CITALOPRAM FARMALIDER 10 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Citalopram FARMALIDER 10 mg tablets

Citalopram

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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

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

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

Citalopram FARMALIDER are film-coated tablets, white, oval, biconvex, and scored. They are available in packs of 14 and 28 tablets.

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

Citalopram FARMALIDER is indicated for:

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

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

Do not take Citalopram FARMALIDER:

• if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
• if you are being treated with other antidepressant medications from the group of monoamine oxidase inhibitors (MAOIs) or if you have been under such treatment in the last two weeks.
• if you have been born with any type of heart rhythm disorder or have ever had any episode of this type (this is observed with an electrocardiogram, a test that evaluates how the heart works).
• if you are taking medications because you have a disease that affects heart rhythm.
• if you are taking medications that may affect heart rhythm.

Also, consult the section "Use of other medications" which is located below.

Warnings and precautions

• If you have liver or severe kidney failure.
• If you have had manic episodes.
• If you have or have a history of epilepsy. If seizures develop or the frequency of attacks increases, treatment with citalopram should be discontinued.
• If you have diabetes, as you may need to adjust the dose of insulin or oral antidiabetics.
• If you have any bleeding disorder or are being treated with medications that affect blood coagulation, or if you are pregnant (see "Pregnancy").
• If you have or have had any heart problems or have recently suffered 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, 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 fast or irregular or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have some heart rhythm disorder.
• An increased risk of bone fractures has been observed in patients treated with this type of medication.

Pregnancy

If you take Citalopram Farmalider in the final stage of pregnancy, there may be a higher risk of abundant 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 Farmalider to advise you accordingly.

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

Some medications from the group to which Citalopram FARMALIDER belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

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 self-harm or suicide. These may increase when taking antidepressants for the first time, as all these medications require time to start taking effect, usually around two weeks, although in some cases it may take longer.

You would be more likely to have these thoughts:

• If you have previously had thoughts of self-harm or suicide.
• 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 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 behavior.

Depression is associated with an increased risk of suicidal ideation, self-aggression, and suicide. This risk persists until significant improvement is achieved. Since such improvement may not be achieved during the first weeks or more of treatment, patients should be closely monitored during that period. Clinical experience indicates that the risk of self-aggression is maximum at the beginning of the depressive process and may increase again when the clinical picture begins to improve. Additionally, antidepressants may rarely increase the risk of suicidal ideation and self-aggression. Patients with a history of suicidal behavior and those who present a significant degree of suicidal ideation prior to the start of treatment have a higher risk of suicidal ideation or suicide attempt during treatment.

When treatment is discontinued, it is common for withdrawal symptoms to appear, particularly if treatment is discontinued abruptly (see section "Possible side effects").

Taking Citalopram FARMALIDER with food and drinks

It is advisable to avoid consuming alcohol while taking this medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medication.

The use of citalopram is not recommended during pregnancy and breastfeeding.

Make sure your midwife and/or doctor knows that you are taking Citalopram FARMALIDER. When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like Citalopram FARMALIDER may increase the risk of a serious disease in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed yet.

Use in children and adolescents under 18 years:

Citalopram FARMALIDER 10 mg should not be used normally 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 higher risk of adverse effects such as suicide attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, the doctor may prescribe Citalopram FARMALIDER 10 mg to patients under 18 years when they decide it is most convenient for the patient. If the doctor has prescribed Citalopram FARMALIDER to a patient under 18 years and you 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 experience complications when patients under 18 years are taking Citalopram FARMALIDER. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Citalopram FARMALIDER 10 mg in this age group have not been demonstrated yet.

Driving and using machines

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

Important information about some of the ingredients of this medication:

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

This medication does not contain gluten.

Use of other medications

Tell your doctor or pharmacist if you are taking or have recently taken any other medication, including those obtained without a prescription.

Do not take Citalopram FARMALIDER tablets if you are taking medications because you already have a disease that affects heart rhythm or if you are taking medications that may affect heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medications, particularly halofantrine), certain antihistamines (e.g., astemizole, mizolastine).

If you have doubts about this, consult your doctor.

The simultaneous administration of citalopram with non-selective or selective B monoamine oxidase inhibitors (MAOIs) (such as selegiline, an antiparkinsonian medication) and during the two weeks following the end of treatment is contraindicated.

The simultaneous administration of citalopram with selective A monoamine oxidase inhibitors (MAOIs) (such as moclobemide, an antidepressant medication) is not recommended.

The simultaneous administration of citalopram with MAOIs involves a risk of serotonin syndrome (see section "Possible side effects").

Precautions should be taken if citalopram is administered with any of the following medications:

• Carbamazepine (antiepileptic medication): may increase carbamazepine levels in the blood, and it may be necessary to reduce the dose of carbamazepine.
• Lithium (medication for the treatment of manic-depressive disorder): increases the risk of serotonin syndrome.
• Oral anticoagulants, acetylsalicylic acid, and non-steroidal anti-inflammatory medications, and other medications that affect blood coagulation: may increase the risk of bleeding.
• Imipramine (antidepressant medication): increases the levels of imipramine's metabolite in the blood.
• Cimetidine (antiulcer medication): may increase citalopram levels in the blood.
• Metoprolol (antihypertensive, antianginal, and antiarrhythmic medication).
• Preparations containing St. John's Wort: may be more frequent adverse effects.
• 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). May increase citalopram levels in the blood.

3. How to take Citalopram Farmalider

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Citalopram FARMALIDER. Do not discontinue treatment before or abruptly, as it may worsen your illness.

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

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

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.

Panic disorder

The initial dose is 10 mg per day during 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.

Elderly patients (over 65 years)

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 Citalopram FARMALIDER have not been established in children and adolescents under 18 years, so its use is not recommended in this population.

Patients with renal insufficiency:

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

Patients with special risks

Patients with liver disease should not take more than 20 mg per day.

If you think the effect of Citalopram FARMALIDER is too strong or too weak, tell your doctor or pharmacist.

If you take more Citalopram FARMALIDER than you should

If you have taken more Citalopram than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount taken.

The most frequent symptoms in case of overdose are: nausea, vomiting, sweating, drowsiness, blue discoloration of the skin, tremors, convulsions, loss of consciousness, and palpitations.

If you forget to take Citalopram FARMALIDER

In case of forgetting a dose, wait for the next one. Do not take a double dose to make up for the forgotten dose.

Effects that occur when treatment with Citalopram FARMALIDER is discontinued

If treatment with Citalopram FARMALIDER is discontinued abruptly, some disorders due to withdrawal may occur, such as dizziness, nausea, sweating, sensory disturbances, sleep disturbances, headache, agitation, or anxiety, and a sensation of tingling in the hands or feet. The risk of withdrawal reactions depends on several factors, including the duration of treatment, the dose used, and the rate of dose reduction. Generally, these symptoms are mild or moderate; however, in some patients, they may be severe. Normally, these symptoms are self-limiting and resolve within two weeks, although in some patients, their duration may be prolonged. Your doctor will advise you on how to gradually discontinue treatment with this medication.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse effects are generally of mild or moderate intensity. They will be evident during the first and even the first two weeks of treatment, and subsequently disappear as the disease improves.

If you notice any of the following symptoms, stop taking Citalopram FARMALIDER 10 mg tablets and consult your doctor immediately:

• 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 adverse effects have been described:

• Neuropsychiatric disorders: nervousness, somnolence, weakness, headaches, dizziness, sleep disorders, memory loss, suicidal tendency, and serotonin syndrome (characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex response, involuntary movements, chills, tachycardia, and tremor), psychomotor agitation/akathisia (characterized by restlessness and need to be in motion, often accompanied by difficulty sitting or remaining still. Its appearance is more likely during the first weeks of treatment).
• Gastrointestinal disorders: nausea, vomiting, diarrhea, constipation, dry mouth.
• Skin disorders: rash, itching, increased sweating.
• Visual disorders: adaptation disorders.
• Metabolic disorders: weight loss or gain.
• Cardiovascular disorders: tachycardia, dizziness when standing up due to a drop in blood pressure, slowing of the heart rate in some patients.
• Disorders of the reproductive system and breast: alterations in sexual desire. Unknown frequency: abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.
• Renal and urinary disorders: alterations in urination.

Rarely, cases of bleeding in the skin and mucous membranes, such as skin hemorrhages, vaginal hemorrhages, and gastrointestinal bleeding, have been observed.

If you observe these adverse effects or any other not described in this prospectus, consult your doctor or pharmacist.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use, Website: www.notificaRAM.es

5. Conservation of Citalopram Farmalider

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after 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 away through the sewers or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Citalopram FARMALIDER

• The active ingredient is citalopram (hydrobromide). Each tablet contains 10 mg of citalopram.
• The other components (excipients) are: cornstarch without gluten, lactose monohydrate, sodium croscarmellose, glycerol, copovidone, magnesium stearate, microcrystalline cellulose, hypromellose 5, macrogol 400, and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Other Presentations:

Citalopram FARMALIDER 20 mg tablets.

Citalopram FARMALIDER 40 mg tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Farmalider S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Laboratorios Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the Last Revision of this Prospectus: January 2021

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