Aurex 40

Package leaflet: Information for the patient

AUREX 20, 20 mg, film-coated tablets
AUREX 40, 40 mg, film-coated tablets
Citalopram
Please read the entire leaflet carefully before using 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 any adverse reactions occur in the patient, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet:

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 — 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 episodes;
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 – drugs used
in the treatment of depression or Parkinson's disease) (see
"Aurex and other medicines");
Your doctor will advise you on how to start taking Aurex after stopping
an MAOI medicine.
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 and other medicines").

Warnings and precautions
Use of Aurex in children and adolescents under 18 years of age
Aurex must not be used in children and adolescents under 18 years of age. Due to
an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and expressions of anger). Nevertheless,
a doctor may prescribe Aurex to patients under 18 years of age if they determine it is in the patient's best interest. If your doctor has prescribed Aurex to a patient under 18 years of age and you have any doubts, please consult the prescribing doctor. If any of the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Aurex, inform the doctor immediately. Furthermore, there is currently no data available on the long-term safety of using 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 harming themselves (self-injury) or of suicide. These thoughts may increase at the beginning of treatment with an antidepressant, as some time must pass before the medicine starts working and mood improves. Patients with suicidal tendencies must not have access to large quantities of medication and, if necessary, should remain under constant supervision.
This is especially important for patients who previously experienced suicidal behavior or thoughts, patients under 25 years of age, and those who had severe suicidal ideation before starting therapy. If such thoughts occur, contact your doctor or go directly to the hospital immediately.
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 them to observe whether symptoms of depression or anxiety worsen or whether there are changes in the patient's behavior.

Akathisia
Taking medicines such as Aurex may cause akathisia (usually during the first weeks of treatment), characterized 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 symptoms (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 rhythm disorders),
• diabetes,
• seizures or epilepsy,
• glaucoma,
• previous bleeding episodes (such as petechiae, genital bleeding, gastrointestinal bleeding, or other skin or mucosal bleeding),
• history of blood clotting disorders, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility"),
• use of anticoagulant medicines (see section "Aurex 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.

Discontinue use of Aurex immediately and contact your doctor if any of the following symptoms occur:

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

Aurex and other medicines
Inform your doctor about all medicines currently taken, recently taken, or planned for use.
Citalopram and other concomitantly used medicines may interact and affect each other's actions and the occurrence of adverse effects. This especially concerns the following medicines:

• pimozide (a medicine used to treat certain psychiatric disorders)
• buspirone (an anxiolytic medicine)
• migraine treatments such as sumatriptan and other triptans,
• antidepressants such as other selective serotonin reuptake inhibitors, monoamine oxidase inhibitors (MAOIs), selegiline (at doses exceeding 10 mg daily), 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 stroke risk),
• anticoagulant medicines,
• medicines affecting platelet function, such as dipyridamole,
• pain and anti-inflammatory medicines such as acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, diclofenac, or celecoxib),
• medicines that may increase bleeding risk, 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 agents (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 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 is planning 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) 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 day after birth. If such symptoms occur in the newborn, contact your doctor and/or midwife immediately.

Taking Aurex near 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, she should inform her doctor or midwife so appropriate advice can be provided.

Breastfeeding
Aurex 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 effect on human fertility has been observed to date.

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

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

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Aurex is 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 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 must 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
No dose adjustment is 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 you should, contact your doctor or pharmacist immediately.
Symptoms of overdose 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 rapid breathing (hyperventilation). Rhabdomyolysis (breakdown of skeletal muscle) has been reported rarely.

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

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

Stopping Aurex
Stopping the medicine abruptly 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 must 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 size, and speed of dose reduction.
The most 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 appear 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 should be discontinued gradually over several weeks or months, depending on individual patient 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 sexual drive, anxiety, nervousness, confusion, orgasm disorders (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 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 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 determined from available data):
decreased platelet count (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 rigidity, sleep disturbances, cardiac disturbances, nausea, vomiting), extrapyramidal disorders (muscle stiffness, reduced facial expression, movement slowing, 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 section "Pregnancy, breastfeeding and fertility" in section 2], prolonged and painful penile erection (priapism), galactorrhoea (in men).

* Cases of suicidal thoughts and behaviours have been reported during citalopram treatment or shortly after discontinuation.

Studies have shown an increased risk of bone fractures in patients receiving selective serotonin reuptake inhibitors (SSRIs) 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 antidepressant treatment, 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 people under 25 years of age with psychiatric disorders who are being treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact a doctor immediately or go to a hospital.

If the patient experiences rapid or irregular heartbeat and/or fainting during treatment, they should stop taking Aurex and seek immediate medical advice. These may be symptoms of life-threatening arrhythmias such as torsade de pointes (i.e. polymorphic ventricular tachycardia).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Aurex

Keep the medicine out of the sight and reach of children.
Do not use the medicine Aurex after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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). One tablet contains 20 mg or 40 mg of citalopram.
The other ingredients are: maize starch, monohydrate lactose, copovidone, glycerol 85%, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch, hypromellose, macrogol 6000, titanium dioxide (E171), talc.

What Aurex looks like and contents of the pack
AUREX 20
White, elongated, biconvex film-coated tablets, with a score line on one side and the imprint "C 20".
The tablets can be divided into two equal parts.

AUREX 40
White, elongated, biconvex film-coated tablets, with a score line on one side and the imprint "C 40".
The tablets can be divided into two equal parts.

The medicine is available in blisters containing 20 film-coated tablets.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

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

For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
tel. 22 209 70 00