Each film coated tablet of Citalex 10 mg contains:

• Escitalopram 10 mg (as oxalate)

• Treatment of major depressive disorder.
• Treatment of panic disorder with or without agoraphobia.
• Treatment of social anxiety disorder (social phobia) (SAD).
• Treatment of generalised anxiety disorder (GAD).
• Treatment of obsessive-compulsive disorder (OCD)

* Allergy (hypersensitivity) to escitalopram or any of the other ingredients of Citalex®.

* 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 Citalex® tablets. After stopping Citalex®, 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.

• Citalex® 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 pains 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 Citalex® tablets, you should contact your docto directly or go to the nearest hospital even if there are no signs of discomfort.

- Depression:

• A dose of 10 mg per day is recommended and may be increased to a maximum daily dose of 20 mg. 

- Social and generalised anxiety disorder, Obsessive-compulsive disorder:

• The normally recommended dose of Citalex® is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

- Panic disorder: 

• A dose of 5 mg per day should be taken for the first week followed by increasing the dose to 10 mg per day. The dose may be increased to a maximum of 20 mg per day. 

- Elderly patients, Hepatic impairment: 

• A starting daily dose of 5 mg is recommended with maximum daily dose kept below 20mg.                                               

 Note:

• Citalex® should not be given to children or adolescents (<18 years).
• Daily doses of Citalex® more than 20 mg have not been investigated.
• If you miss to take your daily dose, take the next dose at the usual time. Do not double your dose.

Method and Duration of Administration:

• Citalex® should be taken as a single once daily dose.
• Citalex® can be taken with or without food.
• Citalex® tablets should be swallowed whole with a little water. Do not chew them.
• Take Citalex® as instructed by your doctor.
• it may take few weeks before you feel any improvement.Therefore you should continue to take Citalex®as instructed by your doctor.
• At least 6 months of treatment is recommended after you feel well again.

• 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 Citalex® 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 escitalopram 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 Citalex®, it is important to informyour 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 escitalopram 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 Citalex® 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 symp- tomatic treatment initiated.

Effects on ability to drive and use machines:

• Citalex® does not cause drowsiness; however, as with any new medicine you should take care while driving or using machinery until you know how it affects you.

• Blister of 10 tablets, pack of 2 blisters.

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