Citalopram Teva-Rimafar 30 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Citalopram Teva-Rimafar 30 mg tablets EFG

Citalopram hydrobromide

Package leaflet:

1. What Citalopram Teva-Rimafar is and what it is 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. How to store Citalopram Teva-Rimafar.
6. Contents of the pack and other information.

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

Citalopram belongs to a group of medicines known as "selective serotonin reuptake inhibitor" antidepressants.

Citalopram Teva-Rimafar is indicated for the treatment of:

• depression and prevention of relapse.
• panic 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 to 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 inhibitors (MAOIs) group, or if you have been treated with such medicines within the last two weeks.
• If you are taking any medicine containing pimozide.
• In combination with linezolid.
• If you have a congenital heart rhythm disorder or have ever experienced such an episode (this is detected by electrocardiogram, a test used to assess heart function).
• If you are taking medicines for a condition that affects heart rhythm.
• If you are taking medicines that may affect heart rhythm.

Warnings and precautions

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

• If you have hepatic impairment or severe renal impairment.
• If you have experienced manic episodes.
• If you have or have a history of epilepsy. If seizures develop or seizure frequency increases, treatment with citalopram should be discontinued.
• If you have diabetes, as you may require adjustment of your insulin or oral antidiabetic dosage.
• If you have a bleeding disorder or are being treated with medicines affecting blood coagulation, or if you 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 heart problems or have recently suffered a heart attack.
• If your heart beats slowly at rest (known as bradycardia) and/or you suspect your body may be losing salts, for example due to severe diarrhea and vomiting over several days or due to diuretic use (medicines for increasing urine production).
• If you have noticed rapid or irregular heartbeats, or have experienced fainting or dizziness upon standing from a sitting or lying position. These symptoms may indicate a heart rhythm disorder.

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

Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide. This risk persists until significant improvement occurs. Since improvement may not occur during the first few weeks or longer of treatment, patients should be closely monitored during this period. Clinical experience indicates that the risk of self-harm is highest at the beginning of a depressive episode and may increase again as clinical improvement begins. Additionally, antidepressants may rarely increase the risk of suicidal thoughts and self-harm. Patients with a history of suicidal behavior and those who have significant suicidal ideation before starting treatment are at greater risk of suicidal thoughts or suicide attempts during treatment.

When stopping treatment, withdrawal symptoms are common, particularly if discontinuation is abrupt (see section "Possible adverse effects").

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

Closed-angle glaucoma

SSRIs, including citalopram, may affect pupil size, causing mydriasis. This mydriatic effect has the potential to narrow the eye angle, leading to increased intraocular pressure and closed-angle glaucoma, especially in predisposed patients. Therefore, citalopram should be used with caution in patients with closed-angle glaucoma or a history of glaucoma.

Other medicines and Citalopram Teva-Rimafar

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

Concomitant administration of citalopram with selective MAO-A inhibitors (such as moclobemide, an antidepressant medicine) is contraindicated.

The concomitant use of citalopram with MAOI medicines carries a risk of serotonin syndrome (see section "Possible adverse effects").

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

• Carbamazepine (antiepileptic medicine): increased blood levels of carbamazepine may occur, possibly requiring a reduction in carbamazepine dosage.
• Lithium (medicine used to treat bipolar disorder): increases the risk of serotonin syndrome.
• Oral anticoagulants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, and other medicines affecting blood coagulation: risk of bleeding may increase.
• Imipramine (antidepressant medicine): increased blood levels of imipramine metabolite occur.
• Cimetidine (anti-ulcer medicine) and fluconazole (used to treat fungal infections): may increase citalopram blood levels.
• Metoprolol (antihypertensive, antianginal, and antiarrhythmic medicine).
• Preparations containing St. John's Wort: adverse effects may be more frequent.
• Do not take citalopram if you are already taking medicines for a condition that affects heart rhythm or if you are taking medicines that may affect heart rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials particularly halofantrine), or certain antihistamines (astemizole, mizolastine). If you have any doubts about this, consult your doctor.
• Medicines inducing hypokalaemia/hypomagnesaemia. Caution should be exercised with concomitant use of products that induce hypokalaemia/hypomagnesaemia, as these conditions increase the risk of malignant arrhythmias.
• Serotonergic 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 alcohol consumption while taking this medicine.

Pregnancy, breastfeeding and fertility

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

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

If you take Citalopram Teva-Rimafar in the late stages 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 be informed that you are taking citalopram so they can advise you appropriately.

Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed to date.

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

Medicines such as Citalopram Teva-Rimafar, when taken during pregnancy, particularly during the last three months, 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 appear bluish. These symptoms usually begin within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

Use in children and adolescents

Citalopram Teva-Rimafar 30 mg should not normally be used in the treatment of children and adolescents under 18 years of age. Additionally, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram Teva-Rimafar 30 mg to patients under 18 years if they decide it is the most appropriate treatment. If your doctor has prescribed Citalopram Teva-Rimafar 30 mg to a patient under 18 years and you wish to discuss this decision, please consult your doctor again. Inform your doctor if any of the above-mentioned symptoms worsen or complications arise while patients under 18 years are taking Citalopram Teva-Rimafar 30 mg. Furthermore, the long-term effects on safety, growth, puberty, and cognitive and behavioral development of Citalopram Teva-Rimafar 30 mg in this age group have not yet been established.

Driving and using machines

During treatment with Citalopram Teva-Rimafar, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this medicine affects you.

Citalopram Teva-Rimafar contains lactose and sodium

This medicine contains lactose. If your doctor has informed 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; essentially "sodium-free".

3. How to take Citalopram Teva-Rimafar

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

Remember to take your medication.

Your doctor will tell you how long to take Citalopram Teva-Rimafar. Do not stop treatment early or abruptly, as this could worsen your condition.

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

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

Adults:

Depression

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

Panic disorder

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

Elderly patients

Treatment should be initiated at half the recommended dose, for example 10–20 mg daily. In general, elderly patients should not take more than 20 mg daily.

Children and adolescents

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

Patients with hepatic impairment:

For patients with mild or moderate hepatic impairment, a dose of 10 mg daily is recommended 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. Particular caution and careful dose adjustment are recommended in patients with severe hepatic impairment.

Patients with renal impairment:

Caution is recommended in patients with severe renal impairment.

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

If you take more Citalopram Teva-Rimafar than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

The most common symptoms in case of overdose are: nausea, vomiting, sweating, drowsiness, bluish discoloration of the skin, tremors, seizures, loss of consciousness, and palpitations.

If you forget to take Citalopram Teva-Rimafar 30 mg

If you miss a dose, wait until the next scheduled dose. Do not take a double dose to make up for the missed dose.

If you stop taking Citalopram Teva-Rimafar 30 mg

If treatment with Citalopram is stopped abruptly, withdrawal symptoms may occur, such as dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and vivid dreams), headache, agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances, and tingling sensations in the hands or feet. The risk of withdrawal reactions depends on several factors, including duration of treatment, dose used, and rate of dose reduction. Generally, these symptoms are mild or moderate, but in some patients they may be severe. These symptoms are usually self-limiting and resolve within two weeks, although in some patients they may last longer.

Your doctor will advise you on how to gradually discontinue treatment with this medicine.

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

4. Possible adverse effects

Like all medicines, Citalopram Teva-Rimafar may produce adverse effects, although not everyone experiences them.

The adverse effects are generally mild or moderate in intensity. They become evident during the first, or even the first two, weeks of treatment and subsequently disappear as the condition improves.

The following adverse effects have been reported:

• Nervous system disorders: nervousness, somnolence, weakness, headache, dizziness, sleep disturbances, memory loss, suicidal ideation, and serotonin syndrome (characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex responses, involuntary movements, chills, tachycardia, and tremor), psychomotor agitation/acathisia (characterized by restlessness and an urge to move, frequently accompanied by difficulty sitting still or remaining at rest. This is more likely to occur 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: accommodation disorders, mydriasis.

• Metabolism and nutrition disorders: weight loss or weight gain, loss or increase in appetite, hyponatremia and hypokalemia.

• Cardiac and vascular disorders: tachycardia, bradycardia, dizziness upon standing due to a drop in blood pressure, slowed heart rate in some patients, rapid and irregular heartbeats or fainting sensation, as these could be symptoms of a serious heart condition known as torsade de pointes, bleeding, orthostatic hypotension.

• Reproductive system and breast disorders: impotence, ejaculation disorder, menorrhagia, metrorrhagia, priapism, galactorrhea.

• Renal and urinary disorders: urinary retention.

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

Frequency not known: Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see «Pregnancy and lactation» in section 2 for further information, increased blood levels of prolactin hormone.

Rarely, cases of bleeding in the skin and mucous membranes have been observed, such as cutaneous hemorrhages, vaginal bleeding, 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalopram Teva-Rimafar

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citalopram Teva-Rimafar

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

The other components (excipients) are: Gluten-free maize starch, lactose monohydrate,
sodium croscarmellose, glycerin, copovidone, magnesium stearate and microcrystalline cellulose.

Excipients in the film coating: Hypromellose type E5, macrogol 400 and titanium dioxide (E 171).

Appearance of the product and contents of the pack

Citalopram Teva-Rimafar 30 mg are film-coated tablets. The coated tablets are oval-shaped, scored on one side and white in colour. They are available in packs 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.
C/ Anabel Segura 11. Edificio Albatros B, 1st floor.
28108 Alcobendas. Madrid.
Spain

Manufacturer:

Teva Pharma, S.L.U.
Malpica Industrial Estate, c/ C 4.
50016 - Zaragoza. Spain

or

Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-68-70.
28923 Alcorcón. Madrid. Spain

Date of latest review of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/