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ENTACT 10MG FILM-COATED TABLETS

Active substance(s): ESCITALOPRAM OXALATE

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Seizures (fits), see also section 2 “Warnings
and precautions”
Yellowing of the skin and the white in the eyes
are 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"

In addition to the above the following side
effects have been reported:
Very common (may affect more than 1 in 10
people):
• Feeling sick (nausea)
• Headache
Common (may affect up to 1 in 10 people):
• 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 disturbances (delayed ejaculation,
problems with erection, decreased sexual
drive and women may experience difficulties
achieving orgasm)
• Fatigue, fever
• Increased weight
Uncommon (may affect up to 1 in 100 people):
• Nettle rash (urticaria), rash, itching (pruritus)
• Grinding one’s teeth, agitation, nervousness,
panic attack, confusion
• Disturbed sleep, taste disturbance, fainting
(syncope)
• Enlarged pupils (mydriasis), visual
disturbance, ringing in the ears (tinnitus)
• Loss of hair
• Excessive menstrual bleeding
• Irregular menstrual period
• Decreased weight
• Fast heart beat
• Swelling of the arms or legs
• Nosebleeds
Rare (may affect up to 1 in 1000 people):
• Aggression, depersonalisation, hallucination
• Slow heart beat
Not known (frequency cannot be estimated from
the available data):
• 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)
• Signs of increased bleeding e.g. from skin and
mucous membranes (ecchymosis)
• Sudden swelling of skin or mucosa
(angioedemas)
• Increase in the amount of urine excreted
(inappropriate ADH secretion)
• Flow of milk in men and 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 Cipralex).

These are:
• Motor restlessness (akathisia)
• Loss of appetite
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. 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.
By reporting side effects, you can help provide
more information on the safety of this medicine.
5. HOW TO STORE CIPRALEX
Expiry Date
Do not use after the expiry date shown on the
carton label or blister strip. If your doctor tells you
to stop taking this medicine, return any unused
tablets to your pharmacist for safe disposal. Only
keep this medicine if your doctor tells you to. If
your tablets become discoloured or show any
other signs of deterioration, consult your
pharmacist (chemist) who will tell you what to do.
Storing your medicine
• Keep out of the sight and reach of children.
• Do not take your tablets out of the blister strip
until it is time to take a dose.
Important
Remember this medicine is for you. It can only be
prescribed by a doctor. Never give your medicine
to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet
does not tell you everything about your medicine.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she
will have additional information about this
medicine and will be able to advise you.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Cipralex contains
Each film-coated tablet contains escitalopram
oxalate equivalent to 10mg escitalopram. The
other ingredients are: microcrystalline cellulose,
colloidal anhydrous silica, talc, croscarmellose
sodium, magnesium stearate, hypromellose,
macrogol 400 and titanium dioxide (E-171).
What Cipralex looks like and contents of the
pack
The tablets are oval, white film-coated tablets. The
tablets are scored and marked with "E and L" on
one side and plain on the other.
They are available in packs of 28.

PATIENT INFORMATION LEAFLET
(escitalopram oxalate)
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.
See section 4
Your medicine is called Cipralex 10mg film-coated
Tablets/ Entact 10mg film-coated Tablets /
Escitalopram 10mg film-coated Tablets and will be
referred to as Cipralex throughout the rest of this
leaflet. Please note that the leaflet also contains
information about other strengths of the medicine,
Cipralex 5mg film-coated Tablets and Cipralex
20mg film-coated Tablets
What is in this leaflet
1. What Cipralex is and what it is used for
2. What you need to know before you take
Cipralex
3. How to take Cipralex
4. Possible side effects
5. How to store Cipralex
6. Contents of the pack and other information
1. WHAT CIPRALEX IS AND WHAT IT IS USED
FOR
Cipralex contains the active substance
escitalopram. Cipralex 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.
Cipralex contains escitalopram and is used to treat
depression (major depressive episodes) and
anxiety disorders (such as panic disorder with or
without agoraphobia, social anxiety disorder,
generalised anxiety disorder and
obsessive-compulsive disorder).

Manufacturer and Licence Holder
This medicine is manufactured by H.Lundbeck
A/S, Ottiliavej 9, DK-2500 Copenhagen, Denmark
and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.

It may take a couple of weeks before you start to
feel better. Continue to take Cipralex, even if it
takes some time before you feel any improvement
in your condition.

If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

2. WHAT YOU NEED TO KNOW BEFORE YOU

POM

PL 15184/0916

Cipralex is a registered trademark of H.Lundbeck
A/S.
Leaflet revision date: 04/11/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref: 0916/041114/1/F

®

You must talk to a doctor if you do not feel better
or if you feel worse.

TAKE CIPRALEX
Do not take Cipralex
• If you are allergic to escitalopram or any of the
other ingredients of this medicine (listed in
section 6).
• If you take other medicines which belong 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 Cipralex”).

Warnings and precautions
Talk to your doctor or pharmacist before taking
Cipralex. 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:
• If you have epilepsy. Treatment with Cipralex
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 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 have or have previously had eye
problems, such as certain kinds of glaucoma
(increased pressure in the eye).
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 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 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.
Children and adolescents under 18 years of
age
Cipralex 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 Cipralex for
patients under 18 because he/she decides that
this is in their best interest. If your doctor has
prescribed Cipralex 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 Cipralex. Also, the
long term safety effects concerning growth,
maturation and cognitive and behavioural
development of Cipralex in this age group have
not yet been demonstrated.
Other medicines and Cipralex
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:
• “Non-selective monoamine oxidase inhibitors
(MAOIs)”, 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 Cipralex. After stopping
Cipralex 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, lansoprazole 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
bleeding-tendency.
• Warfarin, dipyridamole, and phenprocoumon
(medicines used to thin the blood, so called
anti-coagulant). Your doctor will probably
check the coagulation time of your blood when
starting and discontinuing Cipralex in order to
verify that your dose of anti-coagulant is still
adequate.
• Mefloquine (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 for seizures.







Neuroleptics (medicines to treat schizophrenia,
psychosis) and antidepressants
(tricyclic antidepressants and SSRIs) due to a
possible risk of a lowered threshold for
seizures.
Flecainide, propafenone, and metoprolol (used
in cardiovascular diseases) clomipramine, and
nortriptyline (antidepressants) and risperidone,
thioridazine, and haloperidol (antipsychotics).
The dosage of Cipralex may need to be
adjusted.
Medicines that decrease blood levels of
potassium or magnesium, as these conditions
increase the risk of life-threatening heart
rhythm disorders.

Do not take Cipralex 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.
Cipralex with food, drink and alcohol
Cipralex can be taken with or without food (see
section 3 “How to take Cipralex”).
As with many medicines, combining Cipralex with
alcohol is not advisable, although Cipralex is not
expected to interact with alcohol.
Pregnancy, breast-feeding and fertility
Inform your doctor if you are pregnant or planning
to become pregnant. Do not take Cipralex if you
are pregnant or breast-feeding, unless you and
your doctor have discussed the risks and benefits
involved.
If you take Cipralex 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 Cipralex. When taken during pregnancy,
particularly in the last 3 months of pregnancy,
medicines like Cipralex 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 Cipralex should never be
stopped abruptly.
It is expected that Cipralex 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 Cipralex affects
you.

3. HOW TO TAKE CIPRALEX
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 Cipralex is 10
mg taken as one daily dose. The dose may be
increased by your doctor to a maximum of 20 mg
per day.

If you take more Cipralex than you should
If you take more than the prescribed dose of
Cipralex, 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
Cipralex box/container with you when you go to
the doctor or hospital.

Panic disorder
The starting dose of Cipralex 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.

If you forget to take Cipralex
Do not take a double dose to make up for
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.

Social anxiety disorder
The normally recommended dose of Cipralex 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.

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

Generalised anxiety disorder
The normally recommended dose of Cipralex 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 Cipralex is 10
mg taken as one daily dose. The dose may be
increased by your doctor to a maximum of 20 mg
per day.
Elderly patients (above 65 years of age)
The recommended starting dose of Cipralex is 5
mg taken as one daily dose. The dose may be
increased by your doctor to 10 mg per day.
Children and adolescents (below 18 years of
age)
Cipralex should not normally be given to children
and adolescents. For further information please
see section 2 “What you need to know before you
take Cipralex”.
You can take Cipralex 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 as shown in the drawing.

When you stop taking Cipralex, especially if it is
abruptly, you may feel discontinuation symptoms.
These are common when treatment with Cipralex
is stopped. The risk is higher, when Cipralex 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 Cipralex, 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Duration of treatment
It may take a couple of weeks before you start to
feel better. Continue to take Cipralex 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 Cipralex 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.

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 gastrointestinal
bleeds
Rare (may affect up to 1 in 1000 people):
• Swelling of skin, tongue, lips, or face, or have
difficulties breathing or swallowing (allergic
reaction).
• 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
Ref: 0916/041114/1/B

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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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