How does it work?

Cipralex tablets and oral drops both contain the activeingredient escitalopram oxalate, which is a type of antidepressant known as aselective serotonin reuptake inhibitor(SSRI).

Antidepressant medicines act on nerve cells in the brain. In thebrain there are numerous different chemical compounds called neurotransmitters.These act as chemical messengers between the nerve cells. Serotonin is one suchneurotransmitter and has various functions that we know of.

When serotonin is released from nerve cells in the brain it actsto lighten mood. When it is reabsorbed into the nerve cells, it no longer hasan effect on mood. It is thought that when depression occurs, there may be adecreased amount of serotonin released from nerve cells in the brain.

SSRIs work by preventing serotonin from being reabsorbed backinto the nerve cells in the brain. This helps prolong the mood lighteningeffect of any released serotonin. In this way, escitalopram helps relievedepression, panic and fear.

It may take between two to four weeks for the benefits of thismedicine to appear, so it is very important that you keep taking it, even if itdoesn't seem to make much difference at first. If you feel your depression oranxiety has got worse, or if you have any distressing thoughts or feelings inthese first few weeks, then you should talk to your doctor.

What is it used for?

• Depressive illness.
• Generalised anxiety disorder (GAD).
• Obsessive-compulsive disorder (OCD).
• Panic disorder with or without agoraphobia.
• Fear of social situations (social phobia or social anxiety disorder).

How do I take it?

• Escitalopram is taken once a day. Your dose can be taken at any time of day and can be taken either with or without food.
• Cipralex drops can be mixed with water, apple juice or orange juice.
• Do not exceed the dose prescribed by your doctor.
• You should not suddenly stop taking this medicine, as this can cause withdrawal symptoms such as dizziness, sleep disturbances (including intense dreams), nausea, headache, a feeling of weakness, pins and needles and anxiety. Withdrawal symptoms are temporary and are not due to addiction or dependence on the medicine. They can usually be avoided by stopping the medicine gradually, usually over a period of weeks or months, depending on your individual situation. Follow the instructions given by your doctor when it is time to stop treatment with this medicine. On very rare occasions some people have experienced withdrawal symptoms after accidentally missing a dose of this medicine.

Warning!

• This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• It is recommended that you avoid drinking alcohol while taking this medicine.
• Depression and other psychiatric illnesses are associated with an increased risk of suicidal thoughts, self-harm, and suicide. You should be aware that this medicine may not start to make you feel better for at least two to four weeks. However, it is important that you keep taking it in order for it to work properly and for you to feel better. If you feel your depression or anxiety has got worse, or if you have any distressing thoughts, or feelings about suicide or harming yourself in these first few weeks, or indeed at any point during treatment or after stopping treatment, then it is very important to talk to your doctor.
• Some people taking this medicine for panic or generalised anxiety disorder may find they experience increased anxiety at the beginning of treatment. This reaction usually disappears within two weeks during continued treatment, but if you are concerned you should consult your doctor or pharmacist.
• SSRI antidepressants have been associated with the development of unpleasant or distressing restlessness and the 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. If you experience these symptoms you should consult your doctor.
• Antidepressants may cause the amount of sodium in the blood to drop - a condition called hyponatraemia. This can cause symptoms such as drowsiness, confusion, muscle twitching or convulsions. Elderly people may be particularly susceptible to this effect. You should consult your doctor if you develop any of these symptoms while taking this medicine, so that your blood sodium level can be checked if necessary.
• If you experience seizures (convulsions or fits) while taking this medicine, consult your doctor immediately, as you will need to stop treatment with this medicine. This also applies if you suffer from epilepsy and experience more seizures than normal after starting this medicine.
• Following a review of the safety and efficacy of SSRIs to treat depression in children under 18 years of age (unlicensed use), the Committee on Safety of Medicines (CSM) has concluded that the risks of escitalopram outweigh the benefits for treating depressive illness in this age group. If you are under 18 and taking escitalopram for depression you should consult your doctor for advice, but do not suddenly stop taking it as this can cause withdrawal symptoms. Escitalopram is not licensed and not recommended for any uses in children or adolescents under 18 years of age.

Use with caution in

• Elderly people.
• Young adults (under 25 years of age).
• People with a history of suicidal behaviour or thoughts.
• People with a history of mania or hypomania.
• People also receiving electroconvulsive therapy (ECT).
• People taking antipsychotic medicines.
• Decreased kidney function.
• Decreased liver function.
• People with a poorly functioning enzyme in the liver called CYP2C19 (CYP2C19 poor metabolisers).
• Diabetes.
• Epilepsy.
• People with heart disease such as heart failure, a recent heart attack or a slow or irregular heartbeat (your doctor may want you to have an electrocardiogram (ECG) to monitor your heartbeat before treatment is started because this medicine can potentially affect your heart rhythm).
• People with a low level of potassium or magnesium in their blood (hypokalaemia or hypomagnesaemia - this should be corrected before treatment is started).
• People with a history of bleeding disorders.
• People taking medicine that affects blood clotting (eg anticoagulants such as warfarin - for more information go to the 'how can this medicine affect other medicines' section at the end of this page).

Not to be used in

• Children and adolescents under 18 years of age.
• Manic episodes of manic depression (bipolar affective disorder).
• Uncontrolled epilepsy.
• People with an abnormal heart rhythm seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
• People taking medicines that can cause a 'prolonged QT interval' (your doctor will know, but go to the 'how can this medicine affect other medicines' section at the end of this page for some examples).
• People who have taken a type of medicine called a monoamine-oxidase inhibitor (MAOI) in the last 14 days (see end of factsheet for more information).

This medicine should not be used if you are allergic to one orany of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such anallergy. If you feel you haveexperienced an allergic reaction, stop using this medicine and inform yourdoctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine in pregnancy has not been established. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the foetus. This is particularly important in the first and third trimesters where the medicine could have harmful effects on the baby. Symptoms that resemble side effects or withdrawal symptoms of escitalopram have been seen in new-born babies whose mothers took escitalopram in the third trimester. It is important to seek medical advice from your doctor if you think you could be pregnant or plan to have a baby while taking this medicine. If you get pregnant and decide to stop taking escitalopram you should not do so suddenly -– see the warning above about withdrawal symptoms.
• This medicine passes into breast milk, however the effect of this on the nursing infant is unknown. Mothers who need to take this medicine should discuss the risks and benefits of breastfeeding with their doctor. The manufacturer states that breastfeeding is not recommended.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere, it does not mean that all people using this medicine will experience thator any side effect.

Very common (affect more than 1 in 10 people)

• Feeling sick.

Common (affect between 1 in 10 and 1 in 100 people)

• Decreased or increased appetite.
• Weight gain.
• Anxiety.
• Restlessness.
• Abnormal dreams.
• Decreased sex drive.
• Inability to have an orgasm (women).
• Erectile dysfunction or problems with ejaculation in men (impotence).
• Difficulty sleeping (insomnia).
• Sleepiness.
• Dizziness.
• Shaking, usually of the hands (tremor).
• Pins and needles sensations.
• Inflammation of the sinuses (sinusitis).
• Yawning.
• Disturbances of the gut such as diarrhoea, constipation, vomiting.
• Increased sweating.
• Pain in the muscles and joints.
• Fatigue.
• Fever (high body temperature).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Nervousness or agitation.
• Weight loss.
• Alteration in taste.
• Confusion.
• Visual disturbances.
• Dilated pupils.
• Increased heart rate.
• Sensation of ringing or other noise in the ears (tinnitus).
• Rash or itching.
• Nosebleeds.
• Bleeding in the gut.
• Heavy periods in women.
• Fluid retention.

Frequency not known

• Seizures.
• Low level of sodium in the blood.
• Mania.
• Decrease in the number of platelets in the blood (thrombocytopenia).
• Abnormal heart rhythm seen as a 'prolonged QT interval' on an ECG.
• Inflammation of the liver (hepatitis).
• Persistent painful erection of the penis (priapism).
• Bruising under the skin causing red patches (ecchymosis).

The side effects listed above may not include all of the sideeffects reported by the medicine'smanufacturer. For moreinformation about any other possible risks associated with this medicine,please read the information provided with the medicine or consult your doctoror pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicinesyou are already taking, including those bought without a prescription andherbal medicines, before you start treatment with this medicine. Similarly,check with your doctor or pharmacist before taking any new medicines whiletaking this one, to ensure that thecombination is safe.

Escitalopram should not be taken at the same time as monoamineoxidase inhibitor medicines (MAOIs). These include monoamine-oxidase inhibitor antidepressants such as phenelzine, tranylcypromine, isocarboxazid and moclobemide, theantibiotic linezolid and the anti-Parkinson's medicines selegiline (in doses above 10mg per day) and rasagiline.

Escitalopramshould not be started until at least a day after stopping moclobemideor linezolid, and until at least two weeks after stopping other monoamineoxidase inhibitors. Similarly, treatment with any MAOIs should not be starteduntil at least one week after escitalopram has been stopped.

There may be an increased chance of an abnormal heart rhythm, seen as a 'prolonged QT interval' on an ECG, if this medicine is taken in combination with other medicines that can have this side effect, such as those listed below. The manufacturer states that these medicines should not be used in combination with escitalopram:

• medicines to treat abnormal heart rhythms (anti-arrhythmics), eg amiodarone, procainamide, quinidine, disopyramide
• certain antidepressants, eg maprotiline, amitriptyline, clomipramine, imipramine
• the antihistamines terfenadine or mizolastine
• certain antimalarials, eg halofantrine, chloroquine, quinine, Riamet, mefloquine
• certain antimicrobials, eg erythromycin given by injection, clarithromycin, levofloxacin, moxifloxacin, voriconazole or pentamidine
• certain antipsychotics, eg amisulpride, thioridazine, chlorpromazine, sertindole, haloperidol, pimozide, zuclopenthixol, sulpiride
• arsenic trioxide
• atomoxetine
• cisapride
• dronedarone
• droperidol
• ivabradine
• ranolazine
• saquinavir
• tolterodine.

The medicines listed below can sometimes cause the amount of potassium in the blood to drop too low. If this happens in someone taking escitalopram it could increase the risk of irregular heartbeats. Your doctor may want to check your potassium levels regularly if you are taking one of these medicines in combination with escitalopram:

• beta-2-agonists for asthma, eg salbutamol
• corticosteroids by mouth or injection, such as prednisolone
• diuretics such as furosemide, bendroflumethiazide, acetazolamide
• intravenous amphotericin
• stimulant laxatives, eg senna
• tetracosactide
• theophylline.

If you have diabetes, treatment with escitalopram may alter the control of your blood sugar. As a result, you may need an adjustment in your dose of insulin orantidiabetic tablets. If you have diabetes you should discuss this with yourdoctor.

As SSRIs have been associated with bleeding abnormalities, thefollowing medicines, which are known to affect the ability of the blood toclot, should be used with caution in combination with escitalopram:

• anticoagulant medicines such as warfarin
• antiplatelet medicines such as aspirin, clopidogrel or dipyridamole
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac
• some antipsychotic medicines
• some antisickness medicines, eg prochlorperazine
• tricyclic antidepressants, eg amitriptyline.

There may be an increased risk of side effects if escitalopramis taken with the following, which also enhance the activity of serotonin inthe brain:

• duloxetine
• lithium
• rasagiline
• sibutramine
• the herbal remedy St John's wort (Hypericum perforatum) - – this should not be taken in combination withescitalopram
• triptans for migraine, eg sumatriptan
• tramadol
• tryptophan.

The following medicines may prevent the breakdown of escitalopram in the body and so could potentially increase the chance of its side effects. If you are taking any of these medicines with escitalopram you should tell your doctor if you get any new or increased side effects:

• cimetidine
• esomeprazole
• fluvoxamine
• lansoprazole
• omeprazole.

Escitalopram may increase the blood levels of the followingmedicines:

• flecainide
• metoprolol
• propafenone
• antidepressants such as desipramine, clomipramine, nortriptyline
• antipsychotics such as risperidone, thioridazine, haloperidol.

If you are taking any of these in combination with escitalopramyour doctor may need to decrease their dose.

There may be an increased risk of seizures if escitalopram is used in combination with the following medicines:

• tricyclic antidepressant medicines
• antipsychotic medicines
• bupropion
• chloroquine
• mefloquine
• tramadol.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK thatcontain escitalopram as the active ingredient.