CITALVIR 10 mg FILM-COATED TABLETS

2. What you need to know before you take CITALVIR

Do not take CITALVIR:

• If you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine (used to treat depression), selegiline (used to treat Parkinson's disease), and linezolid (an antibiotic).
• If you have been born with or have had a heart rhythm disorder or have experienced any episode of this type (as seen on an electrocardiogram, a test that evaluates how the heart works).
• If you are taking medicines because you have a heart condition that affects your heart rhythm.
• If you are taking medicines that may affect your heart rhythm.

Also, read the section "Using CITALVIR with other medicines" below.

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

A day must pass after taking moclobemide.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting CITALVIR.

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

• If you have manic episodes or anxiety disorder.
• If you have liver or kidney failure. Your doctor may need to adjust the dose.
• If you have diabetes, treatment with CITALVIR may alter blood sugar control. You may need an adjustment of insulin and/or oral hypoglycemic dose.
• If you have epilepsy. Treatment with CITALVIR should be discontinued if seizures occur or if there is an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have a history of bleeding disorders or if you develop unusual bruising, 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 your heart beats slowly when you are at rest (this is known as bradycardia) and/or you think your body may be losing salt, for example, because you have had intense diarrhea and vomiting for several days or because you have used diuretics (medicines to urinate).
• If you have noticed that your heart beats quickly or irregularly or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.
• If you have a problem with the dilation of the pupils (mydriasis).

Talk to your doctor, even if any of the above circumstances have occurred to you in the past.

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

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

Some medicines in the group to which CITALVIR belongs (called SSRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Special information related to your disease

Like other medicines used to treat depression or related diseases, improvement is not achieved immediately. After starting treatment with CITALVIR, it may take several weeks before you experience any improvement.

In the treatment of anxiety disorders, it usually takes 2-4 weeks before any improvement is observed.

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

Suicidal thoughts and worsening of your depression or anxiety disorder

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

You would be more likely to have these thoughts:

• If you have previously had thoughts of taking your own life or harming yourself.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. 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 normally be used in the treatment of children and adolescents under 18 years. At the same time, you should know that in patients under 18 years, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, your doctor may prescribe CITALVIR to patients under 18 years when they decide it is most convenient for the patient. If your doctor has prescribed CITALVIR to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You must inform your doctor if any of the symptoms mentioned above progress or if you experience complications when patients under 18 years are taking CITALVIR. At the same time, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of CITALVIR in this age group have not yet been demonstrated.

Using CITALVIR with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those bought without a prescription.

Some medicines can affect the action of other medicines and may cause serious side effects.

Tell your doctor if you are using any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, 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 medicines.

Reversible MAO-A inhibitors containing moclobemide (used to treat 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 to treat 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); blood levels of metoprolol increase, but no signs of increased effect or adverse effects of metoprolol have been observed.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain) increase the risk of adverse effects. If you experience any unusual symptoms using this combination, you should 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).

• Blood levels of citalopram may be increased, but no increase in adverse effects of CITALVIR has been reported. Medicines that affect platelet function, such as some antipsychotic drugs, acetylsalicylic acid (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); 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 threshold for seizures.
• Neuroleptics (medicines for treating schizophrenia, psychosis), due to a possible risk of lowering the threshold for seizures, and antidepressants.
• Antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medicines against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which pose a risk to life.

Do not take CITALVIR

If you are taking medicines because you already have a heart condition that affects your heart rhythm or if you are taking medicines that may affect your heart rhythm.

If you have doubts about this, consult your doctor.

Using CITALVIR with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or are planning to become pregnant. Pregnant women should not normally take CITALVIR, nor should mothers breastfeed their babies while taking this medicine, unless you and your doctor have analyzed the risks and benefits involved.

If you take CITALVIR during the last 3 months of your pregnancy and up to the date of birth, be aware that the following effects may be observed in the newborn baby: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. 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 greater 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 CITALVIR to be able to advise you.

Breastfeeding

Citalopram passes into breast milk in small amounts. There is a risk of effects in the child. 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, medicines like CITALVIR may increase the risk of a serious disease in newborns called persistent pulmonary hypertension (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you should contact your midwife and/or doctor immediately.

Citalopram has been shown to reduce sperm quality in animal models. This effect could theoretically affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

Generally, CITALVIR does not cause drowsiness; however, if you feel dizzy or drowsy when you start taking this medicine, 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 some sugars, consult with them before taking this medicine.

CITALVIR contains sodium

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

3. How to take Citalvir

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 suspend treatment before or abruptly, as it could worsen your illness.

You must continue taking your medication even if you do not notice improvement, as it may take several weeks for the medication to start working.

CITALVIR is for oral administration. The tablets can be taken at any time of day, regardless of meals, and in a single dose. They should be swallowed with a sufficient amount of liquid (a glass of water) and without chewing.

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 your doctor deems it necessary, they 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 your doctor deems it necessary, they may increase the dose in increments of 20 mg 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.

Children

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

Patient with special risks

Patient with hepatic impairment:

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

Patient with renal impairment:

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

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

If you take more CITALVIR than you should

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

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

Do this even if you do not observe discomfort or signs of intoxication.

Take the CITALVIR packaging with you if you go to the doctor or hospital.

Some of the symptoms of an overdose may include irregular heartbeats with life risk, convulsions, changes in heart rhythm, drowsiness, coma, vomiting, tremors, decrease in blood pressure, increase in blood pressure, nausea (feeling dizzy), serotonin syndrome (see section 4. "Possible adverse effects"), agitation, dizziness, dilation of the pupils, sweating, bluish skin, hyperventilation (increased respiratory rate).

If you forget to take CITALVIR

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

Do not take a double dose to make up for the forgotten dose.

If you interrupt treatment with CITALVIR

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

Abrupt withdrawal of the medication can produce some mild or transient disorders such as dizziness, tingling sensation, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of anxiety, headache, feeling of dizziness (nausea), vomiting, sweating, feeling of restlessness or agitation, tremors, feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or palpitations.

.

When you have finished your treatment period, it is generally recommended that the dose of Citalvir be reduced gradually over a couple of weeks instead of being stopped abruptly.

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

4. Possible adverse effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

Adverse effects usually disappear after a few weeks of treatment. Please note that many of the 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 adverse 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; may be signs of a rare condition called serotonin syndrome, which has been reported with the combined use of antidepressants.

• If you notice skin swelling, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction).

• Unusual bleeding, including gastrointestinal bleeding

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

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

• Hyponatremia: low sodium level in the blood, which can cause fatigue, confusion, and muscle contraction.

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

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

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

Dry mouth increases the risk of cavities. Therefore, you should brush your teeth more often than usual.

Very common adverse effects (May affect more than 1 in 10 people):

Tendency to sleep.

• Difficulty sleeping

Increased sweating.

• Dry mouth
• Nausea (feeling dizzy)
• Headache

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

• Decreased appetite
• Agitation
• Decreased sexual behavior
• Anxiety
• Nervousness
• Confusional state
• Abnormal dreams
• Tremors
• Tingling or numbness of hands or feet
• Dizziness
• Attention disturbance
• Ringing in the ears (tinnitus)
• 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 of the skin
• Weight loss

Uncommon adverse effects (May affect up to 1 in 100 people):

• Bleeding disorders (easy bruising)
• Increased appetite
• Aggression
• Depersonalization
• Hallucinations
• Mania
• Fainting
• Dilated pupils
• Fast heartbeats
• Slow heartbeats
• Hives
• Hair loss
• Rash
• Sensitivity to light
• Difficulty urinating
• Excessive menstrual bleeding
• Swelling of arms and legs
• Weight gain

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

• Seizures
• Involuntary movements
• Taste disturbances
• Bleeding
• Hepatitis
• Fever

Frequency not known (cannot be estimated from the available data):

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

section "Warnings and precautions"

• Decreased platelet count in the blood, which increases the risk of bleeding or bruising (hematoma)
• Hypersensitivity (rash)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Increased urine output
• Hypokalemia: low potassium level in the blood, which can cause muscle weakness, contractions, or abnormal heart rhythm

Crisis of anxiety

• Teeth grinding
• Restlessness
• Abnormal muscle movements or stiffness
• Akathisia (involuntary muscle movements)
• Visual disturbances
• Low blood pressure
• Nosebleeds
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis)
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see 'Pregnancy, breastfeeding, and fertility' in section 2 for more information

Sudden swelling of the skin or mucous membranes

• Painful erections
• Milk flow in men and in women who are not breastfeeding
• Irregular menstrual period
• Altered liver function tests
• Orthostatic hypotension (significant drop in blood pressure that occurs when an individual stands up)

It has been observed that there is an increased risk of bone fractures in patients treated with this type of medication

• Abnormal heart rhythm

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Citalvir

This medication does not require special storage conditions.

Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of CITALVIR:

The active ingredient of CITALVIR 10 mg is citalopram (hydrobromide). Each tablet contains 12.49 mg of citalopram hydrobromide (equivalent to 10 mg of citalopram).

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

Appearance of the product and package contents

CITALVIR 10 mg is presented in film-coated tablets. The film-coated tablets are white, round, and biconvex.

CITALVIR 10 mg is available in blister packs containing 14 and 28 tablets.

It is possible that only some package sizes are marketed.

Other presentations:

CITALVIR 20 mg tablets.

CITALVIR 40 mg tablets.

Marketing authorization holder and manufacturer

Holder:

Ababor Pharmaceuticals, S.L.

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

28290- Las Rozas

Spain

Manufacturers:

Industria Química y Farmacéutica VIR, S.A.

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

Spain

Phone: 91 486 29 90 Fax: 91 486 29 91

Or

Rivopharm, S.A.

6928 Manno - Switzerland

Date of the last revision of this prospectus: June 2021

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