Citabax 20

Patient Information Leaflet: User Information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Citabax 20 (CITALOPRAM BASICS 20 mg), film-coated tablets, 20 mg

Citalopram
Citabax 20 and CITALOPRAM BASICS 20 mg are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

How Citabax 20 works

Citalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines help correct the chemical imbalance in the brain that causes symptoms of the disease.

When Citabax 20 is used

Citabax 20 contains citalopram and is used to treat depression, and when the patient feels better, to prevent the return of its symptoms. Citabax 20 is also used long-term to prevent new episodes of depression, if the patient has recurring depressive disorders.
Citabax 20 also has a beneficial effect on alleviating symptoms when the patient experiences anxiety attacks.

2. Important information before taking Citabax 20

When not to take 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 suspects that they are allergic, they should consult their doctor;
• if the patient is taking medicines called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines that contain: phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, and moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), or linezolid (an antibiotic). Even if the patient has stopped taking any of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine, they should wait 2 weeks before starting to take Citabax 20. After stopping moclobemide, 1 day must pass. After stopping Citabax 20, 1 week must pass before taking any MAOI;

before starting to take Citabax 20, the patient should wait 2 weeks after stopping any of the following MAOIs: phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine. After stopping moclobemide, 1 day must pass. After stopping Citabax 20, 1 week must pass before taking any MAOI;

• at the same time as pimozide (a neuroleptic);
• 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 that may affect heart rhythm (see below "Citabax 20 and other medicines").

Warnings and precautions

The patient should tell their doctor if they have any other disorders or diseases. In particular, they should inform their doctor about:

• liver function disorders;
• kidney function disorders;
• diabetes (it may be necessary to adjust the dose of antidiabetic medicines);
• epilepsy or a history of seizures;
• bleeding disorders or if the patient has ever had bleeding from the stomach or intestines, or if the patient is pregnant (see "Pregnancy");
• mania or anxiety disorders;
• low sodium levels in the blood;
• electroconvulsive therapy;
• eye diseases, such as certain types of glaucoma;
• heart rhythm disorders or if the patient has recently had a heart attack ("heart attack");
• slow resting heart rate and (or) low electrolyte levels due to persistent severe diarrhea, vomiting, or taking diuretics (diuretic medicines);
• rapid or irregular heartbeat, fainting, or dizziness when standing up, which may indicate heart rhythm disorders.

The patient should consult their doctor, even if the above warnings refer to past situations.
Medicines like Citabax 20 (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.
Warning
In some patients with bipolar affective disorder, a manic phase 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.
In the first few weeks of treatment, symptoms such as anxiety or difficulty sitting or standing still may also occur. If such symptoms appear, the patient should immediately inform their doctor.

Additional disease information

As with other medicines used to treat depression or related disorders, improvement does not occur immediately. The patient may only feel it after several weeks of taking Citabax 20. In the initial treatment period, some patients experience increased anxiety, which subsides during treatment. It is therefore very important for the patient to follow their doctor's instructions carefully and not stop treatment or change the dose without consulting their doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

In patients with depression and (or) anxiety disorders, suicidal thoughts or thoughts of self-harm may sometimes occur. They may intensify after starting to take antidepressant medicines, as these medicines start to work only after some time - usually after 2 weeks, or even later.
A greater tendency to such thoughts may occur:

• in patients who have previously had suicidal thoughts or self-harm;
• 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 took 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 to be informed if they notice that the depression or anxiety has worsened or if there are worrying changes in behavior.

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 side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Citabax 20 to patients under 18 years of age, considering that it is in their best interest. If the doctor has prescribed Citabax 20 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 20, the patient should inform their doctor. Additionally, as of now, there is a lack of data on the long-term safety of using Citabax 20 in this age group regarding growth, maturation, and cognitive and behavioral development.

Citabax 20 and other medicines

Medicines can affect the action of other medicines, which can sometimes lead to serious side effects. 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. This includes other medicines used to treat depression (see above "When not to take Citabax 20").

• St. John's Wort (Hypericum perforatum). It should not be taken at the same time as Citabax 20.
• MAOIs. They should not be taken at the same time as Citabax 20 (see above "When not to take Citabax 20").

The patient should inform their doctor if they are taking any of the following medicines:

• 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 increase the level of citalopram in the blood.
• linezolid (an antibiotic);
• sumatriptan (used to treat migraines) or tramadol (a pain reliever). If the patient feels unwell while taking these medicines with Citabax 20, they should consult their doctor;
• lithium (used to prevent and treat mania) and tryptophan (an antidepressant);
• pimozide (a neuroleptic). It should not be taken at the same time as Citabax 20;
• imipramine and desipramine (used to treat depression);
• medicines containing selegiline (used to treat Parkinson's disease);
• mefloquine (used to treat malaria);
• bupropion (used to treat depression);
• medicines with known effects on platelet function (e.g., anticoagulant medicines used to treat or prevent blood clots; acetylsalicylic acid and non-steroidal anti-inflammatory medicines (NSAIDs), such as ibuprofen and diclofenac, used as pain relievers and some antipsychotic medicines and tricyclic antidepressants);

Metoprolol (a beta-blocker used to treat migraines, certain heart diseases, and high blood pressure). The action of these medicines may be enhanced, weakened, or changed;

• neuroleptics (used to treat schizophrenia).

Citabax 20 should not be takenwhile taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as anti-arrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin administered intravenously, pentamidine, antimalarial medicines, especially halofantrine), and some antihistamines (astemizole, mizolastine). If the patient has any further questions, they should consult their doctor.

Citabax 20 with food, drink, and alcohol

Citabax 20 can be taken with or without food (see section 3).
As with all antidepressant medicines, it is reasonable to avoid alcohol during treatment with Citabax 20, although it has not been shown that Citabax 20 enhances the effects of alcohol.

Pregnancy

Before taking any medicine, the patient should consult their doctor or pharmacist.
If the patient is pregnant, suspects that they are pregnant, or plans to become pregnant, they should inform their doctor. Pregnant women should not take Citabax 20 unless their doctor has informed them of the risks and benefits of treatment.
The patient should inform their doctor and (or) midwife about taking Citabax 20. Taking Citabax 20 during pregnancy, especially in the last three months, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn. This condition is characterized by rapid breathing and bluish discoloration of the skin. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, the patient should immediately contact their doctor and (or) midwife. Patients taking Citabax 20 in the last 3 months of pregnancy until 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 flaccidity, increased reflex excitability, tremors, tremors, irritability, drowsiness, or difficulty sleeping.

Breast-feeding

Before taking any medicine, the patient should consult their doctor or pharmacist.
If the patient is breast-feeding, they should consult their doctor. The patient should not breast-feed their child while taking Citabax 20, as small amounts of the medicine may pass into breast milk.

Fertility

In animal studies, it has been shown that citalopram impairs sperm quality. This effect may theoretically affect fertility, although no reduction in fertility has been observed in humans so far.

Driving and using machines

Citabax 20 usually does not affect the ability to perform daily activities. However, if dizziness or drowsiness occurs after starting to take Citabax 20, the patient should be cautious while driving or performing tasks that require concentration until these symptoms subside.

Citabax 20 contains lactose monohydrate

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Citabax 20.

Citabax 20 contains sodium

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

3. How to take Citabax 20

What dose to take

Citabax 20 should always be taken as directed by the doctor.
In case of doubts, the patient should consult their doctor or pharmacist.
Citabax 10 (10 mg), Citabax 20 (20 mg), and Citabax 40 (40 mg) are available on the market.
Adults
Treatment of depression
Usually, 20 mg is taken once a day. The doctor may increase the dose to a maximum of 40 mg once a day.
Treatment of anxiety disorder with panic attacks
The initial dose is 10 mg once a day for the first week. Then, it is increased to 20-30 mg once a day. The doctor may increase the dose to a maximum of 40 mg once a day.
Taking Citabax 20 in elderly patients (over 65 years old)
The initial dose should be reduced to half of the recommended dose, e.g., 10-20 mg once a day.
Elderly patients usually should not take more than 20 mg once a day.
Taking Citabax 20 in children and adolescents (under 18 years old)
Citabax 20 should not be taken by children and adolescents. Additional information is also provided in section 2 "Important information before taking Citabax 20".
Taking Citabax 20 in special patient groups
Patients with liver diseases should not take more than 20 mg once a day.

How to take

Citabax 20 is taken once a day, in a single dose. Citabax 20 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 and anxiety disorders, improvement is achieved after several weeks of treatment. Therefore, the patient should continue to take Citabax 20, even if they do not feel better at first. The duration of treatment varies from patient to patient. Therapy usually lasts at least 6 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.
In patients with recurring depression, maintenance treatment may last for several years to prevent new depressive episodes.
The patient should not change the dose without consulting their doctor.

Taking a higher dose of Citabax 20 than recommended

If it is suspected that the patient or someone else has taken too many Citabax 20 tablets, they should immediately go to the doctor or the emergency department of the nearest hospital, even if there are no symptoms or signs of poisoning. The patient should take the Citabax 20 packaging with them.
Some symptoms of overdose may be life-threatening.
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,
• pupil dilation,
• bluish discoloration of the skin,
• rapid breathing.

Missing a dose of Citabax 20

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

Stopping treatment with Citabax 20

Suddenly stopping treatment with Citabax 20 may cause withdrawal symptoms, such as:
dizziness, nausea, and a feeling of numbness or tingling in the hands or feet, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, nausea, or vomiting, sweating, restlessness or agitation, tremors, feeling of confusion or disorientation, emotional instability or irritability, diarrhea, vision disturbances, or rapid or irregular heartbeat (palpitations). These are usually mild side effects that subside within a few days.
Therefore, when stopping treatment, it is recommended to gradually reduce the dose of Citabax 20 over a few weeks.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Citabax 20 can cause side effects, although not everybody gets them.
It should be remembered that some of these side effects may also be symptoms of the disease and will subside as the patient's condition improves.

Severe side effects

If the patient experiences any of the following symptoms, they should stop taking Citabax 20 and inform their doctor immediately:

• difficulty breathing,
• swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing,
• severe itching (with hives on the skin),
• rapid, irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders (known as torsade de pointes).

If the patient experiences any of the following symptoms, they should inform their doctor immediately, as it may be necessary to reduce the dose or stop taking the medicine:

• seizures (for the first time in their life) or an increase in their frequency,
• changes in behavior, such as feeling excited or overly excited,
• high fever, agitation, confusion, tremors, or sudden muscle contractions. These symptoms may be a sign of a rare condition called serotonin syndrome,
• fatigue, disorientation, and tremors, which may be due to low sodium levels in the blood (hyponatremia).

If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital.
Patient Information Leaflet: User Information

The following side effects are usually mild and subside within a few days of treatment.
Very common side effects (occurring in more than 1 in 10 patients):

• drowsiness;
• difficulty sleeping;
• headaches;
• sleep disturbances;
• weakness;
• increased sweating;
• dry mouth (increases the risk of tooth decay, so the patient should brush their teeth more often than usual);
• nausea.

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

• decreased appetite;
• agitation;
• decreased libido;
• anxiety;
• nervousness;
• disorientation (confusion);
• unusual dreams;
• decreased emotional sensitivity, feeling of indifference (apathy);
• tremors;
• a feeling of tingling or numbness in the hands or feet;
• dizziness;
• attention disturbances;
• migraine;
• memory loss;
• ringing in the ears (tinnitus);
• feeling of irregular heartbeat (palpitations);
• yawning;
• stuffy nose or cold (rhinitis);
• diarrhea;
• vomiting;
• constipation;
• indigestion;
• abdominal pain;
• bloating (gas);
• increased salivation;
• itching;
• muscle and joint pain;
• in men - problems with ejaculation and erection;
• in women - difficulty achieving orgasm;
• feeling of fatigue;
• weight loss.

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

• increased appetite;
• aggression;
• hallucinations;
• mania;
• depersonalization (feeling of being outside the body);
• fainting;
• increased libido;
• pupil dilation;
• rapid heartbeat;
• slow heartbeat;
• hives;
• hair loss;
• rash;
• redness of the skin or spots on the skin (erythema);
• increased sensitivity to sunlight;
• urination disorders;
• heavy menstrual bleeding;
• swelling of the hands or feet;
• weight gain.

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

• low sodium levels in the blood (with symptoms such as fatigue, disorientation, and tremors);
• seizures;
• involuntary movements;
• taste disturbances;
• bleeding;
• cough;
• hepatitis;
• fever, malaise.

Some patients have reported (frequency not known):

• thoughts of self-harm and suicidal thoughts, see also section 2;
• increased risk of bleeding and bruising, due to a decrease in platelet count;
• allergic reactions, sudden, severe allergic reactions (anaphylactic reactions), characterized by difficulty breathing, swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing, severe itching (with hives on the skin). If these symptoms occur, the patient should stop taking Citabax 20 and inform their doctor immediately;
• increased urine production (inappropriate secretion of antidiuretic hormone - vasopressin);
• low potassium levels in the blood, which may cause muscle weakness, tremors, or irregular heartbeat;
• panic attacks;
• teeth grinding;
• feeling of restlessness;
• abnormal or involuntary movements;
• movement disorders;
• low blood pressure, characterized by dizziness when standing up;
• vision disturbances;
• nosebleeds;
• bleeding, including bruising on the skin and mucous membranes;
• sudden onset of swelling of the skin or mucous membranes;
• seizures;
• high fever, agitation, confusion, tremors, or sudden muscle contractions (serotonin syndrome);
• painful erection of the penis in men;
• milk secretion (galactorrhea) in men and in women who are not breast-feeding;
• irregular menstrual periods;
• uterine bleeding, abnormal liver function test results;
• in patients taking medicines from this group, an increased risk of bone fractures has been observed;
• heart rhythm disorders;
• severe vaginal bleeding, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy" in section 2.

In very rare cases, SSRIs may increase the risk of bleeding, including bleeding from the stomach or intestines. The patient should inform their doctor about vomiting blood or black stools or stools with blood.
The patient should also inform their doctor about persistent symptoms related to depression. These may include hallucinations, anxiety, mania, or confusion.
Side effects usually subside within a few days.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects will help gather more information on the safety of the medicine.

5. How to store Citabax 20

The medicine should be stored out of sight and reach of children.
There are no special storage instructions.
The patient should not take this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

Translation of some abbreviations on the immediate packaging:

Ch.-B. / Verwendbar bis: see embossing - batch number and expiry date: see embossing

6. Contents of the pack and other information

What Citabax 20 contains

The active substance is citalopram (in the form of citalopram hydrobromide).
One film-coated tablet contains 20 mg of citalopram (in the form of citalopram hydrobromide) as the active substance and the following excipients:

• the core of the tablet contains: lactose monohydrate, microcrystalline cellulose, maize starch, copovidone, sodium croscarmellose, magnesium stearate.
• the coating (Opadry white 20H 58983) contains: hypromellose, titanium dioxide (E 171), propylene glycol, hydroxypropylcellulose, talc.

What Citabax 20 looks like and contents of the pack

White or almost white tablets, round, biconvex. On one side, they have the inscription "20", and a dividing line on the other side.
Citabax 20 is available in packs of 30 film-coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the 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
Netherlands

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German authorization number: 60782.01.00

Parallel import authorization number: 211/22 Date of leaflet approval: 17.05.2022

[Information about the trademark]