Citabax 20

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

• Keep this leaflet to be able to read it again if necessary.
• 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 someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

Citabax 20 belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs).
Citabax 20 contains citalopram as the active substance and is used in the treatment of depression and anxiety disorders with or without agoraphobia (fear of open spaces).

2. Information before using Citabax 20

When not to use Citabax 20

• if the patient is allergic to citalopram or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking medicines called monoamine oxidase inhibitors (MAO inhibitors) (including selegiline at doses greater than 10 mg per day) within 14 days after stopping irreversible MAO inhibitors (such medicines include, for example, tranylcypromine) and no sooner than one day after discontinuation of moclobemide (used in the treatment of depression) or selegiline (used in the treatment of Parkinson's disease). At least one week must pass after stopping treatment with Citabax 20 before any MAO inhibitor can be started. Serious, and sometimes fatal, reactions have been reported in patients treated with SSRIs (a group of medicines to which Citabax 20 also belongs) in combination with MAO inhibitors (including moclobemide, linezolid, or selegiline).
• if the patient is being treated with linezolid (an antibiotic), unless close monitoring and blood pressure surveillance by the treating physician is possible;
• if the patient has a congenital heart rhythm disorder or has experienced an episode of heart rhythm disturbances (visible on ECG – a test assessing heart function);
• if the patient is taking medicines used for heart rhythm disorders or medicines that may affect heart rhythm (see below: "Citabax 20 with other medicines").

Warnings and precautions
Before starting treatment with Citabax 20, discuss this with your doctor or pharmacist.
Below are situations in which Citabax 20 may be used only under specific conditions and with special caution. Please discuss these with your doctor. You should consult your doctor even if the warnings below refer to conditions that occurred in the past.
Do not use Citabax 20:

• in patients simultaneously treated with medicines containing serotonergic substances [e.g. tramadol, sumatriptan or other triptans, oxytryptamine or tryptophan (serotonin precursors)]. Concurrent use may lead to the so-called "serotonin syndrome". Symptoms of serotonin syndrome may include: high fever, agitation, confusion, tremor, and sudden muscle contractions. In such a case, consult a doctor immediately.

Use Citabax 20 with special caution in:

• patients with heart function disorders or who have recently had a myocardial infarction;
• patients with a slow resting heart rate and/or reduced electrolyte levels due to persistent severe diarrhoea, vomiting, or use of diuretics (water pills);
• patients with rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disturbances.

Liver or kidney function disorders
Inform your doctor if you have liver or kidney function disorders. Your doctor may then adjust the dose (see section 3 "How to use Citabax 20").
Seizures
In patients with epilepsy, treatment with Citabax 20 should be discontinued if seizures occur or their frequency increases (see also section 4 "Possible side effects").
Diabetes
As with other selective serotonin reuptake inhibitors, citalopram may also affect blood glucose control in diabetic patients. Adjustment of insulin or oral glucose-lowering medication doses may be necessary.
Hyponatraemia
Rare cases of hyponatraemia (low blood sodium levels), probably due to inadequate antidiuretic hormone secretion (SIADH), have been reported during citalopram treatment. This condition is usually reversible after discontinuation of treatment. Most cases occurred in elderly patients, patients taking diuretics, or patients with fluid deficiency due to other factors. Symptoms may include general malaise with muscle weakness and confusion.
Bipolar affective disorder
In patients with bipolar affective disorder, a manic phase may occur. This is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult your doctor to discontinue Citabax 20.
Important information about the illness
As with other medicines used in the treatment of depression or associated disorders, improvement does not occur immediately. The patient may notice improvement only after several weeks of treatment with Citabax 20. In the treatment of anxiety disorders, it usually takes 2 to 4 weeks to observe improvement.
In the initial phase of treatment, some patients may experience increased anxiety, which resolves spontaneously after 14 days of treatment. To reduce these symptoms, it is recommended to use an initial dose of 10 mg citalopram during the first week of treatment (see section 3 "How to use Citabax 20").
It is very important to strictly follow your doctor's instructions and not to stop treatment or change the dose without consulting your doctor.
If the patient has psychosis with depressive episodes, treatment with Citabax 20 may worsen psychotic symptoms (e.g. hallucinations or delusions).
Sexual dysfunction
Medicines such as Citabax 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.
Bleeding
Prolonged bleeding time and/or bleeding events [e.g. large, extensive skin bleeding (purpura), gynaecological bleeding, gastrointestinal bleeding, and other bleeding in the skin or mucous membranes] have rarely occurred with the use of medicines such as Citabax 20. If the patient is pregnant, see section "Pregnancy, breastfeeding and fertility". Caution is advised in patients with a history of bleeding disorders and when using other medicines that may increase the risk of bleeding (see also section "Citabax 20 with other medicines").
Electroconvulsive therapy (ECT)
Caution is advised when using Citabax 20 together with electroconvulsive therapy, as clinical experience is currently limited.
Vision disorders
Inform your doctor if the patient has vision problems, such as certain types of glaucoma (increased intraocular pressure). In such cases, Citabax 20 should be used with caution.
Akathisia/psychomotor restlessness
Use of Citabax 20 may lead to akathisia, characterised by an unpleasant feeling of inner restlessness and a need to move, often accompanied by an inability to sit or stand still. This is most likely to occur in the first few weeks of treatment. Increasing the dose may be harmful in patients experiencing these symptoms.
Withdrawal reactions after stopping treatment with a serotonin reuptake inhibitor
Withdrawal reactions often occur after stopping treatment, especially if treatment is stopped abruptly (see section 4 "Possible side effects"). The risk of withdrawal symptoms may depend on various factors, including duration of treatment, dose, and speed of dose reduction. Usually, these symptoms are mild to moderate, but in some patients they may be severe. They typically occur within the first few days after stopping treatment. Generally, symptoms resolve spontaneously within 2 weeks. In some patients, they may persist longer (2–3 months or more). When discontinuing treatment with Citabax 20, gradual dose reduction over several weeks or months, depending on the patient's needs, is recommended (see section 3 "How to use Citabax 20").
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and/or anxiety disorders may sometimes experience thoughts of self-harm or suicidal ideation. These may worsen after starting antidepressant treatment, as these medicines take time to work – usually about two weeks or longer.
Increased risk of such thoughts may occur:

• in patients who previously experienced suicidal thoughts or self-harm;
• in young adults. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were taking antidepressants.

If the patient experiences any thoughts of self-harm or suicide, contact a doctor immediately or go to hospital.
Informing family members or friends about the depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask them to inform him/her if they notice worsening depression or anxiety, or concerning changes in behaviour.
Children and adolescents under 18 years of age
Citabax 20 should not be used in children and adolescents under 18 years of age. When taking medicines from this group, patients under 18 years of age are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (especially aggression, defiant behaviour, and anger). Nevertheless, a doctor may prescribe Citabax 20 to patients under 18 years of age if he/she determines it to be in their best interest. If a doctor has prescribed Citabax 20 to a patient under 18 years of age, contact the doctor in case of any doubts. In case of development or worsening of the above-mentioned symptoms in patients under 18 years of age taking Citabax 20, inform the doctor. Furthermore, there are currently no data on the long-term safety of Citabax 20 in this age group regarding growth, maturation, and cognitive and behavioural development.
Elderly patients (over 65 years of age)
Elderly patients are more sensitive to the effects of antidepressants; therefore, the dose of Citabax 20 will be adjusted by the doctor. If any adverse reactions occur, inform the doctor.
Citabax 20 with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for use. The use of other medicines during treatment with Citabax 20 should be discussed with your doctor. Medicines may affect each other's actions, which may sometimes lead to serious adverse reactions.
Do not use Citabax 20:

• if the patient is taking medicines called monoamine oxidase inhibitors (MAO inhibitors) (including selegiline at doses greater than 10 mg per day), as this combination may lead to serious adverse reactions (serotonin syndrome). An appropriate interval must be observed when switching between these medicines. This change may only occur under the supervision of the treating physician. Citabax 20 must not be taken earlier than two weeks after stopping irreversible MAO inhibitors (e.g. tranylcypromine) or earlier than one day after stopping moclobemide (used in depression treatment) or selegiline (used in Parkinson's disease treatment). MAO inhibitor treatment must not be started earlier than one week after stopping Citabax 20. Severe, and sometimes fatal, reactions have occurred in patients taking SSRIs together with MAO inhibitors (including moclobemide, linezolid, or selegiline);
• if the patient is taking the antibiotic linezolid;
• if the patient is taking medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as antiarrhythmic drugs of class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial drugs, especially halofantrine), certain antihistamines (astemizole, mizolastine, and others). In case of further questions, contact your doctor;
• simultaneously with sumatriptan and similar medicines (used in migraine treatment) or tramadol and similar medicines (opioids used for severe pain), tryptophan, or oxytryptamine (serotonin neurotransmitter precursors), as this may lead to increased serotonergic effects. Isolated cases of "serotonin syndrome" (see section 4 "Possible side effects") have also been reported with citalopram used together with moclobemide or buspirone.

Use caution when using Citabax 20 together with:

• medicines containing cimetidine, lansoprazole, and omeprazole (medicines used in peptic ulcer disease), fluconazole (used in fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of myocardial infarction). These medicines may increase citalopram blood levels. Dose adjustment may be necessary;
• flecainide or propafenone (medicines used in heart disease), desipramine, clomipramine, and nortriptyline (medicines used in depression treatment), or risperidone, thioridazine, and haloperidol (medicines used in schizophrenia and psychosis treatment). Dose adjustment may be necessary;
• metoprolol (a beta-blocker used in hypertension and certain heart conditions). Concurrent use leads to increased metoprolol blood levels. Dose adjustment may be necessary;
• lithium (used in prevention and treatment of manic-depressive disorders), very rare interactions have been reported;
• medicines with known effects on platelet function or other medicines affecting bleeding risk (see section 2 "Warnings and precautions"). These include non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamole, antipsychotics, and ticlopidine;
• medicines that lower potassium or magnesium levels in blood, as these conditions increase the risk of life-threatening heart rhythm disturbances;
• medicines containing imipramine and desipramine (used in depression treatment). Dose adjustment of desipramine may be necessary;
• medicines that may lower the seizure threshold, e.g. mefloquine (an antimalarial), bupropion (used in depression treatment), tramadol (a strong painkiller), neuroleptics (used in schizophrenia or psychosis treatment), and antidepressants (SSRIs). Citabax 20 may also lower the seizure threshold;
• clozapine (used in psychosis treatment), which may increase the risk of adverse reactions associated with clozapine use. The nature of these interactions is not fully understood.

Concomitant use of citalopram and products containing St. John's wort (herbal medicines used in depression treatment) should be avoided due to increased risk of adverse reactions.
Citabax 20 with food, drink, and alcohol
Citabax 20 may be taken independently of meals (see section 3 "How to use Citabax 20").
As with all SSRIs (selective serotonin reuptake inhibitors), alcohol consumption should be avoided during treatment with Citabax 20. However, no interaction between citalopram and alcohol has been demonstrated.
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
Experience with citalopram use during pregnancy is limited. Pregnant women or women planning pregnancy should not use Citabax 20 unless the doctor considers it absolutely necessary.
Do not abruptly stop treatment with citalopram. Taking medicines such as Citabax 20 during pregnancy, especially during the last three months, may increase the risk of severe complications in the newborn. Symptoms usually appear within the first day after birth.
Women who have taken Citabax 20 during the last three months of pregnancy until delivery should be aware that the newborn may experience the following symptoms: seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, drowsiness, constant crying, sleepiness, or difficulty sleeping. If any of these symptoms occur in the newborn, contact a doctor immediately.
Taking medicines such as Citabax 20 during pregnancy, especially during the last three months, may increase the risk of severe complications in the newborn called persistent pulmonary hypertension of the newborn (PPHN). It is characterised by rapid breathing and cyanosis (bluish skin). Symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
Taking Citabax 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 Citabax 20, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
Before using any medicine, consult your doctor or pharmacist.
If the patient is breastfeeding, she should consult her doctor, who will carefully consider whether the benefits of breastfeeding outweigh the possible adverse effects in the child. Small amounts of Citabax 20 may pass into breast milk.
Effect on fertility
Animal studies have shown that citalopram may impair semen quality. This effect may theoretically affect fertility, although reduced fertility has not been observed in humans so far.
Driving and operating machinery
Even when used as intended, this medicinal product may affect reaction ability, impairing the ability to actively participate in road traffic or operate machinery. Do not work without proper safety precautions.
Citabax 20 contains lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, he/she should consult a doctor before starting treatment with this medicine.
Citabax 20 contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Citabax 20

What dose should be used
Citabax 20 should always be used as directed by the physician. In case of doubt, consult your doctor or pharmacist.
Citabax is available in the following doses:
Citabax 10 – 10 mg, Citabax 20 – 20 mg, Citabax 40 – 40 mg.

Adults
Treatment of depression
The usual dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg daily.

Treatment of panic disorder with or without agoraphobia
The initial dose is 10 mg of citalopram daily for the first week. This is then increased to 20 mg daily. Your doctor may increase the dose up to a maximum of 40 mg daily.

Use of Citabax 20 in elderly patients (over 65 years)
The initial dose should be reduced by half of the recommended dose, e.g. 10–20 mg daily. Elderly patients should generally not take more than 20 mg daily.

Use of Citabax 20 in special patient groups
In patients with impaired liver function, elimination of Citabax 20 may be slower. In mild to moderate liver impairment, an initial dose of 10 mg of citalopram daily is recommended for the first two weeks of treatment. Patients with liver impairment should not take more than 20 mg of citalopram daily.
Caution is advised in patients with severe liver impairment, and dose increases should be made with particular care.

Dose adjustment is not necessary in patients with mild or moderate renal impairment. Citalopram is not recommended in patients with severe renal impairment (creatinine clearance below 30 ml/min), as there is no clinical experience in this group.

Use of Citabax 20 in children and adolescents (under 18 years)
Citabax 20 should not be used in children and adolescents. Additional information is also provided in section 2, "Important information before using Citabax 20".

Method of administration
Citabax 20 should be taken daily as a single dose.
Citabax 20 can be taken at any time of day, with or without food.
The tablet should be swallowed whole with water. Do not chew (tablets have a bitter taste).

Duration of treatment
As with other antidepressants, the antidepressant effect is usually seen after 2 to 4 weeks of treatment. Therefore, continue taking Citabax 20 even if you do not feel improvement initially.

In the treatment of panic disorders with or without agoraphobia, the maximum effect is achieved after approximately three months of treatment.

The duration of treatment varies between individual patients. Therapy usually lasts at least 6 months.

Treatment should be continued as long as your doctor recommends, even if your condition improves. The illness may persist for a long time, and if treatment is stopped too early, symptoms may return.

Withdrawal reactions after stopping Citabax 20 are described below in the section "Stopping Citabax 20".

Taking more than the recommended dose of Citabax 20
If you suspect that a patient or anyone else has taken an overdose of Citabax 20 tablets, seek immediate medical attention at the nearest hospital emergency department, even if there are no symptoms of poisoning. Bring the Citabax 20 packaging with you.

Symptoms of overdose may include irregular heartbeat, seizures, changes in heart rhythm, nausea, vomiting, sweating, drowsiness, loss of consciousness, rapid heartbeat, tremors, changes in blood pressure, serotonin syndrome (see section 4), agitation, dizziness, dilated pupils, cyanosis (bluish skin), rapid breathing, hyperventilation, changes in ECG, cardiac arrest, and rhabdomyolysis (muscle breakdown).

Missed dose of Citabax 20
If a patient forgets to take a dose, they should take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Citabax 20
If a patient wishes to stop treatment, they should discuss this with their doctor first. The doctor will take appropriate steps if necessary. Do not stop taking the medication without consulting your doctor.

Withdrawal reactions after stopping Citabax 20:
Abrupt discontinuation of treatment should be avoided. When stopping treatment with Citabax 20, the dose should be gradually reduced over a period of at least one to two weeks to reduce the risk of withdrawal reactions.

If severe withdrawal symptoms occur after dose reduction or discontinuation, consider resuming the previous dose and then tapering the dose in smaller steps according to the doctor's instructions.

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.
Adverse effects usually resolve after a few weeks of treatment. It should be remembered that
some of these effects may also be symptoms of the underlying illness and will subside as the patient's condition improves.

Serious adverse effects
If any of the following symptoms occur, stop taking Citabax 20 immediately and contact your doctor:

• thoughts of self-harm and suicidal thoughts;
• high fever, agitation, confusion, tremors, or sudden muscle contractions. These symptoms may indicate a rare condition called serotonin syndrome, reported when antidepressant medicines are used concomitantly;
• swelling of the face, lips, tongue, or throat causing difficulty in swallowing or breathing (allergic reaction);
• unusual bleeding, including gastrointestinal bleeding;
• rapid or irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders (known as torsade de pointes);
• malaise with muscle weakness and disorientation or difficulty urinating are symptoms of hyponatraemia (low sodium levels in the blood), which may rarely occur during treatment with SSRIs (a group of antidepressants to which Citabax 20 belongs), particularly in elderly patients, patients taking diuretics, or patients with fluid deficiency due to other factors;
• seizures (see section “Warnings and precautions”);
• yellowing of the skin or whites of the eyes, indicating liver dysfunction/hepatitis.

Other possible adverse effects (serious adverse effects are listed above):
Very common adverse effects (occurring in more than 1 in 10 patients):

• drowsiness;
• difficulty sleeping;
• tremor;
• nausea, constipation;
• excessive sweating, dry mouth, fatigue;
• headache.

Common adverse effects (may affect up to 1 in 10 patients):

• nervousness, anxiety, agitation, unusual dreams, apathy, decreased appetite, weight loss, difficulty concentrating;
• dizziness, attention disturbances, tingling or numbness in hands or feet (paraesthesiae), disturbances in motor coordination and muscle tone (extrapyramidal symptoms);
• diarrhoea, vomiting, abdominal pain, indigestion, flatulence;
• sexual dysfunction, such as ejaculation disorders, absence of ejaculation, impotence, decreased libido; in women – delayed orgasm;
• taste disturbances, visual disturbances, tinnitus (ringing in the ears);
• skin rash, itching;
• muscle and joint pain;
• fever;
• urinary disturbances;
• low blood pressure upon sudden change from lying to standing position (orthostatic hypotension), sensation of irregular heartbeat (palpitations), rapid heartbeat;
• increased salivation, yawning; general malaise, feeling of fatigue.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• allergic reaction, urticaria;
• increased appetite, weight gain;
• euphoria, aggression, depersonalisation (loss of sense of self), hallucinations, mania;
• seizures;
• cough, dyspnoea;
• photosensitivity;
• abnormal liver function test results;
• slow heartbeat;
• fainting;
• hair loss;
• dilated pupils;
• heavy menstrual bleeding;
• skin redness or skin spots (purpura);
• swelling of hands or feet.

Rare adverse effects (may affect up to 1 in 1000 patients):

• decreased sodium levels in the blood (with symptoms such as fatigue, muscle weakness, disorientation, or difficulty urinating);
• increased urination (due to inappropriate antidiuretic hormone secretion);
• serotonin syndrome (possible symptoms include high fever, agitation, confusion, tremor, and sudden muscle twitching);
• generalized tonic-clonic seizures (grand mal seizures);
• hepatitis;
• psychomotor agitation/akathisia (inability to sit still) (see section “Warnings and precautions”);
• involuntary movements (dyskinesia);
• haemorrhages, bleeding under the skin or mucous membranes (petechiae).

Frequency not known (frequency cannot be estimated from available data):

• QT interval prolongation on ECG (a change in the electrical conduction pattern of the heart);
• rapid, irregular heartbeat, fainting. These may be symptoms of a life-threatening cardiac arrhythmia called Torsade de Pointes;
• increased prolactin levels;
• increased incidence of bleeding and bruising due to reduced platelet count;
• decreased potassium levels in the blood (which may cause muscle weakness, tremor, and arrhythmia);
• pancreatitis;
• panic attacks;
• bruxism (teeth grinding);
• feeling of restlessness;
• milk secretion in men and in women who are not breastfeeding;
• visual disturbances;
• irregular menstruation in women, severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); see additional information in subsection “Pregnancy, breastfeeding and fertility” in section 2;
• painful penile erection in men;
• sudden swelling of the skin or mucous membranes;
• nosebleeds;
• gastrointestinal bleeding (including rectal bleeding);
• anaphylactic reaction;
• movement disorders.

Cases of suicidal thoughts and behaviour have been reported during treatment with Citabax 20 or
shortly after discontinuation (see section “Warnings and precautions”).
Since the medicine has been marketed, cases of QT interval prolongation have been reported,
mainly in patients with pre-existing heart disease.
An increased risk of bone fractures has been observed in patients treated with this group of medicines.

Withdrawal reactions after stopping treatment with Citabax 20:
Withdrawal reactions commonly occur when treatment is stopped. The most frequently reported symptoms include dizziness, sensory disturbances (including paraesthesiae), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and/or vomiting, tremor, disorientation, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances. These symptoms are usually mild to moderate in intensity and resolve spontaneously, but in some patients they may be severe and persist for a prolonged period. Therefore, it is recommended to gradually reduce the dose when treatment is no longer necessary (see section 2 “Important information before using Citabax 20” and section 3 “How to take Citabax 20”).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring of 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 Citabax 20

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
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 Citabax 20 contains

• The active substance is citalopram (in the form of citalopram hydrobromide). One coated tablet of Citabax 20 contains 20 mg of citalopram (as citalopram hydrobromide).
• Excipients:
  o Core ingredients: monohydrate lactose, microcrystalline cellulose, maize starch, copovidone, sodium croscarmellose, magnesium stearate.
  o Coating (Opadry white 20H 58983): hypromellose, titanium dioxide (E 171), propylene glycol, hydroxypropylcellulose (E 463), talc.

What Citabax 20 looks like and contents of the pack
White or almost white, round, biconvex tablets. On one side there is an embossed mark "20", and a division line on the other side.
Citabax 20 is available in packs of 30 or 60 coated tablets.
For further detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Germany, country of export:
Basics GmbH
Hemmelrather Weg 201
51377 Leverkusen
Germany
Manufacturer:
Terapia S.A.
124 Fabricii Street
Cluj-Napoca 400 632
Romania
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Number of marketing authorisation in Germany, country of export: 60782.01.00
Number of parallel import authorisation: 66/26