NEXPRAM 20 mg Tablets

Contents of the leaflet

1. PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
2. Nexpram, 10 mg, coated tablets
3. Nexpram, 20 mg, coated tablets
   1. Read this leaflet carefully before taking this medicine.
   2. Table of contents of the leaflet:
4. WHAT NEXPRAM IS AND WHAT IT IS USED FOR
5. IMPORTANT INFORMATION BEFORE TAKING NEXPRAM
   1. When not to take Nexpram
   2. Warnings and precautions
   3. Special warnings
   4. Suicidal thoughts and worsening of depression or anxiety disorders
   5. Children and adolescents under 18 years
   6. Nexpram with other medicines
   7. Nexpram with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Nexpram contains lactose and sodium
6. HOW TO TAKE NEXPRAM
   1. Adults
   2. Depression
   3. Panic disorder
   4. Social anxiety disorder
   5. Generalized anxiety disorder
   6. Obsessive-compulsive disorder
   7. Elderly patients (over 65 years)
   8. Children and adolescents under 18 years
   9. Patients with kidney problems
   10. Patients with liver problems
   11. Patients who are poor metabolizers of CYP2C19
   12. Duration of treatment
   13. Overdose
   14. Missed dose
   15. Stopping treatment
7. POSSIBLE SIDE EFFECTS
   1. Tell your doctor if you experience any of the following side effects:
   2. Other side effects that have been reported:
8. HOW TO STORE NEXPRAM
9. CONTENTS OF THE PACK AND OTHER INFORMATION
   1. What Nexpram contains
   2. What Nexpram looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the leaflet:

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Nexpram, 10 mg, coated tablets

Nexpram, 20 mg, coated tablets

Escitalopram (as escitalopram oxalate)

Read this leaflet carefully before taking this medicine.

• 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, 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, see section 4.

Table of contents of the leaflet:

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

1. WHAT NEXPRAM IS AND WHAT IT IS USED FOR

Nexpram contains the active substance escitalopram. Nexpram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the levels of serotonin in the brain.

Nexpram is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, 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 Nexpram even if you do not feel better immediately. If you do not feel better or feel worse, you should talk to your doctor.

2. IMPORTANT INFORMATION BEFORE TAKING NEXPRAM

When not to take Nexpram

• if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Nexpram (see section 6);
• if you are taking other medicines that belong to a group called MAOIs (including selegiline, moclobemide, and linezolid);
• if you have been born with a heart condition or have had episodes of abnormal heart rhythm;
• if you are taking medicines that can affect the heart rhythm (see section 2 "Nexpram with other medicines").

Warnings and precautions

Before taking Nexpram, talk to your doctor or pharmacist if you:

• have epilepsy. If you experience seizures for the first time or if their frequency increases, Nexpram should be stopped (see also section 4 "Possible side effects");
• have liver or kidney disease. Your doctor may need to adjust your dose;
• have diabetes. Nexpram may affect your blood sugar levels. Your doctor may need to adjust your insulin or oral hypoglycemic medication;
• have low sodium levels in your blood;
• have a history of bleeding disorders or are taking medicines that thin the blood (see section 2 "Nexpram with other medicines");
• are receiving electroconvulsive therapy;
• have coronary heart disease;
• have had a recent heart attack;
• have a slow heart rate or are at risk of low blood potassium or magnesium levels due to prolonged diarrhea, vomiting, or the use of diuretics;
• have an irregular heart rhythm, fainting, or dizziness when standing up, which may indicate abnormal heart rhythms;
• have a history of eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Special warnings

In patients with manic-depressive illness, a manic phase may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. You should talk to your doctor if you experience these symptoms.

In the first few weeks of treatment, you may also experience symptoms such as restlessness or difficulty sitting or standing still. If you experience these symptoms, you should talk to your doctor immediately.

Medicines like Nexpram (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Suicidal thoughts and worsening of depression or anxiety disorders

If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These thoughts may be worse when you first start taking antidepressants, as all these medicines take time to start working, usually about two weeks, but sometimes longer.

The risk of having these thoughts is higher if you:

• have had thoughts of harming or killing yourself before.
• are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you experience thoughts of harming or killing yourself at any time, you should contact your doctor or go to the hospital immediately.

It might be helpful for a close relative or friend to read this leaflet. You may want to show them the leaflet because they can help you by keeping an eye on your condition and in case you need to go to the hospital.

Children and adolescents under 18 years

Nexpram should not be given to children and adolescents under 18 years. Also, in patients under 18 years, an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (especially aggression, oppositional behavior, and anger) has been observed in patients with this age group taking medicines of this type.

Your doctor may still prescribe Nexpram to a patient under 18 years if he/she decides that it is in the patient's best interest. If your doctor has prescribed Nexpram to a patient under 18 and you have any concerns, you should discuss them with your doctor.

Also, patients under 18 years should be closely monitored by their doctor when taking Nexpram.

Nexpram with other medicines

Before taking Nexpram, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting Nexpram. After stopping Nexpram, you should wait 7 days before starting any of these medicines.
• Reversible and selective monoamine oxidase inhibitors (e.g., moclobemide, used for depression).
• Irreversible monoamine oxidase inhibitors type B (e.g., selegiline, used for Parkinson's disease). These medicines increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used for manic-depressive illness) and tryptophan.
• Imipramine and desipramine (used for depression).
• Sumatriptan and similar medicines (used for migraine) and tramadol and similar medicines (opioids, used for severe pain). These medicines may increase the risk of side effects.
• Cimetidine, lansoprazole, esomeprazole, and omeprazole (used for stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the levels of escitalopram in the blood.
• St. John's Wort (Hypericum perforatum), a herbal remedy used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory medicines (used for pain relief or to reduce blood clotting, known as anticoagulants). These medicines may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (used to reduce blood clotting, known as anticoagulants). Your doctor may need to monitor your blood clotting.
• Mefloquine (used for malaria), bupropion (used for depression), and tramadol (used for severe pain) due to the risk of lowering the seizure threshold.
• Antipsychotics (used for schizophrenia, psychosis) and antidepressants (used for depression) due to the risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used for heart conditions), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Your doctor may need to adjust the dose of Nexpram.
• Medicines that lower potassium or magnesium levels in the blood, which may increase the risk of life-threatening abnormal heart rhythms.

Do not take Nexpram with medicines used for heart rhythm disorders or medicines that may affect the heart rhythm, such as:

anti-arrhythmic medicines class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine), etc. Talk to your doctor if you have any further questions.

Nexpram with food, drink, and alcohol

Nexpram can be taken with or without food (see section 3 "How to take Nexpram").

As with many medicines, it is recommended not to take Nexpram with alcohol, although it is not expected to interact with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Nexpram should not be used during pregnancy and breastfeeding unless your doctor considers it necessary. If you are taking Nexpram during the last three months of pregnancy, your newborn baby might have some symptoms such as difficulty breathing, bluish skin, convulsions, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased muscle tone, tremors, jitteriness, irritability, lethargy, constant crying, and sleepiness. If your baby experiences any of these symptoms, you should contact your doctor.

Taking Nexpram during pregnancy, especially during the last three months, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and bluish skin and usually appears in the first day after birth. If your baby experiences any of these symptoms, you should contact your doctor or midwife immediately.

Taking Nexpram 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 Nexpram, you should tell your doctor or midwife so that they can give you appropriate advice.

Do not stop taking Nexpram during pregnancy without talking to your doctor first.

It is expected that Nexpram will pass into breast milk.

In animal studies, citalopram, a medicine similar to escitalopram, has been shown to reduce sperm quality. This could affect fertility, although this has not been observed in humans yet.

Driving and using machines

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

Nexpram contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Nexpram.

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

3. HOW TO TAKE NEXPRAM

Always take Nexpram exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults

Depression

The recommended dose of Nexpram is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Panic disorder

The initial dose of Nexpram is 5 mg once daily for the first week, then increased to 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Social anxiety disorder

The recommended dose of Nexpram is 10 mg once daily. Depending on your response to Nexpram, your doctor may decrease the dose to 5 mg once daily or increase it to a maximum of 20 mg once daily.

Generalized anxiety disorder

The recommended dose of Nexpram is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Obsessive-compulsive disorder

The recommended dose of Nexpram is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg once daily.

Elderly patients (over 65 years)

The recommended initial dose of Nexpram is 5 mg once daily. Your doctor may increase the dose to 10 mg once daily.

Children and adolescents under 18 years

Nexpram is not recommended for children and adolescents under 18 years. For additional information, see section 2 "Important information before taking Nexpram".

Patients with kidney problems

Caution should be exercised in patients with severe kidney problems. Your doctor will advise you on the dose of Nexpram.

Patients with liver problems

Patients with liver problems should not take more than 10 mg of Nexpram per day. Your doctor will advise you on the dose of Nexpram.

Patients who are poor metabolizers of CYP2C19

Patients who are poor metabolizers of CYP2C19 should not take more than 10 mg of Nexpram per day. Your doctor will advise you on the dose of Nexpram.

Nexpram can be taken with or without food.

Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, the tablets can be divided into two equal parts. To do this, place the tablet on a flat surface with the score line facing upwards and press the ends downwards with your index fingers, as shown in the picture.

Duration of treatment

You may not feel better immediately. You should continue to take Nexpram even if you do not feel better immediately.

Do not change your dose without talking to your doctor.

Take Nexpram for as long as your doctor recommends. If you stop taking Nexpram too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you feel better.

Overdose

If you take more Nexpram than you should, contact your doctor or go to the hospital immediately. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, abnormal heart rhythms, low blood pressure, and electrolyte disturbances. Take the Nexpram packaging with you to the hospital.

Missed dose

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, take it immediately. The next day, take the dose as usual.

If you remember the missed dose in the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping treatment

Do not stop taking Nexpram without talking to your doctor first. When you stop taking Nexpram, your doctor will usually recommend that you reduce the dose gradually over a few weeks.

When you stop taking Nexpram, you may experience withdrawal symptoms. These symptoms are common, especially if you have been taking Nexpram for a long time or at high doses, or if you stop taking it suddenly. Most people find that the symptoms are mild and disappear within two weeks. However, in some patients, they can be severe or prolonged (2-3 months or longer). If you experience severe withdrawal symptoms, you should talk to your doctor. Your doctor may recommend that you start taking Nexpram again and then stop it more slowly.

Withdrawal symptoms include dizziness (unsteady walk or balance problems), tingling, burning sensations, and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headaches, nausea, excessive sweating (including night sweats), agitation or tremors, confusion or disorientation, mood swings or irritability, diarrhea (loose stools), visual disturbances, heart palpitations or rapid heartbeat.

If you experience any of these symptoms, you should talk to your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nexpram can cause side effects, although not everybody gets them.

Side effects usually disappear after a few weeks of treatment. Remember that many of these side effects can also be symptoms of the underlying illness.

Tell your doctor if you experience any of the following side effects:

Uncommon (affects less than 1 in 100 people):

• unusual bleeding, including bleeding from the digestive tract.

Rare (affects less than 1 in 1000 people):

• swelling of the skin, tongue, lips, or face, hives, or difficulty breathing or swallowing (severe allergic reaction),
• high fever, agitation, confusion, trembling, and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

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

• difficulty urinating
• seizures, see also section 2 "Important information before taking Nexpram"
• yellowing of the skin and whites of the eyes, indicating liver problems and/or hepatitis
• rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes
• suicidal thoughts and behaviors, see also section 2 "Important information before taking Nexpram"
• sudden swelling of the skin or mucous membranes (angioedema)

Other side effects that have been reported:

Very common (affects more than 1 in 10 people):

• nausea
• headaches

Common (affects less than 1 in 10 people):

• nasal congestion or sinusitis (sinus infection)
• decreased or increased appetite
• restlessness, anxiety, vivid dreams, difficulty sleeping, sleepiness, dizziness, yawning, tremors, tingling sensations
• diarrhea, constipation, vomiting, dry mouth
• excessive sweating
• muscle and joint pain
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women)
• fatigue, fever
• weight gain

Uncommon (affects less than 1 in 100 people):

• hives, rash, itching (itching)
• grinding of the teeth, agitation, nervousness, panic attacks, confusion
• sleep disturbances, changes in taste, fainting
• dilated pupils, visual disturbances, ringing in the ears (tinnitus)
• hair loss
• heavy menstrual bleeding
• irregular menstrual periods
• weight loss
• rapid heartbeat
• swelling of the hands and feet
• nosebleeds

Rare (affects less than 1 in 1000 people):

• aggression, depersonalization, hallucinations
• slow heartbeat

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

• low sodium levels in the blood (symptoms include nausea and weakness 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 and prolonged erections (priapism)
• bleeding disorders, including bleeding into the skin and mucous membranes (ecchymoses)
• increased secretion of antidiuretic hormone (ADH), leading to water retention in the body and dilutional hyponatremia (inappropriate ADH secretion)
• galactorrhoea (milk secretion) in men and women who are not breastfeeding
• mania (abnormal activity and excitement)
• increased risk of bone fractures in patients taking medicines of this type
• changes in heart rhythm (prolonged QT interval visible on ECG)
• severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see also section 2 "Pregnancy, breastfeeding, and fertility".

Other side effects that have been reported with medicines of the same type as escitalopram (the active substance in Nexpram) include:

• restlessness (akathisia)
• loss of appetite

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly to the national reporting system:

Department of Drug Safety Monitoring

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

al. Jerozolimskie 181C

02-222 Warszawa

tel.: 22 49-21-301

fax: 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 NEXPRAM

Keep Nexpram out of the sight and reach of children.

No special precautions for storage are necessary.

Do not use Nexpram after the expiry date stated on the blister and carton.

The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Nexpram contains

The active substance is escitalopram (as escitalopram oxalate).

Each tablet contains 10 mg or 20 mg of escitalopram.

The other ingredients are:

excipients in the granules: microcrystalline cellulose, lactose monohydrate, copovidone (K 90-100), cornstarch

excipients on the surface of the granules: microcrystalline cellulose silanized, sodium croscarmellose, talc, anhydrous colloidal silica

tablet coating: Opadry OY-S-58910, which contains hypromellose, titanium dioxide (E 171), macrogol 400, talc

What Nexpram looks like and contents of the pack

Nexpram is available as 10 mg and 20 mg coated tablets.

The tablets are described below:

10 mg: white to off-white, oval, biconvex, coated tablets, one side of the tablet with "E" and "8" on either side of the score line, the other side of the tablet is smooth. Oval tablets with dimensions of approximately 8.1 mm ± 0.40 mm in length and 5.6 mm ± 0.40 mm in width.

20 mg: white to off-white, oval, biconvex, coated tablets, one side of the tablet with "E" and "9" on either side of the score line, the other side of the tablet is smooth. Oval tablets with dimensions of approximately 11.6 mm ± 0.40 mm in length and 7.1 mm ± 0.40 mm in width.

Nexpram 10 mg tablets are available in packs of 28 tablets, in OPA/Aluminum/PVC/Aluminum blisters in a carton.

Nexpram 20 mg tablets are available in packs of 28 tablets, in OPA/Aluminum/PVC/Aluminum blisters in a carton.

Marketing authorization holder

Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.

ul. Ostrzykowizna 14A

05-170 Zakroczym

tel. (+48) (22) 785 27 60

fax (+48) (22) 785 27 60 wew. 106

Manufacturer

Terapia SA

124 Fabricii Street

400632 Cluj – Napoca

Cluj

Romania

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

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

PL

Nexpram 10/20 mg

RO

Serodeps 10/20 mg

ES

Escitalopram SUN 10/20 mg

DE

ESCITALOPRAM BASICS 10/20 mg

FR

ESCITALOPRAM CRISTERS PHARMA 10/20 mg

IT

ESCITALOPRAM SUN 10/20 mg

SE

Escitalopram SUN 10/20 mg

Date of last revision of the leaflet:

• 14.02.2023