Citaxin

LEAFLET INCLUDED IN THE PACKAGE: PATIENT INFORMATION

Citaxin, 20 mg, coated tablets
Citalopram

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

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

1. WHAT IS CITAXIN AND WHAT IS IT USED FOR

Citaxin is an antidepressant that selectively enhances the action of one of the neurotransmitters - serotonin. Due to the fact that its action is limited to only one neurotransmitter, the drug relatively rarely causes side effects (less often than, for example, tricyclic antidepressants).
Citaxin is used in the treatment of depression (both in initial and maintenance treatment, aimed at preventing relapse of the disease) and anxiety disorders with panic attacks (both with agoraphobia, i.e. fear of open spaces, and without).

2. IMPORTANT INFORMATION BEFORE TAKING CITAXIN

When not to take Citaxin

• if the patient is allergic to citalopram or any of the other ingredients of this medicine (listed in section 6);
• if the patient was born with an irregular heart rhythm (so-called congenital prolongation of the QT interval) or had an episode of irregular heart rhythm visible on the ECG (a test evaluating heart function);
• if the patient is taking medications used to treat heart rhythm disorders or medications that may affect heart rhythm. You should read the section "Citaxin and other medicines";
• if the patient is taking pimozide (a medicine used in psychiatric disorders);
• if the patient is taking monoamine oxidase inhibitors, including iproniazid, tranylcypromine, phenelzine, isocarboxazid, nialamide, moclobemide (medicines used in the treatment of depression), selegiline in a dose greater than 10 mg per day (used in the treatment of Parkinson's disease).

Administration of Citaxin can be started no earlier than 2 weeks after the end of administration of medicines such as: phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine. After the end of administration of moclobemide, you should wait at least 1 day before starting administration of Citaxin. Monoamine oxidase inhibitors should not be administered for 7 days after discontinuation of Citaxin.

• Caution should be exercised:
• if the patient has diabetes(it may be necessary to reduce the doses of antidiabetic medicines),
• if the patient has epilepsyand has had seizures in the past,
• if the patient has severe liver diseaseand/or kidney disease,
• if the patient is being treated with electroconvulsive therapy,
• if the patient has glaucoma,
• if the patient has episodes of maniaor panic anxiety,
• if the patient has a feeling of restlessnessand/or a need to move frequently (akathisia),
• if the patient has certain bleeding disorders, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility"),
• if the patient has low sodium levelsin the blood,
• if the patient has heart disease or has recently had a heart attack,
• if the patient has a low resting heart rate and/or may have lost electrolytes due to prolonged, severe diarrhea and vomiting or taking diuretics,
• if the patient experiences rapid or irregular heartbeat, fainting, dizziness or dizziness when standing up, which may indicate abnormal heart function.

Consult a doctor, even if the above warnings refer to situations that have occurred in the past.

Suicidal thoughts and worsening of depression or anxiety disorders

In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm may sometimes occur. This condition may worsen when the patient first starts taking antidepressants, and may persist until the medicine starts to work, which usually happens after 2 weeks of treatment or later.
A greater tendency to suicidal thoughts applies to:

• patients who have had suicidal thoughts or self-harm in the past,
• 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 treated with antidepressants). If the patient experiences any suicidal thoughts or self-harm, they should immediately contact their doctor or go to the nearest hospital.

It may be helpful to inform relatives or friends about the patient's depressionor anxiety disorder and ask them to read the leaflet. The patient may ask their relatives or friends to inform them if they notice an increase in depression or anxiety and other worrying changes in their behavior.

Children and adolescents

Citaxin should not be used in children and adolescents under 18 years of age. It should also be emphasized that in the case of taking medicines of this class, 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 Citaxin to patients under 18 years of age, stating that it is in their best interest. If the doctor has prescribed Citaxin to a patient under 18 years of age, and you have any doubts, please contact the doctor. In the event of development or worsening of the above symptoms in patients under 18 years of age taking Citaxin, the doctor should be informed. Additionally, as of now, there is a lack of data on the long-term safety of Citaxin in this age group regarding growth, maturation, and cognitive and behavioral development.

Citaxin and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect the action of other medicines, which can sometimes cause serious side effects.
Particular caution should be exercised when taking Citaxin with the following medicines:

• lithium (used in the prevention and treatment of bipolar affective disorder) and tryptophan; if high fever and severe muscle spasms, excitement, and disorientation occur, you should immediately consult a doctor;
• selegiline (used in Parkinson's disease) - the dose of selegiline should not exceed 10 mg per day;
• metoprolol (used in hypertension and/or heart disease) - the concentration of metoprolol in the blood increases, but no signs of increased action or side effects of metoprolol have been found;
• sumatriptan and similar medicines (used in the treatment of migraine) - risk of side effects; if unusual symptoms occur during combined use of these medicines, you should consult your doctor;
• cimetidine, lansoprazole, and omeprazole (medicines used in the treatment of stomach ulcers), fluconazole (a medicine used in the treatment of fungal infections), fluvoxamine (an antidepressant) and ticlopidine (a medicine used to reduce the risk of heart attack). These medicines may cause an increase in the concentration of citalopram in the blood;
• medicines that affect platelet function, such as some antipsychotic medicines, tricyclic antidepressants, acetylsalicylic acid (found in painkillers), and non-steroidal anti-inflammatory medicines (used in arthritis) - a slight increase in the risk of bleeding;
• St. John's wort (Hypericum perforatum) - when taken together with Citaxin, it may increase the risk of side effects.

DO NOT TAKE CITAXINwhile taking medicines that regulate heart rhythm and medicines that may change 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, intravenous erythromycin, pentamidine, anti-malarial medicines - especially halofantrine), and some antihistamines (astemizole, mizolastine). In case of doubts, consult your doctor.

Citaxin with food, drink, and alcohol

Citaxin can be taken during meals or independently of meals.

Citaxin does not enhance the effects of alcohol, but it is recommended not to consume alcohol while taking the medicine.

Pregnancy, breastfeeding, and fertility

Before using any medicine, consult your doctor or pharmacist.
Citaxin should not be used in pregnant women.
Women taking Citaxin should not breastfeed.
Patient women taking antidepressant medicines in the last 3 months of pregnancy and up to the time of delivery should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflex excitability, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If any of these symptoms occur in the newborn, you should immediately consult a doctor.
Taking Citaxin at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Citaxin, they should inform their doctor or midwife so that they can provide appropriate advice.
It should be ensured that the midwife and/or doctor are aware that the patient is taking Citaxin. Similar medicines (from the SSRI group) taken by pregnant women may increase the risk of a serious disease called persistent pulmonary hypertension in newborns (PPHN), causing rapid breathing and blue skin in the baby. These symptoms usually occur within the first day of life. If this happens, you should immediately contact the midwife and/or doctor.
Animal studies have shown that citalopram reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

Citaxin usually does not cause drowsiness, but if dizziness or drowsiness occurs after starting treatment, you should not drive vehicles or operate machinery in motion until these symptoms subside.

Citaxin contains lactose (a type of sugar)

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

Citaxin contains sodium

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

3. HOW TO TAKE CITAXIN

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, consult your doctor or pharmacist.

What dose of the medicine should be taken

Adults
Depression
The usual dose is 20 mg per day. The doctor may increase the dose to a maximum of 40 mg per day.
Anxiety disorders with panic attacks
In the first week of treatment, the initial dose is 10 mg, and then it is increased to 20-30 mg per day. The doctor may increase the dose to a maximum of 40 mg per day.
Elderly patients (over 65 years old)
The initial dose should be reduced to half of the recommended dose, i.e. 10-20 mg per day.
Elderly patients usually should not take doses greater than 20 mg per day.
Patients at special risk
Patients with liver function disorders should not take doses greater than 20 mg per day.
In severe renal failure, the medicine should not be used, unless the doctor recommends otherwise.
Children and adolescents (under 18 years old)
Do not use, unless the doctor recommends otherwise (see section 2).
Citaxin should be taken regularly, once a day. It can be taken at any time of day, with or without food.
The tablet should be swallowed with water.
The tablet can be divided into equal doses.
Duration of treatment
As with other medicines used in depression and anxiety disorders with panic attacks, improvement is achieved after a few weeks of treatment.
The duration of treatment in individual patients is different, but it usually lasts at least 6 months.
Treatment should be continued for as long as the doctor recommends, even if there is an improvement in well-being.
The disease may persist for a long time, and if treatment is stopped too early, symptoms may return.
In patients with recurrent depression, it may be necessary to continue maintenance treatment for several years.
Do not change the dosage without consulting your doctor.

Taking a higher dose of Citaxin than recommended

After taking a higher dose of Citaxin than recommended, the following may occur: excessive drowsiness, coma, excitement, dizziness, pupil dilation, seizures, abnormal heart function, low blood pressure, high blood pressure, nausea, vomiting, tremors, serotonin syndrome (see section 4).
In case of suspected overdose of Citaxin, you should immediately consult a doctor or go to the emergency room of the nearest hospital, even if there are no symptoms or signs of poisoning. You should take the Citaxin packaging with you.

Missing a dose of Citaxin

If a dose is missed at the scheduled time, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for the missed dose.

Stopping Citaxin treatment

Sudden discontinuation of the medicine may cause mild and temporary withdrawal symptoms, such as: dizziness, feeling of tingling, sleep disturbances (vivid dreams, nightmares, insomnia), feeling of restlessness, headache, nausea (nausea), vomiting, sweating, psychomotor agitation or excitement, tremors, feeling of disorientation, emotional instability or irritability, diarrhea, vision disturbances, palpitations or increased heart rate (palpitations). For this reason, the medicine should be discontinued gradually.
In case of any further doubts related to 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 gets them.
You should stop taking Citaxin and inform your doctor immediately if you experience any of the following symptoms:

• high fever, excitement, altered consciousness, tremors, and severe muscle spasms (these may be symptoms of a rare disorder called serotonin syndrome, which occurs during combined use of antidepressant medicines),
• swelling of the skin, tongue, lips, or face, difficulty breathing or swallowing (allergic reaction),
• unusual bleeding (including gastrointestinal bleeding),
• nausea and malaise with muscle weakness or altered consciousness (these may be symptoms of a rare, abnormally low sodium level in the blood),
• rapid or irregular heartbeat, fainting, which may be a sign of a life-threatening condition called torsade de pointes.

The following side effects are usually mild and usually disappear after a few days of treatment. However, it should be remembered that some of these symptoms may also be caused by the disease itself and may disappear as the improvement occurs.
Very common side effects (occurring in more than 1 in 10 patients): feeling of drowsiness, insomnia, dryness of the mucous membrane of the mouth, nausea, increased sweating.
Common side effects (occurring in more than 1 in 100 patients but less than 1 in 10): decreased appetite, excitement, decreased libido, restlessness, nervousness, confusion (disorientation), tremors, feeling of tingling or tingling in the skin, tinnitus, yawning, diarrhea, vomiting, itching, muscle pain, joint pain, feeling of fatigue, weight loss, orgasm disorder in women, erection and ejaculation problems in men.
Uncommon side effects (occurring in more than 1 in 1,000 patients but less than 1 in 100): increased appetite, aggression, depersonalization (loss of sense of one's own personality), hallucinations, mania, fainting, pupil dilation, rapid or slow heart rate, hives, hair loss, rash, purpura, urinary retention, menstrual bleeding in women, edema, weight gain.
Rare side effects (occurring in more than 1 in 10,000 patients but less than 1 in 1,000): low sodium levels in the blood, seizures, involuntary movements, hepatitis.
Side effects with unknown frequency (cannot be estimated from available data): decreased platelet count (often manifested as increased tendency to bruising and bleeding), hypersensitivity (often manifested as rash), inappropriate antidiuretic hormone secretion (manifested as increased urine output), panic anxiety attacks, bruxism (grinding teeth), restlessness, suicidal thoughts, suicidal behavior, seizures, serotonin syndrome (see above), feeling of restlessness and/or need to move frequently, movement disorders, vision disturbances, orthostatic hypotension (related to changes in body position), nosebleeds, gastrointestinal bleeding, bruising, angioedema, menstrual bleeding in women, severe postpartum hemorrhage (see additional information in the subsection Pregnancy, breastfeeding, and fertility in section 2), painful erection of the penis and galactorrhea in men, abnormal liver function test results.
Dryness of the mucous membrane of the mouth increases the risk of tooth decay. If such dryness occurs, you should brush your teeth more often than usual.
In patients taking medicines of this type, such as Citaxin, an increased risk of bone fractures has been observed.
If you experience any side effects, including those not listed in this leaflet, you should consult your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to: Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
tel.: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. HOW TO STORE CITAXIN

Store in a temperature below 30°C.
Store in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Citaxin contains

• The active substance of the medicine is citalopram. One tablet contains 20 mg of citalopram (in the form of citalopram hydrobromide - 24.98 mg).
• The other ingredients are: microcrystalline cellulose (E 460), lactose monohydrate, corn starch, sodium carmellose, glycerol (E 422), copovidone, magnesium stearate, and a Sepifilm 752 White coating with the following composition: hypromellose (E 464), microcrystalline cellulose (E 460), magnesium stearate, titanium dioxide (E 171).

What Citaxin looks like and what the package contains

White, oval, biconvex, coated tablets with a dividing line. The tablet can be divided into equal doses.
This medicine is packaged in aluminum/PVC/PVDC blisters in a cardboard box.
Package sizes:
28, 56, or 84 coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-959 Rzeszów, Poland

Date of last revision of the leaflet: