Nexpram

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Nexpram, 10 mg, film-coated tablets
Nexpram, 20 mg, film-coated tablets
Escitalopram (Escitalopramum) (as escitalopram oxalate)
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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 IS NEXPRAM AND WHAT IS IT USED FOR?

Nexpram contains the active substance escitalopram. Nexpram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
Nexpram is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder).
It may take several weeks of treatment before improvement begins. You should continue taking Nexpram even if it takes some time before you start to feel better.
If there is no improvement or if you feel worse, consult your doctor.

2. IMPORTANT INFORMATION BEFORE USING NEXPRAM

When not to use Nexpram

• if the patient is allergic (hypersensitive) to escitalopram or any of the other ingredients of Nexpram (see section 6 “Other information”);
• if the patient is taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs), including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic);
• if the patient was born with a congenital abnormal heart rhythm or if the patient has experienced an episode of abnormal heart rhythm (visible on ECG, a test assessing heart function);
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Nexpram and other medicines”).

Warnings and precautions
Before starting treatment with Nexpram, discuss this with your doctor or pharmacist.
Inform your doctor about any other symptoms or medical conditions, as these may need to be taken into account. In particular, inform your doctor:

• if the patient has epilepsy. If seizures occur for the first time or increase in frequency, treatment with Nexpram should be discontinued (see also section 4 “Possible side effects”);
• if the patient has impaired liver or kidney function. Dose adjustment by the doctor may be necessary;
• if the patient has diabetes. Treatment with Nexpram may alter blood glucose levels. Adjustment of insulin and/or oral antidiabetic medicines may be required;
• if the patient has low sodium levels in the blood;
• if the patient has an increased tendency to bleed or bruise, or if the patient is pregnant (see “Pregnancy, breastfeeding and effect on fertility”);
• if the patient is receiving electroconvulsive therapy;
• if the patient has ischaemic heart disease;
• if the patient has heart problems or has recently had a heart attack;
• if the patient has a slow resting heart rate and/or may have electrolyte imbalances due to prolonged, severe diarrhoea and vomiting (during illness) or use of diuretics;
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disturbances;
• if the patient has or has had eye disorders, such as certain types of glaucoma (increased pressure in the eye);

Note:
Some patients with bipolar disorder may experience a manic phase. This is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. In such cases, consult your doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may occur. If such symptoms appear, inform your doctor immediately.
Medicines such as Nexpram (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety symptoms
Patients with depression and/or anxiety disorders may sometimes experience thoughts of self-harm or suicide. These thoughts may worsen at the beginning of antidepressant treatment. All such medicines take time to work, usually about two weeks, although sometimes longer.
The likelihood of such thoughts is higher if:

• the patient has previously had suicidal or self-harming thoughts.
• the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in patients under 25 years of age.

If at any time during treatment the patient experiences thoughts of self-harm or suicide, seek immediate medical advice or go to hospital.
It may be helpful to inform a relative or friend that the patient has depression or anxiety disorder and to let them read this leaflet. The patient may ask them to inform him or her if they notice worsening of depression or anxiety symptoms or changes in behaviour.
Children and adolescents under 18 years of age
Nexpram should not be used in children and adolescents under 18 years of age. It should also be noted that in patients under 18 years of age taking medicines from this group, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and manifestations of anger). Nevertheless, a doctor may prescribe Nexpram to a patient under 18 years of age if they consider it necessary. If a doctor has prescribed Nexpram to a patient under 18 years of age and you have any doubts, contact the doctor again. If any of the above-mentioned symptoms occur or worsen in a patient under 18 years of age taking Nexpram, inform the doctor. Furthermore, there are no data on the long-term safety of Nexpram in this age group regarding growth, maturation, and cognitive and behavioural development.
Nexpram and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Inform your doctor if the patient is taking any of the following medicines:

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, a 14-day interval must be observed before starting Nexpram. After discontinuing Nexpram, a 7-day interval must be observed before starting any of the above-mentioned medicines.
• “Reversible, selective monoamine oxidase A inhibitors (MAO-A inhibitors)” including moclobemide (used in the treatment of depression).
• Irreversible monoamine oxidase B inhibitors (MAO-B inhibitors) including selegiline (used in the treatment of Parkinson’s disease). These medicines increase the risk of adverse effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (used in the treatment of depression).
• Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol and similar medicines (opioids, used in the treatment of severe pain). These may increase the risk of adverse effects.
• Cimetidine, lansoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase escitalopram blood levels.
• St. John’s wort (Hypericum perforatum) – a herbal medicine used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (NSAIDs) (used for pain relief or to reduce blood clotting, known as anticoagulants). These may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood clotting, known as anticoagulants). Your doctor may order blood clotting time tests at the beginning and after stopping Nexpram to determine whether the anticoagulant dose remains appropriate.
• Mefloquine (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 risk of lowering the seizure threshold.
• Neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used in cardiovascular disorders), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of Nexpram may be necessary.
• Medicines that reduce potassium and magnesium levels in the blood and thereby increase the risk of life-threatening heart rhythm disturbances.

Do not take Nexpram together with medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as: class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials – particularly halofantrine), certain antihistamines (e.g. astemizole, hydroxyzine, mizolastine), etc. Consult your doctor if you have any further questions.
Nexpram with food, drink or alcohol
Nexpram can be taken during meals or independently of meals (see section 3 “How to take Nexpram”).
As with many medicines, it is not recommended to consume alcohol while taking Nexpram, although interaction between Nexpram and alcohol is not expected.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine. Do not use Nexpram in pregnant or breastfeeding women unless discussed with a doctor regarding risks and benefits of treatment.
If the patient takes Nexpram during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin colour, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, shakiness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If any of these symptoms occur in the newborn, seek immediate medical attention.
Inform your doctor and/or midwife about taking Nexpram. Taking medicines such as Nexpram during pregnancy, especially during the last three months, may increase the risk of a serious complication in the newborn called persistent pulmonary hypertension of the newborn (PPHN). It is characterised by rapid breathing and cyanosis and usually occurs within the first day after birth. If such symptoms occur in the newborn, contact your doctor and/or midwife immediately.
Taking Nexpram towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Nexpram, she should inform her doctor or midwife so appropriate advice can be provided.
Do not abruptly stop taking Nexpram during pregnancy.
Nexpram is expected to pass into human milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This may theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
The patient should not drive or operate machinery until they know how Nexpram affects them.
Nexpram contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. HOW TO USE NEXPRAM

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.

Adults
Depression
The usual recommended dose of Nexpram is 10 mg once daily. The physician may increase the dose up to the maximum dose of 20 mg per day.

Panic disorder
The initial dose of Nexpram is 5 mg once daily during the first week of treatment, then the dose is increased to 10 mg per day. The physician may increase the dose up to the maximum dose of 20 mg per day.

Social anxiety disorder
The usual recommended dose of Nexpram is 10 mg once daily. Depending on the patient's response, the physician may reduce the dose to 5 mg per day or increase it up to the maximum dose of 20 mg per day.

Generalized anxiety disorder
The usual recommended dose of Nexpram is 10 mg once daily. The physician may increase the dose up to the maximum dose of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Nexpram is 10 mg once daily. The physician may increase the dose up to the maximum dose of 20 mg per day.

Elderly patients (over 65 years of age)
The usual recommended starting dose of Nexpram is 5 mg once daily. The physician may recommend increasing the dose to 10 mg once daily.

Children and adolescents (under 18 years of age)
Nexpram is generally not used in children and adolescents. For additional information, see section 2.

Renal impairment
Caution is advised in patients with severe renal impairment. The medicine should be used according to the physician's instructions.

Hepatic impairment
Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should be used according to the physician's instructions.

Patients who are poor metabolizers via the CYP2C19 enzyme
Patients with this genotype should not exceed a dose of 10 mg per day. The medicine should be used according to the physician's instructions.

How to use Nexpram
Nexpram may be taken with or without food. Swallow the tablet with water.
Do not chew the tablet, as the tablets have a bitter taste.
If necessary, the tablets may be divided into two equal parts. To do this, place the tablet on a flat surface with the score line facing upwards, and press down on both ends with the index fingers of both hands, as shown in the illustration.

Duration of treatment
Improvement may not be felt until several weeks after starting treatment. Therefore, continue taking Nexpram even if there is no initial improvement in well-being.
Do not change the dosage without first consulting a physician.
Continue taking Nexpram for as long as directed by the physician. If treatment is stopped too early, symptoms may return. It is recommended to continue treatment for at least 6 months after improvement is achieved.

Taking more Nexpram than prescribed
If a patient takes more than the prescribed dose of Nexpram, contact a physician immediately or go to the nearest hospital emergency department, even if no symptoms are present. Symptoms of overdose may include dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, hypotension, and disturbances in water-electrolyte balance. Bring the Nexpram packaging to the physician's visit or hospital.

Missed dose of Nexpram
Do not take a double dose to make up for a missed dose. If the patient forgets to take the medicine but remembers before going to sleep, they should take it immediately. The next day, take the medicine as usual. If the patient remembers during the night or the following day, skip the missed dose and take the next dose at the usual time.

Stopping Nexpram
Do not stop taking Nexpram without consulting a physician. When discontinuing treatment, a gradual reduction of the Nexpram dose over several weeks is usually recommended.
After stopping Nexpram, especially if stopped abruptly, the patient may experience withdrawal symptoms. These symptoms are common when Nexpram treatment is discontinued. The risk is greater if Nexpram has been used for a long time, at high doses, or if the dose was reduced too quickly. In most patients, symptoms are mild and resolve spontaneously within two weeks. However, in some patients, symptoms may be severe or persist longer (2–3 months or more). If severe withdrawal symptoms occur after stopping Nexpram, contact a physician. The physician may recommend restarting the medicine and then tapering it more slowly.

Withdrawal symptoms include: dizziness (unsteady gait or balance disturbances), tingling or burning sensations, and (less commonly) electric shock-like sensations, including in the head; sleep disturbances (vivid dreams, nightmares, insomnia); feelings of anxiety; headache; nausea; excessive sweating (including night sweats); motor restlessness or agitation; tremor; feelings of confusion or disorientation; emotional instability or irritability; diarrhea (loose stools); visual disturbances; palpitations or strong heartbeat (pounding).

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions usually resolve within a few weeks of treatment. It should be remembered that many
of these symptoms may also be manifestations of the disease being treated and may improve as the patient's condition stabilizes.
You should contact your doctor if any of the following adverse reactions occur during treatment:

Not very common (occur in no more than 1 in 100 people):

• unusual bleeding, including gastrointestinal bleeding.

Rare (occur in no more than 1 in 1000 people):

• swelling of the skin, tongue, lips or face, urticaria, or difficulty breathing or swallowing (severe allergic reaction),
• high fever, agitation, disorientation, tremor, and muscle rigidity, which may be symptoms of a rare condition called serotonin syndrome.

Frequency unknown (frequency cannot be estimated from available data):

• difficulty in passing urine
• seizures, see also section "Warnings and precautions"
• yellowing of the skin and whites of the eyes, indicating liver dysfunction and/or hepatitis
• rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsades de pointes
• suicidal thoughts and behaviour, see also section 2 "Warnings and precautions"
• sudden swelling of the skin or mucous membranes (angioedema)

In addition to those listed above, the following adverse reactions have also been reported:

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

• nausea
• headache

Common (occur in less than 1 in 10 people):

• nasal congestion or runny nose (sinusitis)
• decreased or increased appetite
• anxiety, psychomotor agitation, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, skin tingling
• diarrhoea, constipation, vomiting, dryness of the oral mucosa
• excessive sweating
• muscle and joint pain
• sexual disorders (delayed ejaculation, erectile dysfunction, decreased libido, women may have difficulty achieving orgasm)
• feeling of fatigue, fever
• weight gain

Not very common (occur in less than 1 in 100 people):

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

Rare (occur in less than 1 in 1000 people):

• aggression, depersonalization, hallucinations
• slow heartbeat

Frequency unknown – frequency cannot be estimated from available data:

• decreased sodium concentration in blood (manifested by nausea, malaise, muscle weakness or confusion)
• dizziness upon standing due to low blood pressure (orthostatic hypotension)
• abnormal liver function tests (increased liver enzyme activity in blood)
• movement disorders (involuntary muscle movements)
• painful, prolonged erection (priapism)
• bleeding disorders, including skin and mucous membrane bleeding (petechiae) and reduced platelet count (thrombocytopenia)
• increased secretion of a hormone called ADH, leading to water retention in the body, dilution of blood, and reduced sodium levels (syndrome of inappropriate ADH secretion)
• elevated levels of the hormone prolactin in blood
• galactorrhea in men and in women who are not breastfeeding
• mania (abnormal excitement and activity)
• in patients taking medicines in this class, an increased risk of bone fractures has been observed
• changes in heart rhythm (known as "QT interval prolongation" visible on ECG, a test assessing heart function)
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in section 2 "Pregnancy, breastfeeding and fertility".

Additionally, numerous adverse reactions are known for medicines with a mechanism of action similar to escitalopram (the active substance in Nexpram). These include:

• psychomotor restlessness (akathisia)
• loss of appetite

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE NEXPRAM

Keep this medicine out of the sight and reach of children.
No special precautions for storage conditions of the medicine are required.
Do not use Nexpram after the expiry date stated on the blister pack and the cardboard
container. The expiry date refers to the last day of the stated month.
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 PACKAGE AND OTHER INFORMATION

What the medicine Nexpram contains
The active substance is escitalopram (in the form of escitalopram oxalate).
Each film-coated tablet contains 10 mg or 20 mg of escitalopram.
Other components (excipients) of the medicine are:
Excipients contained in the granules: microcrystalline cellulose, lactose monohydrate,
copovidone (K 90-100), maize starch
Excipients located outside the granules: silicified microcrystalline cellulose,
sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate
Tablet coating: Opadry OY-S-58910, which contains hypromellose, titanium dioxide
(E 171), polyethylene glycol 400, talc

What Nexpram looks like and contents of the pack
Nexpram is available as 10 mg and 20 mg film-coated tablets.
The tablets are described below:
10 mg: white to off-white, oval, biconvex film-coated tablets, with the letter “E” and the number “8” embossed on either side of the break line on one side of the tablet; the other side 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 film-coated tablets, with the letter “E” and the number “9” embossed on either side of the break line on one side of the tablet; the other side 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 packages containing 28 tablets, in blisters made of OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
Nexpram 20 mg tablets are available in packages containing 28 tablets, in blisters made of OPA/Aluminium/PVC/Aluminium, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 ext. 106

Manufacturer
Terapia SA
124 Fabricii Street
400632 Cluj – Napoca
Cluj
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

This medicinal product is authorised in the European Economic Area countries 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
December 2025