting
• Visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Vaginal bleeding
• Weight loss
• Rapid heartbeat
• Swelling of the upper or lower limbs
• 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 in the skin and mucous membranes, and decreased platelet count (thrombocytopenia)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine production (inappropriate antidiuretic hormone secretion - SIADH)
• Milk secretion in women who are not breastfeeding
• Mania
• Patients taking this type of medicine have been observed to have an increased risk of bone fractures
• 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)
• Anorexia

Reporting side effects

If you experience any side effects, including any side effects not mentioned in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Email: [email protected]
Reporting side effects helps to gather 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 which is 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. Ask your pharmacist how to dispose of medicines no longer required. 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
Sodium carboxymethylcellulose
Silica, colloidal anhydrous
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 film-coated 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, please contact the 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 mg film-coated tablets)

Date of last revision of the leaflet: 27.02.2025