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

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This 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.

Table of contents of the leaflet

What is Citabax 20 and what it is used for
Important information before taking Citabax 20
How to take Citabax 20
Possible side effects
How to store Citabax 20
Contents of the pack and other information

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

How Citabax 20 works
Citalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines help correct chemical imbalances in the brain that cause symptoms of illness.
When is Citabax 20 used
Citabax 20 contains citalopram and is used in the treatment of depression, and once the patient feels better, to prevent recurrence of depressive symptoms. Citabax 20 is also used long-term to prevent new episodes of depression in patients with recurrent depressive disorders.
Citabax 20 also has a beneficial effect in reducing symptoms when the patient suffers from anxiety attacks.

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 suspects an allergy, they should consult a doctor;
if the patient is taking medicines called monoamine oxidase inhibitors (MAOIs). Monoamine oxidase inhibitors (MAOIs) include medicines containing: phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine and moclobemide (used in the treatment of depression), selegiline (used in the treatment of Parkinson's disease) or linezolid (an antibiotic). Even if the patient has stopped taking any of the following MAO inhibitors: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine, a 2-week interval must be observed before

starting treatment with Citabax 20. After stopping moclobemide,
a 1-day interval must elapse. After stopping Citabax 20,
a 1-week interval must elapse before any MAO inhibitor is used;

concomitantly with pimozide (an antipsychotic);
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 which may affect heart rhythm (see below "Citabax 20 and other medicines").

Warnings and precautions
Tell the doctor if the patient has any other disorders or diseases. In particular, inform the doctor about:

liver function disorders;
kidney function disorders;
diabetes (adjustment of antidiabetic medication dosage may be necessary);
epilepsy or history of seizures;
blood clotting disorders or if the patient has ever experienced bleeding from the stomach or intestines, or if the patient is pregnant (see "Pregnancy");
mania or anxiety disorders;
low blood sodium levels;
treatment with electroconvulsive therapy;
eye disorders, such as certain types of glaucoma;
heart disorders or if a heart attack ("attack") has recently occurred;
slow resting heart rate and (or) reduced electrolyte levels due to persistent severe diarrhoea, vomiting or use of diuretics (water pills);
rapid or irregular heartbeat, fainting, collapse or dizziness upon standing, which may indicate heart rhythm disturbances.

Consult a doctor, even if the above warnings relate to conditions that occurred
in the past.
Medicines such as Citabax 20 (so-called SSRIs or SNRIs) may cause symptoms
of sexual dysfunction (see section 4). In some cases, these symptoms may persist
after discontinuation of treatment.
Note
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 contact their doctor.
In the first weeks of treatment, symptoms such as restlessness or difficulty
sitting or standing still may also occur. If such symptoms appear, the patient should
inform their doctor immediately.
Additional information about the condition
As with other medicines used to treat depression or associated disorders,
improvement does not occur immediately. The patient may only notice improvement
after several weeks of treatment with Citabax 20. In the initial phase of treatment,
some patients may experience increased anxiety, which subsides during treatment.
It is therefore very important that the patient strictly follows the doctor's instructions
and does not discontinue treatment or change the dose without consulting a doctor.
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 about
two weeks or longer.
Increased tendency towards such thoughts may occur:

in patients who previously experienced 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 are taking antidepressants.

If the patient experiences any thoughts of self-harm or suicide, they should
contact a doctor immediately or go to a hospital.
Informing relatives or friends about depression or anxiety disorders
may be helpful, and asking them to read this leaflet. The patient may ask them
to inform the patient 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 medicines from this group are used, patients under 18 years of age are at increased risk
of adverse effects, such as suicide attempts, suicidal thoughts and hostility (particularly
aggression, oppositional behaviour and expressions of anger). Nevertheless, a doctor may
prescribe Citabax 20 to patients under 18 years of age if they determine it is in their best interest.
If a doctor has prescribed Citabax 20 to a patient under 18 years of age, any doubts should be
discussed with the doctor. If any of the above-mentioned symptoms develop or worsen in patients
under 18 years of age taking Citabax 20, the doctor should be informed. Furthermore, there are
currently no data on the long-term safety of Citabax 20 in this age group regarding growth,
puberty, cognitive development and behavioural development.
Citabax 20 and other medicines
Medicines may affect the action of other medicines, which may sometimes lead to serious adverse
reactions. Inform the doctor or pharmacist about all medicines currently taken or recently taken,
as well as medicines the patient plans to take. This also includes other medicines used for depression (see above "When not to use Citabax 20").

St. John's wort ( Hypericum perforatum ). Do not use simultaneously with Citabax 20.
Monoamine oxidase inhibitors (MAOIs). Do not use simultaneously with Citabax 20 (see above "When not to use Citabax 20").

Inform the doctor if the patient is taking any of the following medicines:

cimetidine, lansoprazole and omeprazole (medicines used in the treatment of 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 the blood concentration of citalopram.
linezolid (an antibiotic);
sumatriptan (used to treat migraine) or tramadol (a painkiller). If the patient feels unwell while taking these medicines with Citabax 20, contact the doctor;
lithium (used to prevent and treat mania) and tryptophan (an antidepressant);
pimozide (an antipsychotic). It must not be used simultaneously with 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 known to affect platelet function (e.g. anticoagulants used to treat or prevent blood clots; acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and diclofenac, used as painkillers, and some antipsychotics and tricyclic antidepressants);
metoprolol (a beta-blocker used to treat migraine, certain heart conditions and hypertension). The effect of these medicines may be enhanced, reduced or altered;
antipsychotics (used to treat schizophrenia).

Do not use Citabax 20 during treatment with 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, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have further questions, contact your doctor.
Citabax 20 with food, drink and alcohol
Citabax 20 may be taken with or without food (see section 3).
As with all antidepressants, it is advisable 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, consult a doctor or pharmacist.
If the patient is pregnant, suspects she is pregnant or plans to become pregnant, she should
inform her doctor. Pregnant women should not use Citabax 20 unless the doctor
has explained the risks and benefits of treatment.
Inform the doctor and (or) midwife about taking Citabax 20. Taking medicines such as
Citabax 20 during pregnancy, especially during the last three months of pregnancy, may
increase the risk of serious complications in the newborn, known as persistent pulmonary
hypertension of the newborn (PPHN). It manifests as rapid breathing and cyanosis (bluish skin).
These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn,
contact a doctor and (or) midwife immediately. Women taking 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 falling asleep.
If any of these symptoms occur in the newborn, contact the 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.
Breast-feeding
Before taking any medicine, consult a doctor or pharmacist.
If the patient is breast-feeding, she should consult a doctor. Breast-feeding should not be
undertaken during treatment with Citabax 20, as small amounts of the medicine may pass into
breast milk.
Effect on fertility
Animal studies have shown that citalopram impairs sperm quality. This effect may theoretically
affect fertility, although reduced fertility has not been observed in humans to date.
Driving and operating machinery
Citabax 20 generally does not affect the ability to perform daily activities. However,
if dizziness or drowsiness occurs after starting treatment with Citabax 20,
caution should be exercised when driving or performing tasks requiring concentration,
until these symptoms subside.
Citabax 20 contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars,
they 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 take Citabax 20

What dose to take
Citabax 20 should always be taken exactly as prescribed by your doctor.
If you are unsure, consult your 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
The usual dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg once daily.

Treatment of panic disorder with agoraphobia
The initial dose is 10 mg once daily for the first week. It is then increased to 20–30 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg once daily.

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

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

Use of Citabax 20 in special patient groups
Patients with liver disease should not take more than 20 mg once daily.

How to take it
Citabax 20 should be taken daily as a single dose. Citabax 20 can be taken at any time of day, with or without food. Swallow the tablet with water.
Do not chew the tablet (tablets have a bitter taste).

Duration of treatment
As with other medicines used in the treatment of depression and panic disorder with agoraphobia, improvement may take several weeks. Therefore, continue taking Citabax 20 even if you do not feel better at first. The duration of treatment varies among individual patients. Therapy usually lasts at least 6 months. Treatment should be continued as long as your doctor recommends, even if your mood improves. The condition may persist for a long time, and if treatment is stopped too early, symptoms may return.

In patients with recurrent depression, maintenance treatment may last several years to prevent new depressive episodes.

Do not change the dosage without consulting your doctor.

Taking more Citabax 20 than prescribed
If you or anyone else suspects having taken too many Citabax 20 tablets, seek immediate medical advice from a doctor or the nearest hospital emergency department, even if there are no symptoms or signs of poisoning. Bring the medicine packaging with you.
Some symptoms of overdose may be life-threatening.

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,
skin cyanosis (bluish discoloration),
abnormally rapid breathing.

If you miss a dose of Citabax 20
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 20
Suddenly stopping Citabax 20 may cause withdrawal symptoms such as:
dizziness, nausea, and tingling or numbness in hands or feet, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety, headache, nausea or vomiting, sweating, psychomotor agitation or restlessness, tremors, confusion or disorientation, emotional instability or irritability, diarrhea, visual disturbances, palpitations or rapid heart rate (palpitations). These are usually mild adverse effects that resolve within a few days.

Therefore, when ending treatment, it is recommended to gradually reduce the dose of Citabax 20 over a few weeks.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Please bear in mind that some of these side effects may also be symptoms of the illness itself and may resolve as your condition improves.
Serious side effects
If any of the following symptoms occur, stop taking Citabax 20 immediately and contact your doctor:

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

If any of the symptoms listed below occur, contact your doctor immediately, as it may be necessary to reduce the dose or discontinue the medicine:

seizures (for the first time in life) or increased frequency of seizures,
changes in behaviour such as feeling agitated or overly excited,
high fever, agitation, confusion, tremors or sudden muscle contractions. These symptoms may indicate a rare condition called serotonin syndrome,
fatigue, disorientation and muscle tremors, which may result from low sodium levels in the blood (hyponatraemia).

If a patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact a doctor or go to hospital.
The following side effects are usually mild in intensity and typically resolve within a few days of treatment.
Very common side effects (occurring in more than 1 in 10 patients):

drowsiness;
difficulty falling asleep;
headache;
sleep disturbances;
weakness;
excessive sweating;
dry mouth (increases the risk of tooth decay, so teeth should be brushed more frequently than usual);
nausea.

Common side effects (may affect less than 1 in 10 patients):

decreased appetite;
restlessness;
reduced sexual drive;
anxiety;
nervousness;
disorientation regarding place and time (confusion);
unusual dreams;
reduced emotional response, feeling of indifference (apathy);
tremors;
tingling or numbness in hands or feet;
dizziness;
attention disturbances;
migraine;
memory loss;
ringing in the ears (tinnitus);
sensation of irregular heartbeat (palpitations);
yawning;
stuffy nose or runny nose (rhinitis);
diarrhoea;
vomiting;
constipation;
indigestion;
stomach ache;
bloating (gas);
increased salivation;
itching;
muscle and joint pain;
in men - problems with ejaculation and erection;
in women - delayed orgasm;
feeling of fatigue;
weight loss.

Uncommon side effects (may affect less than 1 in 100 patients):

increased appetite;
aggression;
hallucinations;
mania;
depersonalisation (feeling detached from one's body);
fainting;
increased sexual drive;
dilated pupils;
rapid heartbeat;
slow heartbeat;
urticaria (hives);
hair loss;
rash;
redness of the skin or skin spots (purpura);
photosensitivity (increased sensitivity to sunlight);
problems with urination;
heavy menstrual bleeding;
swelling of hands or feet;
weight gain.

Rare side effects (may affect less than 1 in 1000 patients):

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

Some patients have reported (frequency unknown):

thoughts of self-harm and suicidal thoughts, see also section 2;
increased frequency of bleeding and bruising, caused by reduced platelet count;
hypersensitivity, sudden severe allergic reaction (anaphylactic reaction), manifesting as difficulty breathing, swelling of the face, lips, tongue or throat causing difficulty in swallowing or breathing, severe itching (with raised lumps on the skin). If these symptoms occur, stop taking Citabax 20 immediately and contact your doctor;
increased urine output (inappropriate antidiuretic hormone [vasopressin] secretion);
low potassium levels in the blood, which may cause muscle weakness, tremors or irregular heartbeat;
panic attacks;
teeth grinding;
feeling of restlessness;
unusual movements or muscle stiffness;
involuntary movements (akathisia);
movement disorders;
low blood pressure, manifesting as dizziness upon standing;
visual disturbances;
nosebleeds;
bleeding, including petechiae on the skin and mucous membranes;
sudden swelling of the skin or mucous membranes;
seizures;
high fever, agitation, confusion, tremors or sudden muscle contractions (serotonin syndrome);
painful erection in men (priapism);
milk secretion (galactorrhoea) in men and in women who are not breastfeeding;
irregular menstruation;
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 disturbances;
severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy" in section 2.

In very rare cases, SSRIs may increase the risk of bleeding, including gastrointestinal bleeding (bleeding from the stomach or intestines). Inform your doctor if you experience vomiting blood, black stools or stools with blood.
You should also inform your doctor if other symptoms related to depression persist.
These may include hallucinations, anxiety, mania or confusion.
Side effects usually resolve within a few days.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
By reporting side effects, additional information on the safety of the medicine can be collected.

5. How to store Citabax 20

Keep the medicine out of the sight and reach of children.
No special storage instructions are required.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer in use. This will help protect the environment.
Translation of some abbreviations appearing on the immediate packaging:
Ch.-B. / Verwendbar bis: siehe Prägung – batch number and expiry date: see impression

6. Contents of the packaging and other information

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

Core composition: monohydrate lactose, microcrystalline cellulose, corn starch, copovidone, sodium croscarmellose, magnesium stearate.
Coating (Opadry white 20H 58983): hypromellose, titanium dioxide (E 171), propylene glycol, hydroxypropylcellulose, talc.

What Citabax looks like and contents of the pack
White or almost white, round, biconvex tablets. On one side they have the engraved mark "20" and a score line on the other side.
Citabax is available in packs containing 30 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or 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
Netherlands
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Number of Marketing Authorisation in Germany, country of export: 60782.01.00
Parallel Import Authorisation Number: 211/22