CITALOPRAM AUROVITAS 30 mg FILM-COATED TABLETS

2. What you need to know before you take Citalopram Aurovitas

Do not take Citalopram Aurovitas

• 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 inhibitor – 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 “Other medicines and Citalopram Aurovitas”).
• If you have taken irreversible MAOIs within the last two weeks or if you have taken reversible MAOIs (RIMAs) within the prescribed period in their corresponding summary of product characteristics (see “Other medicines and Citalopram Aurovitas”).
• If you stop taking citalopram and want to start using MAOIs, you must wait at least 7 days (see “Other medicines and Citalopram Aurovitas”).

• 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 “Other medicines and Citalopram Aurovitas” below.

Warnings and precautions

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

Some medicines in the group to which Citalopram Aurovitas belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (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 can 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 likely to have these types of 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 inform a close relative or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety has gotten 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 Aurovitas” and “Possible side effects”). These are common when treatment is stopped. 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. They may ask you to start taking your tablets again and taper them 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 a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines.

Despite this, 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 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 get worse 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.

Consult your doctor if:

• You start to develop fever, muscle stiffness, or tremors 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 “Other medicines and Citalopram Aurovitas”).
• You are taking serotonergic medicines such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan (see “Other medicines and Citalopram Aurovitas”).
• 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 heart problems or have recently had a heart attack.
• You have a low resting heart rate and/or know that 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, or are pregnant (see section Pregnancy and lactation and fertility) e.g., gynecological or gastric bleeding or if you are using medications that affect blood coagulation or increase the risk of bleeding (see “Other medicines and Citalopram Aurovitas”), 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 your 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 dosing regimen are recommended if you have severe liver problems.

Other medicines and Citalopram Aurovitas

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 antimicrobial agents (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 can 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 (QT prolongation, Torsades de Pointes).
• Medicines that decrease 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 adverse 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 produce severe 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 Aurovitas”). 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, lansoprazol, fluconazole (used to treat fungal infections), ticlopidine, or fluvoxamine (another medicine for treating depression). 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 anticoagulant medicines.
• Acetylsalicylic acid and other analgesic medicines of the NSAID type (non-steroidal anti-inflammatory drugs) (e.g., ibuprofen).
• Dipyridamole and ticlopidine (for the heart).
• Atypical antipsychotics (for mental disorders).

Some medicines may increase the side effects of Citalopram Aurovitas and may occasionally cause very severe reactions. Do not take any other medicine while taking Citalopram Aurovitas without consulting your doctor first, especially:

• medicines containing buprenorphine. These medicines may interact with Citalopram Aurovitas, and you may experience symptoms such as involuntary rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you suffer from these symptoms.

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

Citalopram Aurovitas 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take citalopram if you are pregnant or plan 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, the risk of suffering from a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN) may increase, 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, such as breathing difficulties, blue-tinged skin/lips, irregular breathing with breathing 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 Aurovitas in the final stage of pregnancy, there may be an increased risk of abundant 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 Aurovitas 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.

Male 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 drowsy when you start taking 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 if you can carry out the aforementioned activities.

Citalopram Aurovitas 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.

Citalopram Aurovitas contains sodium

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

3. How to take Citalopram Aurovitas

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

Note 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 for 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 full 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:

Citalopram should not normally be used in children and adolescents under 18 years (see "Warnings and precautions").

Hepatic impairment:

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

Renal impairment

Dose adjustment may be necessary. Follow your doctor's recommendations.

If you take more Citalopram Aurovitas 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 service, or pharmacy. Some of the symptoms of overdose can be life-threatening.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

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.

If you forget to take Citalopram Aurovitas

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Citalopram Aurovitas

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 slower rate.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side 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 as you start to feel better.

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

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 can trigger a serious side effect. Consult your doctor.
• Hepatitis, jaundice.
• Seizures that you have had in the past 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 (hives) and edema. Cases related to swelling of the face, lips, and tongue can be life-threatening (angioedema).

Side 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.
• Decrease in 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 side effects have also been reported:

Very common side 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 side 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 prickling of the skin.
• Fatigue, difficulty breathing, strange dreams.
• Migraine, ringing in the ears (tinnitus).
• Visual disturbance.
• Nasal discharge, sinusitis, yawning.
• Difficulty urinating.
• Itching, rash.
• Muscle and joint pain.
• Ejaculation disorders, 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 side 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, pruritic rash, rash, increased skin sensitivity to light (photosensitivity).
• Small bleeding on the skin and mucous membranes (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 heartbeats.

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.

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

• Weakness, limited muscle strength, tremulous and anomalous heart rhythm due to low potassium levels in the blood (hypokalemia). In some patients, this can lead to a serious side effect. Inform your doctor.
• Nosebleeds.
• Blood spots under the skin.
• Irregular and intense menstrual bleeding.
• Persistent and painful erection. Contact your doctor or emergency service as soon as possible.
• Increased blood levels of the hormone prolactin.
• Milk flow.
• 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 section Pregnancy, lactation, and fertility in section 2 for more information.

Additionally, citalopram may cause side 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 side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Citalopram Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the carton after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the SIGRE collection point in the pharmacy. 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 Aurovitas

• The active ingredient is citalopram. Each film-coated tablet contains 30 mg of citalopram (as citalopram hydrobromide).
• Other ingredients are:

Core of the tablet:lactose monohydrate, cornstarch, copovidone, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.

Tablet coating:hypromellose, macrogol 400, titanium dioxide (E171).

Appearance of the product and package contents

Film-coated tablets, white, biconvex, oval-shaped, marked with "J" on one side and with a scored line between "9" and "9" on the other side. The tablet can be divided into equal doses.

Citalopram Aurovitas film-coated tablets are available in blisters and in high-density polyethylene (HDPE) bottles.

Package sizes:

Blister: 10, 14, 20, 28, 30, 50, 56, 90, 98, and 100 tablets.

HDPE bottles: 100 and 250 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Citalopram PUREN 30 mg film-coated tablets

Spain: Citalopram Aurovitas 30 mg film-coated tablets EFG

Netherlands: Citalopram Aurobindo 30 mg film-coated tablets

Portugal: Citalopram Generis

Date of the last revision of this leaflet:March 2024

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