Citalopram Sandoz GmbH: detailed information

Package leaflet: Information for the patient

Citalopram Sandoz GmbH 40 mg/ml oral drops, solution

Generic medicine
Please read this leaflet carefully before you start 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 others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Citalopram Sandoz GmbH is and what it is used for
What you need to know before taking Citalopram Sandoz GmbH
How to take Citalopram Sandoz GmbH
Possible side effects
How to store Citalopram Sandoz GmbH
Contents of the pack and other information

1. What Citalopram Sandoz GmbH is and what it is used for

Citalopram Sandoz GmbH 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 episodes), including those caused by fear of open spaces (agoraphobia).

2. What you should know before taking Citalopram Sandoz GmbH

Do not take Citalopram Sandoz GmbH

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) or selegiline (an irreversible MAOI), used to treat Parkinson’s disease: If you have recently taken MAO inhibitors, depending on the type of MAOI, you may need to wait up to 14 days after stopping the MAOI before starting treatment with Citalopram Sandoz GmbH. If you have taken or are currently taking a reversible MAOI (RIMA), take Citalopram Sandoz GmbH only after having discontinued treatment with the RIMA for the time specified in the RIMA’s package leaflet. If you have taken or are currently taking an irreversible MAOI (such as selegiline), you must wait at least 14 days after stopping treatment with that medicine before taking Citalopram Sandoz GmbH. If you are to take selegiline together with Citalopram Sandoz GmbH, you must not exceed the maximum recommended dose of selegiline of 10 mg per day. If you need to start treatment with an MAOI, you must wait at least 7 days after stopping treatment with Citalopram Sandoz GmbH;
if you are taking pimozide, a medicine used to treat certain mental disorders;
if you are taking linezolid (an antibiotic medicine used to treat infections);
if you have a heart rhythm disorder, are born with it, or have been diagnosed with QT interval prolongation visible on electrocardiogram (ECG);
if you are taking medicines that may affect your heart rhythm (See section “Other medicines and Citalopram Sandoz GmbH”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram Sandoz GmbH.
Talk to your doctor before taking Citalopram Sandoz GmbH and take this medicine with
caution:

if you are elderly or suffer from kidney or liver problems. In these cases, your doctor may 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); in such cases, your doctor may adjust the dose of the medicine (See section 3);
if you have low levels of sodium in the blood (hyponatraemia);
if you suffer from bipolar disorder (manic-depressive illness), as during treatment with Citalopram Sandoz GmbH 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 suffer from seizures or epilepsy. In this case, your doctor will monitor you more closely;
if you have diabetes. In this case, your doctor may adjust the dose of your diabetes medicines;
if you have a coagulation disorder and are at risk of bleeding (haemorrhage), and if you are taking medicines that worsen these problems (See sections “Other medicines and Citalopram Sandoz GmbH”);
if you have a tendency to bleed or bruise easily, or if you are pregnant (see section “Pregnancy, breastfeeding, fertility”);
if you are undergoing electroconvulsive therapy (electroshock);
if you are taking herbal remedies containing St. John’s wort ( Hypericum perforatum );
if you suffer 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 the blood (hypokalaemia and hypomagnesaemia). In such cases, your doctor will correct these abnormalities before starting treatment with this medicine;
if you or someone in your family has a certain eye condition (narrow-angle glaucoma);
if you suffer from so-called psychotic depression: symptoms may worsen if you take medicines with serotonergic effects. Concomitant use of such medicines, by enhancing the effects of Citalopram Sandoz GmbH, may lead to the onset of so-called “serotonin syndrome” (see section “Other medicines and Citalopram Sandoz GmbH”).
If you have stable heart disease, you should have an electrocardiogram (ECG) before starting treatment.

Suicidal thoughts 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 disorders (psychiatric conditions), you may have thoughts of harming yourself or of suicide. For this reason, your doctor should monitor you closely, especially 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 are suffering 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 change in your behaviour.
During the first weeks of treatment, you may experience akathisia, characterised by a subjectively unpleasant or distressing restlessness, anxiety, and a need to move frequently accompanied by an inability to sit still or remain motionless. If you experience 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 Sandoz GmbH (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after discontinuation of treatment.
Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age. Furthermore, it should be noted that when patients under 18 years of age are treated with this class of medicines, they are at increased risk of adverse effects such as suicide attempts, suicidal thoughts and hostility (mainly aggression, hostile behaviour and anger). However, your doctor may prescribe Citalopram Sandoz GmbH to patients under 18 years of age if they consider it the best option for them. In such cases, you must inform your doctor if symptoms such as suicide attempts, suicidal ideation or hostility appear or worsen during treatment with Citalopram Sandoz GmbH.
Other medicines and Citalopram Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Do not take this medicine if you are taking the following medicines:

medicines called monoamine oxidase inhibitors (MAOIs), used for depression (RIMA, moclobemide) or for Parkinson’s disease (irreversible MAOI, selegiline), because serious, even fatal, adverse effects may occur, including serotonin syndrome. Citalopram Sandoz GmbH must not be administered until 14 days after discontinuation of an irreversible MAO inhibitor. After stopping a reversible MAO inhibitor (RIMA), the time intervals specified in the RIMA’s product information must be observed. Treatment with MAO inhibitors must not be started earlier than 7 days after stopping citalopram. Consult your doctor about this. (See section “Do not take Citalopram Sandoz GmbH” and “Warnings and precautions”);
buspirone, a medicine used to treat anxiety, due to the risk of serotonin syndrome;
linezolid (an antibiotic) (See section “Do not take Citalopram Sandoz GmbH”);
medicines for heart rhythm disorders (Class IA and III antiarrhythmics) (See section “Do not take Citalopram Sandoz GmbH”);
medicines used to treat mental disorders, antipsychotics (phenothiazine derivatives, haloperidol and pimozide);
other medicines used to treat depression (tricyclic antidepressants);
antimicrobials such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, used to treat infections;
antimalarials such as halofantrine, used to treat an infectious disease called malaria;
certain antihistamines such as astemizole and mizolastine, used to treat allergies.

Do not take this medicine together with lithium, used to treat certain mental disorders,
sumatriptan and similar medicines, used to treat headache (migraine), and tramadol, used to treat severe pain, because they increase the risk of adverse effects including serotonin syndrome.
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 and antiplatelet agents) such as acetylsalicylic acid, warfarin, dipyridamole, ticlopidine;
medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid; medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine and haloperidol;
medicines used for depression (tricyclic antidepressants); medicines that reduce blood levels of potassium or magnesium (hypokalaemia/hypomagnesaemia); conditions that increase the risk of arrhythmias;
medicines that may provoke seizures such as:
certain medicines used to treat depression (bupropion, desipramine, clomipramine and 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 and omeprazole, esomeprazole (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 cause an increase in blood levels of citalopram;
flecainide, propafenone, used to treat heart rhythm disorders;
metoprolol, used to treat heart problems and high blood pressure.

Citalopram Sandoz GmbH 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.
Pregnancy
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, apnoea, bluish skin colour (cyanosis), seizures, body temperature changes, feeding difficulties, vomiting, low blood sugar levels (hypoglycaemia), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, continuous crying, drowsiness and difficulty sleeping.
When taken during pregnancy, particularly during the last three months of pregnancy, medicines such as Citalopram Sandoz GmbH 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 Citalopram Sandoz GmbH near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you suffer from bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Citalopram Sandoz GmbH so they can advise you on what to do.
If you take this medicine during pregnancy, avoid abruptly stopping treatment (see section “If you stop taking Citalopram Sandoz GmbH”).
Breastfeeding
If you are breastfeeding, take this medicine with caution because citalopram passes into breast milk.
Fertility
Citalopram has been shown in animal studies to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed so far. (See section “Possible side effects”).
Driving and using machines
This medicine may impair your ability to drive or use machinery because it may reduce your judgement and reactivity in dangerous situations. Therefore, do not drive or operate machinery until you are certain of the effects of Citalopram Sandoz GmbH on you. If you have any further doubts, consult your doctor or pharmacist.
Citalopram Sandoz GmbH contains alcohol and parahydroxybenzoates
This medicine contains 72.96 mg of ethanol (alcohol) in 1 ml of solution (equivalent to 20 drops), which corresponds to 9 vol% ethanol, equivalent to 1.8 ml of beer and 0.8 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 Sandoz GmbH

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 Sandoz GmbH may be taken with or without food.
Do not stop treatment with Citalopram Sandoz GmbH abruptly to avoid withdrawal symptoms (see section “If you stop taking Citalopram Sandoz GmbH”).
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 Sandoz GmbH”).

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, your doctor may decide to extend maintenance therapy for a longer period 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. Afterwards, 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. The maximum effect of the medicine appears after 3 months of treatment. If you suffer from anxiety and experience panic attacks, prolonged treatment may be necessary, based on medical evaluation.

If you suffer from insomnia or are very restless, your doctor will 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. Afterwards, 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 metabolizers of CYP2C19)
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. Afterwards, 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 Sandoz GmbH than you should
If you (or someone else) have taken an excessive dose of Citalopram Sandoz GmbH, 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 can cause seizures, increased heart rate (tachycardia), drowsiness,
heart rhythm disturbances (prolongation of the QT interval, torsades de pointes, atrioventricular arrhythmias), 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, electrical conduction block in the heart, changes in heart activity (prolongation of the QRS interval), increased blood pressure (hypertension), pupil dilation (mydriasis), stupor, sweating, bluish discoloration of the skin (cyanosis), increased breathing rate (hyperventilation).
If you forget to take Citalopram Sandoz GmbH
Do not take a double dose to make up for a forgotten dose.
If you stop taking Citalopram Sandoz GmbH
Do not stop treatment with Citalopram Sandoz GmbH 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 heartbeat (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).

Stopping treatment should be done 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 questions 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 occur mainly during the first or second week of treatment and then usually disappear.
If during treatment you think about harming yourself or have thoughts of suicide, contact your doctor immediately and stop taking the 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 sexual desire (libido), anxiety, nervousness, 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 disorders 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), hallucination, mania;
temporary loss of consciousness (syncope);
dilation of the pupil (mydriasis);
decrease/increase in heart rate (bradycardia/tachycardia);
skin irritation (urticaria, rash), hair loss (alopecia), development of red spots on the skin 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):

reduction in 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 (cannot be estimated from the available data):

reduction in the number of platelets in the blood (thrombocytopenia);
allergic reactions, even severe ones (anaphylactic reaction);
inappropriate secretion of the antidiuretic hormone (ADH) which regulates urine production;
reduction in 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 of restlessness and inability to remain in the same position even for a very short time (akathisia), movement disorders;
visual disturbances;
disturbances in heart rhythm (prolongation of QT interval, ventricular arrhythmias, including torsade de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or in those who already suffer from heart disorders;
dizziness when standing up quickly due to a drop in 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);
prolonged and painful erection (priapism), sudden milk production from the breast (galactorrhoea) in men;
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, “Pregnancy, breastfeeding, fertility” for further information.
An increased risk of fractures has been reported following the use of Citalopram Sandoz GmbH together with other medicines used to treat depression 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 Sandoz GmbH

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 the bottle in the outer packaging to protect the medicine from light.
The product should be used within 4 months of first opening the bottle. Any remaining 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 required. This will help protect the environment.

6. Package contents and other information

What Citalopram Sandoz GmbH 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: methyl 4-hydroxybenzoate, propyl 4-hydroxybenzoate, ethanol, hydroxyethylcellulose, purified water.

Description of the appearance of Citalopram Sandoz GmbH and the contents of the pack
Pack containing one 15 ml glass bottle with dropper for solution.
Marketing Authorization Holder
Sandoz GmbH - Biochemiestrasse, 10 – 6250 Kundl – Austria
Representative in Italy: Sandoz S.p.A. - Largo U. Boccioni, 1 - 21040 Origgio (VA) - Italy
Manufacturer
ABC Farmaceutici S.p.A. - Canton Moretti, 29 – Località San Bernardo – 10015 Ivrea (TO)