Citalopram Aurobindo Italia: detailed information

Patient Information Leaflet

Citalopram Aurobindo Italia 20 mg film-coated tablets, 40 mg film-coated tablets

Equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Citalopram Aurobindo Italia is and what it is used for

Citalopram Aurobindo Italia contains the active substance citalopram, which belongs to a class of
antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs), which act by
regulating mood.
This medicinal product is indicated for the treatment of the following disorders:

depression (endogenous depressive syndromes);
prevention of relapses and recurrent episodes of depression;
panic attacks (anxiety disorders with panic attacks), including those caused by fear of open spaces (agoraphobia).

2. What you need to know before taking Citalopram Aurobindo Italia

Do not take Citalopram Aurobindo Italia:

if you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6);
if the person taking the medicine is a child or adolescent under 18 years of age;
if you are taking other medicines belonging to a group of medicines called monoamine oxidase inhibitors (MAOIs). These medicines include selegiline, a selective MAOI used in Parkinson’s disease, linezolid, a reversible (non-selective) MAOI, a medicine used to treat infections, and moclobemide (type IA selective), used in the treatment of depression;
if you are taking an irreversible MAOI, take Citalopram Aurobindo Italia at least 14 days after stopping treatment with such medicine. If you are taking a reversible MAOI (RIMA), take Citalopram Aurobindo Italia after stopping treatment with the RIMA for the time specified in the package leaflet of that medicine;
if you are to start therapy with an MAOI, wait at least 7 days after stopping treatment with Citalopram Aurobindo Italia;
if you are to take selegiline together with Citalopram Aurobindo Italia, the maximum recommended dose of selegiline is 10 mg per day;
if you suffer from a heart rhythm disorder or have been diagnosed with QT interval prolongation or congenital long QT syndrome;
if you are taking medicines that may prolong the QT interval (see section “Other medicines and Citalopram Aurobindo Italia”);
if you are taking pimozide, used to treat certain mental disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Aurobindo Italia.
Take this medicine with caution and inform your doctor in the following cases:

if you are elderly or suffer from kidney or liver problems. In these cases, your doctor will adjust the dose of the medicine (see section 3);
if you suffer from panic attacks, as you may experience severe anxiety at the beginning of treatment (paradoxical anxiety);
if you have low levels of sodium in the blood (hyponatremia);
if you suffer from bipolar disorder (manic-depressive illness), as during treatment with Citalopram Aurobindo Italia you may experience a shift into the manic phase, characterized by rapid and unusual changes in thinking, physical hyperactivity and excitement. In this case, stop treatment;
if you suffer from epilepsy;
if you suffer from diabetes;
if you have a coagulation disorder and are at risk of bleeding (hemorrhage), and if you are taking medicines that worsen these problems (see section “Other medicines and Citalopram Aurobindo Italia”);
if you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
if you are undergoing electroconvulsive therapy (electroshock);
if you are taking products containing St. John’s wort ( Hypericum perforatum );
if you suffer or have suffered from heart problems (bradycardia, uncompensated heart failure) or have recently had a heart attack (acute myocardial infarction);
if you have low levels of potassium or magnesium in the blood (hypokalemia or hypomagnesemia). In such cases, your doctor will correct these abnormalities before starting treatment with this medicine;
if you or someone in your family has an eye condition (closed-angle glaucoma);
if you suffer from psychotic depression;
if you are taking medicines containing buprenorphine. Using these medicines together with Citalopram Aurobindo Italia may lead to serotonin syndrome, which can be fatal (see “Other medicines and Citalopram Aurobindo Italia”).

Medicines such as Citalopram Aurobindo Italia, the so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
During the first weeks or the weeks immediately following the start of treatment, whether you suffer from depression or other mental health conditions (psychiatric disorders), you may have thoughts of harming yourself or of suicide. For this reason, your doctor must monitor you closely, especially at the beginning of treatment or when the dose is increased, if you have previously experienced such symptoms, or if you are young (under 25 years of age). Inform your doctor immediately if you experience these symptoms or if someone caring for you notices changes in your behaviour.
It may be helpful to inform a relative or close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behaviour.
Within the first weeks of treatment, you may experience akathisia, characterized by restlessness, distress, a need to move frequently accompanied by an inability to sit still or remain motionless. If you experience these symptoms, contact your doctor immediately.
Stop treatment with this medicine immediately and inform your doctor if you experience agitation, tremor, involuntary muscle contractions (myoclonus), or increased body temperature (hyperthermia). These may be symptoms of a condition called serotonin syndrome.
Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age. However, your doctor may prescribe Citalopram Aurobindo Italia to patients under 18 years of age if they consider this to be the best option for them. In such cases, the child or adolescent must be closely monitored, and you should inform the doctor if symptoms such as suicide attempts, suicidal ideation, or hostility appear or worsen during treatment with Citalopram Aurobindo Italia.
Other medicines and Citalopram Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can alter the effect of other medicines, and this may sometimes cause serious adverse reactions.
Tell your doctor , in particular, if you are taking the following medicines:

medicines called monoamine oxidase inhibitors (MAOIs), because serious, even fatal, adverse effects may occur, including serotonin syndrome (see sections “Warnings and precautions” and “Possible side effects”). These medicines include selegiline, a selective MAOI used in Parkinson’s disease, linezolid, a reversible (non-selective) MAOI, a medicine used to treat infections, and moclobemide (type IA selective), used in the treatment of depression;
if you are taking an irreversible MAOI, take Citalopram Aurobindo Italia at least 14 days after stopping treatment with such medicine. If you are taking a reversible MAOI (RIMA), take Citalopram Aurobindo Italia after stopping treatment with the RIMA for the time specified in the package leaflet of that medicine;
if you are to start therapy with an MAOI, wait at least 7 days after stopping treatment with Citalopram Aurobindo Italia;
if you are to take selegiline together with Citalopram Aurobindo Italia, the maximum recommended dose of selegiline is 10 mg per day;
buspirone, a medicine used in the treatment of anxiety, due to the risk of serotonin syndrome;
class IA and III antiarrhythmics, medicines used for heart rhythm disorders, due to the risk of QT interval prolongation on the electrocardiogram;
medicines used to treat mental disorders (antipsychotics), due to the risk of QT interval prolongation on the electrocardiogram (e.g. phenothiazine derivatives, haloperidol and pimozide, which must not be taken with Citalopram Aurobindo Italia), due to the risk of lowered seizure threshold (e.g. phenothiazines, thioxanthenes and butyrophenones), and because they may increase the risk of bleeding (e.g. atypical antipsychotics and phenothiazines);
other medicines used to treat depression (antidepressants), due to the risk of QT interval prolongation on the electrocardiogram, lowered seizure threshold, and increased risk of bleeding;
antimicrobials (medicines used to treat infections) such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, due to the risk of QT interval prolongation on the electrocardiogram;
sumatriptan and similar medicines, used to treat headache (migraine), due to the risk of enhanced serotonergic effect;
tramadol, used to treat pain, due to the risk of enhanced serotonergic effect and lowered seizure threshold;
lithium and tryptophan, used to treat certain mental disorders, due to the risk of enhanced serotonergic effect;
products containing St. John’s wort (Hypericum perforatum), used for depression, as they increase the risk of adverse effects;
fluconazole, used to treat fungal infections;
medicines used to thin the blood such as dipyridamole (anticoagulants) and ticlopidine (antiplatelet agents), because they may increase the risk of bleeding;
medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid, because they may increase the risk of bleeding;
medicines that reduce potassium or magnesium levels in the blood (which may cause hypokalemia/hypomagnesemia, conditions that increase the risk of arrhythmias), cimetidine, omeprazole, esomeprazole and lansoprazole, used to treat stomach problems, because a dose adjustment of Citalopram Aurobindo Italia may be necessary. This may also occur with other medicines such as the antidepressant fluvoxamine and the antiplatelet agent ticlopidine;
medicines such as flecainide, propafenone and metoprolol (used to treat heart problems), antidepressants such as desipramine, clomipramine and nortriptyline, or antipsychotics such as risperidone, thioridazine and haloperidol, because a dose adjustment of these medicines may be necessary. Some medicines may intensify the adverse effects of Citalopram Aurobindo Italia and sometimes cause very serious reactions. Do not take other medicines during treatment with Citalopram Aurobindo Italia without first consulting your doctor, in particular:
Medicines containing buprenorphine. These medicines may interact with Citalopram Aurobindo Italia and may cause symptoms such as rhythmic, involuntary muscle contractions, including those controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38 °C. Contact your doctor if you experience such symptoms.

Citalopram Aurobindo Italia and alcohol
Do not drink alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Citalopram Aurobindo Italia must not be used during pregnancy or breastfeeding unless strictly necessary, and only after careful evaluation of risks and benefits by your doctor.
Ensure that your midwife and/or doctor know that you are being treated with Citalopram Aurobindo Italia.
If you have taken this medicine during the later stages of pregnancy, particularly in the third trimester, your baby may experience breathing difficulties, apnea, bluish skin color (cyanosis), seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar levels (hypoglycemia), changes in muscle tone (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, nervousness, irritability, lethargy, persistent crying, drowsiness, and sleep disturbances.
When taken during pregnancy, particularly during the last three months, medicines such as Citalopram Aurobindo Italia may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Citalopram Aurobindo Italia near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Citalopram Aurobindo Italia so they can advise you on what to do.
If you take this medicine during pregnancy, avoid abruptly stopping treatment (see section “If you stop taking Citalopram Aurobindo Italia”).
Breastfeeding
If you are breastfeeding, take this medicine with caution because citalopram passes into breast milk.
Male fertility
Citalopram has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed (see section “Possible side effects”).
Driving and using machines
This medicine may impair your ability to drive or use machinery because it may reduce your judgment and reactivity in dangerous situations. Therefore, exercise caution before driving or operating machinery.
Citalopram Aurobindo Italia contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Citalopram Aurobindo Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Citalopram Aurobindo Italia may be taken with or without food.
Do not stop treatment with Citalopram Aurobindo Italia abruptly to avoid withdrawal symptoms (see the section “If you stop taking Citalopram Aurobindo Italia”).
Your doctor will adjust the dose according to your needs. Do not change the dose without consulting your
doctor (see the section “If you stop taking Citalopram Aurobindo Italia”).

Treatment of depression: the recommended dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg once daily, depending on your response to treatment. The effect of the medicine usually appears within 2–4 weeks after starting treatment, which should be continued for at least 4–6 months to prevent relapse of symptoms in bipolar disorders. If you suffer from recurrent unipolar depression, maintenance treatment should be continued for longer periods to prevent relapses.
Treatment of panic attacks (panic disorder): the recommended initial dose is 10 mg once daily for the first week of treatment. Afterwards, your doctor may increase the dose to 20 mg once daily, up to a maximum of 40 mg once daily depending on your response to treatment. If you suffer from anxiety and experience panic attacks, treatment should be continued for a long duration (1 year). If you have insomnia or are highly agitated, your doctor may also prescribe sedative medicines.

Use in elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose to 10–20 mg daily.
The maximum recommended dose is 20 mg daily.
Use in patients with liver problems (hepatic impairment)
If you have mild or moderate liver problems (mild or moderate hepatic impairment), the recommended initial dose is 10 mg daily for the first 2 weeks. Afterwards, your doctor may increase the dose up to a maximum of 20 mg daily depending on your response to treatment.
If you have severe liver problems (severely reduced liver function), your doctor may decide to reduce the dose.
Use in patients with kidney problems (renal impairment)
If you have kidney problems (renal impairment), your doctor will prescribe the lowest recommended dose.
Use in patients with impaired drug metabolism (CYP2C19 poor metabolisers)
If you have impaired drug metabolism (poor metaboliser of CYP2C19), the recommended initial dose is 10 mg daily for the first two weeks of treatment.
Thereafter, your doctor may increase the dose up to a maximum of 20 mg daily depending on your response to treatment.
If you take more Citalopram Aurobindo Italia than you should
If you (or someone else) have taken an excessive dose of Citalopram Aurobindo Italia, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (QT interval prolongation, torsades de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (high fever, tremors, muscle contractions and anxiety), agitation, reduced heart rate (bradycardia), dizziness, conduction block in the heart, changes in heart activity (QRS prolongation), increased blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis), fatigue, weakness, sedation.
If you forget to take Citalopram Aurobindo Italia
Do not take a double dose to make up for the forgotten dose.
If you stop taking Citalopram Aurobindo Italia
Do not stop treatment with Citalopram Aurobindo Italia suddenly or without first discussing it with your doctor. When stopping treatment with this medicine, the following withdrawal symptoms may occur:

dizziness, sensory disturbances such as tingling sensations in arms and legs (paraesthesiae);
sleep disturbances such as difficulty falling asleep (insomnia) and vivid dreams;
agitation or anxiety, tremors, confusion;
nausea and/or vomiting, diarrhoea;
sweating, headache;
increased awareness of heartbeats (palpitations);
emotional lability, irritability;
visual disturbances.

These symptoms are usually mild to moderate and resolve spontaneously within 2 weeks, although sometimes they may be severe and last much longer (2–3 months or more).

Discontinuation of treatment should be done under medical supervision, with doses gradually reduced over a period of at least 1–2 weeks.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects mainly occur during the first or second week of treatment and then usually disappear.
If during treatment you think about harming yourself or have thoughts of suicide, contact your doctor immediately and stop taking the medicine.

The following side effects may occur:

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

drowsiness, difficulty sleeping (insomnia), headache;
dry mouth, nausea;
excessive sweating.

Common (may affect up to 1 in 10 people):

decreased appetite, weight loss;
agitation, reduced sex drive (libido), anxiety, restlessness, confusion (confusional state), abnormal orgasm in women, abnormal dreams (dream disturbances);
tremor, tingling sensations in arms and legs (paraesthesia), dizziness, attention disturbances;
perception of ringing in the ear (tinnitus);
yawning;
diarrhoea, vomiting, constipation;
itching;
muscle pain (myalgia) and joint pain (arthralgia);
sexual disorders in men (impotence, ejaculation disorders, failure to ejaculate);
fatigue.

Uncommon (may affect up to 1 in 100 people):

increased appetite, weight gain;
aggression, feeling detached from oneself (depersonalization), hallucinations, mania;
temporary loss of consciousness (syncope);
dilation of the pupil (mydriasis);
decrease/increase in heart rate (bradycardia/tachycardia);
skin irritation (urticaria, rash), hair loss (alopecia), development of red skin spots and bleeding (purpura), skin reactions caused by exposure to sunlight (photosensitivity reaction);
difficulty urinating (urinary retention);
prolonged and heavy menstrual bleeding in women (menorrhagia);
swelling due to fluid accumulation (oedema).

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

reduction in sodium levels in the blood (hyponatraemia);
seizures (grand mal), involuntary movements (dyskinesia), taste disturbances;
bleeding (haemorrhage);
inflammation of the liver (hepatitis);
fever (pyrexia).

Frequency not known (frequency cannot be estimated from the available data):

reduction in the number of platelets in the blood (thrombocytopenia);
allergic reactions, including severe reactions (anaphylactic reaction);
inappropriate production of antidiuretic hormone (ADH) which regulates urine production;
reduction in potassium levels in the blood (hypokalaemia);
panic attacks, restlessness;
teeth grinding (bruxism);
suicidal thoughts (suicidal ideation), suicidal behaviour;
seizures, serotonin syndrome (high fever, tremors, muscle contractions and anxiety), extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and contractions, feeling of restlessness and inability to remain still even for a very short time (akathisia), movement disorders;
vision disturbances;
disturbances in heart rhythm (prolongation of QT interval, ventricular arrhythmias, including torsade de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or who already suffer from heart disorders (pre-existing QT interval prolongation or other cardiac diseases);
dizziness upon standing quickly due to a drop in blood pressure (orthostatic hypotension);
nosebleeds (epistaxis);
bleeding with stools (gastrointestinal or rectal haemorrhage);
abnormal liver function laboratory tests;
bruising (ecchymosis), swelling mainly of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema);
irregular menstrual bleeding in women (metrorrhagia);
prolonged and painful erection (priapism), sudden milk production from the breast (galactorrhoea) in men;
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information.

An increased risk of fractures has been reported following the use of this type of medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after "Exp".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Citalopram Aurobindo Italia contains
Citalopram Aurobindo Italia 20 mg film-coated tablets

The active substance is citalopram hydrobromide. Each tablet contains 24.98 mg of citalopram hydrobromide, equivalent to 20 mg of citalopram.
The other components are: maize starch, lactose monohydrate, microcrystalline cellulose, copovidone, glycerol, sodium croscarmellose, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol 400.

Citalopram Aurobindo Italia 40 mg film-coated tablets

The active substance is citalopram hydrobromide. Each tablet contains 49.96 mg of citalopram hydrobromide, equivalent to 40 mg of citalopram.
The other components are: maize starch, lactose monohydrate, microcrystalline cellulose, copovidone, glycerol, sodium croscarmellose, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol 400.

Description of the appearance of Citalopram Aurobindo Italia and contents of the pack
Film-coated, divisible tablets.
20 mg: Pack containing 28 film-coated, divisible tablets in Al/PVC/PVDC opaque aluminium blisters.
40 mg: Pack containing 14 film-coated, divisible tablets in Al/PVC/PVDC opaque aluminium blisters.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102, 21047 Saronno (VA)

Manufacturers
Special Product’s Line S.p.A. - Via Campobello, 15 - 00040 Pomezia (Rome) [only for 40 mg tablets]
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) [only for 20 mg tablets]

Package leaflet: Information for the patient

Citalopram Aurobindo Italia 40 mg/ml oral drops, solution

Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Citalopram Aurobindo Italia is and what it is used for
What you need to know before taking Citalopram Aurobindo Italia
How to take Citalopram Aurobindo Italia
Possible side effects
How to store Citalopram Aurobindo Italia
Package contents and other information

1. What Citalopram Aurobindo Italia is and what it is used for

Citalopram Aurobindo Italia contains the active substance citalopram, which belongs to a class of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs), which work by regulating mood.
This medicinal product is indicated for the treatment of the following disorders:

depression (endogenous depressive syndromes);
prevention of relapses and recurrent episodes of depression;
panic attacks (anxiety disorders with panic episodes), including those caused by fear of open spaces (agoraphobia).

2. What you should know before taking Citalopram Aurobindo Italia

Do not take Citalopram Aurobindo Italia:

if you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6);
if the person taking the medicine is a child or adolescent under 18 years of age;
if you are taking other medicines belonging to a group of medicines called monoamine oxidase inhibitors (MAOIs). These medicines include selegiline, a selective MAOI used in Parkinson’s disease, linezolid, a reversible (non-selective) MAOI used to treat infections, and moclobemide (selective for type IA), used in the treatment of depression;
if you are taking an irreversible MAOI, take Citalopram Aurobindo Italia at least 14 days after stopping treatment with that medicine. If you are taking a reversible MAOI (RIMA), take Citalopram Aurobindo Italia after stopping the RIMA for the time indicated in the package leaflet of that medicine;
if you are to start therapy with an MAOI, wait at least 7 days after stopping treatment with Citalopram Aurobindo Italia;
if you have to take selegiline together with Citalopram Aurobindo Italia, the maximum recommended dose of selegiline is 10 mg per day;
if you suffer from a heart rhythm disorder or have been diagnosed with QT interval prolongation or congenital long QT syndrome;
if you are taking medicines that can prolong the QT interval (see section “Other medicines and Citalopram Aurobindo Italia”);
if you are taking pimozide, used to treat certain mental disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Aurobindo Italia.
Take this medicine with caution and inform your doctor in the following cases:

if you are elderly or suffer from kidney or liver problems. In these cases, your doctor will adjust the dose of the medicine (see section 3);
if you suffer from panic attacks, as you may experience severe anxiety at the beginning of treatment (paradoxical anxiety);
if you have low levels of sodium in the blood (hyponatraemia);
if you suffer from bipolar disorder, as during treatment with Citalopram Aurobindo Italia you may experience a shift into the manic phase, characterised by rapid and unusual changes in thinking, physical hyperactivity and excitement. In this case, stop treatment;
if you suffer from epilepsy;
if you suffer from diabetes;
if you have a coagulation disorder and are at risk of bleeding (haemorrhage), and if you are taking medicines that worsen these problems (see section “Other medicines and Citalopram Aurobindo Italia”);
if you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
if you are undergoing electroconvulsive therapy (electroshock);
if you are taking St. John’s wort (Hypericum perforatum) products;
if you suffer or have suffered from heart problems (bradycardia, uncompensated heart failure) or have recently had a heart attack (acute myocardial infarction);
if you have low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia). In such cases, your doctor will correct these abnormalities before starting treatment with this medicine;
if you or someone in your family has a condition of the eye (closed-angle glaucoma);
if you suffer from psychosis with depression;
if you are taking medicines containing buprenorphine. Using these medicines together with Citalopram Aurobindo Italia may lead to serotonin syndrome, which can be fatal (see “Other medicines and Citalopram Aurobindo Italia”).

Medicines such as Citalopram Aurobindo Italia, known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs), may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
During the first few weeks or immediately after starting treatment, whether you suffer from depression or other mental health conditions (psychiatric disorders), you may have thoughts of harming yourself or of suicide. For this reason, your doctor should monitor you closely, especially at the beginning of treatment or when the dose is increased, if you have previously experienced such disorders, or if you are young (under 25 years of age). Inform your doctor immediately if you experience these symptoms or if someone caring for you notices changes in your behaviour.
It may be helpful to inform a relative or close friend that you suffer from depression or an anxiety disorder, and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behaviour.
Within the first few weeks of treatment, you may develop akathisia, characterised by restlessness, distress, a need to move frequently accompanied by an inability to sit still or remain motionless. If you experience these symptoms, contact your doctor immediately.
Stop treatment with this medicine immediately and inform your doctor if you experience agitation, tremor, involuntary muscle contractions (myoclonus), or increased body temperature (hyperthermia). These may be symptoms of a condition called serotonin syndrome.
For those engaged in sports, the use of medicines containing ethanol may result in positive anti-doping tests in relation to the blood alcohol concentration limits indicated by certain sports federations.
Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age. However, your doctor may prescribe Citalopram Aurobindo Italia to patients under 18 years of age if they consider it the best option for them. In such cases, the child or adolescent must be closely monitored, and you should inform the doctor if symptoms such as suicide attempts, suicidal ideation or hostility appear or worsen during treatment with Citalopram Aurobindo Italia.
Other medicines and Citalopram Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. Some medicines can alter the effect of other medicines, and this may sometimes cause serious adverse reactions.
Tell your doctor, in particular, if you are taking the following medicines:

medicines called monoamine oxidase inhibitors (MAOIs), as serious, even fatal, adverse effects may occur, including serotonin syndrome (see sections “Warnings and precautions” and “Possible side effects”). These medicines include selegiline, a selective MAOI used in Parkinson’s disease, linezolid, a reversible (non-selective) MAOI used to treat infections, and moclobemide (selective for type IA), used in the treatment of depression;
if you are taking an irreversible MAOI, take Citalopram Aurobindo Italia at least 14 days after stopping treatment with that medicine. If you are taking a reversible MAOI (RIMA), take Citalopram Aurobindo Italia after stopping the RIMA for the time indicated in the package leaflet of that medicine;
if you are to start therapy with an MAOI, wait at least 7 days after stopping treatment with Citalopram Aurobindo Italia;
if you have to take selegiline together with Citalopram Aurobindo Italia, the maximum recommended dose of selegiline is 10 mg per day;
buspirone, a medicine used in the treatment of anxiety, due to the risk of serotonin syndrome;
class IA and III antiarrhythmics, medicines used for heart rhythm disorders, due to the risk of QT interval prolongation on the electrocardiogram;
medicines used to treat mental disorders (antipsychotics), due to the risk of QT interval prolongation on the electrocardiogram (e.g. phenothiazine derivatives, haloperidol and pimozide, which must not be taken with Citalopram Aurobindo Italia), due to the risk of lowered seizure threshold (e.g. phenothiazines, thioxanthenes and butyrophenones), and because they may increase the risk of bleeding (e.g. atypical antipsychotics and phenothiazines);
other medicines used to treat depression (antidepressants), due to the risk of QT interval prolongation on the electrocardiogram, lowered seizure threshold, and increased risk of bleeding;
antimicrobials (medicines used to treat infections) such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, due to the risk of QT interval prolongation on the electrocardiogram;
sumatriptan and similar medicines, used to treat headache (migraine), due to the risk of enhanced serotonergic effect;
tramadol, used to treat pain, due to the risk of enhanced serotonergic effect and lowered seizure threshold;
lithium and tryptophan, used to treat certain mental disorders, due to the risk of enhanced serotonergic effect;
products containing St. John’s wort (Hypericum perforatum), used for depression, as they increase the risk of adverse effects;
fluconazole, used to treat fungal infections;
medicines used to thin the blood such as dipyridamole (anticoagulants) and ticlopidine (platelet aggregation inhibitors), as they may increase the risk of bleeding;
medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid, as they may increase the risk of bleeding;
medicines that reduce potassium or magnesium levels in the blood (which may cause hypokalaemia/hypomagnesaemia, conditions that increase the risk of arrhythmias), cimetidine, omeprazole, esomeprazole and lansoprazole, used to treat stomach problems, as a dose adjustment of Citalopram Aurobindo Italia may be necessary. This may also occur with other medicines such as the antidepressant fluvoxamine and the antiplatelet agent ticlopidine; medicines such as flecainide, propafenone and metoprolol (used to treat heart problems), antidepressants such as desipramine, clomipramine and nortriptyline, or antipsychotics such as risperidone, thioridazine and haloperidol, as a dose adjustment of these medicines may be necessary. Some medicines may exacerbate the adverse effects of Citalopram Aurobindo Italia and sometimes cause very serious reactions. Do not take other medicines during treatment with Citalopram Aurobindo Italia without first consulting your doctor, in particular:
Medicines containing buprenorphine. These medicines may interact with Citalopram Aurobindo Italia and may cause symptoms such as rhythmic and involuntary muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, body temperature above 38°C. Contact your doctor if you experience such symptoms.

Citalopram Aurobindo Italia and alcohol
Do not drink alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Citalopram Aurobindo Italia must not be used during pregnancy or breastfeeding unless strictly necessary, and only after careful evaluation of risks and benefits by your doctor.
Ensure that your midwife and/or doctor know that you are being treated with Citalopram Aurobindo Italia.
If you have taken this medicine during the later stages of pregnancy, particularly in the last trimester, your baby may experience breathing difficulties, apnoea, bluish skin colour (cyanosis), seizures, body temperature changes, feeding difficulties, vomiting, low blood sugar levels (hypoglycaemia), changes in muscle tone (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, persistent crying, drowsiness and difficulty sleeping.
When taken during pregnancy, particularly during the last 3 months, medicines such as Citalopram Aurobindo Italia may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours after birth. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take Citalopram Aurobindo Italia near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Citalopram Aurobindo Italia so they can advise you on what to do.
If you take this medicine during pregnancy, avoid abrupt discontinuation of treatment (see section “If you stop taking Citalopram Aurobindo Italia”).
Breastfeeding
If you are breastfeeding, take this medicine with caution, as citalopram passes into breast milk.
Male fertility
Citalopram has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed (see section “Possible side effects”).
Driving and using machines
This medicine may impair your ability to drive or operate machinery, as it may reduce your judgment and reactivity in dangerous situations. Therefore, be cautious before driving or operating machinery.
Citalopram Aurobindo Italia contains alcohol
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per maximum dose. The small amount of alcohol in this medicine will not produce significant effects.
Citalopram Aurobindo Italia contains parahydroxybenzoates
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).

3. How to take Citalopram Aurobindo Italia

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take the drops once daily, after mixing them with a small amount of water, orange juice, or
apple juice.
Citalopram Aurobindo Italia may be taken with or without food.
Do not stop treatment with Citalopram Aurobindo Italia abruptly to avoid withdrawal symptoms (see section “If you stop taking Citalopram Aurobindo Italia”).
Your doctor will adjust the dose according to your needs. Do not change the dose without consulting your
doctor (see section “If you stop taking Citalopram Aurobindo Italia”).

Treatment of depression: the recommended dose is 16 mg (8 drops) daily as a single dose. Your doctor may increase the dose up to a maximum of 32 mg (16 drops) daily, depending on your response to treatment.

The effect of the medicine usually appears within 2–4 weeks after starting treatment, which
should be continued for at least 4–6 months for symptoms of bipolar disorders.
If you suffer from recurrent unipolar depression, maintenance treatment should be continued
for longer periods to prevent relapse.

Treatment of panic attacks (panic disorder): the recommended initial dose is 8 mg (4 drops) daily for the first week of treatment. Afterwards, your doctor may increase the dose to 16 mg (8 drops) daily, up to a maximum of 32 mg (16 drops) daily, depending on your response to treatment. If you suffer from anxiety and experience panic attacks, treatment should be long-term (1 year). If you have insomnia or are very restless, your doctor may prescribe sedative medicines.

Use in elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose to 8–16 mg (4–8 drops) daily.
The maximum recommended dose is 16 mg daily.
Use in patients with liver problems (hepatic impairment)
If you have mild or moderate liver problems (mild or moderate hepatic impairment), the recommended initial dose is 8 mg (4 drops) daily for the first 2 weeks. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) daily, depending on your response to treatment.
If you have severe liver problems (severely reduced liver function), your doctor may decide to reduce the dose.
Use in patients with kidney problems (renal impairment)
If you have kidney problems (renal impairment), your doctor will prescribe the lowest recommended dose.
Use in patients with impaired drug metabolism (poor CYP2C19 metabolizers)
If you have impaired drug metabolism (poor metabolizer of CYP2C19), the recommended initial dose is 8 mg (4 drops) daily for the first two weeks of treatment.
Thereafter, your doctor may increase the dose up to a maximum of 16 mg (8 drops) daily, depending on your response to treatment.
If you take more Citalopram Aurobindo Italia than you should
If you (or someone else) have taken an excessive dose of Citalopram Aurobindo Italia, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (prolongation of QT interval, torsades de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (high fever, tremors, muscle contractions, and anxiety), agitation, reduced heart rate (bradycardia), dizziness, conduction block in the heart, changes in heart activity (QRS interval prolongation), increased blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis), fatigue, weakness, sedation.
If you forget to take Citalopram Aurobindo Italia
Do not take a double dose to make up for the missed dose.
If you stop taking Citalopram Aurobindo Italia
Do not stop treatment with Citalopram Aurobindo Italia suddenly or without first discussing it with your doctor. When stopping treatment with this medicine, the following withdrawal symptoms may occur:

dizziness, sensory disturbances such as tingling sensations in arms and legs (paraesthesiae);
sleep disturbances such as difficulty falling asleep (insomnia) and dreams that seem real (vivid dreams);
agitation or anxiety, tremors, confusion;
nausea and/or vomiting, diarrhoea;
sweating, headache (cephalalgia);
increased awareness of heartbeats (palpitations);
emotional instability, irritability;
visual disturbances.

These symptoms are usually mild to moderate and resolve spontaneously within 2 weeks, although sometimes they may be severe and last much longer (2–3 months or more).

Discontinuation of treatment should be done under the supervision of your doctor, who will gradually reduce the dose over a period of at least 1–2 weeks.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects mainly occur during the first or second week of treatment and then usually disappear thereafter.
If while taking this medicine you have thoughts of harming yourself or of suicide, contact your doctor immediately and stop taking the medicine.

The following side effects may occur:
Very common (may affect more than 1 in 10 people):

drowsiness, difficulty sleeping (insomnia), headache;
dry mouth, nausea;
excessive sweating.

Common (may affect up to 1 in 10 people):

decreased appetite, weight loss;
agitation, reduced sex drive (libido), anxiety, nervousness, confusion (confusional state), abnormal orgasm in women, unusual dreams (dream disturbances);
tremor, tingling sensations in arms and legs (paraesthesia), dizziness, attention disturbances;
perception of ringing in the ear (tinnitus);
yawning;
diarrhoea, vomiting, constipation;
itching;
muscle pain (myalgia) and joint pain (arthralgia);
sexual disorders in men (impotence, ejaculation disorders, failure to ejaculate);
fatigue.

Uncommon (may affect up to 1 in 100 people):

increased appetite, weight gain;
aggression, feeling detached from oneself (depersonalization), hallucinations, mania;
temporary loss of consciousness (syncope);
dilation of the pupil (mydriasis);
decrease/increase in heart rate (bradycardia/tachycardia);
skin irritation (urticaria, rash), hair loss (alopecia), development of red spots on the skin and bleeding (purpura), skin reactions caused by exposure to sunlight (photosensitivity reaction);
difficulty urinating (urinary retention);
prolonged and heavy menstrual periods in women (menorrhagia);
swelling due to fluid accumulation (oedema).

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

reduction in sodium levels in the blood (hyponatraemia);
seizures (grand mal), involuntary movements (dyskinesia), taste disturbances;
bleeding (haemorrhage);
inflammation of the liver (hepatitis);
fever (pyrexia).

Frequency not known (frequency cannot be estimated from the available data):

reduction in the number of platelets in the blood (thrombocytopenia);
allergic reactions, including severe reactions (anaphylactic reaction);
inappropriate production of antidiuretic hormone (ADH) which regulates urine production;
reduction in potassium levels in the blood (hypokalaemia);
panic attacks, restlessness;
teeth grinding (bruxism);
suicidal thoughts (suicidal ideation), suicidal behaviour;
seizures, serotonin syndrome (high fever, tremors, muscle contractions and anxiety), extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and contractions, feeling restless and unable to remain still even for a very short time (akathisia), movement disorders;
vision disturbances;
disturbances in heart rhythm (prolongation of QT interval, ventricular arrhythmias, including torsade de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or who already have heart disorders (pre-existing QT prolongation or other cardiac conditions);
dizziness upon standing quickly due to a drop in blood pressure (orthostatic hypotension);
nosebleeds (epistaxis);
bleeding with stools (gastrointestinal or rectal haemorrhage);
abnormal liver function laboratory tests;
bruising (ecchymosis), swelling mainly of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema);
irregular menstrual periods in women (metrorrhagia);
prolonged and painful erection (priapism), sudden production of milk from the breast (galactorrhea) in men;
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information.

An increased risk of fractures has been reported following the use of this type of medicine.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and label after "Exp".
The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original packaging to protect from light.
The product should be used within 4 months of first opening the bottle. Any excess product should be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Citalopram Aurobindo Italia contains

The active substance is citalopram hydrochloride. 1 ml contains 44.48 mg of citalopram hydrochloride (equivalent to 40 mg of citalopram).
The other components are: methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, ethanol 96%, methylcellulose, purified water.

Description of the appearance of Citalopram Aurobindo Italia and the contents of the pack
Oral drops, solution.
Pack containing one bottle with dropper cap, with 15 ml of solution.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe 102, 21047 Saronno (VA)
Manufacturers
Special Products Line S.p.A., Via Campobello 15 – 00040 Pomezia (Rome)