CITALOPRAM 40 mg /Ml Оральные Капли, Раствор

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1. CITALOPRAM PENSA PHARMA 40 mg/ml oral drops, solution
   1. What is CITALOPRAM PENSA PHARMA and what is it used for
   2. What you need to know before taking CITALOPRAM PENSA PHARMA
   3. How to take CITALOPRAM PENSA PHARMA
   4. Possible side effects
   5. How to store CITALOPRAM PENSA PHARMA
   6. Contents of the pack and other information

CITALOPRAM PENSA PHARMA 40 mg/ml oral drops, solution

Citalopram hydrochloride

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

CITALOPRAM PENSA PHARMA contains the active ingredient citalopram hydrochloride belonging to the
class of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs).
This medicine is indicated for the treatment of the following conditions:

• depression (endogenous depressive syndromes);
• prevention of relapses and recurrent episodes of depression;
• anxiety disorders with panic attacks with or without agoraphobia (fear of open spaces).

2. What you need to know before taking CITALOPRAM PENSA PHARMA

Do not take CITALOPRAM PENSA PHARMA

• if you are allergic to citalopram hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if the person who needs to take the medicine is a child or adolescent under the age of 18 years;
• if you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs). If you need to start therapy with an MAOI, wait at least 7 days after stopping treatment with CITALOPRAM PENSA PHARMA;
• if you are taking a reversible MAOI (RIMA), take CITALOPRAM PENSA PHARMA after

medicine;

• if you are taking irreversible MAOIs, including selegiline, used to treat Parkinson's disease, in doses higher than 10 mg per day. In this case, wait at least 14 days after stopping treatment with the medicine before taking CITALOPRAM PENSA PHARMA.
• if you are using linezolid, a medicine used to treat infections;
• if you suffer from a heart rhythm disorder (prolongation of the QT interval or congenital long QT syndrome) or if you are taking medicines that can cause these disorders;
• if you are taking pimozide, used to treat certain mental disorders;
• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

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Warnings and precautions
Talk to your doctor or pharmacist before taking CITALOPRAM PENSA PHARMA.
Take this medicine with cautionand tell your doctor in the following cases:

• if you are elderly or suffer from kidney and liver problems. In these cases, your doctor will adjust the dose of the medicine (see section “How to take CITALOPRAM PENSA PHARMA”);
• if you suffer from panic attacks, because you may experience severe anxiety at the beginning of treatment (paradoxical anxiety) which usually subsides within the first two weeks of starting treatment; in such cases it is advisable to start therapy with a lower dose (see section “How to take CITALOPRAM PENSA PHARMA”);
• if you have low levels of sodium in your blood (hyponatremia), especially if you are an elderly female.
• if you suffer from manic-depressive syndrome, because during treatment with CITALOPRAM PENSA PHARMA you may observe a shift towards the manic phase characterized by rapid changes in thought, physical hyperactivity and excitement. In this case, stop treatment;
• if you suffer from epilepsy. In this case, your doctor will monitor you more closely. Treatment with CITALOPRAM PENSA PHARMA should be stopped if you have an epileptic seizure or if you have more epileptic seizures than usual;
• if you suffer from diabetes. In this case, it may be necessary to adjust the dose of the medicines used for diabetes;
• if you have a blood clotting problem and are at risk of bleeding (hemorrhage) and if you are taking medicines that worsen these problems (See section “Other medicines and CITALOPRAM PENSA PHARMA”);
• tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding, fertility”).
• if you are undergoing electroconvulsive therapy (electroshock);
• if you are taking products based on St. John's Wort (Hypericum perforatum);
• if you suffer from 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 your blood (hypokalemia and hypomagnesemia). In this case, the doctor will correct these alterations before starting treatment with this medicine;
• if you or someone in your family has an eye disease (closed-angle glaucoma).
• if you suffer from psychosis with depression.

If you have stable heart disease, you should have an electrocardiogram (ECG) before
starting therapy; if you experience signs of cardiac arrhythmia during treatment with the medicine
stop treatment and have an ECG.
At the beginning of treatment, insomnia and agitation may occur; in such cases, an adjustment of the dosage may be helpful.
Medicines such as CITALOPRAM PENSA PHARMA (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline (SNRIs)) can cause symptoms of
sexual dysfunction (see section 4). In some cases, persistence of these symptoms has been observed
after discontinuation of treatment.

Thoughts of suicide and worsening of your depression or anxiety disorder
During the first few weeks or immediately after starting treatment,
especially if you suffer from other mental health problems (psychiatric disorders), you may think about harming yourself or committing suicide. For this reason, your doctor needs to monitor you closely, especially
at the beginning of treatment or when the dose is changed, if you have already experienced these
disorders in the past and if you are young (under 25 years of age). Immediately tell your doctor if you experience these
disorders or if someone who cares for you notices changes in your behavior.
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It may be helpful to inform a relative or close friend that you are suffering from depression or an anxiety disorder
your depression or anxiety is getting worse or if they are concerned about any changes
in your behavior.
In the first few weeks of treatment, you may experience akathisia, characterized by restlessness,
distress, a need to move often accompanied by an inability to sit or remain still. If
you experience these symptoms, see your doctor immediately.
Immediately stop treatment with this medicine and tell your doctor if you experience
agitation, tremor, involuntary muscle contractions (myoclonus), increased body temperature (hyperthermia). These may be symptoms of a condition called serotonin syndrome.
Avoid concomitant use of CITALOPRAM PENSA PHARMA with medicines with serotonergic effects such as sumatriptan or other triptans, tramadol, oxitriptan and tryptophan (see
section “Other medicines and CITALOPRAM PENSA PHARMA”).

Children and adolescents
This medicine is contraindicated in children and adolescents under the age of 18 years.
However, if the doctor decides to carry out the treatment believing that this is the best solution
you must inform the doctor if symptoms such as suicide attempts, suicidal ideation and hostility
(essentially aggression, oppositional behavior and anger) appear or worsen during
taking CITALOPRAM PENSA PHARMA by a patient under the age of
18 years.

Other medicines and CITALOPRAM PENSA PHARMA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Do not takethis medicine if you are taking the following medicines:

• Medicines called monoamine oxidase inhibitors (MAOIs), because serious side effects, including fatal ones, such as serotonin syndrome, may occur (see sections “Warnings and precautions” and “Possible side effects”). These medicines include selegiline, a selective MAOI used in Parkinson's disease, linezolid, a reversible MAOI (non-selective) used to treat infections, moclobemide and buspirone. selegiline (used to treat Parkinson's disease) in doses higher than 10 mg per day;/day;
• class IA and III antiarrhythmics, medicines used for heart rhythm disorders;
• phenothiazine antipsychotics, and the antipsychotics pimozide and haloperidol, used to treat mental disorders;
• tricyclic antidepressants, used to treat depression;
• antimicrobials such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, used to treat infections;
• antimalarials such as halofantrine, used to treat an infectious disease called malaria;
• antihistamines such as astemizole and mizolastine, used to treat allergies.

Do not take this medicine together with sumatriptan and other similar medicines, used for the treatment
of headache (migraine), tramadol, used for the treatment of pain, and products containing
St. John's Wort (Hypericum perforatum), used for depression, because they increase the risk of
side effects.

Take this medicine with cautionand tell your doctor if you are taking the following medicines:

• lithium and tryptophan, used to treat some mental disorders;
• ;

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• medicines used to thin the blood (anticoagulants), or drugs that can affect platelet function such as dipyridamole, ticlopidine and acetylsalicylic acid;
• medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs or NSAIDs);
• medicines that reduce potassium or magnesium levels in the blood (hypokalemia/hypomagnesemia);
• medicines that can cause seizures such as:
• some medicines used to treat depression (bupropion, tricyclic antidepressants and selective serotonin reuptake inhibitors SSRIs);
• neuroleptics (phenothiazines, thioxanthenes and butyrophenones) used to treat some mental disorders;
• tramadol, used to treat moderate to severe pain;
• mefloquine used to treat malaria.
• Medicines that affect the pharmacokinetics of citalopram such as:
• cimetidine, omeprazole, esomeprazole, lansoprazole used to treat stomach problems;
• flecainide, propafenone, used to treat heart rhythm disorders;
• metoprolol, used to treat heart and high blood pressure
• antidepressants such as desipramine, clomipramine and nortriptyline
• antipsychotics such as risperidone, thioridazine and haloperidol.

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

CITALOPRAM PENSA PHARMA with food and alcohol
Do not drink alcohol during treatment with this medicine.
No effects of food on the absorption and other pharmacokinetic properties of
citalopram have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant unless absolutely necessary,
because it can cause serious problems for your baby.
If you have taken this medicine during the last stages of pregnancy, your baby may
experience respiratory problems, apnea, bluish skin color (cyanosis), convulsions, changes in
body temperature, difficulty feeding, vomiting, low blood sugar
(hypoglycemia), altered muscle tone (hypertonia, hypotonia), increased reflexes (hyperreflexia),
tremors, nervousness, irritability, lethargy, and difficulty sleeping. These
symptoms usually appear within the first 24 hours after the baby's birth.
When taken during pregnancy, especially towards the end of pregnancy, medicines such as
CITALOPRAM PENSA PHARMA can increase the risk of a serious condition in newborns,
called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe
faster and makes it appear bluish. If this happens to your baby, you should contact immediately
the midwife and/or doctor.
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If you take this medicine 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 (easy bleeding). Tell your doctor or midwife that you are taking CITALOPRAM PENSA PHARMA, 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 PHARMA”).
If you are breastfeeding, take this medicine with caution because citalopram passes into breast milk.
This medicine can affect the quality of sperm. The effect disappears with discontinuation of
treatment. No impact on fertility has been observed so far.

Driving and using machines
This medicine can alter your ability to drive vehicles or use machines because it can
reduce your ability to judge and react in dangerous situations. Therefore, be careful before
getting behind the wheel and using machines.

CITALOPRAM PENSA PHARMA contains ethanol.
This medicine contains 100 mg of alcohol (ethanol) per ml which is equivalent to 12.4% v/v. The
amount in the maximum daily dose (0.8 ml or 16 drops) of this medicine is equivalent to
2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce
significant effects.

CITALOPRAM PENSA PHARMA contains propylene glycol
This medicine contains 704 mg of propylene glycol per maximum daily dose equivalent to

• 0.8 ml (16 drops).

3. How to take CITALOPRAM PENSA PHARMA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The doctor will adjust the dose according to your needs. Do not change the dose without consulting your
doctor (see section “If you stop taking CITALOPRAM PENSA PHARMA”).

• Treatment of depression:the recommended dose is 16 mg (8 drops) per day in a single dose. The doctor may increase the dose up to a maximum of 32 mg (16 drops) per day based on your response to therapy. The effect of the medicine generally manifests within 2-4 weeks from the start of treatment, which should generally be continued for 4-6 months for the symptoms of manic-depressive illnesses. If you suffer from recurrent unipolar depression, it may be necessary to continue maintenance therapy for longer periods to avoid relapses.
• Treatment of panic attacks (panic disorder):the recommended starting dose is 8 mg (4 drops) per day, for the first week of treatment, subsequently the doctor may increase the dose to 16 mg (8 drops) per day up to a maximum of 32 mg (16 drops) per day based on your response to therapy. If you suffer from anxiety and experience panic attacks, treatment should be long-lasting (1 year). If you suffer from insomnia or are very restless, your doctor will prescribe sedative medicines in the acute phase.

Take the drops once a day after mixing them with a little water, orange juice or
apple juice.
Do not suddenly stop therapy with CITALOPRAM PENSA PHARMA to avoid withdrawal symptoms
(see section “If you stop taking CITALOPRAM PENSA PHARMA”).
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Use in the elderly
If you are elderly (over 65 years of age), your doctor will reduce the dose by half, for example 8 mg (4 drops) up to
16 mg (8 drops) per day.
The maximum recommended dose is 16 mg per day.

Use in people with liver problems (hepatic insufficiency)
If you suffer from mild or moderate liver problems (mild or moderate hepatic insufficiency), the recommended starting dose is 8 mg (4 drops) per day, for the first two weeks. Subsequently, the
doctor may increase the dose up to a maximum of 16 mg (8 drops) per day based on your
response to therapy.
If you suffer from severe liver problems (severely reduced liver function), the doctor will pay
particular attention to the dosage.

Use in people with kidney problems (renal insufficiency)
If you suffer from kidney problems (renal insufficiency), your doctor will prescribe the minimum recommended dose.

Use in people with problems with the metabolism of medicines (slow CYP2C19 metabolizers)
If you suffer from problems with the metabolism of medicines (slow CYP2C19 metabolizer), the recommended starting dose is 8 mg (4 drops) per day, for the first two weeks of treatment.
Subsequently, the doctor may increase the dose up to a maximum of 16 mg (8 drops) per day in
based on your response to therapy.

If you take more CITALOPRAM PENSA PHARMA than you should
If you (or someone else) have taken an excessive dose of CITALOPRAM PENSA PHARMA or if
you think a child may have taken this medicine, immediately inform your doctor or
go to the Emergency Room of the nearest hospital.
An overdose can cause seizures, increased heart rate (tachycardia), drowsiness,
heart rhythm disturbances (prolongation of the QT interval, torsades de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension),
cardiac arrest, nausea, serotonin syndrome (which can present with symptoms including: high fever, tremors, muscle contractions and anxiety), agitation, decreased heart rate (bradycardia),
dizziness, blockage of electrical conduction in the heart, changes in heart activity (prolongation
of the QRS), increased blood pressure (hypertension), pupil dilation (mydriasis),
stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate
(hyperventilation), rarely muscle injury (rhabdomyolysis), fatigue, weakness, sedation.

If you forget to take CITALOPRAM PENSA PHARMA
Do not take a double dose to make up for a missed dose

If you stop taking CITALOPRAM PENSA PHARMA
Do notstoptreatment with CITALOPRAM PENSA PHARMA suddenly or without
first agreeing it with your doctor. When stopping treatment with this medicine
the following withdrawal symptomsmay occur:

• dizziness, sensory disturbances such as tingling sensation (paresthesia);
• sleep disturbances such as inability to fall asleep (insomnia) and dreams that seem real (vivid dreams);
• agitation or anxiety, tremors, confusion;
• nausea and/or vomiting, diarrhea;
• sweating, headache;
• increased perception of heartbeats (palpitations);
• emotional instability, irritability;
• visual disturbances. These symptoms are generally mild to moderate and resolve on their own within 2 weeks, although they can sometimes be severe and/or last a long time (2-3 months or more).

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The cessation of treatment must take place under the control of the doctor who will gradually reduce the doses
over at least 1-2 weeks.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are most likely to occur during the first or second week of therapy, and then
subsequently lessen.
If you think you are harming yourself or have thoughts of suicide during treatment, see your
doctor immediatelyand stop taking the 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, decreased libido, anxiety, nervousness, confusion, abnormal orgasm in women, abnormal dreams (sleep disturbances);
• tremor, tingling sensation (paresthesia), dizziness, attention disorders;
• perception of ringing or whistling inside the ear (tinnitus);
• yawning;
• diarrhea, vomiting, constipation;
• itching;
• muscle pain (myalgia) and joint pain (arthralgia);
• sexual dysfunction in men (impotence, ejaculation disorders, absent ejaculation);
• fatigue.

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

• increased appetite, weight gain;
• aggression, feeling detached from oneself (depersonalization), hallucination, mania;
• temporary loss of consciousness (syncope);
• pupil dilation (mydriasis);
• decreased/increased heart rate (bradycardia/tachycardia);
• skin irritation (urticaria, rash), hair loss (alopecia), formation of red spots on the skin and bleeding (purpura), skin reactions caused by exposure to the sun (photosensitivity reaction);
• difficulty urinating (urinary retention);
• prolonged and heavy menstrual periods in women (menorrhagia);
• swelling due to fluid retention (edema). Rare(may affect up to 1 in 1,000):
• reduced levels of sodium in the blood (hyponatremia);
• convulsions (grand mal), involuntary movements (dyskinesia), altered taste;
• bleeding (hemorrhage);
• liver inflammation (hepatitis);

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• fever (pyrexia).

Frequency not known(the frequency of which cannot be estimated on the basis of available data):

• reduced number of platelets in the blood (thrombocytopenia);
• allergic reactions, including severe ones (hypersensitivity, anaphylactic reaction);
• inappropriate production of the antidiuretic hormone (ADH) which regulates urine production;
• reduced levels of potassium in the blood (hypokalaemia);
• panic attacks, restlessness;
• teeth grinding (bruxism);
• thoughts of suicide (suicidal ideation), suicidal behavior;
• convulsions, serotonin syndrome (which presents with some symptoms including: high fever, tremors, muscle contractions and anxiety), extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and muscle contractions, feeling of restlessness and inability to remain in the same position even for a short time (akathisia), movement disorders;
• vision disorders;
• heart rhythm disturbances (prolongation of the QT interval, ventricular arrhythmias, including torsade de pointes), especially in women who have low levels of potassium in the blood (hypokalaemia) or who already suffer from heart problems;
• sudden drop in blood pressure when standing up (orthostatic hypotension);
• nosebleeds (epistaxis);
• bleeding from the gastrointestinal tract (gastrointestinal or rectal hemorrhage);
• abnormal liver function tests;
• bruising (ecchymosis), swelling of the face, lips, mouth, tongue or throat due to fluid retention (angioedema);
• irregular menstruation in women (metrorrhagia);
• prolonged and painful erection (priapism), sudden production of milk from the breast (galactorrhea), in men;
• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see paragraph 2, “Pregnancy, breastfeeding, fertility”, for further information. An increased risk of fractures has been reported following the intake of CITALOPRAM PENSA PHARMA with other medicines used for the treatment of depression called tricyclic antidepressants (TCAs).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through 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 PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month.
The product must be used within 4 months of first opening the bottle, any excess product
must be discarded.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
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6. Contents of the pack and other information

What CITALOPRAM PENSA PHARMA contains

• The active ingredient is citalopram hydrochloride. 1 ml contains 44.48 mg of citalopram hydrochloride (equivalent to 40 mg of citalopram).
• The other ingredients are: ethanol (96%) and propylene glycol.

Description of the appearance of CITALOPRAM PENSA PHARMA and contents of the pack
Oral drops, solution.
Pack containing a 15 ml bottle of solution equipped with a dropper cap.

Marketing Authorisation Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milan.

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC).
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