-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.