Citalopram Ratiopharm

Package leaflet: Information for the patient

Citalopram ratiopharm 20 mg film-coated tablets, 40 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, 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:

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

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

Citalopram ratiopharm contains citalopram, a substance belonging to a group of antidepressant medicines
called selective serotonin reuptake inhibitors, used to relieve emotional and psychological discomfort
states that cause distress and sometimes limit 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 episodes), with or without agoraphobia (a feeling of fear or intense discomfort experienced by a person when in large open spaces).

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

2. What you should know before taking Citalopram ratiopharm

Do not take Citalopram ratiopharm

• 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, unless your doctor considers it strictly necessary;
• 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 disturbances in heart rhythm (prolongation of the QT interval or congenital long QT syndrome);
• if you are taking medicines that cause disturbances in heart rhythm, such as pimozide (used to treat certain mental disorders); your doctor will inform you if any of your regularly taken medicines fall into this category;
• if you are taking herbal preparations containing St. John’s Wort;
• during pregnancy or breastfeeding, unless your doctor considers it strictly necessary;
• if you suffer from epilepsy and are not taking medication for this condition;
• if you are taking other medicines that affect serotonin, such as medicines called triptans or tryptophan; your doctor will inform you if any of your regularly taken medicines fall into this category.

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

• you are elderly;
• your kidney function is impaired (renal insufficiency);
• your liver function is impaired;
• you need to take the medicine to treat panic disorder;
• you have reduced enzyme activity (poor metabolizer regarding 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 inform you if any of your regularly taken medicines fall into this category), or if you are pregnant (see section “Pregnancy and breastfeeding”);
• you have diabetes;
• you are undergoing concomitant electroconvulsive therapy (ECT);
• 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 shown suicidal tendencies (suicidal thoughts or tendency to harm yourself);
• your heart function is impaired (bradycardia, recent acute myocardial infarction, uncompensated heart failure);
• you suffer from electrolyte imbalances, such as low levels of potassium or magnesium in the blood (hypokalemia and hypomagnesemia);
• you suffer from a disease characterized by a marked increase in eye pressure called “closed-angle glaucoma,” or if you have previously had glaucoma;
• you suffer from epilepsy (controlled with specific medications).

If you suffer from chronic heart disease, before starting treatment with
Citalopram ratiopharm, your doctor will check your heart function properly (including
an echocardiogram).
Also, consult your doctor if, during the first weeks of treatment, you develop
a condition characterized by restlessness and inability to sit still or remain calm (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-norepinephrine 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.
It is important that you consult your doctor if you were previously treated with an irreversible monoamine oxidase inhibitor (MAOI) or a reversible monoamine oxidase inhibitor (RIMA).
Indeed, Citalopram ratiopharm must not be taken within 14 days after stopping treatment with a reversible monoamine oxidase inhibitor (MAOI).
If, instead, you were treated with a reversible monoamine oxidase inhibitor (RIMA), read carefully the package leaflet of the RIMA you were taking to determine the waiting period before starting citalopram.
After stopping Citalopram ratiopharm, you must wait at least 7 days before starting one of these medicines again.
Furthermore, you must stop treatment and contact your doctor immediately if:

• disturbances in heart rhythm (cardiac arrhythmia) occur;
• you suffer from bipolar disorder and during treatment you tend to develop persistent manic behavior;
• you develop epileptic seizures;
• you suffer from epilepsy and the number of epileptic episodes increases;
• you develop serotonin syndrome (excessive accumulation of serotonin in your body), a potentially life-threatening condition manifested by symptoms such as agitation, hallucinations, excessive sweating, tremor, exaggerated reflexes, brief and involuntary contraction of a muscle or group of muscles (myoclonus), including muscles controlling eye movements, increased muscle contraction, and a marked rise in body temperature (hyperthermia) (see “Other medicines and Citalopram ratiopharm”). Suicidal thoughts and worsening of your clinical condition If you suffer from depression, you may be at increased risk of developing suicidal thoughts and behaviors and self-harm. These thoughts may be more frequent at the beginning of treatment with antidepressants, as these medicines take several weeks to work—approximately 2–4 weeks, but sometimes longer. This is more likely to occur 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). Even if you suffer from panic disorders, your anxiety may initially worsen, improving within the first two weeks of therapy.

It is important to know that upon discontinuation of treatment with this medicine, withdrawal symptoms may occur, such as dizziness, sensory disturbances including altered sensitivity of limbs or other body parts (paresthesia), sleep disturbances (insomnia and unusually vivid dreams), agitation, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, disturbances in heart rhythm (palpitations), emotional instability, irritability, and visual disturbances. These symptoms usually appear within the first few days after stopping treatment and typically resolve within 2 weeks.
Since the onset of such withdrawal symptoms is more likely when treatment is stopped abruptly, it is recommended to gradually reduce the dose over time to minimize the occurrence of these 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, the doctor decides to prescribe Citalopram ratiopharm, 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Citalopram ratiopharm 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 cause disturbances in 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, 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:

• lithium (used to treat certain mental disorders);
• tryptophan (used to support proper functioning of mechanisms regulating sleep and mood);
• other serotonergic drugs 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., some atypical antipsychotics);
• medicines that cause a reduction in potassium (hypokalemia) and magnesium (hypomagnesemia) levels;
• medicines that may lower the seizure threshold (e.g., 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 gastric acidity), fluconazole (used to treat fungal infections), and fluvoxamine (an antidepressant);
• medicines metabolized by the CYP2D enzyme such as flecainide, propafenone, and metoprolol (when used in heart failure) or certain CNS-acting medicines, for example, 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 above-mentioned categories.

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

Pregnancy and breastfeeding
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.

Pregnancy
You may take Citalopram ratiopharm during pregnancy if your doctor considers it strictly necessary. If you take Citalopram ratiopharm 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), difficulty breathing (apnea), seizures, unstable body temperature, feeding difficulties, vomiting, low blood glucose levels (hypoglycemia), increased muscle tone (hypertonia), loss of muscle strength (hypotonia), exaggerated reflexes (hyperreflexia), tremors, nervousness, irritability, lethargy, persistent crying, drowsiness, or difficulty sleeping. Additionally, there may be an increased risk that your baby develops high blood pressure in the lungs (pulmonary hypertension).
If you take Citalopram ratiopharm 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 treating doctor or midwife that you are taking Citalopram ratiopharm so they can advise you accordingly.

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

Driving and using machines
Citalopram ratiopharm may have a moderate effect on the ability to drive vehicles or operate machinery.

3. How to take Citalopram ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, 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.

Depression (endogenous depressive syndromes)
The recommended dose is 20 mg (1 tablet) per day.
Your doctor may increase the dose up to a maximum of 40 mg (2 tablets) per day, depending on your response to treatment.
The therapeutic effect usually appears within 2–4 weeks after starting treatment, which should normally be continued for 4–6 months in cases of manic-depressive illness. 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 10 mg (half a tablet) per day during the first week of treatment; thereafter, your doctor will increase the dose to 20 mg (1 tablet) per day.
Your doctor may increase the dose up to a maximum of 40 mg (2 tablets) per day, depending on your response to treatment.
Full therapeutic effect becomes apparent after approximately 3 months of treatment. In disorders involving panic attacks, treatment is usually long-term.
Sustained efficacy has been demonstrated with prolonged treatment (up to 1 year).

Elderly patients (over 65 years)
If you are elderly, the recommended dose is 10–20 mg (½–1 tablet) per day, while the maximum recommended dose is 20 mg per day (1 tablet).

Patients with impaired liver or kidney function and slow metabolizers of CYP2C19
If you have liver problems (mild or moderate hepatic insufficiency) or if your doctor has told you that you are a slow metabolizer of CYP2C19, the recommended initial dose is 10 mg (½ tablet) per day for the first two weeks of treatment.
Your doctor may increase the dose up to a maximum of 20 mg (1 tablet) per day, depending on your response to treatment.
If you have kidney problems, your doctor will advise you on the lowest appropriate dosage.
The tablet can be divided into equal parts.

Instructions for use

The medicine should be taken as a single daily dose, at any time of day and regardless of food intake.
Use in children and adolescents under 18 years of age
Do not use Citalopram ratiopharm to treat a child or adolescent under 18 years of age unless your doctor considers it strictly necessary.
If you take more Citalopram ratiopharm than you should
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go immediately to the nearest hospital.
Overdose of citalopram taken together with other medicines or alcohol may result in a fatal outcome. When taken alone, overdose of citalopram has rarely resulted in a fatal outcome.
Symptoms of overdose may include: seizures, changes 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 the skin and mucous membranes (cyanosis), breathing problems (hyperventilation).
If you forget to take Citalopram ratiopharm
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 forgotten dose.
If you stop taking Citalopram ratiopharm
Do not stop treatment with Citalopram ratiopharm suddenly or without first discussing it with your doctor, as withdrawal symptoms may occur (see section “Warnings and precautions”).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• suicidal thoughts or behaviour, or have a desire to harm yourself (self-harm) during treatment. These thoughts may also occur after stopping treatment;
• changes in heartbeat (cardiac arrhythmia);
• skin rash, itching, difficulty breathing (bronchospasm) 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, or a higher than usual number of seizures if you already suffer from epilepsy;
• serotonin syndrome (excessive accumulation of serotonin in your body), a condition that may be fatal, which manifests with symptoms such as agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, brief and involuntary contraction of a muscle or group of muscles (myoclonus), including those controlling eye movements, increased muscle contraction and a marked rise in body temperature (hyperthermia).
  To help you recognize some side effects, it may be helpful to inform a relative or close 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 occur mainly during the first and second week of treatment and then decrease in intensity and disappear with continued treatment may include:
Very common (may affect more than 1 in 10 people)

• drowsiness;
• insomnia, difficulty sleeping;
• dry mouth;
• nausea;
• increased sweating; These effects may vary from person to person and are usually related to the dose used.
• headache.

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 sensation of ringing in the ears (tinnitus);
• increased tendency to yawn;
• diarrhoea (this effect may vary from person to person and is usually related to the dose used);
• vomiting;
• constipation;
• itching;
• pain localized in one or more muscles (myalgia);
• joint pain (arthralgia);
• sexual disorders in men (impotence, ejaculation disorders, failure to ejaculate);
• fatigue (this effect may vary from person to person and is usually related to the dose used).

Uncommon (may affect up to 1 in 100 people)

• increased appetite;
• weight gain;
• aggression;
• feeling 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 purple spots spread across 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 skin rash accompanied by itching (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 levels of sodium in the blood (hyponatraemia);
• involuntary movement disorders (dyskinesia);
• taste disturbances;
• bleeding (haemorrhages);
• impaired liver function (hepatitis);
• fever.

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);
• alteration in ADH hormone production;
• reduced levels of potassium (hypokalaemia);
• panic attacks;
• restlessness;
• teeth grinding (bruxism);
• extrapyramidal system disorders (involuntary movements, tremors, muscle rigidity and muscle contractions);
• restlessness and inability to sit still or remain at rest (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 sitting or lying position to standing (orthostatic hypotension);
• nosebleeds (epistaxis);
• gastrointestinal or rectal bleeding;
• changes in liver function tests;
• appearance of bruises (ecchymoses);
• angioedema;
• heavy, non-menstrual uterine bleeding occurring independently and outside the menstrual period (metrorrhagia);
• prolonged and painful erection not associated with sexual arousal and not followed by ejaculation (priapism);
• production and discharge of milk 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

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. The expiry date refers to the last day of that month.
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 ratiopharm contains
Citalopram ratiopharm 20 mg film-coated tablets

• The active substance is citalopram bromide. One film-coated tablet contains 24.99 mg of citalopram bromide (equivalent to 20 mg of citalopram).

Citalopram ratiopharm 40 mg film-coated tablets

• The active substance is citalopram bromide. One film-coated tablet contains 49.98 mg of citalopram bromide (equivalent to 40 mg of citalopram).

The other components are: mannitol, microcrystalline cellulose, anhydrous colloidal silica, hypromellose, magnesium stearate, titanium dioxide, macrogols, purified water.
Description of the appearance of Citalopram ratiopharm and pack contents
Citalopram ratiopharm 20 mg film-coated tablets are supplied in a box containing 14 or
28 film-coated tablets in blister packs or in a bottle.
Citalopram ratiopharm 40 mg film-coated tablets are supplied in a box containing 14
film-coated tablets in blister packs or in a bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH - Graf-Arco Strasse, 3 - 89079 Ulm (Germany)
Manufacturer
Merckle GmbH Ludwig-Merckle - Strasse 3 - 89143, Blauberen (Germany)
Merckle GmbH - Graf-Arco-Strasse, 3 - 89079 Ulm (Germany)