ESCITALOPRAM 10 MG TABLETS

Active substance: ESCITALOPRAM OXALATE

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Package Leaflet: Information for The User
Escitalopram 5 mg, 10 mg, 15 mg and 20 mg Film-coated Tablets
Escitalopram
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.






Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet

1.
2.
3.
4.
5.
6.

What ESCITALOPRAM is and what it is used for
What you need to know before you take ESCITALOPRAM
How to take ESCITALOPRAM
Possible side effects
How to store ESCITALOPRAM
Contents of the pack and other information

1. What ESCITALOPRAM is and what it is used for
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 contains escitalopram and is used to treat depression (major depressive episodes).

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 belongs to a group called 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 are 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
Please tell your doctor if you have any other condition or illness, as your doctor may need to take this
into consideration. In particular, talk to your doctor:













If you have epilepsy. Treatment with ESCITALOPRAM should be stopped if seizures occur
for the first time, or if there is an increase in the seizure frequency (see also section 4“Possible
side effects”).
If you suffer from impaired liver or kidney function. Your doctor may need to adjust your
dosage.
If you have diabetes. Treatment with Cipralex may alter glycaemic control. Insulin and/or oral
hypoglycaemic dosage may need to be adjusted.
If you have a decreased level of sodium in the blood
If you have a tendency to easily develop bleedings or bruises.
If you are receiving electroconvulsive treatment
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 diarrhea and vomiting (being sick) or usage of diuretics (water
tablets).
If you experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up,
which may indicate abnormal functioning of the heart rate.
If you suffer or have suffered from angle-closure glaucoma or history of glaucoma

Please note
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 in sitting or standing still can also occur during the first
weeks of treatment. Tell your doctor immediately if you experience these symptoms.
Thoughts of suicide and worsening of your depression
If you are depressed 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 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 and ask them to read
this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are
worried about changes in your behaviour.

Children and adolescents under 18 years of age
ESCITALOPRAM should normally not be used in 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. You should inform your
doctor if any symptoms listed above develop or worsen when patients under 18 are taking

ESCITALOPRAM. Also, the long-term saftey effects concerning growth, maturation and cognitive
and behavioural development of ESCITALOPRAM in this age group have not yet been demonstrated.
Other medicines and ESCITALOPRAM
Tell your doctor 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:

“Non-selective monoamine oxidase inhibitors (MAOIs)” , containing phenelzin, iproniazid,
isocarboxazid, nialamid, 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.

Lithium (used in the treatment of manic-depressive disorder) and tryptophan.

Imipramine and desipramine (both used to treat depression)

Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe
pain). These increase the risk of side effects.

Cimetidine and omeprazole (used to treat stomach ulcers), 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 (medicines used for
pain relief or to thin the blood, so called anti-coagulant). These may increase bleedingtendency.

Warfarin, Dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anticoagulant). 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.

Mefloquin (used to treat Malaria), bupropion (used to treat depression) and tramadol (used to
treat severe pain) due to a possible risk of a lowered threshold of seizures.

Neuroleptics (medicines to treat schizophrenia, psychosis) due to a possible risk of a lowered
threshold for seizures, and antidepressants.

Flecainide, propafenone, and Metoprolol (used in cardiovascular diseases), clomipramine, and
nortriptyline (antidepressants) and Risperidone, thioridazine, and haloperidol (antipsychotics).
The dosage of ESCITALOPRAM may need to be adjusted.
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-malarial treatment
particularly halofantrine), certain antihistamines (e.g. astemizole, mizolastine). If you have any further
questions about this you should speak to your doctor.
Medicines that decrease blood levels of potassium or magnesium as these conditions increase the risk
of life-threatening heart rhythm disorder.
ESCITALOPRAM with food, drink and alcohol
ESCITALOPRAM 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.

Pregnancy, breast-feeding and fertility
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 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 used during pregnancy ESCITALOPRAM should never be stopped abruptly.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You are advised not to drive a car or operate machinery until you know how ESCITALOPRAM
affects you.
3. How to take ESCITALOPRAM
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Adults
Depression
The normally recommended dose of ESCITALOPRAM is 10 mg taken as one daily dose. The dose
may be increased by your doctor to a maximum to 10 mg per day.
Elderly patients (above 65 years of age)
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. For further information
please see section 2 “What you need to know before you take ESCITALOPRAM“.
You can take ESCITALOPRAM with or without food. Swallow the tablet with some water. Do not
chew them, as the taste is bitter.
Duration of treatment
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.

Do not change the dose of your medicine without talking to your doctor first.
Continue to take ESCITALOPRAM for as long as your doctor recommends. If you stop your
treatment too soon, your symtoms may return. It is recommended that treatment should be continued
for at least 6 months after you feel well again.
The 10, 15 and 20 mg tablets can be divided into equal doses.
If you take more ESCITALOPRAM than you should
If you take more than the prescribed dose of ESCITALOPRAM, 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 blood fluid/salt balance. Take the
ESCITALOPRAM box/container 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 (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.
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.

See your doctor if you get any of the following side effects during treatment:
Uncommon (affects 1 to 10 users in 1000):
• Unusual bleeds, including gastrointestinal bleeds.

Rare (affects 1 to 10 users in 10000):
• If you experience swelling of skin, tongue, lips, or face, or have difficulties breathing or
swallowing (allergic reaction), contact your doctor or go to a hospital straight away.
• If you have a high fever, agitation, confusion, trembling and abrupt contractions of muscles
these may be signs of a rare condition called serotonin syndrome. If you feel like this contact
your doctor.
If you experience the following side effects, you should contact your doctor or go to the hospital
straight away:
• Difficulties urinating
• Seizures (fits), see also section “Take special care with ESCITALOPRAM“
• Yellowing of the skin and the white in the eyes are signs of liver function impairment/hepatitis
• Fast, irregular heartbeat, fainting which could be symptoms of a life-threatening condition
known as torsade de pointes
In addition to the above the following side effects have been reported:
Very common (affects more than 1 users in 10):
• Feeling sick (nausea)
• Headache
Common (affects 1 to 10 users in 100):
• Blocked or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulties falling asleep, feeling sleepy, dizziness,
yawning, tremors, prickling of the skin
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Pain in muscle and joints (arthralgia and myalgia)
• Sexual disturbance (delayed ejaculation, problems with erection, decreased sexual drive and
women may experience difficulties achieving orgasm)
• Fatigue, fever
• Increased weight
Uncommon (affects 1 to 10 users in 1000):
• Nettle rash (urticaria), rash, itching (pruritus)
• Grinding one’s teeth, agitation, nervousness, panic attack, confusion state
• Disturbed sleep, taste disturbance, fainting (syncope)
• Enlarged pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)
• Loss of hair
• Vaginal bleeding
• Decreased weight
• Fast heart beat
• Swelling of the arms or legs
• Nosebleeds
Rare (affects 1 to 10 users in 10000):
• Aggression, depersonalization, hallucination
• Slow heart beat
Some patients have reported (frequency can not be estimated from the available data):
• Thoughts of harming yourself or thoughts of killing yourself, see also section “Take special
care with ESCITALOPRAM“
• Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak
muscles or confused)
• Dizziness when you stand up due to low blood pressure (orthostatic hypotension)












Abnormal liver function test (increased amounts of liver enzymes in the blood)
Movement disorders (involuntary movements of the muscles)
Painful erections (priapism)
Bleeding disorders including skin and mucous bleeding (ecchymosis) and low level of blood
platelets (thrombocytopenia)
Sudden swelling of skin or mucosa (angioedemas)
Increase in the amount of urine excreted (inappropriate ADH secretion)
Flow of milk in women that are not nursing
Mania
An increased risk of bone fractures has been observed in patients taking this type of medicine
Alteration of the heart rhythm (called “prolongation of QT interval”, seen on ECG, measuring
electrical activity of the heart)

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). These are:
• Motor restlessness (akathisia)
• Anorexia
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet.
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 outer carton and the blister after
EXP. The expiry date refers to the last day of that month.
This medicinal product 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.

6. Contents of the pack and other information
What ESCITALOPRAM contains
The active substance is escitalopram.
Each ESCITALOPRAM tablet contains 5 mg, 10 mg, 15 mg or 20 mg escitalopram (as oxalate).
The other ingredients are
Tablet core
Microcrystalline cellulose (E460), croscarmellose sodium (E468), silica, colloidal anhydrous,
magnesium stearate (E470b).
Tablet film coating
Hypromellose (E464), titanium dioxide (E171), macrogol 400.
What ESCITALOPRAM film-coated tablets look like and contents of the pack
ESCITALOPRAM 5 mg are round, white, biconvex, film-coated tablets.
ESCITALOPRAM 10 mg / 15 mg / 20 mg are oval, white, film-coated tablets with a break score on
one side. Tablets can be broken into equal halves.

ESCITALOPRAM is available in the following pack sizes:
7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 tablets (blister packs)
Not all pack sizes may be marketed.
Marketing authorisation holder and Manufacturer

ALFRED E. TIEFENBACHER (GmbH & Co. KG)
Van-der-Smissen-Str. 1
22767 Hamburg
Germany
Manufacturer
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany
This medicinal product is authorised in the Member States of the EEA under the following
names:
Germany:
Portugal:
United Kingdom:

Escitalopram beta 5/10/15/20 mg Filmtabletten
Escitalopram Tiefenbacher
Escitalopram 5/10/15/20 mg Tablets

This leaflet was last revised in 05/2013.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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