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PAXORAN 40MG TABLETS
house, entering shops or fear of public places)
If you have any concerns about how you feel, or about this medication, it is important that you talk to your doctor even if you feel anxious or worried about doing so.
You may find it helpful to tell a friend or relative that you are depressed, and that you have been prescribed this
medication; it might be useful to show them this leaflet.
may not start to work immediately. Some people taking antidepressants may feel worse before
feeling better. Your doctor may ask to see you again a couple of weeks after you start treatment and then regularly
until you start to feel well again. Tell your doctor if you do not start to feel better
Some people who are depressed may think of harming or killing themselves. If this happens you should see
your doctor or go to a hospital straight away – see in section 2 'Thoughts of suicide and worsening of your
depression or anxiety disorder'
If you take too many tablets it is important to seek immediate medical attention, even if you feel well, because
of the risk of serious side effects
Do not stop taking Citalopram or change your dose without the advice of your doctor even if you feel better. If
you stop taking Citalopram abruptly you may get withdrawal reactions – see in section 3 'How to take Citalopram
Taking certain other medicines with Citalopram may cause problems. You should tell your doctor if you are
taking any other medicines – see in section 2 'What you need to know before you take Citalopram Tablets - Other
medicines and Citalopram'
Keep this leaflet. You may need to read it again.
If you have more questions, ask your doctor or pharmacist.
Leaflet date May 2013.
Package leaflet: Information for the user
Citalopram 10 mg Film Coated Tablets
Citalopram 20 mg Film Coated Tablets
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,
pharmacist or nurse.
- 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,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Citalopram Tablets are and what are they used
2. What you need to know before you take Citalopram
3. How to take Citalopram Tablets
4. Possible side effects
5. How to store Citalopram Tablets
6. Contents of the pack and other information
1. What Citalopram tablets are and what are they
How does Citalopram work?
Citalopram is a Selective Serotonin Reuptake Inhibitor
(SSRI) and belongs to a group of medicines known as
antidepressants. These medicines help to correct
certain chemical imbalances in the brain that are
causing the symptoms of your illness.
What is Citalopram used for?
Citalopram contains citalopram and is used for the
treatment of depression and, when you feel better, to
help prevent these symptoms recurring. Citalopram is
also used for long-term treatment to prevent the
occurrence of new episodes of depression if you have
Citalopram is also beneficial in relieving symptoms if
you tend to suffer from panic attacks with or without
agoraphobia (e.g. fear of leaving the house, entering
shops, or fear of public places).
2. What you need to know before you take Citalopram
Do not take Citalopram Tablets:
- If you are allergic to Citalopram or any of the other
ingredients of this medicine (listed in section 6). An
allergic reaction may include rash,
itching, swelling of face, lips or hands/feet, or
- If you are taking medicines called monoamine oxidase
inhibitors (MAOIs), or have stopped taking them
within the past two weeks. Treatment must not begin
any sooner than two weeks after you stop taking an
irreversible MAO inhibitor, or the time specified by
your doctor after you stop taking a reversible MAO
inhibitor (e. g. moclobemide). Your doctor will tell you
how to begin taking Citalopram Tablets once you have
stopped taking the MAOI. At least one week should
you stop taking Citalopram
Tablets before beginning treatment with a MAO
- If you are taking medicines such as linezolid (an
antibiotic) and/or pimozide (used to treat mental
- 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
Warnings and precautions
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
-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
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.
Talk to your doctor, pharmacist or nurse before taking
Citalopram tablets, if you have, or ever had
- Epilepsy (seizure or fits).
- Problems with your kidneys and/or liver. Your doctor
may reduce the dose of the tablets if your kidneys
and/or liver are not working properly.
- Low blood levels of sodium which can cause
tiredness and confusion, muscle twitching, fits and
coma. This effect is more likely to occur if you are a
female older patient. However, your blood sodium
level becomes normal once you stop taking this
- You are being treated with electroconvulsive therapy.
- Mania (feeling elated or emotionally “high”).
- Severe mental condition in which the person loses
contact with reality and is unable to think and judge
- Diabetes (dose of insulin and/or oral anti-diabetic
medicines may need to be adjusted).
- Angle-closure glaucoma or history of glaucoma.
- History of bleeding or have ever suffered from
bleeding in the stomach or intestine and/or if you are
taking medicines known to affect blood clotting or
increase risk of bleeding such as:
o NSAIDs (e.g. Aspirin, Ibuprofen and Diclofenac)
o Ticlopidine, dipyridamol (medicine known to
affect blood platelets)
o Atypical antipsychotics (e.g. clozapine),
Phenothiazines (e.g. Chlorpromazine,
Thioridazine), tricyclic antidepressants (e.g.
Imipramine, Desipramine) (see section "Other
medicines and Citalopram tablets" below).
- 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).
- If you experience a fast or irregular heartbeat, fainting,
collapse or dizziness on standing up which may
indicate abnormal functioning of the heart rate.
Symptoms such as restlessness, for example, you
cannot sit or stand still, can occur during the first weeks
of treatment. Tell your doctor immediately if you
experience these symptoms. Then a dosage adjustment
may be helpful.
Some patients with manic-depressive illness may enter
into a manic phase. This is characterized by unusual
and rapidly changing ideas, inappropriate happiness
and excessive physical activity. If you experience this,
contact your doctor.
In some rare instances, during treatment with
Citalopram Tablets, certain concurrent serotonergic
effects serotonin syndrome or a condition resembling
malignant neuroleptic syndrome may develop, in
particular when taken along with other serotonergic
and/or neuroleptic substances. As these syndromes
may possibly lead to life-threatening conditions,
treatment with Citalopram Tablets should be stopped
whenever they occur, and a supportive symptomatic
treatment should be initiated. These syndromes are
characterised by a number of symptoms occurring
simultaneously, such as motor restlessness,
confusion, sweating, hallucinations, increased reflexes,
stiffness in muscle, shaking chills, increased heart rate,
and trembling (see also “Possible side effects”).
Rhabdomyolysis (temporary paralysis or weakness of
muscles) can occur rarely.
Special information relating to your disease
As with other medicines used to treat depression or
related diseases, the improvement is not achieved
immediately. After the start of Citalopram treatment it
may take several weeks before you experience any
improvement. In the beginning of the treatment certain
patients may experience increased anxiety, which will
disappear during continued treatment. Therefore, it is
very important that you follow exactly your doctor's
orders and do not stop the treatment or change the dose
without consulting your doctor.
Children and adolescents
Citalopram Tablets 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 Tablets for patients under 18
because he/she decides that this is in their best
interests. If your doctor has prescribed Citalopram
Tablets 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
Citalopram Tablets with food, drink and alcohol
Citalopram Tablets are to be taken as a single daily dose.
Citalopram Tablets can be taken any time of the day with
or without food.
Do not drink alcohol while you are taking Citalopram
Other medicines and Citalopram tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. Some
medicines can cause problems if you take them with
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.
Your doctor will have to decide whether treatment with
Citalopram Tablets is clearly necessary or whether an
alternative treatment is possible for you.
You should not stop treatment with Citalopram Tablets
abruptly due to pregnancy or other reasons.
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.
Also, if you take Citalopram during the last 3 months of
your pregnancy and until the date of birth you should be
aware that the following effects may be seen in your
newborn: fits, being too hot or cold, breathing
difficulties, blue or purple coloration of the skin or
mucous membranes, 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.
Citalopram is known to be found in breast milk. Its
effects on children taking breast milk have not been
established. If treatment with citalopram is considered
necessary, discontinuation of breast feeding should be
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.
Ask your doctor or pharmacist for advice before taking
Driving and using machines:
This medicine may cause side-effects (such as feeling
dizzy, sleepy, confused and having problems with
eyesight) 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 anything else where you
need to be alert and concentrate.
Citalopram tablets contains lactose monohydrate
If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take Citalopram tablets
How much to take
It is important to take your tablets as instructed by your
The label will tell you how many to take and how often. If
it does not, or you are not sure, ask your doctor or
The usual dose is 20 mg per day. This may be increased
by your doctor to a maximum of 40 mg per day.
The starting dose is 10 mg per day for the first week
before increasing the dose to 20-30 mg per day. The
dose may be increased by your doctor to a maximum of
40 mg per day.
Older 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. Older
patients should not usually receive more than 20 mg per
Children and adolescents (< 18 years)
Citalopram should not be given to children and
adolescents. For further information, please see section
2 what you need to know before you take Citalopram.
Patients with special risks
Patients with liver complaints should not receive more
than 20 mg per day.
How and when to take Citalopram
Citalopram is taken every day as a single daily dose.
Citalopram can be taken any time of the day with or
without food. Swallow the tablets with a drink of water.
Do not chew them (they have a bitter taste).
The score line is not intended for breaking the tablet.
Duration of treatment
Like other medicines for depression and panic disorder
these tablets may take a few weeks before you feel any
improvement. Continue to take Citalopram even if it
takes some time before you feel any improvement in
The duration of treatment is individual, usually at least 6
months. Continue to take the 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. The underlying illness may persist for a
long time and if you stop your treatment too soon your
symptoms may return.
Patients who have recurrent depression benefit from
continued treatment, sometimes for several years, to
prevent the occurrence of new depressive episodes.
Never change the dose of the medicine without talking to
your doctor first.
If you have the impression that the effect of Citalopram
tablets is too strong or too weak, talk to your doctor or
Care is needed if you are taking the following medicines:
Non-selective monoamine oxidase inhibitors
(MAOIs)", containing phenelzine, iproniazid,
isocarboxazid, nialamide, and tranylcypromine as
Reversible, selective monoamine oxidase inhibitors",
containing moclobemide (used to treat depression).
"Irreversible monoamine oxidase inhibitors",
containing selegiline (used to treat Parkinson's
disease). These increase the risk of side effects.
Lithium (used in the treatment of manic-depressive
disorder) and tryptophan.
Imipramine and desipramine (both used to treat
Sumatriptan and similar medicines (used to treat
migraine) dextromethorphan (used to relieve cough),
pethidine (pain killer) and tramadol (used against
severe pain). These increase the risk of side effects.
St. John's Wort (Hypericum perforatum) - a herbal
remedy used for depression.
Aspirin and non-steroidal anti-inflammatory drugs
(medicines used for pain relief or to thin the blood, so
Ticlopidine, dipyridamol (medicine known to affect
For mental illnesses, such as atypical antipsychotics
(e.g., clozapine, risperidone, olanzapine, quetiapine)
or phenothiazines (e.g., chlorpromazine,
trifluperazine), or antidepressants (e.g., imipramine,
clomipramine, desipramine). Taking Citalopram along
with these medicines can increase your chances of
Medicines that lower blood potassium and
Metoprolol, a beta blocker used to treat migraine,
some heart conditions and high blood pressure. The
effects of either drug could be increased, decreased or
Neuroleptics (used in the treatment of schizophrenia).
Carbamazepine (used to treat fits)
Cimetidine (used to treat stomach ulcers).
Mefloquine (used to treat malaria).
Bupropion (used to treat depression).
If you take more Citalopram Tabletsthan you should:
Never take more tablets than your doctor recommends.
If you have taken too many tablets, or if someone
accidentally swallows some, contact your doctor or the
nearest hospital for advice. Show them the pack of
tablets. The most likely signs of taking too many tablets
(overdose) are: feeling dizzy or drowsy, sweating, very
high fever, bluish or purplish tinge to the skin and
mucous membranes, serotonin syndrome, feeling or
being sick (nausea or vomiting), headache, dilated
pupils, rapid or deep breathing, having abnormal
heartbeats, abnormal heart rhythm, high or low blood
pressure, heart attack, uncontrollable muscle spasms
affecting the eyes, head, neck and body, shaking or
tremors, fits, feeling agitated or anxious and coma.
DO NOT TAKE Citalopram tablets 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.
spar floxacin, moxifloxacin, er ythromycin IV,
4. Possible side effects
If you forget to take Citalopram Tablets
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
If you stop taking Citalopram Tablets
Do not stop taking this medicine 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, symptoms
such as dizziness, diarrhoea, numbness and tingling,
sweating, headache, fast or irregular heartbeats,
emotional instability, irritability, agitation or anxiety,
sleep disturbances including inability to sleep and/or
intense dream, shaking or tremor confusion, visual
disturbances, nausea and vomiting may occur. These
symptoms are generally non-serious and disappear
within a few days. Citalopram should always be stopped
gradually over 1-2 weeks period.
If you get withdrawal effects when you are coming off
your tablets your doctor may decide that you should
come off them more slowly.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause sideeffects, although not everybody gets them.
They are most prominent during the first one or two
weeks of treatment and usually decrease as your
 LIT. CITALOPRAM TAB, (DWS-UK-R), Size:140 x 580mm, RLL-DWS : 20.05.13vs, 17.05.13nj,07.03.13vs/v1, (97097)
If you get any of the following symptoms you should
stop taking Citalopram tablets and see your doctor
Angioedema, such as
o swollen face, tongue or pharynx
o difficulty in swallowing
o hives and difficulties to breath
Serotonin syndrome (symptoms: motor restlessness,
confusion, sweating, hallucinations, increased
reflexes, stiffness in muscles, shaking chills,
increased heart rate and trembling)
Fast, irregular heartbeat, fainting which could be
symptoms of a life-threatening condition known as
Torsades de Pointes.
Very common: (more than 1 in 10 patients treated)
Not sleeping well or feeling sleepy
Fluttering or pounding heartbeat
Feeling sick (nausea), dry mouth
Feeling of weakness
Common: (fewer than 1 in 10 but more than 1 in 100
Feeling agitated, nervousness
Sleep disorders (excessive sleepiness, abnormal
dreaming), impaired concentration, abnormal
dreaming, loss of memory, anxiety, decreased sex
drive, abnormal orgasm (female), decreased appetite,
feeling of complete dissatisfaction and confusion.
Migraine and paraesthesia (sensation of pricking,
tingling, or creeping on the skin)
Feeling shaky (tremors)
Change in blood pressure (can increase or drop)
Indigestion, vomiting, constipation, diarrhea (loose
stools), stomach pains, increased wind and saliva
Difficulty in urine passing, excessive secretion of urine
Muscle pain, joint pain
Decrease in weight
Inflammation of the nasal passages and sinuses
Failure of ejaculation in males, impotence, painful
menstruation has been reported in some female
Pruritus (localized or generalized itching of skin)
Problems with eyesight
Ringing of ear
Uncommon: (fewer than 1 in 100 but more than 1 in
1000 patients treated)
Aggression; seeing, feeling or hearing things that are
not there (hallucination); mood of excitement, overactivity and uninhibited behaviour (mania);
depersonalisation; feeling of extreme happiness and
increased sexual drive
Increased appetite, increase in weight
Abnormal heart rate
Rash, hives, hair loss, unusual bleeding or bruising
under the skin,
Unable to pass urine
Heavy menstrual periods
Swelling of hands, ankles or feet
Increase sensitivity of skin to sunlight
Allergic reactions, malaise (general feeling of being
Rare: (fewer than 1 in 1000 but more than 1 in 10000
bleeding, mostly of the skin and mucous
membranes, gatrointestinal bleeding, vaginal bleeding
Tiredness, confusion and twitching of your muscles.
These may be signs of a low blood level of sodium.
Fits, uncontrollable twitching, jerking or writhing
Liver disease, characterised by yellowing of the skin
and eyes, light coloured bowel motions, dark coloured
Fever or high temperature.
Very rare: (fewer than 1 in 10000 patients treated,
including isolated reports)
Rapid rhythm of heart
Increased prolactin levels
Bleeding or bruising more easily than normal
Overproduction of a hormone causing fluid retention,
resulting in weakness, tiredness or confusion
Low potassium levels in the blood
Panic attack, grinding of the teeth, restlessness,
suicidal ideation, suicidal behaviour
Abnormal involuntary movements (extrapyramidal
Restlessness or difficulty sitting still, movement
Feeling faint or light headed on standing up due to
decrease in blood pressure
Abnormal liver function test
Persistent painful erection of the penis which occurs
without sexual arousal
Abnormal production of breast milk in men and
Bone fractures have been reported in patients aged 50
years and older.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. 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
5. How to store Citalopram tablets
Keep this medicine out of the sight and reach of
Do not use this medicine after the expiry date which is
stated on the carton and blister strip. The expiry date
refers to the last day of that month.
This medicinal product does not require any special
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 Tablets contains
The active substance is Citalopram hydrobromide.
Each 10mg film-coated tablet contains 12.5 mg
citalopram hydrobromide equivalent to 10 mg
Each 20mg film-coated tablet contains 25 mg
citalopram hydrobromide equivalent to 20 mg
Each 40mg film-coated tablet contains 50 mg
citalopram hydrobromide equivalent to 40 mg
The other ingredients are lactose monohydrate,
microcrystalline cellulose, maize starch, copovidone,
croscarmellose sodium and magnesium stearate. The
ingredients of the film-coating material, Opadry White
20H 58983 comprise of hypromellose, titanium dioxide
(E171), propylene glycol, hydroxypropyl cellulose and
What Citalopram Tablets looks like and contents of
Citalopram Tablets are white to off-white, circular
biconvex film-coated tablets.
- 10mg tablets are marked with “10” on one side and
plain on the other side.
- 20mg tablets are marked with “20” on one side and a
score line on the other side.
- 40mg tablets are marked with “40” on one side and a
score line on the other side.
Citalopram Tablets are available as blister strips in pack
sizes of 1, 14, 20, 28, 30, 50, 56, 98, 100 or 250
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Ranbaxy (UK) Limited
Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE
Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel,, Co. Tipperary
Republic of Ireland
Font Size: 8pt
Citalopram is not for use in children and adolescents under 18 years of age
pentamidine, anti-malarian treatment particularly
halofantrine), certain antihistamines (astemizole,
If you have any further questions about this you should
speak to your doctor.
Important things you need to know about Citalopram
Please read all of this leaflet before you start to take your medicine as it contains important information about
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.