Package leaflet: Information for the user

Citabax 10, 10 mg, film-coated tablets
Citabax 20, 20 mg, film-coated tablets
Citabax 40, 40 mg, film-coated tablets
Citalopram
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

What Citabax is and what it is used for
What you need to know before taking Citabax
How to take Citabax
Possible side effects
How to store Citabax
Contents of the pack and other information

1. What Citabax is and what it is used for

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

2. Important information before using Citabax

When not to use Citabax

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) within 14 days after stopping irreversible MAO inhibitors (such as tranylcypromine), or less than one day after stopping moclobemide (used to treat depression) or selegiline (used to treat Parkinson's disease). At least one week must pass after stopping Citabax before starting any MAO inhibitor. Serious, and sometimes fatal, reactions have been reported in patients treated with SSRIs (the group of medicines to which Citabax 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 control by the treating physician is possible.
if the patient has congenital heart rhythm disorders 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 with other medicines").

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

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 so-called "serotonin syndrome". Symptoms of serotonin syndrome include: high fever, agitation, confusion, tremors, and sudden muscle spasms. In such cases, consult a doctor immediately.

Exercise particular caution when using Citabax:

in patients with heart function disorders or who recently suffered a heart attack.
in patients with slow resting heart rate and/or reduced electrolyte levels due to prolonged severe diarrhoea, vomiting, or diuretic use (water pills).
in 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").
Seizures
In patients with epilepsy, treatment with Citabax should be discontinued if seizures occur or their frequency increases (see also section 4 "Possible side effects").
Diabetes
As with other serotonin reuptake inhibitors, citalopram may also affect blood glucose control in diabetic patients. Adjustment of insulin or oral antidiabetic drug 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 upon discontinuation of treatment. Most reports involved elderly patients, patients taking diuretics, or patients with fluid deficiency due to other factors. Symptoms may include 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, contact your doctor to discontinue Citabax.
Important information about the illness
As with other medicines used to treat depression or related disorders, improvement does not occur immediately. Patients may notice improvement only after several weeks of treatment with Citabax. In treating anxiety disorders, it usually takes 2 to 4 weeks to observe improvement.
In the initial treatment period, anxiety may worsen in some patients, but usually resolves spontaneously after 14 days of treatment. To reduce these symptoms, a starting dose of 10 mg citalopram in the first week of treatment is recommended (see section 3 "How to use Citabax").
It is very important to strictly follow your doctor's instructions and not discontinue treatment or change the dose without consulting your doctor.
If the patient has psychosis with depressive episodes, treatment with Citabax may worsen psychotic symptoms (e.g. hallucinations or delusions).
Sexual dysfunction
Medicines such as Citabax (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 affecting skin or mucous membranes] have rarely occurred with medicines such as Citabax. 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 bleeding risk (see also section "Citabax with other medicines").
Electroconvulsive therapy (ECT)
Caution is advised when using Citabax 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 should be used cautiously.
Akathisia / psychomotor agitation
Use of Citabax may lead to akathisia, characterised by an unpleasant sense of inner restlessness and a need to move, often accompanied by inability to sit or stand still. This is most likely during the first weeks of treatment. Increasing the dose may be harmful in patients experiencing these symptoms.
Withdrawal reactions after stopping serotonin reuptake inhibitors
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 treatment duration, dose, and speed of dose reduction. Generally, these symptoms are mild to moderate, but may be severe in some patients. They usually appear within the first few days after stopping treatment and resolve spontaneously within 2 weeks. In some patients, they may persist longer (2–3 months or more). When discontinuing Citabax, gradual dose reduction over several weeks or months, depending on patient needs, is recommended (see section 3 "How to use Citabax").
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 thoughts. These may worsen after starting antidepressant treatment, as these medicines take time to work – usually after two weeks or longer.
Increased tendency for such thoughts may occur:

in patients who previously had suicidal or self-harming thoughts,
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.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. 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 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 effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger). Nevertheless, a doctor may prescribe Citabax to patients under 18 years of age if he/she considers it to be in their best interest. If a doctor has prescribed Citabax to a patient under 18 years of age, contact the doctor in case of any doubts. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Citabax, inform the doctor.
Furthermore, there are currently no data on the long-term safety of Citabax in this age group regarding growth, puberty, cognitive development, 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 will be adjusted by the doctor. If any adverse effects occur, inform the doctor.
Citabax with other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
During treatment with Citabax, the use of other medicines should be discussed with a doctor.
Medicines may affect each other's actions, which may sometimes lead to serious adverse effects.
Do not use Citabax:

if the patient is taking monoamine oxidase inhibitors (MAO inhibitors) (including selegiline at doses above 10 mg per day), as this combination may lead to serious adverse effects (serotonin syndrome). An appropriate time interval must be observed when switching between these medicines. This change may only occur under the supervision of the treating doctor. Citabax must not be taken earlier than two weeks after stopping irreversible MAO inhibitors (e.g. tranylcypromine) or earlier than one day after stopping moclobemide (for depression) or selegiline (for Parkinson's disease). MAO inhibitors must not be started earlier than one week after stopping Citabax. 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 antiarrhythmics of class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (astemizole, mizolastine, and others). In case of further questions, contact your doctor.
simultaneously with sumatriptan and similar medicines (used to treat migraine) or tramadol and similar medicines (opioids used to treat severe pain), tryptophan, or oxytryptamine (serotonin neurotransmitter precursors), as this may lead to enhanced serotonergic effects. Cases of "serotonin syndrome" (see section 4 "Possible side effects") have also been reported with citalopram used together with moclobemide or buspirone.

Exercise caution when using Citabax together with:

medicines containing cimetidine, lanzoprazole, and omeprazole (medicines used to treat peptic ulcer disease), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of heart attack). These medicines may increase citalopram blood levels. Dose adjustment may be necessary.
flecainide or propafenone (medicines used to treat heart disease), desipramine, clomipramine, and nortriptyline (medicines used to treat depression), or risperidone, thioridazine, and haloperidol (medicines used to treat schizophrenia and psychosis). Dose adjustment may be necessary.
metoprolol (a beta-blocker used to treat hypertension and certain heart conditions). Concurrent use leads to increased metoprolol blood levels. Dose adjustment may be necessary.
lithium (used to prevent and treat manic-depressive disorders), very rare interactions have been reported.
medicines known to affect 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 blood levels, as these conditions increase the risk of life-threatening heart rhythm disturbances.
medicines containing imipramine and desipramine (used to treat depression). Dose adjustment of desipramine may be necessary.
medicines that may lower the seizure threshold, e.g. mefloquine (an antimalarial), bupropion (used to treat depression), tramadol (a strong painkiller), neuroleptics (medicines used to treat schizophrenia or psychosis), and antidepressants (SSRIs). Citabax may also lower the seizure threshold.
clozapine (used to treat psychosis), which may increase the risk of adverse effects associated with clozapine use. The nature of these interactions is not fully understood.

Concurrent use of citalopram and products containing St. John's wort (herbal medicines used to treat depression) should be avoided due to increased risk of adverse effects.
Citabax with food, drink and alcohol
Citabax can be taken independently of meals (see section 3 "How to use Citabax").
As with all SSRIs, alcohol should be avoided during treatment with Citabax. 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 is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Experience with citalopram use during pregnancy is limited. Pregnant women or those planning pregnancy should not use Citabax unless the doctor considers it absolutely necessary.
Do not abruptly stop citalopram treatment. Taking medicines such as Citabax during pregnancy, especially during the last three months of pregnancy, may increase the risk of serious complications in the newborn. These symptoms usually appear within the first 24 hours after birth.
Women taking Citabax during the last three months of pregnancy up to 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 during pregnancy, especially during the last three months of pregnancy, may increase the risk of serious complications in the newborn called persistent pulmonary hypertension of the newborn (PPHN). It is characterised by rapid breathing and cyanosis. These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact a doctor and/or midwife immediately.
Taking Citabax 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, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
Before using any medicine, consult a doctor or pharmacist.
If the patient is breastfeeding, she should consult her doctor, who will carefully assess whether the benefits of breastfeeding outweigh the possible adverse effects in the child. Small amounts of Citabax may pass into breast milk.
Effect on fertility
Animal studies have shown that citalopram may impair sperm quality. This effect may theoretically affect fertility, although reduced fertility has not been observed in humans to date.
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 appropriate safety measures.
Citabax contains lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before starting treatment.
Citabax 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

What dose to use
Citabax should always be used as directed by your doctor.
If in doubt, consult your doctor or pharmacist.

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 once 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 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 usually should not take more than 20 mg daily.

Use of Citabax in special patient groups
In patients with impaired liver function, elimination of Citabax 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 in children and adolescents (under 18 years)
Citabax should not be used in children and adolescents. Additional information is also provided in section 2, "Important information before taking Citabax".

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

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

In the treatment of panic disorders with or without agoraphobia, maximum benefit 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 advises, even if your mood improves. The condition may persist for a long time, and if treatment is stopped too early, symptoms may return.

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

Taking more Citabax than recommended
If you suspect that you or someone else has taken too many Citabax tablets, seek immediate medical attention from a doctor or the nearest hospital emergency department, even if there are no symptoms of poisoning. Bring the Citabax 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), abnormally fast breathing, hyperventilation, changes in ECG, cardiac arrest, and rhabdomyolysis (muscle breakdown).

If you miss a dose of Citabax
If you forget to take a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

Stopping Citabax
If you wish to stop treatment, discuss this first with your doctor. They will advise you on appropriate steps. Do not stop taking Citabax without consulting your doctor.

Withdrawal reactions after stopping Citabax:
Avoid stopping treatment abruptly. When discontinuing Citabax, the dose should be gradually reduced over a period of at least one to two weeks to minimize the risk of withdrawal reactions.

If severe withdrawal symptoms occur after dose reduction or discontinuation, consider resuming the previous dose and then tapering more gradually in smaller steps, as directed by your doctor.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions usually resolve after a few weeks of treatment. It should be remembered that
some of these symptoms may also be manifestations of the underlying illness and will subside as the patient's condition improves.
Severe adverse reactions
If any of the following symptoms occur, stop taking Citabax immediately and contact your doctor:

Thoughts of self-harm and suicidal thoughts.
High fever, agitation, confusion, tremors, or sudden muscle spasms. These symptoms may indicate a rare condition called serotonin syndrome, reported during concomitant use of antidepressant medicines.
Swelling of the face, lips, tongue, or throat causing difficulty in swallowing or breathing (allergic reaction).
Unusual bleeding, including gastrointestinal bleeding.
Fast, irregular heartbeat, fainting, which may be symptoms of life-threatening cardiac arrhythmias (known as torsade de pointes).
Malaise with muscle weakness and disorientation or difficulty urinating, which are symptoms of hyponatraemia (reduced sodium concentration in the blood). This may rarely occur during treatment with SSRIs (a group of antidepressants to which Citabax belongs), particularly in elderly patients, patients taking diuretics, or patients with fluid deficiency due to other factors.
Seizures (see section "Warnings and precautions").
Yellowish discolouration of the skin and whites of the eyes, indicating liver dysfunction/hepatitis.

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

Drowsiness;
Difficulty sleeping;
Tremor;
Nausea, constipation;
Excessive sweating, dry mouth, fatigue;
Headache.

Common adverse reactions (may affect less than 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 (paresthesia), disturbances in motor coordination and muscle tension (extrapyramidal symptoms);
Diarrhoea, vomiting, abdominal pain, indigestion, bloating;
Sexual dysfunction, such as ejaculation disorders, anejaculation, impotence, decreased libido; in women - delayed orgasm;
Taste disturbances, visual disturbances, ringing in the ears (tinnitus);
Skin rash, itching;
Muscle and joint pain;
Fever;
Urinary disorders;
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 reactions (may affect less than 1 in 100 patients):

Allergic reaction, urticaria;
Increased appetite, weight gain;
Euphoria, aggression, depersonalisation (loss of sense of self), hallucinations, mania;
Seizures;
Cough, shortness of breath;
Photosensitivity;
Abnormal liver function test results;
Slow heartbeat;
Fainting;
Hair loss;
Pupil dilation;
Heavy menstrual bleeding;
Skin redness or spots on the skin (purpura);
Swelling of hands or feet.

Rare adverse reactions (may affect less than 1 in 1000 patients):

Decreased sodium concentration in 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);
Bleeding, skin or mucosal haemorrhages (petechiae).

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

Prolongation of the QT interval on ECG (a change in the recording of electrical conduction in 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 concentration in 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 behaviours have been reported during treatment with Citabax 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:
Withdrawal reactions commonly occur when treatment is discontinued. The most frequently reported symptoms are
dizziness, sensory disturbances (including paresthesia), 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 severity 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" and section 3 "How to take Citabax").
Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions
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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Citabax

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 pack.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer in use. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Citabax contains

The active substance is citalopram (in the form of citalopram hydrobromide). One coated tablet of Citabax 10 contains 10 mg of citalopram (as citalopram hydrobromide). One coated tablet of Citabax 20 contains 20 mg of citalopram (as citalopram hydrobromide). One coated tablet of Citabax 40 contains 40 mg of citalopram (as citalopram hydrobromide).
Excipients:
Core ingredients: monohydrate lactose, microcrystalline cellulose (Avicel PH 101), microcrystalline cellulose (Avicel PH 102), maize starch, copovidone, sodium croscarmellose, magnesium stearate.
Coating (Opadry white 20H 58983) ingredients: hypromellose 29105cP (E 464), titanium dioxide (E 171), propylene glycol, hydroxypropylcellulose (E 463), talc.

What Citabax looks like and contents of the pack
Citabax 10
White or almost white, round, biconvex tablets. One side is engraved with the code "10".
Citabax 20
White or almost white, round, biconvex tablets. One side is engraved with the code "20", and a breakline on the other side.
Citabax 40
White or almost white, round, biconvex tablets. One side is engraved with the code "40", and a breakline on the other side.
Citabax is available in packs containing 14, 28 or 56 coated tablets.
Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp,
The Netherlands
For further information about this medicinal product, please contact the Marketing Authorisation Holder.
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw
Tel. +48 22 642 07 75