Citalopram Medreg

Leaflet accompanying the packaging: patient information

Citalopram Medreg, 20 mg, coated tablets

Citalopram

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

How Citalopram Medreg works

Citalopram Medreg belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the level of serotonin.

When Citalopram Medreg is used

Citalopram Medreg contains citalopram and is used to treat depression, and when the patient feels better, to prevent the recurrence of these symptoms. Citalopram Medreg is used for long-term treatment to prevent the occurrence of new depressive episodes in patients with recurrent depression. Citalopram Medreg is also effective in relieving symptoms in patients with panic attacks and patients with obsessive-compulsive disorder (OCD). It is possible that your doctor has prescribed Citalopram Medreg for another reason. If you have any questions about why Citalopram Medreg has been prescribed for you, you should consult your doctor.

2. Important information before taking Citalopram Medreg

When not to take Citalopram Medreg

• if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
• if you are taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression) and linezolid (an antibiotic).
• if you have congenital or a history of abnormal heart rhythm or if you have had an episode of abnormal heart rhythm (visible on an ECG, a test that evaluates heart function).
• if you are taking medicines used to treat irregular heartbeats or medicines that may affect heart rhythm (see "Citalopram Medreg and other medicines").

In case of stopping MAOI inhibitors, you should wait 2 weeks before starting to take Citalopram Medreg. After stopping moclobemide, you should wait 1 day before starting to take Citalopram Medreg. After stopping Citalopram Medreg, you should wait 1 week before starting to take any MAOI inhibitors.

Warnings and precautions

Before starting to take Citalopram Medreg, you should discuss it with your doctor or pharmacist. You should tell your doctor if you have any other disorders or diseases, as your doctor should take this information into account. In particular, you should inform your doctor:

• if you have episodes of mania or panic attacks.
• if you have liver or kidney function disorders. Dose adjustment may be required by your doctor.
• if you have diabetes. Taking Citalopram Medreg may affect blood sugar levels. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• if you have epilepsy. In case of seizures or increased frequency of seizures, you should discontinue Citalopram Medreg therapy (see also section 4 "Possible side effects").
• if you have an increased tendency to bleed or if you are pregnant (see "Pregnancy, breastfeeding and fertility").
• if you have low sodium levels in the blood.
• if you are being treated with electroconvulsive therapy.
• if you have or have had heart problems or if you have recently had a heart attack.
• if you have a slow resting heart rate and/or low electrolyte levels due to prolonged, severe diarrhea and vomiting or the use of diuretic medicines (tablets that increase urine output).
• if you experience rapid or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate abnormal heart rhythm.
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

You should consult your doctor, even if the above warnings refer to situations that have occurred in the past.

Caution

In some patients with bipolar affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feeling of happiness, and excessive physical activity. If these symptoms occur, you should contact your doctor. In the first few weeks of treatment, symptoms such as anxiety or difficulty sitting or standing still (akathisia) may also occur. If such symptoms occur, you should immediately inform your doctor. Medicines like Citalopram Medreg (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after the end of treatment.

Suicidal thoughts and worsening of depression or anxiety disorders

In patients with depression and/or anxiety disorders, suicidal thoughts or self-harm thoughts may sometimes occur. They may become more severe after starting to take antidepressant medicines, as all these medicines need time to start working, usually about two weeks, but sometimes longer. The occurrence of suicidal thoughts or self-harm thoughts may be more likely:

• if you have had suicidal thoughts or self-harm thoughts before.
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years of age) with mental illness who were treated with antidepressant medicines.

If you experience any thoughts of self-harm or suicide, you should immediately contact your doctor or go to the nearest hospital. It may be helpful to inform your relatives or friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may ask them to monitor you and inform you if your depression or anxiety worsens or if you experience any disturbing changes in behavior.

Children and adolescents

Citalopram Medreg should not be used in children and adolescents under 18 years of age. You should also be aware that in the case of taking medicines from this group, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, rebellious behavior, and manifestations of anger). Nevertheless, your doctor may prescribe Citalopram Medreg to patients under 18 years of age, considering that it is in their best interest. If your doctor has prescribed Citalopram Medreg to a patient under 18 years of age, in case of any doubts, you should consult your doctor again. If the above-mentioned symptoms occur or worsen in patients under 18 years of age taking Citalopram Medreg, you should inform your doctor. Additionally, as of now, there is no data on the long-term safety of Citalopram Medreg in this age group regarding growth, maturation, and cognitive and behavioral development.

Special warnings

As with other medicines used to treat depression or related diseases, improvement does not occur immediately. You may feel it only after a few weeks of taking Citalopram Medreg. In the treatment of panic disorder, improvement is usually observed after 2-4 weeks. At the beginning of treatment, some patients may experience worsening of anxiety, which subsides during treatment. Therefore, it is very important to follow your doctor's instructions carefully and not to stop treatment or change the dose without consulting your doctor. You should immediately inform your doctor or go to the nearest hospital if you experience any disturbing thoughts or any of the above-mentioned symptoms during treatment. Taking SSRIs/SNRIs (such as Citalopram Medreg) is often associated with the development of akathisia (unpleasant internal feeling or anxiety or difficulty sitting or standing still) and may also occur in the first few weeks of treatment. You should immediately inform your doctor if such symptoms occur.

Citalopram Medreg and other medicines

You should tell your doctor or pharmacist 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, and this can sometimes cause serious side effects. You should inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, you should wait 14 days before starting to take Citalopram Medreg. After stopping Citalopram Medreg, you should wait 7 days before taking any of these medicines.
• Reversible, selective inhibitors of monoamine oxidase A (MAO-A) containing moclobemide (used to treat depression).
• The antibiotic linezolid.
• Lithium (used to prevent and treat bipolar affective disorder) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Irreversible inhibitors of monoamine oxidase B (MAO-B) containing selegiline (used to treat Parkinson's disease); these medicines increase the risk of side effects. The dose of selegiline should not exceed 10 mg per day.
• Metoprolol (used to treat high blood pressure and/or heart disease); the level of metoprolol in the blood increases, but no signs of increased action or side effects have been observed due to this increase.
• Sumatriptan and similar medicines (used to treat migraines) and tramadol and similar medicines (opioids, used to treat severe pain); they increase the risk of side effects. If you experience any unusual symptoms while taking these medicines together, you should consult your doctor.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). They may cause an increase in the level of citalopram in the blood.
• Medicines with known effects on platelet function (e.g., certain antipsychotic medicines, acetylsalicylic acid (found in painkillers), non-steroidal anti-inflammatory medicines (used to treat arthritis)); a slight increase in the risk of bleeding.
• St. John's Wort ( Hypericum perforatum) - a herbal medicine used to treat depression. Taken together with Citalopram Medreg, it may increase the risk of side effects.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Antidepressant and neuroleptic medicines (used to treat schizophrenia, psychosis) due to the possible risk of lowering the seizure threshold.
• Medicines that lower potassium or magnesium levels in the blood, as they increase the risk of life-threatening heart rhythm disorders.

You should not take Citalopram Medreg at the same time as medicines used to treat irregular heartbeats or medicines that may affect heart rhythm, such as anti-arrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), and certain antihistamine medicines (astemizole, mizolastine). In case of any further doubts, you should consult your doctor.

Citalopram Medreg with food, drink, and alcohol

Citalopram Medreg can be taken with or without food (see section 3 "How to take Citalopram Medreg"). It has been shown that Citalopram Medreg does not enhance the effects of alcohol. However, it is recommended that you do not drink alcohol during treatment with Citalopram Medreg.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. If you are pregnant or breastfeeding, you should not take Citalopram Medreg unless your doctor has discussed the risks and benefits of treatment with you. Patients taking Citalopram Medreg during the last 3 months of pregnancy and up to delivery should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or limpness, increased reflexes, tremors, tremors, irritability, lethargy, constant crying, and sleep disturbances. If the newborn experiences any of these symptoms, you should immediately contact your doctor. You should ensure that your doctor (or midwife) is aware that you are taking Citalopram Medreg. Taking medicines like Citalopram Medreg, especially in the last three months of pregnancy, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN), characterized by rapid breathing and blue skin. These symptoms usually occur within the first day of life. If such symptoms occur in the newborn, you should immediately contact your doctor. Taking Citalopram Medreg at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Citalopram Medreg, you should inform your doctor or midwife so that they can provide you with appropriate advice. 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

Citalopram Medreg usually does not cause drowsiness; however, if you experience dizziness or drowsiness after starting to take this medicine, you should not drive or operate machinery until these symptoms subside.

Citalopram Medreg contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

Citalopram Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is essentially "sodium-free".

3. How to take Citalopram Medreg

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, you should consult your doctor or pharmacist. The recommended dose is:

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. Panic disorder The initial dose is 10 mg per day for the first week before increasing the dose to 20-30 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day. Obsessive-compulsive disorder (OCD) The initial dose is 20 mg per day. Your doctor may increase the dose to a maximum of 40 mg per day.

Elderly patients (over 65 years of age)

The initial dose should be reduced to half of the recommended dose, e.g., 10-20 mg per day. Elderly patients should not usually receive more than 20 mg per day.

Patients with special warnings

Patients with liver problems should not receive more than 20 mg per day.

Use in children and adolescents

Citalopram Medreg should not be used in children and adolescents. More information can be found in section 2 "Important information before taking Citalopram Medreg".

How and when to take Citalopram Medreg

Citalopram Medreg is taken once a day in a single dose. Citalopram Medreg can be taken at any time of day, with or without food. The tablet should be swallowed with water.

Duration of treatment

As with other medicines used to treat depression, panic disorder, and OCD, it may take a few weeks before you feel any improvement. You should therefore continue to take Citalopram Medreg even if it takes some time before you feel better. You should never change the dose of the medicine without first consulting your doctor. The duration of treatment is determined individually, usually at least 6 months. You should take the tablets for as long as your doctor recommends. You should not stop taking the tablets even if you feel better. The disease may persist for a long time, and if treatment is stopped too early, the symptoms may return. In patients with recurrent depression, maintenance treatment may last for several years to prevent new depressive episodes.

Taking a higher dose of Citalopram Medreg than recommended

If you or someone else has taken too much Citalopram Medreg, you should immediately contact your doctor or the nearest hospital emergency department. You should do this even if you do not feel any symptoms. You should take the Citalopram Medreg package/leaflet with you if you go to your doctor or hospital. Some of the symptoms of overdose may be life-threatening. Symptoms of overdose may include: 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, increased sweating, blue skin, hyperventilation.

Missing a dose of Citalopram Medreg

You should not take a double dose to make up for a missed dose. If you have forgotten to take a dose and remember before going to bed, you should take the missed dose immediately. You should take the next dose the next day. If you remember that you have missed a dose at night or the next day, you should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Citalopram Medreg

You should not stop taking Citalopram Medreg unless your doctor tells you to. After the end of the treatment cycle, it is usually recommended to gradually reduce the dose of Citalopram Medreg over a few weeks. Stopping Citalopram Medreg abruptly may cause mild and temporary withdrawal symptoms, such as: dizziness, tingling sensation, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headaches, nausea, vomiting, sweating, restlessness or agitation, tremors, disorientation or confusion, emotional instability or irritability, diarrhea (loose stools), vision disturbances, palpitations or increased heart rate (palpitations). After the end of the treatment cycle, it is recommended to gradually reduce the dose of Citalopram Medreg over a few weeks, rather than stopping the medicine abruptly. In case of any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Citalopram Medreg can cause side effects, although not everybody gets them. Side effects usually disappear after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of the disease and will improve as you start to feel better. Some patients have reported the following serious side effects. If you experience any of the following symptoms, you should stop taking Citalopram Medreg and seek medical attention:

• high fever, agitation, disorientation, tremors, and severe muscle contractions; these may be symptoms of a rare condition called serotonin syndrome, which has been reported during the concurrent use of antidepressant medicines
• swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction)
• unusual bleeding, including bleeding from the gastrointestinal tract

Rare but serious side effects (may affect up to 1 in 1,000 people). If you experience any of the following symptoms, you should stop taking Citalopram Medreg and seek medical attention:

• hyponatremia: low sodium levels in the blood, which may cause fatigue, disorientation, and tremors

The following side effects are usually mild and disappear after a few days of treatment. You should remember that side effects may also be symptoms of the disease and will improve as you start to feel better. If side effects cause problems or persist for more than a few days, you should consult your doctor. Dry mouth increases the risk of tooth decay, so it is recommended to brush your teeth more frequently. Very common(may affect more than 1 in 10 people)

• drowsiness, difficulty sleeping, headache
• dry mouth, nausea (vomiting)
• increased sweating

Common(may affect up to 1 in 10 people)

• decreased appetite, weight loss
• agitation, decreased libido, anxiety, nervousness, disorientation, unusual dreams
• tremors, tingling or numbness of hands or feet, dizziness, attention disturbances
• ringing in the ears (tinnitus)
• yawning
• diarrhea, vomiting, constipation
• itching
• muscle and joint pain
• men may experience problems with ejaculation and erection
• women may experience problems with achieving orgasm
• fatigue

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

• increased appetite, weight gain
• aggression, depersonalization (loss of sense of one's own personality), hallucinations, mania
• fainting
• pupil dilation
• rapid or slow heartbeat
• hives, hair loss, rash, purpura (red or purple spots on the skin due to bleeding), increased sensitivity to light
• urination problems
• heavy menstrual bleeding
• swelling of hands or feet

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

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

Frequency not known(frequency cannot be estimated from the available data):

• thoughts of self-harm or suicidal thoughts, see also section "Warnings and precautions"
• decreased platelet count, which may increase the risk of bleeding and bruising
• hypersensitivity (rash), severe allergic reaction causing difficulty breathing or dizziness
• increased urine output
• hypokalemia: low potassium levels in the blood, which may cause muscle weakness, muscle tremors, or abnormal heart rhythm
• panic attack, teeth grinding, restlessness
• abnormal movements, stiffness or muscle contractions, akathisia (involuntary muscle movements)
• vision disturbances
• changes visible on an ECG (called "QT interval prolongation"), ventricular arrhythmia (irregular heart rhythm), including torsade de pointes
• low blood pressure
• nosebleeds
• abnormal liver function test results
• sudden swelling of the skin or mucous membranes
• irregular menstrual periods, heavy vaginal bleeding, which may occur shortly after delivery (postpartum hemorrhage), see also section "Pregnancy, breastfeeding, and fertility".
• painful erections, milk secretion in men and women who are not breastfeeding.

Reporting side effects

If you experience any side effects, including those 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 Medreg

The medicine should be stored out of the sight and reach of children. There are no special storage instructions for this medicine. Do not use this medicine after the expiry date stated on the packaging and blister 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Citalopram Medreg contains

• The active substance of the medicine is citalopram (in the form of citalopram hydrobromide). Each coated tablet contains 20 mg of citalopram (in the form of citalopram hydrobromide).
• The other ingredients are: Tablet core: lactose monohydrate, cornstarch, copovidone, microcrystalline cellulose (type 102), sodium croscarmellose, magnesium stearate. Tablet coating: titanium dioxide (E 171), hypromellose 2910, 3 mPas (E 464), hypromellose 2910, 6 mPas (E 464), macrogol 400 (E 1521), polysorbate 80 (E 433).

What Citalopram Medreg looks like and contents of the pack

White or almost white, oval, biconvex, coated tablets (approximately 8.1 mm x 5.6 mm in size), with "Z" and "7" embossed on either side of the break line and "H" on the other side. The tablet can be divided into equal doses. The coated tablets are packaged in white, opaque blisters made of PVC/PVdC/Aluminum, in a cardboard box. Pack sizes: 14, 20, 28, 30, 60, 90, 98, and 100 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Medreg s.r.o. Na Florenci 2116/15 Nové Město 110 00 Prague 1 Czech Republic phone: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s. Průmyslová 961/16 747 23 Bolatice Czech Republic Dr. Max Pharma s.r.o. Na Florenci 2116/15 Nové Město 110 00 Prague 1 Czech Republic

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

Czech Republic: Citalopram Medreg Poland: Citalopram Medreg

Date of last revision of the leaflet: 04/2025