Package leaflet: Information for the patient

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

Citalopram bromide
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 adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CITALOPRAM PENSA is and what it is used for

CITALOPRAM PENSA contains the active substance citalopram hydrobromide, which belongs to a group of
medicinal products known as 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 PENSA

Do not take CITALOPRAM PENSA

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 or are about to take medicines called monoamine oxidase inhibitors (MAOIs). These medicines include selegiline, a selective MAOI used in Parkinson’s disease, linezolid, a reversible (non-selective) MAOI, an antibiotic used to treat infections, and moclobemide (type IA selective), used in the treatment of depression. If you have recently taken MAO inhibitors: depending on the type of MAOI, you may need to wait up to 14 days after stopping the MAOI before starting treatment with CITALOPRAM PENSA; or if you have taken or are taking an irreversible I-MAO, you must wait at least 14 days after stopping such medication before taking CITALOPRAM PENSA.
If you have taken or are taking a reversible MAO inhibitor (RIMA), take
CITALOPRAM PENSA only after discontinuing treatment with the RIMA for the
time indicated in the RIMA’s package leaflet.
If you are to take selegiline together with CITALOPRAM PENSA, you must not exceed
the maximum recommended dose of selegiline of 10 mg per day.
If you are to start therapy with an MAOI, you must wait at least 7 days after stopping
treatment with CITALOPRAM PENSA;
if you are taking linezolid (an antibiotic used to treat infections);
if you are taking pimozide, a medicine used to treat certain mental disorders;
if you suffer from a heart rhythm disorder, or if you were born with or have been diagnosed with QT interval prolongation visible on the electrocardiogram (ECG);
if you are taking medicines that may affect heart rhythm (see section “Other medicines and CITALOPRAM PENSA”). If you are pregnant or breastfeeding, see section “Pregnancy, breastfeeding and fertility”.

Warnings and precautions
Talk to your doctor or pharmacist before taking CITALOPRAM PENSA.
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 may adjust the dose of the medicine (see section 3 “How to take CITALOPRAM PENSA”);
if you suffer from panic attacks, as you may experience severe anxiety at the beginning of treatment (paradoxical anxiety); in such cases, your doctor may adjust the dose of the medicine (see section “How to take CITALOPRAM PENSA”);
if you have low levels of sodium in the blood (hyponatremia);
if you suffer from bipolar disorder (manic-depressive illness), as during treatment with CITALOPRAM PENSA you may experience a shift into the manic phase, characterized by rapid and unusual changes in thought, physical hyperactivity and excitement. In this case, stop treatment;
if you suffer from seizures or epilepsy. In this case, your doctor will monitor you more closely.
If seizures occur or their frequency increases, treatment with CITALOPRAM PENSA must be discontinued;
if you have diabetes. In this case, your doctor may adjust the dose of your diabetes medications;
if you have a coagulation disorder and are at risk of bleeding (hemorrhage), or if you are taking anticoagulant medicines or medicines that worsen these conditions (see section “Other medicines and CITALOPRAM PENSA”);
if you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”);
if you are undergoing electroconvulsive therapy (electroshock);
if you are taking herbal remedies 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 a family member has a condition of the eye (closed-angle glaucoma);
if you suffer from so-called psychotic depression with depressive episodes: symptoms may worsen;
if you are taking medicines with serotonergic effects. Concomitant use of the above-mentioned medicines, by enhancing the serotonergic effects of CITALOPRAM PENSA, may lead to the onset of so-called “serotonin syndrome” (see section “Other medicines and CITALOPRAM PENSA”). If you have stable heart disease, you should have an electrocardiogram (ECG) before starting treatment; if during treatment you experience signs of irregular heartbeat, inform your doctor immediately for instructions on how to discontinue treatment.

Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed, you may sometimes have thoughts of self-harm or suicide, which may increase
at the beginning of treatment with antidepressants, as all these medicines require some time to take
effect, usually about two weeks, but sometimes longer. For this reason, your doctor should monitor you
closely, especially at the beginning of treatment or when the dose is increased.
You may be more likely to have such thoughts in the following cases:

if you have previously had thoughts of self-harm or suicide;
if you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in adult patients under 25 years of age with psychiatric disorders who were already being treated with antidepressants. If at any time you start having thoughts of self-harm or suicide, contact your doctor or go immediately to hospital and inform someone caring for you.

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 change in your behaviour.
Within the first few weeks of treatment, you may experience akathisia, characterized by restlessness,
anxiety, a need to move frequently, accompanied by an inability to sit still or remain motionless. If
you experience these symptoms, contact your doctor immediately.
At the beginning of treatment, insomnia and agitation may occur; in such cases, adjusting the dosage
may be helpful.
If during treatment you experience agitation, tremor, involuntary muscle contractions (myoclonus),
rigidity, confusion, irritability, increased body temperature (hyperthermia), these may be symptoms
of a so-called serotonergic syndrome, which can be life-threatening.
Contact your doctor immediately for instructions on how to discontinue treatment with
CITALOPRAM PENSA.
Medicines such as CITALOPRAM PENSA (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 have been observed to persist after discontinuation of
treatment.
Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age. There are no data
on long-term safety in this age group. In addition, it is important to know that when treated with this
class of medicines, patients under 18 years of age have a higher risk of adverse effects such as suicide
attempts, suicidal thoughts and hostility (mainly aggression, hostile behaviour and anger). However,
your doctor may prescribe CITALOPRAM PENSA to patients under 18 years of age if they consider it
the best option for them. In such cases, you must inform your doctor immediately if any of the
aforementioned symptoms appear or worsen during treatment with CITALOPRAM PENSA.
Other medicines and CITALOPRAM PENSA
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 called monoamine oxidase inhibitors (MAOIs), used for depression (RIMA (moclobemide)) or for Parkinson’s disease (irreversible MAOI (selegiline)), because serious, even fatal, adverse effects may occur, including serotonin syndrome. CITALOPRAM PENSA must not be administered until 14 days after discontinuation of an irreversible MAO inhibitor. After stopping a reversible MAO inhibitor (RIMA), the time intervals prescribed in the RIMA’s product information must be observed. Treatment with MAO inhibitors must not be started until at least 7 days after stopping citalopram. Consult your doctor about this. (See section “Do not take CITALOPRAM PENSA” and “Warnings and precautions”);
buspirone, a medicine used to treat anxiety, due to the risk of serotonin syndrome;
linezolid (an antibiotic) (see section “Do not take CITALOPRAM PENSA”);
medicines for heart rhythm problems (class IA and III antiarrhythmics) (see section “Do not take CITALOPRAM PENSA”);
medicines used to treat mental disorders, antipsychotics (phenothiazine derivatives, haloperidol and pimozide);
other medicines used to treat depression (tricyclic antidepressants);
antimicrobials such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, used to treat infections;
antimalarials such as halofantrine, used to treat an infectious disease called malaria;
certain antihistamines such as astemizole and mizolastine, used to treat allergies. CITALOPRAM PENSA must not be used in combination with medicines that may alter serotonin levels in the brain (see section “Warnings and precautions”):
sumatriptan and similar medicines, used to treat headache (migraine), oxytriptan and tryptophan;
lithium, used to treat certain mental disorders (mania);
tramadol, a medicine used to treat severe pain. Inform your doctor, in particular, if you are taking, have recently taken or might take the following medicines. Some medicines may alter the action of other medicines, and this may sometimes cause serious adverse reactions (see section “Warnings and precautions”):
products containing St. John’s wort ( Hypericum perforatum ), used for depression;
medicines used to thin the blood (anticoagulants and antiplatelet agents) such as acetylsalicylic acid, warfarin, dipyridamole, ticlopidine and/or medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs);
neuroleptics (phenothiazines, butyrophenones, thioxanthenes), used to treat certain mental disorders;
certain medicines used to treat depression (desipramine, imipramine), bupropion,
other antidepressive medicines, serotonin reuptake inhibitors (SSRIs),
mefloquine, used to treat malaria;
medicines that reduce potassium or magnesium levels in the blood (hypokalemia/hypomagnesemia), conditions that increase the risk of arrhythmias;
medicines such as flecainide, propafenone and metoprolol (used to treat heart problems and irregular heartbeat) and certain antidepressants such as desipramine, clomipramine and nortriptyline or antipsychotics such as

risperidone, thioridazine and haloperidol, because a dose adjustment of these medicines may be necessary.

Cimetidine, lansoprazole, omeprazole, esomeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause an increase in blood levels of citalopram.

CITALOPRAM PENSA with food and drink and alcohol
This medicine can be taken regardless of meals (see section 3 “How to take CITALOPRAM PENSA”).
Do not consume alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy unless absolutely necessary and only after careful evaluation of risks and benefits by your doctor, as it may cause serious problems for your baby.
Ensure that your midwife and/or doctor know that you are being treated with CITALOPRAM PENSA.
If you have taken this medicine during the last stages of pregnancy, your baby may experience breathing difficulties, apnea, bluish skin colour (cyanosis), seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar (hypoglycemia), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, continuous crying, drowsiness and sleep difficulties.
When taken during pregnancy, particularly during the last three months, medicines such as CITALOPRAM PENSA 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 CITALOPRAM PENSA 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 PENSA 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 PENSA”).
Breastfeeding
Citalopram passes into breast milk in small amounts. There is a risk that this medicine may affect the newborn. If you are taking CITALOPRAM PENSA, consult your doctor before breastfeeding.
Male fertility
In animal studies, citalopram has been shown to reduce sperm quality. This effect reverses upon discontinuation of treatment (see section “Possible side effects”). To date, no impact on fertility has been observed.
Driving and using machines
This medicine may affect your ability to drive or operate machinery, as it may impair your judgment and reaction time in dangerous situations. Therefore, do not drive or operate machinery until you are certain of the effects of CITALOPRAM PENSA on you. If you have any further doubts, consult your doctor or pharmacist.
CITALOPRAM PENSA contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take CITALOPRAM PENSA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
CITALOPRAM PENSA may be taken with or without food.
Your doctor will adjust the dose and duration of treatment according to your individual needs. Do not change the dose without first consulting your doctor (see section “If you stop taking CITALOPRAM PENSA”).

Treatment of depression: the recommended dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg once daily, depending on your response to therapy. The effect of the medicine usually becomes apparent within 2–4 weeks after starting treatment, and treatment should generally continue for at least 4–6 months to manage symptoms of mood disorders. If you suffer from recurrent unipolar depression, longer-term maintenance treatment may be necessary to prevent relapse.
Treatment of panic attacks (panic disorder): the recommended initial dose is 10 mg once daily for the first week of treatment. Thereafter, your doctor may increase the dose to 20 mg once daily, up to a maximum of 40 mg once daily, depending on your response to therapy. If you suffer from anxiety with panic attacks, prolonged treatment may be required based on medical assessment. If you have insomnia or marked restlessness, your doctor may prescribe sedative medicines.

Do not stop treatment with CITALOPRAM PENSA abruptly to avoid withdrawal symptoms (see section “If you stop taking CITALOPRAM PENSA”).
Use in elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose to 10–20 mg once daily.
The maximum recommended dose is 20 mg once 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 once daily for the first 2 weeks. Thereafter, your doctor may increase the dose up to a maximum of 20 mg once daily, depending on your response to therapy.
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 once daily for the first two weeks of treatment.
Thereafter, your doctor may increase the dose up to a maximum of 20 mg once daily, depending on your response to therapy.
If you take more CITALOPRAM PENSA than you should
If you (or someone else) have taken an excessive dose of CITALOPRAM PENSA, 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 seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (prolongation of QT interval, torsade de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (high fever, tremors, muscle contractions, and anxiety), agitation, reduced heart rate (bradycardia), dizziness, conduction block in the heart, changes in heart activity (QRS prolongation), increased blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis), fatigue, weakness, sedation.
Take the CITALOPRAM PENSA pack or blister with you when you go to the doctor or hospital.
If you forget to take CITALOPRAM PENSA
Do not take a double dose to make up for a forgotten dose.
If you stop taking CITALOPRAM PENSA
Do not stop treatment with CITALOPRAM PENSA suddenly or without first discussing it with your doctor. When stopping treatment with this medicine, the following withdrawal symptoms may occur:

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

These symptoms are usually mild to moderate and resolve spontaneously within 2 weeks, although occasionally they may be severe and persist for a long time (2–3 months or more).
Discontinuation of treatment should be carried out under medical supervision, with doses gradually reduced by your doctor.
If you have any questions 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 everybody will experience them.
Side effects mostly occur during the first or second week of treatment and then usually disappear later.
If during treatment you are thinking about harming yourself or have thoughts of suicide, contact your doctor immediately (see section "Warnings and Precautions").

The following side effects may occur:

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

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

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

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

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

increased appetite, weight gain;
aggression, feeling detached from oneself (depersonalization), hallucinations, mania;
temporary loss of consciousness (syncope);
dilation of the pupil (mydriasis);
reduced heart rate (bradycardia); increased heart rate (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);
seizures (grand mal), involuntary movements (dyskinesia), altered taste;
bleeding (haemorrhage);
inflammation of the liver (hepatitis);
fever (pyrexia).

Frequency not known (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;
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 (akathisia), movement disorders;
visual 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 upon standing quickly due to drop in blood pressure (orthostatic hypotension);
nosebleeds (epistaxis);
bleeding with stools (gastrointestinal or rectal haemorrhage);
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 (galactorrhea) in men;
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, "Pregnancy, breastfeeding and fertility" for further information. An increased risk of fractures has been observed in patients taking this type of medicine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: 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 PENSA

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.
This medicine does not require any special storage conditions.
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. Package contents and other information

What CITALOPRAM PENSA contains
CITALOPRAM PENSA 20 mg film-coated tablets

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

CITALOPRAM PENSA 40 mg film-coated tablets

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

Description of the appearance of CITALOPRAM PENSA and contents of the pack
CITALOPRAM PENSA 20 mg film-coated tablets
Pack sizes of 14 and 28 divisible tablets in blister packs
CITALOPRAM PENSA 40 mg film-coated tablets
Pack size of 14 divisible tablets in blister packs

Marketing Authorization Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milano
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – Quinto De’ Stampi - Rozzano
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Grignano, 43
24041 Brembate (BG)
Italy

Citalopram PensA

Package leaflet: Information for the patient