CITALOPRAM TEVA-RIMAFAR 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Citalopram Teva-Rimafar 30 mg tablets EFG

Citalopram hydrobromide

Contents of the pack:

1. What is Citalopram Teva-Rimafar and what is it used for.
2. What you need to know before taking Citalopram Teva-Rimafar.
3. How to take Citalopram Teva-Rimafar.
4. Possible side effects.
5. Storage of Citalopram Teva-Rimafar.
6. Pack contents and further information

1. What is Citalopram Teva-Rimafar and what is it used for

Citalopram belongs to a group of medicines called antidepressants, specifically selective serotonin reuptake inhibitors.

Citalopram Teva-Rimafar is indicated for the treatment of:

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

2. What you need to know before taking Citalopram Teva-Rimafar

Do not take Citalopram Teva-Rimafar 30 mg:

• If you are allergic (hypersensitive) to citalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are being treated with other antidepressant medicines of the monoamine oxidase inhibitor (MAOI) group or if you have been under such treatment in the last two weeks.
• If you are taking any medicine containing pimozide.
• In combination with linezolid.
• If you have been born with any type of heart rhythm disorder or have ever suffered any episode of this type (this is observed with an electrocardiogram, a test used to evaluate how the heart works).
• If you are taking medicines because you have a disease that affects heart rhythm.
• If you are taking medicines that may affect heart rhythm.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Citalopram Teva-Rimafar 30 mg tablets.

• 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 medicines that affect blood coagulation or are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If you are receiving electroconvulsive therapy.
• If you are taking herbal remedies containing St. John's Wort (Hypericum perforatum).
• 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, 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 heart beats quickly or irregularly 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.

Some medicines of the group to which Citalopram Teva-Rimafar belongs (called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is stopped.

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 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.

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

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Angle-closure glaucoma

SSRIs, including citalopram, may have an effect on pupil size, leading to mydriasis. This mydriatic effect has the potential to reduce the angle of the eye, leading to increased intraocular pressure and angle-closure glaucoma, especially in patients who are predisposed. Citalopram should therefore be used with caution in patients with angle-closure glaucoma or a history of glaucoma.

Other medicines and Citalopram Teva-Rimafar

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

Concomitant administration of citalopram with monoamine oxidase inhibitor (MAOI) medicines is contraindicated.

Concomitant administration of citalopram with MAOI medicines carries a risk of serotonin syndrome (see section "Possible side effects").

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

medicines:

• Carbamazepine (antiepileptic medicine): may cause an increase in carbamazepine blood levels, and it may be necessary to reduce the dose of carbamazepine.

Lithium (medicine for the treatment of manic-depressive disorder): increases the risk of serotonin syndrome.

• Oral anticoagulants, acetylsalicylic acid, and non-steroidal anti-inflammatory medicines, and other medicines that affect blood coagulation: may increase the risk of bleeding.
• Imipramine (antidepressant medicine): causes an increase in imipramine metabolite blood levels.
• Cimetidine (anti-ulcer medicine) and fluconazole (used to treat fungal infections): may increase citalopram blood levels.
• Metoprolol (anti-hypertensive, anti-anginal, and anti-arrhythmic medicine).
• Preparations containing St. John's Wort: may cause more frequent side effects.
• Do not take citalopram if you are taking medicines because you already have a disease that affects heart rhythm or if you are taking medicines that may affect heart rhythm, such as anti-arrhythmic class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medicines against malaria, particularly halofantrine), certain antihistamines (e.g., astemizole, mizolastine). If you have doubts about this, consult your doctor.
• Medicines that induce hypokalemia/hypomagnesemia. Caution should be exercised with concomitant use of products that induce hypokalemia/hypomagnesemia, as these conditions increase the risk of malignant arrhythmias.
• Serotoninergic medicines, such as buprenorphine, as they may increase the risk of serotonin syndrome.

Taking Citalopram Teva-Rimafar 30 mg with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

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

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

If you take Citalopram Teva-Rimafar in the final stage of pregnancy, there may be an increased 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 advise you.

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.

Make sure your midwife and/or doctor knows that you are taking Citalopram Teva-Rimafar.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram Teva-Rimafar 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.

Use in children and adolescents

Citalopram Teva-Rimafar 30 mg should not be used normally 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 higher risk of side effects such as suicide attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, the doctor may prescribe Citalopram Teva-Rimafar 30 mg to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor has prescribed Citalopram Teva-Rimafar 30 mg to a patient under 18 years of age 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 if you experience complications when patients under 18 years of age are taking Citalopram Teva-Rimafar 30 mg. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Citalopram Teva-Rimafar 30 mg in this age group have not yet been demonstrated.

Driving and using machines

During treatment with Citalopram Teva-Rimafar, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Citalopram Teva-Rimafar 30 mg affects you.

Citalopram Teva-Rimafar contains lactose and sodium

This medicine contains lactose. 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 tablet; this is essentially "sodium-free".

3. How to take Citalopram Teva-Rimafar

Follow exactly the administration instructions of Citalopram Teva-Rimafar indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Citalopram Teva-Rimafar. Do not stop treatment before or abruptly, as this may worsen your disease.

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

Citalopram Teva-Rimafar 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 recommended initial dose is 20 mg per day. Depending on the individual patient's response and the severity of the depression, your doctor may progressively increase the dose up to a maximum of 40 mg per day.

Panic disorder

The recommended initial dose is 10 mg per day for the first week before increasing 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 recommended initial dose is 20 mg per day. If necessary, your doctor may increase the dose up to a maximum of 40 mg per day.

Elderly patients

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 and adolescents

The safety and efficacy of Citalopram Teva-Rimafar 30 mg have not been established in children and adolescents under 18 years of age, so its use is not recommended in this population.

Patient with liver failure:

Patient with mild or moderate liver failure is recommended to administer 10 mg per day during the first two weeks of treatment. Depending on the individual patient's response, the dose may be increased up to a maximum of 20 mg/day. Special caution and careful dose adjustment are recommended in patients with severe liver failure.

Patient with renal failure:

Caution is recommended in patient with severe renal failure.

If you think the action of Citalopram Teva-Rimafar 30 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Citalopram Teva-Rimafar than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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 Teva-Rimafar 30 mg

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

If you stop taking Citalopram Teva-Rimafar 30 mg

If treatment with Citalopram is stopped abruptly, some disorders due to withdrawal may occur, such as dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and intense dreams), headache, agitation or anxiety, nausea and/or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual disturbances and 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 stop treatment with this medicine.

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

4. Possible Adverse Effects

Like all medicines, Citalopram Teva-Rimafar 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.

The following adverse effects have been described:

• Nervous system 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 tremors), psychomotor agitation/akathisia (characterized by restlessness and a 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.

• Disorders of the skin and subcutaneous tissue: rash, itching, increased sweating, alopecia, purpura, photosensitivity reaction, ecchymosis, angioedema.

• Ocular disorders: adaptation disorders, mydriasis.

• Metabolic and nutritional disorders: weight loss or gain, loss or increase of appetite, hyponatremia, and hypokalemia.

• Cardiac and vascular disorders: tachycardia, bradycardia, dizziness when standing up due to a drop in blood pressure, slowing of the heart rate in some patients, rapid and irregular heartbeats or a feeling of fainting as they could be symptoms of a serious heart problem known as torsades de pointes, hemorrhage, orthostatic hypotension.

• Disorders of the reproductive system and breast: impotence, ejaculation disorder,

menorrhagia, metrorrhagia, priapism, galactorrhea.

• Renal and urinary disorders: urinary retention.

• Hepatobiliary disorders: exceptional cases of increased liver enzymes have been reported.

Frequency not known: Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information, increased levels of prolactin hormone in the blood.

Rarely, cases of bleeding in the skin and mucous membranes have been observed, such as petechiae,

vaginal hemorrhages, and gastrointestinal bleeding.

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

5. Conservation of Citalopram Teva-Rimafar

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date, which 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. Deposit the packaging and the

medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Citalopram Teva-Rimafar

The active ingredient is citalopram (hydrobromide). Each tablet contains 30 mg of citalopram.

The other components (excipients) are: gluten-free cornstarch, lactose monohydrate,

sodium croscarmellose, glycerin, copolyvidone, magnesium stearate, and microcrystalline cellulose.

The excipients of the coating film are: hypromellose type E5, macrogol 400, and titanium dioxide (E 171).

Appearance of the Product and Package Contents

Citalopram Teva-Rimafar 30 mg are film-coated tablets. The coated tablets

are oval, scored on one side, and white in color. They are available in packages of 28 or 56 tablets.

Other Presentations:

Citalopram Teva-Rimafar 20 mg film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas, Madrid.

Spain

Manufacturer:

Teva Pharma, S.L.U.

Malpica polygon, C/ C 4.

50016 - Zaragoza, Spain

or

Industria Química y Farmacéutica VIR, S.A.

Laguna 66-68-70.

28923 Alcorcón, Madrid, Spain

Date of the Last Revision of this Prospectus: April 2024

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