Prospect: information for the user

Citalopram Teva-Rimafar 30 mg tablets EFG

Citalopram hydrobromide

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

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

3. How to take Citalopram Teva-Rimafar.

4. Possible adverse effects.

5. Storage of Citalopram Teva-Rimafar.

6. Contents of the package and additional information

Citalopram belongs to a group of medicines called 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.

Do not take Citalopram Teva-Rimafar 30 mg:

- If you are allergic (hypersensitive) to citalopram or any of the other ingredients of this medication (listed in section 6).

- If you are being treated with other antidepressant medications of the monoamine oxidase inhibitor (MAOI) group or if you have been treated with such medication in the last two weeks.

- If you are taking any medication with pimozide.

- In combination with linezolid.

- If you have any type of heart rhythm disorder from birth or have ever had such an episode (this is observed with an electrocardiogram, a test that evaluates how the heart works).

- If you are taking medications for any disease that alters the heart rhythm.

- If you are taking medications that can affect the heart rhythm.

Warnings and precautions

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

- If you have severe liver or kidney failure.

- If you have had manic episodes.

- If you have or have a history of epilepsy. In case of developing seizures or increasing the frequency of attacks, the treatment with citalopram should be interrupted.

- If you have diabetes, as you may need to adjust your insulin or oral antidiabetic medication dose.

- If you have any bleeding disorder or are being treated with medications that affect blood clotting or are pregnant (see “Pregnancy, breastfeeding, and fertility”).

- If you are receiving electroconvulsive therapy.

- If you are taking herbal medicines containing St. John's Wort (Hypericum perforatum).

- If you have or have had any heart problems 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 because you have used diuretics (medications to urinate).

- If you have noticed that your heartbeats are rapid 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.

Some medications in the group to which Citalopram Teva-Rimafar belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

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 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 starting treatment have a higher risk of suicidal ideation or attempted suicide during treatment.

When treatment is discontinued, withdrawal symptoms are common, 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 medication.

Angle-closure glaucoma

ISRS, including citalopram, may have an effect on pupil size, causing 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 predisposed patients. Citalopram should therefore be used with caution in patients with angle-closure glaucoma or a history of glaucoma

Other medications and Citalopram Teva-Rimafar

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

Simultaneous administration of citalopram with selective monoamine oxidase (MAOI) inhibitors (such as moclobemide, an antidepressant medication) is contraindicated.

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 cause an increase in carbamazepine levels in the blood, and a reduction in carbamazepine dose may be necessary.

- 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 medication): may cause an increase in imipramine metabolite levels in the blood.

- Cimetidine (antiulcer medication) and fluconazole (used to treat fungal infections): 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 side effects.

- Do not take citalopram if you are taking medications because you already have some disease that alters the heart rhythm or if you are taking medications that could affect the heart rhythm, for example, anti-arrhythmic class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacine, moxifloxacine, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizol, mizolastina). If you have doubts about this, consult your doctor.

- Medications that induce hypopotasemia/hypomagnesemia. Caution should be exercised when using concomitant products that induce hypopotasemia/hipomagnesemia, as these conditions increase the risk of malignant arrhythmias.

• Medications such as buprenorphine, which are serotoninergic, as they may increase the risk of serotonin syndrome.

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

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

Pregnancy, breastfeeding, and fertility

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

Citalopram is not recommended for use during pregnancy and breastfeeding.

If you take Citalopram Teva-Rimafar in the final stages of pregnancy, there may be an increased risk of excessive 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 be able 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 so far.

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

When taken during pregnancy, particularly in the last three months of pregnancy, medications 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 within 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 suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes it may prescribe Citalopram Teva-Rimafar 30 mg to patients under 18 years of age when they decide it is the best option for the patient. If the doctor who prescribes it has prescribed Citalopram Teva-Rimafar 30 mg to a patient under 18 years of age 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 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 operating 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 Citalopram Teva-Rimafar 30 mg affects you.

Citalopram Teva-Rimafar contains lactose and sodium

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 contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

Remember to take your medication.

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

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

Citalopram Teva-Rimafar are oral tablets for administration. The tablets can be taken at any time of the day, regardless of meals, and in a single dose.

They should be taken with a sufficient amount of liquid (a glass of water) and not chewed.

Adults:

Depression

The recommended initial dose is 20 mg per day. Depending on the individual response of the patient and the severity of depression, your doctor may increase the dose progressively 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 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 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.

Older Adults:

In older adults, treatment should be initiated with half the recommended dose, for example 10-20 mg per day. Generally, older adults 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, so it is not recommended for use in this population.

Patients with Liver Insufficiency:

Patients with mild or moderate liver insufficiency should be administered 10 mg per day for the first two weeks of treatment. Depending on the individual response of each patient, the dose may be increased up to a maximum of 20 mg/day. It is recommended to exercise special caution and carefully adjust the dose in patients with severe liver insufficiency.

Patients with Renal Insufficiency:

Caution is recommended in patients with severe renal insufficiency.

If you estimate that the action of Citalopram Teva-Rimafar 30 mg is too strong or weak, inform 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 medication and the amount ingested.

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 forget to take Citalopram Teva-Rimafar 30 mg

In case of forgotten dose, wait for the next one. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Citalopram Teva-Rimafar 30 mg

If treatment with Citalopram is stopped abruptly, some withdrawal symptoms 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 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 stop treatment with this medication.

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

Like all medications, Citalopram Teva-Rimafar 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:

- Nervous system 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 probable during the first weeks of treatment).

- Gastrointestinal disorders:nausea, vomiting, diarrhea, constipation, dry mouth.

- Skin and subcutaneous tissue disorders: rash, itching, increased sweating, alopecia, purpura, photosensitivity reaction, ecchymosis, angioedema.

- Eye 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 due to a drop in blood pressure, slowing of heart rate in some patients, rapid and irregular heartbeats, or a feeling of fainting, which may be symptoms of a serious heart condition known as torsades de pointes, hemorrhage, orthostatic hypotension.

- Reproductive and mammary disorders:impotence, ejaculation disorder,

menorrhagia, metrorrhagia, priapism, galactorrhea.

- Renal and urinary disorders:urinary retention.

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

Unknown frequency: Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information,increased levels of prolactin hormone in the blood.

Rarely, cases of skin and mucous membrane bleeding, such as skin hemorrhages,

vaginal hemorrhages, and gastrointestinal bleeding have been observed.

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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: https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date appearing on the packaging after 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 the

medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Citalopram Teva-Rimafar

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

The other components (excipients) are: Cornstarch without gluten, lactose monohydrate, croscarmellose sodium, glycerin, copovidone, magnesium stearate, and microcrystalline cellulose.

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

Appearance of the product and content of the packaging

Citalopram Teva-Rimafar 30 mg are coated tablets. The coated tablets are oval, scored on one face, and white in color. They are presented in packaging of 28 or 56 tablets.

Other presentations:

Citalopram Teva-Rimafar 20 mg coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid.

Spain

Responsible for manufacturing:

Teva Pharma, S.L.U.

Malpica Industrial Estate c/ C 4.

50016 - Zaragoza. Spain

or

Industrial and Pharmaceutical Company VIR, S.A.

C/ Laguna 66-68-70.

28923 Alcorcón. Madrid. Spain

Last review date of this leaflet: April 2024

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