Leaflet: information for the user

Citalopram TARBIS 20 mg film-coated tablets

Citalopram (hydrobromide)

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Citalopram is an antidepressant medication that belongs to the group of medications known as “selective serotonin reuptake inhibitors”.

Citalopram TARBIS is indicated for:

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

Do not take Citalopram TARBIS 20 mg:

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

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

-If you have a congenital heart rhythm disorder or have experienced an episode of this type (this can be observed with an electrocardiogram, a test that evaluates how the heart functions).

-If you are taking medications for a heart condition or have recently experienced a heart attack.

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

-If you have noticed that your heart beats rapidly or irregularly or have experienced dizziness or fainting when getting up from a sitting or lying position. This could indicate a heart rhythm disorder.

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

Consult also the section “Taking Citalopram TARBIS with other medications” that is located below.

Warnings and precautions

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

• If you have liver or kidney problems.
• If you have had manic episodes.
• If you have epilepsy or have a history of it. In case of seizures or increased seizure frequency, treatment with citalopram should be discontinued.
• If you have diabetes, as you may need to adjust your insulin or oral antidiabetic medication dose.
• If you have a bleeding disorder or are being treated with medications that affect blood clotting, or if you are pregnant (see “Pregnancy, breastfeeding, and fertility”).

-If you have a heart condition or have recently experienced a heart attack.

-If, when at rest, your heart beats slowly (this is known as bradycardia) and/or if 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 taken diuretics (medications to urinate).

-If you have noticed that your heart beats rapidly or irregularly or have experienced dizziness or fainting when getting up from a sitting or lying position. This could indicate a heart rhythm disorder.

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

A higher risk of bone fractures has been observed in patients treated with this type of medication.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed or have an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These may increase when taking antidepressants for the first time, as all these medications require time to start working, usually around two weeks, although in some cases it may take longer.

You are more likely to have these thoughts:

-If you have previously had thoughts of self-harm or suicide.

-If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If you ever have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

Telling a close relative or friend that you are depressed or have an anxiety disorder and asking them to read this leaflet may be helpful. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

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

Use in children and adolescents under 18 years

Citalopram TARBIS should not be used for the treatment of children and adolescents under 18 years. However, you should know that in patients under 18 years, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the doctor who prescribes Citalopram TARBIS may prescribe it to patients under 18 years if they decide it is the best option for the patient. If the doctor who prescribes Citalopram TARBIS has prescribed it to a patient under 18 years 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 are taking Citalopram TARBIS 20 mg. Additionally, the long-term effects of Citalopram TARBIS 20 mg on the safety of growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Taking Citalopram TARBIS with other medications

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

Do not take Citalopram TARBIS:

If you are taking medications for a heart condition or are taking medications that can affect heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizol, mizolastine).

If you are unsure about this, consult your doctor.

Concomitant administration of citalopram with non-selective or selective B monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as during the two weeks following the end of treatment.

Simultaneous administration of citalopram with selective A monoamine oxidase inhibitors (MAOIs) is not recommended.

Concomitant administration of citalopram with MAOIs carries a risk of serotonin syndrome (see “Possible side effects”).

Cautions should be taken when citalopram is administered with any of the following medications:

• Carbamazepine (antiepileptic medication): may cause an increase in carbamazepine levels in the 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, 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 the levels of imipramine metabolite in the blood.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). May increase citalopram levels in the blood.
• Metoprolol (anti-hypertensive, anti-anginal, and anti-arrhythmic medication).
• Preparations containing St. John's Wort: may be more frequent side effects.

Taking Citalopram TARBIS 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 during pregnancy and breastfeeding.

If you take Citalopram TARBIS in the final stages of pregnancy, there may be a higher risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Citalopram TARBIS so they can advise you.

Make sure your midwife and/or doctor know that you are taking Citalopram TARBIS. When taken during pregnancy, particularly in the last three months of pregnancy, medications like Citalopram TARBIS may increase the risk of a serious condition 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.

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.

Driving and operating machines

During treatment with Citalopram TARBIS, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how Citalopram TARBIS 20 mg affects you.

Citalopram TARBIS contains lactose

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.

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 TARBIS. 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 TARBIS are tablets for oral administration. The tablets can be taken at any time of the dayindependently of meals andin a single dose. They should be swallowed with a sufficient amount of liquid (a glass of water) and not chewed.

The recommended dose is:

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 usual dose is 20 mg per day. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Older adults (over 65 years)

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.

Patients with special risks

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

Patients with renal insufficiency:

Citalopram should not be used in patients with severe renal insufficiency.

Children

The safety and efficacy of Citalopram TARBIS 20 mg have not been established in children and adolescents under 18 years, so it is not recommended for use in this population.

If you estimate that the action of Citalopram TARBIS 20 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Citalopram TARBIS than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological 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 discoloration of the skin, tremors, convulsions, loss of consciousness, and palpitations.

If you forgot to take Citalopram TARBIS

In case of forgotten dose, wait for the next one.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Citalopram TARBIS

If treatment with Citalopram TARBIS 20 mg is interrupted abruptly, some withdrawal symptoms 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, 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 discontinue treatment with this medication.

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

Like all medicines, this medicine 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 disappear as the disease improves.

The following side effects have been described. If you notice any of the following symptoms, stop taking Citalopram TARBIS and consult your doctor immediately:

• Mental and neurological 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 likely to occur 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: rapid and irregular heartbeats or a sensation of fainting, as they may be symptoms of a serious heart condition known as torsades de pointes, tachycardia, dizziness when standing due to a drop in blood pressure, slowing of the heart rate in some patients.
• Reproductive and breast disorders: alterations in sexual desire, abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information (unknown frequency).
• Renal and urinary disorders: alterations in urination.

Rarely, cases of skin and mucous membrane bleeding such as skin hemorrhages, vaginal bleeding, and gastrointestinal bleeding have been observed.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use, Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Expiration Date

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

Do not dispose of medications through drains or trash.Deposit empty packaging and unused medications at the SIGRE collection pointofyour pharmacy. If in doubtask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Citalopram TARBIS 20 mg tablets

• The active ingredient is citalopram (hydrobromide). Each tablet contains 20 mg of citalopram.

• The other components (excipients) are: maize starch, lactose monohydrate, sodium croscarmellose, glycerol, copovidone, magnesium stearate, microcrystalline cellulose, hypromellose 5, macrogol 400, and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Citalopram TARBIS 20 mg are film-coated tablets, white, oval, biconvex, and scored. They are presented in packs of 14, 28, 56, and 500 (clinical pack) tablets.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TARBIS FARMA, S.L.

Gran vía Carlos III, 94

08028 – Barcelona

Spain

Responsible for manufacturing

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet: December 2020

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