Citalopram Vitabalans

Leaflet accompanying the packaging: information for the user

Citalopram Vitabalans, 20 mg, film-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. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

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

Citalopram Vitabalans contains the active substance citalopram and belongs to a group of antidepressant medicines (used to treat depression) called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain. Citalopram Vitabalans is used to treat depression, anxiety disorders (panic attacks with or without agoraphobia), obsessive-compulsive disorder (obsessive thinking and behavior), and to prevent relapse of depression.

2. Important information before taking Citalopram Vitabalans

When not to take 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 taking or has taken monoamine oxidase inhibitors (MAOIs) (e.g., moclobemide (used to treat depression) or selegiline (used to treat Parkinson's disease)) in the last 14 days. Treatment with MAOIs should be stopped at least 14 days before changing treatment to Citalopram Vitabalans. Treatment with Citalopram Vitabalans must be stopped at least 7 days before changing treatment to MAOIs.
• if the patient is taking linezolid (an antibiotic), unless there is a possibility of close monitoring and blood pressure control.
• if the patient has congenital heart rhythm disorders or has had an episode of heart rhythm disorders (visible on an ECG; a test that evaluates heart function).
• if the patient is taking medicines for heart rhythm disorders or medicines that may affect heart rhythm. You should also read the section "Citalopram Vitabalans and other medicines" below.

Warnings and precautions

Before starting treatment with Citalopram Vitabalans, discuss it with your doctor. You should inform your doctor if you have any other symptoms or diseases. Especially if:

• the patient has diabetes (see "Citalopram Vitabalans and other medicines");
• the patient is undergoing electroconvulsive therapy;
• the patient has a psychotic disorder or has had episodes of mania (feeling of unjustified good mood or excessive excitement leading to unusual behavior). Treatment with Citalopram Vitabalans should be stopped if the patient enters a manic phase, which should be consulted with a doctor;
• the patient has liver or kidney failure;
• the patient has a tendency to bleed or bruise easily (see "Citalopram Vitabalans and other medicines") or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility");
• the patient has epilepsy. Treatment with Citalopram Vitabalans should be stopped if seizures occur or if their frequency increases, which should be consulted with a doctor;
• the patient has heart problems or has recently had a heart attack;
• the patient has a slow resting heart rate and/or the patient knows that they may have low salt levels due to prolonged diarrhea and vomiting (due to illness) or due to the use of diuretic medicines (tablets that increase the amount of urine excreted);
• the patient has a fast or irregular heartbeat, weakness, fainting, dizziness when standing up, which may indicate abnormal heart function;
• the patient has eye problems, such as glaucoma with a closed angle or a history of glaucoma (including increased pressure inside the eye).

At the beginning of treatment, some patients may feel increased anxiety, which disappears during continued treatment. Therefore, the patient should follow the doctor's instructions exactly and not stop treatment or change the dosage without consulting a doctor. Medicines like Citalopram Vitabalans (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.

Suicidal thoughts and worsening of depression or anxiety

If the patient has depression and/or anxiety, they may sometimes think about self-harm or suicide. Such thoughts may occur more often at the beginning of treatment with antidepressant medicines, because these medicines need time to start working, usually about 2 weeks, but sometimes more. Thoughts of self-harm or suicide are most likely to occur:

• in patients who have had suicidal thoughts or self-harm before;
• in young adults. Data from clinical trials show an increased risk of suicidal behavior in adults under 25 years of age with mental symptoms who were treated with antidepressant medicines.

If the patient experiences suicidal thoughts or self-harm at any time, they should contact their doctor or go to the hospital immediately. It may also be helpful to inform relatives or friendsthat they have depression or anxiety and ask them to read this leaflet. The patient may ask them to tell them if they notice that their symptoms have worsened or if they are concerned about changes in their behavior. Symptoms such as anxiety or difficulty sitting or standing still may also occur during the first few weeks of treatment. The doctor should be informed immediately if these symptoms occur.

Children and adolescents

Citalopram Vitabalans should not normally be used in children and adolescents under 18 years of age. In patients under 18 years of age, the risk of side effects, such as attempted suicide, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and anger), increases during treatment with this class of medicines. Despite this, the doctor may prescribe Citalopram Vitabalans to patients under 18 years of age, considering that it is in their best interest. If the doctor has prescribed Citalopram Vitabalans to a patient under 18 years of age, and you have any doubts, please consult your doctor again. You should inform your doctor if the above symptoms occur or worsen during treatment with Citalopram Vitabalans in a patient under 18 years of age. Additionally, there is currently no data on the long-term safety of Citalopram Vitabalans in this age group, regarding growth, maturation, and cognitive and behavioral development.

Citalopram Vitabalans and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. It is important to inform your doctor or pharmacist if you are taking the following medicinal products:

• MAOIs (used to treat depression and Parkinson's disease) (see "When not to take Citalopram Vitabalans")
• linezolid (an antibiotic) (see "When not to take Citalopram Vitabalans")
• pimozide (used to treat mental disorders)
• metoprolol (used to treat high blood pressure)
• cimetidine, lansoprazole, and omeprazole (medicines used to treat stomach ulcers), fluconazole (a medicine used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of heart attack). These medicines may increase the level of citalopram in the blood.
• lithium and tryptophan (used to treat bipolar disorder)
• imipramine and desipramine (used to treat depression)
• sumatriptan or other triptans (used to treat migraines)
• medicines that lower potassium and magnesium levels in the blood
• medicines that lower the seizure threshold, such as other antidepressants (tricyclic, SSRI), antipsychotics (e.g., phenothiazines, tioksantens, and butyrophenones), mefloquine, bupropion, and tramadol (used to treat pain)
• buprenorphine

Treatment with Citalopram Vitabalans may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic medicines. Citalopram Vitabalans may cause bleeding (e.g., skin and mucous membrane bleeding). The risk of bleeding may be increased if the patient is taking medicines that increase the risk of bleeding, such as anticoagulants (medicines that prevent blood clotting, e.g., warfarin), salicylates (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 taken with herbal products containing St. John's Wort (Hypericum perforatum), as this combination may increase the risk of side effects. DO NOT TAKE Citalopram Vitabalansif you are taking medicines for heart rhythm disorders or medicines that may affect heart rhythm, such as antiarrhythmic medicines class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial agents, especially halofantrine), certain antihistamines (astemizole, mizolastine). For more 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 can be taken with or without food, but they should be taken with a sufficient amount of liquid.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should inform your doctor if you are pregnant or plan to become pregnant. 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 your doctor. In newborns whose mothers have taken medicines from the same group as Citalopram Vitabalans in the later stages of pregnancy, the following symptoms may occur immediately or shortly after birth: breathing difficulties, blue discoloration of the skin, seizures, changes in body temperature, feeding problems, vomiting, low blood sugar, stiffness or flaccidity of muscles, exaggerated reflexes, tremors, tremors, agitation, lethargy, constant crying, and sleep disturbances. If your child experiences any of these symptoms, you should contact your doctor immediately. You should make sure that your midwife and/or doctor know that you are taking Citalopram Vitabalans. If you are taking Citalopram Vitabalans during pregnancy, especially during the last 3 months of pregnancy, medicines like Citalopram Vitabalans may increase the risk of serious complications in children, called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and blue discoloration of the skin. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur, you should contact your midwife or doctor immediately. Taking Citalopram Vitabalans at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If you are taking Citalopram Vitabalans, you should inform your doctor or midwife so that they can give you appropriate advice. Citalopram passes into breast milk. There is a risk of affecting the baby. Citalopram Vitabalans should not be used during breastfeeding, unless clearly indicated by your doctor. Animal studies have shown that citalopram may decrease sperm quality. This may theoretically affect fertility, but no effect on fertility has been observed in humans so far.

Driving and using machines

Citalopram Vitabalans may affect your ability to drive and use machines. Do not drive or use machines until you know how Citalopram Vitabalans affects you. Read all the information in the leaflet to get help. If you have any doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

3. How to take Citalopram Vitabalans

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Citalopram Vitabalans should be taken once a day, in the morning or evening. The medicine can be taken with or without food, with a sufficient amount of water. The tablet can be divided into equal doses. If you feel that 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. The dose may be increased by your doctor to a maximum of 40 mg per day. For at least 2 weeks from the start of treatment, the antidepressant effect will not be noticeable. Treatment should be continued for 4 to 6 months after symptoms have disappeared.
Anxiety disorders
The initial dose is 10 mg per day in the first week, after which the dose can be increased to 20-30 mg per day. The start of therapeutic action usually occurs after 2 to 4 weeks. The dose may be increased by your doctor to a maximum of 40 mg per day. Full therapeutic action may occur after about 3 months. It may be necessary to continue treatment for several months.
Obsessive-compulsive disorder
The initial dose is 20 mg per day. The dose may be increased by your doctor to a maximum of 40 mg per day. The start of therapeutic action usually occurs after 2-4 weeks, and improvement in the patient's condition occurs when treatment is continued.
Preventive treatment
The duration of treatment depends on the individual patient's condition and usually lasts several years. Stopping treatment should be done under close supervision to avoid relapse.
Kidney problems
There is no need to adjust the dose in patients with mild to moderate kidney failure. Caution is advised in patients with severe kidney failure.
Liver problems
Treatment of patients with acute liver failure should be started with half the normal dose. Patients with liver disease should not take a higher dose than 20 mg per day.

Patients over 65 years of age

The initial dose should be reduced to half the recommended dose, e.g., 10-20 mg per day. Patients over 65 years of age should not normally receive a higher dose 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. More information can be found in section 2.

Taking a higher dose of Citalopram Vitabalans than recommended

If you have taken too much Citalopram Vitabalans, contact your doctor. Symptoms of overdose are seizures, rapid heartbeat, drowsiness, changes in heart electrical activity, loss of consciousness, vomiting, tremors, changes in blood pressure, irregular heartbeat, changes in heart rhythm, nausea, serotonin syndrome, agitation, dizziness, dilated pupils, increased sweating, blue discoloration of the skin, and rapid breathing.

Missing a dose of Citalopram Vitabalans

Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Citalopram Vitabalans

Do not stop taking Citalopram Vitabalans unless your doctor tells you to. Usually, your doctor will advise you to reduce the dose gradually over a few weeks. If you stop taking Citalopram Vitabalans, especially if it is done suddenly, you may experience withdrawal symptoms. The risk is higher when Citalopram Vitabalans has been taken for a long time or in high doses, or if the dose is reduced too quickly. Withdrawal symptoms: dizziness (instability or lack of balance), feeling of pins and needles, burning sensation, and (rarely) electric shock sensation, also in the head, sleep disturbances (intense dreams, nightmares, inability to sleep), irritability, headache, nausea, sweating (including night sweats), vomiting, feeling of restlessness or agitation, tremors (shaking), feeling of confusion or disorientation, emotional disturbance or irritability, diarrhea (loose stools), vision disturbances, palpitations (heart pounding or racing). In most people, these symptoms are mild and disappear on their own within two weeks. If you experience severe withdrawal symptoms after stopping Citalopram Vitabalans, contact your doctor. Your doctor may advise you to start taking the medicine again and reduce the dose more slowly. If you are concerned about symptoms after stopping Citalopram Vitabalans, consult your doctor. If you have any further doubts about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common side effects, such as nausea, drowsiness, dry mouth, sweating, are usually mild and in most cases disappear within the first few weeks of treatment. You should go to your doctor or the nearest hospital immediatelyif you experience any of the following symptoms:

• swelling of the skin, tongue, lips, or face, or problems with breathing or swallowing (allergic reaction) (side effects occur less frequently than in 1 in 1,000 patients)
• high fever, tremors, muscle contractions, anxiety; these may be symptoms of a rare disease called serotonin syndrome (frequency unknown, cannot be estimated from available data)
• rapid, irregular heartbeat, weakness, which may be symptoms of a life-threatening condition called torsades de pointes (frequency unknown, cannot be estimated from available data)
• fatigue, confusion, and muscle contractions, which may indicate low sodium levels in the blood (side effects occur less frequently than in 1 in 1,000 patients)

You should stop taking Citalopram Vitabalans immediately.

Other side effects may occur:
Very common(may occur in more than 1 in 10 people)

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

Common(may occur in less than 1 in 10 people)

• decreased appetite, weight loss
• agitation, decreased sexual desire, anxiety, nervousness, disorientation, in women: inability to achieve orgasm, unusual dreams
• tremors, tingling sensation, dizziness, concentration disturbances
• ringing in the ears (tinnitus)
• yawning
• diarrhea, vomiting, constipation
• itching
• muscle and joint pain
• in men: problems with ejaculation and erection
• fatigue

Uncommon(may occur in less than 1 in 100 people)

• increased appetite, weight gain
• aggression, loss of identity, hallucinations, mania
• fainting
• dilated pupils
• rapid heartbeat, slow heartbeat
• hives, hair loss, rash, red or purple discoloration of the skin (purpura), sensitivity to light
• difficulty urinating
• vaginal bleeding
• swelling of hands or feet

Rare(may occur in less than 1 in 1,000 people)

• seizures (epileptic fits), involuntary movements, taste disturbances
• bleeding
• liver inflammation
• fever

Frequency unknown(frequency cannot be estimated from available data)

• increased tendency to bleed or bruise easily due to decreased platelet count
• rash (hypersensitivity)
• improper secretion of antidiuretic hormone (ADH)
• decreased potassium levels in the blood (including swelling of the skin and mucous membranes)
• panic attacks, teeth grinding, restlessness
• suicidal thoughts or self-harm (see "Important information before taking Citalopram Vitabalans")
• seizures, specific movement disorders due to disturbances in certain nerve pathways, involuntary muscle movements (akathisia), movement disorders
• vision disturbances
• changes in the electrical cycle of the heart (prolonged QT interval, ventricular arrhythmia)
• low blood pressure (e.g., when standing up)
• nosebleeds
• gastrointestinal bleeding (including rectal bleeding)
• abnormal liver function test results
• coagulation disorders, including skin and mucous membrane bleeding (ecchymosis), swelling of the skin and mucous membranes
• bleeding outside the menstrual cycle (intermenstrual bleeding) in women, painful/prolonged erection in men, milk secretion in men
• increased prolactin levels in the blood
• Severe vaginal bleeding occurring shortly after delivery (postpartum hemorrhage), see additional information in the "Pregnancy, breastfeeding, and fertility" subsection in section 2.

People taking this type of medicine have been observed to have an increased risk of fractures. Stopping citalopram (especially suddenly) often leads to withdrawal symptoms (see "How to take Citalopram Vitabalans").

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help 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 month stated. Do not use this medicine if you notice damage or changes in the appearance of the tablets. This medicine does not require special storage conditions. 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 pack and other information

What Citalopram Vitabalans contains

Tablet core:

• The active substance is citalopram (in the form of hydrobromide). Each tablet contains 20 mg of citalopram (in the form of hydrobromide).
• The other ingredients of the medicine are microcrystalline cellulose, mannitol (E421), anhydrous colloidal silica, and magnesium stearate.

Tablet coating:
polydextrose, hypromellose, titanium dioxide, and macrogol.

What Citalopram Vitabalans looks like and contents of the pack

What Citalopram Vitabalans tablets look like:
White, round, convex tablets with a dividing line on one side and a "2" logo. Diameter 8 mm. The tablet can be divided into equal doses.
Pack sizes:
10, 14, 20, 30, 60, and 100 tablets.

Marketing authorization holder and manufacturer

Vitabalans Oy
Varastokatu 8
FI-13500 Hämeenlinna
Finland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Citalopram Vitabalans (Czech Republic, Germany, Denmark, Estonia, Finland, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia, Slovakia)

Date of last revision of the leaflet: 2024-04-11