Prospect: information for the user

Citalopram SUN 20 mg film-coated tablets EFG

(Citalopram hydrobromide)

Contents of the package and additional information

How does Citalopram SUN work?

Citalopram SUN is a selective serotonin reuptake inhibitor (SSRI) and belongs to a group of medicines known as antidepressants. These medicines help correct certain chemical imbalances in the brain that cause symptoms of your illness.

What is Citalopram SUN used for?

Citalopram SUN contains citalopram and is used to treat depression and, once you are feeling better, to prevent the recurrence of these symptoms. Citalopram SUN is also used for long-term treatment to prevent the onset of new episodes of depression if you suffer from recurrent depression.

Citalopram SUN is also beneficial in the disappearance of symptoms if you suffer from panic attacks with or without agoraphobia (for example, fear of leaving home, entering shops, or fear of public places).

Do not take CITALOPRAM SUN:

• If you are allergic to citalopram or any of the other ingredients of this medication (listed in section 6). A reaction may include rash, itching, swelling of the face, lips, or hands/feet, or difficulty breathing.
• If you are taking medications called monoamine oxidase inhibitors (MAOIs), or if you have been under such treatment in the past two weeks. Treatment should not be initiated sooner than two weeks after stopping treatment with an irreversible MAOI, or the time specified by your doctor after stopping treatment with a reversible MAOI (e.g. Moclobemida). Your doctor will inform you how to take Citalopram SUN once you have stopped taking the MAOI. At least one week should pass between stopping treatment with Citalopram SUN and starting treatment with an MAOI.
• If you are taking medications such as linezolida (an antibiotic) and/or pimozida (used to treat mental disorders).
• If you have experienced or were born with an abnormal heart rhythm (seen on ECG; a test to evaluate heart function).
• If you are taking medications for heart rhythm problems or that may affect heart rhythm. See also the section “Taking Citalopram SUN with other medications”.

Warnings and precautions:

Medications like Citalopram SUN (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Thoughts of suicide and worsening of depression or anxiety

If you are depressed and/or have anxiety, you may sometimes have thoughts of harming yourself or committing suicide. This could worsen when you start taking antidepressants for the first time, as these medications usually take two weeks or more to have a normal effect.

You may be more prone to thinking this way if:

1. - if you have previously had suicidal thoughts or self-harm
2. - if you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in adults over 25 years old with psychiatric disorders and taking an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time, consult your doctor or go to the hospital immediately.

It may be helpful to tell a close relative or friend that you are depressed or have anxiety, and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Inform your doctor, pharmacist, or nurse before taking Citalopram SUN if you have or have had:

• Epilepsy (seizures)

• Liver and/or kidney problems. Your doctor may reduce your dose of the tablets if your kidneys and/or liver do not function properly.

• Low sodium blood levels that can cause fatigue, confusion, muscle cramps, seizures, and coma. This effect is more likely to occur if you are an elderly woman. However, your sodium blood levels will return to normal once you stop taking the medication.
• You are being treated with electroconvulsive therapy
• Mania (feeling euphoric or emotionally “high”).
• Severe mental condition in which the person loses contact with reality and is unable to think and judge clearly.
• Diabetes (you may need to adjust your insulin and/or oral antidiabetic medication dose)
• Glaucoma with closed angle or history of glaucoma
• History of bleeding disorders or if you are pregnant (see Pregnancy, breastfeeding, and fertility) or if you have ever had bleeding in the stomach or intestines and/or if you are taking medications that affect blood clotting or increase the risk of bleeding such as:
• NSAIDs (e.g. Aspirin, ibuprofen, or diclofenac)
• Ticlopidina, dipiridamol (medication that affects blood platelets)
• Atypical antipsychotics (e.g. Clozapina), phenothiazines (e.g. Chlorpromazine, thioridazine), tricyclic antidepressants (e.g. Imipramine, desipramine) (see section “Other medications and Citalopram SUN”).
• If you have or have had heart problems or recently had a heart attack.
• If you have low heart rate and/or know that you have a decrease in electrolytes due to prolonged diarrhea and vomiting (dizziness) or the use of diuretics.
• If you experience rapid or irregular heartbeat, fainting, collapse, or dizziness when standing up that may indicate abnormal heart function.

Symptoms such as restlessness, for example, inability to sit or stand still, may occur during the first weeks of treatment. Inform your doctor immediately if you experience these symptoms. You may need to adjust your dose.

Some patients with manic-depressive illness may enter a manic phase. This is characterized by rapid and unusual changes in ideas, inappropriate happiness, and excessive physical activity. If you experience these symptoms, contact your doctor.

In rare cases, during treatment with Citalopram SUN, serotoninergic effects, serotonin syndrome, or a condition similar to malignant neuroleptic syndrome may develop, particularly when taken with other serotoninergic and/or neuroleptic medications. As these symptoms can lead to life-threatening conditions for the patient, treatment with Citalopram should be discontinued and symptomatic treatment initiated. These syndromes are characterized by a number of symptoms that occur simultaneously, such as muscle twitching, confusion, sweating, hallucinations, increased reflexes, muscle rigidity, chills, increased heart rate, and tremors (see also “Possible side effects”). Rarely, rhabdomyolysis (temporary paralysis or muscle weakness) may occur.

Special information related to your condition

As with other medications for treating depression or related conditions, improvement is not immediate. After starting treatment with Citalopram SUN, it may take several weeks before you begin to experience any improvement. At the beginning of treatment, some patients may experience an increase in anxiety, which will disappear during continued treatment. Therefore, it is very important that you follow your doctor's instructions exactly and do not interrupt treatment or change your dose without consulting your doctor.

Children and adolescents

Citalopram SUN should not be used normally in the treatment of children and adolescents under 18 years old. At the same time, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes Citalopram SUN may prescribe it to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribes Citalopram SUN has prescribed it to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above progress or if you experience complications when patients under 18 years old are taking Citalopram SUN.

At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Citalopram SUN in this age group have not yet been demonstrated.

Use of Citalopram SUN with food, drinks, and alcohol:

Citalopram SUN should be taken once a day. Citalopram SUN can be taken at any time of the day with or without food.

Do not take alcohol while taking Citalopram SUN.

Other medications and Citalopram SUN:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Some medications may cause problems if taken with this medication.

Precautions should be taken if citalopram is administered with any of the following medications:

• Non-selective monoamine oxidase inhibitors (IMAOs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranilcipromina as active substances.
• Selective reversible MAO-A inhibitors containing moclobemida (used to treat depression).
• “Irreversible MAO inhibitors”, containing selegilina (used to treat Parkinson's disease). This increases the risk of adverse effects.

• Lithium (medication for treating manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Sumatriptan and similar medications (used to treat migraines), dextromethorphan (used to relieve cough), petidina (for pain) and tramadol (for severe pain). This increases the risk of adverse effects.
• St. John's Wort (Hypericum perforatum) – a plant-based treatment used for depression.
• Aspirin and non-steroidal anti-inflammatory drugs (medications used for pain or to thin the blood, also called anticoagulants)
• Ticlopidina, dipiridamol (medication that affects blood platelets)
• For mental disorders, such as atypical antipsychotics (e.g. Clozapina, risperidona, olanzapina, quetiapina) or phenothiazines (e.g. Chlorpromazine, trifluperazina) or tricyclic antidepressants (e.g. Imipramine, clomipramina, desipramina). Taking Citalopram with these medications may increase your risk of bleeding.
• Medications that decrease blood potassium and magnesium levels.
• Metoprolol, a beta blocker used to treat migraines, certain heart conditions, and high blood pressure. The effects of both medications may be increased, decreased, or altered.
• Neuroleptics (used in the treatment of schizophrenia)
• Carbamazepina (used to treat seizures)
• Cimetidina (used to treat stomach ulcers) lansoprazol and omeprazol (used to treat stomach ulcers), fluconazol (used to treat fungal infections), fluvoxamina (antidepressant) and ticlopidina (used to reduce the risk of stroke). These may cause an increase in citalopram blood levels.
• Mefloquina (used to treat malaria).
• Bupropión (used to treat depression).

DO NOT TAKE Citalopram SUNif you are taking medications for heart rhythm or that may affect heart rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g. Derivatives of fentiazine, pimozida, haloperidol), tricyclic antidepressants, certain antibiotics (e.g. Esparfloxacino, moxifloxacino, eritromicina IV, pentamidina, antimalarial treatment particularly halofantrina), certain antihistamines (astemizol, mizolastina).

If you have any further questions, consult your doctor.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will decide if treatment with Citalopram SUN is necessary or if there is any alternative treatment possible.

Do not stop your treatment with Citalopram SUN abruptly due to pregnancy or other reasons.

Ensure that your midwife and/or doctor are informed that you are being treated with Citalopram SUN.

During pregnancy, particularly in the last 3 months, medications like Citalopram SUN may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, contact your midwife and/or doctor immediately.

If you take Citalopram SUN in the final stages of pregnancy, there may be a higher risk of excessive vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Citalopram SUN to be able to advise you.

If you take Citalopram SUN during the last 3 months of your pregnancy and until the date of birth, be aware that the following effects may be observed in the newborn baby: seizures, changes in body temperature, difficulty breathing, blue skin, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Citalopram is known to pass into breast milk. Its effects on the nursing infant have not been established. If treatment with citalopram is considered necessary, breastfeeding should be discontinued.

Citalopram has been observed to reduce sperm quality in animal studies. Theoretically, this may affect fertility, but no impact on human fertility has been observed.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery:

This medication may cause adverse effects (such as dizziness, drowsiness, confusion, and vision problems) that may affect your concentration and reaction time. If you experience these adverse effects, do not drive, operate machinery, or anything that requires you to be alert and focused.

Citalopram SUN contains lactose monohydrate.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How much to take

It is very important that you take your tablets as your doctor has instructed. The labeling will inform you of how much to take and the frequency of doses. If you are not instructed or are unsure, ask your doctor or pharmacist.

Adults

Depression

The usual dose is 20 mg per day.This may be increased by your doctor up to a maximum of 40 mg per day.

Panic disorder

The initial dose is 10 mg per day for the first weekbefore increasing the dose to 20-30 mg per day. Your doctor may increase your dose up to a maximum of 40 mg per day.

Older adults (65 years and older)

The initial dose should be reduced to half of the recommended dose, for example, 10-20 mg per day. Older adults should not usually receive a dose greater than 20 mg per day.

Children and adolescents under 18 years

Citalopram SUN should not be administered to children and adolescents. For more information, see section 2 What you need to know before starting to take Citalopram SUN.

Patients with special risks

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

How and when to take Citalopram SUN

Citalopram SUN is taken once a day as a single daily dose. Citalopram SUN can be taken at any time of the day with or without food. Swallow the tablet with a glass of water. Do not chew (they have a bitter taste).

The groove should not be used to split the tablet.

Treatment duration

As with other depression and panic disorder medications, it may take several weeks to find some improvement. Continue taking Citalopram SUN even if you do not feel any improvement in your condition.

The treatment duration is individual, usually at least 6 months. Continue taking the tablets for the recommended time by your doctor. Do not stop taking them unless your doctor has told you to. The underlying disease may persist for a long time and if you stop treatment too soon, symptoms may reappear.

Patients with recurrent depressions benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.

Never change the medication dose without talking to your doctor first.

If you estimate that the action of Citalopram SUN 20 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more CITALOPRAM SUN than you should:

Never take more tablets than your doctor recommends. If you have taken too many tablets, or if someone has accidentally swallowed some, contact your doctor or go to the nearest hospital. Show the box of tablets. The main symptoms that may appear in case of taking too many tablets (overdose) are: feeling dizzy or feeling drowsy, sweating, very high fever, blue discoloration of the skin and mucous membranes, serotonin syndrome, nausea or vomiting, dilated pupils, rapid or deep breathing, abnormal heart rate, high or low blood pressure, heart attack, uncontrolled muscle spasms affecting the eyes, head, neck, and body, tremors, cramps, agitation, anxiety, and coma.

If you forget to take CITALOPRAM SUN:

In case of forgetting a dose, wait for the next one. But do not take a double dose to compensate for the missed dose.

If you interrupt treatment with CITALOPRAM SUN:

It should be avoided to interrupt treatment abruptly.unless your doctor tells you to, even if you feel better.

Stopping the medication abruptly after a long time may cause withdrawal symptoms, such as dizziness, diarrhea, numbness and tingling, sweating, headache, rapid or irregular heartbeats, emotional instability, irritability, agitation or anxiety, sleep disturbances including inability to sleep and/or intense sleep, convulsions or tremors, confusion, visual disturbances, nausea, and vomiting. These symptoms are usually not severe and disappear within a few days. Citalopram should always be discontinued gradually over a period of 1-2 weeks.

If you experience withdrawal symptoms when stopping your tablets, your doctor may decide to stop the medication more slowly.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, Citalopram SUN may cause side effects, although not everyone will experience them.

Side effects are more noticeable during the first or even the first two weeks of treatment, and then they disappear as the disease improves.

If you experience any of the following symptoms, discontinue your medication and seek immediate medical attention:

• Allergic reactions
• Angioedema, such as
• • Swelling of the face, tongue, or pharynx
  • Difficulty swallowing
  • Urticaria and difficulty breathing
• Serotonin syndrome (symptoms: agitation, confusion, sweating, hallucinations, increased reflexes, muscle rigidity, chills, increased heart rate, and tremors).
• Fast, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as Torsade de Pointes.

Very common: (more than 1 in 10 patients treated)

• Difficulty sleeping or feeling drowsy
• Headaches, dizziness (vertigo)
• Palpitations or strong heartbeats
• Feeling dizzy (nausea), dry mouth
• Increased sweating
• Visual disturbances
• Sensation of weakness

Common: (less than 1 in 10 but more than 1 in 100 patients treated)

• Feeling agitated, nervous
• Sleep disturbances (excessive dreaming, abnormal dreams), lack of concentration, memory loss, anxiety, decreased sexual behavior, sexual dysfunction (women), decreased appetite, feeling completely dissatisfied and confused.
• Migraine and paresthesia (sensation of pinpricks, tingling, or paralysis of the skin)
• Tremors
• Change in blood pressure (may increase or decrease)
• Indigestion, vomiting, constipation, diarrhea, stomach pain, gas, and increased salivation
• Difficulty urinating, excessive urine secretion
• Muscle pain, joint pain
• Weight loss
• Swelling of the nasal and sinus passages
• Ejaculatory failure in men, impotence, menstrual pain in some women
• Itching (generalized or localized skin)
• Visual problems
• Tinnitus in the ears
• Fatigue, yawning

Rare: (less than 1 in 100 but more than 1 in 1000 patients treated)

• Aggression: seeing, feeling, or hearing things that are not real (hallucinations): excitement, hyperactivity, and uninhibited behavior (mania); depersonalization; feeling extremely happy and increased sexual behavior
• Increased appetite, weight gain
• Abnormal heart rhythm
• Fainting
• Dilated pupils
• Urticaria, hives, hair loss, bleeding or bruising on the skin.
• Inability to urinate
• Heavy menstrual periods
• Coughing
• Sweating of the hands, ankles, or feet
• Increased sensitivity of the skin to light
• Allergic reactions, general feeling of discomfort)

Rare: (less than 1 in 1000 but more than 1 in 10,000 patients treated)

• Abnormal bleeding, mainly from the skin and mucous membranes, gastrointestinal bleeding, vaginal bleeding
• Fatigue, confusion, and muscle cramps. These signs may be due to low sodium levels in the blood.
• Disturbances of taste
• Seizures, uncontrollable tics, agitation, or twisting movements
• Liver disease, characterized by yellowing of the skin and eyes, pale stools, dark urine, etc.
• Fever or high temperature.

Very rare: (less than 1 in 10,000 patients treated, including isolated cases)

• Fast heart rate
• Increased levels of prolactin

Unknown frequency

• Bleeding or bruising more easily than normal
• Overproduction of a hormone that causes fluid retention, resulting in weakness, fatigue, or confusion
• Low potassium levels in the blood
• Panic attacks, teeth grinding, nervousness, suicidal thoughts, suicidal behavior
• Involuntary abnormal movements (extrapyramidal disorders)
• Restlessness or difficulty sitting, movement disorders
• Sensation of fainting or dizziness when standing due to decreased blood pressure
• Nasal bleeding
• Altered liver function tests
• Persistent and painful erection of the penis without sexual excitement
• Abnormal milk secretion in men and women
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information.

Fractures have been observed in patients over 50 years old.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Citalopram SUN Composition

The active ingredient is citalopram (hydrobromide).

Each coated tablet of 20 mg contains 25 mg of citalopram hydrobromide equivalent to 20 mg of citalopram.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, copovidone, sodium croscarmellose, and magnesium stearate. The components of the coating material, Opadry Blanco 20H 58983 are hypromellose, titanium dioxide (E171), propylene glycol, hydroxypropyl cellulose, and talc.

Product Appearance and Packaging Content

Citalopram SUN 20 mg are white, film-coated, circular, biconvex tablets with the inscription "20" in low relief on one face and a groove on the other face.

Citalopram SUN 20 mg are presented in packs of 1, 14, 20, 28, 30, 50, 56, 98, 100, or 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132 JH,

Hoofddorp,

Netherlands

Responsible Manufacturer:

Terapia S.A.

Str. Fabricii nr. 124,

Cluj, Napoca,

Romania

or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87, 2132 JH,

Hoofddorp,

Netherlands

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de catalunya 53-55

08007 Barcelona.

Spain

Phone: +34 342 78 90

This medicine is authorized in the member states of the European Economic Area with the following names

United Kingdom: Citalopram 20 mg Tablets

Austria: Zyloram 20 mg Filmtabletten

Czech Republic: Zyloram 20 mg Tablety

Germany: Citatopram Basics 20 mg Filmtabletten

Spain: Citalopram SUN 20 mg comprimidos recubiertos con película EFG

Netherlands: Citalopram Ranbaxy 20 mg Tablets

This leaflet was approved in March 2021