AUREX 20 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. AUREX 20, 20 mg, film-coated tablets
3. AUREX 40, 40 mg, film-coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
4. What is Aurex and what is it used for
5. Important information before taking Aurex
   1. When not to take Aurex
   2. Warnings and precautions
   3. Aurex and other medicines
   4. Citalopram and other medicines taken at the same time may affect each other's action and the occurrence of side effects. This applies in particular to such medicines as:
   5. Aurex with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Aurex contains lactose and sodium
6. How to take Aurex
   1. Taking a higher dose of Aurex than recommended
   2. Missing a dose of Aurex
   3. Stopping Aurex treatment
7. Possible side effects
   1. Reporting side effects
8. How to store Aurex
9. Contents of the pack and other information
   1. What Aurex contains
   2. What Aurex looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. For more information, please contact:

Package Leaflet: Information for the Patient

AUREX 20, 20 mg, film-coated tablets

AUREX 40, 40 mg, film-coated tablets

Citalopram

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

Keep this leaflet, as you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Aurex and what is it used for

Aurex contains the active substance citalopram, an antidepressant belonging to a group of drugs called selective serotonin reuptake inhibitors. Depression and anxiety are associated with a deficiency of substances that transmit information in the brain (including serotonin). Citalopram helps restore the normal concentration of serotonin in the brain.
Aurex is used to treat:
depression and to prevent relapse of depressive disorders;
panic disorder with or without agoraphobia (fear of open spaces).

2. Important information before taking Aurex

When not to take Aurex

if the patient is allergic (hypersensitive) to citalopram or any of the other ingredients of the medicine (listed in section 6);
if the patient is taking a medicine from the group of monoamine oxidase inhibitors (MAOIs - medicines used to treat depression or Parkinson's disease) or has taken them within the last 2 weeks (see "Aurex and other medicines");
The doctor will provide information on how to start taking Aurex after stopping the MAOI medicine.
if the patient is taking linezolid (an antibiotic) and it is not possible to closely monitor their condition or blood pressure;
if the patient has congenital heart rhythm disorders or has had them in the past (detected in an electrocardiogram - ECG);
if the patient is taking medicines that regulate heart rhythm or medicines that may affect heart rhythm (see below "Aurex and other medicines").

Warnings and precautions

Taking Aurex in children and adolescents under 18 years of age
Aurex should not be taken in children and adolescents under 18 years of age. Due to the increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, the doctor may prescribe Aurex to patients under 18 years of age, considering it to be in their best interest. If the doctor has prescribed Aurex to a patient under 18 years of age, and you have any doubts, please consult the doctor. In case of development or worsening of the above-mentioned symptoms in patients under 18 years of age taking Aurex, inform the doctor. Additionally, there is currently a lack of data on the long-term safety of taking Aurex in this age group regarding growth, maturation, and cognitive and behavioral development.
Thoughts of self-harm or suicide
People suffering from depression or anxiety disorders may sometimes have thoughts of self-harm (self-injury) or suicide. Such thoughts may intensify at the beginning of treatment with an antidepressant, as it takes some time for the medicine to start working and for the patient's condition to improve. Patients with suicidal tendencies should not have access to large amounts of medicine and, if necessary, should be under constant supervision.
This is especially true for patients who have had suicidal behavior or thoughts in the past, patients under 25 years of age, and those who showed a high degree of suicidal thoughts before starting therapy.
If such thoughts ever appear, consult a doctor or go directly to the hospital.
Sometimes it may be helpful to inform a friend or relative about depression or anxiety disorder and ask them to read this leaflet. You can also ask them to pay attention if they notice an intensification of depression or anxiety or a change in the patient's behavior.
Akathisia
Taking medicines like Aurex may cause (usually in the first few weeks of treatment) the so-called akathisia, which is characterized by a feeling of inner restlessness, often with an inability to sit or stand still.
Medicines like Aurex (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.
Before starting Aurex, inform your doctor about the following current or past situations:

• mania (feeling of mental and motor excitement),
• kidney or liver disease,
• heart rhythm disorders (including recently suffered myocardial infarction),
• slow resting heart rate,
• fast or irregular heartbeat, fainting, collapse, or dizziness when standing up (which may indicate heart rhythm disorders),
• diabetes,
• seizures or epilepsy,
• glaucoma,
• past bleeding (such as bruising, bleeding from the reproductive tract, gastrointestinal bleeding, and other bleeding in the skin or mucous membranes)
• history of bleeding disorders or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility"),
• taking anticoagulant medicines (see "Aurex and other medicines"),
• electroconvulsive therapy,
• low sodium levels in the blood (e.g., due to prolonged, severe diarrhea, vomiting, or use of diuretics),
• low magnesium levels in the blood.

Stop taking Aurex and consult a doctor immediately if the following symptoms occur:

• restlessness
• feeling of confusion (disorientation)
• muscle tremors
• short-term, involuntary muscle contractions (myoclonic seizures)
• high fever. These may be symptoms of serotonin syndrome.

Aurex and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Citalopram and other medicines taken at the same time may affect each other's action and the occurrence of side effects. This applies in particular to such medicines as:

• pimozide (a medicine used to treat certain mental illnesses)
• buspirone (an anxiolytic medicine)
• migraine medicines, such as sumatriptan and other triptans,
• antidepressants, such as other selective serotonin reuptake inhibitors, monoamine oxidase inhibitors (MAOIs), selegiline (in doses greater than 10 mg per day), tricyclic antidepressants (e.g., desipramine), lithium, as well as herbal preparations containing St. John's Wort (Hypericum perforatum),
• analgesics, such as opioid analgesics (e.g., tramadol and buprenorphine),
• medicines used to treat high blood pressure or heart failure, such as metoprolol, flecainide, propafenone,
• medicines that may increase the concentration of citalopram in the blood: cimetidine, omeprazole, esomeprazole, lansoprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of stroke),
• anticoagulant medicines,
• medicines that affect platelet function, such as dipyridamole,
• analgesic and anti-inflammatory medicines, such as acetylsalicylic acid and other nonsteroidal anti-inflammatory medicines (e.g., ibuprofen, diclofenac, or celecoxib),
• medicines that may increase the risk of bleeding, such as antipsychotic medicines, phenothiazine derivatives, thioxanthenes, butyrophenones, bupropion, risperidone, tiordiazine, and haloperidol,
• mefloquine (an antimalarial medicine).

DO NOT TAKE AUREX if you are taking medicines that regulate heart rhythm or medicines that may affect heart rhythm, such as antiarrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, intravenously administered erythromycin, pentamidine), antimalarial medicines (especially halofantrine), and certain antihistamines (astemizole, mizolastine).
In case of doubt about whether you are taking any of these medicines, consult a doctor or pharmacist.

Aurex with food and drink

Aurex can be taken at any time of day, with or without food.
It is not recommended to drink alcohol while taking Aurex.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Pregnancy
Aurex should not be taken during pregnancy unless the doctor considers it absolutely necessary.
Inform your doctor and/or midwife about taking Aurex. Taking medicines like Aurex during pregnancy (especially in the last three months) may increase the risk of severe complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis and usually occurs in the first day after birth. If such symptoms occur in the newborn, consult a doctor and/or midwife immediately.
Taking Aurex at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If you are taking Aurex, inform your doctor or midwife so that they can provide you with appropriate advice.
Breastfeeding
The medicine can be taken during breastfeeding only if the doctor considers that the benefit to the mother outweighs the potential risk to the child.
Fertility
Animal studies have shown that citalopram reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans.

Driving and using machines

Aurex has a minor to moderate effect on the ability to assess and react in emergency situations, but it may impair concentration. Be cautious when driving or operating machinery.

Aurex contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Aurex

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Aurex is taken in a single dose once a day.
Adults
Treatment of depression
The usual daily dose of citalopram is 20 mg once a day. If necessary, the doctor may increase the dose to a maximum of 40 mg per day, depending on the severity of the depressive symptoms and the patient's response to treatment.
The antidepressant effect of the medicine is usually observed after 2 to 4 weeks of treatment. In preventing relapse, the medicine is usually taken for 6 months after the depressive symptoms have subsided.
Treatment of panic disorder
The initial dose is 10 mg per day for the first week, then increased to 20 mg per day. If necessary, the doctor may increase the dose to a maximum of 40 mg per day.
The effect of the medicine is usually observed after 2-4 weeks, and its maximum effectiveness is achieved after about 3 months.
Elderly patients (over 65 years of age)
The recommended daily dose is 10-20 mg once a day. The doctor may increase the dose to a maximum of 20 mg per day, depending on the patient's response to treatment.
Children and adolescents under 18 years of age
Aurex should not be taken in children and adolescents under 18 years of age.
Patients with liver function disorders
The initial dose is 10 mg per day, and the maximum daily dose should not exceed 20 mg.
Patients with kidney function disorders
In patients with mild or moderate renal impairment, dose adjustment is not necessary.
In patients with severe renal impairment (with creatinine clearance less than 20 ml/min), it is not recommended to take the medicine.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Taking a higher dose of Aurex than recommended

In case of taking a higher dose of Aurex than recommended, consult a doctor or pharmacist immediately.
Overdose symptoms include: seizures, rapid heart rate, drowsiness, changes in the electrocardiogram (ECG), coma, vomiting, tremors, low blood pressure, nausea, cardiac arrest, excitement, slow heart rate, dizziness, hypertension, dilated pupils, arrhythmias, including arrhythmias, fainting, excessive sweating, cyanosis, and deep or rapid breathing (hyperventilation). Rarely, cases of rhabdomyolysis (breakdown of striated muscle) have been reported.
Treatment
There is no specific antidote for citalopram. Symptomatic and supportive treatment should be applied. Consider administering activated charcoal, an osmotic laxative (e.g., sodium sulfate), and gastric lavage. In case of impaired consciousness, intubation should be performed. ECG and vital functions should be monitored.

Missing a dose of Aurex

Do not take a double dose to make up for a missed tablet.

Stopping Aurex treatment

Sudden discontinuation of the medicine after a longer treatment period may cause withdrawal symptoms in some patients, such as dizziness, tingling, muscle tremors, anxiety, nausea, and palpitations. The decision to discontinue the medicine is always made by the doctor. If discontinuation is indicated, the doctor will recommend a gradual reduction of the dose.
Withdrawal symptoms after discontinuing selective serotonin reuptake inhibitors (SSRIs)
After discontinuing the medicine, especially suddenly, withdrawal symptoms often occur. The risk of such symptoms may depend on several factors, including the duration of treatment, the dose used, and the rate of dose reduction.
The most commonly reported symptoms are dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and intense dreams), restlessness or anxiety, nausea and/or vomiting, tremors, and headache. These symptoms are usually mild to moderate, but in some patients, they may be severe.
They usually occur within a few days of stopping the medicine, but there are very rare reports of such symptoms in patients who have missed a dose of the medicine by mistake.
These symptoms usually resolve on their own, usually within 2 weeks, although in some people, they may persist for longer (2-3 months or more). Therefore, Aurex should be discontinued gradually over several weeks or months, depending on the patient's needs.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aurex can cause side effects, although not everybody gets them.
They are usually mild and temporary, occur mainly in the first or two weeks of treatment, and usually resolve during treatment.
Very common side effects (may occur more often than in 1 in 10 people): sleep disturbances, drowsiness, insomnia, headache, dry mouth, nausea, increased sweating, weakness.
Common side effects (may occur less often than in 1 in 10 people): decreased appetite, weight loss, restlessness, decreased libido, anxiety, nervousness, confusion, orgasm disorders (in women), unusual dreams, apathy, tremors, tingling, dizziness, attention disturbances, migraine, memory loss, tinnitus, palpitations, yawning, nasal congestion, diarrhea, vomiting, constipation, indigestion, abdominal pain, bloating, excessive salivation, itching, muscle pain, joint pain, impotence, ejaculation disorders, fatigue.
Uncommon side effects (may occur less often than in 1 in 100 people): increased appetite, weight gain, aggression, depersonalization (e.g., feeling detached from one's own emotions and thoughts), hallucinations, mania, increased libido, fainting, dilated pupils (may lead to acute glaucoma), rapid heart rate, slow heart rate, hypersensitivity to light, urticaria, hair loss, rash, purpura, urinary retention, excessive menstrual bleeding.
Rare side effects (may occur less often than in 1 in 1000 people): low sodium levels in the blood (hyponatremia), seizures, uncoordinated, involuntary movements (dyskinesias), taste disorders, bleeding, cough, hepatitis, fever, malaise.
Side effects with unknown frequency (frequency cannot be estimated from the available data): low platelet count (thrombocytopenia), hypersensitivity reactions, anaphylactic reaction, inappropriate antidiuretic hormone secretion, low potassium levels in the blood (hypokalemia), panic attacks, teeth grinding, restlessness, suicidal thoughts, suicidal behavior*, seizures, serotonin syndrome (a severe disorder caused by too much serotonin in the brain, with symptoms such as headache, hallucinations, fever, muscle stiffness, sleep disturbances, arrhythmias, nausea, vomiting), extrapyramidal disorders (muscle stiffness, poor mimicry, slowed movements, involuntary muscle contractions and movements), akathisia (inability to sit or stand still), movement disorders, vision disturbances, changes in the ECG, low blood pressure when standing up, nosebleeds, gastrointestinal bleeding (including rectal bleeding), abnormal liver function tests, bruising, angioedema, intermenstrual bleeding, severe postpartum hemorrhage (see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2), prolonged, painful erection (priapism), galactorrhea (in men).* Cases of suicidal thoughts and behaviors have been reported during treatment with citalopram or shortly after its discontinuation.
Studies have shown an increased risk of fractures in patients taking selective serotonin reuptake inhibitors and tricyclic antidepressants.
Suicidal thoughts, worsening of depression or anxiety disorders
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such thoughts or behavior may intensify at the beginning of treatment with antidepressants, as these medicines usually start working after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult: the risk of suicidal behavior is increased in people under 25 years of age with mental disorders who are being treated with antidepressants. If you have suicidal thoughts or thoughts of self-harm, consult a doctor or go to the hospital immediately.

If you experience rapid, irregular heartbeat and/or fainting during treatment, stop taking Aurex and consult a doctor immediately. These may be symptoms of life-threatening heart rhythm disorders of the type torsades de pointes (i.e., polymorphic ventricular tachycardia).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Aurex

Keep the medicine out of the sight and reach of children.
Do not take Aurex after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Aurex contains

The active substance of the medicine is citalopram (in the form of citalopram hydrobromide). One tablet contains 20 mg or 40 mg of citalopram.
The other ingredients are: cornstarch, lactose monohydrate, copovidone, glycerol 85%, microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose, hypromellose, macrogol 6000, titanium dioxide (E171), talc.

What Aurex looks like and contents of the pack

AUREX 20
White, oblong, biconvex film-coated tablets with a dividing line on one side and the inscription C 20 on the other side.
The tablets can be divided into halves.
AUREX 40
White, oblong, biconvex film-coated tablets with a dividing line on one side and the inscription C 40 on the other side.
The tablets can be divided into halves.
The medicine is available in blisters containing 20 film-coated tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Salutas Pharma GmbH
Dieselstrasse 5
70839 Gerlingen, Germany

For more information, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:01/2024
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