Package leaflet: Information for the patient

CITALOPRAM ABC 40 mg/ml oral drops, solution

Citalopram hydrochloride
Equivalent medicine
Read all of this leaflet carefully before taking this medicine because 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Citalopram ABC contains the active substance citalopram hydrochloride, 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 attacks), including those caused by fear of open spaces (agoraphobia)

2. What you need to know before taking Citalopram ABC

Do not take Citalopram ABC

if you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6)
if the person who is to take the medicine is a child or adolescent under 18 years of age
if you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs)
if you are taking selegiline (an irreversible MAOI), used to treat Parkinson’s disease. In this case, take Citalopram ABC at least 14 days after stopping treatment with that medicine. If you need to start therapy with an MAOI, wait at least 7 days after stopping Citalopram ABC
if you are using linezolid, a medicine used to treat infections
if you suffer from a heart rhythm disorder (QT interval prolongation or congenital long QT syndrome) or if you are taking medicines that may cause these disorders
during pregnancy and while breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram ABC.
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), because during treatment with Citalopram ABC 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 (haemorrhage), and if you are taking medicines that worsen these problems (See sections “Other medicines and Citalopram ABC”), 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 (hypokalaemia and hypomagnesaemia). In such cases, your doctor will correct these imbalances before starting treatment with this medicine
if you or someone in your family has an eye condition (narrow-angle glaucoma)

Medicines such as Citalopram ABC (so-called 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 your depression or anxiety disorder
During the first few weeks or immediately after starting treatment, especially if you suffer from other mental disorders (psychiatric conditions), you may have thoughts of harming yourself or committing suicide.
For this reason, your doctor should closely monitor you, particularly 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 few weeks of treatment, you may experience akathisia, characterized by restlessness, distress, and a frequent need to move, 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 normally contraindicated in children and adolescents under 18 years of age.
However, your doctor may prescribe Citalopram ABC to patients under 18 years of age if they consider it the best option for them. In such cases, you must inform the doctor if symptoms such as suicide attempts, suicidal ideation or hostility appear or worsen during treatment with Citalopram ABC in a patient under 18 years of age.
Other medicines and Citalopram ABC
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take this medicine if you are taking the following medicines:

medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), because serious, even fatal, adverse effects may occur, including serotonin syndrome, such as with moclobemide (See sections “Warnings and precautions” and “Possible side effects”) and selegiline, a medicine used to treat Parkinson’s disease
linezolid, an antibiotic
class IA and III antiarrhythmics, medicines used for heart rhythm disorders
phenothiazine-derived antipsychotics, pimozide and haloperidol, used to treat mental disorders
tricyclic antidepressants, used to treat depression
antimicrobials such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, used to treat infections
antimalarials such as halofantrine, used to treat an infectious disease called malaria
antihistamines such as astemizole and mizolastine, used to treat allergies
Do not take this medicine together with sumatriptan and similar medicines, used to treat headache (migraine), and tramadol, used to treat pain, because they increase the risk of adverse effects.

Take this medicine with caution and inform your doctor if you are taking the following medicines:

buspirone, a medicine used to treat anxiety;
lithium and tryptophan, used to treat certain mental disorders
products containing St. John’s wort ( Hypericum perforatum ), used for depression
medicines used to thin the blood (anticoagulants) such as dipyridamole and ticlopidine;
medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid
medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine and haloperidol
medicines used for depression (tricyclic antidepressants)
medicines that reduce potassium or magnesium levels in the blood (hypokalaemia/hypomagnesaemia)
medicines that may cause seizures such as:
certain medicines used to treat depression (bupropion, desipramine, clomipramine and nortriptyline, and serotonin reuptake inhibitors SSRIs such as fluvoxamine);
neuroleptics (thioxanthenes and butyrophenones) used to treat certain mental disorders;
tramadol, used to treat severe pain;
mefloquine, used to treat malaria.
cimetidine, omeprazole, esomeprazole, lansoprazole, used to treat stomach problems
flecainide, propafenone, used to treat heart rhythm disorders
metoprolol, used to treat heart problems and high blood pressure

Cimetidine, lansoprazole and omeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant) and ticlopidine (used to reduce the risk of stroke) may cause an increase in blood levels of citalopram.
Citalopram ABC 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 to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary, as it may cause serious problems in your baby.
If you have taken this medicine during the later stages of pregnancy, your baby may experience breathing difficulties, apnoea, bluish skin colour (cyanosis), seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar levels (hypoglycaemia), changes in muscle tone (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, agitation, irritability, lethargy, persistent crying, drowsiness and difficulty sleeping.
When taken during pregnancy, particularly during the last three months, medicines such as Citalopram ABC 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, you must contact your midwife and/or doctor immediately.
If you take Citalopram ABC near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Citalopram ABC, 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 ABC”).
If you are breastfeeding, take this medicine with caution because citalopram passes into breast milk.
This medicine may cause fertility problems in men. This effect disappears when treatment is stopped (See section Possible side effects).
Driving and using machines
This medicine may affect your ability to drive or use machinery because it may reduce your judgment and reaction time in dangerous situations. Therefore, be cautious before driving or operating machinery.
Citalopram ABC oral drops, solution contains ethanol
This medicine contains 60.8 mg of alcohol (ethanol) in 16 drops of solution.
The amount in 16 drops of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.
Citalopram ABC oral drops, solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
These may cause allergic reactions (including delayed reactions).

3. How to take Citalopram ABC

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.
Do not stop treatment with Citalopram ABC abruptly to avoid withdrawal symptoms (see section “If you stop taking Citalopram ABC”).
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 ABC”).

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 therapy should be continued for a longer period to prevent relapses.

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 with panic attacks, treatment should be continued for a long duration (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 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. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) daily, depending on your response to treatment.

Use in patients with kidney problems (renal impairment)
If you have kidney problems (renal impairment), your doctor will prescribe the lowest recommended dose.

If you take more Citalopram ABC than you should
If you (or someone else) have taken an excessive dose of Citalopram ABC, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause fatigue, weakness, sedation, dizziness, 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, electrical conduction block in the heart, changes in heart activity (QRS widening), high blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis).

If you forget to take Citalopram ABC
Do not take a double dose to make up for a forgotten dose.

If you stop taking Citalopram ABC
Do not stop treatment with Citalopram ABC 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 and electric shock sensations)
sleep disturbances such as difficulty falling asleep (insomnia) and 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 for a long time (2–3 months or more).

Discontinuation of treatment should be carried out under medical supervision, with doses gradually reduced over 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 everybody will experience them.
Side effects occur mainly during the first or second week of treatment and then usually disappear.
If during treatment you are thinking about harming yourself or have thoughts of suicide, contact your doctor immediately and stop taking this 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
restlessness, reduced sex drive (libido), anxiety, nervousness, 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 ears (tinnitus)
yawning
diarrhoea, vomiting, constipation
itching
muscle pain (myalgia) and joint pain (arthralgia)
sexual disturbances 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 (depersonalisation), hallucinations, mania
temporary loss of consciousness (syncope)
dilation of the pupil (mydriasis)
decreased/increased 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):

reduced sodium levels in the blood (hyponatraemia)
inability to stay still (psychomotor restlessness/acathisia)
seizures (grand mal), involuntary movements (dyskinesia), taste disturbances
bleeding (haemorrhage)
liver inflammation (hepatitis)
fever (pyrexia)

Very rare (may affect up to 1 in 10,000 people):

hypersensitivity reactions
serotonin syndrome (high fever, tremors, muscle contractions and anxiety)
withdrawal symptoms (dizziness, nausea and paraesthesia, which causes tingling sensations in arms and legs)

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

reduced number of platelets in the blood (thrombocytopenia)
allergic reactions, even severe ones (anaphylactic reaction)
inappropriate production of antidiuretic hormone (ADH), which regulates urine production (especially in elderly women)
reduced 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 in the same position even for a very short time (acathisia), movement disorders
vision disturbances
disturbances in heart rhythm (prolongation of QT interval, ventricular arrhythmias, including torsade de pointes), especially in women with low potassium levels in the blood (hypokalaemia) or who already suffer from heart disorders
dizziness when standing up quickly due to a drop in blood pressure (orthostatic hypotension)
nosebleeds (epistaxis)
bleeding with stools (gastrointestinal or rectal haemorrhage)
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, "Pregnancy, breastfeeding and fertility", for further information
abnormal liver function laboratory tests
bruising (ecchymosis), swelling 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 milk production from the breast (galactorrhoea) in men
increased blood levels of the hormone prolactin

An increased risk of fractures has been reported following the use of Citalopram ABC together with other medicines used to treat depression called tricyclic antidepressants (TCA).

Reporting of suspected adverse reactions
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 website:
https://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 ABC

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

6. Contents of the pack and other information

What Citalopram ABC contains

The active substance is citalopram hydrochloride. 1 ml contains 44.48 mg of citalopram hydrochloride (equivalent to 40 mg of citalopram).
The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, hydroxyethylcellulose, purified water.

Description of the appearance of Citalopram ABC and contents of the pack
Pack containing a bottle with a dropper cap with 15 ml of solution.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. - Corso Vittorio Emanuele II, 72 - 10121 Turin
Manufacturer
ABC Farmaceutici S.p.A. - Canton Moretti, 29 - 10015 San Bernardo d’Ivrea (TO)

Patient information leaflet

CITALOPRAM ABC 20 mg film-coated tablets, 40 mg film-coated tablets

Citalopram hydrobromide
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 others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

7. What Citalopram ABC is and what it is used for

Citalopram ABC contains the active substance citalopram hydrobromide, 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 attacks), including those caused by fear of open spaces (agoraphobia)

8. What you need to know before taking Citalopram ABC

Do not take Citalopram ABC

if you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6)
if you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs)
if you are taking selegiline (an irreversible MAOI), used to treat Parkinson’s disease. In this case, take Citalopram ABC at least 14 days after stopping treatment with that medicine. If you need to start therapy with an MAOI, wait at least 7 days after stopping Citalopram ABC
during pregnancy and while breastfeeding
if you are using linezolid, a medicine used to treat infections
if you suffer from a heart rhythm disorder (prolonged QT interval or congenital long QT syndrome) or if you are taking medicines that may cause these disorders
if the person who is to take the medicine is a child or adolescent under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram ABC.
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 have bipolar disorder, as during treatment with Citalopram ABC you may experience a shift into the manic phase, characterized by rapid and unusual changes in thinking, physical hyperactivity, and excitement. In this case, discontinue treatment
if you suffer from epilepsy
if you have 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 sections “Other medicines and Citalopram ABC”), 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 and hypomagnesemia). In such cases, your doctor will correct these imbalances before starting treatment with this medicine
if you or someone in your family has an eye condition (narrow-angle glaucoma)

Medicines such as Citalopram ABC (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 immediately after starting treatment, especially if you suffer from other mental health conditions (psychiatric disorders), you may have thoughts of harming yourself or committing suicide.
For this reason, your doctor should closely monitor you, particularly 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 behavior.
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 behavior.
Within the first weeks of treatment, you may develop akathisia, characterized by restlessness, distress, and a need to move frequently, accompanied by an inability to sit still or remain motionless. If you experience these symptoms, contact your doctor immediately.
Discontinue 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 normally contraindicated in children and adolescents under 18 years of age.
However, your doctor may prescribe Citalopram ABC to patients under 18 years of age if they consider it the best option for them. In such cases, inform your doctor if symptoms such as suicide attempts, suicidal ideation, or hostility appear or worsen during treatment with Citalopram ABC in a patient under 18 years of age.
Other medicines and Citalopram ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take this medicine if you are taking the following medicines:

medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), as serious, potentially fatal side effects may occur, including serotonin syndrome, such as moclobemide (see sections “Warnings and precautions” and “Possible side effects”) and selegiline, a medicine used to treat Parkinson’s disease
linezolid, an antibiotic
Class IA and III antiarrhythmics, medicines used for heart rhythm disorders
antipsychotics such as phenothiazine derivatives, pimozide, and haloperidol, used to treat mental disorders
tricyclic antidepressants, used to treat depression
antimicrobials such as sparfloxacin, moxifloxacin, intravenous erythromycin, and pentamidine, used to treat infections
antimalarials such as halofantrine, used to treat an infectious disease called malaria
antihistamines such as astemizole and mizolastine, used to treat allergies

Do not take this medicine together with sumatriptan and similar medicines used to treat headache (migraine), or with tramadol, used to treat pain, as this increases the risk of adverse effects.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

buspirone, a medicine used to treat anxiety
lithium and tryptophan, used to treat certain mental disorders
products containing St. John’s wort ( Hypericum perforatum ), used for depression
medicines used to thin the blood (anticoagulants) such as dipyridamole and ticlopidine
medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid
medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine, and haloperidol
medicines used for depression (tricyclic antidepressants)
medicines that reduce potassium or magnesium levels in the blood (hypokalemia/hypomagnesemia)
medicines that may provoke seizures such as:
certain medicines used to treat depression (bupropion, desipramine, clomipramine, nortriptyline, and serotonin reuptake inhibitors (SSRIs) such as fluvoxamine)
neuroleptics (thioxanthenes and butyrophenones) used to treat certain mental disorders
tramadol, used to treat severe pain
mefloquine, used to treat malaria
cimetidine, omeprazole, esomeprazole, lansoprazole (used to treat stomach problems)
flecainide, propafenone, used to treat heart rhythm disorders
metoprolol, used to treat heart problems and high blood pressure

Cimetidine, lansoprazole, and omeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke) may cause an increase in blood levels of citalopram.
Citalopram ABC 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 to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary, as it may cause serious problems for your baby.
If you have taken this medicine during the last stages of pregnancy, 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, agitation, irritability, lethargy, continuous crying, drowsiness, and difficulty sleeping.
When taken during pregnancy, particularly during the last 3 months, medicines such as Citalopram ABC 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 happens to your baby, contact your midwife and/or doctor immediately.
If you take Citalopram ABC 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 ABC 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 ABC”).
If you are breastfeeding, take this medicine with caution, as citalopram passes into breast milk.
This medicine may cause fertility problems in men. The effect reverses upon discontinuation of treatment (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 reaction time in dangerous situations. Therefore, be cautious before driving or operating machinery.
Citalopram ABC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Citalopram ABC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially ‘sodium-free’.

9. How to take Citalopram ABC

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Do not stop treatment with Citalopram ABC abruptly to avoid withdrawal symptoms (see the section “If you stop taking Citalopram ABC”).
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 ABC”).

Treatment of depression: the recommended dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg 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 10 mg daily for the first week of treatment. Afterwards, your doctor may increase the dose to 20 mg daily, up to a maximum of 40 mg daily depending on your response to treatment. The maximum effect of the medicine appears after 3 months of treatment. If you suffer from anxiety and experience panic attacks, treatment should be long-term (1 year). If you have insomnia or are highly agitated, 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 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 (poor metabolizers of CYP2C19)
If you have impaired drug metabolism (poor metabolizer of CYP2C19), the recommended initial dose is 10 mg daily for the first two weeks of treatment. Afterwards, 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 ABC than you should
If you (or someone else) have taken too much Citalopram ABC, 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 fatigue, weakness, sedation, 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 prolongation), high blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis).
If you forget to take Citalopram ABC
Do not take a double dose to make up for the forgotten dose.
If you stop taking Citalopram ABC
Do not stop treatment with Citalopram ABC 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 and electric shock sensations)
sleep disturbances such as difficulty falling asleep (insomnia) and 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 (visual symptoms)

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

Stopping 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.

10. Possible adverse effects

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

The following adverse 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
restlessness, reduced sex drive (libido), anxiety, nervousness, 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 disturbances 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), hallucination, mania
temporary loss of consciousness (syncope)
pupil dilation (mydriasis)
decreased/increased heart rate (bradycardia/tachycardia)
skin irritation (urticaria, rash), hair loss (alopecia), development of red skin spots and bleeding (purpura), skin reactions caused by sun exposure (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):

reduced sodium levels in the blood (hyponatraemia)
inability to remain still (psychomotor restlessness/acathisia)
seizures (grand mal), involuntary movements (dyskinesia), taste disturbances
bleeding (haemorrhage)
liver inflammation (hepatitis)
fever (pyrexia)

Very rare (may affect up to 1 in 10,000 people):

hypersensitivity reactions
serotonin syndrome (high fever, tremors, muscle contractions and anxiety)
withdrawal symptoms (dizziness, nausea and paraesthesia, manifesting as tingling sensations in arms and legs)

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

reduced number of platelets in the blood (thrombocytopenia)
allergic reactions, even severe ones (anaphylactic reaction)
inappropriate production of antidiuretic hormone (ADH), which regulates urine production (especially in elderly women)
reduced 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 inability to remain still even for a very short time (acathisia), movement disorders
visual 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 those who already suffer from heart disorders
dizziness upon standing quickly due to drop in blood pressure (orthostatic hypotension)
nosebleeds (epistaxis)
rectal or gastrointestinal bleeding (gastrointestinal or rectal haemorrhage)
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information
abnormal liver function laboratory tests
bruising (ecchymosis), swelling 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 milk production from the breast (galactorrhoea) in men
increased blood levels of the hormone prolactin

An increased risk of fractures has been reported following the use of Citalopram ABC together with other medicines used to treat depression called tricyclic antidepressants (TCA).
Reporting of suspected adverse reactions
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse effects directly via the website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

11. How to store Citalopram ABC

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 “Expiry”.
The expiry date refers to the last day of that month.
Store below 25°C in the original packaging to protect from light.
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.

12. Package contents and other information

What Citalopram ABC contains
Citalopram ABC 20 mg film-coated tablets

The active substance is citalopram hydrobromide. Each tablet contains 25 mg of citalopram hydrobromide (equivalent to 20 mg of citalopram).
The other components are: monohydrate lactose, maize starch, microcrystalline cellulose, glycerol, copovidone, sodium croscarmellose, magnesium stearate, Opadry Y-1-7000 (hypromellose, titanium dioxide, polyethylene glycol).

Citalopram ABC 40 mg film-coated tablets

The active substance is citalopram hydrobromide. Each tablet contains 50 mg of citalopram hydrobromide (equivalent to 40 mg of citalopram).
The other components are: monohydrate lactose, maize starch, microcrystalline cellulose, glycerol, copovidone, sodium croscarmellose, magnesium stearate, Opadry Y-1-7000 (hypromellose, titanium dioxide, polyethylene glycol).

Description of the appearance of Citalopram ABC and contents of the pack
Pack containing 28 tablets of 20 mg
Pack containing 14 tablets of 40 mg

Marketing Authorization Holder
ABC Farmaceutici S.P.A. – Corso Vittorio Emanuele II, 72 - 10121 Turin

Manufacturer
ABC Farmaceutici S.p.A. Canton Moretti, 29 - 10015 San Bernardo d’Ivrea (TO)