CITALOPRAM ALTER 30 mg FILM-COATED TABLETS

2. What you need to know before taking Citalopram Alter

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 from the group of monoamine oxidase inhibitors (MAOIs) or if you have been under such treatment in the last two weeks.
• If you have had any heart rhythm disorders since birth or have ever had any episode of this type (this is observed with an electrocardiogram, a test used to evaluate how the heart works).
• If you are taking medications for a heart condition that affects heart rhythm.
• If you are taking medications that may affect heart rhythm.

Also, consult the section on "Interaction of Citalopram Alter with other medications" below.

Warnings and precautions:

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

Some medications in the same group as Citalopram Alter (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is stopped.

Inform your doctor:

• If you have liver or severe kidney failure.
• If you have had manic episodes.
• If you have a history of epilepsy. If seizures occur 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 a bleeding disorder or are being treated with medications that affect blood coagulation, or if you are pregnant (see "Pregnancy and breastfeeding").
• 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 (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 a heart rhythm disorder.

Depression is associated with an increased risk of suicidal ideation, self-harm, and suicide. This risk persists until significant improvement is achieved. Since such improvement may not be achieved during the first few weeks or more of treatment, patients should be closely monitored during this period. Clinical experience indicates that the risk of self-harm is greatest at the start 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-harm. 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.

An increased risk of bone fractures has been observed 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 yet.

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

Children and adolescents under 18 years

Citalopram Alter should not normally be used 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 (predominantly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, the doctor may prescribe Citalopram Alter to patients under 18 years when they decide it is most convenient for the patient. If the doctor has prescribed Citalopram Alter to a patient under 18 years and you want to discuss this decision, please return 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 Alter. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Citalopram Alter in this age group have not yet been demonstrated.

Interaction of Citalopram Alter with other medications

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

Do not take Citalopram Alter:

If you are taking medications because you already have a heart condition that affects heart rhythm or if you are taking medications that may affect heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (examples derived from phenothiazine, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medications, particularly halofantrine), certain antihistamines (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) is contraindicated, as well as during the two weeks following the end of treatment.

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 carries 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 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 blood.
• Cimetidine (antiulcer medication), lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). May increase citalopram levels in blood.
• Metoprolol (anti-hypertensive, anti-anginal, and antiarrhythmic medication).
• Preparations containing St. John's Wort: may be more frequent adverse effects.

Citalopram Alter with food, beverages, and alcohol

It is advisable 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 knows that you are taking Citalopram Alter.

When taken during pregnancy, particularly in the last three months, medications like Citalopram Alter 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 within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Citalopram Alter 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 to advise you.

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

Driving and using machines

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

3. How to take Citalopram Alter

Follow the administration instructions of this medication exactly as 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 Alter. Do not stop treatment before or abruptly, as this 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 working.

Citalopram Alter is a tablet 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.

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.

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.

Patients with special risks

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

Patients with renal insufficiency

The use of citalopram is not recommended 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 its use is not recommended in this population.

If you think the effect of Citalopram Alter is too strong or too 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 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, seizures, loss of consciousness, and palpitations.

If you forget to take Citalopram Alter

Do not take a double dose to make up for forgotten doses.

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

If you stop treatment with Citalopram Alter

If treatment with Citalopram is stopped 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 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 stop treatment with this medication.

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

4. Possible side effects

Like all medications, Citalopram Alter can 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 then disappear as the illness improves.

The following side effects have been reported:

• Neuropsychiatric disorders: nervousness, drowsiness, weakness, headaches, dizziness, sleep disturbances, 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 a need to be in motion, often accompanied by difficulty sitting or standing 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: fast and irregular heartbeats or a feeling of fainting, as they could be symptoms of a serious heart problem known as torsades de pointes, tachycardia, dizziness when standing up due to a drop in blood pressure, slowing of heart rate in some patients.
• Reproductive system and breast disorders: sexual dysfunction.
• Renal and urinary disorders: urination disorders.
• Hepatic disorders: exceptional cases of increased liver enzymes have been reported.

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

With unknown frequency, postpartum hemorrhage (postpartum hemorrhage) has been reported, see "Pregnancy and breastfeeding" in section 2 for more information.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Citalopram Alter

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

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, gluten-free corn starch, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide, and glycerol triacetate.

Product Appearance and Packaging Content

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

Other Presentations:

Citalopram Alter 20 mg film-coated tablets EFG

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

The last revision of this prospectus was in January 2021

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