CITALOPRAM 40 mg /Ml Oral Drops, Solution

Зміст інструкції

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

CITALOPRAM EG STADA 40 mg/ml oral drops, solution

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 EG STADA is and what it is used for
• 2. What you need to know before you take Citalopram EG STADA
• 3. How to take Citalopram EG STADA
• 4. Possible side effects
• 5. How to store Citalopram EG STADA
• 6. Contents of the pack and other information

1. What is Citalopram EG STADA and what is it used for

Citalopram EG STADA contains the active ingredient citalopram hydrochloride, belonging to the class of
antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs), which work by regulating
mood tone.
This medicine is indicated for the treatment of the following conditions:

• depression (endogenous depressive syndromes);
• prevention of relapses and recurrent episodes of depression;
• panic attacks (anxiety disorders with panic attacks) including those caused by the fear of open spaces (agoraphobia).

2. What you need to know before taking Citalopram EG STADA

Do not take Citalopram EG STADA

• if you are allergic to citalopram hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), including selegiline (irreversible MAOI), used to treat Parkinson's disease, linezolid, (reversible - non-selective MAOI) used to treat infections;
• if you are taking an irreversible MAOI, take Citalopram EG STADA at least 14 days after stopping treatment with that medicine. If you are taking a reversible MAOI (RIMA), take Citalopram EG STADA after stopping treatment with the RIMA for the time indicated in the package leaflet of that medicine. If you need to start therapy with an MAOI, wait at least 7 days after stopping treatment with Citalopram EG STADA;
• if you are taking pimozide, used to treat certain mental disorders;
• 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;
• Citalopram EG STADA must not be taken by children or adolescents under the age of 18 years.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram EG STADA.
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 3);
• if you suffer from panic attacks, because you may experience severe anxiety at the beginning of treatment (paradoxical anxiety);
• if you have low levels of sodium in your blood (hyponatremia); if you suffer from manic-depressive syndrome, because during treatment with Citalopram EG STADA you may observe a shift towards the manic phase characterized by rapid and unusual changes in thinking, physical hyperactivity and excitement. In this case, stop treatment;
• if you suffer from epilepsy;
• if you suffer from diabetes;
• if you have a blood clotting problem and are prone to bleeding or bruising easily and if you are taking medicines that worsen these problems (see section “Other medicines and Citalopram EG STADA”), or if you are pregnant (see section “Pregnancy, breastfeeding and 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 (hypokalaemia and hypomagnesaemia). In this case, your doctor will correct these alterations before starting treatment with this medicine;
• if you or someone in your family has an eye disease (narrow-angle glaucoma);
• if you are taking medicines containing buprenorphine. The use of these medicines together with Citalopram EG STADA may lead to serotonin syndrome, a condition that can be fatal (see “Other medicines and Citalopram EG STADA”).

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 must monitor you closely, especially at the beginning of treatment or
when the dose is increased, if you have 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 caring for
you notices changes in your behavior.
It may be helpful to inform a relative or close friend that you are suffering from depression or an anxiety
disorder and that your depression or anxiety is worsening or if they are concerned about any changes in your
behavior.
In the first weeks of treatment, you may experience akathisia, characterized by restlessness, anguish,
a need to move frequently 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.
Medicines such as Citalopram EG STADA (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.

Children and adolescents
This medicine is contraindicated in children and adolescents under the age of 18 years. However, the
doctor may prescribe Citalopram EG STADA to patients under the age of 18 years if they believe this is
the best solution for them. In these cases, the child/adolescent must be carefully monitored and
the doctor informed if symptoms such as suicide attempts, suicidal ideation and hostility appear or worsen
during the intake of Citalopram EG STADA.

Other medicines and Citalopram EG STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

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

• medicines used to treat depression 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 (non-selective) MAOI, a medicine used to treat infections, and moclobemide (type IA selective), used in the treatment of depression;
• buspirone, a medicine used in the therapy of anxiety due to the risk of serotonin syndrome;
• class IA and III antiarrhythmics, medicines used for heart rhythm disorders;
• antipsychotics (such as phenothiazine derivatives, pimozide, 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.

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

• lithium and tryptophan, used to treat some mental disorders, due to the risk of potentiation of the serotonergic effect;
• sumatriptan and other similar medicines, used to treat headaches, and tramadol or medicines containing buprenorphine, used to treat pain. The use of citalopram together with these medicines is not recommended, because it increases the risk of side effects; symptoms such as involuntary and rhythmic muscle contractions, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38°C may occur. Contact your doctor if you experience these symptoms (see “Warnings and precautions”);
• products containing St. John's wort (Hypericum perforatum), used for depression, because they increase the risk of side effects;
• medicines used to thin the blood (anticoagulants) such as dipyridamole and ticlopidine, because they may increase the risk of bleeding;
• medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid, because they may increase the risk of bleeding;
• medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine and haloperidol;
• medicines that reduce the levels of potassium or magnesium in the blood (hypokalaemia/hypomagnesaemia);
• some medicines used to treat depression (bupropion, desipramine, clomipramine and nortriptyline and selective serotonin reuptake inhibitors SSRIs);
• neuroleptics (thioxanthenes and butyrophenones) used to treat some mental disorders;
• mefloquine used to treat malaria;
• cimetidine, omeprazole, esomeprazole and lansoprazole, used to treat stomach problems, because a change in the dose of citalopram may be necessary. This can also happen with other medicines such as fluconazole (used to treat fungal infections), the antidepressant fluvoxamine and the antiplatelet agent ticlopidine;
• flecainide, propafenone, used to treat heart rhythm disorders;
• metoprolol, used to treat heart and high blood pressure problems.

Citalopram EG STADA with alcohol
Do not drink alcohol during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Do not take this medicine if you are pregnant, unless absolutely necessary, as it may
cause serious problems for your baby.
If you take Citalopram EG STADA 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 EG STADA, so they can advise you what to do.
If you have taken this medicine during the last stages of pregnancy, your baby may experience
breathing problems, apnea, bluish skin color (cyanosis), convulsions, changes in body temperature,
difficulty feeding, vomiting, low blood sugar levels (hypoglycemia), changes in muscle tone
(hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, nervousness, irritability,
lethargy, difficulty sleeping and drowsiness.
When taken during pregnancy, especially in the last 3 months of pregnancy, medicines such as
Citalopram EG STADA may increase the risk of a serious condition in newborns called
persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually appear within the first 24 hours of the baby's birth.
If this happens to your baby, you should contact your midwife and/or doctor immediately.
If you take this medicine during pregnancy, avoid abruptly stopping treatment (see
section “If you stop taking Citalopram EG STADA”).
Breastfeeding
If you are breastfeeding, take this medicine with caution as citalopram passes into breast milk.
Fertility
This medicine may cause fertility problems in men. The effect disappears when treatment is stopped
(see section “Possible side effects”).

Driving and using machines
This medicine can impair your ability to drive or operate machinery because it can reduce
your judgment and reactivity in dangerous situations. Therefore, be careful before driving and using machinery.

Citalopram EG STADA contains alcohol and para-hydroxybenzoates
This medicine contains 76 mg of alcohol (ethanol) per ml (= 20 drops) which is equivalent to 7.6% v/v.
The amount in 1 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small
amount of alcohol in this medicine will not produce significant effects.
This medicine contains para-hydroxybenzoates which may cause allergic reactions (including delayed reactions).

3. How to take Citalopram EG STADA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take the drops once a day after mixing them with a little water, orange juice or apple juice.
Do not abruptly interrupt the therapy with Citalopram EG STADA to avoid withdrawal symptoms
(see the paragraph “If you stop taking Citalopram EG STADA”).
The doctor will adjust the dose according to your needs. Do not change the dose without consulting your doctor
(see paragraph “If you stop taking Citalopram EG STADA”).

• 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 must be continued for at least 4-6 months for the symptoms of manic-depressive illnesses. If you suffer from recurrent unipolar depression, maintenance therapy must be continued for longer periods to avoid relapses.
• Treatment of panic attacks (panic disorder):the recommended initial 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.

Use in the elderly
If you are elderly (over 65 years of age), your doctor will reduce the dose to 8-16 mg (4-8 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 initial
dose is 8 mg (4 drops) per day, for the first 2 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), your doctor may decide to
reduce the dose.

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 metabolisers)
If you suffer from problems with the metabolism of medicines (slow CYP2C19 metaboliser), the recommended initial
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 based on your response to the
therapy.

If you take more Citalopram EG STADA than you should
If you (or someone else) have taken an excessive dose of Citalopram EG STADA or if you think a child
may have taken this medicine, immediately notify your doctor or go to the Emergency Room
of the nearest hospital.
An excessive dose can cause convulsions, 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 (high fever, tremors, muscle contractions and anxiety), agitation, decreased heart rate (bradycardia), dizziness, blockage of electrical conduction in the heart, alterations 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), muscle injury (rhabdomyolysis), fatigue, weakness, sedation.

If you forget to take Citalopram EG STADA
Do not take a double dose to make up for a missed dose

If you stop taking Citalopram EG STADA
Do notinterruptthe treatment with Citalopram EG STADA suddenly or without first having
agreed with your doctor. Upon discontinuation of treatment with this medicine, the following withdrawal symptomsmay appear:

• dizziness, sensory disturbances such as a sensation of tingling in the arms and legs (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 last for a long time (2-3 months or more).

Discontinuation 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, consult 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, then
disappear subsequently.
If during treatment you think of harming yourself or have suicidal thoughts, consult your
doctor immediately.
The following side effects may occur:

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

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

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

• decreased appetite, weight loss;
• agitation, reduced sexual desire (libido), anxiety, nervousness, confusion, abnormal orgasm in women, abnormal dreams (sleep disturbance);
• tremor, tingling sensation in the arms and legs (paresthesia), dizziness, attention disorders;
• perception of ringing in the ears (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), hallucinations, 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 people):

• reduced levels of sodium in the blood (hyponatremia);
• convulsions, involuntary movements (dyskinesia), altered taste;
• bleeding (hemorrhage);
• liver inflammation (hepatitis);
• fever (pyrexia).

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

• reduced number of platelets in the blood (thrombocytopenia);
• severe allergic reactions (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 (high fever, tremors, muscle contractions and anxiety), extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and 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 potassium levels in the blood (hypokalaemia) or who already suffer from heart problems;
• feeling of dizziness when getting up quickly due to a drop in blood pressure (orthostatic hypotension);
• nosebleeds (epistaxis);
• blood in the stool (gastrointestinal or rectal bleeding);
• abnormal liver function tests;
• bruising (ecchymosis), swelling of the face, lips, mouth, tongue or throat due to fluid retention (angioedema);
• irregular menstrual periods in women (metrorrhagia);
• heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see section 2 “Pregnancy, breastfeeding and fertility” for further information.
• prolonged and painful erection (priapism), sudden production of milk from the breasts (galactorrhea) in men.

An increased risk of fractures has been reported following the use of Citalopram EG STADA with
other medicines used to treat 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 EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Store in the original packaging to protect the
medicine from light.
The product must be used within 2 months of first opening the bottle. Excess product must
be discarded.
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.

6. Contents of the pack and other information

What Citalopram EG STADA 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: methylparahydroxybenzoate, propylparahydroxybenzoate, hydroxyethylcellulose, ethanol 96%, purified water.

Description of the appearance of Citalopram EG STADA and contents of the pack
Pack containing a 15 ml bottle of solution.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan

Manufacturer
ABC FARMACEUTICI S.p.A. Canton Moretti, 29 – 10090 S. Bernardo d’Ivrea (TO)