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Citalopram 20 mg and 40 mg Tablets



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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This
includes any side effects not listed in this leaflet.

In this leaflet:
1. What Citalopram is and what it is used for
2. What you need to know before you take
3. How to take Citalopram
4. Possible side effects
5. How to store Citalopram
6. Contents of the pack and other information


serotonin syndrome. Please inform your doctor
without delay; he/she will discontinue treatment
with Citalopram immediately.
If you start feeling restless and are no longer
able to stand or sit still, please inform your
doctor, since you may be suffering from a
side-affect called akathisia.

At the initiation of treatment, sleeplessness and
intense excitation can occur. In this case, the
doctor may adjust the dose accordingly.

What Citalopram is and what it
is used for

Other medicines and Citalopram
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
medicines, including medicines obtained without
a prescription.

Citalopram belongs to the group of so-called
SSRIs (selective serotonin re-uptake inhibitors)
and is used to treat depressive illnesses
(episodes of major depression). People who are
depressed have lower levels of the substance
serotonin in their brain than others. Citalopram
may help by increasing the level of serotonin.


Do not take Citalopram if you take medicines for
heart rhythm problems or medicines that may
affect the heartʼs rhythm, e.g. such as Class IA
and III antiarrhythmics, antipsychotics (e.g.
fentiazine derviatives, pimozide, haloperidol),
tricyclic antidepressants, certain antimicrobial
agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine, anti-malarian
treatment particularly halofantrine), certain
antihistamines (astemizole, mizolastine). If you
have any further questions about this, you
should speak to your doctor.

What you need to know before
you take Citalopram

Do not take Citalopram
• If you are allergic (hypersensitive) to
citalopram or to any of the other ingredients of
this medicine (See section 6).
• If you are taking MAO (monoamine oxidase)
inhibitors. These medicines are used for
treatment of depression (e.g. moclobemide) or
Parkinsonʼs disease (selegiline) or infections
(antibiotic linezolid). The MAO-inhibitor
selegiline may be used in combination with
citalopram, albeit not more than 10 mg per
• If you have recently taken MAO-inhibitors.
Depending on the type of MAO-inhibitor you
used to use, you may have to wait for up to 14
days after stopping the MAO-inhibitor before
starting with Citalopram (see also “Taking
other medicines”). If you stop taking
Citalopram and want to start using
MAO-inhibitors, you have to wait for at least 7
• If you are taking pimozide (an antipsychotic
• 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
• If you take medicines for heart rhythm problems
or that may affect the heartʼs rhythm. (see
also “Other medicines and Citalopram)

The following medicinal products can influence
the effect of Citalopram or can be influenced in
their effect.
• MAO-inhibitors (likewise medicinal products
against depression or Parkinsonʼs disease):
Citalopram must not be administered until 14
days after an irreversible MAO inhibitor was
discontinued. After discontinuation of a
reversible MAO inhibitor (RIMA), the time
prescribed in the relevant expert information
of the RIMA must be complied with. Therapy
with MAO inhibitors may be initiated 7 days at
the earliest after discontinuation of citalopram.
Please ask your doctor regarding this.
• Pimozide (an antipsychotic medicine).
Concomitant treatment with citalopram and
pimozide is contra-indicated due to the influence
of this combination to the heart function.

It is especially important that you ask your
doctor for advice if you are taking
• Sumatriptan or other triptans (medicinal
products to treat migraine), oxitryptan or
tryptophan (substances that may influence the
level of serotonin in the brain)
• Other medicine for depression: tricyclic
antidepressants, other serotonin re-uptake
inhibitors or medicines containing lithium
• Tramadol (medicinal product to treat severe pain)
• Herbal remedy St. Johnʼs Wort (Hypericum
Concomitant use of above mentioned medicinal
products may lead to “serotonin syndrome” by
potentiating serotonergic effects of Citalopram
(see “Warnings and precautions”).

Warnings and precautions
Talk to your doctor before taking Citalopram.

Use in children and adolescents under 18 years
Citalopram 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
attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional
behaviour and anger) when they take this class
of medicines.
Despite this, your doctor may prescribe Citalopram
for patients under 18 because he/she decides
that this is in their best interests. If your doctor
has prescribed Citalopram for a patient under 18
and you want to discuss this, please go back to
your doctor. You should inform your doctor if any
of the symptoms listed above develop or worsen
when patients under 18 are taking Citalopram.
Also, the long-term safety effects concerning
growth, maturation and cognitive and
behavioural development of Citalopram in this
age group have not yet been demonstrated.

• Desipramine (medicine to treat depression).
The blood level of desipramin may be
increased and a reduction of the desipramin
dose may be needed
• Blood-thinning medicine (warfarin or any other
oral anticoagulant)
• Medicinal products influencing thrombocyte
function (e.g. non-steroidal antirheumatics,
acetylsalicylic acid, dipyridamol and
ticlopidine, atypical antipsychotics,
Concomitant use of above mentioned medicinal
products may lead to increased/prolonged
bleeding (see “Warnings and precautions”)

Thoughts of suicide and worsening of your
If you are depressed you can sometimes have
thoughts of harming or killing yourself. These
may be increased when you 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.

• Cimetidine, a medicinal product to reduce
gastric acid and other medicinal products to
treat stomach ulcers, e.g. omeprazole,
esomeprazole, lansoprazole or fluvoxamine
(other medicine to treat depression).
Combination with citalopram may cause a rise
in the blood level of citalopram
• neuroleptics (used to treat schizophrenia).
Concomitant use can cause seizures
• Metoprolol (medicine to treat high blood
pressure or heart failure), flecainide and
propafenone (to treat irregular heartbeat),
other medicines to treat depression
(clomipramine, nortriptyline) or medicines to
treat psychoses (risperidone, thioridazine,
haloperidol). An increase in the blood level of
these medicines has been reported or may be
• Medicines that have an influence on heart
rhythm (QT-interval prolongation) or decrease
blood levels of potassium or magnesium
because citalopram also has this effect
• Medicines lowering the seizure threshold,
e.g. other antidepressants (tricyclics, SSRIʼs),
antipsychotic medicines (e. g. phenothiazines,
butyrophenones), tramadol (pain killer),
mefloquine (used to treat malaria), bupropion
(used to treat depression).

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.

Check with your doctor if:
• you have diabetes, because your doctor may
need to adjust the dosage of insulin or other
medicine used to lower your blood sugar.
• you have had seizures or have epilepsy. You
will be carefully monitored by your doctor.
Treatment with Citalopram should be stopped
if seizures occur or if there is an increase in
the seizure frequency.
• you are receiving electro-convulsive treatment.
• you have or have had episodes of mania
(overactive behaviour or thoughts).
• you have a history of bleeding disorders or
are using medicines that influence blood
coagulation or increase the bleeding risk (see
“Other medicines and citalopram”).
• you have so-called psychosis with depressive
episodes, because the psychotic symptoms
may increase.
• you are taking herbal products containing St.
John's wort (Hypericum perforatum see also
“Other medicines and citalopram”).
• you are taking sumatriptan or other triptans,
tramadol, oxitriptan or tryptophan (see also
“Other medicines and citalopram”).
• you have reduced liver or kidney function,
because it may be necessary to prescribe a
lower dose for you.
• you are susceptible for deviation of heart
rhythm (QT-interval prolongation) or have
suspected congenital long QT-syndrome or
suffer from low blood levels of potassium or
magnesium (hypokalaemia/
• you start feeling sick and unwell with weak
muscles or confused while being treated with
• you suffer or have suffered from heart
problems or have recently had a heart attack.
• 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).
• you experience a fast or irregular heartbeat,
fainting, collapse or dizziness on standing up
which may indicate abnormal functioning of
the heart rate.

Taking Citalopram with food, drink and
When taking Citalopram, you should not
consume any alcohol.

The film-coated tablets may be taken with or
without food.

Pregnancy and breast-feeding
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.

If you are pregnant, think you might be pregnant,
or are trying to become pregnant, tell your
doctor. Do not take Citalopram if you are
pregnant unless you and your doctor have
discussed the risks and benefits involved.
You should not discontinue treatment with
Citalopram abruptly.

Make sure your midwife and/or doctor know you
are on Citalopram.
If you are taking Citalopram in the last 3 months
of pregnancy your baby might have some
symptoms when it is born. These symptoms
usually begin during the first 24 hours after the
baby is born. They include not being able to
sleep or feed properly, trouble with breathing, a
blueish skin or being too hot or cold, being sick,
crying a lot, stiff or floppy muscles, lethargy,
tremors, jitters or fits. If your baby has any of
these symptoms when it is born, contact your
midwife and/or doctor immediately who will be
able to advise you.
When taken during pregnancy, particularly in the
last 3 months of pregnancy, medicines like
Citalopram may increase the risk of a serious
condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN), making
the baby breath 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.

draft: 44028147, 44030800
laetus code: 641 46114084

If signs such as intense excitation, trembling,
muscular twitching and fever occur during
treatment, this may be a first sign of so-called

Continued on the next page >>


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The following additional side effects have been

Citalopram passes into breast milk in small
amounts. There is a risk of an effect on the baby.
If you are taking Citalopram, talk to your doctor
before you start breast-feeding.

Very common: may affect more than 1 in 10
• sleepiness, sleeplessness, intense excitation,
• headache, trembling, dizziness
• palpitations
• nausea, dry mouth, constipation, diarrhoea
• increased sweating
• accommodation disorders of eyes
• debility (asthenia).

Citalopram 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
Citalopram can influence the ability to drive and
to use machines. As with all medicinal products
acting on the psyche, the ability to judge and
react may be impaired in emergency situations.

Common: may affect up to 1 in 10 people
• sleep disturbances, impaired concentration,
abnormal dreaming, memory defects, anxiety,
decreased libido, increased appetite, loss of
appetite, apathy, confusion
• migraine, spontaneously experiencing feelings
like tickling, itching or tingling (paraesthesia)
• accelerated pulse rate, drop in blood pressure
when changing posture (orthostatic
hypotension), increased blood pressure,
lowered blood pressure
• digestive disorders (dyspepsia), vomiting,
abdominal pain, flatulence, increased
• urination disorders, abnormally high urine
production (polyuria)
• weight loss or gain
• rhinitis, sinusitis
• disturbed ejaculation, orgasmic impairment in
the woman, menstrual complaints, impotence
• rash, itching
• visual disturbances
• fatigue, yawning, taste alterations.

Do not drive or use machines until you know
how Citalopram affects you. Please ask your
doctor or pharmacist if you are unsure about

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


How to take Citalopram

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
Take the film-coated tablets together with
sufficient liquid once daily in the morning or in
the evening. The tablets may be taken with or
without food.

Uncommon: may affect up to 1 in 100 people
• euphoria, increased libido
• disturbances of the motor system
(extrapyramidal disorders), seizures
• decelerated pulse rate
• increase in liver enzymes
• cough
• hypersensitivity to light
• noise in the ear (tinnitus)
• muscle pain (myalgia)
• allergic reactions, short-term
unconsciousness (syncope), general malaise.

The recommended dose for adults is

The starting dose is 20 mg citalopram once
daily. If necessary, the dose may be increased
gradually according to the doctors orders to
40 mg citalopram once daily.

Elderly patients (aged over 65 years)

Rare: may affect up to 1 in 1,000 people
• inability to sit or stand still
• bleeding (gynaecological bleeding,
gastrointestinal bleeding and bleeding soft
skin or mucosa), serotonin syndrome,
reduced sodium level in the blood
(hyponatraemia), predominantly in elderly
patients and sometimes due to syndrome of
inappropriate anti-diuretic hormone secretion
(SIADH) with symptoms like feeling sick and
unwell with weak muscles or confused.

The dose should be reduced to half the normal
dose for adults, e.g. 10-20 mg citalopram per
day. Depending on your individual response, the
dose may be increased by the doctor. The
maximum dose for elderly patients is 20 mg
citalopram per day.

Patients with impaired hepatic function

Patients with impaired hepatic function should
receive an initial dose of 10 mg citalopram per
day. The dose must not exceed 20 mg
citalopram per day. Your doctor will closely
monitor your liver function, while on treatment
with citalopram.

Not known: frequency cannot be estimated
from the available data
• seeing or hearing things that are not real
(hallucinations), overactive behaviour or
thoughts (mania), feeling detached from
yourself (depersonalisation), panic attacks
(these symptoms may be associated with the
underlying disease)
• Cases of suicidal ideation and suicidal
behaviours have been reported during
citalopram therapy or early after treatment
discontinuation (see section 2 “Warnings and
• secretion of milk from the mammary glands
• angioedema has been reported which can
present itself as sudden swelling of the skin
and mucosa due to fluid retention (e.g. of the
throat and tongue), breathing difficulties
and/or itching and rash
• joint pain (arthralgia), increased risk of bone
fractures (observed for all medicines belonging
to certain groups of antidepressants)
• Withdrawal symptoms when treatment is
terminated may occur (see also “If you stop
taking Citalopram”).

Patients with impaired renal function

If you suffer from a mild to moderate decrease in
renal function, you can use the normal dose for
If you suffer from severe renal impairment, use
of citalopram is not recommended since no
information is available on use in these patients.
How long should you take Citalopram?
Your doctor decides on the duration of treatment.

An improvement in the depressive symptoms
cannot be expected before at least 2 weeks
have passed after initiation of treatment.

After the depressive symptoms have subsided,
therapy should be continued for at least 4-6

If you take more Citalopram than you should
If you have taken too much Citalopram a doctor
is to be informed immediately. Some of the signs
of an overdosage could be life-threatening.

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

Depending on the dose ingested, overdosages
with citalopram manifest themselves as
complaints such as irregular heartbeat, seizures,
changes in heart rhythm, feeling sick (nausea),
vomiting, sweating, drowsiness,
unconsciousness, fast heart beats, tremor,
changes in blood pressure, serotonin syndrome
(see Section 4), agitation, dizziness, enlarged
eye pupils, bluish skin, breathing too quickly.


Keep out of the reach and sight of children.

If you forget to take Citalopram
Do not take a double dose to make up for a
forgotten dose. If you have forgotten to take a
dose of Citalopram, take it as soon as possible.
However, if it nearly time for the next dose, skip
the missed dose and continue intake of Citalopram
as prescribed by your doctor. In case of doubt,
always consult your doctor or pharmacist.

Do not use this medicine after the expiry date
which is stated on the carton after EXP. The
expiry date is also indicated on the blisters. 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 dispose of
medicines you no longer use. These measures
will help protect the environment.

If you stop taking Citalopram
Do not stop taking Citalopram until your doctor
tells you to, even if you feel better.


If you stop suddenly after taking this medicine
for a long time you can experience withdrawal
effects; you may feel dizzy, have sensory
disturbances (numbness or ʻpins and needlesʼ,
called paresthesia), sleep disturbances
(including insomnia and intense dreams), feeling
sick (nausea), sweating, headaches, tremor,
feeling agitated or anxious, feeling confused or
disorientated, visual disturbances, fluttering or
pounding heartbeat (palpitations). These
symptoms are generally mild to moderate and
go away on their own within two weeks.
However, in some patients these symptoms may
be more severe, or go on for longer. They
usually happen in the first few days after
stopping the medicine.

Contents of the pack and other

What Citalopram contains
The active substance is citalopram hydrobromide.
Each Citalopram 20 mg and 40 mg tablet
contains citalopram hydrobromide, equivalent to
respectively 20 and 40 mg citalopram.
The other ingredients are: microcrystalline
cellulose, glycerol 85%, magnesium stearate,
maize starch, lactose monohydrate, copovidone,
sodium starch glycollate (type A).
Coating: Macrogol 6000, hypromellose, talc and
titanium dioxide (E171).
What Citalopram looks like and contents of
the pack
Citalopram 20 mg Tablets are white, oblong
biconvex film-coated tablet with a one sided
notch and the embossment C20.
Citalopram 40 mg Tablets are white, oblong
biconvex film-coated tablet with a one sided
notch and the embossment C40.

Citalopram should be withdrawn slowly when
terminating treatment. It is recommended to
reduce the dose gradually over a period of at
least 1-2 weeks.

If you get severe withdrawal effects when you
stop taking Citalopram, please see your doctor.
He or she may ask you to start taking your
tablets again and come off them more slowly.

The tablets can be divided in two equal halves.

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


How to store Citalopram

Citalopram 20 mg Tablets, packed in
PVC/PVDC/Al blisters are available in pack
sizes of 12, 14, 20, 28, 30, 50, 50 x 1, 56, 98,
100 and 250 tablets.
HDPE tablet container containing 250 tablets.

Possible side effects

Citalopram 40 mg Tablets, packed in
PVC/PVDC/Al blisters are available in pack
sizes of 10, 14, 20, 28, 30, 50, 56, 98 and 100
HDPE tablet container containing 250 tablets

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the following happens, stop taking
Citalopram and tell your doctor immediately or
go to your nearest hospital:

Not all pack sizes may be marketed.

• Fast, irregular heart beat, fainting which could
be symptoms of a life-threatening condition
known as Torsades de Pointes
• Serotonin syndrome has been reported.
Symptoms may include restlessness,
confusion, sweating, hallucinations,
exaggeration of reflexes, muscle cramps,
shivering, rapid heart rate and tremor
• Severe hypersensitivity reactions which may
result in a strong decrease in blood pressure,
paleness, anxiety, a fast weak pulse rate, a
clammy skin, decreased consciousness,
tremor, breathing difficulties and sudden
swelling of the skin and mucosa.

Marketing Authorisation Holder and
The Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

The manufacturer:
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,

This leaflet was last approved in 08/2013.

draft: 44028147, 44030800
laetus code: 641 46114084

46114084 SZ90410LT04A

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Ref: V048 - SPC & PIL update as per PhVWP, excipient correction
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Date prepared:

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Dimensions: 148 x 630 mm

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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.