Package leaflet: Information for the user

Citalopram Vitabalans, 20 mg, film-coated tablets
Citalopramum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Citalopram Vitabalans is and what it is used for

Citalopram Vitabalans contains citalopram as the active substance and belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs), which are used as antidepressants (in the treatment of depression). These medicines act on the serotonin system in the brain.
Citalopram Vitabalans is used in the treatment of depression, anxiety disorders (panic attacks) with or without agoraphobia, obsessive-compulsive disorders (obsessive thoughts and behaviors), and in the prevention of recurrence of depression.

2. Important information before using Citalopram Vitabalans

When not to use Citalopram Vitabalans

if the patient is allergic to citalopram or any of the other ingredients of this medicine (listed in section 6);
if the patient is currently taking or has taken monoamine oxidase inhibitors (MAOIs) within the last 14 days (e.g. moclobemide (used to treat depression) or selegiline (used to treat Parkinson's disease)). MAO inhibitors must be discontinued at least 14 days before switching to Citalopram Vitabalans. Treatment with Citalopram Vitabalans must be stopped at least 7 days before starting treatment with MAO inhibitors;
if the patient is taking linezolid (an antibiotic), unless close monitoring and blood pressure surveillance are possible;
if the patient has congenital heart rhythm disorders or has experienced episodes of heart rhythm disturbances (visible on ECG examination; a test assessing heart function);
if the patient is taking medicines for heart rhythm disorders or medicines that may affect heart rhythm. Please also refer to the section “Citalopram Vitabalans with other medicines” below.

Warnings and precautions
Before starting treatment with Citalopram Vitabalans, discuss this with your doctor.
Inform your doctor if the patient has any other symptoms or medical conditions, especially if:

the patient has diabetes (see “Citalopram Vitabalans with other medicines”);
the patient is undergoing electroconvulsive therapy;
the patient suffers from a psychotic disorder or has previously experienced episodes of mania (unjustified good mood or excessive excitement leading to unusual behaviour). Treatment with Citalopram Vitabalans should be discontinued if the patient enters a manic phase, which should be discussed with the doctor;
the patient has liver or kidney insufficiency;
the patient is prone to bleeding or bruising (see “Citalopram Vitabalans with other medicines”) or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”);
the patient suffers from epilepsy. Treatment with Citalopram Vitabalans should be discontinued if seizures occur or increase in frequency, which should be discussed with the doctor;
the patient has heart problems or recently suffered a heart attack;
the patient has a slow resting heart rate and/or knows that low salt levels may occur due to prolonged diarrhoea and vomiting (due to illness) or due to diuretic medicines (tablets increasing urine output);
the patient experiences rapid or irregular heartbeat, weakness, fainting, dizziness upon standing, which may indicate abnormal heart function;
the patient has eye problems such as closed-angle glaucoma or a history of glaucoma (including increased intraocular pressure).

At the beginning of treatment, some patients may experience increased anxiety, which subsides during continued treatment. Therefore, the patient should follow the doctor’s instructions exactly and must not stop treatment or change the dosage without medical consultation.
Medicines such as Citalopram Vitabalans (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression symptoms or anxiety states
If the patient suffers from depression and/or anxiety, they may sometimes think about self-harm or suicide. Such thoughts may occur more frequently at the beginning of treatment with antidepressants, as these medicines require time to start working, usually about 2 weeks, but sometimes longer.
Suicidal or self-harming thoughts are most likely to occur:

in patients who previously experienced suicidal thoughts or self-harm;
in young adults. Clinical trial data show an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric symptoms treated with antidepressants.

If the patient ever experiences suicidal thoughts or thoughts of self-harm, they should contact their doctor immediately or go to hospital.
It may also be helpful to inform relatives or friends that the patient suffers from depression or anxiety and ask them to read this leaflet. The patient may ask them to inform them if they notice worsening of symptoms or if they are concerned about changes in their behaviour.
Symptoms such as anxiety or difficulty sitting or standing still may also occur during the first few weeks of treatment. Inform the doctor immediately if these symptoms occur.
Children and adolescents
Citalopram Vitabalans is generally not recommended for use in children and adolescents under 18 years of age.
In patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) during treatment with this class of medicines. Nevertheless, a doctor may prescribe Citalopram Vitabalans to patients under 18 years of age if they determine it is in their best interest. If your doctor has prescribed Citalopram Vitabalans to a patient under 18 years of age and you have any doubts, please consult your doctor again. Inform the doctor if the above-mentioned symptoms appear or worsen during treatment with Citalopram Vitabalans in a patient under 18 years of age. Furthermore, there are currently no long-term safety data available for the use of Citalopram Vitabalans in this age group regarding growth, puberty, cognitive development, and behavioural development.
Citalopram Vitabalans with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
It is important to inform your doctor or pharmacist if the patient is taking the following medicinal products:

MAO inhibitors (used to treat depression and Parkinson’s disease) (see “When not to use Citalopram Vitabalans”);
linezolid (an antibiotic) (see “When not to use Citalopram Vitabalans”);
pimozide (used to treat psychiatric disorders);
metoprolol (used to treat high blood pressure);
cimetidine, lansoprazole, and omeprazole (medicines used to treat 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;
lithium and tryptophan (used to treat bipolar disorders);
imipramine and desipramine (used to treat depression);
sumatriptan or other triptans (used to treat migraine);
medicines that lower potassium and magnesium levels in blood;
medicines that lower the seizure threshold, e.g. other antidepressants (tricyclics, SSRIs), antipsychotics (e.g. phenothiazines, thioxanthenes, and butyrophenones), mefloquine, bupropion, and tramadol (used to treat pain);
buprenorphine.

Treatment with Citalopram Vitabalans may affect glycaemic control. Adjustment of insulin and/or oral hypoglycaemic agents may be necessary.
Citalopram Vitabalans may cause bleeding (e.g. skin and mucosal bleeding). The risk of bleeding may be increased if the patient is simultaneously taking medicines that increase the risk of bleeding, e.g. anticoagulants (medicines preventing blood clotting, such as warfarin), salicylate derivatives (e.g. acetylsalicylic acid), NSAIDs (medicines used to treat inflammation and pain), dipyridamole, ticlopidine, atypical antipsychotics (e.g. risperidone), phenothiazines (e.g. chlorpromazine), or tricyclic antidepressants (e.g. imipramine).
Citalopram Vitabalans should not be used concomitantly with herbal products containing St. John’s wort (Hypericum perforatum), as this combination may increase the risk of adverse effects.
DO NOT USE Citalopram Vitabalans if the patient is taking medicines for heart rhythm disorders or medicines that may affect heart rhythm, e.g. antiarrhythmics of class IA and III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, especially halofantrine), certain antihistamines (astemizole, mizolastine). For further information, consult your doctor.
Taking Citalopram Vitabalans with food, drink and alcohol
Do not take Citalopram Vitabalans with alcohol, as alcohol may enhance the effect of Citalopram Vitabalans. Citalopram Vitabalans tablets may be taken regardless of meals, but should be taken with sufficient fluid.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Inform your doctor if the patient is pregnant or planning pregnancy.
There is only limited experience with the use of Citalopram Vitabalans during pregnancy. Citalopram Vitabalans should not be used during pregnancy unless clearly indicated by a doctor.
Newborns whose mothers took medicinal products from the same group as Citalopram Vitabalans in late pregnancy may experience the following symptoms immediately or shortly after birth: breathing difficulties, skin cyanosis, seizures, changes in body temperature, feeding problems, vomiting, low blood sugar, muscle stiffness or flaccidity, hyperreflexia, tremor, jitteriness, agitation, lethargy, persistent crying, drowsiness, and difficulty falling asleep.
If any of these symptoms occur in the newborn, contact a doctor immediately.
Ensure that the midwife and/or doctor are aware of the use of Citalopram Vitabalans. If the medicine is used during pregnancy, especially during the last 3 months, medicines such as Citalopram Vitabalans may increase the risk of serious complications in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and skin cyanosis. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, contact the midwife or doctor immediately.
Taking Citalopram Vitabalans 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 Citalopram Vitabalans, she should inform her doctor or midwife so they can provide appropriate advice.
Citalopram passes into human milk. There is a risk of effects on the infant. Citalopram Vitabalans should not be used during breastfeeding unless clearly indicated by a doctor.
Animal studies have shown that Citalopram may reduce sperm quality. This could theoretically affect fertility, but no effect on human fertility has been observed to date.
Driving and using machines
Citalopram Vitabalans may affect the ability to drive and operate machinery. Do not drive or operate machinery until the patient knows how Citalopram Vitabalans affects them. Read all information in this leaflet for guidance.
If the patient has any doubts about using the medicine, they should consult their doctor, pharmacist, or nurse.

3. How to use Citalopram Vitabalans

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Citalopram Vitabalans should be taken once daily, in the morning or evening. The medicine may be taken with or without food, swallowed with water. The tablet may be divided into equal doses.
If you feel the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.

Adults
Depression
The usual daily dose is 20 mg. Your doctor may increase the dose up to a maximum of 40 mg per day. The antidepressant effect will not be apparent until at least 2 weeks after starting treatment. Treatment should continue for 4 to 6 months after symptoms have resolved.

Anxiety disorders
The initial dose is 10 mg per day during the first week, after which the dose may be increased to 20–30 mg per day. Therapeutic effects usually begin after 2 to 4 weeks. The dose may be increased by your doctor up to a maximum of 40 mg per day.
Full therapeutic effect may occur after about 3 months. Continued treatment for additional months may be necessary.

Obsessive-compulsive disorder
The initial dose is 20 mg per day. The dose may be increased by your doctor up to a maximum of 40 mg per day. Therapeutic effects usually begin after 2–4 weeks, and improvement occurs when treatment is continued.

Preventive treatment
The duration of treatment depends on the individual patient's condition and usually lasts several years. Discontinuation of treatment should be done under strict medical supervision to avoid relapses.

Renal impairment
Dose adjustment is not required in patients with mild to moderate renal impairment. Caution is recommended in patients with severe renal impairment.

Hepatic impairment
Treatment in patients with severe hepatic impairment should be initiated at half the normal dose. Patients with liver disease should not take a higher dose than 20 mg per day.

Elderly patients (over 65 years of age)
The initial dose should be reduced to half the recommended dose, e.g. 10–20 mg per day.
Elderly patients usually should not receive doses higher than 20 mg per day.

Use in children and adolescents
Citalopram Vitabalans should not be used in children and adolescents under 18 years of age.
Further information is provided in section 2.

Taking more than the recommended dose of Citalopram Vitabalans
If you have taken more than the recommended dose of Citalopram Vitabalans, contact your doctor immediately.
Symptoms of overdose include seizures, rapid heartbeat, drowsiness, changes in electrical activity of the heart, loss of consciousness, vomiting, tremor, changes in blood pressure, irregular heartbeat, changes in heart rhythm, nausea, serotonin syndrome, agitation, dizziness, pupil dilation (pupil enlargement), increased sweating, bluish skin discoloration, and abnormally rapid breathing.

If you miss a dose of Citalopram Vitabalans
Take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

Stopping Citalopram Vitabalans
Do not stop taking Citalopram Vitabalans unless your doctor advises you to do so. Usually, your doctor will advise you how to gradually reduce the dose over several weeks.
If you stop taking Citalopram Vitabalans, especially if stopped abruptly, you may experience withdrawal symptoms. The risk is greater if Citalopram Vitabalans has been taken for a long time or at high doses, or if the dose has been reduced too quickly.

Withdrawal symptoms: dizziness (unsteadiness or loss of balance), prickling sensation in the skin, burning sensation and (less commonly) electric shock-like sensations, also in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), irritability, headache, nausea, sweating (including night sweats), vomiting, feelings of anxiety or agitation, tremors (shaking), confusion or disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations (fluttering or pounding of the heart).

In most people, these symptoms are mild and resolve spontaneously within two weeks. If you experience severe withdrawal symptoms after stopping Citalopram Vitabalans, contact your doctor. Your doctor may recommend restarting the medicine and reducing the dose more slowly.
If you are concerned about symptoms after stopping Citalopram Vitabalans, you should consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Immediately consult a doctor or go to the nearest hospital if the patient experiences any of the following symptoms:

swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing (allergic reaction) (adverse effects occur in fewer than 1 in 1,000 patients).
high fever, shivering, muscle stiffness, anxiety; these may be symptoms of a rare condition called serotonin syndrome (frequency unknown, cannot be estimated from available data).
rapid or irregular heartbeat, weakness, which may indicate a life-threatening condition known as torsade de pointes (frequency unknown, cannot be estimated from available data).
fatigue, confusion, and muscle spasms, which may indicate low sodium levels in the blood (adverse effects occur in fewer than 1 in 1,000 patients).

Immediately discontinue use of Citalopram Vitabalans.
Other adverse effects may occur:
Very common (may affect more than 1 in 10 people)

drowsiness, difficulty sleeping, headache
dry mouth, nausea
increased sweating

Common (may affect up to 1 in 10 people)

decreased appetite, weight loss
restlessness, reduced libido, anxiety, nervousness, disorientation, in women: difficulty achieving orgasm, unusual dreams
tremor, tingling sensations, dizziness, difficulty concentrating
ringing in the ears (tinnitus)
yawning
diarrhoea, vomiting, constipation
itching
muscle and joint pain
in men: problems with ejaculation and erection
fatigue

Uncommon (may affect up to 1 in 100 people)

increased appetite, weight gain
aggression, depersonalisation, hallucinations, mania
fainting
dilated pupils (dark centre of the eye)
fast heartbeat, slow heartbeat
urticaria, hair loss, rash, red or purple skin discolouration (purpura), photosensitivity
difficulty passing urine
vaginal bleeding
swelling of hands or feet

Rare (may affect up to 1 in 1,000 people)

seizures (epileptic fits), involuntary movements, taste disturbances
bleeding
hepatitis
fever

Frequency unknown (frequency cannot be estimated from available data)

increased bleeding or tendency to bruise due to reduced platelet count
rash (hypersensitivity)
inappropriate secretion of antidiuretic hormone (ADH)
decreased potassium levels in blood (including swelling of skin and mucous membranes)
panic attacks, teeth grinding, psychomotor agitation
thoughts of self-harm or suicidal thoughts (see “Important information before taking Citalopram Vitabalans”)
seizures, specific movement disorders due to disturbances in certain neural pathways, involuntary muscle movements (akathisia), movement disorders
visual disturbances
changes in the heart's electrical cycle (prolonged QT interval, ventricular arrhythmia)
low blood pressure (e.g. upon standing)
nosebleeds
gastrointestinal bleeding (including rectal bleeding)
abnormal liver function test results
coagulation disorders, including skin and mucous membrane bleeding (petechiae), swelling of skin and mucous membranes
bleeding between menstrual periods (intermenstrual bleeding) in women, painful or prolonged erection in men, milk secretion in men
elevated prolactin levels in blood
Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in section "Pregnancy, breastfeeding and fertility" under section 2.

An increased risk of bone fractures has been observed in patients taking this type of medicine.
Discontinuation of citalopram (especially abrupt discontinuation) often leads to withdrawal symptoms (see “How to use Citalopram Vitabalans”).
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 authorisation holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Citalopram Vitabalans

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any damage or changes in the appearance of the tablets.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Citalopram Vitabalans contains
Core of the tablet:

The active substance is citalopram (as hydrobromide). Each tablet contains 20 mg of citalopram (as hydrobromide).
The other constituents are microcrystalline cellulose, mannitol (E421), colloidal anhydrous silica, and magnesium stearate.

Coating of the tablet:
polidekstroza, hypromellose, titanium dioxide, and macrogol.
What Citalopram Vitabalans looks like and contents of the pack
What Citalopram Vitabalans tablets look like:
White, round, biconvex tablets with a division line on one side and the logo “2”. Diameter 8 mm.
The tablet can be divided into equal doses.
Pack sizes:
10, 14, 20, 30, 60 and 100 tablets.
Marketing Authorisation Holder and Manufacturer
Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
Finland
This medicinal product is authorised in the European Economic Area countries under the following names:
Citalopram Vitabalans (Czech Republic, Germany, Denmark, Estonia, Finland, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia, Slovakia)

Citalopram vitabalans