CITALOPRAM DOC GENERICI

Package leaflet: Information for the patient

CITALOPRAM DOC Generici 20 mg film-coated tablets, 40 mg film-coated tablets

Equivalent 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 any adverse reaction occurs, including any not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CITALOPRAM DOC Generici is and what it is used for

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

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

2. What you should know before taking CITALOPRAM DOC Generici

Do not take CITALOPRAM DOC Generici

• if you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6)
• if the person taking the medicine is a child or adolescent under 18 years of age
• if you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), including selegiline (an irreversible MAOI) used to treat Parkinson’s disease. In this case, take CITALOPRAM DOC Generici at least 14 days after stopping treatment with the MAOI. If you need to start therapy with an MAOI, wait at least 7 days after stopping CITALOPRAM DOC Generici
• 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 such disorders

Warnings and precautions
Talk to your doctor or pharmacist before taking CITALOPRAM DOC Generici.
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 sodium levels in the blood (hyponatremia)
• if you suffer from bipolar disorder (manic-depressive illness), as during treatment with CITALOPRAM DOC Generici 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 have diabetes
• if you have a coagulation disorder and are at risk of bleeding (hemorrhage), and if you are taking medicines that worsen these conditions (see section “Other medicines and CITALOPRAM DOC Generici”), or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”)
• if you are undergoing electroconvulsive therapy (electroshock)
• if you are taking St. John’s wort (Hypericum perforatum) products
• if you are taking medicines containing buprenorphine (see section “Other medicines and CITALOPRAM DOC Generici”)
• 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 potassium or magnesium levels 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 DOC Generici (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 few 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 monitor you closely, 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 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 few 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.
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 DOC Generici 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 DOC Generici in patients under 18 years of age.
Other medicines and CITALOPRAM DOC Generici
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), including selegiline and moclobemide, as serious, even fatal, adverse effects may occur, including serotonin syndrome (see sections “Warnings and precautions” and “Possible side effects”)
• linezolid, an antibiotic
• Class IA and III antiarrhythmics, medicines used for heart rhythm disorders
• phenothiazine 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 the infectious disease 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:

• lithium and tryptophan, used to treat certain mental disorders
• medicines containing buprenorphine, used in opioid dependence treatment and for pain relief, as they increase the risk of serotonin syndrome
• products containing St. John’s wort (Hypericum perforatum)
• 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 (desipramine, clomipramine, nortriptyline)
• 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, 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
• fluconazole (used to treat fungal infections)
• flecainide, propafenone, used to treat heart rhythm disorders
• metoprolol, used to treat heart problems and high blood pressure

CITALOPRAM DOC Generici and alcohol
Do not drink alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or 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, apnea, bluish skin color (cyanosis), seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar (hypoglycemia), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, nervousness, irritability, lethargy, continuous crying, drowsiness, and sleep disturbances.
When taken during pregnancy, particularly during the last three months, medicines such as CITALOPRAM DOC Generici 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 occur within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
If you take this medicine during pregnancy, avoid abruptly stopping treatment (see section “If you stop taking CITALOPRAM DOC Generici”).
If you take CITALOPRAM DOC Generici 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 DOC Generici so they can advise you on what to do.
If you are breastfeeding, take this medicine with caution, as citalopram passes into breast milk.
This medicine may affect sperm quality. 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 reactivity in dangerous situations. Therefore, be cautious before driving or using machinery.
CITALOPRAM DOC Generici contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
CITALOPRAM DOC Generici contains sodium
The 20 mg and 40 mg tablets contain less than 1 mmol (23 mg) of sodium per maximum daily dose, i.e., they are essentially ‘sodium-free’.

3. How to take CITALOPRAM DOC Generici

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 DOC Generici abruptly in order to avoid withdrawal symptoms (see section “If you stop treatment with CITALOPRAM DOC Generici”).
Your doctor will adjust the dose according to your individual needs. Do not change the dose without first consulting your doctor (see section “If you stop treatment with CITALOPRAM DOC Generici”).

• Treatment of depression: The recommended dose is 20 mg once daily, taken in the evening as a single dose.

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 becomes apparent within 2–4 weeks after starting treatment. Treatment should be continued for at least 4–6 months to manage symptoms of bipolar disorder.
If you suffer from recurrent unipolar depression, long-term maintenance treatment is recommended 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.
  If you suffer from anxiety with panic attacks, treatment should be continued 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.
Thereafter, your doctor may increase the dose up to a maximum of 20 mg daily, depending on your response to treatment.

If you take more CITALOPRAM DOC Generici than you should
If you (or someone else) have taken an excessive dose of CITALOPRAM DOC Generici, or if you suspect that a child has taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (prolongation of QT interval, torsades de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (high fever, tremors, muscle contractions, and anxiety), agitation, reduced heart rate (bradycardia), dizziness, conduction block in the heart, changes in heart activity (prolongation of QRS interval), increased blood pressure (hypertension), dilation of the pupil (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 DOC Generici
Do not take a double dose to make up for the missed dose.

If you stop treatment with CITALOPRAM DOC Generici
Do not stop treatment with CITALOPRAM DOC Generici 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 the arms and legs (paraesthesiae)
• sleep disturbances such as difficulty falling asleep (insomnia) and vivid dreams that seem real (vivid dreams)
• agitation or anxiety, tremors, confusion
• nausea and/or vomiting, diarrhoea
• sweating, headache (cephalalgia)
• increased awareness of heartbeats (palpitations)
• emotional instability, irritability
• visual disturbances

These symptoms are generally mild to moderate and resolve spontaneously within 2 weeks, although they may sometimes 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 a period of at least 1–2 weeks.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects mainly occur during the first or second week of treatment and then usually subside.
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 ear (tinnitus)
• yawning
• diarrhoea, vomiting, constipation
• itching
• muscle pain (myalgia) and joint pain (arthralgia)
• sexual dysfunction in men (impotence, ejaculation disorders, anejaculation)
• fatigue

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

• increased appetite, weight gain
• aggression, feeling detached from oneself (depersonalization), hallucinations, mania
• temporary loss of consciousness (syncope)
• dilation of the pupil (mydriasis)
• decrease/increase in heart rate (bradycardia/tachycardia)
• skin rash (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 bleeding in women (menorrhagia)
• swelling due to fluid accumulation (oedema)

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

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

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

• reduction in the number of platelets in the blood (thrombocytopenia)
• allergic reactions, even severe ones (anaphylactic reaction)
• inappropriate production of antidiuretic hormone (ADH), which regulates urine production
• reduction in blood potassium levels (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 muscle contractions, feeling restless and unable to remain still even for a very short time (akathisia), movement disorders
• visual disturbances
• disturbances in heart rhythm (prolongation of QT interval, ventricular arrhythmias including torsade de pointes), particularly in women with low blood potassium levels (hypokalaemia) or who already have heart conditions
• sensation of 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 bleeding in women (metrorrhagia)
• prolonged and painful erection (priapism), sudden production of milk from the breast (galactorrhoea) in men

An increased risk of fractures has been reported following the use of CITALOPRAM DOC Generici, particularly when used in combination with other antidepressant medicines known as tricyclic antidepressants (TCAs).

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

5. How to store CITALOPRAM DOC Generici

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.
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 DOC Generici contains
CITALOPRAM DOC Generici 20 mg film-coated tablets

• The active substance is citalopram bromide. Each tablet contains 24.99 mg of citalopram bromide (equivalent to 20 mg of citalopram).
• The other components are: Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Film coating: hydroxyethylcellulose, macrogol, titanium dioxide, purified water.

CITALOPRAM DOC Generici 40 mg film-coated tablets

• The active substance is citalopram bromide. Each tablet contains 49.98 mg of citalopram bromide (equivalent to 40 mg of citalopram).
• The other components are: Tablet core: monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate. Film coating: hydroxyethylcellulose, macrogol, titanium dioxide, purified water.

Description of the appearance of CITALOPRAM DOC Generici and contents of the pack
Film-coated, divisible tablets.
Pack containing 28 film-coated 20 mg tablets in blister
Pack containing 14 film-coated 40 mg tablets in blister
Marketing Authorization Holder
DOC Generici Srl – Via Turati, 40 – 20121 Milan
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43 – 204041 Brembate (Bergamo), Italy.