Aurex 20

Package leaflet: Information for the patient

Warning!
Keep this leaflet. Information on the immediate packaging is in a foreign language.
Aurex 20 (Citalopram Sandoz 20 mg, filmomhulde tabletten), 20 mg
film-coated tablets
Citalopramum
Aurex 20 and Citalopram Sandoz 20 mg, filmomhulde tabletten are different trade names for the
same medicinal product.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Aurex 20 is and what it is 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 pack and other information

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

Aurex 20 contains the active substance citalopram (in the form of citalopram hydrobromide) – an antidepressant belonging to the group of selective serotonin reuptake inhibitors (SSRIs). Depression and anxiety are associated with a deficiency of substances that transmit information in the brain (including serotonin). Citalopram helps restore normal serotonin levels in the brain.

Aurex 20 is used to treat:

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

2. Important information before using Aurex 20

When not to use 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 MAOIs – medicines used in the treatment of depression or Parkinson’s disease) or has taken them within the last 2 weeks (see “Aurex 20 and other medicines”); the doctor will advise how to start taking Aurex 20 after stopping MAOI treatment;
• if the patient is taking linezolid (an antibiotic) and close monitoring of their condition and blood pressure cannot be ensured;
• if the patient has congenital heart rhythm disorders or has previously experienced such disorders (detected during heart function tests – 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
Use of Aurex 20 in children and adolescents under 18 years of age
Aurex 20 must not be used in children and adolescents under 18 years of age. This is due to an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviors, and anger). However, a doctor may prescribe Aurex 20 to patients under 18 years of age if they determine it to be in the patient's best interest. If your doctor has prescribed Aurex 20 to a patient under 18 years of age and you have any doubts, please consult the prescribing doctor. If any of the above symptoms develop or worsen in patients under 18 years of age taking Aurex 20, inform the doctor immediately. Furthermore, there is currently no data on the long-term safety of using Aurex 20 in this age group regarding growth, maturation, cognitive development, and behavioral development.

Thoughts of self-harm or suicide
People suffering from depression or anxiety disorders may sometimes have thoughts of harming themselves (self-injury) or of suicide. Such thoughts may worsen at the beginning of treatment with an antidepressant, as it takes some time for the medicine to take effect and for the patient’s well-being to improve. Patients with suicidal tendencies must not have access to large quantities of medicine and, if necessary, should remain under constant supervision.
This particularly applies to patients who have previously exhibited suicidal behaviors or thoughts, patients under 25 years of age, and those who had significant suicidal ideation before starting treatment. If such thoughts occur at any time, contact a doctor or go directly to a hospital.

Sometimes it may be helpful to inform a friend or relative about the depression or anxiety disorder and ask them to read this leaflet. You may also ask such a person to observe for signs of worsening depression or anxiety or changes in the patient’s behavior.

Akathisia
Treatment with medicines such as Aurex 20 may cause (usually during the first weeks of treatment) a condition called akathisia, characterized by a feeling of inner restlessness, often with an inability to sit or stand still.

Medicines such as Aurex 20 (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Before starting treatment with Aurex 20, inform the doctor about any of the following current or past conditions:

• mania (feeling of mental and physical agitation),
• kidney or liver disease,
• heart function disorders (including recent myocardial infarction),
• slow resting heart rate,
• rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing (which may indicate heart function disorders),
• diabetes,
• seizures or epilepsy,
• glaucoma,
• previous bleeding episodes (such as petechiae, genital bleeding, gastrointestinal bleeding, or other bleeding involving the skin or mucous membranes),
• history of blood clotting disorders, or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”),
• use of anticoagulant medicines (see section “Aurex 20 and other medicines”),
• electroconvulsive therapy,
• low serum sodium levels (e.g., due to prolonged, severe diarrhea, vomiting, or use of diuretics),
• low serum magnesium levels.

Aurex 20 must be discontinued immediately and the doctor contacted if any of the following symptoms occur:

• motor restlessness,
• confusion (disorientation),
• muscle tremors,
• brief, involuntary muscle jerks (myoclonic jerks),
• high fever. These may be symptoms of serotonin syndrome.

Aurex 20 and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Citalopram and other concomitantly used medicines may interact and affect each other’s actions and the occurrence of adverse effects. This particularly applies to the following medicines:

• pimozide (a medicine used in the treatment of certain psychiatric disorders),
• buspirone (an anxiolytic),
• antimigraine medicines such as sumatriptan and other triptans,
• antidepressants, such as other selective serotonin reuptake inhibitors, monoamine oxidase inhibitors (MAOIs), selegiline (at doses greater than 10 mg per day), tricyclic antidepressants (e.g., desipramine), lithium, and herbal preparations containing St. John’s wort (Hypericum perforatum),
• painkillers, such as opioid analgesics (e.g., tramadol and buprenorphine),
• medicines used for hypertension or heart failure, such as metoprolol, flecainide, propafenone,
• medicines that may increase citalopram blood levels: cimetidine, omeprazole, esomeprazole, lansoprazole (used in the treatment of peptic ulcer disease), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke),
• anticoagulant medicines,
• medicines affecting platelet function, such as dipyridamole,
• painkillers and anti-inflammatory medicines, such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (e.g., ibuprofen, diclofenac, or celecoxib),
• medicines that may increase the risk of bleeding, such as antipsychotics, phenothiazine derivatives, thioxanthenes, butyrophenones, bupropion, risperidone, thioridazine, and haloperidol,
• the antimalarial medicine – mefloquine.

Aurex 20 must NOT be used if the patient is taking medicines that regulate heart rhythm 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 medicines (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine), antimalarials (especially halofantrine), and certain antihistamines (astemizole, mizolastine).
If in doubt whether the patient is taking any of the listed medicines, consult a doctor or pharmacist.

Aurex 20 with food and drink
Aurex 20 can be taken at approximately the same time each day, regardless of meals. Alcohol consumption is not recommended during treatment with Aurex 20.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Aurex 20 should not be used during pregnancy unless the doctor considers it absolutely necessary.
Inform the doctor and/or midwife about the use of Aurex 20. Taking medicines such as Aurex 20 during pregnancy (especially during the last three months of pregnancy) may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis and usually occurs within the first 24 hours after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
Taking Aurex 20 towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Aurex 20, she should inform her doctor or midwife so appropriate advice can be provided.

Breastfeeding
The medicine may be used during breastfeeding only if, in the doctor’s opinion, the benefit of treatment for the mother outweighs the potential risk to the infant.

Fertility
Animal studies have shown that citalopram reduces semen quality.
This may theoretically affect fertility, although no effect on human fertility has been observed to date.

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

Aurex 20 contains monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the 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 Aurex 20

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The following products are available: Aurex 20 (20 mg), Aurex 40 (40 mg).
Aurex 20 should be taken as a single dose once daily.

Adults
Treatment of depression
The usual daily dose of citalopram is 20 mg taken once daily. If necessary, your doctor may increase the dose up to a maximum of 40 mg per day, depending on the severity of depressive symptoms and the patient's response to treatment.
The antidepressant effect is usually observed after 2 to 4 weeks of treatment. To prevent relapse, the medicine is usually continued for 6 months after symptoms have resolved.

Treatment of panic disorder
The initial dose is 10 mg daily for the first week, then increased to 20 mg daily. If needed, your doctor may increase the dose up to a maximum of 40 mg per day.
The onset of effect is usually observed after 2–4 weeks, and maximum efficacy is reached after approximately 3 months.

Elderly patients (over 65 years of age)
The recommended daily dose is 10–20 mg once daily. Your doctor may increase the dose up 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 20 should not be used in children and adolescents under 18 years of age.

Patients with impaired liver function
The initial dose is 10 mg per day, and the maximum daily dose should not exceed 20 mg.

Patients with impaired kidney function
In patients with mild or moderate renal impairment, dose adjustment is not required. In patients with severe renal impairment (creatinine clearance less than 20 ml/min), use of this medicine is not recommended.

If you feel the medicine is too strong or too weak, consult your doctor.

Taking more Aurex 20 than prescribed
If you take more Aurex 20 than prescribed, contact your doctor or pharmacist immediately.
Symptoms of overdose may include: seizures, rapid heartbeat, drowsiness, changes in electrocardiogram (ECG), coma, vomiting, tremor, low blood pressure, nausea, cardiac arrest, agitation, slow heartbeat, dizziness, high blood pressure, dilated pupils, cardiac dysfunction including arrhythmias, stupor, sweating, cyanosis, abnormally deep and intense breathing (hyperventilation). Rhabdomyolysis (breakdown of skeletal muscle) has been rarely reported.

Treatment
There is no specific antidote for citalopram. Symptomatic and supportive treatment should be administered. Consider administration of activated charcoal, an osmotic laxative (e.g. sodium sulfate), and gastric lavage. In case of impaired consciousness, intubation should be considered. ECG and vital function monitoring are recommended.

If you miss a dose of Aurex 20
Do not take a double dose to make up for a missed tablet.

Stopping treatment with Aurex 20
Suddenly stopping treatment after prolonged use may cause withdrawal symptoms in some patients, such as dizziness, tingling sensations, muscle tremors, anxiety, nausea, and palpitations. The decision to discontinue the medicine must always be made by your doctor. If discontinuation is indicated, your doctor will recommend gradually reducing the dose.

Withdrawal symptoms after stopping selective serotonin reuptake inhibitors (SSRIs)
After stopping the medicine, especially abruptly, withdrawal symptoms often occur.
The risk of such symptoms may depend on several factors, including duration of treatment, dose used, and speed of dose reduction.
Commonly reported symptoms include dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor, and headache. These symptoms are usually mild to moderate, but may be severe in some patients.
They usually occur within the first few days after discontinuation, although very rare cases have been reported in patients who inadvertently missed a dose.
These symptoms usually resolve spontaneously, typically within 2 weeks, although in some individuals they may persist longer (2–3 months or more). Therefore, Aurex 20 should be discontinued gradually over several weeks or months, depending on the patient's needs.

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

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
These are generally mild and transient, occurring mainly during the first or second week of treatment
and usually resolving during continued treatment.
Very common adverse effects (may occur in more than 1 in 10 people): sleep disturbances,
drowsiness, insomnia, headache, dry mouth, nausea, excessive sweating, fatigue.
Common adverse effects (may occur in less than 1 in 10 people): decreased appetite,
weight loss, restlessness, reduced sexual drive, anxiety, nervousness, confusion,
orgasmic disturbances (in women), unusual dreams, apathy, tremor, tingling, dizziness,
attention disturbances, migraine, memory loss, tinnitus, palpitations, yawning, nasal mucosal inflammation, diarrhoea, vomiting, constipation, indigestion, abdominal pain, bloating, excessive salivation, itching, muscle pain, joint pain, impotence, ejaculation disorders, feeling of tiredness.
Uncommon adverse 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 sexual drive, fainting, pupil dilation (may lead to acute glaucoma), increased heart rate, decreased heart rate, light sensitivity, urticaria, alopecia, rash, purpura, urinary retention, excessive bleeding (in women), oedema.
Rare adverse effects (may occur in less than 1 in 1,000 people): decreased sodium concentration in blood (hyponatraemia), seizures, uncoordinated, involuntary movements (dyskinesia), taste disturbances, bleeding, cough, hepatitis, fever, malaise.
Adverse effects with unknown frequency (frequency cannot be determined from available data): decreased platelet count (thrombocytopenia), hypersensitivity reactions, anaphylactic reaction, inappropriate antidiuretic hormone secretion, decreased potassium concentration in blood (hypokalaemia), panic attacks, teeth grinding, akathisia (motor restlessness), suicidal thoughts, suicidal behaviour*, seizures, serotonin syndrome (a serious condition caused by excessive serotonin in the brain, with symptoms such as headache, hallucinations, fever, muscle rigidity, sleep disturbances, cardiac arrhythmias, nausea, vomiting), extrapyramidal symptoms (muscle rigidity, reduced facial expression, slowed movements, involuntary muscle contractions and movements), akathisia (inability to sit or stand still), movement disorders, visual disturbances, ECG changes, postural hypotension, nosebleeds, gastrointestinal bleeding (including rectal haemorrhage), abnormal liver function test results, petechiae, angioedema, intermenstrual spotting, severe vaginal bleeding occurring shortly after childbirth [(postpartum haemorrhage), see additional information in subsection “Pregnancy, breastfeeding and fertility” in section 2], prolonged painful penile erection (priapism), galactorrhoea (in men).
* Cases of suicidal thoughts and suicidal behaviour have been reported during treatment with citalopram or shortly after discontinuation.
Studies have shown an increased risk of bone fractures in patients receiving medicines from the group of selective serotonin reuptake inhibitors and tricyclic antidepressants.
Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes experience thoughts of self-harm or suicide. Such symptoms or behaviour may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take about 2 weeks, and sometimes longer, to start working.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

• the patient has previously experienced suicidal thoughts or self-harm;
• the patient is a young adult: the risk of suicidal behaviour is increased in individuals under 25 years of age with psychiatric disorders who are being treated with antidepressant medicines. If a patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact a doctor or go to a hospital.

If during treatment the patient experiences rapid or irregular heartbeat and/or fainting, treatment with Aurex 20 should be discontinued and medical advice should be sought immediately. These may be symptoms of life-threatening arrhythmias of the torsade de pointes type (i.e. polymorphic ventricular tachycardia).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aurex 20

• Keep this medicine out of the sight and reach of children.
• No special storage instructions apply.
• Do not use Aurex 20 after the expiry date stated on the packaging. 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. This will help protect the environment.

6. Contents of the pack and other information

What Aurex 20 contains
The active substance is citalopram (in the form of citalopram hydrobromide). One tablet contains 20 mg of citalopram.
The other ingredients are: maize starch, lactose monohydrate, copovidone, glycerol 85%, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A).
Coating: hypromellose, polyethylene glycol 6000, titanium dioxide (E 171), talc.

What Aurex 20 looks like and contents of the pack
White, elongated, convex on both sides coated tablets with a dividing line on one side and engraved with the code "C 20".
The tablets can be divided into halves.
The medicine is available in blisters containing 20 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Netherlands, country of export:
Sandoz B.V.
Hospitaaldreef 29
1315 RC Almere
The Netherlands

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

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Dutch marketing authorisation number, country of export: RVG 26734
Parallel import authorisation number: 319/20