Citalopram Doc Generici: detailed information

Package leaflet: Information for the patient

CITALOPRAM DOC 40 mg/ml oral drops, solution

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CITALOPRAM DOC is and what it is used for

CITALOPRAM DOC contains the active substance citalopram hydrochloride, which belongs to a class of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs). These work by regulating mood.
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 episodes), including those caused by fear of open spaces (agoraphobia)

2. What you should know before taking CITALOPRAM DOC

Do not take CITALOPRAM DOC

if you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6)
if the person taking the medicine is a child or adolescent under 18 years of age
if you are taking other medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), including selegiline, used to treat Parkinson’s disease. In this case, take CITALOPRAM DOC at least 14 days after stopping treatment with the MAOI medicine or for the time specified in the package leaflet of the reversible MAOI. If you need to start therapy with an MAOI, wait at least 7 days after stopping treatment with CITALOPRAM DOC
if you are using linezolid, a medicine used to treat infections, unless you have equipment available to monitor blood pressure
if you suffer from a heart rhythm disorder (QT interval prolongation or congenital long QT syndrome) or if you are taking medicines that may cause these disorders (see section “Other medicines and CITALOPRAM DOC”)

Warnings and precautions
Talk to your doctor or pharmacist before taking CITALOPRAM DOC.
Take this medicine with caution and inform your doctor in the following cases:

if you are elderly or suffer from 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 suffer from psychosis
if you have low levels of sodium in the blood (hyponatremia)
if you suffer from bipolar disorder, as during treatment with CITALOPRAM DOC 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 epilepsy. Stop treatment immediately if you experience epileptic seizures.
if you suffer from diabetes
if you have a coagulation disorder and are at risk of bleeding (hemorrhage), and if you are taking medicines that worsen these problems (see section “Other medicines and CITALOPRAM DOC”), or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”)
if you are undergoing electroconvulsive therapy (electroshock)
if you are taking St. John’s wort (Hypericum perforatum) products
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 (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 an eye condition (closed-angle glaucoma)
if you are taking medicines with serotonergic effects such as sumatriptan, tramadol, buprenorphine and tryptophan (see section “Other medicines and CITALOPRAM DOC”). Stop treatment immediately with these medicines and inform 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 DOC (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 persisted 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 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 these disorders, 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 experience akathisia, characterized by restlessness, distress, a need to move frequently accompanied by an inability to sit still or remain motionless. If you experience these symptoms, contact your doctor immediately.
Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age. However, your doctor may prescribe CITALOPRAM DOC to patients under 18 years of age if they consider it the best option for them. In these cases, you must inform the doctor if symptoms such as suicide attempts, suicidal ideation, or hostility appear or worsen during treatment with CITALOPRAM DOC.
Other medicines and CITALOPRAM DOC
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, as serious, potentially fatal adverse effects may occur, including serotonin syndrome (see sections “Warnings and precautions” and “Possible side effects”):

medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), including selegiline and moclobemide;
buspirone, a medicine used in the treatment of anxiety;
linezolid, an antibiotic.

Do not take this medicine if you are taking the following medicines due to the risk of QT interval prolongation on the electrocardiogram:

class IA and III antiarrhythmics, medicines used for heart rhythm disorders;
phenothiazine antipsychotics, pimozide and haloperidol, used to treat mental disorders;
tricyclic antidepressants, used to treat depression;
antimicrobials such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, used to treat infections;
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) and tramadol, used to treat pain, as they 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, due to the risk of enhanced serotonergic effect;
medicines containing buprenorphine, used in opioid dependence treatment and for pain relief, as they increase the risk of serotonin syndrome, a potentially life-threatening condition. These medicines may interact with CITALOPRAM DOC and you may experience symptoms such as rhythmic involuntary muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, and body temperature above 38°C. Contact your doctor if you experience these symptoms.
products containing St. John’s wort (Hypericum perforatum), as they increase the risk of adverse effects;
medicines used to thin the blood (anticoagulants and antiplatelet agents) such as acetylsalicylic acid, dipyridamole, and ticlopidine, and atypical antipsychotics, as they may increase the risk of bleeding;
medicines used to relieve inflammation and pain, such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
medicines used to treat mental disorders (antipsychotics) such as risperidone, thioridazine, and haloperidol;
medicines used for depression (desipramine, clomipramine, nortriptyline);
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, and serotonin reuptake inhibitors SSRIs such as fluvoxamine);
neuroleptics (thioxanthenes and butyrophenones) used to treat certain mental disorders;
tramadol, used to treat severe pain;
mefloquine, used to treat malaria;
cimetidine, omeprazole, esomeprazole, lansoprazole used to treat stomach problems;
fluconazole (used to treat fungal infections);
flecainide, propafenone, used to treat heart rhythm disorders;
metoprolol, used to treat heart problems and high blood pressure.

CITALOPRAM DOC and alcohol
Do not drink alcohol during treatment with this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take this medicine during pregnancy unless absolutely necessary and only after careful evaluation of risks and benefits by your doctor, 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), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, continuous crying, drowsiness, and sleep disturbances.
Ensure that your midwife and/or doctor know that you are being treated with CITALOPRAM DOC.
When taken during pregnancy, particularly during the last three months, medicines such as CITALOPRAM DOC may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing 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 DOC”).
If you take CITALOPRAM DOC 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 DOC so they can advise you on what to do.
Breastfeeding
If you are breastfeeding, take this medicine with caution, as citalopram passes into breast milk.
Fertility
Citalopram has been shown in animal studies to reduce sperm quality. The impact on human fertility has not yet 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 reaction time in dangerous situations. Therefore, exercise caution before driving or operating machinery.
CITALOPRAM DOC contains ethanol
This medicine contains 75 mg of alcohol (ethanol) per 32 mg/day dose (16 drops). The amount of 32 mg/day of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.
CITALOPRAM DOC Generics contains propylene glycol (E 1520)
This medicine contains 725 mg of propylene glycol (E 1520) per 16-drop dose (corresponding to 32 mg of citalopram).
If the child is under 5 years of age, talk to your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take CITALOPRAM DOC

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the drops either alone or after mixing them with a small amount of water, orange juice, or apple juice.
Do not stop treatment with CITALOPRAM DOC abruptly to avoid withdrawal symptoms (see section “If you stop taking CITALOPRAM DOC”).
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 DOC”).

Treatment of depression: the recommended dose is 16 mg (8 drops) once daily. Your doctor may increase the dose up to a maximum of 32 mg (16 drops) per day, 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 to manage symptoms of mood disorders. If you suffer from recurrent unipolar depression, maintenance treatment should be continued for a longer period to prevent relapse.
Treatment of panic attacks (panic disorder with or without agoraphobia): the recommended initial dose is 8 mg (4 drops) per day for the first week of treatment. Afterwards, your doctor may increase the dose to 16 mg (8 drops) per day, up to a maximum of 32 mg (16 drops) per day, depending on your response to treatment. If you suffer from anxiety with panic attacks, treatment should be continued for a long duration (1 year). If you suffer from 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) per day.
The maximum recommended dose is 16 mg per day.
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) per day for the first 2 weeks. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) per day, 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) per day for the first two weeks of treatment. Afterwards, your doctor may increase the dose up to a maximum of 16 mg (8 drops) per day, depending on your response to treatment.

If you take more CITALOPRAM DOC than you should
If you (or someone else) have taken an excessive dose of CITALOPRAM DOC, 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 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 (QRS prolongation), 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 DOC
Do not take a double dose to make up for the missed dose.

If you stop taking CITALOPRAM DOC
Do not stop treatment with CITALOPRAM DOC 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 awareness of heartbeats (palpitations)
emotional instability, irritability
visual disturbances

These symptoms are generally 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 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 everybody gets 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, contact your doctor immediately 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
restlessness, reduced sexual desire (libido), anxiety, nervousness, confusion (confusional state), abnormal orgasm in women, unusual dreams (dream disturbances)
tremor, tingling sensation 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 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)
decrease/increase in heart rate (bradycardia/tachycardia)
skin rash (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 (frequency cannot be estimated from the available data):

reduction in the number of platelets in the blood (thrombocytopenia)
allergic reactions (hypersensitivity), including severe allergic reactions (anaphylactic reaction)
inappropriate production of antidiuretic hormone (ADH) which regulates urine production
reduction in potassium levels in the blood (hypokalaemia)
panic attacks, agitation
teeth grinding (bruxism)
suicidal thoughts (suicidal ideation), suicidal behaviour during treatment with citalopram or immediately after stopping treatment
seizures
serotonin syndrome (high fever, tremors, muscle contractions and anxiety)
extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and muscle contractions, feeling restless and inability 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 torsade de pointes), especially in women with low potassium levels in the blood (hypokalaemia) or who already have heart problems
dizziness upon standing quickly due to drop in blood pressure (orthostatic hypotension)
nosebleeds (epistaxis)
bleeding in the stool (gastrointestinal or rectal haemorrhage)
excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, Pregnancy, breastfeeding and fertility, for further information
abnormal laboratory tests for liver function
bruising (ecchymoses), 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 production of milk from the breast (galactorrhoea) in men

An increased risk of fractures has been reported following the use of CITALOPRAM DOC.

Reporting of side effects
If you experience any side effects, 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 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 DOC

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 "Expiry".
The expiry date refers to the last day of that month.
The product should be used within 4 months after 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CITALOPRAM DOC contains

The active substance is citalopram hydrochloride. 1 ml (20 drops) contains 44.48 mg of citalopram hydrochloride (equivalent to 40 mg of citalopram).
The other ingredients are: ethanol 96%, propylene glycol (E 1520).

Description of the appearance of CITALOPRAM DOC and contents of the pack
Pack containing one 15 ml bottle of solution with a dropper cap.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturers
Doppel Farmaceutici S.r.l. – Via Martiri delle Fobie 1 – 29016 Cortemaggiore (Piacenza) – Italy.