Escitalopram 5 mg film-coated tablets – patient leaflet, side effects, dosage

1. What Escitalopram is and what it is used for

Escitalopram belongs to a group of medicines called Selective Serotonin Re-uptake Inhibitor (SSRI) antidepressants. These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases.

Escitalopram can be given to treat the following conditions:

• depression (major depressive episodes)
• anxiety disorders (such as panic disorder with or without agoraphobia (fear of open spaces), social anxiety disorder, generalised anxiety and obsessive-compulsive disorder).

2. What you need to know before you take Escitalopram

Do not take Escitalopram:

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section

  6)

• if you take other medicines that belong to a group called monoamine oxidase (MAO) inhibitors, including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic)
• if you were born with or have had an episode of, abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning)

• if you take medicines for heart rhythm problems or that may affect the heart’s rhythm (see section

  2 “Other medicines and escitalopram”)

Warnings and precautions

Talk to your doctor or pharmacist before taking Escitalopram:

• if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage • if you are elderly
• if you have epilepsy or have a history of fits (seizures). Treatment with escitalopram should be stopped if seizures occur for the first time, or if there is an increase of seizure frequency (see also section 4 “Possible side effects”)
• if you have a history of mania (overactive behaviour or thoughts) or hypomania (elevated or irritable mood associated with extreme energy, talkativeness, confidence and assertiveness) • if you are receiving electro-convulsive therapy (ECT)

• if you have a tendency to easily develop bleeding or bruising, or if you are pregnant (see

  ‘Pregnancy, breast-feeding and fertility’)

• if you suffer from diabetes. Treatment with escitalopram may alter glycaemic control (control of blood sugar levels). Your dosage of insulin and/ or oral hypoglycaemic medicine may need to be adjusted.
• if you have a decreased level of sodium, magnesium or potassium in the blood. • if you have coronary heart disease
• if you suffer or have suffered from heart problems, or have recently had a heart attack • if you have a low resting heart-rate and/or you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets) • if you experience a fast or irregular heart-beat, fainting, collapse or dizziness on standing up, which may indicate abnormal functioning of the heart rate
• if you suffer glaucoma (increased pressure in the eye)

Please note

Some patients with manic-depressive illness may enter into a manic phase. This is characterised by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

• If you have previously had thoughts about killing or harming yourself. - If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Sexual dysfunction

Medicines like escitalopram (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

Children and adolescents under 18 years of age

Escitalopram should normally not be used for children and adolescents under 18 years. Also, you should know that patients under 18 have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Escitalopram for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed Escitalopram for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any symptoms listed above develop or get worse when patients under 18 are taking Escitalopram. Also, the long term safety effects of escitalopram concerning growth, maturation and cognitive and behavioural development in this age group have not yet been demonstrated.

Other medicines and Escitalopram

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Escitalopram if you take:

• medicines for heart rhythm problems or medicines that may affect the heart’s rhythm, such as class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol, risperidone, thioridazine), tricyclic antidepressants (e.g. desipramine, clomipramine, nortripytiline, imipramine), certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (e.g. astemizole, hydroxyzine, mizolastine). • ‘Non-selective monoamine oxidase (MAO) inhibitors’, containing phenelzine, iproniazid, isocarboxazid, nialamide and tranylcypromine as active ingredients. If you have taken any of these medicines you will need to wait 14 days before you start taking escitalopram. After stopping escitalopram you must allow 7 days before taking any of these medicines. • Reversible, selective MAO-A inhibitors, containing moclobemide (used to treat depression) • Irreversible MAO-B inhibitors, containing selegiline (used to treat Parkinson’s disease).

  These increase the risk of side effects.

• The antibiotic linezolid

If you have any further questions about this, you should speak to your doctor.

It is especially important to tell your doctor if you are using some of the following medicines:

• Sumatriptan and similar medicines (used to treat migraine) and opioids such as buprenorphine and tramadol (used against severe pain). These medicines may interact with Escitalopram and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms. .

• Cimetidine, omeprazole, esomeprazole and lansoprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of escitalopram. • St. John’s Wort (Hypericum perforatum) - a herbal remedy used for depression. • Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (NSAIDS)

  (medicines used for pain relief or to thin the blood, so called anti-coagulant). These may increase bleeding-tendency.

• Warfarin, dipyridamole and phenprocoumon or other anticoagulants (medicines used to thin the blood). Your doctor will probably check the coagulation time of your blood when starting and discontinuing escitalopram to make sure that your dose of anti-coagulant is still adequate. • Mefloquine (used to treat malaria) and bupropion (used when trying to stop smoking or treat depression) due to a possible risk of a lowered threshold for seizures (fits). • Other SSRI antidepressants, due to a possible risk of a lowered threshold for seizures. • Flecainide, propafenone and metoprolol (used in cardio-vascular diseases). Your dosage of escitalopram may need to be adjusted.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan. • Medicines that decrease blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

Escitalopram with alcohol

You should avoid alcohol while you are taking this medicine.

Pregnancy, breast-feeding and fertility

Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Do not take Escitalopram if you are pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits involved.

If you take escitalopram during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: trouble with breathing, bluish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know you are on Escitalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like escitalopram may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take Escitalopram near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Escitalopram so they can advise you.

If used during pregnancy Escitalopram should never be stopped abruptly.

It is expected that Escitalopram will be excreted into breast milk.

Citalopram, a medicine like escitalopram, has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.

Driving and using machines

Do not drive or use machines until you know how Escitalopram affects you.

Escitalopram contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Escitalopram

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Remember that you may need to take escitalopram tablets for 2 or more weeks before you begin to feel better.

You can take Escitalopram with or without food. Swallow the tablet with some water. Do not chew them, as the taste is bitter.

Escitalopram 10 mg and 20 mg tablets contain a break line. The tablet can be divided into equal doses.

ADULTS

Depression - The recommended dose is 10 mg of escitalopram a day. Your doctor may increase this dose to a maximum of 20 mg a day. It may take 2 to 4 weeks before you start to feel better. Treatment should last for at least 6 months after you feel better.

Panic disorder – The recommended starting dose is 5 mg of escitalopram a day. After the first week, this dose may be increased by your doctor to 10 mg a day, and if necessary up to a maximum dose of 20 mg a day. The maximum effect is reached after 3 months.

Social anxiety disorder

The recommended dose is 10 mg of escitalopram a day. Your doctor can either decrease your dose to 5 mg a day or increase the dose to a maximum of 20 mg a day, depending on how you respond to the medicine.

Generalised anxiety disorder

The recommended dose is 10 mg of escitalopram a day. The dose may be increased by your doctor to a maximum of 20 mg a day.

Obsessive-compulsive disorder

The recommended dose is 10 mg of escitalopram a day. The dose may be increased by your doctor to a maximum of 20 mg a day.

ELDERLY PATIENTS (above 65 years of age)

Your doctor will give you a lower dose to that stated above, as elderly patients may be more sensitive to the effects of escitalopram. The recommended starting dose of Escitalopram is 5 mg taken as one daily dose. The dose may be increased by your doctor to 10 mg per day.

USE IN CHILDREN AND ADOLESCENTS (below 18 years of age)

Escitalopram should not normally be given to children and adolescents under the age of 18. For further information please see section 2 “What you need to know before you take Escitalopram”.

PATIENTS WITH LIVER OR KIDNEY PROBLEMS

If you have liver or severe kidney problems, your doctor will give you a lower dose than stated above.

How long to take Escitalopram for?

Keep on taking your tablets for as long as your doctor recommends, even after you start to feel better. This should be for at least six months after you recover to stop your symptoms coming back.

If you take more Escitalopram than you should

Contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort. Some symptoms of the signs of overdose could be dizziness, shaking, agitation, convulsion, coma, feeling and being sick, change in heart rhythm (slower or faster heartbeat), decreased blood pressure and change in body fluid/salt balance. Take the container and any remaining tablets with you when you go to the doctor or hospital.

If you forget to take Escitalopram

Do not take a double dose to make up for a forgotten dose. If you do forget to take a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose and carry on as usual.

If you stop taking Escitalopram

Do not stop taking Escitalopram until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of escitalopram is gradually reduced over a number of weeks.

When you stop taking escitalopram, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with escitalopram is stopped. The risk is higher, when escitalopram has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking escitalopram, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.

Discontinuation symptoms include: feeling dizzy (unsteady or off-balance), feelings like pins and needles, burning sensations and electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), being sick (vomiting), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances and fluttering or pounding heartbeat (palpitations).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects may also be symptoms of your illness and therefore will improve when you start to get better.

If you experience any of the following symptoms you should contact your doctor or go to the hospital straight away:

Uncommon (may affect up to 1 in 100 people):

• Unusual bleeds, including bleeds from the stomach, gut and rectum (back passage). You may notice fresh blood, or you may have a sticky, tarry poo or, if you are sick, it may contain particles that look like coffee grounds

Rare (may affect up to 1 in 1,000 people):

• Swelling of skin, tongue, lips, or face, or difficulty breathing or swallowing (serious allergic reactions)
• High fever, agitation, confusion, trembling and abrupt contractions of muscles - these may be signs of a rare condition called serotonin syndrome

Not known (frequency cannot be estimated from the available data):

• Difficulties urinating
• Seizures (fits), see also section 2 “Warnings and precautions”
• A lower than normal level of sodium in the blood, which may make you feel weak and confused with aching of muscles. This may be due to inappropriate ADH secretion, a hormone that causes the body to retain water and dilute the blood, reducing the amount of sodium
• Yellowing of the skin and the white in the eyes, which may be signs of liver function impairment/hepatitis
• Fast, irregular heart-beat, fainting, which could be symptoms of a life-threatening condition known as torsade de pointes
• Thoughts of harming or killing yourself, see also section 2 "Warnings and precautions" • Alteration of the heart rhythm (called “prolongation of QT interval”, seen on ECG, electrical activity of the heart)

In addition to above the following side effects have been reported:

Very common (may affect more than 1 in 10 people):

• headache
• feeling sick (nausea)

Common (may affect up to 1 in 10 people):

• lack of appetite
• increased appetite
• weight increase
• feeling anxious or restless
• difficulty falling asleep
• feeling sleepy
• abnormal dreams
• tingling or numbness of the hands and feet • shaking (tremors)
• feeling dizzy
• yawning
• inflamed swollen sinuses causing pain, high temperature, tenderness (known as sinusitis) • diarrhoea
• constipation
• vomiting
• dry mouth
• increased sweating
• fever
• muscle or joint pain
• feeling unusually tired
• sexual problems (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)

Uncommon (may affect up to 1 in 100 people):

• feeling confused
• agitated
• nervous
• grinding teeth while asleep
• panic attack
• taste disturbance
• change in your sleep pattern
• fainting
• enlarged pupils (mydriasis), visual disturbance • ringing in the ears (tinnitus)
• fast heart-beat
• nose bleed
• decreased weight
• hair loss
• nettle rash or hives
• rash
• itchy skin
• heavy periods or bleeding between periods • swelling of the arms or legs

Rare (may affect up to 1 in 1,000 people):

• feeling aggressive or detached from yourself • hallucinations
• slow heart-beat

Some patients have reported (frequency cannot be estimated from the available data):

• thrombocytopenia (reduction in blood platelets which increases risk of bleeding and bruising) • mania (feeling elated or over-excited, which causes unusual behaviour) • abnormal muscle movements
• dizziness when you stand up due to low blood pressure (orthostatic hypotension) • changes to the results of liver enzyme tests
• persistent painful erection of the penis
• flow of milk in women that are not nursing
• an increased risk of bone fractures has been observed in patients taking this type of medicine • heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy, breast-feeding, fertility in section 2 for more information

In addition, other side effects are known to occur with drugs that work in a similar way as escitalopram. These are:

• restlessness or difficulty sitting still (psychomotor restlessness/akathisia) • anorexia

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Escitalopram

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the tablet container /blister and the carton after ‘EXP’ used for the expiry date. The expiry date refers to the last day of that month.

Store below 25 °C.

Do not use this medicine if you notice visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Escitalopram contains

The active substance is escitalopram.

One tablet contains 5 mg, 10 mg or 20 mg of escitalopram (as oxalate).

The other ingredients are:

Tablet core: microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium (see section 2 ‘Escitalopram contains lactose and sodium’) and magnesium stearate. The coating contains lactose monohydrate, (see section 2, ‘Escitalopram contains lactose and sodium’), macrogol 4000, titanium dioxide (E171) and hypromellose.

What Escitalopram looks like and contents of the pack

Escitalopram is a film-coated tablet.

The 5 mg film-coated tablets are white, round and marked ‘EC 5’ on one side and ‘G’ on the other side.

The 10 mg film-coated tablets are white, oblong, scored and marked with "EC|10" on one side and “G” on the other.

The 20 mg film-coated tablets are white, oblong, scored and marked with "EC|20" on one side and “G” on the other.

Escitalopram is available in blisters of 28 film-coated tablets.

Marketing Authorisation Holder

Viatris,

Station Close, Potters Bar, EN6 1TL, United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last revised in March 2026.