CITALOPRAM BEXAL 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Citalopram Bexal 20 mg film-coated tablets EFG

Citalopram Bexal 30 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Citalopram Bexal is and what it is used for.
2. What you need to know before you take Citalopram Bexal.
3. How to take Citalopram Bexal.
4. Possible side effects.
5. Storing Citalopram Bexal.
6. Contents of the pack and other information.

1. What Citalopram Bexal is and what it is used for

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

Citalopram is indicated for the treatment of:

• Depression and prevention of relapse and recurrence.
• Anxiety disorders with or without agoraphobia.
• Obsessive-compulsive disorder (OCD).

Your doctor, however, may prescribe citalopram for another purpose. Ask your doctor if you have any questions about why citalopram has been prescribed for you.

2. What you need to know before you take Citalopram Bexal

Do not take Citalopram Bexal

• 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, as well as selegiline (for Parkinson's disease), moclobemide (for depression), and linezolid (an antibiotic).
• If you have been born with or have ever had any heart rhythm disorder or have had any episode of this type (as seen on an electrocardiogram, a test used to evaluate heart function).
• If you are taking medicines for any heart condition.
• If you are taking medicines that may affect the heart rhythm.
  • Also, see the section "Other medicines and Citalopram Bexal" below.

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

You must wait one day after taking moclobemide.

After stopping citalopram, you must wait one week before taking any MAOI.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Citalopram Bexal.

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

• If you have had manic episodes or anxiety disorders.
• If you have liver or kidney failure. Your doctor may need to adjust the dose.
• If you have diabetes. Treatment with citalopram may alter blood sugar control. You may need an adjustment of insulin dose and/or oral hypoglycemic agents.
• If you have epilepsy. Treatment with citalopram should be discontinued if seizures occur or if there is an increase in seizure frequency (see also section 4 "Possible side effects").

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• If you have a history of bleeding disorders, 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 heartbeats are fast or irregular or if you 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 the dilation of the pupils (mydriasis).

Consult 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, disproportionate 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Some medicines 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.

Special information related to your illness

Like other medicines for the treatment of depression or related illnesses, improvement is not achieved immediately. After starting treatment with citalopram, it may take several weeks before you experience any improvement.

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

At the start of treatment, some patients may experience an increase in anxiety, which

disappears 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 or killing yourself. These may increase when you first start taking antidepressants, 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 killing or harming yourself.
• 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 illnesses who were treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative 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 in the treatment of children and adolescents

under 18 years of age. At the same time, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines.

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

Other medicines and Citalopram Bexal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect the action of others and can sometimes cause serious adverse reactions.

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

• Non-selective monoamine oxidase inhibitors (MAOIs) that contain phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, 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 medicines.
• 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 that 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 medicines (for the treatment of migraine) and tramadol (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, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used for the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase the levels of citalopram in the blood, but no increase in adverse effects of citalopram has been reported. - Medicines that affect platelet function (e.g., some antipsychotic medicines, acetylsalicylic acid (for pain treatment), non-steroidal anti-inflammatory medicines (for arthritis treatment); these 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 depression treatment), and tramadol (for severe pain treatment) due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis), due to a possible risk of lowering the seizure threshold, and antidepressants.
• Antiarrhythmic drugs class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial agents, particularly halofantrine), certain antihistamines (astemizole, mizolastine).
  • Medicines that decrease potassium or magnesium levels in the blood, as they increase the risk of heart rhythm disorders, which can be life-threatening. Do not take citalopram if you are taking medicines because you have any heart condition or if you are taking medicines that may affect the heart rhythm. If you have any doubts about this, consult your doctor.

Taking Citalopram Bexal with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnant women should not normally take citalopram, nor should breastfeeding mothers, unless their 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: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep difficulties. 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 citalopram to be able to advise you.

Citalopram passes into breast milk in small amounts. There is a risk of effects in the child. 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, medicines like citalopram 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, citalopram does not cause drowsiness; however, if you feel dizzy or drowsy when you start taking this medicine, do not drive or use tools or machinery until these effects disappear.

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 medicine.

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

3. How to use Citalopram Bexal

Follow the administration instructions for this medication exactly as 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.

Advanced Age (over 65 years)

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

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

Patients with Special Risks

Patients with liver disease should not take more than 20 mg 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 taking Citalopram Bexal".

How and When to Take Citalopram Bexal

Citalopram is taken every day as a single daily dose.

The tablets can be taken at any time of day, regardless of meals.

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

Duration of Treatment

Like other medications for depression, anxiety disorder, and obsessive-compulsive disorder, it may take several weeks before you notice any improvement. Continue taking citalopram even if it takes some time before you feel any improvement in your condition.

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

The duration of treatment is individual, generally at least 6 months. Continue taking the tablets for the time recommended by your doctor. Do not stop taking them even if you feel better, unless your doctor has indicated so. The underlying disease may persist for a long period, and if you interrupt your treatment too early, your symptoms may reappear.

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

If You Take More Citalopram Bexal Than You Should

If you have taken more Citalopram Bexal than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used. Do this even if you do not observe discomfort or signs of intoxication. Bring the Citalopram Bexal package with you to the doctor or hospital.

Some symptoms of an overdose may include irregular heartbeats with life 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, bluish skin, hyperventilation (increased respiratory rate).

If You Forget 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 make up for forgotten doses.

If You Interrupt Treatment with Citalopram Bexal

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

Abrupt withdrawal of the medication can cause 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 the treatment period, it is generally recommended that the dose of citalopram be gradually reduced 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 or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not all people suffer from them.

Side effects usually disappear after a few weeks of treatment. Note that many of the effects can also be symptoms of your disease 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 should stop taking citalopram and see your doctor immediately.

• High fever, agitation, confusion, tremors, and sudden muscle contractions; can be signs of a rare condition called serotonin syndrome, which has been reported with the use of combined 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, you should stop taking citalopram and see your doctor immediately.

• Hyponatremia: low sodium level in the blood, which can cause fatigue, confusion, and muscle contraction.
• Rapid and irregular heartbeats or feeling of fainting, as they could be symptoms of a serious heart problem known as torsades 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 can be symptoms of your disease 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 caries. Therefore, you should brush your teeth more often than usual.

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

• Drowsiness.
• 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.
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tingling or numbness of hands or feet.
• Dizziness.
• Attention disturbance.
• Ringing in the ears (tinnitus).
• 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 side effects (may affect up to 1 in 100 patients):

• Hemorrhagic skin disorders (easy bruising).
• Increased appetite.
• Aggressiveness.
• Depersonalization.
• Hallucinations.
• Mania.
• Fainting.
• Dilated pupils.
• Rapid heartbeats.
• Slow heartbeats.
• Hives.
• Hair loss.
• Skin rash.
• Sensitivity to light.
• Difficulty urinating.
• 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.
• Taste disturbances.
• Bleeding.
• Hepatitis.
• Fever.

Frequency not known (cannot be estimated from 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.
• Panic crisis.
• Teeth grinding.
• Restlessness.
• Abnormal muscle movements or stiffness.
• Akathisia (involuntary muscle movements).
• Visual disturbances.
• Low blood pressure.
• Nosebleeds.
• Hemorrhagic disorders, including skin and mucous membrane bleeding (ecchymosis).
• Sudden swelling of the skin or mucous membranes.
• Painful erections.
• Milk flow in men and in women who are not breastfeeding.
• Irregular menstrual period.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.
• Abnormal liver function tests.
• Orthostatic hypotension (significant drop in blood pressure that occurs when an individual stands up).
• 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 or pharmacist, even if it is a side effect that does not appear in this prospectus.

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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Citalopram Bexal

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the package after CAD/EXP. 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 packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Citalopram Bexal 20 mg film-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: cornstarch, lactose monohydrate, povidone, glycerol 85% (E-422), microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose (type A) (derived from potato starch), hypromellose, titanium dioxide (E 171), macrogol 6000, and talc.

Composition of Citalopram Bexal 30 mg film-coated tablets:

• The active ingredient is citalopram. Each tablet contains 37.48 mg of citalopram hydrobromide (equivalent to 30 mg of citalopram).
• The other components (excipients) are: cornstarch, lactose monohydrate, povidone, glycerol 85% (E-422), microcrystalline cellulose, magnesium stearate, sodium carboxymethylcellulose (type A) (derived from potato starch), hypromellose, titanium dioxide (E 171), macrogol 6000, and talc.

Appearance of the Product and Package Contents

Citalopram Bexal 20 mg are film-coated tablets, white, oblong, biconvex, scored on one side, and marked with "C20". They are packaged in PVC/Aluminum or Aluminum/PVC/PVDC blisters within packages of 14, 28, or 56 tablets.

Citalopram Bexal 30 mg are film-coated tablets, white, oblong, biconvex, scored on one side, and marked with "C30".

They are packaged in PVC/Aluminum or Aluminum/PVC/PVDC blisters within packages of 28 or 56 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bexal Farmacéutica, s.a.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

Barleben 39179 Germany

LEK, S.A.

Domaniewska 50 C

02-672 Warsaw

Poland

Date of the Last Revision of this Prospectus: February 2023

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