CITALOPRAM TEVA-RIMAFAR 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Citalopram Teva-Rimafar 20 mg Film-Coated Tablets EFG

Contents of the pack:

1. What is Citalopram Teva-Rimafar and what is it used for.
2. What you need to know before you take 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 is an antidepressant medicine that belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).

Citalopram Teva-Rimafar is indicated for the treatment of:

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

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

Do not take Citalopram Teva-Rimafar 20 mg:

• 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 medicines called monoamine oxidase inhibitors (MAOIs) or if you have been treated with MAOIs in the last two weeks.
• If you are taking a medicine called pimozide.
• In combination with linezolid.
• If you have been born with or have had a heart condition that affects your heart rhythm or have had a heart attack.
• If you are taking medicines that affect your heart rhythm.
• If you are taking medicines because you have a heart condition.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Citalopram Teva-Rimafar 20 mg tablets

if you:

• have liver or severe kidney disease.
• have had manic episodes.
• have or have had epilepsy. If you develop seizures or an increase in seizure frequency, treatment with citalopram should be discontinued.
• have diabetes, as you may need to adjust your insulin or oral antidiabetic dosage.
• have a bleeding disorder or are being treated with medicines that affect blood clotting or are pregnant (see "Pregnancy, breast-feeding and fertility").
• are receiving electroconvulsive therapy.
• are taking herbal medicines containing St. John's Wort (Hypericum perforatum).
• have or have had heart problems or have recently had a heart attack.
• have a slow heart rate (bradycardia) and/or think your body may be losing salts (e.g., due to intense diarrhea and vomiting for several days or due to the use of diuretics).
• have noticed that your heart beats rapidly or irregularly or have fainted or felt dizzy when standing up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.

Some medicines in the same class as Citalopram Teva-Rimafar (called SSRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide. This risk persists until significant improvement is achieved. Since such improvement may not occur 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 illness and may increase again when the clinical picture starts to improve.

Additionally, antidepressants may rarely increase the risk of suicidal thoughts and self-harm. Patients with a history of suicidal behavior and those who present with a significant degree of suicidal ideation prior to starting treatment have a greater risk of suicidal ideation or suicide attempts during treatment.

When treatment is stopped, it is common for withdrawal symptoms to occur, particularly if treatment is stopped 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 narrow the eye angle, 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 non-selective MAOIs or selective MAOIs type B (such as selegiline, an antiparkinsonian medicine) is contraindicated and should be avoided for two weeks after stopping treatment.

Concomitant administration of citalopram with selective MAOIs type A (such as moclobemide, an antidepressant) is not recommended.

Concomitant administration of citalopram with MAOIs may lead to the risk of serotonin syndrome (see section "Possible side effects").

Caution should be exercised if citalopram is administered with any of the following medicines:

• Carbamazepine (an antiepileptic medicine): may increase carbamazepine blood levels, and a dose reduction of carbamazepine may be necessary.
• Lithium (a medicine for the treatment of manic-depressive disorder): increases the risk of serotonin syndrome.
• Oral anticoagulants, acetylsalicylic acid, and non-steroidal anti-inflammatory drugs (NSAIDs) and other medicines that affect blood clotting: may increase the risk of bleeding.
• Imipramine (an antidepressant): increases the levels of imipramine's metabolite in the blood.
• Cimetidine (an anti-ulcer medicine) and fluconazole (used to treat fungal infections): may increase citalopram blood levels.
• Metoprolol (an antihypertensive, anti-anginal, and anti-arrhythmic medicine).
• Preparations containing St. John's Wort: may increase the frequency of side effects.
• Do not take citalopram if you are taking medicines because you already have a heart condition that affects your heart rhythm or if you are taking medicines that may affect your heart rhythm, such as anti-arrhythmic medicines class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines, particularly halofantrine), and certain antihistamines (e.g., astemizole, mizolastine). If you are unsure about this, consult your doctor.
• Medicines that induce hypokalemia/hypomagnesemia. Caution should be exercised when using concomitantly 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 20 mg with food, drinks, and alcohol

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

Pregnancy, breast-feeding, and fertility

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

Citalopram is not recommended during pregnancy and breast-feeding.

If you take Citalopram Teva-Rimafar during the late stage of pregnancy, you may have a higher 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 this medicine to advise you properly.

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 three months, medicines like Citalopram Teva-Rimafar may increase the risk of a serious condition in babies 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 birth. If this happens to your baby, contact your midwife and/or doctor immediately.

Children and adolescents

Citalopram Teva-Rimafar 20 mg should not be used in the treatment of children and adolescents under 18 years of age. However, you should know that in patients under 18 years of age, there is an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, your doctor may prescribe Citalopram Teva-Rimafar 20 mg to patients under 18 years of age when they decide it is the most suitable treatment for the patient. If your doctor has prescribed Citalopram Teva-Rimafar 20 mg to a patient under 18 years of age and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms worsen or if you experience complications when patients under 18 years of age are taking Citalopram Teva-Rimafar 20 mg. Additionally, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of Citalopram Teva-Rimafar 20 mg in this age group have not been established yet.

Driving and using machines

Like other psychotropic drugs, citalopram may cause drowsiness and, consequently, impair the ability to drive vehicles and operate machinery.

Citalopram Teva-Rimafar contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult 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 the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Citalopram Teva-Rimafar 20 mg. Do not stop treatment before or abruptly, as this may worsen your condition.

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

Citalopram Teva-Rimafar 20 mg are tablets for oral administration. The tablets can be taken at any time of the day, with or without food, and in a single dose.

They should be swallowed with a sufficient amount of liquid (a glass of water) and without chewing.

The recommended dose is:

Adults:

Depression

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

Panic disorder

The initial recommended dose is 10 mg per day for the first week before increasing to 20-30 mg per day. If necessary, your doctor may increase the dose up to a maximum of 40 mg per day.

Obsessive-compulsive disorder (OCD)

The initial recommended 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, e.g., 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 20 mg in children and adolescents under 18 years of age have not been established, and its use is not recommended in this population.

Patients with liver impairment:

Patients with mild or moderate liver impairment should be given 10 mg per day for 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 per day. Caution and careful dose adjustment are recommended in patients with severe liver impairment.

Patients with renal impairment:

Caution is recommended in patients with severe renal impairment.

If you think that the action of Citalopram Teva-Rimafar 20 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Citalopram Teva-Rimafar 20 mg than you should

If you have taken more Citalopram than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 5620420, 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, seizures, loss of consciousness, and palpitations.

If you forget to take Citalopram Teva-Rimafar 20 mg

In case of a missed dose, wait for the next one. But do not take a double dose to make up for the missed dose.

If you stop taking Citalopram Teva-Rimafar 20 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), agitation or anxiety, nausea and/or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual disturbances or 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 stop treatment with this medicine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Citalopram Teva-Rimafar 20 mg 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:

• 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 movement, often accompanied by difficulty sitting or remaining at rest. 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, alopecia, purpura, photosensitivity reaction, ecchymosis, angioedema.

• Visual disorders: adaptation disorders, mydriasis.

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

• Cardiovascular 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 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.

• Hepatic 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 blood.

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 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 this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging after

EXP. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and 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. Content of the Packaging and Additional Information

Composition of Citalopram Teva-Rimafar 20 mg tablets

• The active ingredient is citalopram (hydrobromide). Each tablet contains 20 mg of citalopram.
• The other components (excipients) are: Cornstarch without gluten, 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 Content of the Packaging

Citalopram Teva-Rimafar 20 mg are film-coated tablets. They are presented in packages of 14, 28, or 56 tablets. The tablets are oval, scored, and white in color.

Only some package sizes may be marketed.

Other Presentations:

Citalopram Teva-Rimafar 30 mg film-coated tablets.

Marketing Authorization Holder and Manufacturer

Holder: Manufacturer:

Teva Pharma, S.L.U. Teva Pharma, S.L.U.

Anabel Segura 11 Street. Albatros Building B, 1st floor Malpica industrial estate C/ C 4.

28108 Alcobendas. Madrid Spain 50016 - Zaragoza. Spain

or

Industria Química y Farmacéutica VIR, S.A.

Laguna 66-68-70 Street.

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/