Package leaflet: Information for the patient

CITALOPRAM ALMUS PHARMA 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CITALOPRAM ALMUS PHARMA is and what it is used for

CITALOPRAM ALMUS PHARMA 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 medicinal product is indicated for the treatment of the following disorders:

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

2. What you should know before taking CITALOPRAM ALMUS PHARMA

Do not take CITALOPRAM ALMUS PHARMA

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 belonging to a group of medicines called monoamine oxidase inhibitors (MAOIs). 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 IA), used in the treatment of depression
if you are taking an irreversible MAOI, take CITALOPRAM ALMUS PHARMA at least 14 days after stopping treatment with that medicine. If you are taking a reversible MAOI (RIMA), take CITALOPRAM ALMUS PHARMA after stopping treatment with the RIMA for the time indicated in the package leaflet of that medicine
if you are about to start treatment with an MAOI, wait at least 7 days after stopping treatment with CITALOPRAM ALMUS PHARMA
if you suffer from a heart rhythm disorder or have been diagnosed with QT interval prolongation or congenital long QT syndrome
if you are taking medicines that may prolong the QT interval (see section “Other medicines and CITALOPRAM ALMUS PHARMA”)
if you are taking pimozide, used to treat certain mental disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking CITALOPRAM ALMUS PHARMA.
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 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)
if you have low levels of sodium in the blood (hyponatremia)
if you suffer from bipolar disorder, as during treatment with CITALOPRAM ALMUS PHARMA 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
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 ALMUS PHARMA”)
if you have a tendency to bleed or bruise easily, 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 abnormalities before starting treatment with this medicine
if you or someone in your family has an eye condition (closed-angle glaucoma)
if you are to take selegiline together with CITALOPRAM ALMUS PHARMA, the maximum recommended dose of selegiline is 10 mg per day
if you suffer from psychosis with depression
medicines such as CITALOPRAM ALMUS PHARMA (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 in the weeks immediately following the start of treatment, whether you suffer from depression or other mental health conditions (psychiatric disorders), you may have thoughts of harming yourself or of suicide. For this reason, your doctor must monitor you closely, especially at the beginning of treatment or when the dose is increased, if you have previously experienced such 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 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 worsening or if they are concerned about any changes in your behaviour.
Within the first few weeks of treatment, you may experience akathisia, characterized by restlessness, distress, 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 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. However, your doctor may prescribe CITALOPRAM ALMUS PHARMA to patients under 18 years of age if they consider it the best option for them. In such cases, the child or 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 ALMUS PHARMA.

Other medicines and CITALOPRAM ALMUS PHARMA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can alter the effect of other medicines, and this may sometimes cause serious adverse reactions.
Tell your doctor, in particular, if you are taking the following medicines:

medicines called monoamine oxidase inhibitors (MAOIs), because serious, even fatal, adverse 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 IA), used in the treatment of depression
if you are taking an irreversible MAOI, take CITALOPRAM ALMUS PHARMA at least 14 days after stopping treatment with that medicine. If you are taking a reversible MAOI (RIMA), take CITALOPRAM ALMUS PHARMA after stopping treatment with the RIMA for the time indicated in the package leaflet of that medicine
if you are about to start treatment with an MAOI, wait at least 7 days after stopping treatment with CITALOPRAM ALMUS PHARMA
if you are to take selegiline together with CITALOPRAM ALMUS PHARMA, the maximum recommended dose of selegiline is 10 mg per day
buspirone, a medicine used in the treatment of anxiety, due to the risk of serotonin syndrome
class IA and III antiarrhythmics, medicines used for heart rhythm disorders, due to the risk of QT interval prolongation on the electrocardiogram
medicines used to treat mental disorders (antipsychotics), due to the risk of QT interval prolongation on the electrocardiogram (e.g., phenothiazine derivatives, haloperidol, and pimozide, which must not be taken with CITALOPRAM ALMUS PHARMA), due to the risk of lowering the seizure threshold (e.g., phenothiazines, thioxanthenes, and butyrophenones), and because they may increase the risk of bleeding (e.g., atypical antipsychotics and phenothiazines). Other medicines used to treat depression (antidepressants), due to the risk of QT interval prolongation, lowering of the seizure threshold, and increased risk of bleeding
antimicrobials (medicines used to treat infections) such as sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, due to the risk of QT interval prolongation on the electrocardiogram
antimalarials such as halofantrine (due to the risk of QT interval prolongation on the electrocardiogram) and mefloquine (due to the risk of lowering the seizure threshold)
antihistamines such as astemizole and mizolastine, used to treat allergies, due to the risk of QT interval prolongation on the electrocardiogram
sumatriptan and similar medicines, used to treat headache (migraine), due to the risk of enhanced serotonergic effect
tramadol, used to treat pain, due to the risk of enhanced serotonergic effect and the risk of lowering the seizure threshold
lithium and tryptophan, used to treat certain mental disorders, due to the risk of enhanced serotonergic effect
products containing St. John’s wort (Hypericum perforatum), used for depression, as they increase the risk of adverse effects
medicines used to thin the blood such as dipyridamole (anticoagulants) and ticlopidine (platelet aggregation inhibitors), because they may increase the risk of bleeding
medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid, because they may increase the risk of bleeding
medicines that reduce potassium or magnesium levels in the blood (which may cause hypokalemia/hypomagnesemia, conditions that increase the risk of arrhythmias)
cimetidine, lansoprazole, esomeprazole, and 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 cause an increase in blood levels of citalopram
medicines such as flecainide, propafenone, and metoprolol (used to treat heart problems), antidepressants such as desipramine, clomipramine, and nortriptyline, or antipsychotics such as risperidone, thioridazine, and haloperidol, because a dose adjustment of these medicines may be necessary.

CITALOPRAM ALMUS PHARMA and alcohol
Do not drink alcohol during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
CITALOPRAM ALMUS PHARMA should not be used during pregnancy unless strictly necessary, or only after careful evaluation of risks and benefits by your doctor.
Ensure that your midwife and/or doctor knows that you are being treated with CITALOPRAM ALMUS PHARMA.
If you have taken this medicine during the later stages of pregnancy, particularly in the third trimester, your baby may experience breathing difficulties, apnea, bluish skin color (cyanosis), seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar levels (hypoglycemia), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, persistent crying, drowsiness, and difficulty sleeping.
When taken during pregnancy, particularly during the last three months, medicines such as CITALOPRAM ALMUS PHARMA 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 occurs in your baby, contact your midwife and/or doctor immediately.
If you take CITALOPRAM ALMUS PHARMA 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 treating doctor or midwife that you are taking CITALOPRAM ALMUS PHARMA 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 ALMUS PHARMA”).

Breastfeeding
If you are breastfeeding, take this medicine with caution because citalopram passes into breast milk.

Male 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 (see section “Possible side effects”).

Driving and using machines
This medicine may affect your ability to drive vehicles or operate machinery because it may impair your judgment and reaction time in dangerous situations. Therefore, exercise caution before driving or operating machinery.

CITALOPRAM ALMUS PHARMA contains alcohol and parahydroxybenzoates
This medicine contains 76 mg of alcohol (96% ethanol) in 1 ml of solution (equivalent to 20 drops), which corresponds to 7.6% w/v. The amount in 20 drops of this medicine is equivalent to less than 2 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 methyl parahydroxybenzoate and propyl parahydroxybenzoate. These may cause allergic reactions (including delayed reactions) and, rarely, bronchospasm.

3. How to take CITALOPRAM ALMUS PHARMA

Take this medicine exactly as directed by your doctor. 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 ALMUS PHARMA may be taken with or without food.
Do not stop treatment with CITALOPRAM ALMUS PHARMA abruptly to avoid withdrawal symptoms (see section “If you stop taking CITALOPRAM ALMUS PHARMA”).
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 ALMUS PHARMA”).

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. Treatment should be continued for at least 4–6 months to manage symptoms of manic-depressive illness. 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): 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, treatment should be prolonged (up to 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) daily.
The maximum recommended dose is 16 mg daily.

Use in patients with liver problems (hepatic impairment)
If you have mild to 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 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. 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 ALMUS PHARMA than you should
If you (or someone else) have taken an excessive dose of CITALOPRAM ALMUS PHARMA, or if you suspect that a child may have ingested 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, slow heart rate (bradycardia), dizziness, electrical conduction block in the heart, changes in heart activity (QRS complex prolongation), high 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 ALMUS PHARMA
Do not take a double dose to make up for the missed dose.

If you stop taking CITALOPRAM ALMUS PHARMA
Do not stop treatment with CITALOPRAM ALMUS PHARMA 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 on their own 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 done under medical supervision, with doses gradually reduced 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 will experience them.
Side effects mainly occur during the first or second week of treatment and then usually disappear later.
If during treatment you are thinking about harming yourself or have thoughts of suicide, 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 sexual desire (libido), anxiety, restlessness, confusion (confusional state), abnormal orgasm in women, abnormal 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)
decreased/increased heart rate (bradycardia/tachycardia)
skin irritation (urticaria, rash), hair loss (alopecia), development of red spots and bleeding on the skin (purpura), skin reactions due to exposure to sunlight (photosensitivity reaction)
difficulty urinating (urinary retention)
prolonged and heavy menstrual bleeding 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 reactions (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
vision disturbances
disturbances in heart rhythm (QT interval prolongation, ventricular arrhythmias, including torsades de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or who already have heart disorders (pre-existing QT interval prolongation or other cardiac diseases)
dizziness upon standing quickly due to a drop in blood pressure (orthostatic hypotension)
nosebleeds (epistaxis)
bleeding with stools (gastrointestinal or rectal haemorrhage)
excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information
abnormal liver function laboratory tests
bruising (ecchymoses), swelling mainly of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema)
irregular menstrual bleeding in women (metrorrhagia)
prolonged and painful erection (priapism), milk production from the breast (galactorrhoea) in men

An increased risk of fractures has been observed in patients taking this type of medicine.

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 ALMUS PHARMA

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.
Do not store above 25°C.
The shelf life after first opening the bottle is 2 months. Any remaining product must be
discarded.
Keep the container in the original outer packaging to protect the medicine from light.
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 ALMUS PHARMA contains

Each ml of solution contains 44.48 mg of citalopram hydrochloride (equivalent to 40 mg of citalopram).
The other components are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, hydroxyethylcellulose, 96% ethanol, purified water.

Description of the appearance of CITALOPRAM ALMUS PHARMA and contents of the pack
Pack containing one 15 ml bottle of solution.

Marketing Authorization Holder
Via Cesarea, 11/10 - 16121 Genoa
E-mail: [email protected]

Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)

Citalopram Almus Pharma

Package leaflet: Information for the patient