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CITALOPRAM 20 MG TABLETS
Active substance(s): CITALOPRAM HYDROBROMIDE / CITALOPRAM HYDROBROMIDE / CITALOPRAM HYDROBROMIDE
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
What Citalopram is and what it is
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
What you need to know before you
Do not take Citalopram
• If you are allergic (hypersensitive) to citalopram
or to any of the other ingredients of this medicine
(listed in section 6)
• If you are taking MAO (monoamine oxidase)
inhibitors (medicines used for treatment of
depression or Parkinson’s disease). The
MAO-inhibitor selegiline may be used in
combination with citalopram, albeit not more than
10mg per day
• 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 “Other medicines and
Citalopram”). If you stop taking Citalopram and
want to start using MAO-inhibitors, you have to
wait for at least 7 days.
• 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 heart’s rhythm. (see also
“Other medicines and Citalopram)
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.
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
If you have thoughts of harming or killing yourself at
any time, contact your doctor or go to a hospital
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
• you have so-called psychosis with depressive
episodes, because the psychotic symptoms
• 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 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
• you start feeling sick and unwell with weak muscles
or confused while being treated with Citalopram.
• 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
If signs such as intense excitation, trembling, muscular
twitching and fever occur during treatment, this may
be a first sign of so-called 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.
Other medicines and Citalopram
Tell your doctor or pharmacist if you are taking or
have recently taken or might take any other
Do not take Citalopram if you take medicines for
heart rhythm problems or medicines that may affect
the heart’s 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.
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 Parkinson’s 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
thiscombination 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. John’s Wort (Hypericum
Concomitant use of above mentioned medicinal
products may lead to “serotonin syndrome” by
potentiating serotonergic effects of Citalopram (see
“Warnings and precautions”).
• Desipramine (medicine to treat depression).
The blood level of desipramin may be increased
and a reduction of the desipramin dose may be
• Blood-thinning medicine (warfarin or any other
• Medicinal products influencing thrombocyte
function (e.g. non-steroidal antirheumatics,
acetylsalicylic acid, dipyridamol and ticlopidine,
atypical antipsychotics, phenothiazines).
Concomitant use of above mentioned medicinal
products may lead to increased/prolonged bleeding
(see “Warnings and precautions”)
• 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
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 possible
• 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, SSRI’s),
antipsychotic medicines (e. g. phenothiazines,
butyrophenones), tramadol (pain killer).
Citalopram with food, drink and alcohol
When taking Citalopram, you should not consume
The film-coated tablets may be taken with or without
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
There is only limited experience concerning the
use of Citalopram during pregnancy. Do not take
Citalopram if you are pregnant or planning to
become pregnant, unless your doctor considers it
You should not discontinue treatment with
Make sure your midwife and/or doctor know you are
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.
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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
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.
Do not drive or use machines until you know how
Citalopram affects you. Please ask your doctor or
pharmacist if you are unsure about anything.
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.
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
Elderly patients (aged over 65 years)
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.
Patients with impaired renal function
If you suffer from a mild to moderate decrease in
renal function, you can use the normal dose for adults.
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 months.
If you take more Citalopram than you should
If you have taken too much Citalopram a doctor is to
be informed immediately.
Depending on the dose ingested, overdosages with
citalopram manifest themselves as complaints such
as nausea, vomiting, sweating, sleepiness, coma,
seizures, accelerated pulse rate, disturbances of
muscle tone, hyperventilation (accelerated and
increased exhalation), increased body temperature
and rare ECG alterations.
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.
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 ‘pins and needles’, called
paresthesia), sleep disturbances (including insomnia
and intense dreams), feeling sick (nausea),
sweating, headaches, tremor, feeling agitated or
anxious. These symptoms are generally mild to
moderate and go away on their own within two
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
Citalopram should be withdrawn slowly when
terminating treatment. It is recommended to reduce
the dose gradually over a period of at least
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 salivation
• urination disorders, abnormally high urine
• weight loss or gain
• rhinitis, sinusitis
• disturbed ejaculation, orgasmic impairment
in the woman, menstrual complaints, impotence
• rash, itching
• visual disturbances
• fatigue, yawning, taste alterations.
Uncommon: may affect up to 1 in 100 people
• euphoria, increased libido
• disturbances of the motor system (extrapyramidal
• decelerated pulse rate
• increase in liver enzymes
• hypersensitivity to light
• noise in the ear (tinnitus)
• muscle pain (myalgia)
• allergic reactions, short-term unconsciousness
(syncope), general malaise.
Rare: may affect up to 1 in 1,000 people
• inability to sit or stand still (restlessness/akathisia)
• 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.
Not known: frequency cannot be estimated from the
• 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
• Cases of suicidal ideation and suicidal behaviours
have been reported during citalopram therapy or
early after treatment discontinuation (see
section 2 “Warnings and precautions”)
• 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
• 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
If you get any of the side effects talk to your doctor
or pharmacist. This includes any side effects not
listed in this leaflet.
How to store Citalopram
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which
is stated on the carton/tablet container and the
blister after EXP.
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.
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
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.
The tablets can be divided in two equal halves.
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.
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.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
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 tablets.
HDPE tablet container containing 250 tablets
Possible side effects
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:
• 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
• 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
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
The Marketing Authorisation Holder:
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
39179 Barleben, Germany.
LEK S.A, Ul. Podlipie 16, 95-010 Stryków, Poland
LEK S.A, Ul. Domaniewska 50 C, PL-02-672
This leaflet was last revised in 02/2016.
The following additional side effects have been
Very common: may affect more than 1 in 10 people
• sleepiness, sleeplessness, intense excitation,
• headache, trembling, dizziness
• nausea, dry mouth, constipation, diarrhoea
• increased sweating
• accommodation disorders of eyes
• debility (asthenia).
draft: 44028147, 44030800
laetus code: 13635
Artwork Proof Box
Ref: V048 - SPC & PIL update, excipient correction + Site switch
Dimensions: 165 x 620 mm
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.