Aurex 20

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the outer packaging in a foreign language!
Aurex 20 (Citalopram Sandoz 20 mg)
20 mg, film-coated tablets
Citalopramum
Aurex 20 and Citalopram Sandoz 20 mg are different trade names for the same medicine.
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

Aurex 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 certain substances that transmit signals in the brain (including serotonin). Citalopram helps restore normal serotonin levels in the brain.

Aurex 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

When not to use 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 or has taken within the last 2 weeks a medicine from the group of monoamine oxidase inhibitors (so-called MAOIs – medicines used in the treatment of depression or Parkinson's disease) (see "Aurex with other medicines"); Your doctor will advise you how to start taking Aurex after stopping treatment with an MAOI;
• 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 in a heart function test – ECG);
• if the patient is taking medicines that regulate heart rhythm or medicines that may affect heart rhythm (see below "Aurex with other medicines").

Warnings and precautions
Use of Aurex in children and adolescents under 18 years of age
Aurex should not be used in children and adolescents under 18 years of age. Due to an increased risk of adverse effects such as suicidal behaviour, suicidal thoughts and hostility (particularly aggression, oppositional behaviours and anger). However, your doctor may prescribe Aurex to patients under 18 years of age if they consider it to be in the patient's best interest. If your doctor has prescribed Aurex for a patient under 18 years of age and you have any concerns, please consult your doctor. If any of the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Aurex, inform your doctor immediately. Furthermore, there is currently no long-term safety data on the use of Aurex in this age group regarding growth, puberty, cognitive development and behavioural development.

Thoughts of self-harm or suicide
People suffering from depression or anxiety disorders may sometimes have thoughts of harming themselves (self-harm) or of suicide. Such thoughts may increase at the beginning of treatment with an antidepressant, as it may take some time before the medicine starts to work and the patient's well-being improves. Patients with suicidal tendencies must not have access to large quantities of medicines and, if necessary, should remain under constant supervision.
This is particularly true for patients who have previously experienced suicidal behaviour or thoughts, patients under 25 years of age, and those who had significant suicidal ideation before starting treatment. If such thoughts occur, contact your doctor or go directly to hospital.
It may sometimes be helpful to inform a friend or relative about your depression or anxiety disorder and ask them to read this leaflet. You may also ask them to watch out for worsening depression or anxiety or changes in your behaviour.

Akathisia
Medicines such as Aurex may cause akathisia (usually during the first weeks of treatment), characterised by a sense of inner restlessness, often with an inability to sit or stand still.
Medicines such as Aurex (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Before starting treatment with Aurex, inform your doctor about 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 within the skin or mucous membranes),
• history of coagulation disorders, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility"),
• use of anticoagulant medicines (see section "Aurex with other medicines"),
• electroconvulsive therapy,
• low serum sodium levels (e.g. due to prolonged, severe diarrhoea, vomiting or use of diuretics),
• low serum magnesium levels.

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

• physical agitation,
• confusion,
• muscle tremors,
• brief, involuntary muscle contractions (myoclonic jerks),
• high fever. These may be symptoms of serotonin syndrome.

Aurex with other medicines
You must 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 simultaneously 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 to treat certain psychiatric disorders),
• buspirone (an anti-anxiety medicine),
• anti-migraine medicines such as sumatriptan and other triptans,
• antidepressants such as other selective serotonin reuptake inhibitors, monoamine oxidase inhibitors (MAOIs), selegiline (in doses exceeding 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 so-called 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 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 you are unsure whether the patient is taking any of the medicines listed above, consult your doctor or pharmacist.

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

Pregnancy, breastfeeding and 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.

Pregnancy
Aurex should not be used during pregnancy unless the doctor considers it absolutely necessary.
Inform your doctor and/or midwife about taking Aurex. Taking medicines such as Aurex 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 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 Aurex towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of coagulation disorders. If the patient is taking Aurex, she should inform her doctor or midwife so that appropriate advice can be provided.

Breastfeeding
The medicine may be used during breastfeeding only if, in the doctor's opinion, the benefit to 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 effects on human fertility have been observed to date.

Driving and operating machinery
Aurex 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 contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their 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

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Aurex should be taken as a single dose once daily.

Adults
Treatment of depression
The usual daily dose of citalopram is 20 mg 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 of the medicine is usually observed after 2 to 4 weeks of treatment. To prevent relapse, the medicine is usually continued for 6 months after symptoms of depression have resolved.

Treatment of panic disorder
The initial dose is 10 mg per day for the first week, then increased to 20 mg per day. 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 achieved 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 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
Dose adjustment is not necessary in patients with mild or moderate renal impairment.
Aurex is not recommended in patients with severe renal impairment (creatinine clearance less than 20 ml/min).

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

Taking more Aurex than prescribed
If you take more Aurex 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, slowed heart rate, dizziness, high blood pressure, dilated pupils, cardiac dysfunction including arrhythmias, stupor, sweating, cyanosis, abnormally deep and intense breathing (hyperventilation). Cases of rhabdomyolysis (breakdown of striated muscle) have been reported rarely.

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

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

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

Withdrawal symptoms observed 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 paresthesias), 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 stopping the medicine, 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 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 all medicines, this medicine can cause adverse effects, although not everyone will experience them.
They are usually mild and temporary, occurring mainly during the first or second week of treatment and typically 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 libido, anxiety, nervousness, confusion, orgasmic disturbances (in women), unusual dreams, apathy, tremor, tingling, dizziness, attention disturbances, migraine, memory loss, tinnitus, palpitations, yawning, nasal 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 libido, fainting, dilated pupils (may lead to acute glaucoma), increased heart rate, slowed heart rate, photophobia, urticaria, alopecia, rash, purpura, urinary retention, abnormal uterine bleeding (in women), oedema.
Rare adverse effects (may occur in less than 1 in 1000 people): decreased sodium concentration in blood (hyponatraemia), seizures, uncoordinated involuntary movements (dyskinesias), taste disturbances, bleeding, cough, hepatitis, fever, malaise.
Adverse effects with unknown frequency (frequency cannot be estimated from available data): decreased number of blood platelets (thrombocytopenia), hypersensitivity reactions, anaphylactic reaction, inappropriate antidiuretic hormone secretion, decreased potassium concentration in blood (hypokalaemia), panic attacks, bruxism, 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 stiffness, sleep disturbances, cardiac disturbances, nausea, vomiting), extrapyramidal disorders (muscle rigidity, reduced facial expression, movement slowness, involuntary muscle contractions and movements), akathisia (inability to sit or stand still), movement disorders, visual disturbances, changes in ECG recording, 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 section “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 selective serotonin reuptake inhibitors and tricyclic antidepressants.
Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, 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 the patient experiences suicidal thoughts or thoughts of self-harm, immediate contact with a doctor or hospital admission is required.

If during treatment the patient experiences rapid or irregular heartbeat and/or fainting, treatment with Aurex should be discontinued immediately and medical advice should be sought without delay. These may be symptoms of life-threatening cardiac 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 or pharmacist. 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 allows the collection of further information on the safety of the medicine.

5. How to store Aurex

• Keep this medicine out of sight and reach of children.
• No special storage instructions apply.
• Do not use Aurex after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• Medicines must 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 contains
The active substance is citalopram (in the form of citalopram hydrobromide). Each 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, macrogol 6000, titanium dioxide (E 171), talc.

What Aurex looks like and contents of the pack
White, elongated, convex on both sides coated tablets with a division line on one side and engraved with the code C 20.
The tablets can be divided into two equal parts.
The medicine is available in PVDC/PVC/Aluminium blisters containing 20 coated tablets, packed in a cardboard box.

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
PL-02-672 Warsaw
Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in the Netherlands, country of export: RVG 26734
Parallel Import Licence number: 132/21