Package Leaflet: Information for the user

Citalopram Vir Pharma 10 mg Film-coated Tablets

5. Storage of Citalopram Vir Pharma

6. Contents of the pack and additional information

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

Citalopram Vir Pharma is indicated for the treatment of:

• Depression and prevention of relapses and recurrences.
• Anxiety disorder with or without agoraphobia.
• Obsessive-compulsive disorder (OCD).

Your doctor may, however, prescribe Citalopram Vir Pharma for any other purpose. Ask your doctor if you have any doubt as to why they have prescribed Citalopram Vir Pharma

Do not take Citalopram Vir Pharma

• If you are allergic to citalopram or any of the other ingredients of this medication (listed in section 6).

• If you are taking other medications that belong to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medications such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
• If you have a congenital heart rhythm disorder or have ever experienced 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 a condition that affects the heart rhythm.
• If you are taking medications that may affect the heart rhythm.
• See also the section "Other medications and Citalopram Vir Pharma" below.

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

You should wait a day after taking moclobemide.

After finishing citalopram, you should wait a week before taking any MAOI.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Citalopram Vir Pharma.

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. The treatment with citalopram may affect blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemic medications.
• If you have epilepsy. Treatment with citalopram should be discontinued if seizures occur or if the frequency of seizures increases (see also section 4 "Possible side effects").
• If you have any type of bleeding disorder or if you are pregnant (see "Pregnancy").

-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 a heart rhythm disorder.

-If you have a problem with pupil dilation (mydriasis)

Consult your doctor, even if any of the above circumstances 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 citalopram belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Special information related to your condition

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

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

At the beginning 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 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.

Youare more likely to have these types of thoughts:

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

If you ever have thoughts of harming yourself or taking your life, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a family member or close friendthat 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.

Children and adolescents

Citalopram should not normally be used to treat 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 it may prescribe citalopram to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribes it has prescribed citalopram to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above progress or if you experience complications when patients under 18 years old are taking citalopram. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of citalopram in this age group have not yet been demonstrated.

Other medications and Citalopram Vir Pharma:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

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

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medications, you should wait 14 days before starting to take citalopram. After finishing treatment with citalopram, you should wait 7 days before taking any of these medications.
• Reversible selective monoamine oxidase A inhibitors (MAO A) 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 increase, 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 when 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 cerebrovascular accidents). They may increase the levels of citalopram in the blood.
• Medications that affect platelet function, such as some antipsychotics, aspirin (used for pain), non-steroidal anti-inflammatory drugs (used for arthritis); they slightly increase the risk of bleeding disorders.
• St. John's Wort (Hypericum perforatum) (a herbal remedy used for depression); the concomitant administration with citalopram may increase the risk of adverse effects.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for 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 (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications for malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medications that decrease potassium or magnesium levels in the blood, as this increases the risk of cardiac arrhythmias, which are life-threatening.

Do not take citalopram

if you are taking medications because you already have a condition that affects the heart rhythm or if you are taking medications that may affect the heart rhythm,

If you have any doubts about this, consult your doctor.

Use of Citalopram Vir Pharma with food, drinks, and alcohol:

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

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

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Pregnant women should not normally take citalopram, 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 citalopram 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 takeCitalopram Vir Pharmain the final stage of pregnancy, there may be an increased 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 takingCitalopram Vir Pharmaso they can 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, inform your doctor before starting breastfeeding.

Make sure your midwife and/or doctor are informed that you are being treated with citalopram.

During pregnancy, particularly in the last 3 months, medications like citalopram may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, you should 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 operating machinery

During treatment with citalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how citalopram affects you.

This medicationcontains lactose.

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

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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Adults

Depression

The usual dose is 20 mg per day. If necessary, your doctor 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 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.

Generally, 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 per day.

Use in children and adolescents

Citalopram should not be administered to children or adolescents. For additional information, please see section 2 “What you need to know before starting to take Citalopram Vir Pharma”.

How and when to take Citalopram Vir Pharma

Citalopram is taken once a day as a single daily dose.

Tablets can be taken at any time of the day, regardless of meals.

Tablets should be swallowed with a glass of water.Do not chew them (they have a bitter taste).

Treatment duration

Like other depression, anxiety disorder, and OCD medications, it may take several weeks to find some improvement. Continue taking citalopram even if you do not feel any improvement in your condition.

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

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

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

If you take more Citalopram Vir Pharma than you should:

If you think you or someone else has taken more citalopram than they should, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call theToxicology Information Service, phone: 91 562 0420, indicating the medication and the amount taken.

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

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

Some symptoms of an overdose may include irregular heartbeats with life-threatening risk, 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 forget to take Citalopram Vir Pharma

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Citalopram Vir Pharma:

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

Abrupt withdrawal of the medication may cause some mild or transient disturbances, such as dizziness, tingling sensation, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of anxiety, headache, dizziness (nausea), vomiting, sweating, feeling 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 your treatment period, it is generally recommended that the citalopram dose be reduced gradually over a couple of weeks instead of stopping it abruptly.

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

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, stop taking citalopram 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.
• If you notice swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction).
• Unusual bleeding, including gastrointestinal bleeding.

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

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

• Hyponatremia: low sodium levels in the blood that can cause fatigue, confusion, and muscle cramps.
• Fast and irregular heartbeats or a feeling of dizziness, 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 side effects mentioned below can 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.

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

• Drowsiness.
• Difficulty sleeping.
• Increased sweating.
• Dry mouth.
• Nausea (feeling dizzy).
• Headaches.

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

• Loss of appetite.
• Agitation.
• Decreased sexual desire.
• Anxiety.
• Nervousness.
• Confusion.
• Abnormal dreams.
• Tremors.
• Numbness or tingling in hands or feet.
• Dizziness.
• Alteration of attention.
• 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.

Rare side effects (May affect up to 1 in 100 people):

• Cutaneous hemorrhagic disorders (easy bruising).
• Increased appetite.
• Aggression.
• Depersonalization.
• Hallucinations.
• Mania.
• Blackouts.
• Dilated pupils.
• Fast heartbeats.
• Slow heartbeats.
• Urticaria.
• Hair loss.
• Cutaneous eruption.
• Photophobia.
• Difficulty urinating.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

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

• Seizures.
• Involuntary movements.
• Alterations in taste.
• Bleeding.
• Hepatitis.
• Fever.

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

• Thoughts of self-harm or thoughts of suicide, see also the "Warnings and precautions" section.
• Reduction of platelets 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 levels in the blood that can cause muscle weakness, cramps, or irregular heartbeats.
• Panic attack.
• Clicking of teeth.
• Anxiety.
• Abnormal muscle movements or stiffness.
• Akathisia (involuntary muscle movements).
• Visual disturbances.
• Low blood pressure.
• Nasal bleeding.
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis).
• Sudden skin or mucous membrane swelling.
• Painful erections.
• Milk flow in men and women who are not breastfeeding.
• Irregular menstrual periods.
• Altered liver function tests.
• Orthostatic hypotension (significant drop in blood pressure when standing up).
• A higher risk of osteoporotic fractures has been observed in patients treated with this type of medication.

• Abnormal heart rhythm.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

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 the Vigilance of Medicinal Products 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 conditions for conservation.

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

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Citalopram Vir Pharma Composition:

The active ingredient is citalopram (hydrobromide). Each tablet contains 10 mg of citalopram.

The other components (excipients) are:

Core: cornstarch without gluten, microcrystalline cellulose, copovidone, croscarmellose sodium, magnesium stearate, glycerol, lactose monohydrate.

Coating: hypromellose E5, macrogol 400, titanium dioxide (E-171).

Product appearance and packaging content:

Citalopram Vir Pharma is presented in the form of coated tablets with a white film coating, round, biconvex, smooth on both sides. It is presented in packaging of 14 and 28 tablets and clinical packaging of 500 tablets.Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70.Industrial Park URTINSA II

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet:December 2020

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/