20 CITAMOOD

20 CITAMOOD

-Escitalopram is an antidepressant that belongs to a group of medicines called Selective 
Serotonin Reuptake Inhibitors (SSRIs) that work by normalizing levels of  Serotonin in the
brain. Serotonin abnormal level is a key factor in developing depression and related 
disorders.  
-Biotransformation of escitalopram is mainly hepatic, with a mean terminal half-life of
about 27-32 hours.
-The peak blood levels occur at about 5 hours.  
-Absorption of escitalopram is not affected by food. 
-The binding of escitalopram to human plasma proteins is approximately 56%. 
-Following oral administrations of escitalopram, the fraction of drug recovered in the urine 
as escitalopram and S-demethyl-citalopram (S-DCT) is about 8% and 10%, respectively

-Each film coated tablet of Citamood® 10 mg contains:
     Escitalopram                            10 mg   (as oxalate)

-Each film coated tablet of Citamood® 20mg contains:
     Escitalopram                            20mg   (as oxalate)
   
   

-Allergy (hypersensitivity) to escitalopram or any of the other ingredients of Citamood®.
-Concomitant use in patient taking non-selective monoamine oxidase inhibitors (MAOIs), 
such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, linezolid and 
moclobemide which are also used for the treatment of depression is contraindicated. In 
some cases, the patient developed serotonin syndrome. If the patient has taken any of these
medicines he/she will need to wait 14 days before starting taking Citamood® tablets. After 
stopping Citamood®, patient must allow 7 days before taking any of these medicines.
-Concomitant use with medicinal products that prolong the QT interval, such as Class IA 
and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, 
haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, 
moxifloxacin, erythromycin IV, pentamidine, antimalarial treatment particularly 
halofantrine), certain antihistamines (e.g. astemizole, mizolastine), is contraindicated.
 

-Please tell your doctor if you are taking or have taken any other medicines (including those
purchased without prescription) during the last 14 days. Escitalopram and the following 
medicines should be combined with caution:
-Lithium and Selegiline: if you get high fever and abrupt contractions of muscles, feel 
agitated and confused you must see your doctor immediately.
-Imipramine and Desipramine and Metoprolol: are eliminated from the body more 
slowly when administered together with escitalopram, leading to increased amounts of 
these drugs in your body. If you receive both escitalopram and any of these medicines you 
should consult your doctor.
-Tramadol, Sumatriptan and other Triptans: increase the risk of side effects; if you get 
any unusual symptoms when using such medications with escitalopram you should see 
your doctor.
-Cimetidine, Omeprazole, Fluvoxamine and Ticlopidine: may cause increased blood
levels of escitalopram if used at high doses at or above 800 mg per day.     
-St. John’s wort (hypericum perforatum): the risk of side effects may increase if you take
escitalopram concomitantly with herbal remedies containing St. John’s wort.
-Oral anti-coagulants (medicines like warfarin): the efficacy of the oral anti-coagulant
may be altered, and your doctor will probably check the coagulation time of your blood
when starting and discontinuing escitalopram in order to verify that your dose of anti- 
coagulant is still adequate.
-Medicines that decrease blood levels of potassium or magnesium: as these conditions 
increase the risk of life-threatening heart rhythm disorders.
 

-There are no adequate and well-controlled studies in pregnant women; therefore, 
Citamood® should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. It is expected that escitalopram will be excreted into human milk.
Consequently, breastfeeding is not recommended during treatment. 
 

Very common (≥ 1 /10): nausea.
-Common  (≥ 1 /100 to < 1 /10): sinusitis, decreased appetite, difficulties falling asleep, 
feeling sleepy, dizziness, yawning, diarrhea, constipation, increased sweating, sexual 
disturbances (delayed ejaculation, problems with erection, decreased sexual drive and 
women may experience difficulties achieving orgasm), fatigue and fever.
-Uncommon  (≥ 1 /1,000 to < 1 /100): Disturbed sleep and taste disturbance.
-Rare (≥ 1 /10,000 to < 1 /1,000): Dizziness when you stand up due to low blood pressure,
decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with
weak muscles or confused), blurring of vision, vomiting, dry mouth, abnormal liver 
function test (increased amounts of liver enzymes in the blood) and pain in muscles and
joints. High fever, agitation, confusion, trembling and abrupt contractions of muscles may
be signs of a serotonin syndrome. Seizures, tremors, movement disorders (involuntary 
movements of the muscles), hallucinations, mania, confusion, agitation, anxiety,
depersonalization, panic attacks and nervousness, difficulties urinating, flow of milk in 
women that are not nursing, rash, increased tendency to develop bruises, itching and 
swelling.
-If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. 

Overdosage:-
-If you or anyone take too many Citamood®  tablets, you should contact your doctor directly
or go to the nearest hospital even if there are no signs of discomfort.

-Abrupt cessation of this kind of medications may cause discontinuation symptoms such as 
dizziness, sensory disturbance (e.g. paraesthesia), anxiety, sleep disturbances (including
intense dreams), agitation, tremor, nausea, sweating and confusion have been reported. 
When you have completed your course of treatment it is therefore advised that the dose of
Citamood® is gradually reduced over a couple of weeks.
-Medical problems: Please tell your doctor if you have any medical problem. Especially if 
you have a severe liver disease or diabetes, adjustment of the dose of medications for these
diseases or your dose of Citamood® may be warranted.
-Epilepsy or a history of seizures or fits: Seizures are a potential risk with all antidepressant medications. If you experience seizures or an increased frequency of seizures while
being treated with Citamood®, it is important to inform your doctor. The risk is further
increased if you also take other medicines where the leaflet contains a warning similar to 
this one.
-Episodes of mania: Some patients with manic-depressive illness may enter into a manic 
phase. This is characterized by profuse and rapidly changing ideas, exaggerated gaiety and
excessive physical activity. In such cases, it is important to contact your doctor.
-Hyponatraemia: Hyponatraemia, probably due to inappropriate antidiuretic hormone 
secretion (SIADH), has been reported rarely with the use of SSRIs and generally resolves
on discontinuation of therapy. Caution should be exercised in patients at risk, such as the 
elderly, or patients with cirrhosis, or if used in combination with other medications which 
may cause hyponatraemia.
-Diabetes: In patients with diabetes, treatment with an SSRI may alter glycaemic control 
(hypoglycaemia or hyperglycaemia). Insulin and/or oral hypoglycaemic dosage may need 
to be adjusted.
-Subcutaneous bleeding: There have been reports that medicines like Citamood® may
cause an increased incidence of subcutaneous bleeding (shown as e.g. increased tendency 
to develop bruises). The risk is increased if you have tendencies to develop bleedings, and
if you also take medicines known to affect the rate of clotting of the blood (like aspirin,  
NSAIDs some anti psychotics or tricyclic antidepressants). The risk is also increased if you
take ticlopidine, dipyridamole or oral anticoagulants.
-Serotonin syndrome: Caution is advisable if Citamood® is used concomitantly with 
medicinal products with serotonergic effects such as sumatriptan or other triptans, tramadol 
and tryptophan. In rare cases, serotonin syndrome has been reported in patients using SSRIs
concomitantly with serotonergic medicinal products. A combination of symptoms, such as
agitation, tremor, myoclonus and hyperthermia may indicate the development of this 
condition. If this occurs, treatment with the SSRI and the serotonergic medicinal product
should be discontinued immediately and symptomatic treatment initiated.
-Alcohol: Citamood® has not been shown to increase the effects of alcohol. Nevertheless, it is recommended not to drink alcohol during treatment with Citamood®.
 


-Blister of 10 tablets, pack of 2 blisters.

Store in a dry place, in temperature below 25º C.