Package Insert: Patient Information

Citalopram Alter 30 mg Film-Coated Tablets

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert.

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

Citalopram Alter is indicated for:

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

Do not take Citalopram Alter:

• If you are allergic to citalopram or any of the other components of this medication (listed in section 6).
• If you are being treated with other antidepressant medications in the group of monoamine oxidase inhibitors (MAOIs) or if you have been treated with such medication in the past two weeks.
• If you have any type of heart rhythm disorder since birth or have ever experienced such an episode (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 can affect the heart rhythm.

Also see the section on “Citalopram Alter interaction with other medications” below.

Warnings and precautions:

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

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

Inform your doctor:

• If you have severe liver or kidney disease.
• If you have had manic episodes.
• If you have epilepsy or have a history of it. In case of seizures or an increase in seizure frequency, treatment with citalopram should be discontinued.
• If you have diabetes, as you may need to adjust your insulin or oral antidiabetic medication dosage.
• If you have a bleeding disorder or are being treated with medications that affect blood clotting, or if you are pregnant (see “Pregnancy and breastfeeding”).
• If you have or have had a heart problem 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 have taken 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 a heart rhythm disorder.

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 this period. Clinical experience indicates that the risk of self-aggression is highest at the beginning of the depressive process and may increase again when the clinical condition 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 starting treatment have a higher risk of suicidal ideation or attempted suicide during treatment.

A study has observed an increased risk of bone fractures in patients treated with this type of medication.

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

When treatment is discontinued, withdrawal symptoms are common, particularly if treatment is stopped abruptly (see section “Possible side effects”).

Children and adolescents under 18 years old:

Citalopram Alter should not be used normally in the treatment of children and adolescents under 18 years old. However, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (primarily aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the doctor who prescribes Citalopram Alter may prescribe it to patients under 18 years old if they decide it is the best option for the patient. If the doctor who prescribes Citalopram Alter has prescribed it 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 Alter. Additionally, the long-term effects of Citalopram Alter on safety, growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Citalopram Alter interaction with other medications:

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

Do not take Citalopram Alter:

If you are taking medications because you already have a condition that affects the heart rhythm or if you are taking medications that could affect the heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (examples derived from phenothiazine, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, malaria medications, particularly halofantrine), certain antihistamines (astemizol, mizolastine).

If you are unsure about this, consult your doctor.

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

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

The simultaneous administration of citalopram with monoamine oxidase inhibitors (MAOIs) carries a risk of serotonin syndrome (see section “Possible side effects”).

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

• Carbamazepine (antiepileptic medication): may cause an increase in carbamazepine levels in the blood, and it may be necessary to reduce the carbamazepine dose.
• Lithium (medication for the treatment of manic-depressive disorder): increases the risk of serotonin syndrome.
• Oral anticoagulants, aspirin, and nonsteroidal anti-inflammatory drugs, and other medications that affect blood clotting: may increase the risk of bleeding.
• Imipramine (antidepressant): may cause an increase in the levels of imipramine metabolite in the blood.
• Cimetidine (antiulcer medication), 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). May increase citalopram levels in the blood.
• Metoprolol (anti-hypertensive, anti-anginal, and anti-arrhythmic medication).
• Preparations containing St. John's Wort: may increase the frequency of adverse effects.

Citalopram Alter with food, drinks, and alcohol:

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

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Make sure your midwife and/or doctor know that you are taking Citalopram Alter.

When taken during pregnancy, particularly in the last three months of pregnancy, medications like Citalopram Alter may increase the risk of a serious condition in newborns, called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and turn blue. These symptoms usually begin within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Citalopram Alter 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 so they can advise you.

Citalopram is not recommended for use during pregnancy and breastfeeding.

Driving and operating machinery:

During treatment with Citalopram Alter, you may feel drowsy or dizzy. Do not drive or operate machinery until you know how Citalopram Alter affects you.

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

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

Your doctor will indicate the duration of your treatment with Citalopram Alter. Do not suspend the treatment before or abruptly, as it could worsen your disease.

You must continue taking your medication even if you do not notice improvement, as several weeks may be needed for the medication to start acting.

Citalopram Alter 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 not chewed.

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.

In general, 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.

Patients with renal insufficiency

Citalopram is not recommended for use in patients with severe renal insufficiency.

Children

The safety and efficacy of Citalopram Alter have not been established in children and adolescents under 18 years, so it is not recommended for use in this population.

If you estimate that the action of Citalopram Alter is too strong or weak, inform your doctor or pharmacist.

If you take more Citalopram Alter than you should

If you have taken more Citalopram Alter than you should, consult your doctor, pharmacist, or call the Toxicological 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 skin discoloration, tremors, convulsions, loss of consciousness, and palpitations.

If you forgot to take Citalopram Alter

Do not take a double dose to compensate for the missed doses.

In case of forgetting a dose, wait for the next one.

If you interrupt treatment with Citalopram Alter

If treatment with Citalopram is interrupted abruptly, some withdrawal symptoms 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, but in some patients they can 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.

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

Like all medications, Citalopram Alter may cause side effects, although not everyone will experience them.

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

The following side effects have been described:

• Neuropsychiatric disorders: nervousness, drowsiness, weakness, headaches, dizziness, sleep disorders, memory loss, suicidal tendencies, and serotonin syndrome (characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex response, involuntary movements, chills, tachycardia, and tremors), psychomotor agitation/akathisia (characterized by restlessness and a need to be in motion, often accompanied by difficulty sitting or remaining at rest. Its appearance is more likely to occur 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: rapid and irregular heartbeats or a feeling of fainting, which may be symptoms of a serious heart condition known as torsade de pointes, tachycardia, dizziness when standing due to a drop in blood pressure, slowing of heart rate in some patients.
• Reproductive and breast disorders: alterations in sexual desire.
• Renal and urinary disorders: alterations in urination.
• Hepatic disorders:exceptional cases of increased liver enzymes have been reported.

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

Unknown frequency, postpartum hemorrhage (excessive vaginal bleeding after delivery) has been reported. See "Pregnancy and lactation" 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 side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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 medication.

Keep 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 the abbreviation CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Citalopram Alter 30 mg

• The active ingredient is citalopram (hydrobromide). Each tablet contains 30 mg of citalopram.
• The other components (excipients) are: lactose monohydrate, cornstarch without gluten, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide, and triacetin.

Appearance of the product and contents of the packaging

Citalopram Alter 30 mg are film-coated tablets. The tablets are white, round, coated, and biconvex. They are presented in packs of 28 or 56 tablets.

Other presentations:

Citalopram Alter 20 mg film-coated tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

The last review of this leaflet was in January 2021

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