


Ask a doctor about a prescription for CITALOPRAM AUROVITAS 20 mg FILM-COATED TABLETS
Package Leaflet: Information for the Patient
Citalopram Aurovitas 20 mg Film-Coated Tablets EFG
citalopram hydrobromide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the pack
Citalopram Aurovitas belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). Citalopram is used in the treatment of:
Do not take Citalopram Aurovitas
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.
Thoughts of suicide 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, more.
You may be more likely to have these types of thoughts:
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 attitude.
Restlessness/difficulty staying still
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 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. They may ask you 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 a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, 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 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 must 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:
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, you should consult your doctor.
Citalopram may affect or be affected by other medicines. Some of these medicines are listed below:
The following medicines may increase the serotonergic effect of citalopram and cause an increase in adverse effects:
The following medicines increase the risk of bleeding:
Some medicines may increase the side effects of Citalopram Aurovitas and, in some cases, may cause very serious reactions. Do not take any other medicine while taking Citalopram Aurovitas without consulting your doctor first, especially:
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 serious 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, abnormally 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.
Fertility in men
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”.
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.
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 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:
Normally, citalopram should not 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 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.
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, dizziness, 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 doubts about the use of this medication, ask your doctor or pharmacist.
Like all medications, this medication can cause side effects, although not all people suffer from 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 when 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)
Rare side effects (may affect up to 1 in 1,000 people)
Very rare side effects (may affect up to 1 in 10,000 people)
Side effects with unknown frequency (cannot be estimated from available data)
The following side effects have also been reported:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Side effects with unknown frequency (cannot be estimated from available data)
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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Medication Pharmacovigilance 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.
Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.
Composition of Citalopram Aurovitas
Core of the tablet:lactose monohydrate, cornstarch, copovidone, croscarmellose sodium, microcrystalline cellulose, and magnesium stearate.
Coating of the tablet:hypromellose, macrogol 400, titanium dioxide (E171).
Appearance of the product and package contents
Film-coated tablets, white, biconvex, capsule-shaped, marked with "A" on one face and with a scored line between "0" and "6" 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.
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
O
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 with the following names:
Germany: Citalopram PUREN 20 mg Filmtabletten
Spain: Citalopram Aurovitas 20 mg film-coated tablets EFG
Malta: Citalopram Aurobindo 20 mg film-coated tablets
Netherlands: Citalopram Aurobindo 20 mg filmomhulde tabletten
Portugal: Citalopram Generis
Date of the last revision of this prospectus: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)
The average price of CITALOPRAM AUROVITAS 20 mg FILM-COATED TABLETS in November, 2025 is around 5.12 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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