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CITALOPRAM 10MG TABLETS
Active substance(s): CITALOPRAM HYDROBROMIDE
CITALOPRAM 10mg, 20mg AND
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What 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
WHAT CITALOPRAM IS AND WHAT IT IS USED FOR
How does Citalopram work?
Citalopram is a SSRI (Selective Serotonin Reuptake Inhibitor)
and belongs to a group of medicines called antidepressants.
These medicines help to correct certain chemical imbalances
in the brain that are causing the symptoms of your illness.
Depression is linked to a shortage of substances which carry
messages in the brain (including serotonin and noradrenaline).
Citalopram helps to relieve the shortage of these ‘brain
messages’. Common signs of depression include feelings of
worthlessness or deep sadness; difficulty with everyday tasks;
sleeping too much or not being able to sleep; feeling anxious;
and changes in appetite.
What is Citalopram used for?
Citalopram tablets are used to treat the symptoms of depression
and, when you are feeling better, to help prevent these
symptoms recurring. Citalopram tablets are also beneficial in
relieving symptoms in patients prone to panic attacks. Treatment
for depression is usually continued for at least six months and for
panic disorder for at least three months.
It may take a while before you start to feel better. In general,
improvement in patients starts after one week, but may only
become evident from the second week of therapy. It is
important to take citalopram every day and not to stop taking it
unless your doctor tells you to. If you do, your symptoms may
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
Important information about some of the ingredients of
Citalopram tablets contain lactose monohydrate. If you have
been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
Do not take citalopram:
• If you are allergic (hypersensitive) to citalopram or any of the
other ingredients of this medicine (see Section 6).
• If you are also taking a medicine containing
pimozide. Talk to your doctor.
• If you are also taking medications known as monoamine
oxidase inhibitors (MAOI’s). MAOIs include medicines
such as phenelzine, iproniazid, isocarboxazid,
nialamide, tranylcypromine and moclobemide (used for the
treatment of depression), selegiline (used in the treatment of
Parkinson’s disease) and linezolid (an antibiotic). Even if you
have finished taking one of the following MAOIs: phenelzine,
iproniazid, isocarboxazid, nialamide or tranylcypromine you
will need to wait 2 weeks before you start taking your
Citalopram tablets. One day must elapse after you have
finished taking moclobemide. After stopping citalopram you
must allow 1 week before taking any MAOI.
• For information on medicines that should not be taken with
citalopram, see section on ‘Taking other medicines’.
• If you were 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 “Taking
other medicines” below.
Warnings and precautions
Talk to your doctor or pharmacist before taking Citalopram
Take special care with citalopram:
If you have or have had:
• Liver disease
• Kidney disease
• Low blood levels of sodium
• ECT (electroconvulsive therapy)
• Suffered or suffer from heart problems or have recently had a
• A low resting heart-rate
• Mania or panic disorder
• Salt depletion as a result of prolonged severe diarrhoea and
vomiting (being sick) or usage of diuretics (water tablets)
• A fast or irregular heartbeat, fainting, collapse or dizziness on
standing up which may indicate abnormal functioning of the
• Diabetes (you may need an adjustment of your antidiabetic
• Epilepsy or a history of seizures or fits
• A bleeding disorder or have ever suffered from bleeding in the
stomach or intestine
Problem with your eyes, such as certain kinds of glaucoma
Please consult your doctor, even if these statements were
applicable to you at any time in the past.
Some patients with manic-depressive illness may enter into a
manic phase. This is characterised by unusual and rapidly
changing ideas, inappropriate happiness and excessive physical
activity. If you experience this, contact your doctor.
Symptoms of restlessness or difficulty sitting or standing
can also occur during the first few weeks of treatment. Tell
your doctor immediately if you experience these
As with all antidepressants, it is advisable to avoid drinking any
Children and adolescents
Citalopram Tablets should normally not be used for children and
adolescents under 18 years. Patients under 18 have an
increased risk of side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression, defiant
behaviour and anger) when they take this class of medicines.
Despite this, your doctor may prescribe this medicine for patients
under 18 because he/she decides that this is in their best
interests. If your doctor has prescribed this medicine 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 this medicine. The long-term safety effects concerning
growth, maturation and cognitive and behavioural development
of this medicine in this age group have not yet been
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before taking any
Do not take this medicine if you are pregnant unless you have
discussed the risks and benefits involved. If you take this group
of medicines (antidepressants) during the last few months of your
pregnancy and until the date of birth, you should be aware that
the following effects have been seen in newborns: fits, being too
hot or cold, feeding difficulties, vomiting, low blood sugar, stiff or
floppy muscles, overactive reflexes, tremor, jitteriness, irritability,
lethargy, constant crying, sleepiness or sleeping difficulties. If
your newborn baby gets any of these symptoms please contact
your midwife and/or doctor immediately.
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 new born (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
You should not breastfeed your baby while taking Citalopram as
small amounts of the medicine can pass into the breast milk.
Citalopram has been shown to reduce the quality of sperm in
Theoretically, this could affect fertility, but impact on human
fertility has not been observed yet.
Driving and using machines
Most people do not find their ability to carry out normal daily
activities affected. However, make sure your abilities are not
affected before you drive or operate machinery.
Other medicines and Citalopram
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any othermedicines.
DO NOT take the following medicines while on
• Other antidepressants:
- Monoamine Oxidase Inhibitors (MAOIs), or in the two weeks
after they have been stopped. If your doctor asks you to
take a MAOI you will be asked to stop taking this medicine
at least seven days before starting the MAOI.
- If you are or were taking a RIMA (Reversible MAOI), e.g.
moclobemide, consult your doctor and/or pharmacist on
how long you must wait after stopping therapy before
• Medicines for heart rhythm problems or medicines that may
affect the heart’s rhythm, such as:
- Class IA and III antiarrhythmics
- Antipsychotics (e.g. phenothiazine derivatives, pimozide,
- Tricyclic antidepressants
- Certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin,
erythromycin IV, pentamidine, anti-malaria treatment
- Certain antihistamines (astemizole, mizolastine)
- Linezolid, used in the treatment of skin infections or
- Medicines containing selegiline (used to treat Parkinson’s
If you have any further questions about this you should
speak to your doctor.
Take care when taking any of the following medicines:
• Lithium or tryptophan – drugs for depression or mania attacks
• Drugs to prevent blood clotting (Anticoagulants) – e.g. warfarin
• Antiplatelet agents e.g. aspirin
• Drugs for pain relief e.g. Non-steroidal anti-inflammatory drugs
• Drugs for migraine – e.g. Sumatriptan
• Medicines for depression (antidepressants) e.g. Imipramine,
• Antimalarial drugs e.g. artemether with lumefantrine, Mefloquin
• Buproprion –A drug used to help you stop smoking
• Medicines for mental health problems (Antipsychotics) e.g.
• Beta-blockers e.g. Metoprolol
• The herbal remedy St. John’s Wort (Hypericum perforatum). If
you already take a St. John’s Wort preparation stop taking the
St John’s Wort and mention it to your doctor at your next visit.
• Drugs that decrease the amount of acid produced in the
stomach e.g. omeprazole, cimitidine.
• Neuroleptics (used in the treatment of schizophrenia)
• Medicinal products inducing hypokalaemia/hypomagnesaemia
Please inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, even those not prescribed.
Citalopram with food and drink
Citalopram can be taken with or without food (see section 3 “How
to take citalopram”)
HOW TO TAKE CITALOPRAM
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The tablets should be taken regularly according to your doctor’s
instructions. The dispensing label on the pack will tell you how
many to take and when to take them.
The recommended dose is:
• Depression: The usual dose is 20mg per day. This may be
increased by your doctor to a maximum of 40mg per day.
• Panic disorder: The starting dose is 10mg per day for the first
week before increasing the dose to 20-30mg per day. The
dose may be increased by your doctor to a maximum of 40mg
The starting dose should be decreased to half of the
recommended dose, e.g. 10-20mg per day. Elderly patients
should not usually receive more than 20mg per day.
Originated by: Kent Pharm
Product: Citalopram 10mg, 20mg and 40mg Tablets PIL
Dimensions: 360mm x 230mm
Item Code: CP.CIP.JNT.T.ID.V9P2
Proof No and Date: 2
ARTWORK FOR SUBMISSION
Patients with liver problems
Patients with liver problems should not receive more than 20mg
Citalopram can be taken any time of the day with or without food.
The tablets should be swallowed whole without chewing and with
plenty of fluid. This medicine is not recommended for use in
children or adolescents (under the age of 18).
This medicine can be taken by elderly patients. Patients with
kidney or liver problems may be given a lower dose of
Citalopram, between 20 and 40mg per day.
It may take several weeks before you feel any benefit from these
tablets. This is normal for this type of medicine. The duration of
treatment is individual, usually at least 6 months. Continue to
take your tablets for as long as your doctor recommends. Do not
stop taking them even if you begin to feel better, unless you are
told to do so by your doctor. Never change the dose of your
medicine without talking to your doctor first. The underlying
illness may persist for a long time and if you stop your treatment
too soon your symptoms may return.
If you take more citalopram than you should
Call a doctor straight away or go immediately to the nearest
casualty department, taking the remaining tablets with you. The
most likely signs of overdose are convulsions, tiredness,
unconsciousness, coma, feeling or being sick, tremor, enlarged
eye pupils, dizziness, changes in blood pressure,
hyperventilation, increased heart rate, agitation, sweating and/or
If you forget to take citalopram
Do not take a double dose to make up for forgotten individual
doses. Just skip that dose and take your next one at the normal
If your stop taking citalopram
Do not suddenly stop taking citalopram even if your depression
has lifted. If you stop suddenly, you may experience dizziness,
tingling in hands and feet, anxiety, numbness, nausea and
headaches, feeling or being sick, sleep disturbances (vivid
dreams, nightmares, inability to sleep), sweating, feeling restless
or agitated, tremor, feeling confused or disorientated, feeling
emotional or irritable, diarrhoea (loose stools), visual
disturbances, fluttering or pounding heartbeat (palpitations). It is
possible that some of your symptoms may come back. Once you
are feeling better, talk to your doctor who will tell you how to
reduce the dose gradually.
POSSIBLE SIDE EFFECTS
Like all medicines, citalopram can have side effects. 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 1-2 weeks.
STOP taking Citalopram tablets and seek medical advice
immediately if you have any of the following symptoms:
• Difficulty in breathing
• Swelling of the face, lips, tongue or throat that causes difficulty
in swallowing or breathing
• Severe itching of the skin (with raised lumps)
• Fast, irregular heartbeat, fainting which could be symptoms of
a life-threatening condition known as torsades de pointes
• Hepatitis (inflammation of the liver) – may cause yellowing of
the skin and whites of the eyes
If you notice any of the following symptoms you should
contact your doctor immediately as your dose may need to
be reduced or stopped:
• You start having fits for the first time or fits that you have
suffered from in the past become more frequent
• Your behaviour changes because you feel elated or over
• You experience high fever, agitation, confusion, trembling or
abrupt contractions of muscles. These may be signs of a rare
condition called serotonin syndrome
• Tiredness, confusion and twitching of your muscles. These
may be signs of a low blood level of sodium or potassium
Thoughts of suicide and worsening of your depression or
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
• 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.
The following side effects are often mild and usually disappear
after a few days’ treatment.
Very Common (likely to affect more than 1 in 10 people)
• Feeling sick (nausea)
• Dry mouth (a dry mouth increases the risk of tooth decay, so
be sure to clean your teeth more often than usual)
• Increased sweating
• Difficulty in sleeping
Common (likely to affect up to 1 in 10 people)
• Lack of appetite, loss of weight
• Anxiety, nervousness, problems with concentration, confusion,
• Abnormal dreams
• Tiredness, constantly yawning, exhaustion
• Reduced libido (decreased sex drive)
• For women, problems with reaching orgasm, abnormal
• Tingling (pins and needles)
• Ringing in the ears (tinnitus)
• Diarrhoea, vomiting, constipation
• Muscle or joint pain
• For men, problems with ejaculation and erection
• blocked or runny nose
• Abnormal pain
• Flatulence (wind)
• Increased saliva production
• Reduced emotions, indifference (apathy)
Uncommon (likely to affect up to 1 in every 100 people)
• Increase in appetite, weight gain
• Aggression, hallucination
• Depersonalisation (having ‘out of body’ experiences)
• Feeling faint or light headed, losing consciousness
• Fast heart rate
• Slow heart rate
• Large pupils (the dark centre of the eye)
• Hair loss
• Sensitivity to sunlight
• Difficulty passing urine
• Heavy menstrual periods
• Swelling of the arms and legs
• Libido increased (increased sex drive)
Rare (likely to affect up to 1 in every 1000 people)
• Taste disturbances
• Low blood sodium level
• Difficulty in controlling voluntary movements, i.e. walking and
increased involuntary movements
Frequency not known
• A reduction in blood platelets which increase the risk of
bleeding or bruising
• Abnormal heart rhythm
• Thoughts of harming or killing themselves
• Panic attacks, restlessness, grinding of teeth or clenching of
• Abnormal movements or jerky movements, inability to sit still
• Disturbed vision
• A fall in blood pressure on standing up which causes dizziness,
light-headedness or fainting
• Nose bleeds
• Rash (hypersensitivity)
• Unusual bleeding from the stomach and back passage
• Bleeding between menstrual periods
• Bruising/skin discolouration due to bleeding (ruptured blood
vessels), skin swelling
• In men, painful/prolonged erection
• Secretion of breast milk in men or women who are not breast
• Abnormal liver function tests
• Low potassium levels in the blood (hypokalaemia)
• An increased risk of bone fractures has been observed in
patients taking this type of medicines
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 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.
Comment [SC1]: Moved up to be in line
with our SPC
HOW TO STORE CITALOPRAM
Do not use this medicine after the expiry date stated on the foil
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
This product does not require any special storage
conditions. If your doctor tells you to stop treatment, return
any left over to the pharmacist
Do not throw away any medicines via waste water or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
CONTENTS OF THE PACK AND OTHER INFORMATION
Citalopram 10mg Tablets are supplied as white, round,
biconvex, embossed 10 on one side and plain on the other
Citalopram 20mg Tablets are supplied as white, oval, biconvex,
embossed 20 on one side with a break-line on the other side,
Citalopram 40mg Tablets are supplied as white, oval, biconvex,
embossed 40 on one side with a break-line on the other side,
What Citalopram 10mg, 20mg, 40mg Tablets contain:
Each tablet contains 10, 20 or 40mg of the active ingredient
citalopram as citalopram hydrobromide
Other ingredients are maize starch, lactose monohydrate,
copovidone, magnesium stearate, glycerol, microcrystalline
cellulose, croscarmellose sodium,
hydroxypropylmethylcellulose, polyethylene stearate, and
titanium dioxide (E-171).
Marketing Authorisation Holder
Athlone Laboratories Limited, Ballymurray, Co. Roscommon,
Company responsible for release of this medicine
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford,
Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12,
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12
This leaflet was revised: Jan 2016
What Citalopram looks like and contents of the pack
Originated by: Kent Pharm
Product: Citalopram 10mg, 20mg and 40mg Tablets PIL
Dimensions: 360mm x 230mm
Item Code: CP.CIP.JNT.T.ID.V9P2
Proof No and Date:
ARTWORK FOR SUBMISSION