Citalopram Aurovitas 30 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Citalopram Aurovitas 30 mg film-coated tablets EFG

Citalopram hydrobromide

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Citalopram Aurovitas is and what it is used for
What you need to know before taking Citalopram Aurovitas
How to take Citalopram Aurovitas
Possible side effects
How to store Citalopram Aurovitas
Contents of the pack and other information

1. What Citalopram Aurovitas is and what it is used for

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

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

2. What you need to know before taking Citalopram Aurovitas

Do not take Citalopram Aurovitas

If you are allergic to citalopram or to 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 MAO inhibitor – linezolid (an antibiotic), unless under close monitoring and blood pressure surveillance.
Irreversible MAO inhibitor – selegiline (a medicine for Parkinson's disease), may 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 (RIMAs) within the period specified in their respective package leaflet (see “Other medicines and Citalopram Aurovitas”).
If you stop taking citalopram and wish to start using MAO inhibitors, 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 ECG; a test to assess heart function).
If you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm.

Also refer to the section “Other medicines and Citalopram Aurovitas” below.

Warnings and precautions

Talk to 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 may increase when first taking antidepressants, as all such medicines require time to become effective, usually about two weeks, but sometimes longer.

You may be more likely to experience such thoughts:

If you have previously had thoughts of self-harm or suicide.
If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

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

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

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. Contact 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 initial increase in anxiety at the beginning of treatment, which will disappear with continued treatment. Therefore, it is very important that you follow your doctor’s instructions exactly and do not stop treatment or change the dose without consulting your doctor.

Mania (hyperactive behaviour or thinking)

If you enter a manic phase characterised by unusually rapid and frequent changes of thought, inappropriate happiness, and excessive physical activity, please contact your doctor.

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

When stopping treatment with citalopram, especially if abruptly, you may experience 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, at high doses, or when the dose is reduced too quickly. Many people find that symptoms are mild and disappear on their own within two weeks. However, in some patients, symptoms may be severe or prolonged (2–3 months or more). If you experience severe withdrawal symptoms when stopping citalopram treatment, please contact your doctor. They may advise you to restart taking your tablets and taper off more gradually.

Children and adolescents under 18 years of age

Antidepressants should not normally be used in children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine.

Nevertheless, your doctor may prescribe citalopram to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed citalopram to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above progress or worsen while patients under 18 years of age are taking citalopram. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development of citalopram in this age group have not yet been established.

Talk to your doctor if:

You start developing fever, muscle stiffness, or tremor and extreme agitation; you may be experiencing what is known as serotonin syndrome. Although this syndrome is rare, it can be life-threatening. Contact your doctor immediately; discontinuation of citalopram may be necessary.
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 heart rhythm variations (QT interval prolongation) or suspect you have congenital long QT syndrome or low levels of potassium and magnesium (hypokalaemia/hypomagnesaemia).
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 salt depletion due to severe and prolonged diarrhoea and vomiting (feeling dizzy) or due to the use of diuretics.
You experience a fast or irregular heartbeat, fainting, syncope, or dizziness upon standing, which may indicate abnormal heart rate function.
You are at risk of low sodium levels in the blood (hyponatraemia), e.g., due to concomitant medicines and cirrhosis. Hyponatraemia associated with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) has rarely been reported during citalopram treatment, especially in elderly patients.
You have diabetes. You may need adjustment of 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 breastfeeding and fertility), e.g., gynaecological or gastric bleeding, or if you are taking medicines 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.
At the beginning 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 renal impairment.
You have hepatic insufficiency. Your doctor should monitor your liver function. Caution and extremely careful dosing 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.: Class IA and III antiarrhythmics, antipsychotics (e.g.: phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.: sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment especially halofantrine), certain antihistamines (astemizole, mizolastine). If you have any questions about this, you should consult your doctor.

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

Desipramine (for depression). Blood levels of desipramine may increase; a reduction in desipramine dose may be necessary.
Metoprolol (e.g.: for heart failure), flecainide and propafenone (to treat irregular heart rate), other medicines to treat depression (clomipramine, nortriptyline), or medicines to treat psychosis (risperidone, thioridazine, haloperidol). Increased blood levels of these medicines may be reported or are possible.
Pimozide (an antipsychotic medicine). Concomitant treatment with citalopram and pimozide is contraindicated due to the influence of this combination on cardiac function.
Medicines that reduce potassium and magnesium levels in blood, as these changes increase the risk of developing a life-threatening heart rhythm disturbance (QT prolongation, Torsades de Pointes).
Medicines that lower the seizure threshold, e.g.: other antidepressants (SSRIs), antipsychotic medicines (e.g.: butyrophenones, thioxanthenes), mefloquine, bupropion, and tramadol (analgesic).

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

MAO inhibitors (for depression or Parkinson’s disease) (e.g.: moclobemide and selegiline or linezolid, an antibiotic). You must not use citalopram concomitantly with MAO inhibitors, as serious or even fatal reactions (serotonin syndrome) may occur, except for selegiline at doses not exceeding 10 mg/day. There must be a washout period between treatments (see section “Do not take Citalopram Aurovitas”). Consult your doctor.
Oxitriptan and tryptophan (serotonergic precursors).
Lithium (for mental disorders).
Sumatriptan and other triptans (for migraines).
Tramadol (for severe pain).
St. John’s wort (Hypericum perforatum).
Cimetidine (for stomach problems) and other medicines to treat stomach ulcers, e.g.: omeprazole, esomeprazole, lansoprazole, fluconazole (used to treat fungal infections), ticlopidine, or fluvoxamine (another medicine for treating depression). Combination with citalopram may cause increased blood levels of citalopram.

The following medicines increase the risk of bleeding:

Warfarin and other anticoagulant medicines.
Acetylsalicylic acid and other analgesic NSAIDs (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 occasionally may cause very serious 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 rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38 °C. Contact your doctor if you experience these symptoms.

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

Citalopram Aurovitas with food, drinks and alcohol

Food does not affect the action of citalopram. Alcohol consumption is not recommended.

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 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 wish to stop or discontinue treatment.

Ensure your midwife and/or doctor knows you are being treated with citalopram. When medicines such as citalopram are taken during pregnancy, particularly during the last three months, there may be an increased risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually appear within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take citalopram during the last three months of pregnancy up to the day of your child’s birth, your newborn may experience serious adverse effects or withdrawal symptoms such as breathing difficulties, blue skin/lips, irregular breathing with breathing pauses, temperature fluctuations, seizures, lethargy, difficulty sleeping, feeding difficulties, vomiting, low blood sugar, rigid or floppy muscles, abnormally increased reflexes, tremors, extreme nervousness or nervous agitation, irritability, constant crying, and drowsiness.

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 late 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 be aware that you are taking Citalopram Aurovitas so they can advise you appropriately.

Breastfeeding

Citalopram is excreted in breast milk in small amounts. There is a risk of effects on the infant. 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, 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 operate machinery until you know how this medicine affects you. Normally, citalopram does not affect the ability to perform normal daily activities. However, if you feel dizzy or drowsy when starting this medicine, you should be cautious when driving, operating machinery, or performing tasks requiring alertness until these effects subside. If you are unsure, consult your doctor about whether you can carry out the activities mentioned above.

Citalopram Aurovitas contains lactose

This medicine contains lactose. If your doctor has informed 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 exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Please note that it may take 2–4 weeks before you notice improvement. Treatment should continue until you have been symptom-free for 4–6 months. When you are going to stop treatment with citalopram, the dose should be gradually reduced over a period of at least 1–2 weeks.

Take citalopram once daily, either in the morning or in the afternoon. Drink a glass of water with this medicine; it may be taken with or without food. For dosages that cannot be achieved with this strength, other more suitable strengths of this medicine are available.

How much to take

Adults:

Depression

The recommended dose is 20 mg daily. Your doctor may increase this dose up to a maximum of 40 mg daily.

Panic disorder

The initial dose is 10 mg daily for the first week, before increasing to 20–30 mg daily. Your doctor may increase this dose up to a maximum of 40 mg daily. Full therapeutic response may take up to 3 months.

Elderly patients (over 65 years of age):

Depression and panic disorder

Treatment should be initiated at half the recommended dose, e.g.: 10–20 mg daily. Elderly patients should generally not take more than 20 mg daily.

Use in children and adolescents under 18 years of age:

Citalopram is generally not recommended for use in children and adolescents under 18 years of age (see "Warnings and precautions").

Hepatic impairment:

The usual starting dose is 10 mg once daily. Patients with liver disease should not take more than 20 mg daily.

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 prescribed by your doctor, contact your doctor, emergency services, or pharmacist immediately. Some symptoms of overdose may be life-threatening.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount taken.

Depending on the dose ingested, citalopram overdose may cause symptoms such as irregular heartbeat, seizures, changes in heart rhythm (faster or slower heartbeat), dizziness (nausea), vomiting, sweating, drowsiness, loss of consciousness, tremor, changes in blood pressure (which may increase or decrease), serotonin syndrome (see section 4), agitation, vertigo, dilated pupils, bluish skin, abnormally 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 stop taking Citalopram Aurovitas

Abrupt discontinuation should be avoided. When stopping 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 intolerable symptoms occur following dose reduction or after stopping treatment, resumption of the previously prescribed dose may be considered. Subsequently, your doctor may continue to reduce the dose, but at a slower rate.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 resolve as you start to feel better.

If you experience one or more of the following adverse effects, you must stop treatment with Citalopram Aurovitas and contact your doctor or emergency services immediately.

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

Intense itching of the skin (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 levels of sodium in the blood. In some patients, this may trigger a serious adverse effect. Consult your doctor.
Hepatitis, jaundice.
Past seizures 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, breathing difficulty, dizziness and fainting (anaphylactic reaction).
Rash (hives) and swelling. Cases involving swelling of the face, lips, and tongue may be life-threatening (angioedema).

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

Suicidal thoughts and behaviours. Cases of suicidal ideation and behaviour have been reported during treatment with citalopram or shortly after discontinuation of treatment (see “Warnings and precautions”). Contact your doctor or emergency services.
Severe disturbances in heart rhythm 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 as a result of bleeding in the stomach and intestines), and uterine bleeding.
Rapid and irregular heartbeat, fainting which could be symptoms of a potentially life-threatening condition called Torsade de Pointes.
New onset of seizures.

The following adverse effects have also been reported:

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

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

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

Decreased appetite, weight loss, increased appetite, altered taste.
Diarrhoea, vomiting, gastric discomfort (including acid reflux and heartburn), stomach pain, flatulence, increased salivation.
High blood pressure. Inform your doctor. High blood pressure must be treated. Severely elevated blood pressure is serious.
Dizziness and possible fainting (likely upon standing) due to low blood pressure.
Low blood pressure.
Fever.
Sensation of tingling, prickling or numbness of the skin.
Fatigue, difficulty breathing, unusual 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 achieving orgasm.
Reduced libido.
Anxiety, confusion, indifference.
Impaired concentration, attention disorder, unusual dreams, memory loss.
Excessive urine production (polyuria).

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

Hallucinations, which may be severe. Contact your doctor or emergency services.
Fainting.
Seizures.
Movement disorders and involuntary movements.
Dilated pupils.
Cough.
Difficulty urinating, possibly urinary retention. This may be or become serious. Consult your doctor.
Oedema (fluid retention).
Hair loss.
Hives, itchy rash, rash, increased skin sensitivity to light (photosensitivity).
Small bleedings on the skin and mucous membranes (purpura).
Heavy and unusual menstrual bleeding.
Aggression (threatening, possibly violent behaviour), feeling of unreality or detachment from oneself.
Pathological euphoria (mania).
Euphoria.
Increased libido.
Anorexia.
Malaise.
Weight gain.
Slower heartbeats.

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

Involuntary movements.
Bleeding (e.g., gynaecological bleeding, gastrointestinal bleeding, bruising and other forms of skin bleeding or bleeding from mucous membranes).
Inability to remain still. Restless legs.

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

Weakness, limited muscle strength, tremulous and abnormal heart rhythm due to low levels of potassium in the blood (hypokalaemia). In some patients, this may lead to a serious adverse effect. Inform your doctor.
Nosebleeds.
Blood spots under the skin.
Irregular and heavy menstrual bleeding.
Persistent and painful erection. Contact your doctor or emergency services as soon as possible.
Increased blood levels of the hormone prolactin.
Breast milk production.
Panic attack.
Teeth grinding.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section Pregnancy, breastfeeding and fertility in section 2 for more information.

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalopram Aurovitas

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citalopram Aurovitas

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

Tablet core: lactose monohydrate, corn starch, copovidone, sodium croscarmellose, microcrystalline cellulose and magnesium stearate.

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

Appearance of the product and contents of the pack

Film-coated tablets, white in colour, biconvex and oval-shaped, marked with “J” on one side and a score 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.

Pack sizes:

Blisters: 10, 14, 20, 28, 30, 50, 56, 90, 98 & 100 tablets.

HDPE bottles: 100 & 250 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

Generis Farmacêutica, S.A.

Rua João de Deus, 19

Amadora 2700-487

Portugal

This medicinal product is authorised in the Member States of the European Economic Area (EEA) under the following names:

Germany: Citalopram PUREN 30 mg Filmtabletten

Spain: Citalopram Aurovitas 30 mg film-coated tablets EFG

Netherlands: Citalopram Aurobindo 30 mg filmomhulde tabletten

Portugal: Citalopram Generis

Date of the latest revision of this leaflet: March 2024

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