Package leaflet: Information for the patient

Pramatis, 5 mg, film-coated tablets
Pramatis, 10 mg, film-coated tablets
Pramatis, 20 mg, film-coated tablets
Escitalopram
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Pramatis is and what it is used for
What you need to know before taking Pramatis
How to take Pramatis
Possible side effects
How to store Pramatis
Contents of the pack and other information

1. What Pramatis is and what it is used for

Pramatis contains the active substance escitalopram. Pramatis belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonin system in the brain by increasing serotonin levels. Disturbances in the serotonin system are considered to play an important role in the development of depression and related disorders.

Pramatis is indicated for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take several weeks before the patient starts to feel better. Therefore, continue taking Pramatis regularly, even if you do not initially notice an improvement in your condition. If there is no improvement or if your condition worsens, contact your doctor.

2. Important information before using Pramatis

When not to use Pramatis

if the patient is allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6);
if the patient is taking other medicines from the group of so-called monoamine oxidase inhibitors (MAO inhibitors), including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic);
if the patient has congenital heart rhythm disorders or has previously experienced such disorders (detected during heart function tests - ECG);
if the patient is taking medicines affecting heart rhythm or medicines that may influence heart rhythm (see below "Pramatis with other medicines").

Warnings and precautions
Before starting treatment with Pramatis, discuss this with your doctor or pharmacist.
Inform your doctor about any conditions or illnesses the patient may have so they can be taken into account. In particular, inform if:
the patient has epilepsy. Treatment with Pramatis should be discontinued if seizures occur for the first time or if the frequency of seizures increases (see also section 4 "Possible side effects");
the patient has liver or kidney dysfunction. Dose adjustment by the doctor may be necessary;
the patient has diabetes. Treatment with Pramatis may alter blood glucose levels, and adjustment of insulin and/or oral antidiabetic medications may be required;
the patient has been diagnosed with low sodium levels in the blood;
the patient has a tendency to bleeding or bruising, or if the patient is pregnant (see "Pregnancy");
the patient is undergoing electroconvulsive therapy;
the patient has been diagnosed with ischaemic heart disease;
the patient has or has previously had heart function disorders, or recently suffered a heart attack;
the patient has slow resting heart rate and/or may have electrolyte deficiency (e.g. due to prolonged severe diarrhoea, vomiting, or use of diuretics);
the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up (which may indicate heart function disorders);
the patient has or has previously had eye disorders such as a certain type of glaucoma (increased intraocular pressure).
Note
In some patients with bipolar affective disorder (formerly known as manic-depressive disorder), a manic phase may begin. This is characterised by unusual and rapidly changing thoughts, unjustified euphoria, and excessive physical activity. If these symptoms occur, consult your doctor.
In the initial weeks of treatment, symptoms such as restlessness, particularly motor restlessness, or difficulty sitting or standing still, may also occur. The occurrence of these symptoms should be reported to the doctor immediately.
Medicines such as Pramatis (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
Patients with depression and/or anxiety disorders may sometimes have thoughts of harming themselves or of suicide. These thoughts may intensify at the beginning of treatment with antidepressants, as it takes some time—usually about 2 weeks, sometimes longer—for the medicine to take effect.
This may particularly affect the following patients:

those who have previously experienced suicidal thoughts or self-harm thoughts;
young adults. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressant medicines. If such thoughts of self-harm or suicide ever occur, you must contact your doctor or go directly to hospital.

Sometimes it may be helpful to inform a relative or friend about the depression or anxiety disorder and ask them to read this leaflet. You may also ask such a person to watch for worsening of depression or anxiety, or any change in the patient's behaviour that causes concern.
Children and adolescents
Pramatis should not usually be used in children and adolescents under 18 years of age. It should also be emphasized that during treatment with medicines of this group, patients under 18 years of age are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, the 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, discuss this with your doctor. If any of the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Pramatis, inform your doctor immediately.
Furthermore, the long-term safety of Pramatis in this age group with regard to growth, puberty, cognitive development, and behavioural development has not yet been established.
Pramatis with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:
non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substances. If the patient is taking any of these medicines, they must wait 14 days before starting Pramatis. After stopping Pramatis, 7 days must pass before starting any of these medicines;
reversible, selective MAO-A inhibitors containing moclobemide (also used in the treatment of depression);
irreversible MAO-B inhibitors containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects;
the antibiotic linezolid;
lithium (a medicine used in the treatment of bipolar disorder) and tryptophan;
imipramine and desipramine (both used in the treatment of depression);
sumatriptan and similar medicines (used in the treatment of migraine), tramadol (used for severe pain). These medicines increase the risk of adverse effects;
buprenorphine (used for severe pain), as there is an increased risk of serotonin syndrome, a potentially life-threatening condition.
cimetidine, lansoprazole, and omeprazole (medicines used in peptic ulcer disease), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the blood concentration of Pramatis;
St. John's wort ( Hypericum perforatum ) – a herbal remedy used in the treatment of depression;
acetylsalicylic acid and non-steroidal anti-inflammatory drugs – NSAIDs (medicines used to reduce pain or blood clotting, so-called anticoagulants). These medicines may increase the tendency to bleeding;
warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). Your doctor will likely check the patient's blood clotting time at the beginning of treatment and during discontinuation of Pramatis to ensure the anticoagulant dose remains appropriate;
mefloquine (a medicine used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used in the treatment of severe pain) due to the possible risk of lowering the seizure threshold;
antipsychotics (used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold;
flecainide, propafenone, and metoprolol (medicines used in the treatment of cardiovascular disorders), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Pramatis may be necessary;
medicines that reduce blood potassium or magnesium levels, as this increases the risk of life-threatening heart rhythm disturbances.
Do not use Pramatis if the patient is taking medicines affecting heart rhythm or medicines that may influence heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (i.e. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarial drugs (especially halofantrine), certain antihistamines (astemizole, hydroxyzine, mizolastine).
If in doubt whether the patient is taking any of the listed medicines, consult your doctor.
Pramatis with food, drink, and alcohol
Pramatis can be taken regardless of meals (see section 3 "How to take Pramatis"). As with many medicines, alcohol consumption is not recommended during treatment with Pramatis, although interactions between the medicine and alcohol should not occur.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use Pramatis during pregnancy or breastfeeding without first discussing the risks and benefits of treatment with your doctor.
If the patient takes Pramatis during the last three months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, exaggerated reflexes, tremors, nervousness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances. If any of these symptoms occur in the child, contact a doctor immediately.
Ensure that the midwife and/or doctor are aware that the patient is taking Pramatis.
Medicines such as Pramatis, taken during pregnancy (especially during the last 3 months), may increase the risk of a serious condition in the child called persistent pulmonary hypertension in the newborn (PPHN), which causes rapid breathing and bluish skin. These symptoms usually occur within the first 24 hours after birth. In such a case, contact the midwife and/or doctor immediately.
If Pramatis is taken during pregnancy, treatment should never be stopped abruptly.
Taking Pramatis towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Pramatis, she should inform her doctor or midwife so they can provide appropriate advice.
Escitalopram probably passes into breast milk.
Animal studies have shown that citalopram (a medicine similar to escitalopram) reduces semen quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans to date.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Pramatis affects them.
Pramatis contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Pramatis

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults
Depression
The usual recommended dose is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Panic disorder with agoraphobia
The initial dose is 5 mg taken once daily during the first week of treatment, before increasing the dose to 10 mg per day. Subsequently, your doctor may increase the dose up to a maximum of 20 mg per day.

Social phobia
The usual recommended dose is 10 mg taken once daily. Your doctor may reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day, depending on the patient's response to treatment.

Generalized anxiety disorder
The usual recommended initial dose is 10 mg taken once daily. Your doctor may increase the dose up to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended initial dose is 10 mg taken once daily. Your doctor may increase the dose up 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 is generally not recommended for use in children and adolescents. Further details are provided in section 2, "Warnings and precautions".

Renal impairment
Caution is advised in patients with severe renal impairment. This medicine should be used according to your doctor's instructions.

Hepatic impairment
Patients with impaired liver function should not exceed a dose of 10 mg per day. This medicine should be used according to your doctor's instructions.

Patients who are poor metabolizers of drugs metabolized by CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. This medicine should be used according to your doctor's instructions.

Method of administration
This medicine can be taken independently of meals. Tablets should be swallowed with water.

Pramatis 10 mg only: if necessary, tablets may be divided into two equal doses.

Pramatis 20 mg only: if necessary, tablets may be divided into four equal doses.

Duration of treatment
It may take several weeks before the patient starts to feel better. Pramatis should be taken continuously, even if improvement in well-being takes some time.

Do not change the dose of this medicine without consulting your doctor.

Continue taking Pramatis for as long as your doctor recommends. Stopping treatment too early may lead to a recurrence of symptoms. It is recommended to continue taking the medicine for at least 6 months after improvement in well-being has been achieved.

Taking more than the recommended dose of Pramatis
If you take more than the recommended dose of Pramatis, contact your doctor or the emergency department of the nearest hospital immediately, even if you do not experience any symptoms or feel unwell. Possible symptoms include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, decreased blood pressure, and disturbances in water and electrolyte balance. Take the Pramatis packaging with you when visiting the doctor or hospital.

Missed dose of Pramatis
Do not take a double dose to make up for a missed tablet. If you forget to take a dose and remember before going to bed, take the missed tablet. The next day, take the medicine as usual. If you remember about the missed dose during the night, skip that dose and take the next tablet at the usual time.

Stopping treatment with Pramatis
Do not stop taking Pramatis without consulting your doctor. When ending treatment, the dose of Pramatis is usually gradually reduced over several weeks.

After discontinuation of Pramatis, especially if abrupt, withdrawal symptoms may occur. This is a common phenomenon after stopping treatment with escitalopram, particularly if Pramatis has been used for a long time and at high doses, or if the dose was reduced too quickly.

In most patients, these symptoms are mild and resolve spontaneously within 2 weeks. However, in some patients, symptoms may be severe or may persist for a long time (2 to 3 months or longer).

If severe withdrawal symptoms occur after stopping Pramatis, contact your doctor. Your doctor may recommend restarting the medicine and then reducing the dose more slowly.

Withdrawal symptoms include: dizziness (unsteadiness or loss of balance), tingling sensations, burning sensations or (less commonly) electric shock-like feelings, for example in the head, sleep disturbances (vivid dreams, nightmares or difficulty falling asleep), anxiety, headache, nausea, sweating (including night sweats), feelings of restlessness or agitation, tremor, confusion or disorientation, emotional instability or irritability, diarrhea (loose stools), visual disturbances, palpitations (sensation of fluttering or pounding in the chest).

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects usually resolve within a few weeks of treatment. It should be remembered that many of these
effects may also be symptoms of the underlying disease itself, and therefore will improve as the patient's
condition improves.
If the patient experiences any of the adverse effects listed below, contact a doctor or go directly to hospital.

Uncommon (may occur in fewer than 1 in 100 people):

Unusual bleeding, including gastrointestinal bleeding.

Rare (may occur in fewer than 1 in 1000 people):

Swelling of the skin, tongue, lips, throat or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction).
High fever, agitation, confusion, tremor, and sudden muscle contractions (may be symptoms of a rare condition called serotonin syndrome) (see section 2).

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

Difficulty in passing urine.
Seizures; see also section 2 "Warnings and precautions".
Yellowing of the skin or whites of the eyes (symptoms of liver dysfunction or hepatitis).
Rapid or irregular heartbeat, fainting – may be symptoms of life-threatening heart rhythm disorders such as torsade de pointes.
Thoughts of self-harm or suicide (see also "Warnings and precautions").
Sudden swelling of the skin or mucous membranes (angioedema).

In addition, the following adverse effects have been reported:

Very common (may occur in more than 1 in 10 people):

Nausea
Headache

Common (may occur in fewer than 1 in 10 people):

Nasal congestion or watery nasal discharge (sinusitis)
Decreased or increased appetite
Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin tingling
Diarrhoea, constipation, vomiting, dry mouth
Excessive sweating
Muscle and joint pain
Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, in women difficulty achieving orgasm)
Feeling of fatigue, fever
Weight gain

Uncommon (may occur in fewer than 1 in 100 people):

Urticaria, rash, itching
Teeth grinding, agitation, nervousness, panic attacks, confusion
Taste disturbances, sleep disorders, fainting
Pupil dilation, visual disturbances, tinnitus (ringing in the ears)
Hair loss
Heavy menstrual bleeding
Irregular menstruation
Weight loss
Rapid heartbeat
Swelling of hands or feet
Nosebleeds

Rare (may occur in fewer than 1 in 1000 people):

Aggression, depersonalization, hallucinations
Slow heart rate

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

Decreased sodium concentration in blood (symptoms include nausea, malaise, muscle weakness, or confusion)
Dizziness upon standing due to low blood pressure (orthostatic hypotension)
Abnormal liver function test results (increased liver enzyme activity in blood)
Movement disorders (involuntary muscle movements)
Painful penile erection (priapism)
Signs of abnormal bleeding, e.g. under the skin or mucous membranes (petechiae)
Increased secretion of antidiuretic hormone (ADH), leading to water retention, blood dilution, and reduced sodium levels
Milk secretion in men and in women who are not breastfeeding
Mania
Changes in heart rhythm (so-called "QT interval prolongation", observed in heart function tests – ECG)
Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); see additional information in subsection "Pregnancy" in section 2.

In addition, it is known that several adverse effects are associated with the use of medicines with action similar to escitalopram (the active substance in Pramatis). These include:

Restless movement (akathisia)
Loss of appetite
Increased risk of bone fractures

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Pramatis

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label or on the carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
HDPE bottles
After first opening, tablets may be stored in the opened HDPE bottle for up to 6 months. Do not store the opened bottle at temperatures above 25 °C.
After the six-month period, do not take any tablets remaining in the bottle, but dispose of them appropriately.
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 package and other information

What Pramatis contains

The active substance is escitalopram. Each film-coated tablet contains 5 mg, 10 mg, or 20 mg of the active substance – escitalopram (as oxalate).
Other ingredients are: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hypromellose, magnesium stearate, colloidal anhydrous silica.
Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E 171), talc.

What Pramatis looks like and contents of the pack
Pramatis 5 mg: white, round film-coated tablets with a diameter of 5.7–6.3 mm.
Pramatis 10 mg: white, oval film-coated tablets, 7.7–8.3 mm in length and 5.2–5.8 mm in width, with a score line on one side to facilitate splitting.
Pramatis 20 mg: white, round film-coated tablets with a diameter of 9.2–9.8 mm, with cross-scored lines on both sides to facilitate splitting.
The medicine is available in the following pack sizes:
Blister packs made of OPA/Aluminium/PVC/Aluminium in cardboard boxes
Pramatis 5 mg and Pramatis 20 mg: 28 or 30 tablets
Pramatis 10 mg: 28, 30 or 56 tablets
HDPE bottles with PP closure containing a desiccant, in cardboard boxes
28 or 30 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia

For further information about this medicine and its names in other European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Tel: 22 209 70 00