Citalopram Hexal AG

Package leaflet: Information for the patient

Citalopram Hexal AG 40 mg/ml oral drops, solution

Equivalent medicinal product
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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Citalopram Hexal AG is and what it is used for

Citalopram Hexal AG contains the active substance citalopram, 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 attacks), including those caused by fear of open spaces (agoraphobia).

2. What you need to know before taking Citalopram Hexal AG

Do not take Citalopram Hexal AG

• if you are allergic to citalopram 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). If you need to start treatment with an MAOI, wait at least 7 days after stopping Citalopram Hexal AG;
• if you are taking a reversible MAOI (RIMA), take Citalopram Hexal AG only after the time interval specified in the RIMA’s package leaflet has passed since discontinuation;
• if you are taking irreversible MAOIs, including selegiline used to treat Parkinson’s disease, at doses exceeding 10 mg/day. In this case, take Citalopram Hexal AG at least 14 days after stopping the MAOI;
• if you are using linezolid, a medicine used to treat infections;
• if you suffer from a heart rhythm disorder (prolonged QT interval or congenital long QT syndrome) or if you are taking medicines that may cause these conditions;
• if you are taking pimozide, used to treat certain mental disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Hexal AG, especially if you:

• have previously experienced bleeding problems or are taking medicines that affect blood clotting or increase the risk of bleeding, if you tend to bleed easily or bruise easily, or if you are pregnant (see "Pregnancy, breastfeeding and fertility"). Take this medicine with caution and inform your doctor if:
• you are elderly or suffer from kidney or liver problems. In these cases, your doctor will adjust the dose (see section 3);
• you suffer from panic attacks, as you may experience worsening anxiety symptoms at the beginning of treatment (paradoxical anxiety);
• you have low sodium levels in the blood (hyponatremia);
• you suffer from bipolar disorder (manic-depressive illness), as during treatment with Citalopram Hexal AG you may experience a switch into the manic phase, characterized by rapid and unusual changes in thinking, physical hyperactivity and excitement. In this case, stop treatment;
• you suffer from epilepsy;
• you have diabetes;
• you have a coagulation disorder and are at risk of bleeding (hemorrhage), or if you are taking medicines that worsen these conditions (see sections “Other medicines and Citalopram Hexal AG”);
• you are undergoing electroconvulsive therapy (electroshock);
• you are taking St. John’s wort (Hypericum perforatum) products;
• you suffer or have suffered from heart problems (bradycardia, uncompensated heart failure) or have recently had a heart attack (acute myocardial infarction);
• 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;
• you have a specific eye condition (closed-angle glaucoma).

Medicines such as Citalopram Hexal AG (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4).
In some cases, these symptoms may persist after discontinuation of treatment.

Suicidal thoughts and worsening of depression or anxiety disorder
During the first few weeks or immediately after starting treatment, especially if you suffer from other mental disorders (psychiatric conditions), you may have thoughts of harming yourself or committing suicide. For this reason, your doctor should closely monitor you, particularly at the beginning of treatment, when the dose is increased, or if you have previously experienced such symptoms, or if you are young (under 25 years of age). Inform your doctor immediately if you experience these symptoms or if someone caring for you notices changes in your behavior.
It may be helpful to inform a relative or close friend that you suffer from depression or an anxiety disorder and ask them to read this leaflet. You may ask them to tell you if they think your depression or anxiety is worsening or if they are concerned about any changes in your behavior.
Within the first few weeks of treatment, you may develop akathisia, characterized by restlessness, distress, a constant need to move, and inability to sit still or remain motionless. If you experience these symptoms, contact your doctor immediately.
Stop treatment with this medicine immediately and contact 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.

Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age. Patients under 18 years of age have an increased risk of experiencing adverse effects such as suicidal behavior, suicidal ideation, and hostility (mainly aggression, oppositional behavior, and anger). If your doctor considers treatment with Citalopram Hexal AG necessary, they will closely monitor the patient for the emergence of suicidal behaviors.

Other medicines and Citalopram Hexal AG
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), such as selegiline and moclobemide, as serious, even fatal, adverse reactions may occur, including serotonin syndrome (see sections “Warnings and precautions” and “Possible side effects”);
• buspirone (a medicine used for anxiety);
• linezolid (an antibiotic used to treat bacterial infections);
• 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 malaria;
• antihistamines such as astemizole and mizolastine, used to treat allergies.

Do not take this medicine together with sumatriptan and similar medicines used to treat headache (migraine), or with tramadol (used to treat pain), oxitriptan, and tryptophan, as they may increase the risk of adverse effects.

Take this medicine with caution and inform your doctor if you are taking the following medicines:

• lithium and tryptophan, used to treat certain mental disorders;
• products containing St. John’s wort (Hypericum perforatum), used for depression;
• medicines used to thin the blood (anticoagulants);
• medicines that affect platelet function, such as non-steroidal anti-inflammatory drugs (used to relieve inflammation and pain), dipyridamole, ticlopidine, and acetylsalicylic acid;
• medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine, and haloperidol;
• medicines used for depression (tricyclic antidepressants);
• medicines that reduce potassium or magnesium levels in the blood (hypokalemia/hypomagnesemia);
• medicines that may provoke seizures, such as:
• certain medicines used to treat depression (bupropion, desipramine, clomipramine, nortriptyline, and SSRIs);
• neuroleptics (thioxanthenes, butyrophenones, and phenothiazines) used to treat certain mental disorders;
• tramadol, used to treat severe pain;
• mefloquine, used to treat malaria.
• cimetidine, lansoprazole, omeprazole (used to treat gastric ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase blood levels of citalopram;
• flecainide, propafenone, used to treat heart rhythm disorders;
• metoprolol, used to treat heart problems.

Citalopram Hexal AG and alcohol
Do not drink alcohol during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy unless absolutely necessary, as it may cause serious problems for your baby.
If you have taken this medicine during the later stages of pregnancy, your baby may experience breathing difficulties, apnea, bluish skin color (cyanosis), seizures, body temperature fluctuations, feeding difficulties, vomiting, low blood sugar (hypoglycemia), changes in muscle tone (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, nervousness, irritability, lethargy, continuous crying, drowsiness, and sleep disturbances.
When taken during pregnancy, particularly during the last three months, medicines such as Citalopram Hexal AG 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 occur 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 Hexal AG”).
If you take Citalopram Hexal AG close to 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 Hexal AG so they can advise you accordingly.
If you are breastfeeding, take this medicine with caution, as citalopram passes into breast milk.
Citalopram, in animal studies, has been shown to affect sperm quality. This could potentially affect fertility, although no impact on human fertility has been observed (see section “Possible side effects”).

Driving and using machines
This medicine may impair your ability to drive or operate machinery, as it may reduce your judgment and reactivity in dangerous situations. Therefore, be cautious before driving or operating machinery.

Citalopram Hexal AG contains alcohol and parahydroxybenzoates
This medicine contains 72.96 mg of alcohol (ethanol) per 1 ml, equivalent to 9% v/v ethanol. The volume 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 is unlikely to cause significant effects.
This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).

3. How to take Citalopram Hexal AG

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.
Citalopram Hexal AG may be taken with or without food.
Do not stop treatment with Citalopram Hexal AG abruptly. When deciding to discontinue treatment, the dose should be gradually reduced over a period of at least 1–2 weeks or months to avoid withdrawal symptoms (see section “If you stop taking Citalopram Hexal AG”).

Citalopram Hexal AG
Your doctor will adjust the dose according to your individual needs. Do not change the dose without consulting your doctor (see section “If you stop taking Citalopram Hexal AG”).

Use in Adults:

• 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 therapy. The effect of the medicine usually appears within 2–4 weeks after starting treatment. Treatment should be continued for at least 4–6 months to manage symptoms of depressive illness. If you suffer from recurrent unipolar depression, your doctor may decide to extend maintenance therapy for a longer period to prevent relapse.
• Treatment of panic disorder with or without agoraphobia (fear of open spaces): 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 therapy. If you suffer from anxiety with panic attacks, treatment should be continued for a long duration (1 year). If you have insomnia or are highly agitated, your doctor may prescribe sedative medicines.

Use in the Elderly
If you are elderly (over 65 years of age), your doctor will reduce the dose to half of the adult recommended dose.
The maximum recommended dose is 16 mg (8 drops) 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 therapy.
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 therapy.

If you take more Citalopram Hexal AG than you should
If you (or someone else) have taken an excessive dose of Citalopram Hexal AG, or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
An overdose may cause seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (QT interval prolongation, 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 (QRS prolongation), high blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), and increased breathing rate (hyperventilation).

If you forget to take Citalopram Hexal AG
Do not take a double dose to make up for the missed dose.

If you stop taking Citalopram Hexal AG
Do not stop treatment with Citalopram Hexal AG 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 (cephalalgia);
• increased heart rate (palpitations);
• emotional lability, irritability;
• visual disturbances.

These symptoms are usually mild to moderate and resolve spontaneously within 2 weeks, although they can sometimes be severe and last for a long time (2–3 months or more).
Discontinuation of treatment should be carried out under medical supervision, with doses gradually reduced over a period of at least 1–2 weeks.
If you have any 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.
Side effects occur mainly during the first or second week of treatment and then usually disappear later.
If during treatment you think about harming yourself or have thoughts of suicide, seek immediate medical advice and stop taking this medicine.

The following side effects may occur:

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

• drowsiness, difficulty sleeping (insomnia), headache;
• dry mouth, nausea;
• 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;
• tremor, tingling sensations in arms and legs (paraesthesia), dizziness, attention disturbances;
• perception of ringing in the ears (tinnitus);
• yawning;
• diarrhoea, vomiting, constipation;
• itching;
• muscle pain (myalgia) and joint pain (arthralgia);
• sexual dysfunction in men (impotence, ejaculation disorders, failure to ejaculate);
• fatigue.

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

• increased appetite, weight gain;
• aggression, feeling detached from oneself (depersonalization), hallucinations, mania;
• temporary loss of consciousness (syncope);
• dilation of the pupil (mydriasis);
• decreased/increased heart rate (bradycardia/tachycardia);
• skin irritation (urticaria, rash), hair loss (alopecia), development of red skin spots and bleeding (purpura), skin reactions caused by sun exposure (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);
• inflammation of the liver (hepatitis);
• fever (pyrexia).

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

• reduced number of platelets in the blood (thrombocytopenia);
• allergic reactions, even 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 unable to remain still even for a very short time (akathisia), movement disorders;
• visual disturbances;
• disturbances in heart rhythm (prolongation of QT interval, ventricular arrhythmias, including torsades de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or those who already have heart conditions;
• dizziness upon standing quickly due to a drop in blood pressure (orthostatic hypotension);
• nosebleeds (epistaxis);
• bleeding with stools (gastrointestinal or rectal haemorrhage);
• abnormal liver function tests;
• bruising (ecchymosis), swelling of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema);
• irregular menstrual periods in women (metrorrhagia);
• prolonged and painful erection (priapism), sudden milk production from the breast (galactorrhea) in men;
• severe vaginal bleeding immediately after childbirth (postpartum haemorrhage); see Pregnancy, breastfeeding and fertility in section 2 for further information.

An increased risk of fractures has been reported following the use of Citalopram Hexal AG together with other medicines used to treat depression known as tricyclic antidepressants (TCA).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Citalopram Hexal AG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the bottle in the outer packaging to protect the medicine from light.
The product should be used within 16 weeks of first opening the bottle. Any excess product must be discarded.
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 Hexal AG 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, ethanol, hydroxyethylcellulose, purified water.

Description of the appearance of Citalopram Hexal AG and package contents
Pack containing one 15 ml glass bottle with dropper for oral solution.
Marketing Authorization Holder
HEXAL AG - Industriestrasse, 25 - 83607 Holzkirchen (Germany)
Representative in Italy: Sandoz S.p.A. - Largo U. Boccioni, 1 - 21040 Origgio (VA)
Manufacturers
ABC Farmaceutici S.p.A. Canton Moretti 29, Località San Bernardo - 10015 Ivrea (TO)