CITALOPRAM TARBIS FARMA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Citalopram Tarbis Farma 10 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Citalopram Tarbis Farma and what is it used for
2. What you need to know before you take Citalopram Tarbis Farma
3. How to take Citalopram Tarbis Farma
4. Possible side effects
5. Storage of Citalopram Tarbis Farma
6. Contents of the pack and further information

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

Citalopram belongs to a group of antidepressants called 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 the house, entering stores, or fear of public spaces).

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

Do not take Citalopram Tarbis Farma

• If you are allergic to citalopramor any of the other ingredients of this medicine (listed in section 6).
• If you are taking monoamine oxidase inhibitors (MAOIs):
• • e.g., the antidepressant moclobemide or if you are being treated with a non-selective MAOI - linezolid (an antibiotic), unless you are under close supervision and monitoring of blood pressure.
  • Irreversible MAOI selegiline (a medicine for Parkinson's disease) can be used in combination with citalopram in daily doses not exceeding 10 mg of selegiline per day (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 may affect heart rhythm.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take citalopram.

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

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from 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, longer.

You may be more likely to have these thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years with psychiatric disorders who were treated with an antidepressant.

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

It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this package leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.

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. A dose adjustment may be necessary.

Increased anxiety

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

Mania (hyperactive behavior or thinking)

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

Withdrawal symptoms seen when stopping treatment with a Selective Serotonin Reuptake Inhibitor (SSRI)

When stopping treatment with citalopram, especially if it is sudden, you may feel withdrawal symptoms (see “How to take Citalopram Tarbis Farma” and “Possible side effects”). These are common when stopping treatment. The risk is greater when citalopram has been used for a long time, in high doses, or when the dose is reduced too quickly. Many people find that the symptoms are mild and go away on their own within two weeks. However, in some patients, they can be severe or prolonged (2-3 months or more). If you experience severe withdrawal symptoms when stopping treatment with citalopram, please contact your doctor. You may ask them to start taking your tablets again and taper them off more gradually.

Children and adolescents under 18 years

Antidepressants should not normally be used in children and adolescents under 18 years. Moreover, you should know that in patients under 18 years, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this class of medicines.

However, your doctor may prescribe citalopram to patients under 18 years when they decide it is the most convenient for the patient. If your doctor has prescribed citalopram to a patient under 18 years and you wish to discuss this decision, please go back to your doctor. You must inform your doctor if any of the symptoms listed above worsen or progress when patients under 18 years are taking citalopram. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of citalopram in this age group have not yet been demonstrated.

Talk to your doctor if:

• You start to develop fever, muscle stiffness, or tremor and extreme agitation; you may suffer from what is known as serotonin syndrome. Although this syndrome occurs rarely, it can be life-threatening. Contact your doctor immediately; it may be necessary to discontinue the use of citalopram.
• You are taking herbal preparations containing St. John's Wort (Hypericum Perforatum, see “Taking Citalopram Tarbis Farma with other medicines”).
• You are taking serotonergic medicines such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan (see “Taking Citalopram Tarbis Farma with other medicines”).
• You are prone to suffering from heart rhythm variations (prolongation of the QT interval) or have a suspicion of congenital long QT syndrome or low potassium and magnesium levels (hypokalemia/hypomagnesemia).
• You suffer or have suffered from heart problems or have recently had a heart attack.
• You have a low resting heart rate and/or know you may have a decrease in salts as a result of intense and prolonged diarrhea and vomiting (feeling dizzy) or due to the use of diuretics.
• You experience a fast or irregular heartbeat, fainting, syncope, or dizziness when standing up, which may indicate abnormal heart function.
• You are at risk of having low sodium levels in the blood (hyponatremia), e.g., due to concomitant medications and cirrhosis. During treatment with citalopram, hyponatremia associated with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) has been rarely reported, especially in elderly patients.
• You have diabetes. You may need to adjust your antidiabetic treatment.
• You have epilepsy. Treatment should be discontinued in case of seizures. Contact your doctor.
• You have a bleeding disorder, e.g., gynecological or gastric bleeding, or if you are using medicines 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.
• At the start of treatment, you develop difficulty sleeping or excitement. Your doctor may adjust the dose.
• You are receiving electroconvulsive therapy.
• You have psychosis with depressive episodes, as psychotic symptoms may increase.
• You have or have had panic attacks.
• You have eye problems, such as certain types of glaucoma.
• You have severe kidney problems. The use of citalopram is not recommended in patients with severe kidney problems.
• You have liver failure. Your doctor must 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 may affect heart rhythm, e.g., antiarrhythmics Class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment especially halofantrine), certain antihistamines (astemizole, mizolastine). If you have any questions about this, consult your doctor.

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

• Desipramine (for depression). Desipramine levels in the blood may increase; a reduction in the dose of desipramine may be necessary.
• Metoprolol (e.g., for heart failure), flecainide, and propafenone (for treating irregular heart rhythm), other medicines for treating depression (clomipramine, nortriptyline), or medicines for treating psychosis (risperidone, thioridazine, haloperidol). These medicines may increase in the blood.
• Pimozide (an antipsychotic medicine). 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 changes increase the risk of suffering from a life-threatening heart rhythm disorder (prolonged QT, Torsades de Pointes).
• Medicines that lower the seizure threshold, e.g., other antidepressants (SSRIs), antipsychotic medicines (e.g., butyrophenones, thioxanthenes), mefloquine, bupropion, and tramadol (a pain reliever).

The following medicines may increase the serotonergic effect of citalopram and cause an increase in side effects:

• MAOIs (for depression or Parkinson's disease) (e.g., moclobemide and selegiline or linezolid, an antibiotic). You must not take citalopram with MAOIs, as they can cause serious or even fatal reactions (serotonin syndrome), with the exception of selegiline, not exceeding 10 mg/day. There must be a pause between treatments (see section “Do not take Citalopram Tarbis Farma”). Consult your doctor.
• Oxitriptan and tryptophan (serotonergic 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, e.g., omeprazole, esomeprazole, lansoprazole, fluconazole (used to treat fungal infections), ticlopidine, or fluvoxamine (another medicine for treating depression). The combination with citalopram may cause an increase in citalopram blood levels.

The following medicines increase the risk of bleeding:

• Warfarin and other anticoagulant medicines.
• Acetylsalicylic acid and other analgesic medicines of the NSAID type (e.g., ibuprofen).
• Dipyridamole and ticlopidine (for the heart).
• Atypical antipsychotics (for mental disorders).

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

Citalopram Tarbis Farma with food, drinks, and alcohol

Food does not affect the effect of citalopram. It is not recommended to consume alcohol simultaneously.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 treatment with 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 being treated with citalopram. When medicines like citalopram are taken during pregnancy, particularly in the last three months of pregnancy, there is an increased risk of the baby suffering from a serious condition called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe more rapidly and have a bluish appearance. These symptoms usually appear within the first 24 hours after the baby's birth. If this happens to your baby, you must contact your midwife and/or doctor immediately.

If you are taking citalopram during the last three months of pregnancy and up to the day of your child's birth, you may experience severe side effects or withdrawal symptoms, such as breathing difficulties, blue-tinged skin/lips, irregular breathing with pauses, temperature fluctuations, seizures, apathy, difficulty sleeping, difficulty feeding, vomiting, low blood sugar levels, stiff or flexible muscles, increased reflexes, tremors, extreme nervousness or agitation, irritability, constant crying, and drowsiness.

If your newborn baby suffers from 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 bleeding 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 child. If you are taking citalopram, inform your doctor before starting breastfeeding.

Fertility

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

Driving and using machines

Citalopram has a mild to moderate influence on the ability to drive and use machines. Do not drive or use machines until you know how this medicine affects you. Normally, citalopram does not affect the ability to perform daily activities. However, if you feel dizzy or sleepy when you start taking this medicine, 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 these 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 some sugars, consult them before taking this medicine.

3. How to take Citalopram Tarbis Farma

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

Keep in mind that it may take between 2-4 weeks before you notice an improvement. Treatment should continue until you no longer notice symptoms for 4-6 months. When you are going to interrupt treatment with citalopram, you should gradually reduce the dose 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, other more suitable doses of this medication are available.

How much to take

Adults:

Depression

The recommended dose is 20 mg per day. 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 during the first week before increasing it to 20-30 mg per day. Your doctor may increase this dose up to a maximum of 40 mg per day. The complete therapeutic response may take up to 3 months.

Elderly patients (over 65 years):

Depression and anxiety disorder

Treatment should be started with half the recommended dose, e.g., 10-20 mg per day. Normally, elderly patients should not take more than 20 mg per day.

Use in children and adolescents under 18 years:

Normally, citalopram should not be used in children and adolescents under 18 years (see "Warnings and precautions").

Liver failure:

The normal starting dose is 10 mg once a day. Patients with liver disease should not take more than 20 mg per day.

Kidney failure

It may be necessary to adjust the dose. 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 prospectus or more than your doctor has prescribed, contact your doctor, emergency service, or pharmacy. Some of the symptoms of overdose can be life-threatening.

Depending on the dose ingested, citalopram overdose manifests with ailments such as irregular heartbeat, seizures, changes in heart rhythm (faster or slower heartbeat), 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, bluish 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 make up for forgotten doses.

If you interrupt treatment with Citalopram Tarbis Farma

Abrupt interruption should be avoided. When interrupting treatment with citalopram, the dose should be gradually reduced over a period of at least 1-2 weeks to reduce the risk of withdrawal reactions. If unbearable symptoms appear after a dose reduction or after treatment interruption, it may be considered to resume the previously prescribed dose. Subsequently, your doctor may continue to decrease the dose, but at a more gradual pace.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

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

If you experience one or more of the following adverse effects, you should interrupt treatment with citalopram and contact your doctor or emergency service immediately.

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

• Severe skin itching (with raised bumps).

Rare adverse 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 can trigger a serious adverse effect. Consult your doctor.
• Hepatitis, jaundice.
• Seizures that you have suffered in the past become more frequent.

Very rare adverse 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 (hives) and edema. Cases related to swelling of the face, lips, and tongue can be life-threatening (angioedema).

Adverse effects with unknown frequency (cannot be estimated from available data)

• Suicidal thoughts and behaviors. Cases of suicidal ideas and behaviors have been reported during treatment with citalopram or shortly after treatment interruption (see "Warnings and precautions"). Contact your doctor or emergency service.
• Severe heart rhythm disorders 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 blood and/or black stools due to bleeding in the stomach and intestine), and uterine bleeding.
• Rapid and irregular heartbeat, fainting that could be a symptom of a potentially fatal disease called Torsade de Pointes.
• Having seizures for the first time.

The following adverse effects have also been reported:

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

• Palpitations, agitation, increased sweating.
• Lethargy (urge to sleep), drowsiness, weakness, and fragility.
• Difficulty sleeping.
• Restless agitation, nervousness.
• Dizziness.
• Blurred vision (difficulty reading small print).
• Dry mouth that can increase the risk of cavities – you should therefore brush your teeth more frequently than usual while being treated with citalopram.
• Nausea, constipation.
• Headache.

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

• Decreased appetite, weight loss, increased appetite, altered taste.
• Diarrhea, vomiting, gastric discomfort (including acid reflux and heartburn), stomach pain, flatulence, increased salivation.
• High blood pressure. Inform your doctor. High blood pressure should be treated. Severely increased blood pressure is serious.
• Dizziness and possibility of fainting (probably only when standing up) due to low blood pressure.
• Low blood pressure.
• Fever.
• Feeling of tingling, numbness, or tingling of the skin.
• Fatigue, difficulty breathing, strange dreams.
• Migraine, ringing in the ears (tinnitus).
• Visual disturbance.
• Runny nose, sinusitis, yawning.
• Difficulty urinating.
• Itching, rash.
• Muscle and joint pain.
• Ejaculation problems, impotence (erectile dysfunction).
• Menstrual pain, difficulty having an orgasm.
• Decreased libido.
• Anxiety, confusion, indifference.
• Altered concentration, attention disorder, strange dreams, memory loss.
• Excessive urine production (polyuria).

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

• Hallucinations, can be serious. Contact your doctor or emergency service.
• Fainting.
• Seizures.
• Movement disorder and involuntary movements.
• Dilated pupils.
• Cough.
• Difficulty urinating, possibly urinary retention. It can be or become serious. Consult your doctor.
• Edema (fluid retention).
• Hair loss.
• Urticaria, pruriginous rash, rash, increased skin sensitivity to light (photosensitivity).
• Small skin and mucous membrane bleeding (purpura).
• Intense and unusual menstrual bleeding.
• Aggression (threat, possibly violent behavior), feeling of unreality or strangeness towards your own person.
• Pathological euphoria (mania).
• Euphoria.
• Increased libido.
• Anorexia.
• Discomfort.
• Weight gain.
• Slower heartbeats.

Rare adverse 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 adverse effects (may affect up to 1 in 10,000 people)

• Milk flow.

Adverse effects with unknown frequency (cannot be estimated from available data)

• Weakness, limited muscle strength, irregular and abnormal heart rhythm due to low potassium levels in the blood (hypokalemia). In some patients, this can lead to a serious adverse effect. Inform your doctor.
• Nosebleeds.
• Blood spots under the skin.
• Irregular and intense menstrual bleeding.
• Persistent and painful erections. Contact your doctor or emergency service as soon as possible.
• Panic attack.
• Teeth grinding.
• An increased risk of bone fractures has been observed in patients taking this type of medication.
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information.

In addition, citalopram may cause adverse effects that you will not normally notice. These are changes in certain laboratory test results, such as liver counts, which normalize once treatment is stopped.

Reporting 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 Medicines Surveillance System website: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Citalopram Tarbis Farma

Keep this medication out of 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 storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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:

Core of the tablet: 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 package contents

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 side and "H" on the other.

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

Only some package sizes may be marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medication 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 film-coated tablets

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 film-coated tablets

Date of the last revision of this prospectus: August 2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/