Cital

Package leaflet: Information for the user

Cital, 20 mg, coated tablets
Citalopramum
Read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Cital is and what it is used for

How Cital works
Cital belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotoninergic system in the brain by increasing serotonin levels. Disturbances in the function of the brain's serotoninergic system play a key role in the development of depression and associated disorders.

When is Cital used?
Cital contains citalopram and is used in the treatment of depression and in preventing relapses of recurrent depressive disorders.
Cital is indicated for the treatment of panic disorder with agoraphobia (e.g. fear of leaving home, crowds, and public places) or without agoraphobia.

2. Important information before using Cital

When not to use Cital:

• if the patient is allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
• simultaneously with medicines called monoamine oxidase inhibitors (MAOIs). MAO inhibitors include medicines such as: phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), and linezolid (an antibiotic).
• if the patient has a congenital abnormal heart rhythm or has experienced an episode of abnormal heart rhythm (visible on ECG; a test assessing heart function).
• when taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section "Cital with other medicines").

If stopping MAO inhibitors: wait 2 weeks before starting Cital.
If stopping moclobemide: wait 1 day before starting Cital.
After stopping Cital: wait 1 week (7 days) before starting any MAO inhibitors.

Warnings and precautions
Before starting Cital, discuss this with your doctor. Inform your doctor if the patient has any other disorders or illnesses, as the doctor should take such information into account. In particular, inform the doctor:

• if the patient has episodes of mania or panic attacks;
• if the patient has impaired liver or kidney function. Dose adjustment by the doctor may be required;
• if the patient has diabetes. Treatment with Cital may affect blood glucose levels. Adjustment of insulin and (or) oral glucose-lowering medicines may be necessary;
• if the patient has epilepsy. If seizures occur or their frequency increases, treatment with Cital should be discontinued (see also section 4: Possible side effects);
• if the patient has an increased tendency to bleed;
• if the patient has low sodium levels in the blood;
• if the patient is undergoing electroconvulsive therapy;
• if the patient has heart disease or recently had a heart attack;
• if the patient has a slow resting heart rate and (or) low electrolyte levels due to prolonged, severe diarrhoea, vomiting, or use of diuretic medicines;
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate an abnormal heart rate;
• if the patient has a problem with dilated pupils of the eye;
• if the patient has a history of blood clotting disorders or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility");
• if the patient is being treated for acute or chronic pain or other conditions with buprenorphine. Using this medicine together with Cital may lead to serotonin syndrome, a potentially life-threatening condition (see "Cital with other medicines").

Medicines such as Cital (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.
Consult your doctor, even if the above warnings relate to conditions that occurred in the past.

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, consult a doctor.
In the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still (akathisia) may also occur. If such symptoms appear, inform the doctor immediately.

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 medicines, as these medicines take some time to work – usually about 2 weeks or longer.
Increased likelihood of such thoughts may occur:

• in patients who previously had suicidal thoughts or thoughts of self-harm.
• 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 were treated with antidepressant medicines.

If the patient experiences any thoughts of self-harm or suicidal thoughts, contact a doctor immediately or go to the nearest hospital.
Informing family members or friends about the depression or anxiety disorder and asking them to read this leaflet may be helpful. The patient may ask them to inform him or her if they notice worsening depression or anxiety or concerning changes in behaviour.

Children and adolescents under 18 years of age
Cital should not be used in children and adolescents under 18 years of age. It should also be emphasized that when taking medicines from this group, patients under 18 years of age are at increased risk of adverse reactions, such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger). Nevertheless, a doctor may prescribe Cital to patients under 18 years of age if he or she considers it to be in their best interest. If a doctor has prescribed Cital to a patient under 18 years of age, consult the doctor in case of any doubts. If the patient under 18 years of age taking Cital experiences or worsening of the above-mentioned symptoms, inform the doctor. Additionally, there is currently no data on the long-term safety of Cital use in this age group regarding growth, maturation, and cognitive and behavioural development.

Additional information about the condition
As with other medicines used to treat depression or related disorders, improvement does not occur immediately. The patient may only feel it several weeks after starting Cital. In the treatment of anxiety disorder with panic attacks, improvement is usually observed after 2–4 weeks. In the initial period of treatment, anxiety may worsen in some patients, 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 the doctor.

Sometimes suicidal thoughts or thoughts of self-harm may be part of the symptoms of depression or anxiety disorder with panic attacks. These symptoms may persist or worsen until the full antidepressant effect of the medicine becomes apparent. The occurrence of these symptoms is more likely in young adult patients, i.e. under 25 years of age, who have not previously taken antidepressant medicines.

Sometimes the patient may not be aware of the occurrence of the above-mentioned symptoms, so it may be advisable to ask someone from family or friends to help monitor possible changes in the patient's behaviour.

If the patient has disturbing thoughts or experiences or if any of the above-mentioned symptoms occur during treatment, seek immediate medical advice from a doctor or the nearest hospital.

Cital with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Some medicines may affect the action of other medicines, which may sometimes cause serious adverse effects. During treatment with Cital, do not take other medicines without prior consultation with a doctor, especially:

• Opioid medicine used to treat acute or chronic pain – buprenorphine. Do not take Cital together with buprenorphine without prior consultation with a doctor. This medicine may interact with Cital and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If such symptoms occur, contact a doctor.

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

• non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, wait 14 days before starting Cital. After stopping Cital, wait 7 days before taking any of these medicines.
• reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (used in the treatment of depression).
• the antibiotic linezolid.
• lithium (used in the prevention and treatment of bipolar affective disorder) and tryptophan.
• imipramine and desipramine (used in the treatment of depression).
• irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used in the treatment of Parkinson's disease); these medicines increase the risk of adverse effects. The dose of selegiline 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 the treatment of migraine) and tramadol, buprenorphine (used in severe pain). These increase the risk of adverse effects; if unusual symptoms occur during combined use of these medicines, consult the treating doctor.
• cimetidine, lansoprazole, and omeprazole (medicines used in the treatment of peptic ulcer disease), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of heart attack). These medicines may increase blood levels of citalopram.
• medicines with known effects on platelet function (e.g. some antipsychotics, tricyclic antidepressants, acetylsalicylic acid (found in painkillers), non-steroidal anti-inflammatory drugs (used in joint inflammation)) – slight increase in bleeding risk.
• St. John's wort (Hypericum perforatum) (a herbal medicine used for depression) – when taken together with Cital, may increase the risk of adverse effects.
• mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (given for severe pain) due to possible risk of lowering the seizure threshold.
• neuroleptics (medicines used in the treatment of schizophrenia, psychosis) due to possible risk of lowering the seizure threshold, and antidepressants.
• medicines that lower potassium or magnesium levels in the blood (increase the risk of life-threatening heart rhythm disorders).
• Do not take Cital simultaneously with medicines used for heart rhythm disorders or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antibacterial medicines (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials – especially halofantrine), some antihistamines (astemizole, mizolastine).

Cital with food, drink and alcohol
Cital can be taken during meals or independently of meals, with liquid (see section 3: "How to take Cital").
It has been shown that Cital does not intensify the effects of alcohol. However, it is recommended not to consume alcohol during treatment with Cital.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Cital is generally not recommended for use in pregnant women, and women taking Cital should not breastfeed unless the risks and benefits of treatment have been discussed with a doctor.
Women taking Cital during the last three months of pregnancy and until delivery should be aware that the newborn 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, constant crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek immediate medical advice.
Inform the doctor and (or) midwife about the use of Cital. Taking medicines such as Cital during pregnancy, especially during the last three months, 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. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact a doctor and (or) midwife immediately.
Taking Cital 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 Cital, she should inform the doctor or midwife so they can provide appropriate advice.
Animal studies have shown that citalopram reduces semen quality. This may theoretically affect fertility, although no effect on human fertility has been observed so far.

Driving and operating machinery
Cital generally does not cause drowsiness; however, if dizziness or drowsiness occurs after starting Cital, do not drive or operate machinery until these symptoms subside.

Cital contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should contact a doctor before taking the medicine.

3. How to take Cital

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
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 daily.
Treatment of anxiety disorder with panic attacks
The initial dose is 10 mg daily for the first week, then increased to 20–30 mg daily. Your doctor may increase the dose up to a maximum of 40 mg daily.
Use of Cital in elderly patients (aged over 65 years)
The initial dose should be reduced by half of the recommended dose, e.g. 10–20 mg daily. In elderly patients, doses exceeding 20 mg daily should not be used.
Use of Cital in specific patient groups
In patients with liver disease, doses exceeding 20 mg daily should not be used.
Use of Cital in children and adolescents (under 18 years of age)
Cital must not be used in children and adolescents under 18 years of age. Additional information is also provided in section 2: "Important information before taking Cital".
Method of administration
Cital should be taken as a single daily dose.
Cital may be taken at any time of day, with or without food.
The tablet should be swallowed whole with water.
Duration of treatment
As with other medicines used in depression and anxiety disorder with panic attacks, improvement may take several weeks. Therefore, continue taking Cital even if it takes some time before you feel better. Do not change the dose without consulting your doctor.
The duration of treatment varies among individual patients; therapy usually lasts at least 6 months.
Treatment should be continued for as long as your doctor recommends, even if your condition improves. The illness 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.
Taking more Cital than prescribed
If you suspect that an overdose of Cital has occurred, contact your doctor or nearest hospital immediately, even if no symptoms or signs of poisoning are present. Take the medicine packaging with you.
Some symptoms of overdose may be life-threatening: irregular heartbeat, seizures, changes in heart rhythm, drowsiness, coma, vomiting, tremors, low blood pressure, high blood pressure, nausea, serotonin syndrome (see section 4), agitation, dizziness, dilated pupils, excessive sweating, cyanosis (bluish skin), hyperventilation.
If you miss a dose of Cital
Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before going to sleep, take the missed dose immediately. Take the next dose at the usual time the following day. If you remember about the missed dose during the night or the next day, skip the missed dose and take the next dose at the usual time.
Stopping Cital
Do not stop taking Cital unless your doctor advises you to do so. When ending treatment, your doctor will usually recommend gradually reducing the dose of Cital over a period of several weeks.
Suddenly stopping Cital may cause mild and transient withdrawal symptoms such as dizziness, prickling sensations, sleep disturbances (vivid dreams, nightmares, insomnia), feeling of restlessness, headache, nausea, vomiting, sweating, psychomotor agitation or restlessness, tremors, feeling of disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations or rapid heartbeat.
Therefore, when ending treatment, it is recommended to gradually reduce the dose of Cital over a few weeks rather than stopping abruptly.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicinal product, this medicine may cause adverse effects, although not everyone experiences them.
Adverse effects usually resolve after a few weeks of treatment. It should be remembered that
some of these effects may also be symptoms of the underlying illness and will subside as the patient's condition improves.
Some patients have reported the following serious adverse effects.
If any of the symptoms listed below occur, treatment with Cital must be discontinued immediately and the prescribing physician must be informed:

• high fever, agitation, disturbances in consciousness, muscle tremors, and violent muscle contractions – these may be symptoms of a rare condition called serotonin syndrome, reported during concomitant use of antidepressant medicines;
• swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction);
• unusual bleeding, including gastrointestinal bleeding.

Rare but serious adverse effects (may occur in less than 1 in 1,000 patients)
If any of the following symptoms occur, treatment with Cital must be discontinued and the prescribing physician must be informed immediately:

• hyponatraemia: reduced sodium concentration in the blood, which may cause fatigue, disorientation, and muscle tremors;
• rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called torsade de pointes.

The adverse effects listed below are usually mild and typically resolve within a few days of treatment. However, it should be remembered that some of the symptoms listed below may also be symptoms of the illness and will subside as the patient's condition improves.
If adverse effects are particularly bothersome and persist for longer than a few days, the physician should be informed.
Very common (may affect more than 1 in 10 patients):

• drowsiness
• headache
• difficulty falling asleep
• excessive sweating
• dryness of the oral mucosa (Dryness of the oral mucosa increases the risk of dental caries. Therefore, teeth should be brushed more frequently than usual.)
• nausea

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

• decreased appetite
• agitation
• reduced sexual drive
• anxiety
• restlessness
• confusion (disorientation)
• unusual dreams
• tremors
• tingling or numbness in hands or feet
• dizziness
• attention disturbances
• ringing in the ears (tinnitus)
• yawning
• diarrhoea
• vomiting
• constipation
• itching
• muscle and joint pain
• in men – problems with ejaculation and erection
• in women – delayed orgasm
• feeling of fatigue
• prickling sensation in the skin
• weight loss

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

• skin bleeding (easy bruising)
• increased appetite
• aggression
• depersonalization (loss of sense of self)
• hallucinations
• mania
• fainting
• dilated pupils
• increased heart rate
• decreased heart rate
• urticaria
• hair loss
• rash
• photosensitivity
• difficulty urinating
• heavy menstrual bleeding
• swelling of hands or feet
• weight gain

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

• seizures
• involuntary movements
• taste disturbances
• bleeding
• hepatitis
• fever

Adverse effects with unknown frequency (cannot be estimated from available data):

• suicidal thoughts and behaviour – see also section “Warnings and precautions”
• reduced platelet count, leading to increased risk of bleeding and development of petechiae on the skin
• hypersensitivity (rash)
• severe allergic reactions causing difficulty breathing or dizziness
• increased urine output
• hypokalaemia: abnormally low potassium levels in the blood, which may cause muscle weakness, muscle tremors, or irregular heart rhythm
• panic attacks
• bruxism (teeth grinding)
• anxiety
• unusual movements or muscle stiffness
• akathisia – psychomotor restlessness – a state of inner restlessness associated with an urge to move
• convulsions
• serotonin syndrome
• visual disturbances
• low blood pressure
• nosebleeds
• bleeding, including petechiae on the skin and mucous membranes
• sudden swelling of the skin or mucous membranes
• painful penile erection
• galactorrhoea in men and in women who are not breastfeeding
• irregular menstrual bleeding, uterine haemorrhage
• abnormal liver function test results
• in patients taking medicines from this group, an increased risk of bone fractures has been observed
• irregular heart rhythm
• severe vaginal bleeding shortly after childbirth (postpartum haemorrhage) – see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Cital

Keep the medicine out of sight and reach of children.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the outer carton and on the blister after:
"Expiry date (EXP)". The first two digits indicate the month and the last four digits indicate the year.
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 how to dispose of medicines you no longer require. This will help protect the environment.

6. Contents of the pack and other information

What Cital contains

• The active substance is citalopram (in the form of citalopram hydrobromide). Each Cital coated tablet contains 20 mg of citalopram (as citalopram hydrobromide).
• Other ingredients are:
  Tablet core: monohydrate lactose, corn starch, microcrystalline cellulose, glycerol 85%, crospovidone, sodium croscarmellose, magnesium stearate.
  Tablet coating: Opadry II: hypromellose 2910 6cP, macrogol 3000, monohydrate lactose, triacetin, titanium dioxide (E171).

What Cital looks like and contents of the pack
Cital 20 mg is a white, round, biconvex film-coated tablet with a score line.
Pack sizes:
Cital film-coated tablets are packed in PVC/Aluminium blisters placed in a cardboard box containing 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert Str. 23
40764 Langenfeld
Germany

Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

For further information, please contact the marketing authorisation holder's representative:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warszawa
[email protected]