Citalopram Zentiva Italia: detailed information

Package leaflet: Information for the patient

Citalopram Zentiva Italia 20 mg film-coated tablets

Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Citalopram Zentiva Italia contains the active substance citalopram bromide, which belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs), that act by regulating mood.
This medicine 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 Zentiva Italia

Do not take Citalopram Zentiva Italia

if you are allergic to citalopram bromide 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 used to treat depression called monoamine oxidase inhibitors (MAOIs), including selegiline (an MAOI used to treat Parkinson’s disease). If you have taken any of these medicines, you must wait 14 days before starting to take Citalopram Zentiva Italia. After stopping Citalopram Zentiva Italia, you must wait 7 days before taking any of these medicines. In these situations, always consult your doctor
if you are using antibiotics containing linezolid
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 you are taking pimozide, used to treat certain mental disorders.

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

if you are elderly (over 65 years) or suffer from kidney or liver problems. In these cases, your doctor may adjust the dose of the medicine (see section 3 “How to take Citalopram Zentiva Italia”)
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 mental disorders such as psychosis and have suicidal tendencies (suicidal thoughts or self-harming behaviour), as your condition may worsen
if you suffer from depression, because during treatment with Citalopram Zentiva Italia you may experience rapid and unusual changes in thinking, physical hyperactivity and excitement. In this case, contact your doctor immediately
if you suffer from epilepsy
if you have diabetes
if you have a bleeding disorder and are at risk of bleeding (bruising, various types of hemorrhage) and if you are taking medicines that worsen these problems (see section “Other medicines and Citalopram Zentiva Italia”)
if you have a history of bleeding disorders or if you are pregnant (see “Pregnancy”)
if you are undergoing electroconvulsive therapy (electroshock)
if you are using this medicine together with buprenorphine. This combination may lead to serotonin syndrome, a potentially fatal condition (see below and section “Other medicines and Citalopram Zentiva Italia”)
if you are taking herbal products containing St. John’s wort ( Hypericum perforatum ), use of Citalopram Zentiva Italia is not recommended
if you suffer from or have previously suffered from heart problems (bradycardia, uncompensated heart failure, arrhythmias, i.e. irregular heartbeats) 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 a family member has a certain eye condition (closed-angle glaucoma)
if you suffer from psychosis with depression

Medicines such as Citalopram Zentiva Italia (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
If you suffer from depression and/or anxiety disorders, you may sometimes think about harming yourself or committing suicide.
These thoughts may be more frequent at the beginning of treatment with antidepressants, as these medicines take time to work, usually about two weeks, but sometimes longer.
You are more likely to have these thoughts:

if you have previously had suicidal thoughts or self-harming behaviour
if you are a young adult. Clinical study data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If at any time you think about harming yourself or committing suicide, contact your doctor or go to hospital immediately.
Akathisia/psychomotor agitation
Within the first few weeks of treatment, you may develop akathisia, characterized by restlessness, distress, an urge to move frequently, and inability to sit still or remain motionless. If you experience these symptoms, contact your doctor.
Serotonin syndrome
Stop taking this medicine immediately and contact your doctor if you experience symptoms of serotonin syndrome (such as high fever (hyperthermia), muscle rigidity, muscle twitching (myoclonus), tremor, rapid changes in breathing and heart rate, confusion, irritability and agitation), which can sometimes be fatal.
Children and adolescents
This medicine is normally contraindicated in children and adolescents under 18 years of age. However, if your doctor, after careful evaluation, considers treatment necessary, the patient must be closely monitored for the risk of developing suicidal thoughts.
Other medicines and Citalopram Zentiva Italia
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 such as moclobemide and selegiline), because serious, potentially fatal side effects may occur, including serotonin syndrome (see sections “Warnings and precautions” and “Possible side effects”)
linezolid, an antibiotic
medicines that cause a specific heart disorder called “prolongation of the QT interval” such as:
- those used for heart rhythm disorders like class IA and III antiarrhythmics
- phenothiazine antipsychotics, pimozide, haloperidol, medicines used to treat mental disorders (antipsychotics)
- tricyclic antidepressants, used to treat depression
- antibiotics 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.

Avoid taking this medicine together with sumatriptan and similar medicines (oxitriptan and tryptophan), used to treat headache (migraine), and tramadol, used to treat pain, as they increase the risk of adverse effects.
Take this medicine with caution and inform your doctor if you are taking the following medicines:

lithium, used to treat certain mental disorders
herbal products containing St. John’s wort ( Hypericum perforatum ), used for depression
medicines that may increase the risk of bleeding, such as anticoagulants, 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)
buprenorphine (a strong painkiller). This combination may cause serotonin syndrome (see section "Warnings and precautions"), and you may experience symptoms such as rhythmic, involuntary muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C. Contact your doctor if you experience these symptoms.
medicines that may cause heart rhythm disturbances (prolongation of the QT interval) or that induce low potassium or magnesium levels in the blood (hypokalemia/hypomagnesemia)
medicines that may provoke seizures such as:
- certain antidepressants (tricyclics, bupropion, desipramine, clomipramine and nortriptyline and medicines belonging to the SSRI class, such as fluvoxamine)
- neuroleptics (phenothiazines, thioxanthenes and butyrophenones) used to treat certain mental disorders
- buspirone, a medicine used in the treatment of anxiety due to the risk of serotonin syndrome
- tramadol, used to treat severe pain
- mefloquine, used to treat malaria
cimetidine, omeprazole, esomeprazole, lansoprazole, used to treat stomach problems
flecainide and 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 increase blood levels of citalopram.
Citalopram Zentiva Italia and alcohol
Avoid drinking alcoholic beverages 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
Do not take Citalopram Zentiva Italia during pregnancy unless advised by your doctor and under their direct supervision.
If you take this medicine during pregnancy, avoid abruptly stopping treatment (see section “If you stop taking Citalopram Zentiva Italia”).
If you take this medicine during the later stages of pregnancy, your baby may experience breathing difficulties, apnea, circulation problems with bluish skin (cyanosis), seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar levels (hypoglycemia), changes in muscle tone (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, persistent crying, drowsiness and sleep difficulties. These symptoms may be due to serotonergic effects or withdrawal symptoms. When taken during pregnancy, particularly during the last three months, medicines such as Citalopram Zentiva 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 problems usually occur within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
If you take Citalopram Zentiva Italia towards the end of pregnancy, there may be an increased risk of severe vaginal bleeding immediately after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Citalopram Zentiva Italia so they can advise you accordingly.
Breastfeeding
If you intend to breastfeed while taking this medicine, consult your doctor.
Fertility
Citalopram has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed so far.
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, driving and operating machinery are not recommended.
Citalopram Zentiva 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 Zentiva Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablets once daily.
Do not stop treatment with Citalopram Zentiva Italia abruptly, to avoid withdrawal symptoms (see section “If you stop taking Citalopram Zentiva Italia”).
Your doctor will adjust the dose according to your needs. Always consult your doctor before changing the dose (see section “If you stop taking Citalopram Zentiva Italia”).

Treatment of depression: The recommended dose in adults is 20 mg (1 tablet) daily as a single dose. Your doctor may increase the dose up to a maximum of 40 mg (2 tablets) daily, depending on your response to treatment. The effect of the medicine appears within 2–4 weeks after starting treatment and should be continued for at least 4–6 months in manic-depressive disorders. If you suffer from recurrent unipolar depression, maintenance therapy may be continued for longer periods to prevent relapse, always under medical supervision.
Treatment of panic attacks (anxiety disorders with panic attacks) with or without agoraphobia: In adults, the recommended initial dose is 10 mg (half a tablet) daily for the first week of treatment. Your doctor will then increase the dose to 20 mg (1 tablet) daily and, if necessary, up to a maximum of 40 mg (2 tablets) daily, depending on your response to treatment. Treatment is long-term. If you suffer from anxiety and experience panic attacks, treatment should be prolonged (1 year). If you have insomnia or are very restless, your doctor may prescribe calming medicines (sedatives).

Elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose to 10–20 mg (half – 1 tablet) daily.
The maximum recommended dose is 20 mg daily (1 tablet).
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 (half a tablet) daily for the first 2 weeks. Afterwards, your doctor may increase the dose up to a maximum of 20 mg (1 tablet) daily, depending on your response to treatment.
If you have severe liver problems (severely reduced liver function), your doctor may decide to further 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 problems in drug metabolism (poor metabolizers of CYP2C19)
If you have problems in drug metabolism (poor metabolizer of CYP2C19), the recommended initial dose is 10 mg (half a tablet) daily for the first two weeks of treatment. Afterwards, your doctor may increase the dose up to a maximum of 20 mg (1 tablet) daily, depending on your response to treatment.
If you take more Citalopram Zentiva Italia than you should
If you (or someone else) have taken an excessive amount of Citalopram Zentiva Italia, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
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 (hyperthermia), muscle stiffness, muscle jerks (myoclonus), tremor, possible rapid changes in breathing and heart rate, confusion, irritability and agitation), agitation, slow heart rate (bradycardia), dizziness, disturbances in heart activity (conduction block, QRS prolongation), high blood pressure (hypertension), dilated pupils (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 Zentiva Italia
Do not take a double dose to make up for the forgotten dose.
If you stop taking Citalopram Zentiva Italia
Do not stop treatment with Citalopram Zentiva Italia suddenly. Contact your doctor first, who will advise you on how to gradually reduce the dose. 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)
mood 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 must be carried out under close medical supervision, with the doctor gradually reducing the dose over several weeks or months, depending on the patient's response.
If you have any doubts about using 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 occur mainly 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 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
increased sweating.

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

decreased appetite, weight loss
agitation, reduced sexual desire (libido), anxiety, nervousness, confusion, abnormal orgasm in women, abnormal dreams (disturbances in dream activity)
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), hallucinations, mania
temporary loss of consciousness (syncope)
dilation of the pupil (mydriasis)
decreased/increased heart rate (bradycardia/tachycardia)
skin irritation (urticaria, skin rash), hair loss (alopecia), development of red spots on the skin (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)
seizures (grand mal), involuntary movements (dyskinesia), taste disturbances
bleeding (haemorrhage)
liver inflammation (hepatitis)
fever (pyrexia).

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

reduced number of platelets in the blood (thrombocytopenia)
allergic reactions, including severe ones (hypersensitivity, anaphylactic reaction)
inappropriate secretion of antidiuretic hormone (ADH) which regulates urine production
reduced potassium levels in the blood (hypokalaemia)
panic attacks, restlessness
teeth grinding (bruxism)
suicidal thoughts (suicidal ideation), suicide attempts, during or after stopping treatment
seizures, serotonin syndrome (high fever (hyperthermia), muscle rigidity, muscle jerks (myoclonus), tremor, possible rapid changes in breathing and heart rate, confusion, irritability and agitation), extrapyramidal disorders (such as involuntary movements, tremors, muscle rigidity and muscle contractions), feeling restless and unable to remain still even for a very short time (akathisia), movement disorders
visual disturbances
heart rhythm disturbances (prolongation of the QT interval, ventricular arrhythmias, including torsade de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or who already have heart problems
sensation of dizziness when standing up quickly due to a drop in blood pressure (orthostatic hypotension)
nosebleeds (epistaxis)
rectal or gastrointestinal bleeding (gastrointestinal or rectal haemorrhage)
abnormal liver function 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 production of milk from the breast (galactorrhea) in men
increased levels of prolactin hormone in the blood
severe vaginal bleeding immediately after childbirth (postpartum haemorrhage); see "Pregnancy" in section 2 for further information.

Risk of fractures
In patients aged 50 years and older, an increased risk of fractures has been reported following the use of Citalopram Zentiva Italia in combination with other antidepressant medicines known as tricyclic antidepressants (TCAs).

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 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 Zentiva 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 after "EXP.".
The expiry date refers to the last day of that month.
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 Zentiva Italia contains

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, monohydrate lactose, microcrystalline cellulose, vinylpyrrolidone vinylacetate copolymer, glycerol, sodium croscarmellose, magnesium stearate. Film coating: titanium dioxide, hypromellose, polyethylene glycol 400.

Description of the appearance of Citalopram Zentiva Italia and package contents
Citalopram Zentiva Italia 20 mg film-coated tablets are white, biconvex tablets with a score line.
Pack containing 28 divisible tablets in blister packs.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa 7, 20121 Milan
Manufacturer
ICE S.p.A., Canton Moretti 29, 10015 S. Bernardo d'Ivrea (TO)