Package Insert: Information for the User

Citalopram Bexal 20 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine,because it contains important information for you.

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

Citalopram is a selective serotonin reuptake inhibitor (SSRI) and belongs to a group ofmedicines known as antidepressants. These medicines help correct certainchemical imbalances in the brain, which cause symptoms of your illness.

Citalopram is indicated for the treatment of:

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

Do not take Citalopram Bexal

• If you are allergic to citalopram or any of the other components 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 (for the treatment of Parkinson's disease), moclobemide (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 disease that alters the heart rhythm.

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

• Also see the section “Other medications and Citalopram Bexal” that is located below.

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

You must wait a day after taking moclobemide.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take citalopram.

Please inform your doctor if you have any other condition or disease since 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 insufficiency. Your doctor may need to adjust the dose.

-If you have diabetes. The treatment with citalopram may alter blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemic agents.

-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.

-If you have a history of bleeding disorders 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 intense 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 experienced dizziness or fainting 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 circumstances mentioned above have occurred at any time.

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

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.

Special information related to your disease

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

In the treatment of anxiety disorder, it usually takes 2 to 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 that you follow your doctor's instructions exactly and do not interrupt treatment or change the dose without consulting your doctor.

Thoughts of suicide and worsening of your 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 you first start taking antidepressants, as all these medications take time to start working, usually around 2 weeks, although in some cases it may take longer.

You are more likely to have these thoughts:

• If you have previously had thoughts of harming yourself or taking your life.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years old) with psychiatric illnesses 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 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 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 they ingest this type of medication.

However, your doctor may prescribe citalopram to patients under 18 years old when they decide what is best for the patient. If your doctor has prescribed citalopram and you are a patient under 18 years old and want to discuss this decision, please go back 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 this citalopram. At the same time, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of this citalopram in this age group have not yet been demonstrated.

Other medications and Citalopram Bexal

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

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

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

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

-Selective reversible MAO-A inhibitors that contain moclobemide (for the treatment of depression).

-The antibiotic linezolid.

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

-Imipramine and desipramine (for the treatment of depression).

-Irreversible MAO-B inhibitors, which contain selegiline (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 (for the treatment of 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 (for the treatment of migraines) andopioids such as tramadol and buprenorphine(for the treatment of severe pain) increase the risk of adverse effects, if you experience any unusual symptoms using this combination, you should see your doctor.

-Cimetidine when used at high doses (for the treatment of stomach ulcers); the blood levels of citalopram may be increased, but no increased adverse effects of citalopram have been reported.

-Medications that affect platelet function (for example, some antipsychotics, aspirin (for pain relief), nonsteroidal anti-inflammatory drugs (for arthritis treatment); slightly increase the risk of bleeding disorders.

-St. John's Wort (Hypericum perforatum) (a herbal remedy used for depression); concomitant administration with citalopram may increase the risk of adverse effects.

-Mefloquine (for the treatment of malaria), bupropion (for the treatment of depression), and tramadol (for the treatment of severe pain) due to a possible risk of lowering the seizure threshold.

-Neuroleptics (medications for the treatment of 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 they increase the risk of cardiac arrhythmias, which are life-threatening. Do not take citalopram if you are taking medications for a disease that alters 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.
• 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). They may increase blood levels of citalopram.

Taking Citalopram Bexal with food, drinks, and alcohol

Citalopram can be taken with or without food (see section 3. “How to take Citalopram Bexal”).

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 your doctor has analyzed the risks and benefits involved.

If you take citalopram 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: respiratory difficulty, 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 sleeping. If your newborn baby has any of these symptoms, please contact your doctor immediately.

If you take citalopram in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking citalopram to be able to advise you.

Citalopram passes into breast milk in small amounts. There is a risk of effects in 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 taking 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 machines

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.

Citalopram Bexal contains lactose and sodium

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 1 mmol of sodium (23 mg) per coated tablet; it 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 again.

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 or 30 mg per day. Your doctor, if necessary, 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. Your doctor, if necessary, may increase this dose 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 or 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, see section 2 “What you need to know before starting Citalopram Bexal”.

How and when to take Citalopram Bexal

Citalopram is taken daily 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 obsessive-compulsive disorder medications, it may take several weeks to notice some improvement. Continue taking citalopram even if you do not feel any improvement in your condition.

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

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 has told you to. The underlying disease may persist for a long period, 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 Bexal than you should

Take it even when you do not observe any discomfort or signs of intoxication.

Some symptoms of an overdose may include irregular heartbeats with life-threatening risk, convulsions, 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 Citalopram Bexal

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 doses.

If you interrupt treatment with Citalopram Bexal

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

Abrupt withdrawal of the medication may cause some mild or transient disturbances such as dizziness, feeling of tingling, 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 irritability, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

When you have finished the treatment period, it is generally recommended that the citalopram 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 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 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 that 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 side effects (may affect up to 1 in 1,000 patients):

If you have any of the following symptoms, stop taking citalopram 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 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 note 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.

Very common side effects (may affect more than 1 in 10 patients):

• Tendency to sleep.
• Difficulty sleeping.
• Increased sweating.
• Dry mouth.
• Nausea (feeling dizzy).
• Headache.

Common side effects (may affect up to 1 in 10 patients):

• 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 heartbeats.
• Slow heartbeats.
• Urticaria.
• Hair loss.
• Cutaneous eruption.
• Photophobia.
• Urination difficulties.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

Rare side effects (may affect up to 1 in 1,000 patients):

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

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

• Thoughts of self-harm or suicidal thoughts, see also the "Warnings and precautions" section.
• 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, cramps, or irregular heart rhythm.
• Panic attack.
• Chattering teeth.
• Restlessness.
• 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.
• Increased prolactin levels in the blood.
• Milk flow in men and women who are not breastfeeding.
• Irregular menstrual period.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information.
• Altered liver function tests.
• Orthostatic hypotension (significant drop in blood pressure when standing up).
• A higher 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 or pharmacist, even if they are side effects that do not appear in this leaflet.

Reporting 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 theSpanish Medicines Vigilance System for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears 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 packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Citalopram Bexal 20 mgfilm-coated tablets:

• The active ingredient is citalopram.

Each tablet contains 24.99 mg of citalopram hydrobromide (equivalent to 20 mg of citalopram).

The other components (excipients) are: maize starch, lactose monohydrate, povidone K64, 85% glycerol (E-422), microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch), hypromellose, titanium dioxide (E 171), macrogol 6000, and talc.

Appearance of the product and content of the packaging

Citalopram Bexal 20 mg are film-coated tablets, white, oblong, biconvex, scored on one face and marked with “C20” on the other.

They are presented in packaging of 14, 28, or 56 tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bexal Farmacéutica, s.a.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-vonGuericke Allee1

Barleben 39179 Germany

LEK, S.A.

Ul Domaniewska 50 C,

Warsaw, PL 02-672

Poland

Full revision date of thisleaflet:July 2024

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