Pramatis

Package Leaflet: Information for the Patient

Pramatis, 5 mg, coated tablets

Pramatis, 10 mg, coated tablets

Pramatis, 20 mg, coated tablets

Escitalopram

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

• You should 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Pramatis and what is it used for

Pramatis contains the active substance escitalopram. Pramatis belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain, which helps to improve mood. Pramatis is used to treat depression(major depressive episodes) and anxiety disorders(such as panic disorder, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder). It may take a few weeks before you start to feel better. You should continue to take Pramatis even if you do not feel better immediately. If you do not feel better or if your condition worsens, you should consult your doctor.

2. Important information before taking Pramatis

When not to take Pramatis

• 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 congenital heart rhythm disorders or have had them in the past (detected by an electrocardiogram);
• if you are taking medicines that regulate heart rhythm or medicines that may affect heart rhythm (see "Pramatis and other medicines").

Warnings and precautions

Before starting treatment with Pramatis, you should discuss it with your doctor or pharmacist. You should inform your doctor about any disorders or diseases you have, so that they can take them into account. You should especially tell your doctor if you have epilepsy. You should stop taking Pramatis if you have a seizure for the first time or if the frequency of seizures increases (see also section 4 "Possible side effects"); if you have liver or kidney problems. Your doctor may need to adjust the dose of Pramatis; if you have diabetes. Taking Pramatis may change your blood sugar levels and you may need to adjust your insulin or oral antidiabetic medication; if you have low sodium levelsin your blood; if you have a bleeding tendencyor if you are pregnant (see "Pregnancy"); if you are being treated with electroconvulsive therapy; if you have ischemic heart disease; if you have or have had heart rhythm disorders or have recently had a heart attack; if you have slow resting heart rateand/or may have low levels of salts (e.g., due to prolonged, severe diarrhea, vomiting, or use of diuretics); if you experience fast or irregular heartbeat, fainting, or dizziness when standing up (which may indicate heart rhythm disorders); if you have or have had eye disorders, such as a certain type of glaucoma (increased pressure in the eye).

Caution

In some patients with bipolar affective disorder(formerly called manic-depressive disorder), a manic phase may begin. This is characterized by unusual and rapidly changing ideas, unjustified joy, and excessive physical activity. If these symptoms occur, you should consult your doctor. In the first few weeks of treatment, symptoms such as restlessness, especially motor restlessness or difficulty sitting or standing stillmay also occur. You should inform your doctor about these symptoms immediately. Medicines like Pramatis (SSRIs) 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

Patients with depression and/or anxiety disorders may sometimes have thoughts of harming themselves or committing suicide. These thoughts may worsen at the beginning of treatment with antidepressant medicines, as it may take about 2 weeks, sometimes longer, for them to start working. This may be more likely to occur in the following patients:

• those who have had suicidal thoughts or self-harm in the past;
• young adults. Clinical trials have shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders treated with antidepressant medicines. If you ever have thoughts of self-harm or suicide, you should contact your doctor or go directly to the hospital.

Sometimes, it may be helpful to inform a relative or friendabout your depression or anxiety disorder and ask them to read this leaflet. You can also ask them to pay attention if they notice a worsening of your depression or anxiety or a change in your behavior.

Children and adolescents

Pramatis should not be used in children and adolescents under 18 years of age. It should also be noted that patients under 18 years of age who take medicines of this group are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and manifestations of anger). However, your doctor may prescribe Pramatis to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Pramatis to a patient under 18 years of age and you have any doubts, you should consult your doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Pramatis, you should inform your doctor. Additionally, the long-term safety of Pramatis in this age group has not been established in terms of growth, maturation, and cognitive and behavioral development.

Pramatis and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You should inform your doctor about taking the following medicines: non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you are taking any of these medicines, you must wait 14 days before starting treatment with Pramatis. After stopping treatment with Pramatis, you must wait 7 days before starting to take any of these medicines; reversible, selective MAO-A inhibitors, containing moclobemide (also used to treat depression); irreversible MAO-B inhibitors, containing 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(both used to treat depression); sumatriptan and similar medicines(used to treat migraines), tramadol(used to treat severe pain). These medicines increase the risk of side effects; buprenorphine(used to treat severe pain), as the risk of serotonin syndrome, a potentially life-threatening condition, increases; cimetidine, lansoprazole, and omeprazole(medicines used to treat stomach ulcers), fluconazole(a medicine used to treat fungal infections), fluvoxamine(an antidepressant), and ticlopidine(used to reduce the risk of stroke). These medicines may increase the levels of Pramatis in your blood; St. John's Wort (Hypericum perforatum)- a herbal medicine used to treat depression; acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (NSAIDs)- medicines used to reduce pain or thin the blood (anticoagulants). These medicines may increase the risk of bleeding; warfarin, dipyridamole, phenprocoumon- medicines used to thin the blood (anticoagulants). Your doctor will likely check your blood clotting time at the start of treatment and when stopping Pramatis to ensure that the anticoagulant dose is still correct; mefloquine(a medicine used to treat malaria), bupropion(used to treat depression), and tramadol(used to treat severe pain) due to the possible risk of lowering the seizure threshold; antipsychotic medicines(used to treat schizophrenia, psychosis) and antidepressant medicines (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold; flecainide, propafenone, metoprolol(medicines used to treat heart conditions), clomipramine and nortriptyline(antidepressants), and risperidone, thioridazine, and haloperidol(antipsychotics). Your doctor may need to adjust the dose of Pramatis; medicines that lower blood potassium or magnesium levels, as this increases the risk of life-threatening heart rhythm disorders. You should not take Pramatis if you are taking medicines that regulate heart rhythm or medicines that may affect heart rhythm, 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, intravenous erythromycin, pentamidine), antimalarial medicines (especially halofantrine), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If you are unsure whether you are taking any of these medicines, you should consult your doctor.

Pramatis with food, drink, and alcohol

Pramatis can be taken with or without food (see section 3 "How to take Pramatis"). As with many medicines, it is not recommended to drink alcohol while taking Pramatis, although interactions between Pramatis and alcohol are unlikely to occur.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. You should not take Pramatis during pregnancy or breastfeeding without first discussing the risks and benefits with your doctor. If you take Pramatis during the last three months of pregnancy, you should be aware that your newborn baby 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, exaggerated reflexes, trembling, nervousness, irritability, lethargy, persistent crying, and sleep disturbances. If your baby experiences any of these symptoms, you should contact your doctor immediately. You should ensure that your midwife and/or doctor are aware that you are taking Pramatis. Medicines like Pramatis, taken during pregnancy (especially during the last three months), may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn, which causes rapid breathing and blue discoloration of the skin. These symptoms usually occur within the first 24 hours after birth. In such cases, you should contact your midwife and/or doctor immediately. If you are taking Pramatis, you should never stop taking it abruptly. Taking Pramatis at the end of pregnancy may increase the risk of severe bleeding from the uterus, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Pramatis, you should inform your doctor or midwife so that they can provide you with appropriate advice. Escitalopram is likely to pass into breast milk. In animal studies, citalopram (a medicine similar to escitalopram) has been shown to reduce sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans.

Driving and using machines

You should not drive or operate machinery until you know how Pramatis affects you.

Pramatis contains lactose and sodium

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Pramatis

You should always take this medicine exactly as your doctor has told you. If you are unsure, you should ask your doctor or pharmacist.

Adults

Depression
The recommended dose is 10 mg taken once daily. Your doctor may increase the dose to a maximum of 20 mg per day.
Anxiety disorder with panic attacks
The initial dose is 5 mg taken once daily for the first week of treatment, before increasing the dose to 10 mg per day. Your doctor may then increase the dose to a maximum of 20 mg per day.
Social anxiety disorder
The recommended dose is 10 mg taken once daily. Your doctor may reduce the dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on your response to treatment.
Generalized anxiety disorder
The recommended initial dose is 10 mg taken once daily. Your doctor may increase the dose to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The recommended initial dose is 10 mg taken once daily. Your doctor may increase the dose to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)

The recommended initial dose of Pramatis is 5 mg taken once daily. Your doctor may increase the dose to 10 mg per day.

Use in children and adolescents (under 18 years of age)

Pramatis should not be used in children and adolescents. For more information, see section 2 "Warnings and precautions".

Renal impairment

Care should be taken when treating patients with severe renal impairment. The medicine should be used as directed by your doctor.

Hepatic impairment

Patients with liver impairment should not exceed a dose of 10 mg per day. The medicine should be used as directed by your doctor.

Poor metabolizers of CYP2C19

Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be used as directed by your doctor.

Method of administration

The medicine can be taken with or without food. The tablets should be swallowed with water. Only Pramatis, 10 mg: if necessary, the tablets can be divided into two equal doses. Only Pramatis, 20 mg: if necessary, the tablets can be divided into four equal doses.

Duration of treatment

It may take a few weeks before you start to feel better. You should continue to take Pramatis even if you do not feel better immediately. You should not change the dose of the medicine without consulting your doctor. You should take the medicine for as long as your doctor has prescribed it. Stopping treatment too early may cause your symptoms to return. It is recommended to continue treatment for at least 6 months after you have started to feel better.

Overdose of Pramatis

If you have taken more than the prescribed dose of Pramatis, you should contact your doctor or the emergency department of the nearest hospital immediately, even if you do not feel any symptoms or feel unwell. Symptoms that may occur include: dizziness, tremors, agitation, seizures, coma, nausea, vomiting, changes in heart rhythm, decreased blood pressure, and electrolyte imbalance. You should take the packaging of Pramatis with you to the doctor or hospital.

Missed dose of Pramatis

You should not take a double dose 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. The next day, you should take the medicine as usual. If you remember about the missed dose in the night, you should skip it and take the next dose at the usual time.

Stopping treatment with Pramatis

You should not stop taking Pramatis without consulting your doctor. When stopping treatment, the dose of Pramatis is usually gradually reduced over a few weeks. After stopping Pramatis, especially if it is stopped abruptly, you may experience withdrawal symptoms. This is a common phenomenon when treatment with escitalopram is stopped, especially if Pramatis has been taken for a long time and in high doses or if the dose has been reduced too quickly. In most cases, these symptoms are mild and disappear within 2 weeks. However, in some patients, the symptoms may be severe or may last for a long time (2 to 3 months or longer). If you experience severe withdrawal symptoms after stopping Pramatis, you should contact your doctor. Your doctor may recommend that you start taking the medicine again and then gradually reduce the dose. Withdrawal symptoms include:dizziness (unsteadiness or loss of balance), tingling sensation, sensation of burning or electric shock, and (rarely) tremors, sleep disturbances (vivid dreams, nightmares, or difficulty sleeping), anxiety, headaches, nausea, sweating (including night sweats), restlessness or agitation, tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), vision disturbances, sensation of palpitations or pounding heart (palpitations).

Further information

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

4. Possible side effects

Like all medicines, Pramatis can cause side effects, although not everybody gets them. Side effects usually disappear after a few weeks of treatment. You should remember that many of these side effects may also be symptoms of the underlying disease, and they will decrease as you start to feel better.

If you experience any of the following side effects, you should contact your doctor or go directly to the hospital.

Uncommon (may affect up to 1 in 100 people)
unusual bleeding, including bleeding from the gastrointestinal tract.
Rare (may affect up to 1 in 1,000 people)
swelling of the skin, tongue, lips, throat, or face, hives, or difficulty breathing or swallowing (severe allergic reaction)
high fever, agitation, confusion, tremors, and sudden muscle contractions (may be symptoms of a rare condition called serotonin syndrome), (see section 2).
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 (symptoms of liver dysfunction or hepatitis)
fast, irregular heartbeat, fainting - may be symptoms of life-threatening heart rhythm disorders of the type torsades de pointes
thoughts of self-harm or suicide (see also "Warnings and precautions")
sudden swelling of the skin or mucous membranes (angioedema)

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 nose or runny nose (sinusitis)
decreased or increased appetite
anxiety, restlessness, unusual dreams, difficulty sleeping, feeling sleepy, dizziness, yawning, tremors, tingling sensation
diarrhea, constipation, vomiting, dry mouth
increased sweating
muscle and joint pain
sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women)
feeling tired, fever
weight gain
Uncommon (may affect up to 1 in 100 people)
hives, rash, itching
grinding of teeth, agitation, nervousness, panic attacks, confusion
disturbances of taste, sleep disturbances, fainting
pupil dilation, vision disturbances, ringing in the ears (tinnitus)
hair loss
excessive menstrual bleeding
irregular menstrual periods
weight loss
fast heart rate
swelling of hands or feet
nosebleeds
Rare (may affect up to 1 in 1,000 people)
aggression, depersonalization, hallucinations
slow heart rate
Frequency not known (cannot be estimated from the available data):
decreased sodium levels in the blood (symptoms are nausea and malaise with muscle weakness or confusion)
dizziness when standing up, caused by low blood pressure (orthostatic hypotension)
abnormal liver function test results (increased liver enzyme activity in the blood)
movement disorders (involuntary muscle movements)
painful erection of the penis (priapism)
symptoms of abnormal bleeding, e.g., in the skin and mucous membranes (ecchymoses)
increased secretion of antidiuretic hormone (ADH), leading to water retention in the body, blood dilution, and decreased sodium levels
milk secretion in men and in women who are not breastfeeding
mania
change in heart rhythm (so-called "QT interval prolongation", detected by an electrocardiogram)
severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see additional information in the "Pregnancy" subsection of section 2.
Additionally, it is known that several side effects are associated with the use of medicines with a similar action to escitalopram (the active substance of Pramatis). These include:
motor restlessness (akathisia)
loss of appetite
increased risk of bone fractures

Reporting side effects

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

The medicine should be stored out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label or carton after EXP. The expiry date refers to the last day of the month stated. There are no special storage precautions. HDPE bottles
After opening, the tablets can be stored in the opened HDPE bottle for a maximum of 6 months. Do not store the opened bottle in a temperature above 25°C. After the 6-month period, you should not take the tablets that remain in the bottle, but discard them. 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 Pramatis contains

• The active substance is escitalopram. Each tablet contains 5 mg, 10 mg, or 20 mg of the active substance - escitalopram (as escitalopram oxalate).
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, hypromellose, magnesium stearate, silicon dioxide. Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E 171), talc.

What Pramatis looks like and contents of the pack

Pramatis, 5 mg: white, round, coated tablets with a diameter of 5.7-6.3 mm.
Pramatis, 10 mg: white, oval, coated tablets with a length of 7.7-8.3 mm and a width of 5.2-5.8 mm, with a score line on one side.
Pramatis, 20 mg: white, round, coated tablets with a diameter of 9.2-9.8 mm, with intersecting score lines on both sides.
The medicine is available in the following packs:
Blister packs of OPA/Aluminum/PVC/Aluminum in a cardboard box
Pramatis, 5 mg and Pramatis, 20 mg: 28 or 30 tablets
Pramatis, 10 mg: 28, 30, or 56 tablets
HDPE bottles with a PP cap containing a desiccant in a cardboard box
28 or 30 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland

For more information about this medicine and its names in other EU countries, you should contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet: 10/2024
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