PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Citaxin, 20 mg, film-coated tablets
Citalopramum
Please read this leaflet carefully before taking 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. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT CITAXIN IS AND WHAT IT IS USED FOR

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

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 abnormal heart rhythm (so-called congenital QT prolongation) or has experienced episodes of abnormal heart rhythm visible on ECG (a test assessing heart function);
if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm. Please refer to the section "Citaxin and other medicines";
if the patient is taking pimozide (a medicine used to treat psychiatric disorders);
if the patient is taking medicines known as monoamine oxidase inhibitors (MAOIs), including iproniazid, tranylcypromine, phenelzine, isocarboxazid, nialamide, mocllobemide (medicines used in the treatment of depression), or selegiline at a dose greater than 10 mg per day (used in the treatment of Parkinson's disease).
Citaxin treatment may be started no earlier than 2 weeks after discontinuation of medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine. After stopping mocllobemide, at least 1 day must elapse before starting Citaxin. MAO inhibitors should not be used within 7 days after discontinuation of Citaxin.

Warnings and precautions
Before starting Citaxin, discuss this with your doctor or pharmacist.
Medicines such as Citaxin (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Special caution is required:

if the patient has diabetes (dose adjustment of antidiabetic medicines may be necessary),
if the patient has epilepsy or has had epileptic seizures in the past,
if the patient has severe liver and/or kidney disease,
if the patient is undergoing electroconvulsive therapy,
if the patient has glaucoma,
if the patient experiences episodes of mania or panic attacks,
if the patient experiences a feeling of psychomotor restlessness and/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 levels in 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 diarrhoea and vomiting or use of diuretics,
if the patient experiences rapid or irregular heartbeat, fainting, dizziness upon standing, which may indicate abnormal heart function.

Please consult your doctor, even if the above warnings relate to conditions from the past.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and/or anxiety disorders may sometimes experience thoughts of self-harm or suicide. This condition may worsen when patients first start taking antidepressants, and may persist until the medicine begins to work fully, which usually occurs after 2 weeks of treatment or later.
Increased risk of suicidal thoughts occurs in:

patients who previously experienced suicidal thoughts or self-harm,
young adults (clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with antidepressants). If the patient experiences any thoughts of self-harm or suicide, immediately contact a doctor or go to the nearest hospital.

Informing family members or friends about the patient's depression or anxiety disorders and asking them to read this leaflet may be helpful. The patient may ask family members or friends to inform them if they notice worsening of depression or anxiety, or other worrying changes in behaviour.
Children and adolescents
Citaxin should not be used in children and adolescents under 18 years of age. It should also be emphasized that when taking medicines of this class, patients under 18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviours, and anger). Nevertheless, a doctor may prescribe Citaxin to patients under 18 years of age if they determine it is in their best interest. If your doctor has prescribed Citaxin for a patient under 18 years of age and you have any doubts, please contact the prescribing doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Citaxin, inform the doctor. Furthermore, there are currently no data on the long-term safety of Citaxin use in this age group regarding growth, maturation, cognitive development, and behavioural development.
Citaxin and other medicines
Tell your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Some medicines may affect the action of other medicines, which may sometimes cause serious adverse effects.
Special caution is required when using Citaxin with the following medicines:

lithium (used in prevention and treatment of bipolar affective disorder) and tryptophan; if high fever, severe muscle spasms, agitation, or disorientation occur, seek immediate medical attention;
selegiline (used in Parkinson's disease) – selegiline dose must not exceed 10 mg per day;
metoprolol (used in hypertension and/or heart disease) – blood levels of metoprolol increase, but no symptoms of enhanced or adverse effects of metoprolol have been observed;
sumatriptan and similar medicines (used in migraine treatment) – risk of adverse effects; if unusual symptoms occur during concomitant use of these medicines, consult your treating physician;
cimetidine, lansoprazole, and omeprazole (medicines used in peptic ulcer disease), fluconazole (used in fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of heart attack). These medicines may increase blood levels of citalopram;
medicines affecting platelet function, e.g. certain antipsychotics, tricyclic antidepressants, acetylsalicylic acid (found in painkillers), nonsteroidal anti-inflammatory drugs (used in joint inflammation) – slight increased risk of bleeding;
St. John's wort (Hypericum perforatum) – when used concomitantly with Citaxin, may increase the risk of adverse effects.

DO NOT USE CITAXIN during treatment with medicines that regulate heart rhythm or medicines that may alter heart rhythm, e.g. antiarrhythmic agents of class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials – especially halofantrine), certain antihistamines (astemizole, mizolastine). If in doubt, consult your doctor.
Citaxin with food, drink and alcohol
Citaxin may be taken during meals or independently of meals.
Citaxin does not enhance the effects of alcohol; however, it is recommended not to consume alcohol while taking this medicine.
Pregnancy, breastfeeding and fertility
Before taking any medicine, consult your doctor or pharmacist.
Citaxin should not be used in pregnant women.
Women taking Citaxin should not breastfeed.
Women taking antidepressants during the last 3 months of pregnancy until delivery should be aware that newborns may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflex excitability, tremors, jitteriness, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If any of these symptoms occur in the newborn, seek immediate medical attention.
Taking Citaxin near the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of coagulation disorders. If a patient is taking Citaxin, she should inform her doctor or midwife so they can provide appropriate advice.
Ensure that the midwife and/or doctor are aware that the patient is taking Citaxin. Similar medicines (selective serotonin reuptake inhibitors - SSRIs) taken during pregnancy may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and bluish skin. These symptoms usually occur within the first day of the baby's life. If this occurs, contact the midwife and/or doctor immediately.
Animal studies have shown that citalopram reduces semen quality. This may theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
Citaxin usually does not cause drowsiness; however, if dizziness or drowsiness occurs after starting treatment, driving motor vehicles or operating mechanical equipment should be avoided until these symptoms subside.
Citaxin contains lactose (a type of sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Citaxin contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning 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 instructions. If in doubt, consult your doctor or pharmacist.
What dose should be taken
Adults
Depression
The usual dose is 20 mg daily. The doctor may increase the dose up to a maximum of 40 mg daily.
Anxiety disorders with panic attacks
During the first week of treatment, the initial dose is 10 mg, then increased to 20–30 mg daily. The doctor may increase the dose up to a maximum of 40 mg daily.
Elderly persons (over 65 years)
The initial dose should be reduced by half of the recommended dose, i.e. 10–20 mg daily.
Elderly persons should generally not take doses exceeding 20 mg daily.
Persons at particular risk
Patients with impaired liver function should not take doses exceeding 20 mg daily.
Citaxin should not be used in severe renal insufficiency unless otherwise directed by a doctor.
Children and adolescents (under 18 years)
Do not use, unless otherwise directed by a doctor (see section 2).
Citaxin should be taken regularly, once daily. It can be taken at any time of day, with or without food.
Swallow the tablet with water.
The tablet may be divided into equal doses.
Duration of treatment
As with other medicines used in depression and anxiety disorders with panic attacks, improvement is usually seen after several weeks of treatment.
The duration of treatment varies among individual patients but usually lasts at least 6 months.
Treatment should be continued as long as directed by the doctor, even if well-being improves.
The illness may persist for a long time, and if treatment is stopped too early, symptoms may return.
In patients with recurrent depression, long-term maintenance treatment may be necessary for several years to prevent new depressive episodes.
Do not change the dosage without consulting your doctor.
Taking more than the recommended dose of Citaxin
After taking more than the recommended dose of Citaxin, the following may occur: excessive drowsiness, coma, agitation, dizziness, pupil dilation, seizures, abnormal heart function, low blood pressure, high blood pressure, nausea, vomiting, tremors, serotonin syndrome (see section 4).
If overdose is suspected, seek immediate medical attention from a doctor or the nearest hospital emergency department, even if there are no symptoms or signs of poisoning. Bring the Citaxin packaging with you.
Missing a dose of Citaxin
If a dose is missed at the scheduled time, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.
Stopping Citaxin
Abruptly stopping the medicine may cause mild and transient withdrawal symptoms such as: dizziness, prickling sensations, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea, vomiting, sweating, psychomotor agitation or restlessness, tremors, feelings of disorientation, emotional instability or irritability, diarrhoea, visual disturbances, palpitations or increased heart activity (heart palpitations). Therefore, the medicine should be discontinued gradually.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should stop taking Citaxin immediately and contact your doctor if any of the following symptoms occur:

high fever, agitation, disturbances in consciousness, muscle tremors, or sudden muscle spasms (these may be symptoms of a rare condition called serotonin syndrome, which may occur when antidepressant medicines are used together),
swelling of the skin, tongue, lips, or face, difficulty breathing or swallowing (an allergic reaction),
unusual bleeding (including gastrointestinal bleeding),
nausea and malaise accompanied by muscle weakness or disturbances in consciousness (these may be symptoms of a rare condition involving abnormally low blood sodium levels),
rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.

The adverse reactions listed below are usually mild and typically resolve within a few days of treatment.
However, it should be remembered that some of these symptoms may also be caused by the underlying illness itself and may resolve as the condition improves.

Very common adverse reactions (observed in more than 1 in 10 patients): drowsiness, insomnia, dryness of the oral mucosa, nausea, excessive sweating.

Common adverse reactions (observed in more than 1 but less than 10 in 100 patients): decreased appetite, agitation, reduced libido, anxiety, nervousness, confusion (disorientation), tremors, tingling or pricking sensations in the skin, tinnitus, yawning, diarrhoea, vomiting, itching, muscle pain, joint pain, feeling of fatigue, weight loss, orgasmic disturbances in women, erectile dysfunction and ejaculation problems in men.

Uncommon adverse reactions (observed in more than 1 but less than 10 in 1,000 patients): increased appetite, aggression, depersonalization (loss of sense of one's own identity), hallucinations, mania, fainting, dilated pupils, increased or slowed heart rate, urticaria, alopecia, rash, purpura, urinary retention, menstrual bleeding in women, oedema, weight gain.

Rare adverse reactions (observed in more than 1 but less than 10 in 10,000 patients): low blood sodium levels, seizures, involuntary movements, hepatitis.

Adverse reactions with unknown frequency (cannot be estimated from available data): reduced platelet count (often presenting as increased tendency to bruising and bleeding), hypersensitivity (often manifesting as rash), inappropriate secretion of antidiuretic hormone (presenting as increased urine output), panic attacks, bruxism (teeth grinding), restlessness, suicidal thoughts, suicidal behaviour, convulsions, serotonin syndrome (see above), feeling of inner restlessness and/or need to move frequently, movement disorders, visual disturbances, orthostatic hypotension (related to changing to an upright position), nosebleeds, gastrointestinal bleeding, petechiae, angioedema, vaginal bleeding in women, severe postpartum vaginal bleeding (postpartum haemorrhage), see additional information in section Pregnancy, breastfeeding and fertility in section 2, painful penile erection, and galactorrhoea in men, abnormal results of liver function tests.

Dryness of the oral mucosa increases the risk of dental caries. If dry mouth occurs, teeth should be brushed more frequently than usual.

In patients taking medicines of the same type as Citaxin, an increased risk of bone fractures has been observed.

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult a doctor or pharmacist.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE CITAXIN

Store below 30°C.
Keep in the original packaging.
Keep the medicine 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Citaxin contains

The active substance is citalopram. Each tablet contains 20 mg of citalopram (as citalopram hydrobromide – 24.98 mg).
Other ingredients are: microcrystalline cellulose (E 460), lactose monohydrate, corn starch, sodium croscarmellose, glycerol (E 422), copovidone, magnesium stearate, and Sepifilm 752 White coating containing: hypromellose (E 464), microcrystalline cellulose (E 460), polyglyceryl stearate, titanium dioxide (E 171).

What Citaxin looks like and contents of the pack
White, oval, biconvex film-coated tablets with a division line. The tablet can be divided into equal doses.
This medicine is packed in blisters made of Aluminium/PVC/PVDC, placed in a cardboard box.
Pack sizes:
28, 56 or 84 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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