Package Insert: Information for the User.

CITALVIR 20 mg Film-Coated Tablets EFG

Citalopram

Read this package insert carefully before starting to use this medication because it contains important information for you

• Keep this package insert. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4

Information in this package insert:

1. What CITALVIR is and for what it is used.
2. What you need to know before starting to take CITALVIR.
3. How to take CITALVIR.
4. Possible adverse effects.
5. Storage of CITALVIR.
6. Contents of the package and additional information.

CITALVIR is an antidepressant medication that belongs to the group of "selective serotonin reuptake inhibitors".

CITALVIR is indicated for:

• Treatment of depression and prevention of relapses.
• Treatment of anxiety disorder with or without agoraphobia.
• Treatment of obsessive-compulsive disorder.

Do not take CITALVIR:

• If you are allergic to citalopram or any of the other ingredients in the medication (listed in section 6).
• If you are taking other antidepressant medications that belong to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medications such as phenelzine, iproniazid, isocarboxazid, nialamide, tranilcipromina, selegiline (used in the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
• If you have any type of heart rhythm disorder since birth or have ever had an episode of this type (this is observed with an electrocardiogram, a test that evaluates how the heart functions).
• If you are taking medications for any disease that alters the heart rhythm.
• If you are taking medications that can affect the heart rhythm.

Also, see the section "Use of Citalvir with other medications" below.

Even if you have finished treatment with MAOIs, you will need to wait 2 weeks before starting your treatment with CITALVIR.

You must wait a day after taking moclobemide.

After finishing CITALVIR, you must wait a week before taking any MAOI.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Citalvir.

Please inform your doctor if you have any other condition or disease, as your doctor may need to take it into account. In particular, inform your doctor:

• If you have manic episodes or anxiety disorder.
• If you have liver or kidney insufficiency. Your doctor may need to adjust the dose.
• .
• If you have diabetes. The treatment with CITALVIR may alter blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have epilepsy. The treatment with CITALVIR should be discontinued if seizures occur or if there is an increase in seizure frequency (see also section 4 "Possible side effects").
• If you have a history of bleeding disorders, or if you develop unusual bleeding, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you have low sodium levels in the blood.
• If you are receiving electroconvulsive therapy.
• If you have or have had any heart problems or have recently had a heart attack.
• 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 (medications to urinate).
• If you have noticed that your heartbeats are rapid 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.
• If you have a problem with pupil dilation (mydriasis).

.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

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

Symptoms such as restlessness or difficulty sitting or staying upright (akathisia) may also occur during the first weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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

Special information related to your disease

Like other medications used to treat depression or related diseases, improvement is not immediate. After starting treatment with CITALVIR, it may take several weeks to experience any improvement.

In the treatment of anxiety disorder, it usually takes 2-4 weeks to observe any improvement.

At the beginning of treatment, some patients may experience an increase in anxiety, which will disappear with continued treatment. Therefore, it is very important to follow your doctor's instructions exactly and not interrupt or change the dose without consulting your doctor.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or taking your life. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around 2 weeks, although in some cases it may take longer.

You would be more prone to having these thoughts:

• If you have previously had thoughts of harming yourself or taking your life.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric diseases treated with an antidepressant.

If you ever have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

Telling a family member or close friend that you are depressed or have an anxiety disorder and asking them to read this leaflet may be helpful. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

Use in children and adolescents

CITALVIR 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 attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes CITALVIR may prescribe it to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribes CITALVIR 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 CITALVIR. At the same time, the long-term effects on safety related to growth, maturity, and cognitive and behavioral development of CITALVIR in this age group have not yet been demonstrated.

Use of CITALVIR with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, even those purchased without a prescription.

Some medications may affect the action of others and may cause sometimes severe adverse reactions.

Inform your doctor if you are using any of the following medications:

Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranilcipromina as active substances. If you have taken any of these medications, you should wait 14 days before starting to take CITALVIR. After finishing treatment with CITALVIR, you should wait 7 days before taking any of these.

Selective reversible MAO-A inhibitors containing moclobemide (used for the treatment of depression).

The antibiotic linezolid.

-Lithium (used for the prophylaxis and treatment of manic-depressive disorder) and tryptophan.

-Imipramine and desipramine (both used to treat depression).

-Irreversible MAO-B inhibitors, containing selegiline (used for the treatment of Parkinson's disease); these increase the risk of adverse effects. The dose of selegiline should not exceed 10 mg per day.

-Metoprolol (used for high blood pressure and/or heart disease); the blood levels of metoprolol are increased, but no signs of increased effect or adverse effects of metoprolol have been observed.

-Sumatriptan and similar medications (used to treat migraines) and tramadol (used for severe pain) increase the risk of adverse effects, if you experience any unusual symptoms using this combination, see your doctor.

Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). The levels of citalopram in the bloodmay be increased, but no increase in the adverse effects of CITALVIR has been reported.. Medications that affect platelet function, for example, some antipsychotics, aspirin (used for pain), non-steroidal anti-inflammatory drugs (used for arthritis); slightly increase the risk of bleeding disorders.

-St. John's Wort (Hypericum perforatum) (a herbal remedy used for depression); the concomitant administration with CITALVIR 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 a possible risk of lowering the seizure threshold.

-Neuroleptics (medications for schizophrenia, psychosis), due to a possible risk of lowering the seizure threshold, and antidepressants.

-Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (esparfloxacine, moxifloxacine, eritromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizol, mizolastine).

-Medications that decrease potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which are life-threatening.

.

Do not take CITALVIR

If you are taking medications because you already have some disease that alters the heart rhythm or if you are taking medications that could affect the heart rhythm

If you are unsure about this, consult your doctor.

Taking CITALVIR with food, drinks, and alcohol

CITALVIR can be taken with or without food (see section 3. "How to take CITALVIR").

CITALVIR has been observed not to increase the effects of alcohol. However, it is recommended to avoid consuming alcohol during treatment with CITALVIR.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or are planning to become pregnant. Pregnant women should not normally take CITALVIR, and mothers should not breastfeed their babies while taking this medication, unless you and your doctor have analyzed the risks and benefits involved.

Pregnancy

If you take CITALVIR 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: difficulty breathing, blue skin, seizures, changes in body temperature, 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.

If you take citalopram in the final stage 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 CITALVIR to be able to advise you.

Breastfeeding

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

Make sure your midwife and/or doctor are informed that you are being treated with CITALVIR. During pregnancy, particularly in the last 3 months, medications like CITALVIR may increase the risk of a serious disease 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.

Citalopram has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but until now, it has not been observed in human fertility.

Driving and using machines

Generally, CITALVIR does not cause drowsiness; however, if you feel dizzy or drowsy when starting to take this medication, do not drive or use tools or machines until these effects disappear

.

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

Citalvir contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free"

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with CITALVIR. Do not discontinue treatment before or abruptly, as this could worsen your condition.

You must continue taking your medication even if you do not notice improvement, as several weeks may be needed for the medication to take effect.

CITALVIR for oral administration. 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 recommended dose is

Adults:

Depression

The usual dose is 20 mg per day. If your doctor deems it necessary, they may increase this dose up to a maximum of 40 mg per day.

Anxiety disorder

The initial dose is 10 mg per day for the first week before increasing it 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 initial dose is 20 mg per day. If necessary, your doctor may increase the dose in increments of 20 mg up to a maximum of 40 mg per day.

Older adults (65 years and older)

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

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

Children

The safety and efficacy of CITALVIR 10 mg in children and adolescents under 18 years have not been established, so its use is not recommended in this population.

Patients with special risks

Patients with liver insufficiency:

It is recommended not to exceed a dose of 20 mg per day.

Patients with renal insufficiency:

The use of citalopram is not recommended in patients with severe renal insufficiency.

If you estimate that the action of CITALVIR is too strong or weak, inform your doctor or pharmacist.

If you take more CITALVIR than you should

If you believe you or someone else has taken more CITALVIR than they should, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department

call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

Do so even if you do not observe symptoms or signs of intoxication.

Bring the CITALVIR packaging with you if you visit the doctor or hospital.

Some of the symptoms of an overdose may include irregular heartbeats with life-threatening risk, seizures, changes in heart rhythm, drowsiness, coma, vomiting, tremors, decreased blood pressure, increased blood pressure, nausea (feeling dizzy), serotonin syndrome (see section 4. "Possible side effects"), agitation, dizziness, dilated pupils, sweating, blue skin, hyperventilation (increased respiratory rate).

.

If you forgot to take CITALVIR

If you forgot to take a dose, take the next dose at the usual time

. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with CITALVIR

Do not stop taking CITALVIR until your doctor tells you to. When you have completed your treatment period, it is generally recommended that the CITALVIR dose be gradually reduced over several weeks

Abrupt withdrawal of the medication may cause some mild and transient disturbances such as dizziness, sensation of pins and needles, sleep disturbances (intense dreams, nightmares, inability to sleep), sensation of anxiety, headache, sensation of dizziness (nausea), vomiting, sweating, sensation of restlessness or agitation, tremors, feeling of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

When you have completed the treatment period, it is generally recommended that the CITALVIR dose be gradually reduced over a couple of weeks instead of stopping it abruptly

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects usually disappear after a few weeks of treatment. Please note that many of the side effects can also be symptoms of your illness and will therefore improve when you start to feel better.

Some patients have reported the following serious side effects.

If you have any of the following symptoms, you must stop taking CITALVIR and see your doctor immediately:

• High fever, agitation, confusion, tremors, and sudden muscle contractions; they 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, or difficulty breathing or swallowing (allergic reaction).

• Unusual bleeding, including gastrointestinal bleeding.

Rare but serious side effects (May affect up to 1 in 1,000 people):

If you have any of the following symptoms, you must stop taking CITALVIR and see your doctor immediately.

• Hypontremia: low sodium levels in the blood that can cause fatigue, confusion, and muscle cramps.

Fast and irregular heartbeats or a feeling of fainting, as they may be symptoms of a serious heart condition known as torsade de pointes.

The following side effects are generally mild and usually disappear after a few days of treatment. Please be aware that several of the effects mentioned below may be symptoms of your illness and will therefore improve when you start to feel better.

If the side effects are bothersome or last longer than a few days, consult your doctor.

Dry mouth increases the risk of tooth decay. Therefore, you should brush your teeth more frequently than usual.

Frequent side effects (May affect more than 1 in 10 people):

Tendency to sleep.

• Difficulty sleeping

Increased sweating.

• Dry mouth.
• Nausea (feeling dizzy).
• Headache

Common side effects (May affect up to 1 in 10 people):

• Decreased appetite.
• Agitation.
• Decreased sexual behavior.
• Anxiety.
• Nervousness.
• Confusion.
• Abnormal dreams.
• Tremors.
• Numbness or tingling in hands or feet.
• Dizziness.
• Attention alteration.
• Tinnitus (ringing in the ears).
• Yawning.
• Diarrhea.
• Vomiting.
• Constipation.
• Rash.
• Muscle and joint pain.
• Men may experience problems with ejaculation and erection.
• Women may experience difficulty reaching orgasm.
• Fatigue.
• Fever.
• Itching skin.
• Weight loss.

• Cutaneous hemorrhagic disorders (easy bruising).
• Increased appetite.
• Aggression.
• Depersonalization.
• Hallucinations.
• Mania.
• Loss of consciousness.
• Dilated pupils.
• Fast heart rate.
• Slow heart rate.
• Hives.
• Hair loss.
• Cutaneous eruption.
• Photophobia.
• Urination difficulties.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

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

• Seizures.
• Involuntary movements.
• Taste alterations.
• Bleeding.
• Hepatitis.
• Fever

Frequency not known (Cannot be estimated from available data):

• Thoughts of self-harm or suicidal thoughts, see also the

section "Warnings and precautions"

• Reduction of platelets in the blood, which increases the risk of bleeding or ecchymosis (hematoma).
• Hypersensitivity (rash).
• Severe allergic reaction that causes difficulty breathing or dizziness.
• Increased urine output.
• Hypokalemia: low potassium levels in the blood that can cause muscle weakness,

contractions, or abnormal heart rhythm.

• Panic attack.
• Chattering teeth.
• Restlessness.
• Abnormal muscle movements or rigidity.
• Akathisia (involuntary movements of the muscles).
• Visual disturbances.
• Low blood pressure.
• Nasal bleeding.
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis).
• Excessive postpartum bleeding (hemorrhage), see 'Pregnancy, lactation, and fertility' in the section 2 for more information.

Swelling of the skin or mucous membranes.

• Painful erections.
• Milk leakage in men and women who are not breastfeeding.
• Irregular menstrual periods.
• Abnormal liver function tests.
• Orthostatic hypotension (significant drop in blood pressure when standing).

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

• Abnormal heart rhythm.

.

If you experience side effects, consult your doctor, pharmacist, or nurse even if they are side effects that do not appear in this leaflet.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the Vigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine

This medication does not require special storage conditions.

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

Do not use this medication after the expiration date indicated on the packaging, after CAD. The expiration date is the last day of the month indicated.

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 of the pharmacy. If in doubt, ask your pharmacist how to dispose of medications you no longer need. By doing so, you will help protect the environment.

Composition of CITALVIR:

The active ingredient of CITALVIR 20 mg is citalopram (hydrobromide). Each tablet contains 24.98 mg of hydrobromide of citalopram (equivalent to 20 mg of citalopram).

The other components (excipients) are: cornstarch, lactose monohydrate, croscarmellose sodium, glycerol, copovidone, magnesium stearate microcrystalline cellulose, hypromellose, macrogol 400, and titanium dioxide (E-171).

Appearance of the product and content of the packaging

CITALVIR 20 mg is presented in film-coated tablets. The film-coated tablets are white, oval, biconvex, and scored.

CITALVIR 20 mg is available in blister packs containing 14, 28, and 56 tablets.

Only some package sizes may be marketed.

Other presentations:

CITALVIR 10 mg tablets.

CITALVIR 40 mg tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

ABABOR PHARMACEUTICALS, S.L.

Chile, 4 - Building 1 - Office 1 - Las Matas

28290- Las Rozas

Spain

Responsible for manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

Spain

Tel.: 91 486 29 90Fax: 91 486 29 91

Or

RIVOPHARM PHARMACEUTICALS LABORATORIES

Via Cantonale, Centro Insema C

CH-6928 Manno, Switzerland

Last review date of this leaflet:June 2021

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