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Citalopram Bluefish 10 mg film-coated tablets
Citalopram Bluefish 20 mg film-coated tablets
Citalopram Bluefish 40 mg film-coated tablets

Citalopram Bluefish 10 mg film-coated tablets:
Each tablet contains 12.49 mg citalopram hydrobromide, equivalent to 10 mg citalopram.
Citalopram Bluefish 20 mg film-coated tablets:
Each tablet contains 24.98 mg citalopram hydrobromide, equivalent to 20 mg citalopram.
Citalopram Bluefish 40 mg film-coated tablets:
Each tablet contains 49.96 mg citalopram hydrobromide, equivalent to 40 mg citalopram.
Excipients: Lactose monohydrate
Each tablet Citalopram Bluefish 10 mg contains 12.665 mg lactose (anhydrous).
Each tablet Citalopram Bluefish 20 mg contains 25.330 mg lactose (anhydrous).
Each tablet Citalopram Bluefish 40 mg contains 50.659 mg lactose (anhydrous).
For a full list of excipients, see section 6.1.

Film-coated tablet
Citalopram Bluefish 10 mg film-coated tablets are round, white tablets with a diameter of 6
Citalopram Bluefish 20 mg film-coated tablets are oval, white tablets scored and with a
diameter of 8 mm.
Citalopram Bluefish 40 mg film-coated tablets are oval, white tablets scored and with a
diameter of 11 mm.
The 20mg and 40mg tablet can be divided into equal halves.

4.1 Therapeutic indications

Treatment of major depressive episodes.
4.2 Posology and method of administration

Citalopram should be administered as a single oral dose, either in the morning or in the
evening. The tablets can be taken with or without food, but with fluid.
Following treatment initiation, an antidepressant effect should not be expected for at least two weeks. Treatment should continue until the patient has been free of symptoms for 4-6 months. Use in children and adolescents under 18 years of age
Citalopram should not be used in the treatment of children and adolescents under the age of
18 years (see section 4.4).
Citalopram should be administered as a single oral dose of 20 mg daily.
Dependent on individual patient response, the dose may be increased to a maximum of 40 mg
Elderly patients (>65 years):

For elderly patients the dose should be decreased to half of the recommended dose, e.g. 10-20
mg daily. The recommended maximum dose for the elderly is 20 mg daily.
Renal impairment:
Dosage adjustment is not required if the patient has mild to moderate renal impairment.
Caution is advised in patients with severe renal impairment since there are no clinical data in
this population (creatinine clearance less than 30mL/min, see section 5.2).
Reduced hepatic function:
An initial dose of 10 mg daily for the first two weeks of treatment is recommended in patients
with mild or moderate hepatic impairment. Depending on individual patient response, the
dose may be increased to 20 mg daily. Caution and extra careful dose titration is advised in
patients with severely reduced hepatic function (see section 5.2).
Poor metabolisers of CYP2C19
An initial dose of 10 mg daily during the first two weeks of treatment is recommended for
patients who are known to be poor metabolisers with respect to CYP2C19. The dose may be
increased to a maximum of 20 mg daily depending on individual patient response, (see
section 5.2).
Withdrawal symptoms seen on discontinuation
Abrupt discontinuation should be avoided. When stopping treatment with citalopram the dose
should be gradually reduced over a period of at least one to two weeks in order to reduce the
risk of withdrawal reactions (see section 4.4 and section 4.8). If intolerable symptoms occur
following a decrease in the dose or upon discontinuation of treatment, then resuming the
previously prescribed dose may be considered. Subsequently, the physician may continue
decreasing the dose, but at a more gradual rate.
4.3 Contraindications
• Hypersensitivity to citalopram or any of the excipients.
• Citalopram should not be given to patients receiving Monoamine Oxidase Inhibitors (MAOIs) including selegiline in daily doses exceeding 10 mg/day. Citalopram should not be given for fourteen days after discontinuation of an irreversible MAOI or for the time specified after discontinuation of a reversible MAOI (RIMA) as stated in the prescribing text of the RIMA. MAOIs should not be introduced for seven days after discontinuation of citalopram (see section 4.5). • Citalopram is contraindicated in the combination with linezolid unless there are facilities for close observation and monitoring of blood pressure (see section 4.5). • Citalopram is contraindicated in patients with known QT-interval prolongation or • Citalopram is contraindicated together with medicinal products that are known to prolong • Concomitant treatment with pimozide (see also section 4.5)

4.4 Special warnings and precautions for use

Use in children and adolescents under 18 years of age:
Citalopram Bluefish should not be used in the treatment of children and adolescents under the
age of 18 years (see 4.4). Suicide-related behaviours (suicide attempt and suicidal thoughts)
and hostility (principally aggression, oppositional behaviour and anger) were more frequently
observed in clinical trials among children and adolescents treated with antidepressants
compared to those treated with placebo. If, based on clinical need, a decision to treat is taken,
the patient should be carefully monitored for the appearance of suicidal symptoms. In
addition, long-term safety data in children and adolescents concerning growth, maturation
and cognitive and behavioural development are lacking.

Suicide/suicidal thoughts or clinical worsening:
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide
(suicide-related events). This risk persists until significant remission occurs. As improvement
may not occur during the first few weeks or more of treatment, patients should be closely
monitored until such improvement occurs. It is general clinical experience that the risk of
suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of
suicidal ideation prior to commencement of treatment are known to be at greater risk of
suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients
with psychiatric disorders showed an increased risk of suicidal behaviour with
antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug
therapy especially in early treatment and following dose changes. Patients (and caregivers of
patients) should be alerted about the need to monitor for any clinical worsening, suicidal
behaviour or thoughts and unusual changes in behaviour and to seek medical advice
immediately if these symptoms present.
Akathisia/psychomotor restlessness
The use of citalopram has been associated with the development of akathisia, characterised
by a subjectively unpleasant or distressing restlessness and need to move often accompanied
by an inability to sit or stand still. This is most likely to occur within the first few weeks of
treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
Diabetes In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted. Seizures Seizures are a potential risk with antidepressant drugs. Citalopram should be discontinued in any patient who develops seizures. Citalopram should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored. Citalopram should be discontinued if there is an increase in seizure frequency. ECT (electroconvulsive therapy) There is little clinical information on the concurrent use of citalopram and electroconvulsive therapy (ECT), and caution is therefore advised. Mania Citalopram should be used with caution for patients with a history of mania/hypomania. Use of citalopram should be discontinued in any patient who enters a manic phase. Haemorrhage There have been reports of prolonged bleeding time and/or bleeding abnormalities such as ecchymosis, gynaecological haemorrhages, gastrointestinal bleedings and other cutaneous or mucous bleedings with SSRIs (see section 4.8). Caution is advised in patients taking SSRIs, particularly in concomitant use with active substances known to affect platelet function or other active substances that can increase the risk of haemorrhage as well as in patients with a history of bleeding disorders (see section 4.5). Serotonine Syndrome There have been rare reports of the occurrence of serotonin syndrome during use of SSRIs. A combination of symptoms, such as agitation, tremor, myoclonus and hyperthermia, may indicate the development of this syndrome. Treatment with citalopram should be discontinued immediately and symptomatic treatment initiated. Serotonergic medicines Citalopram should not be used concomitantly with medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol, oxitriptan and tryptophan. Psychosis Treatment of psychotic patients with depressive episodes may increase psychotic symptoms. Renal impairment Citalopram use in patients with severe impairment of renal function (creatinine clearance less than 30 ml/min) is not advised, as no information is available on use in these patients.(see 4.2). Hepatic impairment In cases of impaired hepatic function dose reduction is recommended (see section 4.2) and liver function has to be closely monitored. St John’s Wort (Hypericum perforatum)
Undesirable effects may occur more in concurrent use of citalopram and herbal medicines
containing St John’s wort (Hypericum perforatum). Citalopram and St John’s wort products
should therefore not be taken concurrently (see 4.5 ).
Dose titration
Drowsiness and agitation may occur at the start of treatment. Dose titration may be useful.
QT interval prolongation

Citalopram has been found to cause a dose-dependent prolongation of the QT-interval. Cases
of QT interval prolongation and ventricular arrhythmia including torsade de pointes have
been reported during the post-marketing period, predominantly in patients of female gender,
with hypokalemia, or with pre-existing QT prolongation or other cardiac diseases (see
sections 4.3, 4.5, 4.8, 4.9 and 5.1).
Caution is advised in patients with significant bradycardia; or in patients with recent acute
myocardial infarction or uncompensated heart failure.
Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for
malignant arrhythmias and should be corrected before treatment with citalopram is started.
If patients with stable cardiac disease are treated, an ECG review should be considered before
treatment is started.
If signs of cardiac arrhythmia occur during treatment with citalopram, the treatment should be
withdrawn and an ECG should be performed.
Withdrawal symptoms seen on discontinuation
Withdrawal symptoms when treatment is discontinued are common, particularly if
discontinuation is abrupt (see section 4.8). The risk of withdrawal symptoms may be
dependent on several factors including the duration and dose of therapy and the rate of dose
reduction. Dizziness, sensory disturbances (including paraesthesia and electric shock
sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety,
nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations,
emotional instability, irritability, and visual disturbances have been reported. Generally these
symptoms are mild to moderate, however, in some patients they may be severe in intensity.
They usually occur within the first few days of discontinuing treatment, but there have been
very rare reports of such symptoms in patients who have inadvertently missed a dose.
Generally these symptoms are self-limiting and usually resolve within 2 weeks, though in
some individuals they may be prolonged (2-3 months or more). It is therefore advised that
citalopram should be gradually tapered when discontinuing treatment over a period of several
weeks or months, according to the patient’s needs (see “Withdrawal Symptoms Seen on
Discontinuation”, section 4.2).
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption should not take this medicinal product.
4.5 Interactions with other medicinal products and other forms of interaction
Pharmacodynamic interactions: MAO-Inhibitors − The simultaneous use of citalopram and MAO-inhibitors can result in severe undesirable effects, including the serotonin syndrome (see section 4.3). − Cases of serious and sometimes fatal reactions have been reported in patients receiving an SSRI in combination with a monoamine oxidase inhibitor (MAOI), including the irreversible MAOI selegiline and the reversible MAOIs linezolid and moclobemide and in patients who have recently discontinued an SSRI and have been started on a MAOI. − Some cases presented with features resembling serotonin syndrome. Symptoms of an active substance interaction with a MAOI include: hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma (see section 4.3). Pimozide Concomitant administration of a single dose of 2 mg pimozide to healthy volunteers, who were treated with citalopram 40 mg/day for 11 days, caused only a minor increase in the AUC and Cmax of pimozide of approximately 10%, not being statistically significant. Despite the minor increase in plasma pimozide levels, the QTc interval was more prolonged after concomitant administration of citalopram and pimozide (on average 10 ms) as compared to administration of a single dose of pimozide alone (on average 2 ms). Since this interaction was already observed after administration of a single dose of pimozide, concomitant treatment with citalopram and pimozide is contraindicated. 5-HT-agonists The serotonergic action of sumatriptan may be reinforced by SSRIs. Until further information is available, concurrent use of citalopram and 5-HT agonists, such as sumatriptan and other triptans, tramadol, oxitriptan and tryptophan is not advised(see section 4.4). Haemorrhage Caution is warranted for patients who are being treated simultaneously with anticoagulants, medicinal products that affect the function of thrombocytes, such as non steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamol, and ticlopidine or other medicines (e.g. atypical antipsychotics, phenothiazines, tricyclic depressants) that can increase the risk of haemorrhage (see section 4.4). Contraindicated combinations QT interval prolongation Pharmacokinetic and pharmacodynamic studies between citalopram and other medicinal products that prolong the QT interval have not been performed. An additive effect of citalopram and these medicinal products cannot be excluded. Therefore, co-administration of citalopram with medicinal products that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsycotics (e.g. fentiazine derviatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine) etc., is contraindicated. Medicinal products lowering the seizure threshold SSRIs can lower the seizure threshold. Caution is advised when concomitantly using other medicinal products capable of lowering the seizure threshold (e.g. antidepressants [tricyclics, SSRIs], neuroleptics [phenothiazines, thioxanthenes and butyrophenones]), mefloquin, bupropion and tramadol). Neuroleptics Experience with citalopram use has not provided evidence of any clinically relevant interactions with neuroleptics. The possibility of a pharmacodynamic interaction, as with other SSRIs, cannot, however, be ruled out. St. John’s Wort (Hypericum perforatum) Adverse reactions may occur more in concurrent use of citalopram and herbal medicinal products containing St John’s wort (Hypericum perforatum) (see section ). Alcohol Clinical studies have not shown any adverse pharmacodynamic or pharmacokinetic interactions between citalopram and alcohol. However, the combination of citalopram and alcohol is not advised. Pharmacokinetic interactions: Cytochrome P450 (CYP) isoenzymes − Escitalopram (the active enantiomer of citalopram) is an inhibitor of the enzyme CYP2D6. Caution is recommended when citalopram is co-administered with medicinal products that are mainly metabolised by this enzyme, and that have a narrow therapeutic index, e.g. flecainide, propafenone and metoprolol (when used in cardiac failure), or some CNS acting medicinal products that are mainly metabolised by CYP2D6, e.g. antidepressants such as desipramine, clomipramine and nortryptyline or antipsychotics like risperidone, thioridazine and haloperidol. Dosage adjustment may be warranted. Co-administration with metoprolol resulted in a twofold increase in the plasma levels of metoprolol. − The metabolism of escitalopram is mainly mediated by CYP2C19. CYP3A4 and CYP2D6 may also contribute to the metabolism although to a smaller extent. The metabolism of the major metabolite S-DCT (demethylated escitalopram) seems to be partly catalysed by CYP2D6. Influence of other medicinal products on the pharmacokinetics of citalopram - Cimetidine (potent CYP2D6, 3A4 and 1A2 inhibitor) caused a moderate increase in the average steady state levels of citalopram. Caution is advised when administering citalopram in combination with cimetidine. Dose adjustment may be warranted. − Co-administration of escitalopram with omeprazole 30 mg once daily (a CYP2C19 inhibitor) resulted in moderate (approximately 50%) increase in the plasma concentrations of escitalopram. Thus, caution should be exercised when used concomitantly with CYP2C19 inhibitors (e.g. omeprazole, esomeprazole, fluvoxamine, lansoprazole, ticlopidine) or cimetidine. A reduction in the dose of citalopram may be necessary based on monitoring of undesirable effects during concomitant treatment. In a pharmacokinetic study no effect was demonstrated on either citalopram or imipramine
levels, although the level of desipramine, the primary metabolite of imipramine was
increased. When desipramine is combined with citalopram, an increase of the desipramine
plasma concentration has been observed. A reduction of the desipramine dose may be needed
Lithium, tryptophan
Citalopram does not show any pharmacokinetic interaction with lithium. There are, however,
reports of increased serotonergic effects when SSRIs are administered in combination with
lithium or trytophan. Caution should therefore be exercised in the concurrent use of
citalopram and these agents.
The lithium level should be monitored as usual.
Levopromazine, digoxine, carbamazepine
No pharmacokinetic interaction was found between citalopram and levomepromazine,
digoxin or carbamazepine and the metabolite carbamazepine epoxide.
The absorption and other pharmacokinetic properties of citalopram are not affected by food.

4.6 Pregnancy and lactation
There are limited data from the use of citalopram in pregnant women. Studies in animals have
shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Citalopram should not be used during pregnancy unless clearly necessary.
Cases of withdrawal symptoms in the newborn child have been described after the use of
SSRI at the end of pregnancy. Neonates should be observed if maternal use of citalopram
continues into the later stages of pregnancy. Abrupt discontinuation should be avoided during
The following symptoms may occur in the neonate after maternal SSRI/SNRI use in later
stages of pregnancy: respiratory distress, cyanosis, apnoea, seizures, temperature instability,
feeding difficulty, vomiting, hypoglycaemia, hypertonia, hypotonia, hyperreflexia, tremor,
jitteriness, irritability, lethargy, constant crying, somnolence and difficulty sleeping. These
symptoms could be due to either serotonergic effects or withdrawal symptoms. In a majority
of instances the complications begin immediately or soon (< 24 hours) after delivery
Epidemiological data have suggested that the use of SSRIs in pregnancy, particular in late
pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn
(PPHN). The observed risk was approximately 5 cases per 1000 pregnancies. In the general
population 1 to 2 cases of PPHN per 1000 pregnancies occur.
Citalopram is excreted in breast milk in small quantities. The advantage of breastfeeding
should outweigh the potential undesirable effects for the child.
4.7 Effects on ability to drive and use machines

Citalopram has a minor or moderate effect on the ability to drive and use machines.
Psychoactive medicinal products may reduce ability to assess ability to react to unexpected
events. Patients should therefore be warned and informed that ability to drive and operate
machines may be affected.
4.8 Undesirable effects

Undesirable reactions to citalopram are generally mild and transient in nature. They mostly
occur during the first weeks of treatment and usually decrease as the depressive condition
Treatment emergent adverse events reported in clinical trials:
The following undesirable effects have been reported at the approximate frequencies shown: cannot be estimated from the available data Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Blood and lymphatic system disorders Rare: haemorrhage (for example, gynaecological haemorrhage, gastrointestinal haemorrhage, ecchymosis and other forms of skin haemorrhage or bleeding in the mucous membranes). Metabolism and nutrition disorders Common: weight decrease, weight increase. Psychiatric disorders Very common: somnolence, insomnia, agitation, nervousness. Common: sleep disorders, impaired concentration, abnormal dreaming, amnesia, anxiety, decreased libido, increased appetite, anorexia, apathy, confusion. psychomotor restlessness/akathisia (see section 4.4). hallucinations, mania, depersonalisation, panic attack (these symptoms may be due to the underlying disease). suicidal thoughts/behaviour (cases of suicidal ideation and suicidal behaviours have been reported during citalopram therapy or early after treatment discontinuation [see section 4.4]). Nervous system disorders Very common: headache, tremor, dizziness. Common: Eye disorders Very common: abnormal accommodation. Common: Ear and labyrinth disorders Uncommon: Cardiac disorders Very common: palpitations. Common: supraventricular and ventricular arrhythmia. Not known: ventricular arrhythmia including torsade de pointes Vascular disorders Common: postural hypotension, hypotension, hypertension. Respiratory, thoracic and mediastinal disorders Common: Gastrointestinal disorders Very common: nausea, dry mouth, constipation, diarrhoea. Common: dyspepsia, vomiting, abdominal pain, flatulence, increased salivation. Hepatobiliary disorders Uncommon: Skin and subcutaneous tissue disorders Very common: increased sweating. Common: Musculoskeletal and connective tissue disorders Uncommon: Renal and urinary disorders Common: hyponatriaemia and the syndrome of inappropriate anti-diuretic hormone secretion (SIADH), predominantly in the elderly (see section 4.4). Reproductive system and breast disorders Common: ejaculation failure, female anorgasmia, dysmenorrhoea, impotence. General disorders and administration site conditions Very common: asthenia. Common: serotonin syndrome has been reported in patients using SSRIs.
Cases of QT-prolongation and ventricular arrhythmia including torsade de pointes have been
reported during the post-marketing period, predominantly in patients of female gender, with
hypokalemia, or with pre-existing QT prolongation or other cardiac diseases (see sections
4.3, 4.4, 4.5, 4.9 and 5.1).
Withdrawal symptoms seen on discontinuation
Discontinuation of citalopram (particularly when abrupt) commonly leads to withdrawal
symptoms. Dizziness, sensory disturbances (including paraesthesia and electric shock
sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety,
nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations,
emotional instability, irritability, and visual disturbances have been reported. Generally these
events are mild to moderate and are self-limiting, however, in some patients they may be
severe and/or prolonged. It is therefore advised that when citalopram treatment is no longer
required, gradual discontinuation by dose tapering should be carried out (see section 4.2 and
Class effects
Epidemiological studies, mainly conducted in patients 50 years of age and older, show an
increased risk of bone fractured in patients receiving SSRIs and TCAs. The mechanism
leading ti this risk is unknown.
4.9 Overdose

Symptoms of overdose:
Somnolence, coma stupor, seizures, ECG changes (e.g. prolonged QT interval), atrial and
ventricular arrhythmia, nausea, vomiting, transpiration, cyanosis, hyperventilation. Features
of serotonin syndrome may occur, particularly when other substances are co-ingested.
Treatment of overdose:
There is no known specific antidote to citalopram. Treatment should be symptomatic and
supportive. Activated charcoal, osmotically working laxative (such as sodium sulphate) and
stomach evacuation should be considered. If consciousness is impaired the patient should be
intubated. ECG and vital signs should be monitored.
ECG monitoring is advisable in case of overdose in patients with congestive heart
failure/bradyarrhythmias, in patients using concomitant medications that prolong the QT
interval, or in patients with altered metabolism, e.g. liver impairment.

5.1 Pharmacodynamic properties
Pharmacotherapeuticgroup: Antidepressants, Selective serotonin reuptake inhibitors
ATC code: N06A B04
Mechanism of action and pharmacodynamic effects
Tolerance with respect to the inhibiting action on uptake of 5-HT does not occur in the long-
term use of citalopram.
The antidepressant action is assumed to be associated with the specific inhibition of serotonin
uptake in the neurons of the brain.
Citalopram has almost no effect on neuronal uptake of noradrenaline, dopamine and gamma-
aminobutyric acid. Citalopram shows no or only little affinity for cholinergic, histaminergic
and a variety of adrenergic, serotonergic and dopaminergic receptors.
Citalopram is a bicyclic isobenzofuran derivative and is chemically not related to tricyclic,
tetracyclic and other available antidepressants.
The principal metabolites of citalopram are, like citalopram, selective serotonin reuptake
inhibitors, although to a lesser extent.
As far as is known, the metabolites do not make any contribution to the therapeutic effect.
In a double-blind, placebo-controlled ECG study in healthy subjects, the change from
baseline in QTc (Fridericia-correction) was 7.5 (90%CI 5.9-9.1) msec at the 20 mg/day dose
and 16.7 (90%CI 15.0-18.4) msec at the 60 mg day/dose (see sections 4.3, 4.4, 4.5, 4.8 and
5.2 Pharmacokinetic properties
General characteristics of the active ingredient:

Citalopram is rapidly absorbed after oral administration: the maximum plasma concentration
is reached on average after around 4 (1-7) hours. Absorption is independent of any food
intake. The biological availability is approximately 80 %.
The apparent volume of distribution is 12-17 l/kg. The plasma protein binding of citalopram
and its metabolites is less than 80%.
Citalopram is metabolised into demethylcitalopram, didemethylcitalopram, citalopram-N-
oxide and the deaminated propionic acid-derivative. The propionic acid-derivative is
pharmacologically inactive. Demethylcitalopram, didemethylcitalopram and citalopram-N-
oxide are selective serotonin uptake inhibitors, although weaker than the parent compound.
The main metabolising enzyme is CYP2C19. Some contribution from CYP3A4 and CYP2D6
is possible.
Plasma half-life is approximately one and a half days. Plasma clearance following systemic
administration is approximately 0.3-0.4 l/min and plasma clearance following oral
administration is approximately 0.4 l/min.
Citalopram is principally excreted via the liver (85%) but partially (15%) also via the
kidneys. 12-23% of the administered quantity of citalopram is excreted unchanged in the
urine. Hepatic clearance is approximately 0.3 l/min and renal clearance is 0.05-0.08 l/min.
Steady-state concentrations are reached after one to two weeks. A linear relation has been
found between the steady-state plasma level and the administered dose. At a dosage of 40 mg
daily a mean plasma concentration of approximately 300 nmol/l is reached. No clear relation
has been found between the citalopram plasma level on the one hand and the therapeutic
effect or possible adverse reactions on the other.
Characteristics relating to patients

Elderly patients (≥ 65 years)
Longer half-lives and decreased clearance values due to a reduced rate of metabolism have
been demonstrated in elderly patients.
Hepatic impairment Citalopram is eliminated more slowly in patients with reduced hepatic function. The half-life of citalopram is about twice as long and steady state citalopram concentrations at a given dose will be about twice as high as in patients with normal liver function. Renal impairment
In patients with a mildly to moderately reduced renal function a longer half-life and a small
increase in the exposure of citalopram has been observed. Citalopram is eliminated more
slowly, without an important effect on the pharmacokinetics of citalopram. There is no
information on the pharmacokinetics in patients with severe renal impairment.

5.3 Preclinical safety data

Preclinical data revealed no special hazard for humans based on conventional studies of
safety pharmacology, genotoxicity and carcinogenic potential.
Phospholipidosis has been observed in several organs following multiple administration in
rats. The effect was reversible at discontinuation. Accumulation of phospholipids has been
observed in long term animal studies with many cation-amphophilic drugs. The clinical
relevance of these results is not clear.
Reproduction toxicity studies in rats have demonstrated skeletal anomalies in the offspring,
but no increased frequency of malformations. The effects may be related to the
pharmacological activity or may be a consequence of maternal toxicity. Peri- and postnatal
studies have revealed reduced survival in offspring during the lactation period. The potential
risk for humans is unknown.

6.1 List of excipients
Tablet core:
croscarmellose sodium (E468)
glycerol (E471)
lactose monohydrate
magnesium stearate (E470b)
maize starch
microcrystalline cellulose (E460)
Film coating:
Hypromellose (E464)
microcrystalline cellulose (E460)
macrogol stearate (E431)
titanium dioxide (E171)
6.2 Incompatibilities

Not applicable
6.3 Shelf life

4 years.
6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container

Citalopram Bluefish 10 mg, 20 mg and 40 mg, film-coated tablets packed in PVC/PVDC/Al
blister are available in pack sizes of 20, 28, 30, 50, or 100 tablets per carton.
Not all pack sizes/strengths may be marketed.
6.6 Special instructions for disposal

No special requirements.

Bluefish Pharmaceuticals AB Torsgatan 11 SE-111 23 Stockholm Sweden MARKETING AUTHORISATION NUMBER

<To be completed nationally>





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