CITALOPRAM VIR 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Citalopram VIR 20 mg film-coated tablets EFG

Citalopram

Read the entire package leaflet carefully before starting to take this medication

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the package leaflet

1. What Citalopram VIR 20 mg film-coated tablets are and what they are used for
2. Before taking Citalopram VIR 20 mg film-coated tablets
3. How to take Citalopram VIR 20 mg film-coated tablets
4. Possible side effects
5. Storage of Citalopram VIR 20 mg film-coated tablets
6. Additional information

1. What Citalopram VIR 20 mg film-coated tablets are and what they are used for

Citalopram VIR is a Selective Serotonin Reuptake Inhibitor (SSRI), and belongs to a group of medications known as antidepressants. These medications help to normalize serotonin levels in the brain. Alterations in brain serotonin 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.

2. Before taking Citalopram VIR 20 mg film-coated tablets

Do not take Citalopram VIR

• If you are allergic (hypersensitive) to citalopram or any of the other components of Citalopram VIR.

Citalopram VIR.

• If you are taking monoamine oxidase inhibitors (also called MAOIs, e.g., 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 MAOIs (see "Use of other medications").

• If you are taking pimozide (see "Use of other medications").
• If you have been born with any type of heart rhythm disorder or have ever suffered any episode of this type (this is observed with an electrocardiogram, a test that evaluates how the heart works).

If you are taking medications because you have a disease that alters the heart rhythm.

• If you are taking medications that may affect the heart rhythm.

Also, consult the "Use of other medications" section below.

Be especially careful with Citalopram VIR

Use in children and adolescents under 18 years of age:

Normally, Citalopram VIR should not be used in children and adolescents under 18 years of age. You should also know that patients under 18 years of age who take this class of medications have a higher risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, confrontational behavior, and anger). Nevertheless, your doctor may prescribe Citalopram VIR to patients under 18 years of age if they think it is best for them. If the doctor has prescribed Citalopram VIR to a patient under 18 years of age and you want to consult, tell your doctor. You should inform your doctor if the symptoms described above appear or worsen in patients under 18 years of age 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 an increase in anxiety symptoms at the start of treatment. Your doctor will adjust the 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, treatment with Citalopram VIR should be discontinued.
• If you have a history of mania/hypomania; Citalopram VIR should be used with caution and discontinued if the manic phase appears.
• If you have diabetes; treatment with Citalopram VIR may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemics.
• If you develop symptoms such as unpleasant or anxious restlessness, psychomotor agitation, and need to move, often accompanied by inability to sit or stand, and usually associated with subjective anxiety (akathisia). These symptoms appear with greater 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 a bleeding disorder. Citalopram VIR may cause bleeding (e.g., skin and mucous membrane bleeding) or if you are pregnant (see "Pregnancy").
• If you are using medications that affect blood coagulation (see "Use of other medications").
• If you have stomach ulcers or have suffered bleeding in the stomach or intestines.
• If you are undergoing electroconvulsive therapy. Caution is recommended since there is limited experience.
• If you have serotonin syndrome. The development of this disease can appear as a combination of symptoms: agitation, tremors, muscle contractions, and hyperthermia. Treatment with Citalopram VIR should be discontinued immediately.
• If you are taking herbal preparations containing St. John's Wort (Hypericum Perforatum). Concomitant use may increase the incidence of adverse reactions (see "Use of other medications").
• If you have severe kidney or liver problems. Citalopram VIR should not be used in patients with severe kidney dysfunction. In patients with severe liver problems, the dose of Citalopram VIR should be reduced.
• If you have psychosis with depressive episodes.
• If you are susceptible to suffering from certain disorders (prolongation of the so-called QT interval in the electrocardiogram - ECG), or are suspected to have congenital long QT syndrome, or have low potassium or magnesium levels (hypokalemia/hypomagnesemia).
• If you interrupt treatment, as withdrawal reactions may occur (see "If you stop taking Citalopram VIR").

Withdrawal reactions include: dizziness, muscle aches or numbness, headache, nausea, and anxiety. Most withdrawal reactions are mild and self-limiting. If you are going to stop treatment, it is recommended to gradually reduce the dose over 1-2 weeks.

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

An increased risk of bone fractures has been observed in patients treated with this type of medication.

Suicidal thoughts and worsening of depression or anxiety disorder

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

You are more likely to think this way:

contact your doctor or go to the hospital immediately.

It may help to inform a family member or close friendwho is depressed or has an anxiety disorder, and ask them to read this package leaflet. You could 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 same group as Citalopram VIR (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

Use of other medications

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Note that this may apply to medications you used in the past or will use in the future.

Some medications may cause problems if taken with Citalopram VIR:

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

Do not take Citalopram VIR

If you are taking medications because you already have a disease that alters the heart rhythm or if you are taking medications that may affect the heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine).

If you have doubts about this, consult your doctor.

Taking Citalopram VIR with food and drinks

It is recommended that you do not drink 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.

Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed yet.

Pregnancy

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 stop treatment with Citalopram VIR abruptly.

Tell your doctor if you are taking Citalopram VIR in the last 3 months of pregnancy, as the baby may have some symptoms at birth. These symptoms usually appear in the first 24 hours after birth and include: inability to sleep or feed properly, breathing problems that can become faster (symptom along with blue skin due to persistent pulmonary hypertension of the newborn (PPHN)), blue or too hot or cold skin, 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 abundant 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 using machines

Citalopram may affect your ability to drive or use machines.

Do not drive or use machines 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 them before taking this medication.

This medication does not contain gluten.

3. How to take Citalopram VIR 20 mg tablets

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

Consult your doctor or pharmacist if you have any doubts.

Citalopram VIR 20 mg is an oral tablet. The tablets can be taken at any time of day, regardless of meals, and in a single dose. They should be swallowed whole with a sufficient amount of liquid (a glass of water) and without chewing.

The usual dose is:

Adults:

Depression

The usual dose is 20 mg per day. Depending on the individual patient's response 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.

Elderly patients (over 65 years old)

In elderly patients, treatment should be started with half the recommended dose, for example, 10-20 mg per day.

In general, elderly patients should not take more than 20 mg per day.

Patients with special risks

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

Care should be taken when administering the dose to patients with severe liver dysfunction.

Patients with liver dysfunction should be clinically monitored.

Renal insufficiency

The doctor may decide to prescribe a lower dose than those described above.

In patients with severe renal 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 old

Citalopram VIR should not be used in the treatment of children and adolescents under 18 years old (see "Special warnings and precautions for use of Citalopram VIR").

Oral use.

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.

Duration of treatment:

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 indicated by your doctor. Do not stop taking them, even if you start to feel better, unless your doctor tells you to do so. Do not change the dose of the medication without consulting your doctor first.

Withdrawal symptoms observed after treatment interruption:

Abrupt 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 sections "If you stop taking 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

Symptoms in case of overdose:

Sleepiness, near-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, bluish discoloration of the skin due to inadequate oxygen in the blood (cyanosis), hyperventilation. Serotonin syndrome characteristics may appear (see "Possible side effects"), especially if other medications are taken at the same time.

If you forget to take Citalopram VIR

If you forget to take a dose, do not take a double dose to make up for the forgotten dose.

If you stop taking Citalopram VIR

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

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

Withdrawal reactions include dizziness, muscle aches 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.

4. Possible side effects

Like all medications, Citalopram VIR can cause side effects, although not everyone will experience them.

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

• Rapid and irregular heartbeats or feeling of fainting that could be symptoms of a serious heart problem known as torsades de pointes.
• Serotonin syndrome has been reported in patients treated with this type of antidepressant (SSRI). Inform your doctor if you experience high fever, trembling, muscle cramps, and anxiety, as these symptoms may indicate the onset of this syndrome. Treatment with Citalopram VIR should be discontinued immediately.
• You should go to your doctor immediately if you experience symptoms such as swelling of the face, tongue, and/or pharynx and/or difficulty swallowing or hives and difficulty breathing (angioedema).

These are very serious side effects. If you experience them, you may have had 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 indicated frequencies:

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

• Heart rate changes
• 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 100 patients treated):

• Rapid heartbeat
• Weight loss, weight gain
• Migraine, muscle aches or numbness
• Abnormal vision
• Rhinorrhea, sinusitis
• Indigestion/heartburn, vomiting, stomach pain, flatulence, increased salivation
• Urinary disorders, excessive urination
• Rash, itching
• Dizziness when standing up quickly, low blood pressure, high blood pressure
• Fatigue, yawning, changes in taste
• Women's inability to reach orgasm, menstrual pain, impotence, ejaculation failure
• Sleep disorders, concentration problems, abnormal dreams, memory loss, anxiety, decreased libido, increased appetite, loss of appetite, lack of emotion or enthusiasm, confusion.

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

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

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

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

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

• Abnormal heart rhythm (arrhythmia)
• Swelling and itching (angioedema) of the skin or mucous membranes
• Joint pain
• Severe allergic reaction, sudden, characterized by a significant drop in blood pressure, itching, rash, and difficulty breathing
• Abnormal milk secretion from the breast (galactorrhea)
• Hallucinations, permanent hyperactivity, and rapid mood swings, loss of contact with personal reality, along with feelings of unreality and eccentricity, panic attacks
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Hypersensitivity reactions:

Anaphylactic shock (severe drop in blood pressure, paleness, agitation, weak and rapid pulse, cool and moist skin, decreased consciousness) caused by the sudden and powerful dilation of blood vessels, due to severe hypersensitivity to certain substances.

Withdrawal symptoms observed after treatment interruption:

It is recommended to gradually reduce the dose over 1-2 weeks since withdrawal reactions may appear after treatment interruption. Withdrawal reactions include dizziness, muscle aches or numbness, headache, nausea, and anxiety. Most withdrawal reactions are mild and self-limiting. If treatment is to be interrupted, it is recommended to gradually reduce the dose over 1-2 weeks.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Citalopram VIR 20 mg tablets

Keep out of the reach and sight of children.

Do not use Citalopram VIR after the expiration date stated on the carton, after EXP. 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 wastewater or household waste. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Citalopram VIR 20 mg tablets

• The active ingredient is citalopram. One tablet contains 20 mg of citalopram (as citalopram hydrobromide).
• The other ingredients (excipients) are: cornstarch, lactose monohydrate, sodium croscarmellose, glycerol, copovidone, magnesium stearate, microcrystalline cellulose, hypromellose 5, macrogol 400, and titanium dioxide (E-171).

Appearance and packaging of the productFilm-coated tablet. The tablet is film-coated, oval, biconvex, white, and scored.

It is available in packs of 14, 28, and 56 film-coated tablets, packaged in blisters.

Not all pack sizes may be marketed.

Other presentations:

Citalopram VIR 10 mg tablets.

Marketing authorization holder and manufacturer

Holder:

Industria Química y Farmacéutica VIR, S.A.

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

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

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/