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Escitalopram 5 mg, 10mg, 20mg film-coated tablets
Escitalopram 5 mg film-coated tablets
Escitalopram 10 mg film-coated tablets
Escitalopram 20 mg film-coated tablets
Escitalopram
1. What Escitalopram is and what it is used for
2. What you need to know before you take Escitalopram
3. How to take Escitalopram
4. Possible side effects
5. How to store Escitalopram
6. Contents of the pack and other information
Escitalopram film-coated tablets contains the active substance escitalopram.
Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). 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 is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia which is fear of being in places where help might not be available, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder).
It may take a couple of weeks before you start to feel better. Continue to take Escitalopram, even if it takes some time before you feel any improvement in your condition.
You must talk to a doctor if you do not feel better or if you feel worse.
Talk to your doctor or pharmacist before taking Escitalopram film-coated tablets.
Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor:
Some patients with manic-depressive illness may enter into a manic phase. This is characterized 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 to sit or stand still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.
Medicines like Escitalopram film-coated tablets (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
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 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.
Use in Children and adolescents
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 (predominately 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 worsen when patients under 18 are taking escitalopram. Also, the long term safety effects concerning growth, maturation and cognitive and behavioural development of escitalopram in this age group have not yet been demonstrated.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking any of the following 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), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarian treatment particularly halofantrine), certain antihistamines (e.g.astemizole, hydroxyzine, mizolastine). If you have any further questions about this you should speak to you doctor.
Escitalopram film-coated tablets can be taken with or without food (see section 3 “How to take Escitalopram”).
As with many medicines, combining escitalopram with alcohol is not advisable, although escitalopram is not expected to interact with alcohol.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Escitalopram film-coated-tablets 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 new-born 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 new-born baby has any of these symptoms, please contact your doctor immediately.
Make sure your midwife and/or doctor know you are on Escitalopram film-coated tablets. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram film- coated tablets may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new-born (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 film-coated tablets 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 film-coated tablets so they can advise you.
If used during pregnancy escitalopram should never be stopped abruptly.
It is expected that Escitalopram film-coated tablets 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
You are advised not to drive a car or operate machinery until you know how escitalopram affects you.
Escitalopram film-coated tablets contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Depression
The normally recommended dose of Escitalopram film-coated tablets 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
The starting dose of Escitalopram film-coated tablets is 5 mg as one daily dose for the first week before increasing the dose to 10 mg per day. The dose may be further increased by your doctor to a maximum of 20 mg per day.
Social anxiety disorder
The normally recommended dose of Escitalopram film-coated tablets is 10 mg taken as one daily dose. Your doctor can either decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on how you respond to the medicine.
Generalised anxiety disorder
The normally recommended dose of Escitalopram film-coated tablets is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The normally recommended dose of Escitalopram film-coated tablets is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.
The recommended starting dose of Escitalopram film-coated tablets is 5 mg taken as one daily dose. The dose may be increased by your doctor to 10 mg per day.
Escitalopram film-coated tablets should not normally be given to children and adolescents. For further information please see section 2 “Warnings and precautions”.
Reduced kidney function
Caution is advised in patients with severely reduced renal function. Take as prescribed by your doctor.
Reduced liver function
Patients with liver complaints should not receive more than 10 mg per day. Take as prescribed by your doctor.
Patients known to be poor metabolisers of the enzyme CYP2C19
Patients with this known genotype should not receive more than 10 mg per day. Take as prescribed by your doctor.
How to take Escitalopram film-coated tablets
You can take Escitalopram film-coated tablets with or without food. Swallow the tablet with some water. Do not chew them, as the taste is bitter.
If necessary, you can divide the tablets by firstly placing the tablet on a flat surface with the score facing upwards. The tablets may then be broken by pressing down on each end of the tablet, using both forefingers.
It may take a couple of weeks before you start to feel better. Continue to take Escitalopram film-coated tablets even if it takes some time before you feel any improvement in your condition.
Do not change the dose of your medicine without talking to your doctor first.
Continue to take Escitalopram film-coated tablets for as long as your doctor recommends. If you stop your treatment too soon, your symptoms may return. It is recommended that treatment should be continued for at least 6 months after you feel well again.
If you take more than the prescribed dose of Escitalopram film-coated tablets, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort. Some of the signs of an overdose could be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and change in body fluid/salt balance.
Take the Escitalopram film-coated tablets box/container with you when you go to the doctor or hospital.
Do not take a double dose to make up for a forgotten doses. 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.
Do not stop taking Escitalopram film-coated tablets 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 film-coated tablets 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 film-coated tablets, 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 (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
In addition to above the following side effects have been reported:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
In addition, a number of side effects are known to occur with drugs that work in a similar way to escitalopram (the active ingredient of Escitalopram film-coated tablets). These are:
If you get any side effects, talk to you doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: 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.
Keep this medicine out of the sight and reach of children.
Do not use Escitalopram film-coated tablets after the expiry date, which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.
The active substance is escitalopram. Each Escitalopram film-coated tablet contains 5 mg, 10 mg or 20 mg escitalopram (as oxalate).
The other ingredients are:
Tablet core:
Cellulose, microcrystalline (E460), Croscarmellose sodium (E468), Magnesium Stearate (E572), Colloidal Anhydrous Silica and Talc
Tablet coating:
Hypromellose (E464), Titanium dioxide (E171), Macrogol 400
Escitalopram film-coated tablets is presented as 5 mg, 10 mg and 20 mg film-coated tablets.
The tablets are described below.
5 mg: White to off-white, circular, biconvex, film coated tablets with ‘E 1’ debossed on one side and plain on the other side.
10 mg: White to off-white, oval, biconvex, film coated tablets with ‘E 2’ debossed on one side and scoreline on the other side. The tablet can be divided into equal halves.
20 mg: White to off-white, oval, biconvex, film coated tablets with “E 4” debossed on one side and scoreline on the other side. The tablet can be divided into equal halves.
The tablets are packed in either plain Aluminium/Aluminium blisters or clear PVC-Aclar/Aluminium blisters
Escitalopram film-coated tablets is available in the following pack sizes:
5 mg film-coated tablets
Blister: 14, 20, 28, 50, 100 and 200
10 mg film-coated tablets
Blister: 14, 20, 28, 50, 56, 100 and 200
20 mg film-coated tablets
Blister: 14, 20, 28, 50, 56, 100 and 200
Not all pack sizes may be marketed
This leaflet was last revised in July 2023