Package Leaflet: Information for the Patient

Citalopram Aurovitas 30 mg Film-Coated Tablets EFG

Citalopram hydrobromide

Read this leaflet carefully before you start taking 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isCitalopram Aurovitasand what it is used for

2. What you need to know before takingCitalopram Aurovitas

3. How to takeCitalopram Aurovitas

4. Possible side effects

5. Storage ofCitalopram Aurovitas

6. Contents of the pack and additional information

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

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

Do not take Citalopram Aurovitas

• If you are allergic to citalopramor to any of the other ingredients of this medicine (listed in section 6).
• If you are taking monoamine oxidase (MAO) inhibitors:

• 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 your 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 “Other medicines and Citalopram Aurovitas”).
• If you have taken irreversible MAO inhibitors within the last two weeks or if you have taken reversible MAO inhibitors (RIMA) within the prescribed period in your corresponding leaflet (see “Other medicines and Citalopram Aurovitas”).
• If you stop taking citalopram and want to start using MAO inhibitors, you must wait for 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 see 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 ISRS/IRSN) 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 you first start taking antidepressants, 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 obtained from clinical trials has shown an increased risk of suicidal behavior in people under 25 years of age with psychiatric illnesses 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.

You may find it 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 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 that you follow exactly the instructions of your doctor 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 change of ideas, inappropriate happiness, and excessive physical activity, please contact your doctor.

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

When you stop taking citalopram, especially if you stop suddenly, you may experience withdrawal symptoms (see “How to take Citalopram Aurovitas” and “Possible side effects”). These are common when treatment is stopped. The risk is higher when citalopram has been used for a long time, 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 stopping treatment with citalopram, please contact your doctor. You can ask them to start you taking your tablets again and to stop them more gradually.

Children and adolescents under 18 years

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

Despite this, your doctor may prescribe citalopram to patients under 18 years if they decide what is best 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 doctorif 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 be life-threatening. Contact your doctor immediately, it may be necessary to discontinue the use of citalopram.
• You are taking preparations containing St. John's Wort (Hypericum perforatum,see “Other medicines and Citalopram Aurovitas”).
• You are taking serotoninergic medicines such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan (see “Other medicines and Citalopram Aurovitas”).
• You are prone to heart rhythm variations (prolongation of the QT interval) or have a suspicion of congenital long QT syndrome or low potassium and magnesium levels (hypopotasemia/hypomagnesemia).
• You have or have had heart problems or 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 by 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: by concomitant medications and cirrhosis. During treatment with citalopram, hyponatremia has been rarely reported, especially in elderly patients, associated with the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
• 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 the section Pregnancy and breastfeeding and fertility) for example: gynecological or gastrointestinal bleeding or if you are using medications that affect blood clotting or increase the risk of bleeding (see “Other medicines and Citalopram Aurovitas”), 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 renal impairment.
• 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.

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, 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 (astemizol, 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 reported.
• 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 alterations increase the risk of life-threatening heart rhythm abnormalities (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 (pain reliever).

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

• MAO inhibitors (for depression or Parkinson's disease) (for example: moclobemide and selegiline or linezolid, an antibiotic). Do not use citalopram concomitantly with MAO inhibitors, 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 Aurovitas”). 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.
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (for example: ibuprofen).
• Dipyridamole and ticlopidine (for the heart).
• Atypical antipsychotics (for mental disorders).

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

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

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

Citalopram Aurovitas 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 discontinue treatment.

Ensure that 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 serious condition in the baby, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe more rapidly and appear blue. 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/lips, irregular breathing with pauses, temperature fluctuations, seizures, 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 Aurovitas 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 Aurovitas to be able to advise you.

Breastfeeding

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

Fertility in men

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 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; it is essentially “sodium-free”.

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 before you 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 usual starting dose is 10 mg once a 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 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 services, or pharmacist. Some overdose symptoms may put your life at risk.

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 symptoms such as irregular heartbeat, convulsions, 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, blue skin, rapid breathing, cardiac arrest, coma.

If you forgot to take Citalopram Aurovitas

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

If you interrupt treatment with Citalopram Aurovitas

It should be avoided to interrupt treatment abruptly. 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 unbearable symptoms appear followed by a decrease in dose or after treatment interruption, it may be considered to resume the previously prescribed dose. 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 must interrupt treatment with Citalopram Aurovitas and contact your doctor or emergency services 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 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)

• Immediate 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 stopped (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.
• Severe decrease in 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.

Also, the following side effects have 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, gastrointestinal discomfort (including acid reflux and heartburn), stomach pain, flatulence, increased salivation.
• High blood pressure. Inform your doctor. High blood pressure should be treated. Severe hypertension 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 pain, 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.

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.
• Increased prolactin levels in the blood.
• Milk production.
• Panic attack.
• Grinding of teeth.
• A higher risk of bone fractures has been observed in patients taking this type of medication.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see section Pregnancy, lactation, and fertility in section 2 for more information.

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

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 them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://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 packaging after CAD. 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition ofCitalopram Aurovitas

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

Core tablet:lactose monohydrate, maize starch, copovidone, croscarmellose sodium, microcrystalline cellulose and magnesium stearate.

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

Appearance of the product and contents of the package

Film-coated tablets, white in color, biconvex, oval in shape, marked with “J” on one face and with a scored line between “9” and “9” on the other face. 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 & 100 tablets.

HDPE bottles: 100 & 250 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

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

Germany:CitalopramPUREN30 mg Filmtabletten

Spain:Citalopram Aurovitas30 mg film-coated tablets EFG

Netherlands:Citalopram Aurobindo 30 mgfilm-coated tablets

Portugal:Citalopram Generis

Last review date of this leaflet:March 2024

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