Package Leaflet: Information for the User

Citalopram VIR 20 mg Film-Coated Tablets EFG

Citalopram

Read this leaflet carefully before you start taking this medicine

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist

1. What isCitalopram VIR 20 mg Film-Coated Tabletsand what it is used for

2. Before takingCitalopram VIR 20 mg Film-Coated Tablets

3. How to takeCitalopram VIR 20 mg Film-Coated Tablets

4. Possible side effects

5. Storage ofCitalopram VIR 20 mg Film-Coated Tablets

6. Additional information

Citalopram VIR is a Selective Serotonin Reuptake Inhibitor (SSRI), and belongs to a group of medicines known as antidepressants. These medicines help to normalize serotonin levels in the brain. Alterations in brain serotonin levels are a key factor in the development of depression and related disorders.

Citalopram is indicated for:

- Treatment of depression and prevention of relapse.

- Treatment of anxiety disorder with or without agoraphobia.

- Treatment of obsessive-compulsive disorder.

Do not take Citalopram VIR

• If you are allergic (hypersensitive) to citalopram or to any of the other ingredients of

Citalopram VIR.

• If you are taking the same time inhibitors of monoamine oxidase (also called IMAO, for example, selegiline or moclobemide) or have taken them in the last two weeks.

Your doctor will tell you how to start taking citalopram when you have stopped taking the IMAO (see "Use of other medicines").

• If you are taking the same time pimozide (see "Use of other medicines").
• If you have had since birth some type of heart rhythm disorder or have had at any time some episode of this type (this is observed with the electrocardiogram, a test that serves to evaluate how the heart works).

If you are taking medicines because you have some disease that alters the heart rhythm.

• If you are taking medicines that can affect the heart rhythm.

See also the section "Use of other medicines" that is located below.

Be especially careful with Citalopram VIR

Use in children and adolescents under 18 years:

Normally, Citalopram VIR should not be used in children and adolescents under 18 years. Also, you should know that patients under 18 years who take this type of medication have a higher risk of side effects, such as suicidal thoughts, suicidal thoughts, and hostility (especially, aggression, confrontational behavior, and anger). Despite this, your doctor may prescribe Citalopram VIR to patients under 18 years if they think it is best for them. If your doctor has prescribed Citalopram VIR to a patient under 18 years and wants to consult, tell your doctor. You should inform your doctor if symptoms described above appear or worsen in patients under 18 years who are taking Citalopram VIR.

In this age group, the long-term safety of Citalopram VIR has not been demonstrated in terms of growth, maturity, and cognitive and behavioral development.

• If you are being treated for panic attacks; you may experience anincrease in anxiety symptomsat the beginning of treatment. Your doctor will adjust your treatment (see section 3 "How to take Citalopram VIR").
• If you have epilepsy; there is a potential risk of seizures with antidepressant medications. If the frequency of seizures increases, you should interrupt treatment with Citalopram VIR.
• If you have a history of mania/hypomania; Citalopram VIR should be used with caution and interrupted if a manic phase appears.
• If you havediabetes; treatment with Citalopram VIR may alter blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you develop symptoms such as unpleasant restlessness or anxiety, psychomotor agitation, and a need to move, frequently accompanied by an inability to sit or stand, and usually associated with subjective anxiety (akathisia). These symptoms appear with a higher probability in the first weeks of treatment. In patients who develop these symptoms, it may be harmful to increase the dose, and these symptoms may worsen.
• If you have ableeding disorder. Citalopram VIR may cause bleeding (for example, bleeding in the skin and mucous membranes) or if you are pregnant (see“Pregnancy”).
• If you are using medications that affect blood coagulation (see “Use of other medicines”).
• If you havestomach ulcersor if you have had bleeding in the stomach or intestines.
• If you are undergoingelectroconvulsive therapy. Caution is recommended since there is little experience.
• If you have the so-calledserotonin syndrome. The development of this disease may appear as a combination of symptoms: agitation, tremor, muscle contractions, and hyperthermia. You should interrupt treatment with Citalopram VIR immediately.
• If you are taking preparations of plants that contain St. John's Wort (Hypericum
• Perforatum). The concurrent use may cause an increase in the incidence of adverse reactions (see section “Use of other medicines”).
• If you havesevere kidney or liver problems. Citalopram VIR should not be used in patients with severe kidney dysfunction. In patients with severe liver problems, it is recommended to reduce the dose of Citalopram VIR.
• If you havepsychosis with depressive episodes.
• If you are susceptible to suffering certain disorders (prolongation of the so-called QT interval in the electrocardiogram -ECG-), or suspect, have the congenital long QT syndrome, or have low levels of potassium or magnesium (hypokalemia/hypomagnesemia).
• If treatment is interrupted, since you may experiencewithdrawal reactions(see “If you interrupt treatment with Citalopram VIR”).

Withdrawal reactions include: dizziness, muscle cramps or numbness, headache, nausea, and anxiety. Most withdrawal reactions are of a mild and self-limiting nature. If treatment is to be interrupted, it is recommended to gradually reduce the dose over 1-2 weeks.

• If you have or have had some heart problem or have recently had a heart attack.
• cardiac.
• If, when at rest, your heart beats slowly (this is known as bradycardia) and/or you think your body may be losing salt, for example, because you have had diarrhea and vomiting for several days or because you have used diuretics (medicines to urinate).
• If you have noticed that your heartbeats are fast or irregular or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have some heart rhythm disorder.

A higher risk of bone fractures has been observed in patients treated with this type of medication.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, sometimes you may have thoughts of self-harm or suicide. These thoughts may increase when you start taking antidepressants for the first time, as all these medications need time to start working, usually two weeks, but sometimes more.

It is more likely that you will think this way:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. The information obtained from clinical trials has shown an increase in the risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.
• If you have thoughts of self-harm or suicide at any time,contact your doctor or go to the hospital immediately.

It may help to inform a family member or close friend,who is depressed or has 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 changes in your behavior.

Some medications in the group to which Citalopram VIR belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after treatment is stopped.

Use of other medicines

Inform your doctor or pharmacist if you are using or have recently used other medicines, even those purchased without a prescription.

Take into account that this may apply to medicines you used a long time ago or that you will use in the future.

Some medicines may cause problems if taken with Citalopram VIR:

• Antidepressants of the type called monoamine oxidase inhibitors (IMAO), such as phenelzine, isocarboxazid, and tranylcypromine. Do not take citalopram until 14 days after stopping treatment with an irreversible IMAO. Do not take citalopram until the specified time after stopping treatment with a reversible IMAO (for example, moclobemide), as described in the IMAO prospectus. Do not take an IMAO until 7 days after stopping treatment with citalopram.
• Do not use citalopram if you are taking more than 10 mg/day of the MAO selegiline.
• Do not take citalopram if you are taking pimozide (for psychiatric disorders).
• Medicines for depression, for example, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, bupropion, tricyclic antidepressants such as nortriptyline, desipramine, clomipramine, and St. John's Wort (Hypericum Perforatum)
• Medicines for migraines, for example, sumatriptan and other triptans
• Medicines for pain, such as tramadol
• Medicines for pain and inflammation, such as nonsteroidal anti-inflammatory drugs (NSAIDs), for example, ibuprofen, ketoprofen, and diclofenac
• Medicines for infections, for example, the antibiotic linezolid
• Medicines to prevent blood coagulation (anticoagulants), for example, warfarin, aspirin, dipiridamol, ticlopidine
• Medicines for irregular heartbeat, for example, propafenone, flecainide
• Medicines for heart failure, such as metoprolol
• Medicines for stomach ulcers, such as omeprazole, lansoprazole, cimetidine
• Medicines for psychiatric disorders, for example, lithium, risperidone, chlorpromazine, thioridazine, chlorprothixene, haloperidol, phenothiazine derivatives.
• Medicines for malaria, for example, mefloquine and particularly halofantrine.
• Other medications with serotoninergic effects, such as oxitriptan or tryptophan
• Medications that prolong the QT interval or that decrease potassium/magnesium levels in the blood.
• Medications for treating fungal infections, for example, fluconazole.

Do not take Citalopram VIR

If you are taking medicines because you already have some disease that alters the heart rhythm or if you are taking medicines that by themselves could affect the heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (e.g. phenothiazine derivatives, primozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria particularly halofantrine), certain antihistamines (astemizol, mizolastine).

If you have doubts about this, consult your doctor.

Taking Citalopram VIR with food and drinks

It is recommended not to take alcohol during treatment with Citalopram VIR.

Citalopram VIR can be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Studies in animals have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

Pregnancy

The experience with the use of Citalopram VIR during pregnancy is limited. Do not take Citalopram VIR if you are pregnant or are planning to become pregnant, unless your doctor considers it absolutely necessary. Do not interrupt treatment with Citalopram VIR abruptly.

Inform your doctor if you are taking Citalopram VIR in the last 3 months of pregnancy, as the baby may have some symptoms at birth. Usually, these symptoms appear in the first 24 hours after birth. They include: inability to sleep or feed properly, respiratory problems that can become faster (symptom along with blue skin of persistent pulmonary hypertension of the newborn (HPPN)), blue skin or too hot or cold, discomfort, continuous crying, stiff or soft muscles, lethargy, tremors, tics, or seizures. If the baby has any of these symptoms, contact your doctor immediately, who will advise you.

If you take Citalopram VIR in the final stage of pregnancy, there may be a higher risk of heavy 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 VIR to be able to advise you.

Breastfeeding

Citalopram passes into breast milk in small amounts. There is a risk of effects on the baby. If you are taking Citalopram VIR, inform your doctor before starting breastfeeding.

Driving and operating machinery

Citalopram may affect your ability to drive or operate machinery.

Do not drive or operate machinery until you know how citalopram affects you. Consult your doctor or pharmacist if you have doubts.

Important information about some of the components of this medication:

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

This medication does not contain gluten.

Follow exactly the administration instructions for Citalopram VIR indicated by your doctor.

Consult your doctor or pharmacist if you have doubts.

Citalopram VIR 20 mg are oral tablets. The tablets can be taken at any time of the day, regardless of meals, and in a single dose. They should be swallowed with a sufficient amount of liquid (a glass of water) and not chewed.

The usual dose is:

Adults:

Depression

The usual dose is 20 mg per day. Depending on the individual response of the patient and the severity of the depression, your doctor may gradually increase the dose up to a maximum of 40 mg per day.

Panic disorder

The recommended initial dose is 10 mg per day for the first week. Then, the dose is increased to 20-30 mg per day. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Obsessive-compulsive disorder (OCD)

The recommended initial dose is 20 mg per day. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Older adults (over 65 years)

In older adults, treatment should be initiated with half the recommended dose, for example 10-20 mg per day.

In general, older adults should not take more than 20 mg per day.

Patients with special risks

Patients with liver disease should not take more than 20 mg.

Caution is advised and the dose should be carefully administered in patients with severe liver dysfunction.

Patients with severe liver dysfunction should be clinically monitored.

Renal insufficiency

Your doctor may decide to prescribe a lower dose than the ones described above.

In patients with severe renal function impairment, the use of citalopram is not recommended since there is no information available on its use in these patients.

Use in children and adolescents under 18 years

Citalopram VIR should not be used in the treatment of children and adolescents under 18 years (see “Be especially careful with Citalopram VIR”).

Oral administration.

Citalopram VIR should be taken as a single dose, in the morning or at night. The tablets can be taken with or without food.

The tablets should be swallowed whole with water or another liquid.

Treatment duration:

Citalopram VIR does not act immediately. It may take 2-4 weeks before you notice improvement. This is normal with this type of medication.

For the treatment of panic disorders, the complete therapeutic response may take up to 3 months to appear. It may be necessary to continue treatment for several months.

Continue taking the tablets for the time your doctor tells you to. Do not stop taking them, even if you start feeling better, unless your doctor tells you to. Do not change the medication dose without consulting your doctor first.

Withdrawal symptoms observed after treatment interruption:

Brusque treatment interruption should be avoided. When treatment with citalopram is interrupted, the dose should be gradually reduced over 1-2 weeks to minimize the risk of withdrawal reactions (see “If you interrupt treatment with Citalopram VIR” and “Possible side effects”).

If you notice that the effect of citalopram is too strong or too weak, inform your doctor or pharmacist.

If you take more Citalopram VIR than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

Symptoms in case of overdose:

Sleep, a state close to unconsciousness, with apparent mental inactivity and reduced ability to respond to stimuli (coma, stupor), convulsions, changes in heart rhythm (e.g., prolonged QT interval), nausea, vomiting, sweating, blue discoloration of the skin due to inadequate oxygen in the blood (cyanosis), hyperventilation. Characteristics of serotonin syndrome may appear, especially if other medications are taken at the same time (see “Possible side effects”).

If you forget to take Citalopram VIR

If you forget to take a dose, do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Citalopram VIR

Do not stop taking Citalopram VIR unless your doctor tells you to.

It is recommended to gradually reduce the dose over 1-2 weeks since withdrawal reactions may occur when treatment is interrupted.

Withdrawal reactions include: dizziness, muscle cramps or numbness, headache, nausea, and anxiety. Most withdrawal reactions are mild and self-limiting. It is recommended to gradually reduce the dose over 1-2 weeks when treatment is to be interrupted.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Citalopram VIR may cause side effects, although not everyone will experience them.

If the following side effects occur, stop taking Citalopram VIR and inform your doctor immediately or go to the nearest hospital:

• Fast or irregular heartbeats or a feeling of fainting that could be symptoms of a serious heart problem known as torsade de pointes.
• Serotonin syndrome has been reported in patients treated with this type of antidepressant (ISRS). Inform your doctor if you experience high fever, shivering, muscle cramps, and anxiety, as these symptoms may indicate the onset of this syndrome. Treatment with Citalopram VIR should be stopped immediately.
• Seek medical attention immediately if you experience symptoms such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria and difficulty breathing (angioedema).

These are very serious side effects. If you experience them, you may have suffered a severe allergic reaction to Citalopram VIR. You may need urgent medical attention or hospitalization.

• All these very serious side effects are very rare.

The following side effects have been reported at the frequencies indicated:

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

• Alteration in heart rhythm
• Headache, tremor, dizziness
• Blurred vision
• Nausea, dry mouth, constipation, diarrhea
• Increased sweating
• Feeling of weakness (lethargy)
• Feeling of sleepiness, difficulty sleeping, agitation, nervousness

Common (between 1 and 10 in every 100 patients treated):

• Fast heart rate
• Weight loss, weight gain
• Migraine, muscle cramps or numbness
• Abnormal vision
• Nasal discharge, breast inflammation
• Indigestion/heartburn, vomiting, stomach pain, flatulence, increased salivation
• Urinary tract problems, excessive urine production
• Rash, itching
• Dizziness when standing up quickly, low blood pressure, high blood pressure
• Fatigue, yawning, taste alterations
• Female inability to achieve orgasm, menstrual pain, impotence, ejaculation failure
• Sleep disorders, difficulty concentrating, abnormal dreams, memory loss, anxiety, decreased libido, increased appetite, loss of appetite, absence of emotion or enthusiasm, confusion.

Uncommon (between 1 and 10 in every 1,000 patients treated):

• Slow heart rate
• Motor system disorders (extrapyramidal symptoms), convulsions
• Tinnitus (ringing in the ears)
• Cough
• Light sensitivity
• Muscle pain
• Allergic reactions, fainting, general feeling of discomfort
• Increased liver enzymes
• Feeling of euphoria, happiness, and well-being, increased sexual desire.

Rare (between 1 and 10 in every 10,000 patients treated):

• Bleeding (e.g., vaginal bleeding, gastrointestinal bleeding, skin and mucous membrane bleeding)
• Low sodium levels in the blood (hyponatremia), and a condition called SIHAD (syndrome of inappropriate antidiuretic hormone secretion), especially in the elderly
• Serotonin syndrome
• Thoughts of suicide or suicidal behavior, inability to stay still and restlessness

Very rare (less than 1 in 10,000 patients treated), frequency unknown (cannot be estimated from available data):

• Abnormal heart rhythm or heart rate (arrhythmia)
• Swelling and itching (angioedema) in the skin or in the tissues surrounding internal body cavities (mucous membrane)
• Joint pain
• Severe allergic reaction, sudden, characterized by a strong decrease in blood pressure, skin itching, rash, and difficulty breathing
• Abnormal milk secretion by the breast (galactorrhea)
• Hallucinations, permanent hyperactivity, and rapid changes in mood and ideas, loss of personal contact with reality, accompanied by feelings of unreality and eccentricity, panic attacks
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Reactions of hypersensitivity:

Shock (severe decrease in blood pressure, pallor, agitation, weak and rapid pulse, cold and moist skin, decreased consciousness) caused by the sudden and potent dilation of blood vessels due to severe hypersensitivity to certain substances (anaphylactic reactions).

Symptoms of withdrawal observed after discontinuation of treatment:

It is recommended to gradually reduce the dose over 1-2 weeks as withdrawal symptoms may occur after discontinuation of treatment. Withdrawal symptoms include dizziness, muscle cramps or numbness, headache, nausea, and anxiety. Most withdrawal symptoms are mild and self-limiting. If treatment is to be discontinued, it is recommended to gradually reduce the dose over 1-2 weeks.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use Citalopram VIR after the expiration date appearing on the box, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Do not dispose of medications through drains or trash. Deposit containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This way, you will help protect the environment.

Citalopram VIR 20 mg Tablet Composition

• The active ingredient is citalopram. One tablet contains 20 mg of citalopram (as citalopram hydrobromide).
• The other components (excipients) are: cornstarch without gluten, lactose monohydrate, sodium croscarmellose, glycerol, copovidone, magnesium stearate microcrystalline cellulose, hypromellose 5, macrogol 400, and titanium dioxide (E-171).

Product Appearance and Packaging ContentCoated tablet. Coated, oval, biconvex, white tablet with a notch.

It is presented in packaging of 14, 28, and 56 coated tablets, conditioned in blisters.

Only some packaging sizes may be commercially available.

Other presentations:

Citalopram VIR 10 mg tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/. Laguna 66-68-70, 28923 ALCORCÓN (Madrid) Spain

Responsible Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/. Laguna 66-68-70, 28923 ALCORCÓN (Madrid) - Spain

Or

RIVOPHARM PHARMACEUTICALS LABORATORIES

Via Cantonale, Centro Insema CManno- Switzerland

This leaflet was revised in December 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/