CITALOPRAM MEDREG

Patient Information Leaflet

Citalopram Medreg 20 mg film-coated tablets

citalopram
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Citalopram Medreg is and what it is used for
2. What you need to know 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 serotonin system in the brain by increasing serotonin levels.

What Citalopram Medreg is used for
Citalopram Medreg contains citalopram and is used to treat depression and, once you start feeling better, to help prevent the return of symptoms.
Citalopram Medreg is used for long-term treatment to prevent the recurrence of new episodes of depression in patients with recurrent depression.
Citalopram Medreg is also helpful in relieving symptoms in patients prone to panic attacks and in patients with obsessive-compulsive disorder (OCD).
Your doctor may have prescribed Citalopram Medreg for other purposes. If you have questions about why Citalopram Medreg has been prescribed for you, please ask your doctor.

2. What you should know before taking Citalopram Medreg

Do not take Citalopram Medreg

• if you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking other medicines belonging to a group of medicines called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazide, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression), and linezolid (an antibiotic).
• if you were born with or have had an episode of heart rhythm disorder (identified by an ECG; a test performed to assess how the heart functions).
• if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm (refer to “Other medicines and Citalopram Medreg”).

Even if you have stopped taking MAOIs, you must wait 2 weeks before starting your treatment with Citalopram Medreg.
After stopping moclobemide, you must wait 1 day before taking Citalopram Medreg.
After stopping treatment with Citalopram Medreg, you must wait 1 week before taking any MAOI.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Medreg.
Inform your doctor if you have any other condition or illness, as your doctor may need to take this into account. In particular, inform your doctor:

• if you have episodes of mania or panic disorder.
• if you have impaired liver or kidney function. Your doctor may need to adjust your dose.
• if you have diabetes. Treatment with Citalopram Medreg may alter glycaemic control. It may be necessary to adjust the dosage of insulin and/or oral hypoglycaemic agents.
• if you have epilepsy. Treatment with Citalopram Medreg should be discontinued if seizures occur or if there is an increase in their frequency (see also section 4 “Possible side effects”).
• if you have any bleeding disorders, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
• if you have low levels of sodium in the blood.
• if you are undergoing electroconvulsive therapy.
• if you have or have had heart problems or recently suffered a heart attack.
• if you have a low resting heart rate and/or if you know you have salt deficiencies due to severe and prolonged diarrhoea or vomiting (illness) or due to the use of diuretics (water tablets).
• if, when standing up, you experience a rapid or irregular heartbeat, fainting, collapse, or dizziness, which could indicate an abnormality in heart rhythm function.
• if you have or have previously had eye problems such as certain types of glaucoma (increased pressure in the eye).

Please consult your doctor, even in cases where such conditions occurred in the past.
Please note
Some patients with bipolar disorder may enter a manic phase. This is characterized by unusual and rapid changes in thoughts, inappropriate happiness, and physical hyperactivity. If these symptoms occur, contact your doctor.
During the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing (akathisia) may also occur. If you develop these symptoms, 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 have been observed to persist after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety disorder
If you suffer from depression and/or have anxiety disorders, you may occasionally think about harming yourself or committing suicide.
These thoughts may be more common at the beginning of treatment with antidepressants, as these medicines take time to work, usually about two weeks but sometimes longer.
You are more likely to start thinking about harming yourself or committing suicide:

• if you have previously thought about suicide or self-harm.
• if you are a young adult. Data from clinical studies have shown an increased risk of suicidal behaviour in adults (under 25 years of age) with psychiatric disorders treated with an antidepressant.

If at any time you think about harming yourself or committing suicide, contact your doctor or go immediately to the hospital.
It may be helpful to inform a relative or close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about any changes in your behaviour.

Children and adolescents
Citalopram Medreg is generally contraindicated in children and adolescents under 18 years of age. You should also know that patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram Medreg to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Citalopram Medreg to a patient under 18 years of age and you would like more information, contact your doctor. You must inform your doctor if any of the above symptoms appear or worsen during treatment with Citalopram Medreg in patients under 18 years of age.
In addition, the long-term safety effects of Citalopram Medreg on growth, maturation, and cognitive and behavioural development in this age group have not yet been established.

Important information about the illness
As with other medicines used to treat depression or related conditions, improvement is not immediate. Several weeks may pass after starting treatment with Citalopram Medreg before you feel any improvement.
In the treatment of panic disorders, improvement generally occurs within 2–4 weeks.
At the beginning of treatment, some patients may experience increased anxiety, which will disappear with continued treatment. Therefore, it is very important that you follow your doctor’s instructions exactly and do not stop treatment or change the dose without first consulting your doctor.
Speak immediately with your doctor or contact the nearest hospital if you have distressing thoughts or experience any of the symptoms listed above during treatment.
The use of medicines in the SSRI/SNRI group (to which Citalopram Medreg belongs) is often associated with the development of akathisia (distress or restlessness or difficulty sitting or standing), which may occur even during the first few weeks of treatment. If you experience these symptoms, contact your doctor immediately.

Other medicines and Citalopram Medreg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can alter the action of other medicines, and this may sometimes cause serious adverse reactions.
Inform your doctor if you are taking the following medicines:

• “Non-selective monoamine oxidase inhibitors (MAOIs)” containing active substances such as phenelzine, iproniazide, isocarboxazide, nialamide, and tranylcypromine. If you have taken any of these medicines, you must wait 14 days before starting to take Citalopram Medreg.

After stopping Citalopram Medreg, you must wait 7 days before taking any of these medicines.

• “Reversible selective MAO-A inhibitors” containing moclobemide (used to treat depression).
• The antibiotic linezolid.
• Lithium (used for prophylaxis and treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• “Irreversible MAO-B inhibitors” containing selegiline (used to treat Parkinson’s disease); these medicines increase the risk of adverse effects. The dose of selegiline must not exceed 10 mg per day.
• Metoprolol (used for high blood pressure and/or heart disease); blood levels of metoprolol increase, but no enhancement of effect or occurrence of adverse effects related to this increase has been reported.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar medicines (opioids, used to treat severe pain); these medicines increase the risk of adverse effects. If you experience unusual symptoms while taking this combination, you must contact 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). These medicines may cause an increase in citalopram blood levels.
• Medicines known to affect platelet function (e.g. certain antipsychotics, acetylsalicylic acid (used as an analgesic), non-steroidal anti-inflammatory drugs (used for arthritis)); slightly increased risk of bleeding abnormalities.
• St. John’s wort (Hypericum perforatum) – an herbal preparation used to treat depression. Concomitant use with Citalopram Medreg may increase the risk of adverse 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.
• Antidepressants and neuroleptics (medicines for the treatment of schizophrenia, psychoses) due to a possible risk of lowering the seizure threshold.
• Medicines that reduce potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disorders.

Do not take Citalopram Medreg if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), and certain antihistamines (astemizole, mizolastine).
If you have any further doubts, contact your doctor.

Citalopram Medreg with food, drinks, 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 drink alcohol during treatment with Citalopram Medreg.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Citalopram Medreg if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.
If you take Citalopram Medreg during the last 3 months of pregnancy and up to the time of delivery, you should be aware that the following adverse effects may occur in the newborn: breathing difficulties, bluish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, low blood sugar levels, muscle stiffness or floppiness, exaggerated reflexes, tremors, agitation, irritability, lethargy, persistent crying, drowsiness, and sleep difficulties. If your newborn has any of these symptoms, contact your doctor immediately.
Ensure that your doctor (or midwife) knows that you are taking Citalopram Medreg. When taken during pregnancy, particularly during the last 3 months, medicines such as Citalopram Medreg may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually occur within the first 24 hours after birth. If this happens to your baby, contact your doctor immediately.
If you take Citalopram Medreg during the late stages of pregnancy, there may be an increased risk of severe vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed if you are taking Citalopram Medreg so they can advise you.
Citalopram, in animal studies, has been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines
Citalopram Medreg generally does not cause drowsiness; however, if you experience dizziness or drowsiness at the beginning of treatment, do not drive and do not operate tools or machinery until these effects subside.

Citalopram Medreg contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Citalopram Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Citalopram Medreg

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dose:
Adults
Depression
The usual dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg daily.

Panic disorder
The initial dose is 10 mg daily for the first week of treatment, after which the dose may be increased to 20–30 mg daily. Your doctor may increase the dose up to a maximum of 40 mg daily.

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

Elderly patients (over 65 years of age)
The initial dose should be reduced by half of the recommended dose, for example 10–20 mg daily. Elderly patients should generally not take more than 20 mg daily.

Patients with particular risk factors
Patients with liver problems should not take more than 20 mg daily.

Use in children and adolescents
Citalopram Medreg must not be given to children or adolescents. For further information, please refer to section 2 “What you need to know before taking Citalopram Medreg”.

How and when to take Citalopram Medreg
Citalopram Medreg is taken every day as a single daily dose. Citalopram Medreg can be taken at any time of day, with or without food. Swallow the tablets with a glass of water.

Duration of treatment
Like other medicines used for depression, panic disorder, and OCD, it may take several weeks before improvement is noticeable with these tablets. Continue taking Citalopram Medreg even if it takes time before you feel better.
Never change the dose of this medicine without first consulting your doctor.
The duration of treatment is individual and usually lasts at least 6 months. Continue taking the tablets for as long as your doctor has advised. Do not stop taking them even if you start to feel better. The underlying condition may persist for a long time, and if treatment is stopped too early, symptoms may return.
Patients with recurrent depression benefit from continued treatment, sometimes for several years, to prevent the recurrence of new depressive episodes.

If you take more Citalopram Medreg than you should
If you think that you or someone else has taken too much Citalopram Medreg, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if there are no signs of discomfort. Take the Citalopram Medreg packaging/foil with you if you go to a doctor or to hospital.
Some symptoms of overdose may be life-threatening. Symptoms of overdose may include: irregular heartbeat, seizures, changes in heart rhythm, drowsiness, coma, vomiting, tremor, low blood pressure, high blood pressure, nausea (feeling unwell), serotonin syndrome (see section 4), agitation, dizziness, dilated pupils, sweating, bluish discoloration of the skin, hyperventilation.

If you forget to take Citalopram Medreg
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember before going to bed, take it immediately. Continue taking the medicine as usual the next day. If you only remember during the night or the following day, skip the missed dose and continue with your regular dosing schedule.

If you stop taking Citalopram Medreg
Do not stop taking Citalopram Medreg unless your doctor tells you to. When treatment is completed, it is generally recommended that the dose of Citalopram Medreg be gradually reduced over several weeks.
If you stop taking Citalopram Medreg suddenly, you may experience mild and transient withdrawal symptoms such as: dizziness, sensations like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headache, feeling unwell (nausea), vomiting, sweating, restlessness or agitation, tremor, confusion or disorientation, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, rapid or pounding heartbeat (palpitations).
At the end of treatment, it is recommended to gradually reduce the dose of Citalopram Medreg over a couple of weeks rather than stopping abruptly.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The side effects usually disappear after a few weeks of treatment. Please note that many of the side effects may also be symptoms of your illness and, therefore, will improve as you start to feel better.
The following serious side effects have been reported in some patients.
Stop taking Citalopram Medreg and contact your doctor immediately if you experience any of the following symptoms:

• high fever, agitation, confusion, tremor, and sudden muscle contractions; these may be signs of a rare condition called serotonin syndrome, which has been reported with the combined use of antidepressants
• swelling of the skin, tongue, lips, or face, difficulty breathing or swallowing (allergic reaction)
• abnormal bleeding, including gastrointestinal bleeding

Rare but serious side effects (may affect up to 1 in 1,000 patients):
Stop taking Citalopram Medreg and contact your doctor immediately if you experience any of the following symptoms:

• hyponatraemia: low levels of sodium in the blood which may cause tiredness, confusion, and muscle spasms

The following side effects are generally mild and disappear after a few days of treatment.
Please note that side effects are often symptoms of your illness and therefore will improve as you start to feel better. If side effects cause problems or last longer than a few days, contact your doctor.
Dry mouth increases the risk of tooth decay; 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 (feeling unwell)
• increased sweating

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

• decreased appetite, weight loss
• restlessness, reduced sexual desire, anxiety, nervousness, confusion, abnormal dreams
• tremor, tingling or numbness in arms and feet, dizziness, attention disturbances
• perception of ringing in the ears (tinnitus)
• yawning
• diarrhoea, vomiting, constipation
• itching
• muscle and joint pain
• men may experience problems with ejaculation and erection
• women may fail to reach orgasm
• fatigue

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

• increased appetite, weight gain
• aggression, depersonalisation (feeling detached from oneself), hallucinations, mania
• fainting
• dilated pupils
• increased heart rate, decreased heart rate
• hives, hair loss, rash, purpura (red or purple spots on the skin caused by underlying bleeding), photosensitivity
• difficulty urinating
• heavy menstruation
• swelling of arms or legs

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

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

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

• thoughts of self-harm or suicidal thoughts – see also section “Warnings and precautions”
• reduction in the number of platelets in the blood, increasing the risk of bleeding or bruising
• hypersensitivity (rash), severe allergic reaction causing difficulty breathing or dizziness
• increased urine volume
• hypokalaemia: low levels of potassium in the blood which may cause muscle weakness, cramps, or abnormal heart rhythm
• panic attacks, teeth grinding, restlessness
• involuntary muscle movements, stiffness or cramps, akathisia (involuntary movements of muscles)
• visual disturbances
• changes in ECG (known as “prolongation of the QT interval”), ventricular arrhythmia (irregular heartbeat) including torsade de pointes
• low blood pressure
• nosebleeds
• abnormal liver function tests
• sudden swelling of the skin or mucosa
• irregular menstruation, heavy vaginal bleeding immediately after childbirth (postpartum haemorrhage); for further information, see section 2 “Pregnancy, breastfeeding and fertility”
• painful erection, milk secretion in men and in women who are not breastfeeding

An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Medreg

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton or blister after “Scad” and “EXP”.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Citalopram Medreg contains

• The active substance is citalopram (as citalopram hydrobromide). Each film-coated tablet contains 20 mg of citalopram (as citalopram hydrobromide).
• The other components are:
  Tablet core: monohydrate lactose, maize starch, copovidone, microcrystalline cellulose (Grade 102), sodium croscarmellose, magnesium stearate.
  Film coating: titanium dioxide (E171), hypromellose 2910, 3 mPas (E464), hypromellose 2910, 6 mPas (E464), macrogol 400 (E1521), polysorbate 80 (E433).

Description of the appearance of Citalopram Medreg and package contents
Citalopram Medreg 20 mg:
Biconvex, oval, film-coated tablets, white to almost white in colour (approximately 8.1 mm x 5.6 mm), marked with the characters “Z” and “7” on both sides of the score line and “H” on the other side.
The tablet can be divided into equal doses.
The film-coated tablets are supplied in opaque white PVC/PVdC/Al blisters packed in cardboard boxes.
Pack sizes: 14, 20, 28, 30, 60, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

Manufacturer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Pharmazet Group s.r.o.
Třtinová 260/1
Čakovice
196 00 Prague 9
Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Citalopram Medreg
Poland: Citalopram Medreg
Czech Republic: Citalopram Medreg