Package leaflet: Information for the user

SINTOPRAM 40 mg/ml oral drops, solution

Citalopram
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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sintopram is and what it is used for

Sintopram contains the active substance citalopram and belongs to a group of medicines called
selective serotonin reuptake inhibitors (SSRIs), also known as antidepressants.
Sintopram is used to treat endogenous depressive disorders (i.e. those not caused by an external factor, such as bereavement or a traumatic event) and to prevent relapses and recurrences.
Sintopram is also used for anxiety disorders with panic attacks, with or without agoraphobia (fear of leaving home).

2. What you should know before taking Sintopram

Do not take Sintopram

If you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
If you are under 18 years of age.
If you are being treated with monoamine oxidase inhibitors (MAO inhibitors). These medicines include selegiline, a selective MAO inhibitor used in Parkinson’s disease, linezolid, a reversible (non-selective) MAO inhibitor used to treat infections, and moclobemide (selective for type IA), used in the treatment of depression. Concomitant administration of serotonin reuptake inhibitors (SSRIs) and MAO inhibitors (medicines used for depression) may cause serious adverse reactions, sometimes fatal. Some cases present with features similar to serotonin syndrome (due to excess serotonin in the blood).
If you are being treated with monoamine oxidase inhibitors (MAOIs), including selegiline, at daily doses exceeding 10 mg/day.
Within 14 days after stopping an irreversible MAOI or within the time specified after discontinuation of a reversible MAO inhibitor (RIMA), as indicated in the RIMA’s package leaflet.
If you stop treatment with citalopram and need to start a new therapy with MAO inhibitors. MAO inhibitors must not be administered until at least 7 days after stopping citalopram (see section “Other medicines and Sintopram”).
If you are being treated with linezolid, a reversible monoamine oxidase inhibitor, unless adequate equipment is available for careful observation and monitoring of blood pressure (see section “Other medicines and Sintopram”).
If you are being treated with pimozide (an antipsychotic drug used in the treatment of psychiatric disorders) (see section “Other medicines and Sintopram”).
If you suffer from QT interval prolongation or congenital long QT syndrome.
If you are taking medicines known to cause QT interval prolongation (see section “Other medicines and Sintopram”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Sintopram.
Exercise particular caution with Sintopram:

If you are elderly and/or if your renal and hepatic function are reduced: see section 3 “How to take Sintopram”.
c
If you suffer from panic disorders: some patients with panic disorders may experience increased anxiety symptoms at the beginning of antidepressant treatment. These paradoxical reactions usually diminish within the first two weeks of treatment. Your doctor may recommend a lower starting dose to reduce the likelihood of paradoxical anxiogenic effects (see section 3 “How to take Sintopram”).
If you suffer from depression, you may experience increased suicidal thoughts, self-harm, and suicidal tendencies (suicide-related events). This risk persists until a significant improvement or remission of symptoms occurs. Since improvement may not occur during the first few weeks or longer of treatment, you should be closely monitored until such improvement occurs. Other psychiatric disorders for which citalopram is prescribed may also be associated with an increased risk of suicide-related events. Additionally, such disorders may coexist with major depression (disabling depressive symptoms). Therefore, if you have major depression, the same precautions applied in treating patients with other psychiatric disorders will be adopted. If you have a positive clinical history of suicide-related events or if you exhibit a significant degree of suicidal ideation before starting therapy, you may be at higher risk of suicidal thoughts or suicide attempts and will be closely monitored during treatment. Pharmacological treatment with antidepressants, especially during the initial phases of treatment and following dosage adjustments, must always be accompanied by close monitoring of patients, particularly those at high risk. You (and those caring for you) should be alerted to the need to monitor any worsening clinical condition, suicidal behavior or thoughts, and unusual changes in behavior, and to contact your doctor immediately if such symptoms occur.
The use of SSRIs/SNRIs has been associated with the development of akathisia (inability to remain still), characterized by restlessness and a frequent need to move, often accompanied by an inability to sit or remain still. You are more likely to experience such symptoms within the first weeks of treatment. If you develop these symptoms, increasing the dosage may be harmful.
If you are elderly: elderly female patients appear to be at particularly high risk of hyponatremia (an electrolyte disorder in which plasma sodium concentration is lower than normal). This condition is usually reversible after discontinuation of therapy.
If you suffer from bipolar disorder (depression alternating with aggression/mania): a switch to the manic phase may occur. Citalopram should be discontinued if the patient enters a manic phase.
If you suffer from epilepsy: seizures are a potential risk with the use of antidepressant drugs. If seizures occur, discontinue citalopram in all patients. Citalopram should be avoided if you have unstable epilepsy, while if you have controlled epilepsy, you should be closely monitored. If you experience an increase in seizure frequency, treatment with citalopram should be discontinued.
If you have diabetes: in diabetic patients, treatment with selective serotonin reuptake inhibitors (SSRIs) may alter glycaemic control. Adjustment of insulin or oral hypoglycaemic agent dosage (medicines that lower blood sugar concentration) may be necessary.
If you are taking SSRIs, as serotonin syndrome has been reported in rare cases. A combination of symptoms such as agitation, tremor, myoclonus (sudden, brief muscle contractions, tics), and hyperthermia (increased body temperature) may indicate the development of this condition. Your doctor will immediately discontinue citalopram therapy and advise you to start symptomatic treatment.
Do not take citalopram in combination with medicines having a serotoninergic effect, such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan (see section “Other medicines and Sintopram”).
With SSRIs, prolonged coagulation times and/or coagulation abnormalities such as bruising (purplish spots due to blood leakage), gynecological bleeding, gastrointestinal bleeding, and other forms of cutaneous or mucosal bleeding have been reported (see section 4 “Possible side effects”). If you are taking SSRIs, exercise caution, particularly if you are also taking active substances that may affect platelet function or other substances that may increase the risk of bleeding, as well as if you have a clinical history of coagulation disorders (see section 4 “Possible side effects”) or if you are pregnant (see section “Pregnancy”).
Clinical experience with concomitant administration of ECT (electroconvulsive therapy) and citalopram is limited; therefore, caution is recommended.
Do not take citalopram together with MAO-A inhibitors due to the risk of serotonin syndrome (see section “Other medicines and Sintopram”). For further information on concomitant treatment with non-selective irreversible MAO inhibitors, consult section “Other medicines and Sintopram”.
Adverse effects may be more common during concomitant use of citalopram and herbal preparations containing St. John’s wort (Hypericum perforatum). Therefore, do not take citalopram simultaneously with preparations containing St. John’s wort (see “Other medicines and Sintopram”).
In case of discontinuation of SSRI treatment: if you need to stop treatment, avoid doing so abruptly and gradually reduce the dose of citalopram to reduce the risk of withdrawal reactions (see sections “If you stop taking Sintopram”).
If you are a psychotic patient with depressive episodes, treatment with citalopram may increase psychotic symptoms.
Citalopram may cause dose-dependent QT interval prolongation. In post-marketing experience, cases of QT interval prolongation and ventricular arrhythmias, including Torsade de Pointes (alterations in heart beat frequency), have been reported, mainly in women, with hypokalemia (low blood potassium concentration), or with pre-existing QT interval prolongation or other cardiac diseases.
Use Sintopram with caution if you have significant bradycardia (reduced heart rate), if you have recently had an acute myocardial infarction, or if you suffer from uncompensated heart failure.
You may develop electrolyte imbalances such as hypokalemia (reduced potassium in the blood) and hypomagnesemia (reduced magnesium concentration in the blood), which increase the risk of malignant arrhythmias. Your doctor will correct these imbalances before you start treatment with citalopram.
If you have stable cardiac disease, an ECG check should be performed before starting treatment. If, during treatment with citalopram, you develop signs of cardiac arrhythmia, treatment should be suspended and an ECG should be performed.
SSRIs, including citalopram, may affect pupil size, leading to mydriasis (pupil dilation). This effect may increase intraocular pressure and cause a condition called angle-closure glaucoma (increased pressure of fluid within the eye due to impaired drainage), especially if you are predisposed. Therefore, citalopram should be used with caution if you have angle-closure glaucoma or a history of glaucoma.
Medicines such as Sintopram (so-called selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine 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.

Insomnia and agitation may occur at the beginning of treatment. In such cases, your doctor may adjust the dosage.
Children and adolescents
This medicine is contraindicated in children and adolescents under 18 years of age.
However, your doctor may prescribe Sintopram to patients under 18 years of age if they consider it the best solution for them. In such cases, the child or adolescent should be closely observed, and you should inform the doctor if symptoms such as suicide attempts, suicidal ideation, or hostility appear or worsen during Sintopram treatment.
“For those engaged in sports: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.”
Other medicines and Sintopram
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines can alter the action of other medicines, and this may sometimes cause serious adverse reactions.
In particular, inform your doctor or pharmacist if you are taking:

Moclobemide and buspirone (antidepressants): cases of serotonin syndrome have been reported with concomitant use of citalopram with moclobemide and buspirone.
MAO inhibitors (such as selegiline, linezolid, or moclobemide): concomitant use of citalopram and MAO inhibitors may cause serious adverse effects, including serotonin syndrome (see sections “Possible side effects” and “Warnings and precautions”).

Symptoms of interaction between an active substance and MAO inhibitors include: agitation, tremor,
myoclonus (sudden, brief muscle contractions, tics), and hyperthermia (increased temperature). (see section 4 “Possible side effects”).

Medicines that prolong the QT interval, such as class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatments, particularly halofantrine), and certain antihistamines (astemizole, mizolastine). Medicines that prolong the QT interval or drugs that induce hypokalemia/hypomagnesemia (low potassium and magnesium in the blood), as they, like citalopram, may potentially prolong the QT interval.
Pimozide (antipsychotic). Concomitant use of citalopram and pimozide is contraindicated (see section 4 “Possible side effects”).
Selegiline, a selective MAO-B inhibitor (at doses exceeding 10 mg per day), since concomitant use of this drug with citalopram is not recommended.
Lithium or tryptophan-containing medicines, due to the risk of enhanced serotoninergic effect. In this case, you will be subjected to routine monitoring of lithium levels, which should continue as usual.
Tramadol, sumatriptan, as they may lead to increased serotoninergic effects. Concomitant use of citalopram and serotonin agonists (or 5-HT), such as sumatriptan and other triptans, as well as tramadol, is not recommended. (see section “Warnings and precautions”).
Buprenorphine-containing medicines, which may interact with Sintopram and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle contraction, and fever above 38°C. Contact your doctor if you experience such symptoms.
St. John’s wort. The use of citalopram and herbal preparations containing St. John’s wort (Hypericum perforatum) may cause an increase in adverse effects (see section “Warnings and precautions”).
Anticoagulants, medicines that may affect platelet function, such as non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamole, and ticlopidine, or other drugs (e.g., atypical antipsychotics), as they may increase the risk of bleeding (see section “Warnings and precautions”).
Medicines that cause hypokalemia/hypomagnesemia, as these conditions increase the risk of malignant arrhythmias (see section “Warnings and precautions”).
Medicines that may lower the seizure threshold (e.g., antidepressants such as SSRIs, neuroleptics such as butyrophenones and thioxanthenes, mefloquine, bupropion, and tramadol).
Medicines such as cimetidine, a known enzyme inhibitor, CYP2C19 inhibitors (such as omeprazole, esomeprazole (anti-ulcer), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), lansoprazole (anti-ulcer), ticlopidine (antiplatelet agent used to reduce stroke risk)). These may cause an increase in citalopram blood levels. Your doctor may adjust the citalopram dose.
Medicines primarily metabolized by the CYP2D6 enzyme, such as flecainide, propafenone, and metoprolol (when used in heart failure), or certain central nervous system-acting medicines primarily metabolized by the CYP2D6 enzyme, such as antidepressants like desipramine, clomipramine, and nortriptyline, or antipsychotics such as risperidone, thioridazine, and haloperidol. Your doctor may adjust the dosage.
Metoprolol (a medicine used in certain heart conditions), as when taken concomitantly with citalopram, the amount of metoprolol in the blood doubles. No clinically significant effects on blood pressure or heart rate have been observed.
Desipramine (antidepressant), the main metabolite of imipramine. When citalopram is associated with desipramine, an increase in desipramine blood levels is observed. Therefore, your doctor may consider a dosage reduction necessary.

Sintopram with food, drinks, and alcohol
Do not take citalopram with alcohol.
No effects of food on the absorption and other properties of citalopram have been reported.
Pregnancy and breastfeeding
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
You should not take citalopram during pregnancy unless considered necessary by your doctor, and only after careful assessment of the risk to the child versus the benefit to you.
If you have taken citalopram in the late stages of pregnancy, particularly in the third trimester, the newborn should be monitored. During pregnancy, avoid abrupt discontinuation.
If you have taken SSRIs/SNRIs during the late stages of pregnancy, the newborn may exhibit the following symptoms: respiratory distress, cyanosis (bluish skin discoloration), apnea (cessation of breathing), seizures, unstable temperature, feeding difficulties, vomiting, hypoglycemia (low blood sugar), hypertonia (increased normal muscle contraction at rest), hypotonia (reduced normal muscle contraction at rest), hyperreflexia (increased tendon reflex response), tremors, restlessness, irritability, lethargy (pathological sleep state), chronic crying, drowsiness, and difficulty sleeping. These symptoms may be due to serotoninergic effects or withdrawal symptoms. In most cases, complications begin immediately after birth or in the following hours (less than 24 hours).
Ensure that your doctor and/or midwife are aware that you are taking Sintopram. If you take medicines like Sintopram during pregnancy, especially in the last three months, it may increase the risk of a serious condition in newborns called persistent pulmonary hypertension (PPHN) (increased pressure in the pulmonary arterial circulation), which manifests with increased respiratory rate and bluish skin discoloration. These symptoms usually begin within 24 hours after birth. If this occurs in your baby, you must contact the midwife and/or doctor immediately.
If you take Sintopram 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 Sintopram so they can advise you on what to do.
Breastfeeding
Citalopram is excreted in breast milk. Only mild events have been observed in newborns. However, caution is recommended as available information is insufficient to assess the risk in infants.
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 and use machinery.
Psychotropic medicines may reduce your judgment and reactivity in emergency situations; use caution when driving vehicles or operating machinery.
Sintopram contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e., essentially ‘sodium-free’.
Sintopram contains methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate
May cause allergic reactions (including delayed reactions).
Sintopram contains alcohol
This medicine contains 75.8 mg of alcohol (ethanol) in each ml, equivalent to 75.8 mg/ml (7.58% w/v). The amount in 1 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Sintopram

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Route of administration:
The drops may be mixed with water, orange juice, or apple juice.
1 drop = 2 mg of citalopram.

Treatment of endogenous depressive syndromes
(i.e. not caused by an external factor, such as bereavement or a traumatic event)

Adults:
The recommended dose is 16 mg (8 drops) daily.
Depending on your individual response, your doctor may increase the dose up to a maximum of 32 mg (16 drops) daily.
The antidepressant effect usually becomes evident within 2–4 weeks after starting treatment. It is advisable that you remain under medical supervision until the depressive symptoms have resolved.

Since antidepressant treatment is symptomatic, it should be continued for an appropriate period of time—generally 4–6 months in manic-depressive illness.

If you suffer from recurrent unipolar depression (severe major depression with mood disorder), long-term maintenance therapy may be necessary to prevent new depressive episodes.

Treatment of anxiety disorders with panic attacks, with or without agoraphobia

Adults:
During the first week of treatment, the recommended dose is 8 mg (4 drops). Subsequently, the dose is increased to 16 mg (8 drops) daily. Depending on your individual response, your doctor may increase the dose up to a maximum of 32 mg (16 drops) daily.

Panic disorder requires long-term treatment. 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 your doctor decides to discontinue treatment, you will be instructed to reduce the dose gradually to minimize withdrawal symptoms.

Withdrawal symptoms observed after discontinuation of treatment
Avoid abrupt discontinuation of treatment. When your doctor decides to stop treatment with Sintopram, you will be advised to gradually reduce the dose over a period of at least 1–2 weeks to reduce the risk of withdrawal reactions.

If you experience intolerable symptoms following dose reduction or upon stopping treatment, your doctor may consider reinstating the previously prescribed dose. The doctor may then continue reducing the dose, but more gradually.

Elderly patients (over 65 years of age)
If you are elderly, your doctor may advise reducing the dose to half the standard recommended dose, e.g. 8 mg (4 drops) up to 16 mg (8 drops) daily. The maximum recommended dose in elderly patients is 16 mg (8 drops) daily.

Use in children and adolescents under 18 years of age
Sintopram must not be taken by children and adolescents under 18 years of age.

Impaired liver function
If you have mild or moderate hepatic impairment, the recommended initial dose for the first two weeks of treatment is 8 mg (4 drops) daily. Depending on your individual response, your doctor may increase the dose up to a maximum of 16 mg (8 drops) daily. Your doctor will exercise caution and increased vigilance in dose selection if you have severely impaired liver function.

Renal impairment
If you have renal insufficiency, your doctor will prescribe the lowest recommended dosage.

Poor metabolizers of CYP2C19
If you belong to a patient group known to be poor metabolizers of CYP2C19, your doctor will prescribe an initial dose of 8 mg (4 drops) daily for the first two weeks of treatment. Depending on your individual response, the dose may be increased up to a maximum of 16 mg (8 drops) daily.

Use in children and adolescents under 18 years of age
Sintopram must not be taken by individuals under 18 years of age.

If you take more Sintopram than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

The following adverse effects have been reported in cases of overdose: seizures, tachycardia, somnolence, QT interval prolongation, coma, vomiting, tremor, hypotension, cardiac arrest, nausea, serotonin syndrome, agitation, bradycardia, dizziness, cardiac conduction block, QRS widening, hypertension, mydriasis, torsades de pointes, stupor, sweating, cyanosis (bluish discoloration of skin and mucous membranes), hyperventilation (increased respiratory rate), and atrioventricular arrhythmia. Rhabdomyolysis is rare.

Possible symptoms with doses up to 600 mg include fatigue, weakness, sedation, tremor, nausea, and tachycardia (increased heart rate).

With doses exceeding 600 mg, seizures may occur within a few hours of ingestion. ECG changes and, rarely, rhabdomyolysis may also occur.

Fatal outcomes following overdose are rare.

ECG monitoring is recommended in case of overdose if you have congestive heart failure/bradyarrhythmias (altered and reduced heart rate), if you are taking concomitant medications that prolong the QT interval, or if you have metabolic disorders, such as hepatic impairment.

Treatment
If your level of consciousness is impaired, intubation may be required. Your ECG and vital signs must be closely monitored.

In case of hypoxia (reduced blood oxygen), oxygen will be administered, and diazepam may be given if you have seizures. If the ingested dose exceeds 600 mg, you should be kept under medical observation for approximately 24 hours, with ECG monitoring.

If you forget to take Sintopram
Do not take a double dose to make up for the missed dose.

If you stop taking Sintopram
Avoid abrupt discontinuation of treatment.

Withdrawal symptoms observed after stopping SSRI treatment
Withdrawal symptoms commonly occur upon discontinuation of SSRI treatment, especially if stopping abruptly.

The risk of withdrawal symptoms may depend on several factors, including duration and dose of treatment, and the speed of dose reduction. The most commonly reported adverse effects are: dizziness, sensory disturbances (including paresthesia and altered sensation), sleep disturbances (including insomnia and vivid dreams), agitation 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 in intensity; however, in some patients they may be severe. Withdrawal symptoms usually appear within the first few days after stopping treatment; however, very rare cases of withdrawal symptoms have been reported in patients who inadvertently missed a single dose.

These symptoms usually resolve spontaneously within 2 weeks without the need for medication, although in some patients they may persist for 2–3 months or longer.

If you need to discontinue treatment, the dose of citalopram should be gradually reduced over a period of several weeks or months, according to your individual needs (see section 3 “How to take Sintopram”).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The side effects observed with citalopram are generally mild in severity and transient. They usually occur during the first or second week of treatment and then gradually diminish over time.
The following reactions have been shown to be dose-dependent: increased sweating, dry mouth, insomnia, drowsiness, diarrhoea, nausea, and fatigue.

Very common (affects more than 1 in 10 people)

Drowsiness
Insomnia
Headache
Dry mouth
Nausea
Increased sweating

Common (affects up to 1 in 10 people)

Decreased appetite, weight loss
Agitation
Decreased libido (reduced sexual desire)
Anxiety, nervousness
Confusional state
Abnormal orgasm (in women)
Dream disturbances (abnormal dreams)
Tremor, paraesthesia
Dizziness
Attention disturbances
Tinnitus (ringing or buzzing in the ears)
Yawning
Diarrhoea
Vomiting
Constipation
Itching
Myalgia, arthralgia (muscle and joint pain)
Impotence, ejaculation disorders, anejaculation
Fatigue

Uncommon (affects up to 1 in 100 people)

Increased appetite, weight gain
Aggressiveness
Depersonalization (feeling detached from one's own body)
Hallucination (seeing or hearing things that are not real), mania (obsessive excitement)
Syncope (drop in blood pressure)
Mydriasis (dilation of the pupil)
Bradycardia (reduced heart rate)
Tachycardia (increased heart rate)
Urticaria (appearance of red, raised patches on the skin)
Alopecia (hair loss)
Rash (skin redness), purpura (appearance of small pinpoint skin haemorrhages)
Photosensitivity reaction (increased sensitivity to light)
Urinary retention
Menorrhagia (in women) (excessive menstrual blood loss)
Oedema

Rare (affects between 1 and fewer than 10 in 10,000 people)

Hyponatraemia (low sodium levels in the blood)
Seizures, grand mal (epilepsy)
Dyskinesia (alternating fast and slow movements)
Taste disturbances
Bleeding
Hepatitis
Pyrexia (fever)

Not known (frequency cannot be estimated from the available data)

Thrombocytopenia (reduced platelet count)
Hypersensitivity
Anaphylactic reaction (severe allergic reaction affecting multiple organs)
Inappropriate secretion of ADH hormone (water retention in the body and reduced urine production)
Hypokalaemia (reduced potassium concentration in the blood)
Panic attacks
Bruxism (jaw muscle contractions with teeth grinding)
Restlessness
Suicidal ideation, suicidal behaviour
Seizures
Serotonin syndrome (due to increased serotonin levels in the blood)
Extrapyramidal disorders (movement disturbances and lack of coordination)
Akathisia (inability to remain still), movement disorders
Visual disturbances
QT interval prolongation
Ventricular arrhythmias, including torsades de pointes (serious disturbances in heart rhythm and rate)
Orthostatic hypotension (drop in blood pressure upon standing)
Epistaxis (nosebleed)
Gastrointestinal haemorrhage (including rectal bleeding)
Excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2, Pregnancy, for further information
Abnormal liver function tests
Bruising (appearance of subcutaneous haematomas)
Angioedema (sudden swelling of the skin and mucous membranes, lining membranes of certain internal organs)
Metrorrhagia (in women) (abnormal, heavy, and prolonged uterine bleeding occurring between two consecutive menstrual periods)
Priapism (persistent and abnormal erection), galactorrhoea (secretion of a milk-like substance from the nipples in men)

Bone fractures:
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: reazioni-avverse.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Sintopram

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after "Exp." The expiry date refers to the last day of that month.
The expiry date refers to the product in its original packaging, correctly stored.
Store below 25°C.
Keep in the original 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 SINTOPRAM contains

The active substance is citalopram. 1 ml (= 20 drops) of solution contains 44.48 mg of citalopram hydrochloride, equivalent to 40 mg of citalopram.
The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol 96%, hypromellose, disodium hydrogen phosphate dihydrate, sodium hydroxide, purified water.

Description of the appearance of Sintopram and contents of the pack
Oral drops 40 mg/ml, solution. Glass bottle of 15 ml with dropper cap.
Marketing Authorization Holder
BIOMEDICA FOSCAMA INDUSTRIA CHIMICO-FARMACEUTICA S.p.A.
Via Morolense, 87
03013 Ferentino (FR), Italy
Manufacturers
OFFICINA FRANCIA FARMACEUTICI S.r.l.,
Via dei Pestagalli n° 7
20138 Milano
SPECIAL PRODUCT’S LINE S.P.A.
Via Frattarotonda Vado Largo, 1
03012 Anagni (FR), Italy