Citalopram Almus

Italy
Brand name Citalopram Almus
Form tablets, film-coated
Active substance / Dosage
CITALOPRAM HYDROBROMIDE
Prescription type Prescription only
ATC code
N06AB04
Registration number 036434
Manufacturer ALMUS S.R.L.
Citalopram Almus tablets, film-coated

Table of Contents

Package leaflet: Information for the patient

CITALOPRAM ALMUS 20 mg film-coated tablets

Generic medicine
Please read all of 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

CITALOPRAM ALMUS 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 ALMUS

Do not take CITALOPRAM ALMUS

  • 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, a medicine used to treat infections, and moclobemide (type IA selective), used in the treatment of depression
  • if you are taking an irreversible MAOI, take CITALOPRAM ALMUS at least 14 days after stopping treatment with such medicine. If you are taking a reversible MAOI (RIMA), take CITALOPRAM ALMUS after stopping treatment with the RIMA for the time indicated in the package leaflet of that medicine
  • if you are to start therapy with an MAOI, wait at least 7 days after stopping treatment with CITALOPRAM ALMUS
  • 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”)
  • if you are taking pimozide, used to treat certain mental disorders.

Warnings and precautions
Talk to your doctor or pharmacist before taking CITALOPRAM ALMUS.
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 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 have diabetes
  • if you have a bleeding 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”)
  • if you tend to bleed easily 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 )
  • 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 a certain eye condition (closed-angle glaucoma)
  • if you are to take selegiline together with CITALOPRAM ALMUS, the maximum recommended dose of selegiline is 10 mg per day
  • if you suffer from psychosis with depression
  • medicines such as CITALOPRAM ALMUS (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, persistence of these symptoms after discontinuation of treatment has been observed.

Suicidal thoughts and worsening of depression or anxiety disorder
During the first few weeks or immediately after starting treatment, whether you suffer from depression or other mental disorders (psychiatric conditions), you may have thoughts of harming yourself or committing 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 getting worse 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, a need to move frequently, and 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.

Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age. However, your doctor may prescribe CITALOPRAM ALMUS 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.

Other medicines and CITALOPRAM ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. Some medicines can alter the action of other medicines, and this may sometimes cause serious adverse reactions.
Inform 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, a medicine used to treat infections, and moclobemide (type IA selective), used in the treatment of depression
  • if you are taking an irreversible MAOI, take CITALOPRAM ALMUS at least 14 days after stopping treatment with such medicine. If you are taking a reversible MAOI (RIMA), take CITALOPRAM ALMUS after stopping treatment with the RIMA for the time indicated in the package leaflet of that medicine
  • if you are to start therapy with an MAOI, wait at least 7 days after stopping treatment with CITALOPRAM ALMUS
  • if you are to take selegiline together with CITALOPRAM ALMUS, 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), 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 on the electrocardiogram, 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 serotonin effects
  • tramadol, used to treat pain, due to the risk of enhanced serotonin effects and lowering of the seizure threshold
  • lithium and tryptophan, used to treat certain mental disorders, due to the risk of enhanced serotonin effects
  • 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 (antiplatelet agents), 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 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 must not be used during pregnancy unless strictly necessary, and only after careful evaluation of risks and benefits by your doctor.
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 colour (cyanosis), seizures, body temperature changes, feeding difficulties, vomiting, low blood sugar levels (hypoglycemia), muscle tone abnormalities (hypertonia, hypotonia), increased reflexes (hyperreflexia), tremors, restlessness, irritability, lethargy, continuous crying, drowsiness, and sleep difficulties.
When taken during pregnancy, particularly during the last 3 months, medicines such as CITALOPRAM ALMUS 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 ALMUS 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 ALMUS 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”).
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 the impact on human fertility has not yet been observed (see section “Possible side effects”).
Driving and using machines
This medicine may affect your ability to drive or use machines because it may impair your judgment and reaction time in dangerous situations. Therefore, be cautious before driving or operating machinery.
CITALOPRAM ALMUS contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take CITALOPRAM ALMUS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
CITALOPRAM ALMUS may be taken with or without food.
The tablet may be divided into equal parts.
Do not stop treatment with CITALOPRAM ALMUS abruptly to avoid withdrawal symptoms (see section “If you stop taking CITALOPRAM ALMUS”).
Your doctor will adjust the dose according to your individual needs. Do not change the dose without first consulting your doctor (see section “If you stop taking CITALOPRAM ALMUS”).

  • Treatment of depression: The recommended dose is 20 mg once daily. Your doctor may increase the dose up to a maximum of 40 mg once daily, depending on your response to treatment. The effect of the medicine usually appears within 2–4 weeks after starting treatment, which should be continued for at least 4–6 months for symptoms of bipolar disorders. If you suffer from recurrent unipolar depression, maintenance treatment should be continued for a longer period to prevent relapse.
  • Treatment of panic attacks (panic disorder): The recommended initial dose is 10 mg once daily for the first week of treatment. Afterwards, your doctor may increase the dose to 20 mg once daily, up to a maximum of 40 mg once daily depending on your response to treatment. The maximum effect of the medicine is seen after 3 months of treatment. If you suffer from anxiety and experience panic attacks, treatment should be continued long-term (1 year). If you have insomnia or are highly agitated, your doctor may prescribe sedative medicines.

Use in elderly patients
If you are elderly (over 65 years of age), your doctor will reduce the dose to 10–20 mg once daily.
The maximum recommended dose is 20 mg once 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 10 mg once daily for the first 2 weeks. Afterwards, your doctor may increase the dose up to a maximum of 20 mg once 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 10 mg once daily for the first two weeks of treatment.
Thereafter, your doctor may increase the dose up to a maximum of 20 mg once daily depending on your response to treatment.
If you take more CITALOPRAM ALMUS than you should
If you (or someone else) have taken an excessive dose of CITALOPRAM ALMUS, or if you think a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
An overdose may cause seizures, increased heart rate (tachycardia), drowsiness, disturbances in heart rhythm (prolongation of QT interval, torsades de pointes, atrioventricular arrhythmia), coma, vomiting, tremor, low blood pressure (hypotension), cardiac arrest, nausea, serotonin syndrome (high fever, tremors, muscle contractions, and anxiety), agitation, reduced heart rate (bradycardia), dizziness, conduction block in the heart, changes in heart activity (prolongation of QRS interval), 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 ALMUS
Do not take a double dose to make up for the missed dose.
If you stop taking CITALOPRAM ALMUS
Do not stop treatment with CITALOPRAM ALMUS 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 (visual disorders).
    These symptoms are usually mild to moderate and resolve spontaneously within 2 weeks, although occasionally they may be severe and last for a long time (2–3 months or more).

Stopping 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 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.

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 sex drive (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);
  • 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 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):

  • 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 blood platelets (thrombocytopenia);
  • allergic reactions including severe 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;
  • seizures, serotonin syndrome (high fever, tremors, muscle contractions and anxiety), extrapyramidal disorders such as involuntary movements, tremors, muscle rigidity and muscle contractions, feeling of restlessness 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 torsades de pointes), particularly in women with low potassium levels in the blood (hypokalaemia) or who already have heart problems (pre-existing QT interval prolongation or other cardiac conditions);
  • dizziness when standing up quickly due to a drop in blood pressure (orthostatic hypotension);
  • nosebleeds (epistaxis);
  • bleeding with stools (gastrointestinal or rectal haemorrhage);
  • heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for further information;
  • abnormal liver function laboratory tests;
  • bruising (ecchymosis), 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 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 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

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.
This medicine does not require any special storage conditions.
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. Package contents and other information

What CITALOPRAM ALMUS contains
CITALOPRAM ALMUS 20 mg film-coated tablets

  • The active substance is citalopram bromide. Each tablet contains 24.98 mg of citalopram bromide (equivalent to 20 mg of citalopram).
  • The other components are: maize starch, lactose monohydrate, microcrystalline cellulose, vinylpyrrolidone-vinyl acetate copolymer, glycerin, sodium croscarmellose, magnesium stearate. Coating film: titanium dioxide (E 171), hydroxypropyl-methylcellulose (E 463), polyethylene glycol 400 (E 1521).

Description of the appearance of CITALOPRAM ALMUS and package contents
Pack containing 28 film-coated tablets of 20 mg.
Marketing Authorization Holder
Almus S.r.l. - 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)