Patient Information Leaflet

Ricap 20 mg film-coated tablets, 40 mg film-coated tablets

Citalopram
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 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:

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

1. What Ricap is and what it is used for

Ricap belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs), also known as antidepressants.
This medicine is used to treat:

Depression (including prevention of relapse and recurrence)
Anxiety disorders with panic attacks, with or without fear of open spaces (agoraphobia)

2. What you should know before taking Ricap

Do not take Ricap

If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6);
If you have congenital or have experienced episodes of heart rhythm disorders (prolonged QT interval or congenital long QT syndrome, identified by an electrocardiogram, a test to monitor heart function), or if you are taking medicines that may cause such disturbances;
If you are taking medicines called monoamine oxidase inhibitors (MAOIs), due to the risk of severe adverse reactions, in some cases resembling "serotonin syndrome" (see "Other medicines and Ricap");
If you are taking selegiline, an irreversible MAOI used to treat Parkinson’s disease, at daily doses exceeding 10 mg. Depending on the type of MAOI, a 14-day interval may be required before starting citalopram. Citalopram must not be administered within 14 days after discontinuation of an irreversible MAOI (including selegiline) or within the time specified after stopping a reversible MAOI (RIMA), as indicated in the RIMA’s package leaflet. If you discontinue treatment with Ricap and intend to start taking MAO inhibitors, you must wait at least 7 days after stopping Ricap (see "Other medicines and Ricap");
If you are taking linezolid (an antibiotic);
If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Ricap.
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 "How to take Ricap").
If you suffer from panic attacks, as severe anxiety may occur at the beginning of treatment (paradoxical anxiety);
If you have epilepsy, since seizures are a potential risk with the use of antidepressant medicines. If you experience seizures, stop treatment with Ricap. Avoid using the medicine if you have unstable epilepsy; if your condition is controlled, you may use this medicine but must be closely monitored during treatment.
If you have diabetes, as your doctor may need to adjust the dosage of insulin and/or other medications used to lower blood sugar levels;
If you have low sodium levels in the blood (especially if you are an elderly woman);
If you have bipolar disorder (manic-depressive illness), as there may be a shift into the manic phase. In this case, consult your doctor to initiate appropriate treatment with neuroleptic medicines. If you enter a manic phase, stop taking Ricap.
If you experience a combination of symptoms including fever, muscle rigidity or tremor, changes in your mental state such as confusion, irritability and extreme agitation, and/or gastrointestinal symptoms; you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Although rare, this syndrome can lead to potentially life-threatening conditions. In this case, stop treatment with Ricap immediately and consult your doctor to begin appropriate therapy.
If you have a coagulation disorder and are at risk of bleeding (haemorrhage), and if you are taking medicines that worsen these problems (see section "Other medicines and Ricap");
If you are undergoing electroconvulsive therapy (ECT);
If you suffer or have suffered from mental illnesses (psychosis) with depressive episodes, as your psychotic symptoms may worsen;
If you are prone to heart rhythm disturbances (prolonged QT interval) or other heart diseases, especially if you are a woman and/or have low potassium levels in the blood, due to the risk of heart rhythm disorders such as prolonged QT interval and ventricular arrhythmias, including Torsades de Pointes;
If you suffer or have suffered from heart diseases, for example, very slow heart rate (significant bradycardia), recent acute myocardial infarction, or uncompensated heart failure. Low levels of potassium and/or magnesium in the blood increase the risk of heart rhythm disturbances (arrhythmias) and should therefore be corrected before starting treatment with Ricap. If your heart disease is stable, your doctor should consider performing an ECG check before starting treatment. If, during treatment with Ricap, you develop signs of heart rhythm disturbances, treatment should be suspended and an ECG performed.
If you have or have previously had a condition of the eye called closed-angle glaucoma (increased pressure inside the eye);
If you are taking herbal preparations containing St. John’s wort (Hypericum perforatum), as adverse effects may be more common when citalopram is used concomitantly with herbal products containing St. John’s wort. Therefore, do not take this medicine together with such preparations (see "Ricap with beverages" and "Other medicines and Ricap");
If you are taking medicines containing buprenorphine (with or without naloxone). The use of these medicines together with citalopram may lead to serotonin syndrome (see "Other medicines and Ricap").

When stopping treatment with Ricap, especially if this occurs abruptly, withdrawal symptoms may occur (see section “If you stop taking Ricap”).
Medicines such as Ricap, known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs), may cause symptoms of sexual dysfunction (see section 4. “Possible side effects”). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of your depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may occasionally have thoughts of harming yourself or of suicide.
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 self-harm or suicide. For this reason, your doctor should monitor you closely, particularly 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).
It may be helpful to inform a relative or friend that you are depressed or have anxiety disorders and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening or if they are concerned about changes in your behaviour.
If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go immediately to hospital.
During treatment, you may experience an inner sense of restlessness, agitation, and inability to sit still or remain motionless (akathisia), generally associated with subjective discomfort. This is more likely to occur within the first few weeks of treatment.
If you develop these symptoms, increasing the dose of Ricap may be harmful.
If you experience these symptoms, contact your doctor immediately.
Children and adolescents
RICAP must not be used to treat children and adolescents under 18 years of age.
Patients under 18 years of age taking this class of medicines have an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, oppositional behaviour, and anger).
Despite this, your doctor may prescribe Ricap to patients under 18 years of age if they consider it strictly necessary. If your doctor has prescribed Ricap to a patient under 18 years of age and you wish to obtain further information, contact your doctor. Inform your doctor immediately if any of the above symptoms appear or worsen during treatment with Ricap in patients under 18 years of age.
Furthermore, the long-term safety effects of Ricap on growth, maturation, and cognitive and behavioural development in this patient group have not yet been established.
Other medicines and Ricap
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ricap if you are taking the following medicines:

Medicines called monoamine oxidase inhibitors (MAOIs), due to the risk of severe adverse effects (including serotonin syndrome), sometimes fatal (see "Do not use Ricap"). Symptoms of serotonin syndrome with an MAOI include agitation, tremors, muscle spasms, and increased body temperature. Medicines for heart rhythm disorders or medicines that may affect heart rhythm;
Linezolid (an antibiotic);
Medicines with serotonergic effects such as sumatriptan (used to treat migraine) or other triptans, tramadol, oxytriptan, and tryptophan;
Moclobemide (used for depression) and buspirone (used for anxiety);
Selegiline (used to treat Parkinson’s disease) may be taken with Ricap only if the daily dose of selegiline does not exceed 10 mg. If you have discontinued treatment with MAOI medicines and intend to start treatment with Ricap, you must wait at least 2 weeks after stopping before taking Ricap. If you discontinue treatment with Ricap and intend to start taking MAO inhibitors, you must wait at least 7 days after stopping Ricap (see "Do not take Ricap").
Medicines for heart rhythm disorders or medicines that may affect heart rhythm (which prolong the QT interval), such as class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (such as sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), and some antihistamines (astemizole, mizolastine).

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

Buprenorphine (with or without naloxone) may interact with RICAP and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38°C. Contact your doctor if you experience such symptoms.
Lithium and tryptophan (used to treat mental illnesses);
Sumatriptan and similar medicines (used to treat migraine);
St. John’s wort (Hypericum perforatum), a herbal remedy;
Medicines used to thin the blood (anticoagulants);
Medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid);
Medicines used to prevent blood clotting such as dipyridamole, ticlopidine;
Medicines that reduce potassium or magnesium levels in the blood, due to increased risk of heart rhythm disturbances;
Neuroleptic medicines (used to treat schizophrenia), mefloquine (used for malaria), bupropion (to help you stop smoking), tramadol (used for severe pain), as there is a risk of possible lowering of the seizure threshold;
Cimetidine, lansoprazole, 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 for heart conditions such as flecainide and propafenone (used to treat irregular heartbeat) and metoprolol (when used in heart failure);
Other medicines used to treat depression such as desipramine, clomipramine, imipramine, nortriptyline, fluvoxamine, medicines for mental disorders (atypical antipsychotics), and medicines used to treat psychosis (risperidone, thioridazine, and haloperidol).

Ricap with beverages and alcohol
Adverse effects may be more common when Ricap is used concomitantly with herbal preparations containing St. John’s wort (St. John’s wort or Hypericum perforatum). Therefore, do not take this medicine together with preparations containing St. John’s wort (see "Warnings and precautions" and "Other medicines and Ricap").
Avoid alcohol consumption during treatment with Ricap.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Ricap during pregnancy or if you are planning a pregnancy, unless your doctor considers it strictly necessary.
Do not abruptly stop treatment with Ricap during pregnancy. Inform your doctor if you wish to discontinue or stop treatment.
If you take Ricap near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders.
Inform your attending doctor or midwife that you are taking RICAP so they can advise you on what to do.
Newborns should be monitored if Ricap has been used during the late stages of pregnancy, particularly in the third trimester. When taken during pregnancy, especially in the last 3 months, medicines like Ricap may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which manifests as increased breathing rate and bluish skin colour. These symptoms usually begin within the first 24 hours after birth. If this occurs with your baby, contact the midwife and/or doctor immediately.
If you take Ricap during the late stages of pregnancy, your baby may experience the following symptoms: breathing difficulties, bluish or purplish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, low blood glucose, stiff or floppy muscles, hyperactive reflexes, tremors, restlessness, irritability, lethargy, continuous crying, drowsiness, and sleep difficulties.
These symptoms may be due to either serotonergic effects or withdrawal symptoms. In most cases, complications begin immediately after birth or in the hours immediately following (less than 24 hours). If your baby shows any of these symptoms at birth, contact your doctor immediately.
Breastfeeding
Ricap passes into breast milk in small amounts. If you are taking Ricap, consult your doctor before starting breastfeeding.
Fertility
In animal studies, citalopram has been shown to reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed to date.
Driving and use of machines
Ricap has a minor or moderate influence on the ability to drive vehicles and use machines. It may reduce your judgment and reactivity in emergency situations. Do not drive or operate tools or machinery if you notice that your abilities are impaired.
Ricap contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Ricap contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Ricap

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Ricap is available in two strengths: 20 mg and 40 mg.
Recommended doses:
Depression
The usual dose is 1 tablet of 20 mg daily. Your doctor may increase this dose up to a maximum of
2 tablets of 20 mg or 1 tablet of 40 mg per day.
The antidepressant effect usually appears within 2–4 weeks after starting treatment; it is advisable that
you remain under medical supervision until remission of the depressive state is achieved.
Treatment should be continued for an appropriate period of time, generally 4–6 months in
manic-depressive disorders.
If you suffer from recurrent unipolar depression, long-term maintenance therapy may be necessary to
prevent new depressive episodes.
Anxiety disorders with panic attacks
The initial dose is 10 mg daily for the first week; thereafter, the dose may be increased to 20 mg daily.
Your doctor may further increase the dose up to a maximum of 2 tablets of 20 mg or 1 tablet of 40 mg
per day.
In anxiety disorders with panic attacks, long-term treatment is required. Maintenance of clinical response
has been demonstrated during prolonged treatment (up to 1 year).
If you experience insomnia or marked restlessness, additional treatment with sedatives is recommended
during the acute phase.
When deciding to discontinue treatment, doses should be gradually reduced to minimize withdrawal
symptoms (see “If you stop taking Ricap”).
Use in children and adolescents under 18 years of age
Ricap should normally not be used in children and adolescents under 18 years of age (see section
“Children and adolescents”).
Use in elderly patients (over 65 years of age)
The initial dose should be halved compared to the recommended dose, for example 10–20 mg daily.
Elderly patients should normally not take more than 1 tablet of 20 mg daily.
Use in patients with liver problems (hepatic impairment)
If you have liver problems, the recommended initial dose for the first two weeks is 10 mg daily.
Thereafter, your doctor may increase the dose up to a maximum of 20 mg daily, based on your
response to therapy.
Use in patients with kidney problems (renal impairment)
If you have reduced kidney function (renal impairment), follow the lowest recommended dosage regimen.
If you take more Ricap than you should
If you accidentally ingest or take an excessive dose of Ricap, contact your doctor immediately or go to the
nearest hospital.
The following symptoms have been reported in cases of overdose: fatigue, weakness, sedation, seizures,
changes in heart rhythm (e.g. faster or slower heartbeat, or irregular heartbeat), drowsiness, vomiting,
tremor, excessive drop or rise in blood pressure, nausea, serotonin syndrome, agitation, dizziness, pupil
dilation, stupor, sweating, bluish discoloration of the skin, severe damage to skeletal muscle (rhabdomyolysis),
rapid and deep breathing, cardiac arrest, coma.
If you forget to take Ricap
If you forget to take a dose of this medicine, simply take the next dose at the usual time. Do not take a
double dose to make up for the missed dose.
If you stop taking Ricap
Do not stop treatment with RICAP 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 the arms and legs (paresthesia), and electric shock-like sensations
sleep disturbances (including insomnia and vivid dreams)
agitation or anxiety, tremor, confusion
nausea and/or vomiting, diarrhea
sweating, headache
palpitations
emotional instability, irritability
visual disturbances.
The risk is higher when Ricap has been used for a long time or at high doses, or when the dose is reduced too quickly. Generally, the intensity of symptoms is mild to moderate, but in some patients it may be severe. Symptoms usually appear within the first few days after stopping treatment, although very rarely they may occur even if a single dose is missed. In most cases, symptoms resolve within two weeks, although in some patients they may last longer (2–3 months or more). Therefore, it is recommended to gradually reduce the dose of Ricap over a period of several weeks or months, according to your individual needs, when discontinuing treatment. If you experience intolerable symptoms after dose reduction or stopping treatment, re-institution of the previously prescribed dose may be considered. Your doctor may then continue to reduce the dose more gradually.

If you have any questions 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.
Adverse events observed with citalopram are generally mild in severity and transient. They occur more frequently during the first or second week of treatment and then tend to diminish later on.
Warning: If during treatment or shortly after discontinuation you have thoughts of harming yourself or of suicide, contact your doctor immediately (see section “Warnings and precautions”).
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

drowsiness or insomnia
headache
dry mouth
nausea
increased sweating

Common (may affect up to 1 in 10 people)

decreased appetite, weight loss
restlessness, anxiety, nervousness, confusion
fatigue
yawning, abnormal dreams
tremor, tingling
dizziness, attention disturbances
ringing in the ears
diarrhoea, vomiting, constipation
itching
muscle pain, joint pain
impaired sexual function in men (impotence, ejaculation disorders, failure to ejaculate)
decreased sexual desire or abnormal orgasm in women

Uncommon (may affect up to 1 in 100 people)

increased appetite, weight gain
aggression, feeling detached from oneself (depersonalization), hallucinations, sensation of excitement leading to unusual behaviour (mania)
fainting
dilated pupils
slow or rapid heartbeat
hives, rash, reddish skin spots, photosensitivity
loss of hair and/or body hair
difficulty urinating
heavy menstrual bleeding
swelling due to excessive fluid accumulation in the body

Rare (may affect up to 1 in 1,000 people)

low sodium levels in the blood
seizures (epileptic convulsions)
movement disorders (e.g. uncontrollable spasms or involuntary movements)
taste disturbances
bleeding
hepatitis
fever

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

reduced platelet count (thrombocytopenia)
hypersensitivity
severe, rapidly developing allergic reaction (anaphylactic reaction)
inappropriate secretion of antidiuretic hormone (ADH), causing fluid retention, weakness, tiredness or confusion
low potassium levels in the blood
panic attacks
teeth grinding during sleep (bruxism)
feeling restless and unable to sit still (akathisia)
suicidal thoughts and suicidal behaviour (during treatment or immediately after discontinuation of treatment)
seizures, serotonin syndrome, movement disorders, abnormal involuntary movements (extrapyramidal disorders)
visual disturbances
unusual or very fast heart rate (QT interval prolongation, ventricular arrhythmias including Torsade de Pointes), especially in female patients, patients with low potassium levels in the blood, or those suffering from heart diseases (see sections “Do not take Ricap”, “Warnings and precautions”, “Other medicines and Ricap”, and “If you take more Ricap than you should”)
feeling faint or dizzy when standing up due to a drop in blood pressure
nosebleeds
gastrointestinal bleeding (including rectal bleeding)
abnormal liver function tests
blood spots under the skin
severe allergic reaction causing swelling of the face and mucous membranes (angioedema)
irregular menstrual bleeding (metrorrhagia), heavy
excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage); see sections “Warnings and precautions” and “Pregnancy” for further information
prolonged painful erection
abnormal milk secretion from the breasts in men
An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Withdrawal symptoms following discontinuation of treatment
Stopping treatment with Ricap (especially if abrupt) usually leads to withdrawal symptoms.
The most commonly reported adverse effects have been dizziness, sensory disturbances (including tingling), sleep disturbances (including insomnia and vivid dreams), restlessness or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability and visual disturbances.
These symptoms are generally mild to moderate and self-limiting; however, in some patients they may be severe and/or prolonged. Therefore, if you need to stop treatment with Ricap, your doctor will gradually reduce your dose (see “How to take Ricap”).
Following the instructions provided in the package leaflet reduces the risk of side effects.
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 Ricap

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month. The stated expiry date applies to the product stored in its original, intact packaging and properly stored.
Store the medicine at a temperature not exceeding 25°C in the original packaging to protect it from light.
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 Ricap contains

The active substance is citalopram hydrochloride. Each 20 mg tablet contains 25 mg citalopram hydrochloride (equivalent to 20 mg citalopram); each 40 mg tablet contains 50 mg citalopram hydrochloride (equivalent to 40 mg citalopram).
The other components are: lactose monohydrate, maize starch, microcrystalline cellulose, glycerol, copovidone, sodium croscarmellose, magnesium stearate, Opadry Y-1-7000 (hypromellose (E464), titanium dioxide (E171), macrogol 400).

Description of the appearance of Ricap and package contents
Ricap is presented as film-coated tablets.
The 20 mg tablet pack contains 28 tablets.
The 40 mg tablet pack contains 14 tablets.
Marketing Authorization Holder
Farmaceutici Caber S.r.l. - Via del Mare, 36 - Pomezia (Rm)
Manufacturer
Help S.A. Pharmaceuticals -10 Valaoritou str. - GR 144 52 Metamorphosis – Athens (Greece)

Patient information leaflet

Ricap 40 mg/ml oral drops, solution

Citalopram
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 their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ricap is and what it is used for

Ricap belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs), also known as antidepressants.
This medicine is used to treat:

Depression (including prevention of relapse and recurrence)
Anxiety disorders with panic attacks, with or without fear of open spaces (agoraphobia)

2. What you should know before taking Ricap

Do not take Ricap

If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6);
If you have congenital or have experienced an episode of abnormal heart rhythm (QT interval prolongation) or congenital long QT syndrome, identified by an electrocardiogram (ECG), a test to monitor heart function), or if you are taking medicines that may cause these conditions.
If you are taking medicines called monoamine oxidase inhibitors (MAOIs) due to the risk of severe adverse reactions, in some cases with features similar to "serotonin syndrome" (see "Other medicines and Ricap"); If you are taking selegiline, an irreversible MAOI (used to treat Parkinson’s disease), at daily doses exceeding 10 mg. Depending on the type of MAOI, a 14-day interval may be required before starting citalopram. Citalopram must not be administered earlier than 14 days after discontinuation of an irreversible MAOI (including selegiline) or the time specified after stopping a reversible MAOI (RIMA) as indicated in the RIMA’s package leaflet. If you stop treatment with Ricap and intend to start taking MAO inhibitors, you must wait at least 7 days after stopping Ricap (see "Other medicines and Ricap").
If you are taking linezolid (an antibiotic);
If you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Ricap.
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 "How to take RICAP").
If you suffer from panic attacks, as severe anxiety may occur at the beginning of treatment (paradoxical anxiety);
If you have epilepsy, as seizures are a potential risk with the use of antidepressant medicines. If you experience seizures, stop treatment with Ricap. Avoid using the medicine if you have unstable epilepsy; if your condition is controlled, you may use this medicine but must be closely monitored during treatment.
If you have diabetes, as your doctor may need to adjust the dose of insulin and/or other medicines used to lower blood sugar levels;
If you have low levels of sodium in the blood (especially if you are an elderly woman);
If you have bipolar disorder (manic-depressive illness), as a shift towards the manic phase may occur. In this case, consult your doctor to initiate appropriate treatment with antipsychotic medicines. If you enter a manic phase, stop taking Ricap.
If you experience a combination of symptoms such as fever, muscle stiffness or tremor, changes in your mental state such as confusion, irritability and extreme agitation and/or gastrointestinal symptoms; you may be experiencing serotonin syndrome or neuroleptic malignant syndrome. Although this syndrome is rare, it may lead to potentially life-threatening conditions. In this case, stop treatment with Ricap immediately and consult your doctor to start therapy to treat the symptoms.
If you have a coagulation disorder and are at risk of bleeding (haemorrhage), and if you are taking medicines that worsen these problems (see section "Other medicines and RICAP");
If you are undergoing electroconvulsive therapy (ECT);
If you suffer or have suffered from mental illnesses (psychosis) with depressive episodes, as your psychotic symptoms may worsen;
If you are prone to disturbances in heart rhythm (QT interval prolongation) or other heart diseases, especially if you are a woman and/or have low levels of potassium in the blood, due to the risk of heart rhythm disturbances such as QT prolongation and ventricular arrhythmias, including Torsades de Pointes; If you suffer or have suffered from heart diseases, for example very slow heart rate (significant bradycardia), recent acute myocardial infarction or uncompensated heart failure. Low levels of potassium and/or magnesium in the blood increase the risk of heart rhythm disturbances (arrhythmias) and therefore must be corrected before starting treatment with Ricap. If your heart disease is stable, your doctor should consider performing an ECG check before starting treatment. If, during treatment with Ricap, you develop signs of heart rhythm disturbances, treatment must be stopped and an ECG performed.
If you have or have previously had an eye condition called closed-angle glaucoma (increased pressure inside the eye);
If you are taking herbal preparations containing St. John’s wort (Hypericum perforatum), as adverse effects may be more common when citalopram is used concomitantly with herbal products containing St. John’s wort. Therefore, do not take it together with these preparations (see "Ricap with beverages" and "Other medicines and Ricap").
If you are taking medicines containing buprenorphine (with or without naloxone). The use of these medicines together with citalopram may lead to serotonin syndrome (see "Other medicines and RICAP").

When stopping treatment with Ricap, especially if this occurs suddenly, withdrawal symptoms may occur (see section "If you stop taking Ricap").
Medicines such as Ricap (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-noradrenaline reuptake inhibitors (SNRIs)) may cause symptoms of sexual dysfunction (see section 4. "Possible side effects"). In some cases, these symptoms may persist after discontinuation of 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 health conditions (psychiatric disorders), you may have thoughts of harming yourself or of suicide. For this reason, your doctor should monitor you closely, 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).
It may be helpful to inform a relative or friend that you are depressed or have anxiety disorders 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 changes in your behaviour.
If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go immediately to hospital.
During treatment, you may experience an inner sense of restlessness, agitation and inability to sit or stand still (akathisia), generally associated with subjective discomfort. This is more likely to occur within the first few weeks of treatment. If you develop these symptoms, increasing the dose of Ricap may be harmful.
Children and adolescents
RICAP must not be used to treat children and adolescents under 18 years of age. When taking this class of medicines, patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, suicidal ideation and hostility (mainly aggression, oppositional behaviour and anger).
Nevertheless, your doctor may prescribe Ricap to patients under 18 years of age if he or she considers it strictly necessary. If your doctor has prescribed Ricap to a patient under 18 years of age and you wish to obtain more information, contact your doctor. Inform your doctor immediately if any of the above symptoms appear or worsen during Ricap treatment in patients under 18 years of age.
In addition, the long-term safety effects of Ricap on growth, maturation and cognitive and behavioural development in this patient group have not yet been established.
Other medicines and Ricap
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Do not take Ricap if you are taking the following medicines:

Medicines called monoamine oxidase inhibitors (MAOIs), due to the risk of severe adverse effects (including serotonin syndrome), sometimes fatal (see "Do not use Ricap"). Symptoms of serotonin syndrome with an MAOI include: agitation, tremors, muscle spasms and increased body temperature.
Medicines for heart rhythm disorders or that may affect heart rhythm;
Linezolid (an antibiotic);
Medicines with serotonergic effects such as sumatriptan (used to treat migraine) or other triptans, tramadol, oxytriptan and tryptophan;
Moclobemide (used for depression) and buspirone (used for anxiety);
Selegiline (used to treat Parkinson’s disease) may be taken with Ricap only if the daily dose of selegiline does not exceed 10 mg. If you have stopped treatment with MAOI medicines and intend to start treatment with Ricap, you must wait at least 2 weeks after stopping before taking Ricap. If you stop treatment with Ricap and intend to start taking MAO inhibitors, you must wait at least 7 days after stopping Ricap (see "Do not take Ricap").
Medicines for heart rhythm disorders or medicines that may affect heart rhythm (which prolong the QT interval), such as class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (such as sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), some antihistamines (astemizole, mizolastine).

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

Buprenorphine (with or without naloxone) may interact with RICAP and symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, fever above 38°C may occur. Contact your doctor if you experience such symptoms.
Lithium and tryptophan (used to treat mental illnesses);
Sumatriptan and similar medicines (used to treat migraine);
St. John’s wort, a herbal remedy;
Medicines used to thin the blood (anticoagulants);
Medicines used to relieve inflammation and pain (non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid; medicines used to prevent blood clotting such as dipyridamole, ticlopidine;
Medicines that reduce potassium or magnesium levels in the blood, due to increased risk of heart rhythm disturbances;
Neuroleptic medicines (used to treat schizophrenia);
Mefloquine (used for malaria), bupropion (to help you stop smoking), tramadol (used for severe pain), as there is a risk of a possible lowering of the seizure threshold;
Cimetidine, lansoprazole 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 for heart conditions such as flecainide and propafenone (used to treat irregular heartbeat) and metoprolol (when used in heart failure);
Other medicines to treat depression such as desipramine, clomipramine, imipramine, nortriptyline, fluvoxamine, medicines for mental disorders (atypical antipsychotics) and medicines to treat psychosis (risperidone, thioridazine and haloperidol).

Ricap with beverages and alcohol
Adverse effects may be more common when Ricap is used concomitantly with herbal preparations containing St. John’s wort (Hypericum perforatum). Therefore, do not take this medicine together with preparations containing St. John’s wort (see "Warnings and precautions" and "Other medicines and Ricap").
Avoid consuming alcohol during treatment with Ricap.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Ricap during pregnancy or if you are planning a pregnancy, unless your doctor considers it strictly necessary.
Do not stop treatment with Ricap abruptly during pregnancy. Inform your doctor if you wish to discontinue or stop treatment.
If you take Ricap near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders.
Inform your attending doctor or midwife that you are taking RICAP so they can advise you on what to do.
Newborns should be monitored if Ricap has been used by the mother during the late stages of pregnancy, particularly in the third trimester. When taken during pregnancy, especially in the last 3 months, medicines such as Ricap may increase the risk of a serious condition in children called persistent pulmonary hypertension of the newborn (PPHN), which manifests as increased breathing rate and bluish skin colour. These symptoms usually begin within the first 24 hours after the baby’s birth. If this occurs for your baby, contact the midwife and/or doctor immediately.
If you take Ricap during the late stages of pregnancy, your baby may show the following symptoms: breathing difficulties, bluish or purplish skin colour, seizures, unstable body temperature, feeding difficulties, vomiting, low blood glucose, rigid or floppy muscles, hyperactive reflexes, tremor, restlessness, irritability, lethargy, continuous crying, drowsiness and difficulty sleeping.
These symptoms may be due to either serotonergic effects or withdrawal symptoms. In most cases, complications begin immediately after birth or in the hours immediately following (less than 24 hours). If your baby shows any of these symptoms at birth, contact your doctor immediately.
Breastfeeding
Ricap passes into breast milk in small amounts. If you are taking Ricap, consult your doctor before starting breastfeeding.
Fertility
In animal studies, citalopram has been shown to reduce sperm quality. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.
Driving and using machines
Ricap has a minor or moderate influence on the ability to drive and use machines. It may reduce your judgment and reactivity in emergency situations. Do not drive or use tools or machinery if you notice that your abilities are impaired.
Ricap contains ethanol and para-hydroxybenzoates (parabens)
This medicine contains 15.2 mg of alcohol (ethanol) in each minimum dose and 60.8 mg of alcohol (ethanol) in each maximum dose. The amount of this medicine is equivalent to less than 0.380 ml of beer or 0.152 ml of wine for the minimum dose and less than 1.520 ml of beer or 0.608 ml of wine for the maximum dose. The small amount of alcohol in this medicine will not produce significant effects. Harmful for patients suffering from liver disease, alcoholism, epilepsy, brain injury or brain diseases, or for pregnant women and children.
It may alter or increase the effect of other medicines.
In addition, the medicine contains para-hydroxybenzoates such as methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to take Ricap

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Ricap is administered as a single daily dose. The drops may be mixed with water, orange juice,
or apple juice.
1 drop = 2 mg of citalopram.
Recommended doses are:
Depression
The usual dose is 8 drops (16 mg)/(0.4 ml) per day. This dose may be increased by your doctor up to
a maximum of 16 drops (32 mg)/(0.8 ml) per day.
The antidepressant effect generally appears within 2–4 weeks after starting treatment; it is advisable
that you remain under medical supervision until remission of the depressive state is achieved.
Treatment should be continued for an appropriate period of time, usually 4–6 months in manic-depressive disorders.
If you suffer from recurrent unipolar depression, long-term maintenance therapy may be necessary to prevent new depressive episodes.
Anxiety disorders with panic attacks
The initial dose is 4 drops (8 mg)/(0.2 ml) per day for the first week; thereafter, the dose is increased to 8 drops (16 mg)/(0.4 ml) per day. The dose may be increased by your doctor up to
a maximum of 16 drops (32 mg)/(0.8 ml) per day.
In anxiety disorders with panic attacks, treatment is long-term. Maintenance of clinical response has been demonstrated during prolonged treatment (1 year).
If insomnia or marked restlessness occurs, additional treatment with sedatives is recommended during the acute phase.
When deciding to discontinue treatment, doses should be gradually reduced to minimize withdrawal symptoms (see "If you stop taking Ricap" and "Warnings and precautions").
Use in children and adolescents under 18 years of age
Ricap should normally not be used in children and adolescents under 18 years of age (see section "Children and adolescents").
Use in elderly patients (over 65 years of age)
The initial dose should be reduced to half the recommended dose, for example 4 drops (8 mg) per day. Elderly patients should not normally take more than 8 drops (16 mg)/(0.4 ml) per day.
Use in patients with hepatic or renal impairment
If you have liver problems, you should not take more than 8 drops (16 mg)/(0.4 ml) per day.
Use in patients with kidney problems (renal impairment)
If you have reduced kidney function (renal impairment), follow the minimum recommended dosage.
If you take more Ricap than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
The following symptoms have been reported in cases of overdose:
fatigue, weakness, sedation, seizures, changes in heart rhythm (e.g., faster or slower heartbeat, or irregular heartbeat), drowsiness, vomiting, tremor, excessive drop or rise in blood pressure, nausea, serotonin syndrome, agitation, dizziness, pupil dilation, stupor, sweating, bluish discoloration of the skin, severe damage to skeletal muscle (rhabdomyolysis), rapid and deep breathing, cardiac arrest, coma.
If you forget to take Ricap
If you forget to take a dose of this medicine, simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Ricap
Do not stop treatment with RICAP 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 (paraesthesia), and electric shock sensations
sleep disturbances (including insomnia and vivid dreams)
agitation or anxiety, tremor, confusion
nausea and/or vomiting, diarrhoea
sweating, headache
palpitations
emotional instability, irritability
visual disturbances.
The risk is higher when Ricap has been used for a long time or at high doses, or when dose reduction is carried out too rapidly. Generally, the intensity of symptoms is mild to moderate, but in some patients it may be severe. Symptoms usually appear within the first few days after stopping treatment, although very rarely they may occur even if a single dose is missed. In most cases, symptoms resolve within two weeks, although in some patients they may last longer (2–3 months or more). Therefore, it is recommended to gradually reduce the dose of Ricap when discontinuing treatment, over a period of several weeks or months, according to your individual needs.

If you experience intolerable symptoms after reducing the dose or stopping treatment, re-institution of the previously prescribed dose may be considered.
Subsequently, your doctor may continue reducing the dose, but more gradually.
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 get them.
The adverse events observed with Ricap are generally mild in severity and transient in nature. They most commonly occur during the first or second week of treatment and then gradually diminish thereafter.
Warning: If during treatment or shortly after stopping treatment you are thinking about harming yourself or have thoughts of suicide, contact your doctor immediately (see section "Warnings and precautions").

The following side effects may occur:

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

drowsiness or insomnia
headache
dry mouth
nausea
increased sweating

Common (may affect up to 1 in 10 people)

decreased appetite, weight loss
restlessness, anxiety, nervousness, confusion
fatigue
yawning, abnormal dreams
tremor, tingling sensations
dizziness, attention disturbances
ringing in the ears
diarrhoea, vomiting, constipation
itching
muscle pain, joint pain
impaired sexual function in men (impotence, ejaculation disorders, failure to ejaculate)
reduced sexual desire or abnormal orgasm in women

Uncommon (may affect up to 1 in 100 people)

increased appetite, weight gain
aggression, feeling detached from oneself (depersonalization), hallucinations, sensation of excitement leading to unusual behaviour (mania)
fainting
dilated pupils
slow or fast heartbeat
urticaria, rash, red skin spots, skin sensitivity to light
loss of hair and/or body hair
difficulty urinating
heavy menstrual periods
swelling due to excessive fluid accumulation in the body

Rare (may affect up to 1 in 1,000 people)

low sodium levels in the blood
epileptic seizures (grand mal convulsions)
movement disorders (e.g., uncontrollable spasms or involuntary movements)
taste disturbances
bleeding
hepatitis
fever

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

reduced number of platelets (thrombocytopenia)
hypersensitivity
severe, rapidly developing allergic reaction (anaphylactic reaction)
inappropriate secretion of antidiuretic hormone (ADH), causing fluid retention, weakness, tiredness, or confusion
low potassium levels in the blood
panic attacks
teeth grinding during sleep (bruxism)
feeling restless and unable to stay still (akathisia), especially when sitting
suicidal ideation and suicidal behaviour (during treatment or shortly after stopping treatment)
seizures, serotonin syndrome, movement disorders, abnormal involuntary movements (extrapyramidal disorders)
visual disturbances
unusual or very rapid heart rate (QT interval prolongation, ventricular arrhythmias, including Torsade de Pointes), especially in female patients, those with low potassium levels in the blood, or those with heart conditions (see sections “Do not take Ricap”, “Warnings and precautions”, “Other medicines and Ricap”, and “If you take more Ricap than you should”)
feeling faint or dizzy when standing due to a drop in blood pressure
nosebleeds
gastrointestinal bleeding (including rectal bleeding)
abnormal results in liver function tests
blood spots under the skin
severe allergic reaction causing swelling of the face and mucous membranes (angioedema)
irregular, heavy menstrual bleeding (metrorrhagia)
heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see sections “Warnings and precautions” and “Pregnancy” for further information
persistent painful erection
abnormal milk secretion from the breasts in men

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Withdrawal symptoms observed following discontinuation of treatment
Stopping treatment with Ricap (especially if abruptly) generally leads to withdrawal symptoms.
The most commonly reported adverse effects include dizziness, sensory disturbances (including tingling), sleep disturbances (including insomnia and vivid dreams), restlessness or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances.
These symptoms are usually mild to moderate and self-limiting; however, in some patients they may be severe and/or prolonged. Therefore, if you need to stop treatment with Ricap, your doctor will gradually reduce your dose (see “How to take Ricap”).

Following the instructions in this leaflet can reduce the risk of side effects.

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 Ricap

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month. The stated expiry date applies to the product stored in its original, unopened packaging and kept under recommended storage conditions.
Store the medicine at a temperature not exceeding 25°C, protected from light, in the original container.
Use the product within 4 months of first opening the bottle. After this period, dispose of any remaining medicine.
Do not dispose of medicines 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 Ricap 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 components are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, hydroxyethylcellulose, purified water.

Description of the appearance of Ricap and contents of the pack
Ricap is an oral solution, presented as drops.
15 ml bottle of solution 40 mg/ml.
Marketing Authorization Holder
Farmaceutici Caber S.r.l. - Via del Mare, 36 - Pomezia (Rm)
Manufacturer
Help S.A. Pharmaceuticals - 10 Valaoritou str. GR 144 52 Metamorphosis – Athens, Greece
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)