Aurex 20

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Aurex 20

(Citalopram Sandoz 20 mg)

20 mg, coated tablets

Citalopram
Aurex 20 and Citalopram Sandoz 20 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Aurex 20 and what is it used for
• 2. Important information before taking Aurex 20
• 3. How to take Aurex 20
• 4. Possible side effects
• 5. How to store Aurex 20
• 6. Contents of the packaging and other information

1. What is Aurex 20 and what is it used for

Aurex 20 contains the active substance citalopram - an antidepressant from the group of so-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 20 is used to treat:

• depression and to prevent relapses of depressive disorders;
• panic disorder with or without agoraphobia (fear of open spaces).

2. Important information before taking Aurex 20

When not to take Aurex 20

• 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 (so-called IMAO - medicines used to treat depression or Parkinson's disease) or has taken them within the last 2 weeks (see "Aurex 20 and other medicines"). The doctor will provide information on how to start taking Aurex 20 after stopping the IMAO 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 such disorders in the past (detected in an electrocardiogram - ECG);

disorders (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 20 and other medicines").

Warnings and precautions

Taking Aurex 20 in children and adolescents under 18 years of age
Aurex 20 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 20 to patients under 18 years of age, considering that it is in their best interest. If the doctor has prescribed Aurex 20 to a patient under 18 years of age, and you have any doubts, please consult the doctor. If the above-mentioned symptoms worsen in patients under 18 years of age taking Aurex 20, the doctor should be informed. Additionally, there is currently a lack of data on the long-term safety of taking Aurex 20 in this age group regarding growth, maturation, and cognitive and behavioral development.
Suicidal thoughts or self-harm
People suffering from depression or anxiety disorders may sometimes have thoughts of self-harm (self-mutilation) 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 mood to improve. Patients with suicidal tendencies should not have access to large amounts of medicine and, if necessary, should remain under constant supervision.
This applies especially to 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, you should contact your 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 such a person to pay attention if they notice an intensification of depression or anxiety or a change in the patient's behavior.
Akathisia
Taking such medicines as Aurex 20 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 such as Aurex 20 (so-called SSRI or SNRI) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.
Before starting treatment with Aurex 20, you should 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 genital tract, gastrointestinal bleeding, and other bleeding in the skin or mucous membranes),

bleeding (such as bruising, bleeding from the genital 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 20 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.

You should stop taking Aurex 20 and contact your doctor immediately if you experience any of the following symptoms:

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

Aurex 20 and other medicines

You should tell your doctor about all medicines you are currently 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 especially 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,
• antidepressant medicines, such as other selective serotonin reuptake inhibitors, monoamine oxidase inhibitors (MAOI), selegiline (in a dose greater than 10 mg per day), tricyclic antidepressants (e.g., desipramine), lithium, as well as herbal preparations containing St. John's wort (Hypericum perforatum),
• painkillers, such as opioid painkillers (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 level 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,
• painkillers and anti-inflammatory medicines, such as acetylsalicylic acid and other non-steroidal 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, tiordazine, and haloperidol,
• the antimalarial medicine - mefloquine.

Aurex 20 should not be taken if the patient is 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, some antibacterial medicines (e.g., sparfloxacin, moxifloxacin, intravenously administered erythromycin, pentamidine), antimalarial medicines (especially halofantrine), and some antihistamines (astemizole, mizolastine).
In case of doubt as to whether the patient is taking any of the mentioned medicines, the doctor or pharmacist should be consulted.

Aurex 20 with food and drink

Aurex 20 can be taken at the same time every day, regardless of meals.
It is not recommended to drink alcohol while taking Aurex 20.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Aurex 20 should not be taken during pregnancy unless the doctor considers it absolutely necessary.
The doctor and/or midwife should be informed about the use of Aurex 20. Taking such medicines as Aurex 20 during pregnancy (especially in the last three months of pregnancy) may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis and usually occurs within the first day after birth. If such symptoms occur in the newborn, the doctor and/or midwife should be contacted immediately.
Taking Aurex 20 at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Aurex 20, she should inform her doctor or midwife so that they can provide 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.
Theoretically, this may affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Aurex 20 has a minor or moderate effect on the ability to assess and react in emergency situations, but it may impair concentration. Caution should be exercised when driving vehicles or operating machinery in motion.

Aurex 20 contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Aurex 20

This medicine should always be taken according to the doctor's instructions. In case of doubts, the doctor or pharmacist should be consulted.
Aurex 20 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 the prevention of relapses, 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, and then it is 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 old)
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 old
Aurex 20 should not be taken in children and adolescents under 18 years old.
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, you should consult your doctor.

Taking a higher dose of Aurex 20 than recommended

In case of taking a higher dose of Aurex 20 than recommended, you should immediately contact your doctor or pharmacist.
Symptoms of overdose include: seizures, rapid heartbeat, drowsiness, changes in the electrocardiogram (ECG), coma, vomiting, tremors, low blood pressure, nausea, cardiac arrest, agitation, slow heartbeat, dizziness, hypertension, dilated pupils, arrhythmias, including torsades de pointes (a type of ventricular tachycardia), stupor, sweating, cyanosis, and excessive and deep 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. The administration of activated charcoal, an osmotic laxative (e.g., sodium sulfate), and gastric lavage should be considered. In case of impaired consciousness, intubation should be performed. ECG and vital functions should be monitored.

Missing a dose of Aurex 20

A double dose should not be taken to make up for a missed tablet.

Stopping treatment with Aurex 20

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.
Symptoms of withdrawal after discontinuation of selective serotonin reuptake inhibitors (SSRIs)
After discontinuation of the medicine, especially sudden discontinuation, 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), agitation 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 20 should be discontinued gradually over several weeks or months, depending on the patient's needs.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aurex 20 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 disappear during treatment.
Very common side effects (may occur in more than 1 in 10 people): sleep disturbances, drowsiness, insomnia, headache, dry mouth, nausea, increased sweating, weakness.
Common side effects (may occur in less than 1 in 10 people): decreased appetite, weight loss, agitation, decreased libido, anxiety, nervousness, confusion, orgasm disorders (in women), unusual dreams, apathy, tremors, tingling, dizziness, attention disorders, 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 in less than 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 (which may lead to acute glaucoma), rapid heartbeat, slow heartbeat, hypersensitivity to light, urticaria, hair loss, rash, purpura, urinary retention, excessive menstrual bleeding.
Rare side effects (may occur in less than 1 in 1000 people): low sodium levels in the blood (hyponatremia), seizures, uncoordinated, involuntary movements (dyskinesia), 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 serious 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 disorders, changes in the ECG, hypotension when standing up, nosebleeds, gastrointestinal bleeding (including rectal bleeding), abnormal liver function test results, 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 the patient has suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital.

If the patient experiences rapid or irregular heartbeat and/or fainting, they should stop taking Aurex 20 and immediately consult their doctor. These may be symptoms of life-threatening heart rhythm disorders of the torsades de pointes type (i.e., polymorphic ventricular tachycardia).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Aurex 20

• The medicine should be stored out of sight and reach of children.
• There are no special storage instructions.
• Aurex 20 should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aurex 20 contains

The active substance of the medicine is citalopram (in the form of citalopram hydrobromide). One tablet contains 20 mg of citalopram.
Other ingredients are:
Core:corn starch, lactose monohydrate, copovidone, glycerol 85%, microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose (type A).
Coating:hypromellose, macrogol 6000, titanium dioxide (E 171), talc.

What Aurex 20 looks like and what the packaging contains

White, oblong, biconvex tablets with a dividing line on one side and the inscription C 20 on the other side.
The tablets can be divided into halves.
The medicine is available in blisters, and the packaging contains 20 coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Sandoz B.V.
Veluwezoom 22
1327 AH Almere
Netherlands

Manufacturer:

Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben
Germany
LEK S.A.
Domaniewska 50 C
02-672 Warsaw
Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

Parallel importer:

InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Netherlands marketing authorization number, country of export:RVG 26734
Parallel import authorization number:419/14

Leaflet approval date: 03.12.2024

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