Citalopram Zentiva

Package leaflet: Information for the patient

Citalopram Zentiva 40 mg/ml oral drops, solution

Generic medicine
Please read 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Citalopram Zentiva is and what it is used for
2. What you need to know before taking Citalopram Zentiva
3. How to take Citalopram Zentiva
4. Possible side effects
5. How to store Citalopram Zentiva
6. Contents of the pack and other information

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

Citalopram Zentiva contains the active substance citalopram hydrochloride, which belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs), which work 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 should know before taking Citalopram Zentiva

Do not take Citalopram Zentiva

• if you are allergic to citalopram hydrochloride 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 Citalopram Zentiva. After stopping Citalopram Zentiva, you must wait 7 days before taking any of these medicines. In these situations, always consult your doctor
• if you are using linezolid-containing medicines for 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 such 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.
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”)
• 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, as during treatment with Citalopram Zentiva 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 suffer from diabetes
• if you have a bleeding disorder or are at risk of bleeding (presence of bruises, various types of bleeding) and if you are taking medicines that worsen these problems (see section “Other medicines and Citalopram Zentiva”)
• 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 also section “Other medicines and Citalopram Zentiva”)
• if you are taking St. John’s wort (Hypericum perforatum) products, the use of Citalopram Zentiva is not recommended
• if you suffer or have 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 this case, your doctor will correct these imbalances before starting treatment with this medicine
• if you or someone in your family has an eye condition (closed-angle glaucoma).

Medicines such as Citalopram Zentiva (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 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 thoughts of suicide or self-harm
• 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
During the first weeks of treatment, you may develop akathisia, characterized by restlessness, distress, a need to move frequently, and inability to sit still or remain motionless. If you experience these symptoms, consult your doctor.
Serotonin syndrome
Stop treatment with this medicine immediately and inform 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.
For people engaged in sports, the use of medicines containing ethanol may result in positive anti-doping tests, depending on the blood alcohol concentration limits set by certain sports federations.
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
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), as serious, potentially fatal adverse effects, including serotonin syndrome, may occur (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, such as 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
• St. John’s wort (Hypericum perforatum) products, 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 involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.
• medicines that may cause heart rhythm disorders (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 and alcohol
Avoid drinking alcoholic beverages 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
Do not take Citalopram Zentiva 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”).
If you have taken this medicine during the last stages of pregnancy, your baby may develop breathing difficulties, apnea, circulation problems with bluish skin colouration (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 disturbances. 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 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 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 so they can advise you.
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 contains alcohol and parahydroxybenzoates
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per maximum dose.
This medicine contains parahydroxybenzoates which may cause allergic reactions (including delayed reactions).

3. How to take Citalopram Zentiva

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 Zentiva abruptly to avoid withdrawal symptoms
(see section “If you stop taking Citalopram Zentiva”).
Take Citalopram Zentiva drops as follows :

• To open the bottle: press down on the cap and simultaneously unscrew it (Fig. 1).
• Let the drops fall into a glass, holding the bottle in an upright position with the opening facing downwards (Fig. 2).
• To close the bottle: screw the cap on tightly until it is securely sealed (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
Your doctor will adjust the dose according to your needs. To change the dose, you must always consult your
doctor (see section “If you stop taking Citalopram Zentiva”).

• Treatment of depression: the recommended dose in adults is 16 mg (8 drops) once daily in a single dose in the evening. 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 appears within 2–4 weeks after starting treatment and should be continued for at least 4–6 months in cases of manic-depressive illness. If you suffer from recurrent unipolar depression, maintenance treatment may continue for longer periods to prevent relapse, always under medical supervision.
• Treatment of panic attacks (anxiety disorder with panic attacks) with or without agoraphobia: in adults, the recommended initial dose is 8 mg (4 drops) daily for the first week of treatment. Afterwards, your doctor will increase the dose to 16 mg (8 drops) daily and, if necessary, up to a maximum of 32 mg (16 drops) daily, depending on your response to treatment. Treatment is long-term. If you suffer from anxiety and experience panic attacks, treatment should last for a prolonged period (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 8–16 mg (4–8 drops) daily.
The maximum recommended dose is 16 mg daily (8 drops).
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 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 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 Zentiva than you should
If you (or someone else) have taken an excessive dose of Citalopram Zentiva, 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, heart rhythm disturbances (QT interval prolongation, torsades de pointes, atrioventricular block), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (high fever (hyperthermia), muscle rigidity, muscle jerks (myoclonus), tremor, rapid changes in breathing and heart rate, confusion, irritability and agitation), agitation, reduced heart rate (bradycardia), dizziness, changes in heart activity (conduction block, 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 Zentiva
Do not take a double dose to make up for the missed dose.
If you stop taking Citalopram Zentiva
Do not stop treatment with Citalopram Zentiva 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 that seem real
• agitation or anxiety, tremors, confusion
• nausea and/or vomiting, diarrhoea
• sweating, headache
• increased awareness of heartbeats (palpitations)
• mood instability, irritability
• visual disturbances.

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

Stopping treatment must be done 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 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 experiences 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 sex drive (libido), anxiety, nervousness, confusion, 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 dysfunction 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)
• pupil dilation (mydriasis)
• reduced/increased heart rate (bradycardia/tachycardia)
• skin irritation (urticaria, rash), hair loss (alopecia), development of red skin spots (purpura), skin reactions due to sun exposure (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):

• reduced sodium levels in the blood (hyponatraemia)
• seizures (epilepsy), involuntary movements (dyskinesia), taste disturbances
• bleeding (haemorrhage)
• liver inflammation (hepatitis)
• fever (pyrexia)

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

• reduced number of platelets in the blood (thrombocytopenia)
• allergic reactions, including severe ones (hypersensitivity, anaphylactic reaction)
• inappropriate production 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 discontinuation of treatment
• seizures, serotonin syndrome (high fever (hyperthermia), muscle rigidity, muscle twitching (myoclonus), tremor, possible rapid changes in breathing and heart rate, confusion, irritability and agitation), extrapyramidal disorders (such as involuntary movements, tremors, muscle stiffness and contractions), feeling restless and unable to remain still even for a very short time (akathisia), movement disorders
• visual disturbances
• heart rhythm disturbances (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 have heart conditions
• sensation of dizziness when standing up quickly due to low blood pressure (orthostatic hypotension)
• nosebleeds (epistaxis)
• bleeding with stools (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 bleeding in women (metrorrhagia)
• prolonged and painful erection (priapism), sudden milk production from the breast (galactorrhoea) 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

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

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after "EXP.".
The expiry date refers to the last day of that month.
Do not store above 25°C.
The product should be used within 4 months after 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Citalopram Zentiva 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 parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, hydroxyethylcellulose, purified water.

Description of the appearance of Citalopram Zentiva and contents of the package
Pack containing one 15 ml bottle of solution with a dropper cap.
Marketing Authorization Holder
Zentiva Italia S.r.l. - Via P. Paleocapa 7, 20121 Milan
Manufacturers
ICE S.p.A., Canton Moretti 29, 10015 S. Bernardo d'Ivrea (TO)