NEXPRAM 10 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 you start taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. WHAT NEXPRAM IS AND WHAT IT IS USED FOR
5. IMPORTANT INFORMATION BEFORE YOU TAKE NEXPRAM
   1. When not to take Nexpram
   2. Warnings and precautions
   3. Special considerations
   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, drinks, 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. Side effects to report to your doctor
   2. Other side effects
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 you start taking this medicine because 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Nexpram is and what it is used for
• 2. Important information before you take 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 after a few weeks, you should talk to your doctor.

2. IMPORTANT INFORMATION BEFORE YOU TAKE 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 MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic);
• if you are born with or have had a heart condition that affects your heart rhythm;
• if you are taking medicines that affect your heart rhythm.

Warnings and precautions

Before you start taking Nexpram, tell your doctor if you have:

• epilepsy. If you have a fit (seizure) while taking Nexpram, stop taking it and contact your doctor immediately;
• liver or kidney disease. Your doctor may need to adjust your dose;
• diabetes. Nexpram may affect your blood sugar levels. You may need to adjust your dose of insulin or other diabetes medications;
• low sodium levels in your blood;
• a tendency to bleed easily or if you are taking medicines that may increase the risk of bleeding;
• if you are receiving electroconvulsive therapy;
• if you have coronary heart disease;
• if you have had a heart attack recently;
• if you have a slow heart rate or if you are at risk of low blood pressure;
• if you have a heart condition that may increase the risk of abnormal heart rhythms (see section 2, "Do not take Nexpram");
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Special considerations

In patients with manic-depressive illness, a "high" phase (mania) may occur. This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. You should contact your doctor if this happens.

In the first few weeks of treatment, you may experience anxiety or difficulty sitting or standing still. If you experience these symptoms, you should contact your doctor immediately.

Medicines like Nexpram (SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have continued 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 yourself or suicide. These thoughts may be more frequent when you first start taking antidepressants, as all these medicines take time to start working (usually about 2 weeks, but sometimes longer).

• you have had thoughts of harming yourself or suicide in the past;
• you 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 any of these symptoms during treatment, you should contact your doctor or go to the hospital immediately.

It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You should also ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

Children and adolescents under 18 years

Nexpram should not be given to children and adolescents under 18 years. Also, be aware that patients under 18 are at an increased risk of side effects such as suicide attempt, suicidal thoughts, and hostility (especially aggression, oppositional behavior, and anger) when they take this class of medicines.

Nexpram with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you will need to wait 14 days before you can start taking Nexpram. After stopping Nexpram, you will need to wait 7 days before you can take any of these medicines;
• reversible selective MAO-A inhibitors, such as moclobemide (used to treat depression);
• irreversible MAO-B inhibitors, such as 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 tryptofan;
• imipramine and desipramine (used to treat depression);
• sumatriptan and similar medicines (used to treat migraine) and tramadol (a pain killer). These medicines may increase the risk of side effects;
• cimetidine, lansoprazole, esomeprazole, and omeprazole (used to treat 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 your blood;
• St. John's Wort (a herbal remedy used to treat depression);
• aspirin and non-steroidal anti-inflammatory drugs (used to treat pain or inflammation). These medicines may increase the risk of bleeding;
• warfarin, dipyridamole, and phenprocoumon (used to prevent blood clots). Your doctor may need to check your blood to see how well it is clotting;
• mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat pain) due to the risk of lowering the seizure threshold;
• neuroleptics (used to treat schizophrenia) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold;
• flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Your doctor may need to adjust your dose of Nexpram;
• medicines that lower potassium or magnesium levels in the blood, which may increase the risk of life-threatening heart rhythm disorders.

Do not take Nexpram with medicines that affect your heart rhythm, such as:

• anti-arrhythmic drugs (class IA and III) and antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol);
• tricyclic antidepressants;
• certain antibiotics (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial drugs, especially halofantrine);
• certain antihistamines (e.g., astemizole, hydroxyzine, mizolastine).

Nexpram with food, drinks, and alcohol

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

As with many medicines, it is recommended to avoid taking Nexpram with alcohol, although no adverse effects have been reported.

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.

Do not take Nexpram if you are pregnant or breastfeeding unless your doctor has decided that it is necessary.

If you take Nexpram during the last 3 months of your pregnancy, your newborn baby might have some symptoms such as difficulty breathing, bluish skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, exaggerated reflexes, tremors, jitteriness, irritability, lethargy, constant crying, sleepiness, and difficulty sleeping. If your baby experiences any of these symptoms, you should contact your doctor.

Taking Nexpram during pregnancy, especially during the last 3 months, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN). This condition makes it difficult for the baby to breathe and can be life-threatening. If your baby experiences any of these symptoms, you should contact your doctor immediately.

Taking Nexpram during pregnancy may increase the risk of heavy bleeding from the vagina after giving birth, especially if you have a history of bleeding disorders. You should tell your doctor if you are taking Nexpram so that they can give you appropriate advice.

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

Escitalopram has been shown to pass into breast milk. Animal studies have shown that escitalopram, a substance similar to the active substance in Nexpram, can affect fertility.

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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Depression

The recommended dose is 10 mg per day. Your doctor may increase the dose to a maximum of 20 mg per day.

Panic disorder

The starting dose is 5 mg per day for the first week, then increased to 10 mg per day. Your doctor may increase the dose to a maximum of 20 mg per day.

Social anxiety disorder

The recommended dose is 10 mg per day. Your doctor may reduce the dose to 5 mg per day or increase it to a maximum of 20 mg per day.

Generalized anxiety disorder

The recommended dose is 10 mg per day. Your doctor may increase the dose to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The recommended dose is 10 mg per day. Your doctor may increase the dose to a maximum of 20 mg per day.

Elderly patients (over 65 years)

The recommended starting dose is 5 mg per day. Your doctor may increase the dose to 10 mg per day.

Children and adolescents under 18 years

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

Patients with kidney problems

Caution should be exercised when treating patients with severe kidney problems. Your doctor will advise you on the dose to take.

Patients with liver problems

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

Patients who are poor metabolizers of CYP2C19

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

Nexpram can be taken with or without food. Swallow the tablet with water. Do not chew the tablet, as it tastes bitter.

If necessary, the tablet 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 edges down with your index fingers on both sides of the tablet, as shown in the picture.

Duration of treatment

You may not feel better immediately. This is because Nexpram takes time to start working (usually about 2-4 weeks). You should continue to take Nexpram even if you do not feel better immediately.

Do not change your dose without talking to your doctor first.

Take Nexpram for as long as your doctor recommends. If you stop taking Nexpram too soon, 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 nearest hospital emergency department immediately. Symptoms of overdose include dizziness, tremors, agitation, convulsions, coma, nausea, vomiting, changes in heart rhythm, low blood pressure, and changes in electrolyte balance.

Take the Nexpram packaging with you to show the doctor or nurse.

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 as soon as you remember. The next day, take the next dose at the usual time.

If you forget to take a dose and only remember 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 gradually reduce your dose over a few weeks.

After stopping 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. The risk is higher if you stop taking Nexpram 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 after stopping Nexpram, you should contact your doctor. Your doctor may recommend that you start taking Nexpram again and then gradually stop it.

Withdrawal symptoms include dizziness (unsteady walk or balance problems), tingling sensations, numbness, or "electric shock" sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, nausea, sweating (including night sweats), restlessness or agitation, tremors, confusion or disorientation, irritability, diarrhea, visual disturbances, or palpitations (pounding heart).

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

4. POSSIBLE SIDE EFFECTS

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

Side effects to report to your doctor

Uncommon (affects less than 1 in 100 people):

• unusual bleeding, including bleeding from the digestive tract.

Rare (affects less than 1 in 1,000 people):

• severe allergic reactions, including swelling of the skin, tongue, lips, or face, hives, or difficulty breathing or swallowing;
• high fever, agitation, confusion, tremors, 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, "Warnings and precautions";
• yellowing of the skin and whites of the eyes, which may be a sign of liver problems or hepatitis;
• fast 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, "Warnings and precautions";
• sudden swelling of the skin or mucous membranes (angioedema).

Other side effects

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

• nausea;
• headache.

Common (affects less than 1 in 10 people):

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

Uncommon (affects less than 1 in 100 people):

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

Rare (affects less than 1 in 1,000 people):

• aggression, depersonalization, hallucinations;
• slow heartbeat.

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

• low sodium levels in the blood (which may cause nausea and weakness, 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 levels of a hormone called ADH, which can cause water retention in the body and dilute the blood, leading to low sodium levels;
• galactorrhoea (milk secretion) in men and women who are not breastfeeding;
• mania (abnormal excitement);
• increased risk of bone fractures;
• changes in heart rhythm (called "QT prolongation" visible on an electrocardiogram, a test that measures heart function);
• severe bleeding from the vagina after childbirth (postpartum hemorrhage), see also section 2, "Pregnancy, breastfeeding, and fertility".

Other side effects that have been reported with medicines similar to escitalopram (the active substance in Nexpram) include:

• restlessness (akathisia);
• loss of appetite.

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 via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NEXPRAM

Keep this medicine out of the sight and reach of children.

There are no special storage requirements for this medicine.

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.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. 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.

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" engraved on one side and "8" on the other side of the score line, the other side of the tablet is smooth. The oval tablets are 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" engraved on one side and "9" on the other side of the score line, the other side of the tablet is smooth. The oval tablets are 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 blisters of OPA/Aluminum/PVC/Aluminum in a cardboard box.

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

Marketing authorization holder

LEK-AM Pharmaceutical Company Ltd.

Ostrzykowizna 14A

05-170 Zakroczym

Poland

Manufacturer

Terapia SA

124 Fabricii Street

400632 Cluj-Napoca

Cluj

Romania

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH 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