Package Insert: Information for the Patient

Citalopram Tarbis Farma 10 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Citalopram Tarbis Farma is and for what it is used

2. What you need to know before starting to take Citalopram Tarbis Farma

3. How to take Citalopram Tarbis Farma

4. Possible adverse effects

5. Storage of Citalopram Tarbis Farma

6. Contents of the package and additional information

Citalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Citalopram is used in the treatment of:

• Depressive disorders (major depressive episodes).
• Anxiety disorders with or without agoraphobia (e.g. intense anxiety when leaving home, entering shops or fear of public spaces).

Do not take Citalopram Tarbis Farma

• If you are allergic to citalopramor to any of the other ingredients of this medication (listed in section 6).
• If you are taking monoamine oxidase inhibitors (MAOIs):
• • for example: the antidepressant moclobemide or if you are being treated with a non-selective MAO inhibitor - linezolid (antibiotic), unless you are under close supervision and monitoring of blood pressure.
  • irreversible MAO inhibitor selegiline (Parkinson's disease medication), can be used in combination with citalopram at daily doses not exceeding 10 mg of selegiline per day (see “Taking Citalopram Tarbis Farma with other medicines”).
  • if you have taken irreversible MAOIs within the last two weeks or if you have taken reversible MAOIs (RIMAs) within the prescribed period in your corresponding leaflet (see “Taking Citalopram Tarbis Farma with other medicines”).
  • if you stop taking citalopram and want to start using MAOIs, you must wait for at least 7 days (see “Taking Citalopram Tarbis Farma with other medicines”).
• If you have or have had an episode of irregular heart rhythm (detected on an ECG; a test to evaluate heart function).
• If you are taking medicines for heart rhythm problems or that can affect heart rhythm.

Also see the section “Taking Citalopram Tarbis Farma with other medicines”, below.

Warnings and precautions

Consult your doctor or pharmacist before starting to take citalopram.

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

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These may increase when taking antidepressants for the first time, as all these medicines need time to start working, usually around two weeks, but in some cases, more.

You may be more prone to having these thoughts:

If you have thoughts of self-harm or suicide at any time,contact your doctor or go to the hospital immediately.

You may find it helpful to inform a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your attitude.

Restlessness/difficulty staying still or stopping

Symptoms such as restlessness, for example difficulty staying still or stopping (akathisia), may occur during the first weeks of treatment. Consult your doctor immediately if you experience these symptoms. You may need a dose adjustment.

Increased anxiety

In the treatment of panic disorder, it usually takes 2-4 weeks to notice any improvement. Some patients may experience an increase in anxiety at the beginning of treatment, which will disappear during continued treatment. Therefore, it is very important to follow exactly your doctor's instructions and do not stop using the treatment or change the dose without consulting your doctor.

Mania (hyperactive behavior or thought)

If you enter a manic phase characterized by unusual and rapid changes in ideas, inappropriate happiness, and excessive physical activity, please contact your doctor.

Symptoms of withdrawal observed when interrupting treatment with a Selective Serotonin Reuptake Inhibitor (SSRI)

When you interrupt treatment with citalopram, especially if it is done abruptly, you may feel withdrawal symptoms (see “How to take Citalopram Tarbis Farma” and “Possible side effects”). They are common when treatment is interrupted. The risk is higher when citalopram has been used for a long period, at high doses, or when the dose is reduced too quickly. Many people find that the symptoms are mild and disappear on their own within two weeks. However, in some patients, they are severe or may persist (2-3 months or more). If you experience severe withdrawal symptoms when interrupting treatment with citalopram, please contact your doctor. You can ask them to start taking your tablets again and stop them more gradually.

Children and adolescents under 18 years

Antidepressants should not be used normally in children and adolescents under 18 years. You should also know that in patients under 18 years, there is a higher risk of experiencing adverse effects such as attempts at suicide, thoughts of suicide, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines.

Despite this, your doctor may prescribe citalopram to patients under 18 years if they decide it is the best option for the patient. If your doctor has prescribed citalopram to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above worsen or progress when patients under 18 years are taking citalopram. You should also be aware that the long-term safety effects and those related to growth, maturity, and cognitive and behavioral development of citalopram in this age group have not yet been demonstrated.

Consult your doctor if:

• You start to develop fever, muscle stiffness, or extreme agitation; you may suffer from what is known as serotonin syndrome. Although this syndrome occurs rarely, it can put your life at risk. Contact your doctor immediately, it may be necessary to discontinue the use of citalopram.
• You are taking preparations of plants that contain St. John's Wort (Hypericum Perforatum, see “Taking Citalopram Tarbis Farma with other medicines”).
• You are taking serotoninergic medicines such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan (see “Taking Citalopram Tarbis Farma with other medicines”).
• You are prone to experiencing variations in heart rhythm (prolongation of the QT interval) or have a suspicion of congenital long QT syndrome or low levels of potassium and magnesium (hypopotasemia/hypomagnesemia).
• You have or have had heart problems or have recently had a heart attack.
• You have a low resting heart rate and/or know that you may have decreased electrolytes as a result of intense and prolonged diarrhea and vomiting (feeling dizzy) or the use of diuretics.
• You experience a rapid or irregular heartbeat, fainting, dizziness when standing up, which may indicate abnormal heart rhythm.
• You are at risk of having low sodium levels in the blood (hyponatremia), for example: due to concomitant medications and cirrhosis. During treatment with citalopram, hyponatremia has been rarely associated with the syndrome of inappropriate antidiuretic hormone secretion (SIADH), especially in elderly patients.
• You have diabetes. You may need to adjust your antidiabetic treatment.
• You have epilepsy. Treatment should be interrupted in case of seizures. Contact your doctor.
• You have a hemorrhagic disorder, for example: gynecological or gastrointestinal bleeding or if you are using medications that affect blood coagulation or increase the risk of bleeding (see “Taking Citalopram Tarbis Farma with other medicines”), as the use of citalopram may increase the risk of bleeding.
• You experience difficulty sleeping or excitement at the beginning of treatment. Your doctor may adjust your dose.
• You are receiving electroconvulsive therapy.
• You have psychosis with depressive episodes, as the psychotic symptoms may worsen.
• You have or have had panic attacks.
• You have eye problems, such as some types of glaucoma.
• You have severe kidney problems. Citalopram is not recommended for use in patients with severe kidney problems.
• You have liver insufficiency. Your doctor should monitor your liver function. Caution and an extremely careful dosage regimen are recommended if you have severe liver problems.

Taking Citalopram Tarbis Farma with other medicines

DO NOT TAKE citalopram if you are taking medicines for heart rhythm problems or medicines that can affect heart rhythm, for example: antiarrhythmic Class IA and III, antipsychotics (for example: phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (for example: sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment especially halofantrine), certain antihistamines (astemizole, mizolastine). If you have any questions about this, you should consult your doctor.

Citalopram may affect or be affected by other medicines. Some of these medicines are listed below:

• Desipramine (for depression). The levels of desipramine in the blood may increase, and a reduction in the dose of desipramine may be necessary.
• Metoprolol (for example: for heart failure), flecainide, and propafenone (for irregular heart rhythm), other medicines for treating depression (clomipramine, nortriptyline) or medicines for treating psychosis (risperidone, thioridazine, haloperidol). An increase in these medicines in the blood may be possible or has been reported.
• Pimozide (an antipsychotic medicine). The concomitant treatment with citalopram and pimozide is contraindicated due to the influence of this combination on heart function.
• Medicines that decrease potassium and magnesium levels in the blood, as these alterations increase the risk of life-threatening heart rhythm disturbances (prolongation of QT, Torsades de Pointes).
• Medicines that decrease the seizure threshold, for example: other antidepressants (SSRIs), antipsychotic medicines (for example: butyrophenones, thioxanthenes), mefloquine, bupropion, and tramadol (analgesic).

The following medicines may increase the serotoninergic effect of citalopram and cause an increase in adverse effects:

• MAOIs (for depression or Parkinson's disease) (for example: moclobemide and selegiline or linezolid, an antibiotic). Do not use citalopram concomitantly with MAOIs, as they may produce severe or even fatal reactions (serotonin syndrome), except for selegiline, not exceeding 10 mg/day. There should be a pause between treatments (see “Do not take Citalopram Tarbis Farma”). Consult your doctor.
• Oxitriptan and tryptophan (serotoninergic precursors).
• Lithium (for mental illnesses).
• Sumatriptan and other triptans (for migraines).
• Tramadol (for severe pain).
• St. John's Wort (Hypericum perforatum).
• Cimetidine (for the stomach) and other medicines for treating stomach ulcers, for example: omeprazole, esomeprazole, lansoprazole, fluconazole (used to treat fungal infections), ticlopidine, or fluvoxamine (another antidepressant). The combination with citalopram may cause an increase in citalopram levels in the blood.

The following medicines increase the risk of bleeding:

• Warfarin and other anticoagulants.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (for example: ibuprofen).
• Dipyridamole and ticlopidine (for the heart).
• Atypical antipsychotics (for mental disorders).

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

Citalopram Tarbis Farma with food, drinks, and alcohol

Foods do not affect the effect of citalopram. It is not recommended to consume alcohol simultaneously.

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 medicine.

Pregnancy

Do not take citalopram if you are pregnant or planning to become pregnant, unless you and your doctor have discussed the risks and benefits.

Do not stop taking citalopram abruptly during pregnancy. Consult your doctor if you want to stop or interrupt treatment.

Make sure your midwife and/or doctor knows that you are taking citalopram. When medicines like citalopram are taken during pregnancy, particularly in the last three months of pregnancy, there may be an increased risk of a severe condition in the baby, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe more rapidly and have a blue appearance. These symptoms usually appear within the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you are taking citalopram during the last three months of pregnancy and until the day of your baby's birth, you may experience severe or withdrawal symptoms, such as respiratory difficulties, blue skin/labial discoloration, irregular breathing with pauses, temperature fluctuations, convulsions, lethargy, difficulty sleeping, difficulty feeding, vomiting, low blood sugar, stiff or flexible muscles, abnormal reflexes, tremors, extreme nervousness or agitation, irritability, constant crying, and somnolence.

If your newborn baby experiences any of these symptoms, contact your doctor immediately, they will be able to advise you.

If you take citalopram in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of hemorrhagic disorders. Your doctor or midwife should know that you are taking citalopram to be able to advise you.

Breastfeeding

Citalopram is excreted in breast milk in small amounts. There is a risk of effects on the baby. If you are taking citalopram, inform your doctor before starting breastfeeding.

Fertility

Citalopram has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, there has been no observed impact on human fertility.

Driving and operating machinery

Citalopram has a mild to moderate effect on the ability to drive and operate machinery. Do not drive or operate machinery until you know how this medicine affects you. Normally, citalopram does not affect the ability to perform daily normal activities. However, if you feel dizzy or drowsy when starting to take this medicine, you should be careful when driving, operating machinery, or performing tasks that require you to be alert until these effects disappear. If you are unsure, consult your doctor to see if you can perform the aforementioned activities.

This medicine contains sodium

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

This medicine contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Be aware that it may take between 2-4 weeks to notice improvement. Treatment should continue until you no longer notice symptoms for 4-6 months. When going to interrupt treatment with citalopram, you must reduce the dose gradually over a period of at least 1-2 weeks.

You should take citalopram once a day, either in the morning or in the afternoon. Drink a glass of water with this medication; it can be taken with or without food. For dosages that cannot be achieved with this concentration, there are other more suitable doses of this medication available.

How much to take

Adults:

Depression

The recommended dose is 20 mg per day. Your doctor may increase this dose 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. Your doctor may increase this dose to a maximum of 40 mg per day. The complete therapeutic response may be prolonged for up to 3 months.

Older adults (65 years and older):

Depression and anxiety disorder

Treatment should be initiated with half the recommended dose, e.g., 10-20 mg per day. Normally, older adults should not take more than 20 mg per day.

Use in children and adolescents under 18 years:

Citalopram is usually not used in children and adolescents under 18 years (see "Warnings and precautions").

Liver impairment:

The initial dose is usually 10 mg per day. Patients with liver disease should not take more than 20 mg per day.

Renal impairment:

The dose may need to be adjusted. Follow your doctor's recommendations.

If you take more Citalopram Tarbis Farma than you should

If you have taken more citalopram than indicated in this leaflet or more than your doctor has prescribed, contact your doctor, emergency services, or pharmacist. Some overdose symptoms may put your life at risk.

Depending on the dose ingested, citalopram overdose manifests with symptoms such as irregular heartbeat, convulsions, changes in heart rhythm (faster or slower heart rate), feeling dizzy (nausea), vomiting, sweating, drowsiness, loss of consciousness, tremors, changes in blood pressure (may increase or decrease), serotonin syndrome (see section 4), agitation, vertigo, dilated pupils, blue skin, rapid breathing, cardiac arrest, coma.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forgot to take Citalopram Tarbis Farma

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

If you interrupt treatment with Citalopram Tarbis Farma

It is advisable to avoid abrupt interruption. When interrupting treatment with citalopram, the dose should be reduced gradually over a period of at least 1-2 weeks to reduce the risk of withdrawal reactions. If intolerable symptoms appear followed by a decrease in dose or after treatment interruption, reinitiation of the previously prescribed dose may be considered. Subsequently, your doctor may continue to reduce the dose, but at a slower rate.

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 usually disappear after a few weeks of treatment. Several of the side effects listed below may also be symptoms of your illness and may disappear when you start feeling better.

If you experience one or more of the following side effects, you should discontinue treatment with citalopram and immediately contact your doctor or emergency services.

Uncommon side effects (may affect up to 1 in 100 people)

• Intense skin itching (with raised bumps).

Rare side effects (may affect up to 1 in 1,000 people)

• Nausea, muscle weakness, confusion, fatigue, muscle spasms due to low sodium levels in the blood. In some patients, this may trigger a severe side effect. Consult your doctor.
• Hepatitis, jaundice.
• Previous seizures become more frequent.

Very rare side effects (may affect up to 1 in 10,000 people)

• Sudden allergic reaction (within minutes to hours), e.g.: rash, difficulty breathing, dizziness, and fainting (anaphylactic reaction).
• Rash and edema. Cases related to facial, lip, and tongue swelling may be life-threatening (angioedema).

Side effects of unknown frequency (cannot be estimated from available data)

• Thoughts and suicidal behavior. Cases of suicidal thoughts and behavior have been reported during treatment with citalopram or shortly after treatment has been discontinued (see "Warnings and precautions"). Contact your doctor or emergency services.
• Severe heart rhythm disturbances with rapid and irregular pulse.
• High fever, chills, and sudden muscle spasms, confusion, pathological euphoria, and agitation.
• Decreased platelet count, leading to an increased risk of bleeding and bruising.
• Unusual bleeding, including gastrointestinal bleeding (vomiting with blood and/or black stools due to stomach and intestinal bleeding), and uterine bleeding.
• Rapid and irregular heartbeat, fainting, which may be a symptom of a potentially life-threatening condition called Torsade de Pointes.
• Start experiencing seizures for the first time.

Other side effects have also been reported:

Very common side effects (may affect more than 1 in 10 people)

• Palpitations, agitation, increased sweating.
• Drowsiness (urge to sleep), drowsiness, weakness, and fragility.
• Difficulty sleeping.
• Restless agitation, nervousness.
• Dizziness.
• Blurred vision (difficulty reading small print).
• Dry mouth, which may increase the risk of tooth decay – you should therefore brush your teeth more frequently than usual while taking citalopram.
• Nausea, constipation.
• Headache.

Common side effects (may affect up to 1 in 10 people)

• Decreased appetite, weight loss, increased appetite, altered taste.
• Diarrhea, vomiting, stomach upset (including acid reflux and heartburn), stomach pain, flatulence, increased salivation.
• High blood pressure. Inform your doctor. High blood pressure should be treated. Severe high blood pressure is serious.
• Dizziness and possibility of fainting (probably only when getting up) due to low blood pressure.
• Low blood pressure.
• Fever.
• Sensation of tingling, numbness, or prickling of the skin.
• Fatigue, difficulty breathing, strange dreams.
• Migraine, tinnitus (ringing in the ears).
• Visual disturbances.
• Nasal discharge, sinusitis, yawning.
• Difficulty urinating.
• Itching, rash.
• Muscle and joint pain.
• Sexual dysfunction, impotence (erectile dysfunction).
• Menstrual cramps, difficulty achieving orgasm.
• Reduced libido.
• Anxiety, confusion, indifference.
• Altered concentration, attention disorder, strange dreams, memory loss.
• Excessive urine production (polyuria).

Uncommon side effects (may affect up to 1 in 100 people)

• Hallucinations, which may be severe. Contact your doctor or emergency services.
• Fainting.
• Seizures.
• Movement disorder and involuntary movements.
• Dilated pupils.
• Cough.
• Difficulty urinating, possibly leading to urinary retention. May be or become severe. Consult your doctor.
• Edema (fluid retention).
• Hair loss.
• Urticaria, pruritic rash, rash, increased skin sensitivity to light (photosensitivity).
• Small skin and mucous membrane hemorrhages (purpura).
• Intense and unusual menstrual bleeding.
• Aggression (threat, possibly violent behavior), feeling of unreality or strangeness towards oneself.
• Pathological euphoria (mania).
• Euphoria.
• Increased libido.
• Anorexia.
• Discomfort.
• Weight gain.
• Slower heart rate.

Rare side effects (may affect up to 1 in 1,000 people)

• Involuntary movements.
• Bleeding (e.g. gynecological bleeding, gastrointestinal bleeding, ecchymosis, and other forms of skin or mucous membrane bleeding).
• Inability to remain still. Restless legs.

Very rare side effects (may affect up to 1 in 10,000 people)

• Milk flow.

Side effects of unknown frequency (cannot be estimated from available data)

• Weakness, limited muscle strength, abnormal heart rhythm due to low potassium levels in the blood (hypokalemia). In some patients, this may trigger a severe side effect. Inform your doctor.
• Nasal bleeding.
• Bleeding under the skin.
• Irregular and intense menstrual bleeding.
• Persistent and painful erection. Contact your doctor or emergency services as soon as possible.
• Panic attack.
• Grinding of teeth.
• An increased risk of bone fractures has been observed in patients taking this type of medication.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information.

Citalopram may also cause side effects that you will not normally notice. These are changes in certain laboratory test results, such as liver function tests, which normalize once treatment is discontinued.

Reporting 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 directly through the Spanish System for 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.

Do not use this medication after the expiration date that appears on the box and on the blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Citalopram Tarbis Farma

The active ingredient is citalopram.

Each film-coated tablet contains 10 mg of citalopram (as citalopram hydrobromide).

The other components are:

Tablet core:Lactose monohydrate, cornstarch, copovidone (E1208), microcrystalline cellulose (ph 102) (E460), croscarmellose sodium, and magnesium stearate.

Tablet coating:Titanium dioxide (E171), hypromellose 3 and 6mPas (E464), macrogol (E1521), Polysorbate 80 (E433).

Appearance of the product and content of the container

Film-coated tablet.

Citalopram Tarbis Farma 10 mg film-coated tablets EFG

Round, biconvex, film-coated tablets, white to off-white in color, engraved with “Z and 6” on one face and “H” on the other.

This medicine is available in blisters containing 20, 28, 30, 50, 56, and 100 film-coated tablets.

Only some container sizes may be marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Citalopram Amarox 10 mg/20 mg/30 mg/40 mg Filmtabletten

Spain: Citalopram Tarbis Farma 10 mg/20 mg/30 mg film-coated tablets EFG

Netherlands: Citalopram Amarox 10 mg/20 mg/30 mg/40 mg filmomhulde tabletten

Last review date of this leaflet: August 2021

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/