Patient
Information Leaflet
®
Cipralex 10 mg tablets/Escitalopram 10mg
Tablets
®
Cipralex 20 mg tablets/Escitalopram 20mg
Tablets
(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.
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
These products are available as one of the
above names but will be referred
to as Cipralex throughout this leaflet.
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).
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.
You must talk to a doctor if you do not feel
better or if you feel worse.
2. What you need to know before you 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 anticoagulant). 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 lA and lll 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.
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.
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.
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.
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.
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.
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.
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.
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.
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
• 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 (see details below).
By reporting side effects you can help provide
more information on the safety
of this medicine.
United Kingdom
Via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
Alternatively you can call Freephone 0808 100
3352 (available between 10am2pm Monday – Friday) or fill in a paper form available
from your local
pharmacy.
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D’Argens
GŻR-1368
Gżira
Website: www.medicinesauthority.gov.mt
email: [email protected]
5. How to store Cipralex
Keep out of the reach and sight of children.
Do not use Cipralex after the expiry date,
which is stated on the label or carton
after EXP.
The expiry date refers to the last day of that
month.
This medicinal product does not require any
special storage conditions.
Medicines should not be disposed of via
wastewater or household waste. Ask
your pharmacist how to dispose of medicines no
longer required. These
measures will help to protect the environment.
6. Contents of the pack and other information
What Cipralex contains
The active substance is escitalopram. Each
Cipralex tablet contains
10 mg, or 20 mg escitalopram (as oxalate).
The other ingredients are: Core:
microcrystalline cellulose, colloidal anhydrous
silica, talc, croscarmellose sodium and
magnesium stearate.
Coating: hypromellose, macrogol 400 and
titanium dioxide (E 171).
What Cipralex looks like and contents of the
pack
Cipralex is presented as 10 mg and 20 mg
film-coated tablets. The tablets are
described below.
10 mg: Oval, white film-coated tablets. The
tablets are scored and marked
with “E” and “L” on each side of the score on
one side of the tablet.
20 mg: Oval, white film-coated tablets. The
tablets are scored and marked
with “E” and “N” on each side of the score on
one side of the tablet.
Cipralex Tablets come in press-through blister
strips and are available in
packs containing 28 tablets in total.
Manufacturer
H Lundbeck A/S ,Ottiliavej 7-9, DK-2500
Copenhagen Denmark
Procured within the EU. Product Licence
holder: Ecosse Pharmaceuticals Ltd,
3 Young Place, East Kilbride, G75 0TD.
Re-packaged by: Munro Wholesale Medical
Supplies Limited,
3 Young Place, East Kilbride, G75 0TD.
PL 19065/0262
PL 19065/0263
Cipralex 10mg Tablets
Cipralex 20mg Tablets
This leaflet was last revised 27/11/2013
E0262/3-3
® is a Registered Trade mark of H.Lundbeck A/S
POM
