Citabax 20

Leaflet accompanying the packaging: information for the user

Citabax 10, 10 mg, coated tablets

Citabax 20, 20 mg, coated tablets

Citabax 40, 40 mg, coated tablets

Citalopram

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Citabax and what is it used for

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

2. Important information before taking Citabax

When not to take 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 (MAOIs) (including selegiline in doses above 10 mg per day) within 14 days of stopping irreversible MAOIs (these medicines include, for example, tranylcypromine) and not earlier than one day after stopping moclobemide (in the treatment of depression) or selegiline (in the treatment of Parkinson's disease). After stopping Citabax, at least one week should pass before taking any MAOI. In patients treated with SSRIs (a group of antidepressant medicines that includes Citabax) in combination with MAOIs (including moclobemide, linezolid, or selegiline), serious, sometimes fatal, complications have been reported.
• if the patient is being treated with linezolid (an antibiotic), unless there is no alternative and the patient can be closely monitored and blood pressure monitored by the attending physician.
• if the patient has congenital heart rhythm disorders or has had an episode of heart rhythm disorders (visible in the ECG - a test that evaluates heart function).
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see below under "Citabax and other medicines").

Warnings and precautions

Before starting treatment with Citabax, the patient should discuss it with their doctor or pharmacist.
The situations described below are those in which Citabax can only be used under certain conditions and with special caution. The patient should discuss this with their doctor. The patient should consult their doctor, even if the above warnings refer to situations that have occurred in the past.
Citabax should not be used:

• in patients being treated with medicines containing serotonergic substances [e.g., tramadol, sumatriptan, or other triptans, oxitriptan, or tryptophan (serotonin precursors)]. Concomitant use may lead to the so-called "serotonin syndrome". Symptoms in the event of serotonin syndrome include high fever, agitation, disorientation, tremors, and sudden muscle contractions. In such a case, the patient should immediately consult a doctor.

Special caution should be exercised when using Citabax:

• in patients with heart problems or if they have recently had a heart attack.
• in patients with slowed resting heart rate and (or) reduced electrolyte levels due to persistent severe diarrhea, vomiting, or taking diuretics (medicines that increase urine production).
• in patients with rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate heart rhythm disorders.

Liver or kidney function disorders
The patient should inform their doctor about liver or kidney function disorders. The doctor may then adjust the dose (see section 3 "How to take Citabax").
Seizures
In patients with epilepsy, treatment with Citabax should be discontinued if seizures occur or if their frequency increases (see also section 4 "Possible side effects").
Diabetes
As with other SSRIs, citalopram may also affect blood glucose control in patients with diabetes. It may be necessary to adjust the dose of insulin or oral hypoglycemic agents.
Hyponatremia
During treatment with citalopram, rare cases of hyponatremia (decreased sodium levels in the blood) have been reported, probably due to inadequate secretion of antidiuretic hormone (SIADH), which was usually reversible after discontinuation of treatment. Most reports concerned elderly patients, patients taking diuretics, or patients with fluid deficiency caused by other factors. Symptoms may include malaise with muscle weakness and confusion.
Bipolar affective disorder
In patients with bipolar affective disorder, mania may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, the patient should consult their doctor to discontinue Citabax.

Important disease-related information

As with other medicines used to treat depression or related disorders, improvement does not occur immediately. The patient may only feel it after a few weeks of taking Citabax. In the treatment of anxiety disorders, it usually takes 2 to 4 weeks to observe improvement.
In the initial period of treatment, some patients experience increased anxiety, which resolves on its own after 14 days of treatment. To reduce these symptoms, it is recommended to use an initial dose of 10 mg of citalopram in the first week of treatment (see section 3 "How to take Citabax").
It is very important to follow the doctor's instructions exactly and not to stop treatment or change the dose without consulting a doctor.
If the patient has psychosis with depressive episodes, treatment with Citabax may exacerbate psychotic symptoms (e.g., hallucinations or delusions).
Sexual disorders
Medicines like Citabax (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 [e.g., large, extensive skin bleeding (ecchymoses), gynecological bleeding, gastrointestinal bleeding, and other bleeding in the skin or mucous membranes] have rarely occurred in association with the use of medicines like Citabax. If the patient is pregnant, see the section "Pregnancy, breastfeeding, and fertility". Caution is advised in patients with a history of bleeding disorders and during concomitant use of medicines that may increase the risk of bleeding (see also the section "Citabax and other medicines").
Electroconvulsive therapy
Caution is advised when using Citabax and electroconvulsive therapy, as clinical experience is currently limited.
Visual disturbances
The patient should inform their doctor if they experience vision problems, such as certain types of glaucoma (increased intraocular pressure). In such a case, Citabax should be used with caution.
Akathisia/psychomotor restlessness
The use of Citabax is associated with the development of akathisia, which is characterized by an unpleasantly perceived state of 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 to patients who experience these symptoms.
Withdrawal reactions after discontinuing treatment with an SSRI
Withdrawal reactions often occur after discontinuation of treatment, especially if treatment is discontinued abruptly (see section 4 "Possible side effects"). The risk of withdrawal symptoms may depend on various factors, including the duration of treatment, dose, and rate of dose reduction. Generally, these symptoms are mild to moderate, but in some patients, they may also be severe. They usually occur within the first few days after discontinuation of treatment. Generally, these symptoms resolve on their own within two weeks. In some patients, they may persist for longer (2-3 months or longer). When discontinuing Citabax, it is recommended to gradually reduce the dose over a period of several weeks or months, depending on the patient's needs (see section 3 "How to take Citabax").

Suicidal thoughts and worsening of depression or anxiety disorders

In patients with depression and (or) anxiety disorders, suicidal thoughts or self-harm thoughts may sometimes occur. They may worsen after starting treatment with antidepressant medicines, as these medicines begin to work only after some time – usually after two weeks, or even later.
A greater tendency to such thoughts may occur:

• in patients who have previously had suicidal thoughts or self-harm thoughts,
• in young adults. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with mental illness who were taking antidepressant medicines.

If the patient experiences any thoughts of self-harm or suicide, they should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friendsabout depression or anxiety disorders and ask them to read this leaflet. The patient may ask them to monitor their condition and inform them if their depression or anxiety worsens or if they notice any worrying changes in behavior.

Children and adolescents under 18 years of age

Citabax should not be used in children and adolescents under 18 years of age. In the case of taking medicines from this group, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, the doctor may prescribe Citabax to patients under 18 years of age, considering it to be in their best interest. If the doctor has prescribed Citabax to a patient under 18 years of age, in case of any doubts, the patient should consult their doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Citabax, the patient should inform their doctor.
Additionally, as of now, there is a lack of data on the long-term safety of using Citabax in this age group regarding growth, maturation, and cognitive and behavioral development.

Elderly patients (over 65 years of age)

Elderly patients are more sensitive to the effects of antidepressant medicines, so the dose of Citabax will be adjusted by the doctor. If any side effects occur, the patient should inform their doctor.

Citabax and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
During treatment with Citabax, the use of other medicines should be consulted with a doctor.
Medicines can affect the action of other medicines, which can sometimes lead to serious side effects.
Citabax should not be used:

• if the patient is taking medicines called monoamine oxidase inhibitors (MAOIs) (including selegiline in doses above 10 mg per day), as this combination may lead to serious side effects (serotonin syndrome). When switching between the two medicines, an appropriate time interval should be observed. This switch can only be made under the supervision of the attending physician. Citabax should not be taken earlier than two weeks after discontinuation of irreversible MAOIs (e.g., tranylcypromine) or earlier than one day after stopping moclobemide (in the treatment of depression) or selegiline (in the treatment of Parkinson's disease). Treatment with MAOIs should not be started earlier than one week after discontinuation of Citabax. In patients taking SSRIs (a group of antidepressant medicines that includes Citabax) in combination with MAOIs (including moclobemide, linezolid, or selegiline), serious, sometimes fatal, reactions have been reported.

Caution should be exercised when using Citabax with:

• medicines containing cimetidine, lansoprazole, and omeprazole (medicines used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of heart attack). These medicines may cause an increase in citalopram levels in the blood. Dose adjustment may be necessary.
• flecainide or propafenone (medicines used to treat heart diseases), 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 high blood pressure and certain heart diseases). Concomitant use leads to an increase in metoprolol levels in the blood. Dose adjustment may be necessary.
• lithium (used to prevent and treat manic-depressive disorders), very rare interactions have been reported.
• medicines with known effects on platelet function or other medicines that affect the risk of bleeding (see section 2 "Warnings and precautions"). These medicines include non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamole, antipsychotic medicines, and ticlopidine.
• medicines that lower potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disorders.
• medicines containing imipramine and desipramine (used to treat depression). Dose adjustment of desipramine may be necessary.
• medicines that may lower the seizure threshold, such as mefloquine (an antimalarial medicine), bupropion (used to treat depression), tramadol (a strong pain reliever), neuroleptics (medicines used to treat schizophrenia or psychosis), and medicines used to treat depression (SSRIs). Citabax may also lower the seizure threshold.
• clozapine (used to treat psychosis), which may increase the risk of side effects associated with clozapine use. The nature of these interactions is not fully understood.

The patient should avoid concomitant administration of citalopram and products containing St. John's wort (herbal medicines used to treat depression) due to the increased risk of side effects.

Citabax with food, drink, and alcohol

Citabax can be taken with or without food (see section 3 "How to take Citabax").
As with all antidepressant medicines, the patient should avoid drinking alcohol during treatment with Citabax. However, it has not been shown that citalopram interacts with alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Experience with the use of citalopram during pregnancy is limited. Women who are pregnant or plan to become pregnant should not take Citabax unless their doctor considers it absolutely necessary.
The patient should not stop taking citalopram abruptly. Taking Citabax during pregnancy, especially in the last three months, may increase the risk of serious complications in the newborn. These symptoms usually appear within the first day after birth.
Patients taking Citabax in the last three months of pregnancy up to delivery should be aware that the following symptoms may occur in the newborn: seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, tremors, tremors, irritability, drowsiness, sleep disturbances, or constant crying. If any of these symptoms occur in the newborn, the patient should immediately contact their doctor.
Taking Citabax during pregnancy, especially in the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). Symptoms include rapid breathing and cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, the patient should immediately contact their doctor or midwife.
Taking Citabax at the end of pregnancy may increase the risk of severe vaginal bleeding occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Citabax, they should inform their doctor or midwife so that they can provide appropriate advice.
Breastfeeding
Before taking any medicine, the patient should consult their doctor or pharmacist.
If the patient is breastfeeding, they should consult their doctor, who will carefully weigh the benefits of breastfeeding against the potential risks to the baby. Small amounts of Citabax may pass into breast milk.
Fertility
In animal studies, it has been shown that citalopram may impair sperm quality. This effect may theoretically affect fertility, although no reduction in fertility has been observed in humans so far.

Driving and using machines

Even if the medicinal product is used as intended, it may affect the ability to react, making it difficult to participate actively in traffic or operate machinery. The patient should not work without proper protection.

Citabax contains lactose monohydrate.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Citabax.

Citabax contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Citabax

What dose to take

Citabax should always be taken as directed by the doctor.
In case of doubts, the patient should consult their doctor or pharmacist.
Adults
Treatment of depression
Usually, 20 mg per day is taken. The doctor may increase the dose to a maximum of 40 mg per day.
Treatment of anxiety disorder with agoraphobia or without agoraphobia
The initial dose is 10 mg of citalopram per day for the first week. Then, it is increased to 20 mg per day. The doctor may increase the dose to a maximum of 40 mg per day.
Use of Citabax in elderly patients (over 65 years of age)
The initial dose should be reduced to half of the recommended dose, e.g., 10-20 mg per day.
Elderly patients usually should not take more than 20 mg per day.
Use of Citabax in special patient groups
In patients with impaired liver function, the elimination of Citabax may be slower.
In the case of mild or moderate liver function disorders, it is recommended to use an initial dose of 10 mg of citalopram per day for the first two weeks of treatment. Patients with liver function disorders should not take more than 20 mg of citalopram per day.
Caution is advised in patients with severe liver function disorders, and the dose should be increased with special caution.
No dose adjustment is necessary in patients with mild or moderate kidney function disorders. It is not recommended to use citalopram in patients with severe kidney function disorders (creatinine clearance below 30 ml/min), as there is no experience in this area.
Use of Citabax in children and adolescents (under 18 years of age)
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 is taken once a day, in a single dose.
Citabax can be taken at any time of day, with or without food. The tablet should be swallowed, washed down with water. Do not chew (the tablets have a bitter taste).
Duration of treatment
As with other medicines used to treat depression, the antidepressant effect is achieved after 2 to 4 weeks of treatment. Therefore, the patient should continue taking Citabax, even if they do not feel improvement at first.
In the treatment of anxiety disorders with agoraphobia and without agoraphobia, the maximum effect is achieved after about three months of treatment.
The duration of treatment varies from patient to patient. Therapy usually lasts at least six months.
Treatment should be continued for as long as the doctor recommends, even if the patient feels better. The disease may persist for a long time, and if treatment is stopped too early, symptoms may return.
Withdrawal reactions after discontinuing Citabax:
see below in the section "Discontinuing Citabax".

What to do if a higher than recommended dose of Citabax is taken

If it is suspected that the patient or someone else has taken too many Citabax tablets, they should immediately consult a doctor or the emergency department of the nearest hospital, even if there are no symptoms or signs of poisoning. The patient should bring the packaging of Citabax with them.
Symptoms of overdose may include irregular heartbeat, seizures, changes in heart rhythm, nausea (nausea), vomiting, sweating, drowsiness, loss of consciousness, rapid heartbeat, tremors, changes in blood pressure, serotonin syndrome (see section 4), agitation, dizziness, dilated pupils, cyanosis of the skin, too rapid breathing, hyperventilation, changes in ECG, cardiac arrest, muscle breakdown (rhabdomyolysis).

What to do if a dose of Citabax is missed

If the patient forgets to take a dose, they should take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Discontinuing Citabax

If the patient wants to stop treatment, they should first discuss it with their doctor. If necessary, the doctor will take appropriate action. The patient should not stop taking Citabax without consulting their doctor.
Withdrawal reactions after discontinuing Citabax:
The patient should avoid sudden discontinuation of treatment. When stopping Citabax, the dose should be gradually reduced over a period of at least one to two weeks to reduce the risk of withdrawal reactions.
If very unpleasant withdrawal symptoms occur after dose reduction or discontinuation of the medicinal product, it may be necessary to reconsider the last dose and then reduce it in smaller steps, as advised by the doctor.
If the patient has any further doubts about taking Citabax, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Citabax can cause side effects, although not everybody gets them.
Side effects usually go away after a few weeks of treatment. It should be remembered that some of these side effects may also be symptoms of the disease and will resolve as the patient's condition improves.

Severe side effects

If any of the following symptoms occur, the patient should immediately stop taking Citabax and inform their doctor:

• thoughts of self-harm and suicidal thoughts.
• high fever, agitation, confusion, tremors, or sudden muscle contractions. These symptoms may be signs of a rare condition called serotonin syndrome, reported during concomitant use of antidepressant medicines.
• swelling of the face, lips, tongue, or throat, causing difficulty swallowing or breathing (allergic reaction).
• unusual bleeding, including bleeding from the gastrointestinal tract.
• rapid, irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders (known as torsades de pointes).
• malaise with muscle weakness and confusion or difficulty urinating are symptoms of hyponatremia (decreased sodium levels in the blood), which may rarely occur during treatment with SSRIs (a group of antidepressant medicines that includes Citabax), especially in elderly patients, patients taking diuretics, or patients with fluid deficiency caused by other factors.
• seizures (see section "Warnings and precautions").
• yellowing of the skin and whites of the eyes, which is a sign of liver function disorders/liver inflammation.

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

• drowsiness;
• difficulty sleeping;
• tremors;
• nausea, constipation;
• increased sweating, dry mouth, weakness;
• headaches.

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

• nervousness, anxiety, agitation, unusual dreams, apathy, decreased appetite, weight loss, concentration disorders
• dizziness, attention disorders, feeling of tingling or numbness in hands or feet (paresthesia), extrapyramidal symptoms (symptoms of movement and muscle tone disorders);
• diarrhea, vomiting, abdominal pain, indigestion, bloating;
• sexual function disorders, such as ejaculation disorders, anejaculation, impotence, decreased libido, in women - inhibited orgasm;
• taste disorders, vision disorders, ringing in the ears (tinnitus);
• skin rash, itching;
• muscle and joint pain;
• fever;
• urination disorders;
• low blood pressure when changing position from lying down to standing, feeling of uneven heartbeat (palpitations), rapid heartbeat;
• increased salivation, yawning; general malaise, feeling of fatigue;

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

• allergic reaction, hives,
• increased appetite, weight gain;
• euphoria, aggression, depersonalization (loss of sense of one's own personality), hallucinations, mania;
• seizures;
• cough, shortness of breath;
• increased sensitivity to sunlight;
• abnormal liver function test results;
• slow heartbeat;
• fainting;
• hair loss;
• pupil dilation;
• heavy menstrual bleeding;
• skin redness or spots (erythema);
• swelling of the hands or feet.

Rare side effects (may affect up to 1 in 1,000 patients):

• decreased sodium levels in the blood (with symptoms such as fatigue, muscle weakness, and confusion or difficulty urinating);
• increased urine production (inappropriate secretion of antidiuretic hormone)
• serotonin syndrome (possible symptoms include high fever, agitation, confusion, tremors, and sudden muscle contractions)
• grand mal seizures;
• liver inflammation;
• psychomotor agitation/akathisia (inability to sit still) (see section "Warnings and precautions");
• involuntary movements (dyskinesia);
• bleeding, bleeding on the skin or mucous membranes (ecchymoses).

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

• prolongation of the QT interval in the ECG (a change in the conduction of the heart impulse)
• rapid, irregular heartbeat, fainting. These may be symptoms of life-threatening heart rhythm disorders called torsades de pointes.
• increased prolactin levels;
• increased frequency of bleeding and bruising, caused by a decrease in platelet count;
• decreased potassium levels in the blood (which may cause muscle weakness, tremors, and arrhythmia);
• pancreatitis;
• panic attacks;
• teeth grinding;
• feeling of restlessness;
• milk secretion in men and in women who are not breastfeeding;
• vision disorders;
• irregular menstrual periods in women, heavy vaginal bleeding occurring shortly after delivery (postpartum hemorrhage), see additional information in the subsection "Pregnancy, breastfeeding, and fertility" in section 2.
• painful erection in men;
• sudden swelling of the skin or mucous membranes;
• nosebleeds;
• gastrointestinal bleeding (including rectal bleeding);
• anaphylactic reaction;
• movement disorders.

There have been reports of suicidal thoughts and behaviors during treatment with Citabax or shortly after discontinuation (see section "Warnings and precautions").
After the medicine was placed on the market, there have been reports of QT interval prolongation, mainly in patients with pre-existing heart disease.
In patients treated with this group of medicines, an increased risk of bone fractures has been observed.
Withdrawal reactions after discontinuing Citabax:
Withdrawal reactions often occur after discontinuation of treatment. The most commonly reported withdrawal reactions are dizziness, sensation disorders (including paresthesia), sleep disorders (including insomnia and intense dreams), agitation or anxiety, nausea and (or) vomiting, tremors, disorientation, sweating, headache, diarrhea, palpitations, emotional instability, irritability, and vision disorders. Generally, these symptoms are mild to moderate, but in some patients, they may also be severe. They usually occur within the first few days after discontinuation of treatment. Generally, these symptoms resolve on their own within two weeks. In some patients, they may persist for longer. Therefore, it is recommended to gradually reduce the dose when treatment is no longer necessary (see section 2 "Important information before taking Citabax" and section 3 "How to take Citabax").

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Citabax

The medicine should be stored out of the 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 month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Citabax contains

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

What Citabax looks like and contents of the pack

Citabax 10
White or almost white tablets, round, biconvex. On one side, they have the inscription "10".
Citabax 20
White or almost white tablets, round, biconvex. On one side, they have the inscription "20", and a dividing line on the other side.
Citabax 40
White or almost white tablets, round, biconvex. On one side, they have the inscription "40", and a dividing line on the other side.
Citabax is available in packs of 14, 28, or 56 coated tablets.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o. o.
ul. Idzikowskiego 16
00-710 Warsaw

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp,
Netherlands
To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.
Ranbaxy (Poland) Sp. z o. o.
ul. Idzikowskiego 16
00-710 Warsaw
phone: +48 22 642 07 75

Date of last revision of the leaflet: