Skip to Content

UK Edition. Click here for US version.

CITALOPRAM 10 MG TABLETS

Active substance(s): CITALOPRAM HYDROBROMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Citalopram 10 mg Tablets
Citalopram 20 mg Tablets
Citalopram 40 mg Tablets
Citalopram

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.




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.
you have problems with your eyes, such as certain kinds of
glaucoma.

Other medicines and Citalopram:
• Tell your doctor if you are taking or have recently taken or
might take any other medicines. Some medicines can cause
problems if you take them with this medicine.

Do not take Citalopram



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 is one of a group of medicines called “selective
serotonin reuptake inhibitors” (SSRIs) which are
antidepressants. Everyone has a substance called serotonin in
their brain. People who are depressed have lower levels of
serotonin than others. It is not fully understood how Citalopram
and other SSRIs work but they may help by increasing the level
of serotonin in the brain. This medicine is used to treat:
• Depressive illness (major depressive episodes).



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 derivatives,
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.
if you take or have recently taken 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.
if you take linezolid (an antibiotic medicine).

Take care with the following medicines:
Talk to your doctor before taking Citalopram if you are taking any
of these other medicines:
• medicines which increase the serotonin levels, such as,
oxitriptan, or tryptophan (a dietary supplement)
• for depression, such as other SSRIs (e.g. fluoxetine,
fluvoxamine, paroxetine, sertraline, venlafaxine), bupropion,
and St John’s Wort (a herbal remedy)
• for migraine called triptans, such as sumatriptan
• for pain, such as tramadol
• for mental illness, such as lithium, risperidone,
• for high blood pressure or heart failure, such as metoprolol
• for irregular heartbeat, e.g. propafenone, flecainide
• to prevent blood clotting, such as warfarin, dipyridamol,
ticlopidine (called anticoagulants)
• for pain and inflammation, such as acetylsalicylic acid or
other medicines called NSAIDs (non-steroidal anti-inflammatory
drugs) like ibuprofen, diclofenac and celecoxib
• for stomach ulcers, such as omeprazole, lansoprazole,
esomeprazole or cimetidine
• for malaria prophylaxis, such as mefloquine

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 recently taken medicines called
monoamine oxidase inhibitors (MAOIs; amongst others used
to treat depression). Before starting with Citalopram, you must
talk to your doctor, because you may have to wait for up to
14 days after quitting the use of a MAOI (see also “Other
medicines and Citalopram”). The MAOI selegiline (used to
treat Parkinson’s disease) may be used, but not in doses
exceeding 10 mg per day. When changing from Citalopram,
you have to wait for at least seven days before you start
taking MAOIs.
• if you are taking linezolid (an antibiotic medicine)
• 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)

Citalopram with food, drink and alcohol:
Do not drink alcohol while you are taking Citalopram. Alcohol
may make your symptoms or side effects worse. Citalopram can
be taken with or without food.

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.

Warnings and precautions:
Talk to your doctor before taking Citalopram.

Children and adolescents under 18 years of age
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.

Pregnancy:
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
absolutely necessary.

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 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.

Breast-feeding:
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.

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.

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 of yet.

Driving and using machines:
This medicine may cause side effects (such as feeling dizzy,
sleepy, or confused) that affect how well you concentrate and
how quickly you can react. If you get these side effects, do not
drive or use machines, or do anything else where you need to be
alert and concentrate.

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.

3. 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.

Talk to your doctor before taking Citalopram if you have, or
ever had:
• kidney or liver disease
• diabetes: treatment with Citalopram may alter glycaemic
control. Insulin and/or oral hypoglycaemic dosage may need
to be adjusted
• a history of mania/hypomania: Citalopram should be used with
caution and should be discontinued when you enter a
manic phase.
• psychosis with depressive episodes
• panic disorders
• seizures or fits (epilepsy): seizures are a potential risk with
antidepressant drugs
• bleeding problems or if you are taking medicines which prevent
blood clotting (see section “Other medicines and Citalopram”
below): Citalopram may cause bleedings (e.g. skin and
mucous bleeding)
• electro-convulsive therapy (ECT), because there is limited
clinical experience; caution is advisable.
• a low level of sodium in your blood
• 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

Your doctor will decide your dose and will adjust it individually for
you. It will take at least two weeks before you start feeling better.
If you do not start to feel better after this time, talk to your doctor,
who will advise you. Your doctor may decide to increase your
dosage gradually, up to a maximum daily dose. This depends on
how you respond to the treatment.

The recommended starting dose for adults is 20 mg per day.

If necessary, the dose can be increased up to a maximum of
40 mg per day.

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.

Hepatic impairment
If you have liver disease your doctor will prescribe a starting dose
of 10 mg. The maximum dose of Citalopram is 20 mg per day.

Artwork Proof Box
Ref: V050 - Update SPC & PIL to P-RMS + RFI + V053
Proof no.
011.0

Date prepared:
12/07/2016

Colours:
Black
Black 20%
Dimensions: 146 x 380 mm

Font size:
6pt
Fonts:
Helvetica

Renal impairment
If you suffer from severe kidney disease use of citalopram is not
recommended, as no information is available on use in these
patients. If you have mild or moderate kidney disease, you can
use the normal dose of Citalopram.
Take your tablets once a day- either in the morning or in the
evening with or without food. Swallow them with sufficient fluid
(e.g. a glass of water). Do not chew the tablets.

difficulties urinating
loss of hair
swelling of arms and legs
large pupils (the dark centre of the eye)
hives
bleeding disorders including skin and mucosal bleeding
(purpura)








Rare (may affect up to 1 in 1,000 people)
• hepatitis
• fever
• taste disturbances
• dyskinesia
• convulsions

Treatment should continue until you are free of symptoms for
4-6 months.
Do not stop taking citalopram unless your doctor has told you to
do so, even if you begin to feel better. Your doctor will tell you
how long you will need to keep taking your tablets.

If you take more Citalopram than you should:
If you take too many of these tablets, talk to your doctor or go to
a hospital straight away, and show them the pack of tablets. The
most likely signs of taking too many tablets (overdose) are:
feeling dizzy or drowsy, having a fit, feeling sick (nausea) having
fast heartbeats, fast breathing, sweating.

Not known (frequency cannot be estimated from the available data):
• an increased risk of bone fractures has been observed in
patients taking this type of medicines.
• a fall in blood pressure/ fainting when you suddenly stand up.
• movement disorders such as stiffness, shaking or abnormal
involuntary movements in the mouth and tongue
(extrapyramidal disorders) and other movement disorders
• panic attacks, restlessness
• grinding one’s teeth
• blurred vision
• abnormal production of breast milk in men and women
• hypokalaemia
• nosebleed
• abnormal bleeding that occurs between periods or that is not
associated with menstruation painful erections
• sudden swelling of skin or mucosa
• abnormal liver function test
• an increase in bleeding or bruising caused by a decrease in
blood platelets
• bleeding disorders including skin and mucosal bleeding
(ecchymosis)
• disturbed ADH secretion (a hormone which influences renal
water retention)
• gastrointestinal bleeding

If you forget to take Citalopram:
If you forget to take your dose of this medicine, simply carry on
with the next dose as usual. Do not take a double dose to make
up for a forgotten dose.

If you stop taking Citalopram:
Do not stop taking this medicine without talking to your doctor
first, even if you feel better.

If you stop suddenly after taking this medicine for a long time,
you may feel dizzy, have sensory disturbances (numbness or
‘pins and needles’, called paresthesia), feeling sick (nausea),
headaches, feeling anxious. 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.

When stopping Citalopram, your doctor will help you to lower your
dose slowly over a number of weeks or months. This should help
lower the chance of withdrawal effects. If you get severe
withdrawal effects in spite of this, please see your doctor. He or
shemay ask you to start taking your tablets again and come off
them more slowly.

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.

Possible withdrawal effects when stopping treatment
• feeling dizzy
• feelings like pins and needles, burning sensations and
electric shock sensations
• sleep disturbances (vivid dreams, nightmares, inability to sleep)
• feeling anxious
• feeling restless or agitated
• tremor (shakiness)
• feeling confused or disorientated
• feeling emotional or irritable
• headaches
• feeling sick (nausea)
• diarrhoea
• sweating
• visual disturbances
• fluttering or pounding heartbeat (palpitations)

Reporting of 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 Yellow Card Scheme:
www.mhra.gov.uk/yellowcard.. By reporting side effects you can
help provide more information on the safety of this medicine.

If you get any of the following symptoms you should stop
taking Citalopram and see your doctor immediately
• Fast, irregular heartbeat, fainting which could be symptoms
of a life-threatening condition known as Torsades de Pointes.

Following side-effects are rare (may affect up to 1 in 1000 people):
• Unusual bruising or bleeding, including vomiting blood or
passing blood in your stools
• Feeling tired, weak or confused and having muscles which
ache, and are stiff or clumsy (uncoordinated). This may be
because your blood is low in sodium.

5. How to store Citalopram
Keep this medicine out of the sight and reach of children.

Following side-effects are very rare (may affect up to 1 in 10,000
people) or it is not known (frequency cannot be estimated from
the available data):
• Fits (seizures or convulsions)
• Allergic reactions: If you develop swelling of the eyelids, face,
lips, mouth or tongue, start to itch or have difficulty breathing
or swallowing, you may have an allergic reaction
• Feeling restless and like you cannot sit or stand still (doctors
call this akathisia). Increasing your dose of Citalopram may
make these feelings worse
• Serotonin syndrome: If you have some or all of the following
symptoms you may have something called “serotonin
syndrome”. The symptoms include: feeling confused, feeling
restless, sweating, shaking, shivering, hallucinations (strange
visions or sounds), sudden jerks of the muscles or a fast
heartbeat
• Cases of people developing thoughts of harming or killing
themselves, or showing such behaviour have been reported
during the use of citalopram or shortly after stopping treatment.

Do not use this medicine after the expiry date which is stated on
the carton or blister/tablet container 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 film-coated tablet contains citalopram hydrobromide,
equivalent to 10, 20 and 40 mg citalopram.
• The other ingredients are: mannitol, microcrystalline cellulose,
colloidal silica anhydrous, magnesium stearate,
hypromellose, macrogol 6000 and titanium dioxide(E171)

Other possible side-effects during treatment:

Very common (may affect more than 1 in 10 people ):
• not sleeping well (insomnia) or feeling sleepy,
• fluttering or pounding heartbeat (palpitations)
• feeling sick (nausea), , dry mouth
• headache,
• increased sweating
• abnormal eye-accomodation
• feeling of weakness (asthenia)

What Citalopram looks like and contents of the pack
Citalopram 10 mg film-coated tablets are round, white
film-coated tablets with a diameter of 6 mm.
Citalopram 20 mg film-coated tablets are round, white tablets
with a break-line and diameter of 8 mm. The tablet can be
divided into equal doses.

Citalopram 40 mg film-coated tablets are round, white
film-coated tablets with a break-line and diameter of 10 mm.
The tablet can be divided into equal doses.

Common (may affect up to 1 in 10 people):
• agitation, nervousness
• lack of concentration, loss of memory, sleep disorder,
nightmares, vivid dreams, feeling anxious
• lack of motivation or interests, feeling confused, anorexia
• migraine, numbness or ‘pins and needles’ (doctors call this
paresthesia)
• feeling dizzy or shaky (tremors)
• lack of appetite
• increased or decreased blood pressure
• diarrhoea, constipation, digestion disturbances, vomiting,
abdominal pain, flatulence, increased salivation
• weight loss
• sinusitis, runny nose
• decreased sex drive. Lack of orgasm in women and in men,
Men may experience problems with ejaculation and erection,
impotence; painful menstrual periods
• itching
• yawning, fatigue
• ringing in the ear (tinnitus)
• muscle pain
• pain in your joints
• urination problems or need to urinate more often
• tiredness

Citalopram 10 mg, 20 mg and 40 mg film-coated tablets, packed
in PVC/PVDC/Al blisters are available in pack sizes of 10, 14,
20, 28, 30, 50, 56, 98 or 100 film-coated tablets per box,
100x1 unit dose blister HDPE tablet container with a LDPE
tamper evident cap containing 250 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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, Germany

or

Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany.

Uncommon (may affect up to 1 in 100 people):
• more appetite
• weight gain
• mania (feeling elated, or emotionally ‘high’)
• feeling euphoric
• feeling detached from yourself (depersonalisation)
• hallucinations
• increased sex drive
• aggression
• slow heartbeat, fast heartbeat
• heavy and prolonged menstrual period
• coughing
• sensitivity to sunlight,
• malaise, fainting.
• skin rashes

or

Lek Pharmaceuticals d.d., Verovškova ulica 57, 1526 Ljubljana,
Slovenia
This leaflet was last revised in 07/2016.

SZ00000LT000

Artwork Proof Box
Ref: V050 - Update SPC & PIL to P-RMS + RFI + V053
Proof no.
011.0

Date prepared:
12/07/2016

Colours:
Black
Black 20%
Dimensions: 146 x 380 mm

Font size:
6pt
Fonts:
Helvetica

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.

Hide