Citalopram Pensapharma

Italy
Brand name Citalopram Pensapharma
Form drops, oral solution
Active substance / Dosage
CITALOPRAM HYDROCHLORIDE
Prescription type Prescription only
ATC code
N06AB04
Registration number 038199
Manufacturer TOWA PHARMACEUTICAL S.P.A.

Table of Contents

Package leaflet: Information for the patient

CITALOPRAM PENSA PHARMA 40 mg/ml oral drops, solution

Citalopram hydrochloride
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, as it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact 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 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

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

CITALOPRAM PENSA PHARMA contains the active substance citalopram hydrochloride, which belongs to a class of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs).
This medicinal product 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 should 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 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). If you need to start treatment with an MAOI, wait at least 7 days after stopping CITALOPRAM PENSA PHARMA;
  • if you are taking a reversible MAOI (RIMA), take CITALOPRAM PENSA PHARMA only after stopping the RIMA for the time indicated in the RIMA’s package leaflet;
  • if you are taking irreversible MAOIs, including selegiline used to treat Parkinson’s disease, at doses exceeding 10 mg per day. In this case, wait at least 14 days after stopping the MAOI before taking CITALOPRAM PENSA PHARMA;
  • 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;
  • 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 caution and inform your doctor in the following cases:

  • if you are elderly or have kidney or 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, as you may experience severe anxiety at the beginning of treatment (paradoxical anxiety), which usually subsides within the first two weeks of 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 sodium levels in the blood (hyponatremia), especially if you are an elderly woman;
  • if you suffer from bipolar disorder (manic-depressive illness), as during treatment with CITALOPRAM PENSA PHARMA you may experience a shift into the manic phase, characterized by rapid thought changes, 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 must be stopped if you have a seizure or experience more seizures than usual;
  • if you have diabetes. In this case, it may be necessary to adjust the dose of your diabetes medications;
  • if you have a bleeding disorder or 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 St. John’s wort (Hypericum perforatum) products;
  • 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 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 a certain eye condition (closed-angle glaucoma);
  • if you suffer from psychosis with depression.

If you have stable heart disease, you should undergo an electrocardiogram (ECG) before starting therapy; if during treatment you develop signs of cardiac arrhythmia, stop treatment and have an ECG performed.
At the beginning of treatment, insomnia and agitation may occur; in such cases, adjusting the dosage may be helpful.
Medicines such as CITALOPRAM PENSA PHARMA (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
During the first weeks or immediately after starting treatment, especially if you suffer from other mental disorders (psychiatric conditions), 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 changed, 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.
Avoid concomitant use of CITALOPRAM PENSA PHARMA with medicines that have a serotonergic effect, 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 18 years of age.
However, if your doctor decides to prescribe treatment, considering it the best option, you must inform the doctor if symptoms such as suicide attempts, suicidal ideation, or hostility (mainly aggression, oppositional behavior, and anger) appear or worsen during treatment with CITALOPRAM PENSA PHARMA in patients under 18 years of age.
Other medicines and CITALOPRAM PENSA PHARMA
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), because serious, even fatal, adverse reactions may occur, including serotonin syndrome (see sections “Warnings and precautions” and “Possible side effects”). These medicines include selegiline, a selective MAOI used in Parkinson’s disease, linezolid, a reversible (non-selective) MAOI used to treat infections, moclobemide, and buspirone. Selegiline (used to treat Parkinson’s disease) at doses exceeding 10 mg per 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 similar medicines used to treat headache (migraine), tramadol used to treat pain, or products containing St. John’s wort (Hypericum perforatum), used for depression, 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 and tryptophan, used to treat certain mental disorders;
  • ;

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  • medicines used to thin the blood (anticoagulants), or drugs that may 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 may provoke seizures such as:
  • certain medicines used to treat depression (bupropion, tricyclic antidepressants, and serotonin reuptake inhibitors SSRIs);
  • neuroleptics (phenothiazines, thioxanthenes, and butyrophenones) used to treat certain mental disorders;
  • tramadol, used to treat moderate to severe pain;
  • mefloquine, used to treat malaria.
  • Medicines that affect citalopram pharmacokinetics such as:
  • cimetidine, omeprazole, esomeprazole, lansoprazole used to treat stomach problems;
  • flecainide, propafenone, used to treat heart rhythm disorders;
  • metoprolol, used to treat heart problems 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 gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke) may 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 may be pregnant, are planning a pregnancy, or are 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, restlessness, irritability, lethargy, chronic crying, drowsiness, and sleep difficulties. These symptoms usually appear within the first 24 hours after birth.
When taken during pregnancy, particularly towards the end of pregnancy, medicines such as CITALOPRAM PENSA PHARMA 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. If this occurs in your baby, contact your midwife and/or doctor immediately.
If you take CITALOPRAM PENSA PHARMA 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 PENSA PHARMA so they can advise you on what to do.
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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, as citalopram passes into breast milk.
This medicine may affect sperm quality. This effect disappears upon discontinuation of treatment. To date, no impact on fertility has been observed.
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 operating machinery.
CITALOPRAM PENSA PHARMA contains ethanol.
This medicine contains 100 mg of alcohol (ethanol) per ml, 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will adjust the dose according to your needs. Do not change the dose without first consulting your doctor (see section “If you stop taking CITALOPRAM PENSA PHARMA”).

  • Treatment of depression: The recommended dose is 16 mg (8 drops) once daily as a single dose. Your doctor may increase the dose up to a maximum of 32 mg (16 drops) per day, depending on your response to treatment. The effect of the medicine usually appears within 2–4 weeks after starting treatment, which should generally be continued for 4–6 months to manage symptoms of mood disorders. If you suffer from recurrent unipolar depression, longer-term maintenance therapy may be necessary to prevent relapse.
  • Treatment of panic attacks (panic disorder): The recommended starting dose is 8 mg (4 drops) per day during the first week of treatment. Afterwards, your doctor may increase the dose to 16 mg (8 drops) per day, up to a maximum of 32 mg (16 drops) per day depending on your response to treatment. If you suffer from anxiety with panic attacks, treatment should be prolonged (1 year). If you have insomnia or are highly agitated, your doctor will prescribe sedative medicines during the acute phase.

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 PENSA PHARMA abruptly to avoid withdrawal symptoms (see section “If you stop taking CITALOPRAM PENSA PHARMA”).
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Use in elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose by half, for example to 8 mg (4 drops) up to 16 mg (8 drops) per day.
The maximum recommended dose is 16 mg per day.

Use in patients with liver problems (hepatic impairment)
If you have mild or moderate liver problems (mild or moderate hepatic impairment), the recommended starting dose is 8 mg (4 drops) per day for the first two weeks. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) per day depending on your response to treatment.
If you have severe liver problems (severely reduced liver function), your doctor will pay particular attention to dosing.

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 starting dose is 8 mg (4 drops) per day for the first two weeks of treatment. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) per day depending on your response to treatment.

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 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 the QT interval, torsade de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (which may present with symptoms including: high fever, muscle rigidity, tremors, and anxiety), agitation, reduced heart rate (bradycardia), dizziness, electrical 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), rarely muscle damage (rhabdomyolysis), fatigue, weakness, sedation.

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

If you stop taking CITALOPRAM PENSA PHARMA
Do not stop treatment with CITALOPRAM PENSA PHARMA 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 (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 lability, irritability;
  • visual disturbances.

These symptoms are usually mild to moderate and resolve spontaneously within 2 weeks, although sometimes they may be severe and/or persist for a long time (2–3 months or more).
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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 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 mainly occur during the first or second week of treatment and usually diminish thereafter.
If during treatment you are thinking about harming yourself or have thoughts of suicide, contact your doctor immediately and 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, reduced sex drive (libido), anxiety, restlessness, confusion (confusional state), abnormal orgasm in women, unusual dreams (dream disturbances);
  • tremor, tingling sensation (paraesthesia), dizziness, attention disturbances;
  • perception of ringing or buzzing sounds in the ear (tinnitus);
  • yawning;
  • diarrhoea, vomiting, constipation;
  • itching;
  • muscle pain (myalgia) and joint pain (arthralgia);
  • sexual disturbances in men (impotence, ejaculation disorders, failure to ejaculate);
  • fatigue.

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

  • increased appetite, weight gain;
  • aggression, feeling detached from oneself (depersonalization), hallucinations, mania;
  • temporary loss of consciousness (syncope);
  • pupil dilation (mydriasis);
  • decreased/increased heart rate (bradycardia/tachycardia);
  • skin irritation (urticaria, skin rash), hair loss (alopecia), development of red spots and bleeding on the skin (purpura), skin reactions due to 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):

  • reduction in sodium levels in the blood (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 the available data):

  • reduction in the number of platelets in the blood (thrombocytopenia);
  • allergic reactions, even severe ones (hypersensitivity, anaphylactic reaction);
  • inappropriate production of antidiuretic hormone (ADH), which regulates urine production;
  • reduction in potassium levels in the blood (hypokalaemia);
  • panic attacks, restlessness;
  • teeth grinding (bruxism);
  • suicidal thoughts (suicidal ideation), suicidal behaviour;
  • seizures, serotonin syndrome (characterized by symptoms such as high fever, tremors, muscle contractions, and anxiety), extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and 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 the 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;
  • sudden drop in blood pressure when standing up (orthostatic hypotension);
  • nosebleeds (epistaxis);
  • bleeding in the gastrointestinal tract (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 (galactorrhoea) in men;
  • heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, "Pregnancy, breast-feeding and fertility", for further information.

An increased risk of fractures has been reported following the use of CITALOPRAM PENSA PHARMA together with other medicines used to treat depression called tricyclic antidepressants (TCA).

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 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 stated on the pack after “Expiry”.
The expiry date refers to the last day of that month.
The product should be used within 4 months after first opening the bottle; any remaining product
should be discarded.
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.
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6. Package contents and other information

What CITALOPRAM PENSA PHARMA 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: ethanol (96%) and propylene glycol.

Description of the appearance of CITALOPRAM PENSA PHARMA and contents of the pack
Oral drops, solution.
Pack containing one 15 ml bottle of solution with dropper cap.
Marketing Authorization Holder
Pensa Pharma S.p.A. - Via Ippolito Rosellini, 12 - 20124 Milano.
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC).
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