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CITALOPRAM 40MG FILM COATED TABLETS

Active substance(s): CITALOPRAM HYDROBROMIDE

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Citalopram 40 mg
Film-coated 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 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 side effects, talk to your doctor or
pharmacist. This includes any possible any side
effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Citalopram is and what it is used for
Citalopram belongs to a group of medicines called
selective serotonin reuptake inhibitors (SSRIs), also
known as antidepressants.
Citalopram is used to treat:
• depression (major depressive episodes)
• panic disorder (panic attacks, including those caused
by agoraphobia, which is a fear of open spaces).

2. What you need to know before you
take Citalopram
Do not take Citalopram

• if you are allergic to citalopram or any of the other
ingredients of this medicine (listed in section 6).
• if you are taking, or have taken within the last two
weeks, any monoamine oxidase inhibitors (MAOIs).
These medicines are used to treat depression or
Parkinson’s disease (e.g. selegiline, moclobemide).
After stopping Citalopram you must allow one week
before taking any MAOIs
• if you are taking the antibiotic linezolid unless your
doctor is able to monitor your blood pressure
• if you are taking pimozide (to treat mental illnesses)
• if you are taking sumatriptan (5-HT agonist)
used to treat migraine, or a similar medicine (see
section ‘Other medicines and Citalopram’).
• 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. Also refer to the
section “Other medicines and Citalopram” below.

Warnings and precautions

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Talk to your doctor or pharmacist before
taking Citalopram
• are diabetic, as your doctor may need to adjust the
dose of insulin or other medicine used to lower your
blood sugar
• if you suffer from epilepsy, as your doctor will monitor
you closely. Citalopram treatment should be stopped
if you have a fit or suffer from more fits than usual
(see section 4)
• if you are having electric shock treatment
• if you suffer from manic phases characterised by
overactive behaviour or thoughts. If you enter into a
manic phase, contact your doctor immediately
• if you have a history of mental illness as your
psychotic symptoms may increase
• if you have or have had problems with your eyes
such as certain kinds of glaucoma
• if you have a history of bleeding disorders or are
using medicines that affect blood clotting or
increase the risk of bleeding (see section ‘Other
medicines and Citalopram’)
• if you suffer from liver or kidney problems, as your
doctor may need to adjust your dose
• if you have an abnormal heart rhythm or have low
levels of salts (potassium, magnesium) in the blood.
Your doctor may treat you to correct these symptoms
before starting your treatment with citalopram
• 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)

During treatment

Talk to your doctor or pharmacist:
• If you start to feel agitated, confused, very hot, and
notice trembling and abrupt contractions of the
muscles, you may be suffering from a rare condition
called serotonin syndrome, tell your doctor straight
away. Do not suddenly stop Citalopram treatment as
you may suffer from withdrawal effects (see section 3).
• if you get symptoms such as restlessness, agitation
or difficulty remaining still during first few weeks of
treatment. Your doctor may increase your dose.
• if you suffer from increased anxiety at the start of
your treatment.
• if you experience a fast or irregular heartbeat,
fainting, collapse or dizziness on standing up which
may indicate abnormal functioning of the heart rate.
• Citalopram can reduce sodium levels in the blood
making you feel weak, confused or have aching
stiff muscles. Tell your doctor if you experience
these symptoms

Children and adolescents under 18 years of age

Citalopram should not normally be used to treat
children and adolescents under 18 years of age.
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 years 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
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.

Other medicines and Citalopram

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
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.
phenothiazine derivatives, pimozide, haloperidol),
tricyclic antidepressants, certain antimicrobial agents
(e.g. sparfloxacin, moxifloxacin, erythromycin IV,
pentamidine, anti-malarial treatment particularly
halofantrine), certain antihistamines (astemizole,
mizolastine). If you have any further questions about
this you should speak to your doctor.
• sumatriptan and similar medicines used to treat
migraine (see section ‘Do not take Citalopram’)
• linezolid (an antibiotic) (see section ‘Do not
take Citalopram’)
• medicines for depression called MAOIs eg. selegiline,
moclobemide (see section ‘Do not take Citalopram’).
If you stop taking Citalopram you must allow 7 days
before you start taking any MAOI medicine
Tell your doctor if you are taking or have taken any of
the following medicines:
• tryptophan and oxitriptan (used for depression) and
tramadol (to treat severe pain), as these medicines
can increase the risk of side effects
• other antidepressants e.g. fluvoxamine
• lithium (to treat mental illness)
• medicine to treat stomach ulcers e.g. cimetidine,
omeprazole, esomeprazole, lansoprazole
• medicine to thin your blood (anticoagulants) e.g.
warfarin, acetylsalicylic acid (aspirin)
• medicine to prevent blood clots e.g. ticlopidine,
dipyridamole
• any medicine that can reduce the amount of
potassium or magnesium in the blood
• metoprolol a beta-blocker used to treat heart failure
or lower high blood pressure
• bupropion (to help stop smoking) as there is a risk of
possible lowered seizure threshold
• the herbal remedy St John’s wort (Hypericum
perforatum)
• medicines known as non-steroidal anti-inflammatory
drugs (NSAIDs) e.g. Ibuprofen

Citalopram with alcohol

It is recommended not to drink alcohol while taking
this medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.

Pregnancy

Citalopram is recommended if you are pregnant or
planning to become pregnant, unless your doctor
considers it absolutely necessary. There is only limited
experience on the use of Citalopram during pregnancy.
You should not stop Citalopram treatment abruptly
during pregnancy. If you are taking Citalopram in the
last three months of pregnancy, let your doctor know
as 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 blue-ish skin or being too hot or
cold, being sick, crying a lot, stiff or floppy muscles,
lethargy, tremors, drowsiness, irritabilitys, decreased
blood sugar, jitters or fits. If your baby has any of
these symptoms when it is born, contact your doctor
immediately who will be able to advise you.
Make sure your midwife and/or doctor know you are on
Citalopram. 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 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.

Breast-feeding

Citalopram passes into breast milk in small amounts.
There is a risk of an effect on the baby. Speak to your
doctor first before you start breast-feeding. Your doctor
may ask you to stop feeding your baby if the treatment
with this medicine is considered necessary for you.

Fertility

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

Do not drive or use any tools or machinery if you
feel that your abilities are affected. Medicines for the
treatment of mental illnesses may decrease your ability
to perform tasks requiring precision or close attention.

Date: 02 Mar 2015
Description Citalopram 40mg All

No. of colours

Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 581371

SAP No. N/A

Superceded Affiliate Item Code 10004949

Vendor Job No. 247372

TrackWise PR No. 581371

Proof No. 2

MA No. N/A

Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

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Package leaflet: Information for the patient

Colours

1

Time: 15:50
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9 pt

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 medicine.

3. How to take Citalopram
Always take this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.

How much to take
Adults
Depression

The recommended dose is 20 mg taken once daily.
After 3 to 4 weeks of starting treatment your doctor
may review your treatment and may decrease or
increase the dose of your medicine. This may be
increased to a maximum of 40 mg per day.

Panic disorder

The recommended starting dose is 10 mg per day for
the first week before increasing the dose to 20 mg
per day. The dose may be increased gradually by your
doctor to a maximum of 40 mg per day.

Other side effects
Very common side effects (may affect more than 1 in
10 people):
• drowsiness, sleep problems or difficulty sleeping
• headache • feeling sick • dry mouth • increased
sweating • a feeling of weakness
Common: may affect up to 1 in 10 people
• weight loss, lack of appetite • memory loss, difficulty
concentrating • strange dreams • feeling anxious,
feeling confused • decreased sexual drive • feeling
agitated, nervous • lack of feeling • migraine • fast,
irregular heart beats or thumping in your chest
(palpitations) • tingling or pins and needles • shaking
• dizziness • attention difficulties • ringing in the ears
(tinnitus) • an itchy runny nose • indigestion, stomach
pain, discomfort • being sick (vomiting) • wind
• increased saliva • constipation or diarrhoea • itchy
skin • muscle pain, joint pain • impaired sexual function
in males (such as impotence, ejaculation problems)
• abnormal orgasm in females • tiredness, yawning

Patients with special risks

Uncommon: may affect up to 1 in 100 people
• increased appetite • increased weight • feeling high
• increased sexual drive • aggression • depersonalisation
• hallucinations • fainting • dilated pupils, which may
even lead to visual disturbances due to increased
pressure in your eye • a slow heart beat • a fast heart
beat • sensitivity of the skin to light • hives (nettle rash)
• rash • hair loss • reddish spots on skin • heavy periods
• feeling generally unwell • swelling due to excessive
fluid in the body.

Children and adolescents under 18 years

Rare: may affect up to 1 in 1,000 people
• changes in taste • uncontrollable twitching, jerking
or writhing body movements and other movement
disorders • feeling generally unwell • coughing
• decreased levels of sodium in the blood • fever

Elderly patients (above 65 years of age)

The starting dose should be decreased to half of the
recommended dose, e.g. 10-20 mg per day.
Elderly patients should not usually receive more than
20 mg per day.
The recommended starting dose for patients with
liver problems is 10 mg per day for first two weeks
after which it may be increased to a maximum of
20 mg per day.
Citalopram should not be normally given to
children and adolescents under 18 years of age (see
section ‘Warning and precautions’)

Method of administration

• Swallow the tablets with a glass of water
• Try to take the tablets at the same time every day,
with or without, either in the morning or evening.
• Citalopram 40 mg tablets can be divided into
equal doses.

If you take more Citalopram than you should

Contact your doctor or nearest hospital emergency
department immediately. Take the container and any
remaining tablets with you. Symptoms of overdose
may include drowsiness, dizziness, increase or
decrease in blood pressure, widening of the black of
the eye, coma, fits or shaking, feeling agitated, lack
of consciousness, sweating, blue colouration of skin,
increased rate of breathing, fever, change in mental
status, restlessness, inability to sit or stand still, muscle
wasting, feeling or being sick and changes in heart
rate or heart rhythm (which can be seen in tests such
as ECG).

If you forget to take Citalopram

If you have forgotten to take a dose, take it as soon
as you remember. However, if it is nearly time for the
next dose, miss the forgotten dose altogether and
continue with the rest of the tablets as normal. Do not
take a double dose to make up for a forgotten dose.

If you stop taking Citalopram

Do not suddenly stop taking your medicine as you
may experience withdrawal symptoms (see section 4
‘Withdrawal Symptoms’). If you need to stop taking
your medicine, the doctor will reduce your dose
slowly over at least one or two weeks.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them. The very
common side effects are most likely in the first two
weeks of treatment.
If you get any of the following symptoms
you should stop taking Citalopram and see your
doctor immediately:
Uncommon: may affect up to 1 in 100 people
• feeling excited leading to unusual behaviour (mania)
• inability to urinate
Rare: may affect up to 1 in 1,000 people
• nausea, vomiting, loss of appetite, feeling generally
unwell, fever, itching, yellowing of the skin and eyes,
light coloured bowel motions, dark coloured urine
(hepatitis) • a fit (seizure), or if you are epileptic, you
may notice an increase in the number of fits you are
having • generally heavy bleeding or bleeding of the
gut or rectum
Not known: frequency cannot be estimated from the
available data
• a severe allergic reaction causing swelling of the
face or the throat, tightness in the chest, difficulty
breathing or swallowing • high fever, feel agitated
or confused, trembling, sudden muscle movements.
These symptoms may be a sign of a rare condition
called serotonin syndrome • fast, irregular heart
beat, fainting which could be symptoms of a lifethreatening condition known as Torsades de Pointes
• restlessness or difficulty to sit or stand still. These
effects are more likely during the first weeks of
treatment. Tell your doctor straight away if you notice
these symptoms • overproduction of a hormone
causing fluid retention, resulting in weakness,
tiredness or confusion

Thoughts of suicide and worsening of your
depression or anxiety disorder

Thoughts of suicide or self-harm may occur or may
increase in the first few weeks of treatment for
depression, until the antidepressant effect becomes
apparent. Tell your doctor immediately if you have
any distressing thoughts or experiences. Patients who
are prone to panic attacks may actually experience a
temporary period of heightened anxiety after starting
treatment. This generally resolves during the first two
weeks (see also section 2 ‘Thoughts of suicide and
worsening of your depression or anxiety disorder’).

Not known: frequency cannot be estimated from the
available data
• feeling faint or light-headed on standing up
• reduction in blood platelets which increases risk of
bleeding or bruising • low blood levels of potassium
which can cause muscle weakness, twitching or
abnormal heart rhythm • panic attack • teeth grinding
(when asleep) • movement disorders • problems
with eyesight • nose bleed • abnormal results in liver
function tests • bruising • persistent painful erection
• abnormal milky discharge from the breast • irregular
vaginal bleeding
An increased risk of bone fractures has been observed
in patients taking this type of medicines.

Withdrawal symptoms

When you stop taking Citalopram you may experience
withdrawal symptoms. This is most likely if you stop
taking your medicine suddenly. Some patients have
experienced the following side effects within the first
few days of discontinuing treatment:
• dizziness • sensory disturbances (e.g. tingling or
numbness in the hands and feet, electric shock
sensations) • sleep disturbances (e.g. difficulty in
sleeping or strange dreams) • agitation or anxiety
• feeling or being sick • tremor • confusion • sweating
• headache • diarrhoea • palpitations • emotional
instability, irritability • visual disturbances.
These symptoms are usually mild to moderate and
generally resolve within two weeks. However, in some
patients these symptoms may be more severe, or go
on for longer. If you need to stop taking your medicine,
the doctor will reduce your dose slowly over a period of
at least one or two 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.

Reporting side effects

If you get any side effects, talk to your doctor or
pharmacist. 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 Citalopram
Keep this medicine out of the sight and reach
of children.
Do not use Citalopram after the expiry date which
is stated on the carton/label or blister after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special
storage conditions.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other information
What Citalopram contains

The active substance is citalopram. Each tablet contains
40 mg of citalopram (as citalopram hydrobromide).
The other ingredients are lactose monohydrate (see
section 2 ‘Citalopram contains lactose’), maize starch,
cellulose microcrystalline, povidone, crospovidone and
magnesium stearate. The film-coating also includes
titanium dioxide (E171), macrogol and hypromellose
and lactose monohydrate.

What Citalopram looks like and contents of the pack
Citalopram 40 mg Film-coated tablets are white oval
tablets marked ‘CM’ breakline ‘40’ on one side and
‘G’ on the other side. The tablet can be divided into
equal doses.

Citalopram 40 mg Film-coated tablets are available in
blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90,
98 and 100 tablets, calendar blister packs of 28 tablets
and plastic bottles of 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
This leaflet was last revised in February 2015.

Date: 02 Mar 2015
Description Citalopram 40mg All

No. of colours

Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 581371

SAP No. N/A

Superceded Affiliate Item Code 10004949

Vendor Job No. 247372

TrackWise PR No. 581371

Proof No. 2

MA No. N/A

Client Market United Kingdom

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

Colours

1

581371

Time: 15:50
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 480 mm

Body Text Size 9 pt

Expand view ⇕

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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