Citalopram Ratiopharm Italia

Package leaflet: information for the patient

Citalopram ratiopharm Italia 40 mg/ml oral drops, solution

citalopram
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 side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Citalopram ratiopharm Italia is and what it is used for

Citalopram ratiopharm Italia contains citalopram, a substance belonging to a group of antidepressant medicines called selective serotonin reuptake inhibitors, used to relieve emotional and psychological distress that causes discomfort and sometimes impairs normal daily activities by acting on mood regulation.
This medicine is indicated for the treatment of the following disorders:

• depression (endogenous depressive syndromes);
• prevention of relapses and recurrent depressive episodes;
• panic attacks (anxiety disorders with panic attacks), with or without agoraphobia (a feeling of fear or intense discomfort experienced by a person when in open or crowded spaces).

Contact your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Citalopram ratiopharm Italia

Do not take Citalopram ratiopharm Italia

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• to treat a child or adolescent under 18 years of age;
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression), selegiline (used in the treatment of Parkinson’s disease) at daily doses exceeding 10 mg/day, or antibiotics containing linezolid (unless your blood pressure is carefully monitored);
• if you suffer from heart rhythm disorders (prolongation of the QT interval or congenital long QT syndrome);
• if you are taking medicines that affect heart rhythm, such as pimozide (used to treat certain mental disorders); your doctor will advise you if any of the medicines you are currently taking fall into this category;
• if you are taking herbal preparations containing St. John’s wort (Hypericum perforatum);
• during pregnancy and breastfeeding, unless your doctor considers it strictly necessary;
• if you suffer from unstable epilepsy and are not receiving treatment for this condition;
• if you are taking other medicines that affect serotonin, such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan; your doctor will advise you if any of these are included among the medicines you are currently taking.

It is important that you consult your doctor if you were previously treated with an irreversible monoamine oxidase inhibitor (MAOI) or a reversible inhibitor of monoamine oxidase (RIMA).
Indeed, Citalopram ratiopharm Italia must not be taken until at least 14 days after stopping treatment with a reversible monoamine oxidase inhibitor (RIMA).
If you were treated with a reversible inhibitor of monoamine oxidase (RIMA), carefully read the package leaflet of the RIMA you were taking to determine the required waiting period before starting citalopram.
After stopping Citalopram ratiopharm Italia, you must wait at least 7 days before starting any of these medicines again (see sections “Warnings and precautions” and “Other medicines and Citalopram ratiopharm Italia”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram ratiopharm Italia.
Pay particular attention and consult your doctor before taking Citalopram ratiopharm Italia if:

• you are elderly;
• you have impaired kidney function (renal insufficiency);
• you have impaired liver function;
• you need to take the medicine to treat panic disorder;
• you have reduced enzyme activity (poor metabolizer for CYP2C19); In these cases, your doctor may consider adjusting your dose.
• you suffer from coagulation disorders or are taking medicines that affect platelet function (anticoagulants), or that may increase the risk of bleeding (your doctor will advise you if any of your current medicines fall into this category), or if you are pregnant (see section “Pregnancy and breastfeeding”);
• you have diabetes;
• you are undergoing concomitant electroconvulsive therapy (electroshock);
• you suffer from a psychotic disorder (a severe mental condition in which a person loses touch with reality and the ability to think and judge clearly) associated with depressive episodes;
• you have previously experienced suicidal tendencies (suicidal thoughts or self-harming behavior);
• you have impaired heart function (bradycardia, recent acute myocardial infarction, uncompensated heart failure, long QT interval);
• you suffer from electrolyte imbalances, such as low levels of potassium or magnesium in the blood (hypokalemia and hypomagnesemia);
• you suffer from a condition characterized by a marked increase in eye pressure called “closed-angle glaucoma,” or if you have previously had glaucoma;
• you suffer from epilepsy (under control with specific medications).

If you suffer from chronic heart disease, your doctor will check your heart function (including performing an echocardiogram) before starting treatment with Citalopram ratiopharm Italia.
Also consult your doctor if, during the first weeks of treatment, you develop a condition characterized by restlessness and inability to sit still (akathisia), as increasing the dose could be harmful. Insomnia and agitation may also occur at the beginning of treatment.
Medicines such as Citalopram ratiopharm (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 persisted after discontinuation of treatment.
It is important that you consult your doctor if you were previously treated with a monoamine oxidase inhibitor (MAOI) or a reversible inhibitor of monoamine oxidase (RIMA); see also section “Do not take Citalopram ratiopharm Italia”.

Furthermore, you must stop treatment and contact your doctor immediately if:

• you experience changes in heart rhythm (cardiac arrhythmia);
• you suffer from bipolar disorder and develop persistent manic behavior during treatment;
• you develop epileptic seizures;
• you suffer from epilepsy and the number of seizures increases;
• you develop serotonin syndrome (excessive accumulation of serotonin in your body), a potentially life-threatening condition characterized by symptoms such as agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, brief and involuntary muscle contractions (myoclonus), including those controlling eye movements, increased muscle contraction, and a marked rise in body temperature (hyperthermia) (see “Other medicines and Citalopram ratiopharm Italia”).

Suicidal thoughts and worsening of your condition
If you suffer from depression, you may have an increased risk of developing suicidal thoughts and self-harming behaviors. These thoughts may be more common at the beginning of treatment with antidepressants, as these medicines take several weeks to work—approximately 2–4 weeks, sometimes longer.
This is more likely if:

• you have previously had suicidal thoughts or attempted suicide or self-harm;
• you are under 25 years of age and suffer from psychiatric disorders treated with an antidepressant (such as citalopram).

It is important that you (and people close to you) immediately inform your doctor if your condition worsens, or if you experience suicidal thoughts or behaviors or unusual changes in behavior.
Even if you suffer from panic disorder, your anxiety may initially worsen, but usually improves within the first two weeks of therapy.

It is important to know that when stopping treatment with this medicine, withdrawal symptoms may occur, such as dizziness, sensory disturbances including altered sensation in limbs or other body parts (paresthesia), sleep disturbances (insomnia and vivid dreams), agitation, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, changes in heart rhythm (palpitations), emotional instability, irritability, and visual disturbances. These symptoms usually appear in the first few days after stopping treatment and typically resolve within 2 weeks.
Since withdrawal symptoms are more likely when treatment is stopped abruptly, it is recommended to gradually reduce the dose before stopping treatment completely to minimize the occurrence of such symptoms.

Children and adolescents
The use of citalopram is contraindicated in children or adolescents under 18 years of age, unless the doctor considers it strictly necessary.
If, after careful evaluation, your doctor decides to prescribe Citalopram ratiopharm Italia, the patient must be closely monitored for the risk of developing suicidal behavior and hostility (mainly aggression, oppositional behavior, and anger).

Other medicines and Citalopram ratiopharm Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Citalopram ratiopharm Italia if you are already taking any of the following medicines:

• monoamine oxidase inhibitors (MAOIs) such as selegiline (used in the treatment of Parkinson’s disease), linezolid (an antibiotic), or moclobemide (used to treat depression);
• medicines that affect heart rhythm such as pimozide and other antipsychotics such as phenothiazine derivatives and haloperidol (used to treat certain mental disorders), some antiarrhythmics, some tricyclic antidepressants, some antimicrobials (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, and particularly halofantrine), and some antihistamines (e.g., astemizole, mizolastine);
• St. John’s wort (used as a treatment for depression).

Pay particular attention and inform your doctor if you are taking any of the following medicines:

• buspirone (used for anxiety disorders);
• lithium (used to treat certain mental disorders);
• tryptophan (used to support proper functioning of sleep and mood regulation mechanisms);
• other medicines with serotonergic activity such as tramadol and buprenorphine (strong painkillers), sumatriptan, or other triptans (a group of medicines used for migraine);
• medicines to prevent blood clotting (anticoagulants and antiplatelet agents), including NSAIDs (non-steroidal anti-inflammatory drugs), acetylsalicylic acid, dipyridamole, or ticlopidine;
• medicines that may increase the risk of bleeding (e.g., certain atypical antipsychotics);
• medicines that cause reduced levels of potassium (hypokalemia) and magnesium (hypomagnesemia);
• medicines that may lower the seizure threshold and provoke seizures, such as antidepressants (selective serotonin reuptake inhibitors or SSRIs), neuroleptics (thioxanthenes and butyrophenones), mefloquine, and bupropion;
• medicines that inhibit the liver enzyme CYP2C19, such as omeprazole, esomeprazole, lansoprazole, or cimetidine (used to treat excessive stomach acidity), fluconazole (used to treat fungal infections), and fluvoxamine (an antidepressant);
• medicines metabolized by the CYP2D6 enzyme, such as flecainide, propafenone, and metoprolol (when used for heart failure), or certain CNS-acting medicines, e.g., antidepressants such as desipramine, clomipramine, and nortriptyline, or antipsychotics such as risperidone and thioridazine.

Your doctor will help you determine whether any of the medicines you are taking belong to one of the categories listed above.

Citalopram ratiopharm Italia and alcohol
Concomitant use of alcohol during treatment with this medicine is not recommended.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Citalopram ratiopharm Italia should not be used during pregnancy unless your doctor considers it strictly necessary. If you take Citalopram ratiopharm Italia during the final stages of pregnancy, as directed by your doctor, your newborn may experience breathing difficulties, bluish discoloration of the skin and mucous membranes (cyanosis), breathing pauses (apnea), seizures, unstable body temperature, feeding difficulties, vomiting, low blood sugar levels (hypoglycemia), increased muscle tone (hypertonia), loss of muscle strength (hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, persistent crying, drowsiness, or difficulty sleeping. In addition, there may be an increased risk that your baby develops high blood pressure in the lungs (pulmonary hypertension).
If you take Citalopram ratiopharm Italia 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 ratiopharm Italia so they can advise you on appropriate measures.

Breastfeeding
Use Citalopram ratiopharm Italia with caution during breastfeeding and only after consulting your doctor, as citalopram is excreted in breast milk.

Fertility
Male fertility
This medicine may affect sperm quality, although no changes in fertility have been observed. Reports from patients treated with selective serotonin reuptake inhibitors (SSRIs) have shown that the effect on sperm quality is reversible.

Driving and using machines
Citalopram ratiopharm Italia has a moderate effect on the ability to drive vehicles or operate machinery, as it may reduce judgment and reaction time in dangerous situations. Therefore, exercise caution before driving or operating machinery.

Citalopram ratiopharm Italia 40 mg/ml oral drops, solution contains:

• methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate: may cause allergic reactions (including delayed reactions);
• ethanol: this medicine contains 57.1 mg of alcohol (ethanol) in each 0.8 ml dose (16 drops). The amount in 16 drops of this medicine is equivalent to less than 2 ml of beer and 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Citalopram ratiopharm Italia

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
You must continue taking this medicine for as long as your doctor tells you to, and avoid stopping
treatment abruptly in order to prevent the risk of withdrawal symptoms
(see section “Warnings and precautions”).
Your doctor will determine the correct dose for you based on your health condition.
During treatment, your doctor may adjust the dosage: always follow carefully the prescribed dose.
Each drop contains 2 mg of citalopram.

Depression (endogenous depressive syndromes)
The recommended dose is 16 mg (8 drops) per day.
Your doctor may increase the dose up to a maximum of 32 mg (16 drops) per day, depending on your
response to therapy.
Therapeutic effect usually appears within 2–4 weeks after starting treatment, which should generally be
continued for 4–6 months in cases of bipolar disorders. If you suffer from recurrent unipolar depression,
maintenance therapy should be continued for longer periods to prevent relapses.

Panic attacks (anxiety disorders with panic attacks), with or without agoraphobia
The recommended initial dose is 8 mg (4 drops) per day during the first week of treatment;
afterwards, your doctor will increase the dose to 16 mg (8 drops) per day.
Your doctor may increase the dose up to a maximum of 32 mg (16 drops) per day depending on your
response to therapy.
Full therapeutic effect becomes evident after approximately 3 months of treatment. Panic disorders are
usually treated long-term.
Maintenance of efficacy has been demonstrated with prolonged treatment (up to 1 year).

Elderly patients (over 65 years of age)
If you are elderly, the recommended dose is 8–16 mg (4–8 drops) per day, while the maximum
recommended dose is 16 mg per day (8 drops).

Patients with impaired liver function and slow metabolizers of CYP2C19
If you have liver problems (mild or moderate hepatic insufficiency) or your doctor has informed you that
you are a poor metabolizer of CYP2C19, the recommended initial dose is 8 mg (4 drops) per day for the
first two weeks of treatment.
Your doctor may increase the dose up to a maximum of 16 mg (8 drops) per day depending on your
response to therapy.

Patients with kidney problems
If you have kidney problems, your doctor will determine the most appropriate dosage for you (which is
generally equivalent to the lowest recommended dose).

Method of administration
This medicine should be taken as a single daily dose, at any time of day, and independently of food intake.
The medicine may be mixed with water, orange juice, or apple juice.

How to use the dropper bottle
To deliver the correct dose of medicine, hold the bottle in a vertical position with the opening facing
downwards. If the liquid does not flow, shake the bottle or turn it upside down several times, then repeat
the dispensing procedure as described above.

Use in children and adolescents under 18 years of age
Do not use Citalopram ratiopharm Italia to treat children or adolescents under 18
years of age, unless your doctor considers it strictly necessary.

If you take more Citalopram ratiopharm Italia than you should
In case of accidental ingestion or overdose of this medicine, contact your doctor immediately or go to the
nearest hospital emergency department.
Taking an excessive dose of citalopram together with other medicines or alcohol may result in a fatal
outcome. When taken alone, overdose of citalopram has rarely led to fatal outcomes.
Symptoms of overdose may include: seizures, disturbances in heart function (tachycardia, QT interval or
QRS complex prolongation, cardiac arrest, bradycardia, conduction block in the heart, torsades de
pointes, atrioventricular arrhythmia), drowsiness, coma, vomiting, tremor, low or high blood pressure
(hypotension or hypertension), nausea, serotonin syndrome, agitation, dizziness, pupil dilation in the
absence of light (mydriasis), loss of critical cognitive function (stupor), sweating, bluish discoloration of
skin and mucous membranes (cyanosis), breathing difficulties (hyperventilation).

If you forget to take Citalopram ratiopharm Italia
If you forget to take a dose of the medicine, take it as soon as you remember, unless it is almost time for
your next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Citalopram ratiopharm Italia
Do not stop treatment with Citalopram ratiopharm Italia suddenly or without first discussing it with your
doctor, as withdrawal symptoms may occur (see section “Warnings and precautions”).

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment immediately and contact your doctor if you experience:

• suicidal thoughts and behaviour, or thoughts of harming yourself (self-harm), during therapy. These thoughts may also appear after stopping treatment;
• changes in heart rhythm (cardiac arrhythmia);
• skin rash, itching, difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema). These may be signs of severe allergic reactions (anaphylactic shock);
• a bipolar disorder and a tendency to develop persistent manic behaviour;
• epileptic seizures (grand mal seizures), or an increased number of epileptic seizures than usual, if you already suffer from epilepsy;
• serotonin syndrome (excessive accumulation of serotonin in your body), a potentially life-threatening condition, which manifests with symptoms such as agitation, hallucinations, coma, excessive sweating, tremor, overactive reflexes, brief and involuntary contraction of a muscle or group of muscles (myoclonus), including the muscles controlling eye movements, increased muscle rigidity, and a marked increase in body temperature (hyperthermia).

To help you recognize some of these side effects, it may be helpful to inform a close family member or
friend that you are taking this medicine, and ask them to read this leaflet. You may ask them to alert you if they notice any changes in your behaviour.

Side effects that usually occur especially during the first and second week of treatment and then decrease in intensity or disappear with continued treatment may include:

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

• headache. The following effects are usually related to the dose used:
• drowsiness;
• insomnia (difficulty sleeping);
• dry mouth;
• nausea;
• increased sweating.

Common (may affect up to 1 in 10 people)

• decreased appetite;
• weight loss;
• restlessness;
• reduced sexual desire;
• anxiety;
• nervousness;
• confusion;
• altered orgasm in women;
• abnormal dreams;
• tremor;
• altered sensation in limbs or other parts of the body (paraesthesia);
• dizziness;
• attention disturbances;
• unpleasant ringing sensation in the ears (tinnitus);
• increased tendency to yawn;
• diarrhoea (this effect is related to the dose used);
• vomiting;
• constipation;
• itching;
• pain localized in one or more muscles (myalgia);
• joint pain (arthralgia);
• sexual dysfunction in men (impotence, ejaculation disorders, failure to ejaculate);
• fatigue (this effect is related to the dose used).

Uncommon (may affect up to 1 in 100 people)

• increased appetite;
• weight gain;
• aggression;
• sensation that things are not real (depersonalization);
• hallucinations;
• manic behaviour;
• fainting (syncope);
• dilation of the pupil of the eye in the absence of light (mydriasis);
• changes in heart rate (bradycardia or tachycardia);
• skin irritation (urticaria, skin rash);
• hair loss (alopecia);
• small red or purplish spots spread over the skin, with or without joint pain, muscle pain, weakness and fever; these may be symptoms of inflammation of blood vessel walls (purpura);
• immune system reaction to sunlight causing a skin rash accompanied by itching (photosensitivity reaction);
• difficulty urinating (urinary retention);
• prolonged and heavy menstrual periods in women (heavy menstrual flow);
• swelling due to fluid accumulation (oedema).

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

• reduced levels of sodium in the blood (hyponatraemia);
• generalized tonic-clonic seizures (grand mal);
• involuntary movement disorders (dyskinesia);
• taste disturbances (dysgeusia);
• bleeding (haemorrhage);
• altered liver function (hepatitis);
• fever (pyrexia).

Frequency not known (cannot be estimated from the available data)

• reduced number of platelets in the blood (thrombocytopenia);
• allergic reactions, including severe reactions (anaphylactic reaction);
• altered production of ADH hormone;
• increased levels of prolactin hormone in the blood (hyperprolactinaemia);
• reduced potassium levels (hypokalaemia);
• panic attacks;
• suicidal ideation and suicidal behaviour;
• restlessness;
• teeth grinding (bruxism);
• epileptic seizures;
• extrapyramidal system disorders (involuntary movements, tremors, muscle rigidity, and muscle contractions);
• restlessness and inability to sit still (akathisia);
• movement disorders;
• visual disturbances;
• heart function disorders (prolongation of QT interval, ventricular arrhythmias, including torsade de pointes);
• sudden drop in blood pressure upon rapidly changing from a lying or sitting position to standing (orthostatic hypotension);
• nosebleeds (epistaxis);
• gastrointestinal or rectal bleeding;
• altered liver function test results;
• appearance of bruises (ecchymoses);
• angioedema;
• heavy uterine bleeding unrelated to menstruation and occurring outside the menstrual period (intermenstrual bleeding);
• prolonged and painful erection not associated with sexual arousal and not followed by ejaculation (priapism);
• milk production and discharge from the mammary gland in men (galactorrhoea);
• increased risk of bone fractures;
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy and breastfeeding” for further information.

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 ratiopharm Italia

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Keep the medicine in the original packaging to protect it from light.
Use the product within 4 months after first opening the bottle.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Citalopram ratiopharm Italia contains

• The active substance is citalopram hydrochloride. 1 ml (20 drops) of solution contains citalopram hydrochloride 44.48 mg (equivalent to citalopram 40 mg);
• The other components are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol 96 percent, hydroxyethylcellulose, purified water.

Description of the appearance of Citalopram ratiopharm Italia and package contents
Citalopram ratiopharm Italia 40 mg/ml oral drops, solution is supplied in a box containing a bottle of 15 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands
Manufacturer
ICE S.p.A. - Via Cantone Moretti, 29 10015 - Ivrea (TO) - Italy