Citalopram Eg Stada

Italy
Brand name Citalopram Eg Stada
Form drops, oral solution
Active substance / Dosage
CITALOPRAM
Prescription type Prescription only
ATC code
N06AB04
Registration number 036869
Manufacturer EG S.P.A.

Table of Contents

Patient Information Leaflet

Citalopram EG STADA 40 mg/ml oral drops, solution

Generic medicine
Please read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including those not listed in this leaflet, contact 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 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

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

Citalopram EG STADA contains the active substance citalopram hydrochloride, which belongs to a class of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs), which work by regulating mood.
This medicine is indicated for the treatment of the following disorders:

  • depression (endogenous depressive syndromes);
  • prevention of relapses and recurrent episodes of depression;
  • panic attacks (anxiety disorders with panic episodes), including those caused by 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, or linezolid (reversible non-selective MAOI) used to treat infections;
  • if you are taking an irreversible MAOI, do not take Citalopram EG STADA until at least 14 days after stopping treatment with that medicine. If you are taking a reversible MAOI (RIMA), wait the time specified in the package leaflet of that medicine after stopping treatment with the RIMA before taking Citalopram EG STADA. If you need to start treatment with an MAOI, wait at least 7 days after stopping Citalopram EG STADA;
  • if you are taking pimozide, used to treat certain mental disorders;
  • if you have a heart rhythm disorder (prolonged QT interval or congenital long QT syndrome) or if you are taking medicines that may cause these disorders;
  • Citalopram EG STADA must not be taken by children or adolescents under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram EG STADA.
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 3);
  • if you suffer from panic attacks, as you may experience severe anxiety at the beginning of treatment (paradoxical anxiety);
  • if you have low levels of sodium in the blood (hyponatremia);
  • if you have bipolar disorder, as during treatment with Citalopram EG STADA you may experience a shift into the manic phase, characterized by rapid and unusual changes in thinking, physical hyperactivity, and excitement. In this case, stop treatment;
  • if you have epilepsy;
  • if you have diabetes;
  • if you have a bleeding disorder and are prone to bleeding or bruising easily, and if you are taking medicines that worsen these conditions (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 (ECT);
  • if you are taking herbal products containing St. John’s wort (Hypericum perforatum);
  • if you have or have had 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 (narrow-angle glaucoma);
  • if you are taking medicines containing buprenorphine. Using 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”).

Suicidal thoughts and worsening of depression or anxiety disorder
During the first few weeks or immediately after starting treatment, especially
if you have other mental health conditions (psychiatric disorders), you may have thoughts of harming yourself or committing suicide.
For this reason, your doctor should closely monitor you, particularly at the beginning of treatment or
when the dose is increased, 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 behaviour.
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 getting worse or if they are concerned about any changes in your
behaviour.
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 develop 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.
Medicines such as Citalopram EG STADA (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 stopping treatment.
Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age. However,
your doctor may prescribe Citalopram EG STADA to patients under 18 years of age if they consider it the best option for them. In such cases, the child/adolescent must be closely monitored, and you should inform the doctor if symptoms such as suicide attempts, suicidal ideation, or hostility appear or worsen during treatment with Citalopram EG STADA.
Other medicines and Citalopram EG STADA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines.
Do not take this medicine if you are taking the following medicines:

  • medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), because serious, potentially fatal side effects 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, and moclobemide (selective for type A), used to treat depression;
  • buspirone, a medicine used to treat 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 caution and inform your doctor if you are taking the following medicines:

  • lithium and tryptophan, used to treat certain mental disorders, due to the risk of enhanced serotonergic effects;
  • sumatriptan and 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, as it increases the risk of side effects; symptoms such as rhythmic and involuntary muscle contractions, including those controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C may occur. Contact your doctor if you experience such symptoms (see “Warnings and precautions”);
  • products containing St. John’s wort (Hypericum perforatum), used for depression, as they increase the risk of side effects;
  • medicines used to thin the blood (anticoagulants) such as dipyridamole and ticlopidine, as they may increase the risk of bleeding;
  • medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid, as they may increase the risk of bleeding;
  • medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine, and haloperidol;
  • medicines that reduce potassium or magnesium levels in the blood (hypokalemia/hypomagnesemia);
  • certain medicines used to treat depression (bupropion, desipramine, clomipramine, nortriptyline, and other SSRIs);
  • neuroleptics (thioxanthenes and butyrophenones) used to treat certain mental disorders;
  • mefloquine, used to treat malaria;
  • cimetidine, omeprazole, esomeprazole, and lansoprazole, used to treat stomach problems, as a dose adjustment of citalopram may be needed. This may also occur 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 problems and high blood pressure.

Citalopram EG STADA and alcohol
Do not drink alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy unless absolutely necessary, as it may cause serious problems to 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 have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Citalopram EG STADA so they can advise you on what to do.
If you have taken this medicine during the last 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, persistent crying, drowsiness, and sleep disturbances.
When taken during pregnancy, particularly during the last 3 months, 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 after birth.
If this happens to your baby, 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
Take this medicine with caution if you are breastfeeding, as citalopram passes into breast milk.
Fertility
This medicine may cause fertility problems in men. This effect disappears when treatment is stopped (see section “Possible side effects”).
Driving and using machines
This medicine may affect your ability to drive or operate machinery, as it may reduce your judgment and reaction time in dangerous situations. Therefore, be cautious before driving or operating machinery.
Citalopram EG STADA contains alcohol and parahydroxybenzoates
This medicine contains 76 mg of alcohol (ethanol) per ml (= 20 drops), equivalent to 7.6% w/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 parahydroxybenzoates which may cause allergic reactions (including delayed reactions).

3. How to take Citalopram EG STADA

Take this medicine exactly as directed by your doctor or pharmacist. If you
have
any doubts, consult your doctor or pharmacist.
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 EG STADA abruptly to avoid withdrawal symptoms
(see the section “If you stop taking Citalopram EG STADA”).
Your doctor will adjust the dose according to your needs. Do not change the dose without consulting your doctor
(see section “If you stop taking Citalopram EG STADA”).

  • Treatment of depression: the recommended dose is 16 mg (8 drops) daily as a single dose. Your doctor may increase the dose up to a maximum of 32 mg (16 drops) daily, depending on your response to treatment. The effect of the medicine usually appears within 2–4 weeks after starting treatment, which should be continued for at least 4–6 months for symptoms of bipolar disorders. If you suffer from recurrent unipolar depression, maintenance treatment should be continued for longer periods to prevent relapses.
  • Treatment of panic attacks (panic disorder): the recommended initial dose is 8 mg (4 drops) daily for the first week of treatment; thereafter, your doctor may increase the dose to 16 mg (8 drops) daily, up to a maximum of 32 mg (16 drops) daily, depending on your response to treatment. If you suffer from anxiety and experience panic attacks, treatment should be long-term (1 year). If you have insomnia or are highly agitated, your doctor may prescribe sedative medicines.

Use in elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose to 8–16 mg (4–8 drops) daily.
The maximum recommended dose is 16 mg daily.
Use in patients with liver problems (hepatic impairment)
If you have mild or moderate liver problems (mild or moderate hepatic impairment), the recommended initial
dose is 8 mg (4 drops) daily for the first 2 weeks. Thereafter, your doctor may
increase the dose up to a maximum of 16 mg (8 drops) daily, depending on your response to treatment.
If you have severe liver problems (severely reduced liver function), your doctor may decide to reduce the dose.
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 initial
dose is 8 mg (4 drops) daily for the first two weeks of treatment. Thereafter, your
doctor may increase the dose up to a maximum of 16 mg (8 drops) daily, depending on your response to
treatment.
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, 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, 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, reduced heart rate (bradycardia), dizziness, conduction block in the heart, changes in heart activity (prolongation of the QRS complex), increased blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation), muscle damage (rhabdomyolysis), fatigue, weakness, sedation.
If you forget to take Citalopram EG STADA
Do not take a double dose to make up for the forgotten dose.
If you stop taking Citalopram EG STADA
Do not stop treatment with Citalopram EG STADA 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 in arms and legs (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 instability, irritability;
  • visual disturbances.

These symptoms are usually mild to moderate and resolve spontaneously within 2 weeks, although sometimes they may be severe and last for a long time (2–3 months or more).

Discontinuation of treatment should be carried out under the supervision of your doctor, who will gradually reduce the dose over a period of at least 1–2 weeks.
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 gets them.
Side effects occur mainly during the first or second week of treatment and then usually disappear later.
If you have thoughts of harming yourself or of suicide while on treatment, contact 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 sex drive (libido), anxiety, restlessness, confusion (confusional state), abnormal orgasm in women, abnormal dreams (dream disturbances);
  • tremor, tingling sensations in arms and legs (paraesthesia), dizziness, attention disturbances;
  • perception of ringing 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 (depersonalisation), hallucinations, mania;
  • temporary loss of consciousness (syncope);
  • pupil dilation (mydriasis);
  • reduced/increased heart rate (bradycardia/tachycardia);
  • skin irritation (urticaria, rash), hair loss (alopecia), development of red skin spots and bleeding (purpura), skin reactions caused by 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):

  • reduced sodium levels in the blood (hyponatraemia);
  • seizures (grand mal), involuntary movements (dyskinesia), taste disturbances;
  • bleeding (haemorrhage);
  • liver inflammation (hepatitis);
  • fever (pyrexia).

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

  • reduced number of platelets in the blood (thrombocytopenia);
  • allergic reactions, including severe ones (anaphylactic reaction);
  • inappropriate production of antidiuretic hormone (ADH) which regulates urine production;
  • reduced potassium levels in the blood (hypokalaemia);
  • panic attacks, restlessness;
  • teeth grinding (bruxism);
  • suicidal thoughts (suicidal ideation), suicidal behaviour;
  • seizures, serotonin syndrome (high fever, tremors, muscle contractions and anxiety), extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and contractions, feeling restless and inability to remain still even for a very short time (akathisia), movement disorders;
  • visual disturbances;
  • disturbances in heart rhythm (QT interval prolongation, ventricular arrhythmias, including torsade de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or who already suffer from heart disorders;
  • dizziness upon standing quickly due to low blood pressure (orthostatic hypotension);
  • nosebleeds (epistaxis);
  • bleeding with stools (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);
  • heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information;
  • prolonged and painful erection (priapism);
  • increased levels of prolactin hormone in the blood;
  • sudden milk production from the breast (galactorrhoea) in men.

An increased risk of fractures has been reported following the use of Citalopram EG STADA together with other antidepressant medicines known as tricyclic antidepressants (TCA).

Reporting of side effects
If you get any side effects, including ones 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 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 above 25°C. Keep in the original packaging to protect the medicine from light.
The product should be used within 2 months of first opening the bottle. Any excess product should be discarded.
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 EG STADA 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: methylparahydroxybenzoate, propylparahydroxybenzoate, hydroxyethylcellulose, ethanol 96%, purified water.

Description of the appearance of Citalopram EG STADA and package contents
Pack containing one 15 ml bottle of solution.
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan
Manufacturer
ICE S.p.A., Via Cantone Moretti, 29, Località San Bernardo - 10015 Ivrea (TO) - Italy