Citalopram medreg

Patient Information Leaflet

Citalopram Medreg, 20 mg, film-coated tablets
Citalopramum
Please read the entire leaflet before using this 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. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of Contents:

1. What is Citalopram Medreg and what is it 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 pack and other information

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

How Citalopram Medreg works
Citalopram Medreg belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing serotonin levels.

When is Citalopram Medreg used
Citalopram Medreg contains citalopram and is used to treat depression, and to prevent recurrence of depressive symptoms once the patient has started to feel better.
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 a tendency to panic attacks and in patients with obsessive-compulsive disorder (OCD).
Your doctor may have prescribed Citalopram Medreg for another reason. If you have any questions about why Citalopram Medreg has been prescribed for you, please consult your doctor.

2. Important information before using Citalopram Medreg

When not to use Citalopram Medreg

• 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 other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs). MAOIs 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 irregular heart rhythm or has experienced an episode of irregular heart rhythm (visible on ECG; a test assessing heart function).
• if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section "Citalopram Medreg with other medicines").

After stopping treatment with MAO inhibitors, a 2-week interval must elapse before
starting treatment with Citalopram Medreg.
After stopping moclobemide, a 1-day interval must elapse before starting treatment with
Citalopram Medreg.
After stopping Citalopram Medreg, a 1-week interval must elapse before starting treatment
with any MAO inhibitors.
Warnings and precautions
Before starting treatment with Citalopram Medreg, discuss this with your doctor or
pharmacist.
Tell your doctor if the patient has any other disorders or medical conditions, 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 Citalopram Medreg may affect blood glucose levels. Adjustment of insulin and/or oral glucose-lowering medicines may be necessary.
• if the patient has epilepsy. In case of seizures or increased seizure frequency, treatment with Citalopram Medreg should be discontinued (see also section 4 "Possible side effects").
• if the patient has an increased tendency to bleed or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility").
• if the patient has low sodium levels in the blood.
• if the patient is receiving electroconvulsive therapy.
• if the patient has heart problems currently or in the past, or if the patient recently had a heart attack.
• if the patient has a slow resting heart rate and/or low electrolyte levels due to prolonged, severe diarrhoea and vomiting or use of diuretics (tablets that increase urine output).
• if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm.
• if the patient has current or past eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

Consult your doctor, even if the above warnings relate to conditions that occurred
in the past.
Note
Some patients with bipolar affective disorder may experience a manic phase. This is
characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and
excessive physical activity. If these symptoms occur, contact your 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 your doctor
immediately.
Medicines such as Citalopram Medreg (so-called SSRIs/SNRIs) may cause symptoms of
sexual dysfunction (see section 4). In some cases, these symptoms persisted after
treatment ended.
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 treatment,
as all these medicines require time to take effect, usually about two weeks, but sometimes
longer.
The occurrence of thoughts of self-harm or suicide may be more likely:

• if the patient previously had thoughts of self-harm or suicide.
• if the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young 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 suicide, contact a doctor immediately or go to the nearest hospital.
Informing relatives 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 that depression or anxiety worsens or if there are worrying changes in behaviour.
Children and adolescents
Citalopram Medreg should generally not be used in children and adolescents under 18
years of age. It should also be noted that when taking medicines from this group, patients under 18 years of age are at increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviour, and expressions of anger). Nevertheless, a doctor may prescribe Citalopram Medreg to patients under 18 years of age if he or she considers it to be in their best interest. If a doctor has prescribed Citalopram Medreg to a patient under 18 years of age, contact the doctor again in case of any doubts. If any of the above-mentioned symptoms appear or worsen in patients under 18 years of age taking Citalopram Medreg, inform the doctor.
Moreover, to date, there are no data on the long-term safety of Citalopram Medreg in this age group regarding growth, puberty, cognitive development, and behavioural development.
Specific disease information
As with other medicines used to treat depression or related disorders, improvement does
not occur immediately. The patient may only feel improvement several weeks after starting
treatment with Citalopram Medreg.
In the treatment of panic disorder, improvement is usually observed after 2–4 weeks. At the beginning of treatment, anxiety may worsen in some patients, but subsides during treatment. Therefore, it is very important that the patient strictly follows the doctor's instructions and does not discontinue treatment or change the dose without consulting the doctor.
Inform your doctor immediately or contact the nearest hospital if disturbing thoughts or any of the above-mentioned symptoms occur during treatment.
Treatment with SSRIs/SNRIs (to which Citalopram Medreg belongs) is often associated
with the development of akathisia (an unpleasant inner feeling of restlessness or inability to sit or stand still), which may also occur in the first weeks of treatment. Inform your doctor immediately if such symptoms occur.
Citalopram Medreg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking,
has recently taken, or plans to take.
Some medicines may affect the action of other medicines, which may sometimes lead to
serious adverse effects.
Inform your doctor if the patient is taking any of the following medicines:

• "Non-selective monoamine oxidase inhibitors (MAOIs)" containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as the active substance. If the patient has taken any of these medicines, a 14-day interval must elapse before starting Citalopram Medreg. After stopping Citalopram Medreg, a 7-day interval must elapse 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 selegiline dose must not exceed 10 mg per day.
• Metoprolol (used in hypertension and/or heart disease); blood levels of metoprolol increase, but no symptoms of enhanced effect or adverse effects related to this increase have been observed.
• Sumatriptan and similar medicines (used in migraine treatment) and tramadol and similar medicines (opioids, used for severe pain); these increase the risk of adverse effects. If any unusual symptoms occur during concomitant use of these medicines, consult a doctor.
• Cimetidine, lansoprazole, and omeprazole (used in peptic ulcer disease), fluconazole (used in fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase blood levels of citalopram.
• Medicines known to affect platelet function (e.g. some antipsychotics, acetylsalicylic acid (found in painkillers), non-steroidal anti-inflammatory drugs (used in joint inflammation)); slight increase in the risk of bleeding abnormalities.
• St. John's wort (Hypericum perforatum) – a herbal medicine used in the treatment of depression. When taken together with Citalopram Medreg, it may increase the risk of adverse effects.
• Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used in the treatment of severe pain) due to possible risk of lowering the seizure threshold.
• Antidepressants and neuroleptics (medicines used in the treatment of schizophrenia, psychosis) due to possible risk of lowering the seizure threshold.
• Medicines that lower blood potassium or magnesium levels, as they increase the risk of life-threatening heart rhythm disturbances.

Do not take Citalopram Medreg together with medicines used for heart rhythm disorders or
medicines that may affect heart rhythm, e.g. class IA and III antiarrhythmics,
antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic
antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine, antimalarials – particularly halofantrine), certain
antihistamines (astemizole, mizolastine).
If you have any further doubts, 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 not to consume alcohol during treatment with Citalopram Medreg.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have
a baby, she should consult her doctor or pharmacist before using this medicine.
If the patient is pregnant or breastfeeding, she should not use Citalopram Medreg unless
her doctor has discussed the risks and benefits of treatment with her.
Patients who have taken Citalopram Medreg during the last three months of pregnancy until delivery should be aware that the newborn may experience the following symptoms: breathing difficulties, blue skin, seizures, temperature changes, 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, contact a doctor immediately.
Ensure that your doctor (or midwife) knows that you are taking Citalopram Medreg. Taking medicines such as Citalopram Medreg 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), characterized by rapid breathing and cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact a doctor immediately.
Taking Citalopram Medreg 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 Medreg, she should inform her doctor or midwife so they can provide 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 to date.
Driving and operating machinery
Citalopram Medreg generally does not cause drowsiness; however, if dizziness or
drowsiness occurs after starting this medicine, the patient should not drive or operate
machinery until these symptoms subside.
Citalopram Medreg contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient
should consult a doctor before taking this medicine.
Citalopram Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Citalopram Medreg

This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dosage:

Adults
Depression
The usual daily dose is 20 mg. The doctor may increase the dose up 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. The doctor may increase the dose up to a maximum of 40 mg per day.

Obsessive-compulsive disorder (OCD)
The initial dose is 20 mg per day. The doctor may increase the dose up to a maximum of 40 mg per day.

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

Patients with specific risks
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. Further information is provided in section 2, "Important information before taking Citalopram Medreg".

How and when to take Citalopram Medreg
Citalopram Medreg should be taken once daily as 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 for depression, panic disorder, and OCD, it may take several weeks before the patient feels any improvement. Therefore, treatment with Citalopram Medreg should be continued even if it takes some time before well-being improves.

The dosage of this medicine must never be changed without first consulting a doctor. The duration of treatment is determined individually and usually lasts at least 6 months. Tablets should be taken for as long as prescribed by the doctor. Do not stop taking the tablets even if well-being improves. The illness may persist for a long time, and if treatment is stopped too early, symptoms may return.

In patients with recurrent depression, maintenance treatment may continue for several years to prevent further depressive episodes.

Taking more than the recommended dose of Citalopram Medreg
If it is suspected that a patient or another person has taken too much Citalopram Medreg, contact a doctor or the nearest hospital emergency department immediately. This should be done even if there are no symptoms. Bring the medicine pack or blister with you if going to a doctor or hospital.

Some 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, excessive sweating, cyanosis (bluish skin), hyperventilation.

Missed dose of Citalopram Medreg
Do not take a double dose to make up for a missed dose. If a patient forgets to take a dose and remembers before going to sleep, they should take the missed dose immediately and take the next dose the following day at the usual time. If the patient remembers the missed dose during the night or the next day, they should skip the missed dose and take the next dose at the usual time.

Stopping Citalopram Medreg
Do not stop taking Citalopram Medreg unless advised by a doctor. At the end of a treatment cycle, it is usually recommended to gradually reduce the dose of Citalopram Medreg over several weeks.

Suddenly stopping Citalopram Medreg may cause mild and transient withdrawal symptoms such as: dizziness, tingling sensations, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety, headache, nausea, vomiting, sweating, feelings of anxiety or agitation, tremor, feelings of disorientation or confusion, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, palpitations or increased heart activity (heart racing).

At the end of a treatment cycle, it is recommended to gradually reduce the dose of Citalopram Medreg over a few weeks rather than stopping abruptly.

If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions usually resolve after a few weeks of treatment. It should be remembered that
some of these reactions may also be symptoms of the illness itself and will subside as the patient's condition improves.
Some patients have reported the following serious adverse reactions.
If any of the symptoms listed below occur, stop taking Citalopram Medreg immediately and seek medical help:

• high fever, agitation, confusion, tremor, and severe muscle contractions; these may be symptoms of a rare condition called serotonin syndrome, which has been 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 reactions (may occur in up to 1 in 1,000 patients).
If any of the symptoms listed below occur, stop taking Citalopram Medreg immediately and seek medical help:

• hyponatraemia: low sodium levels in the blood, which may cause fatigue, confusion, and muscle tremors

The following adverse reactions are usually mild and resolve after a few days of treatment. It should be remembered that adverse reactions may often be symptoms of the illness and therefore will improve as the patient starts to feel better. If adverse reactions are troublesome or persist for more than a few days, contact a doctor.
Dry mouth increases the risk of dental caries, so more frequent tooth brushing is recommended.
Very common (may occur in more than 1 in 10 patients)

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

Common (may occur in up to 1 in 10 patients)

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

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

• increased appetite, weight gain
• aggression, depersonalisation (loss of sense of self), hallucinations, mania
• fainting
• dilated pupils
• increased heart rate, decreased heart rate
• urticaria, hair loss, rash, purpura (red or purple spots on the skin due to bleeding), photosensitivity
• difficulty passing urine
• heavy menstrual bleeding
• swelling of hands or feet

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

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

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

• thoughts of self-harm or suicidal thoughts, see also section “Warnings and precautions”
• decreased platelet count, leading to increased risk of bleeding and bruising
• hypersensitivity (rash), severe allergic reaction causing difficulty breathing or dizziness
• increased volume of urine passed
• hypokalaemia: low potassium levels in the blood, which may cause muscle weakness, muscle tremors, or irregular heartbeat
• panic attacks, teeth grinding, restlessness
• unusual muscle movements, stiffness or contractions, akathisia (involuntary muscle movements)
• visual disturbances
• changes seen on ECG (called “QT interval prolongation”), ventricular arrhythmia (irregular heartbeat), including torsade de pointes
• low blood pressure
• nosebleeds
• abnormal liver function test results
• sudden swelling of the skin or mucous membranes
• irregular menstruation, severe vaginal bleeding shortly after childbirth (postpartum haemorrhage); additional information, see section 2 “Pregnancy, breastfeeding and fertility”
• painful erections, galactorrhoea in men and in women who are not breastfeeding.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 reactions may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Citalopram Medreg

Keep the medicine out of sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help protect the
environment.

6. Contents of the package and other information

What Citalopram Medreg contains

• The active substance is citalopram (in the form of citalopram hydrobromide). Each coated tablet contains 20 mg of citalopram (as citalopram hydrobromide).
• Other ingredients are: Tablet core: monohydrate lactose, corn starch, 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 Clopidogrel Medreg looks like and contents of the pack
White or almost white, oval, biconvex coated tablets (approximately 8.1 mm x 5.6 mm), with engraved markings "Z" and "7" on either side of the division line and "H" on the reverse side. The tablet can be divided into equal doses.
Coated tablets are packed in white, opaque blisters made of PVC/PVdC/Aluminum, placed 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 Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+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 medicinal product is authorised for marketing in the European Economic Area countries under the following names:
Czech Republic: Citalopram Medreg
Poland: Citalopram Medreg