Citalopram 40mg Tablets
FRONT
FRONT
©What you need to know before you take Citalopram
Do NOT take Citalopram:
♦ Ifyou are allergictocitalopram or any ofthe other ingredients of Citalopram (listed in section 6)
♦ Ifyou are taking, or have taken in the last 2 weeks an antidepressant medicine of the type called monoamine oxidase inhibitors (MAOIs) e g. selegiline or moclobemide ♦ If you are treated with linezolid (an antibiotic medicine) unless you are underdose observation and monitoring of blood pressure ♦ Ifyou are born with or have had an episode of abnormal heart rhythm (seen at ECG; an examination to evaluate how the heart is functioning)
♦ Ifyou take medicines for heart rhythm problems or that may affectthe heart's rhythm. Also referto the section "Other medicines and Citalopram" below.
CITALOPRAM 10 mg, 20 mg AND 40 mg FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
♦ Keepthis leaflet.You may need to read it again.
♦ Ifyou have further questions, please askyour doctor orpharmacist.
♦ This medicine has been prescribed foryou only. Do not pass it on to others. It may harm them, even if their signs of illness arethe same as yours.
♦ Ifyou get any side effects talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.
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
Eight important things you need to know about Citalopram
Please read all of the leaflet. It includesa lot of additional important information about this medicine.
♦ Citalopram treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore importantthat you and your doctorweigh up the benefits of treatment against the possible unwanted effects, before starting treatment.
♦ Citalopram is not for use in children and adolescents under 18. See section 3, 'Children and adolescents underthe age of 18', insidethis leaflet.
♦ Citalopram won't work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should askto see you again a couple of weeks after you first start treatment.Tell your doctor ifyou have started feeling better. See section 3, 'How to take Citalopram', inside this leaflet.
♦ Some people who are depressed or anxious think of harming or killing themselves. If you startto feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See Thoughts of harming yourself', inside this leaflet.
♦ Don't stop taking Citalopram without talking to your doctor. Ifyou stop taking Citalopram suddenly or miss a dose,you may get withdrawal effects. See section 3, 'Ifyou stop taking Citalopram', inside this leaflet.
♦ If you feel restless and feel like you can't sit or stand still, tell your doctor. Increasing the dose of Citalopram may make thesefeelings worse. See section 4, 'Possible side effects', inside this leaflet.
♦ Taking some other medicines with Citalopram can cause problems.You may need to talkto your doctor. See 'Taking other medicines and Citalopram', inside this leaflet.
♦ If you are pregnant or planning to become pregnant, talktoyour doctor. See 'Pregnancy and breast-feeding', inside this leaflet.
Read this leaflet. It includes a lot of additional
important information aboutthis medicine.
Keep this leaflet.You may need to read it again.
If you have any more questions, askyour doctor or pharmacist (chemist). You may also find it helpful to contact a self-help group, or patient organisations find out more aboutyourcondition.Your doctorwill be able to give you details.
OWhat Citalopram is and what it is used for
♦ Citalopram belongsto a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
♦ Citalopram is used forthe treatment of depression (major depressive episodes).
Warnings and precautions:
Talktoyour doctor or pharmacist beforetaking
Citalopram ifyou:
♦ Sufferfrom diabetes,treatmentwith Citalopram may altercontrol ofyour sugar levels
♦ Sufferfrom epilepsy or seizures, as seizures are a potential riskwith antidepressant drugs
♦ Receive electro-convulsive therapy
♦ Have a history of mania/hypomania,citalopram should be used with caution and should be discontinued when you enter a manic phase
♦ Have kidney or liver problems. Citalopram is not recommended for use in patients with severe kidney
♦ Have a bleeding disorder, Citalopram maycause bleeding
♦ Are using medicinal products that effect the clotting of blood (see section "Other medicines and Citalopram")
♦ Have a stomach ulcer or have had any bleeding in the stomach or intestine in the past
♦ Suffer from low blood potassium or magnesium levels
♦ Suffer from psychosis with depressive episodes
♦ Experience 'serotonin syndrome'. Acombination of symptoms, such as agitation,tremor, muscle contractions and hyperthermia may indicate the development of this condition.Treatment with Citalopram should be discontinued immediately.
♦ Suffer or have suffered from heart problems or have recently had a heart attack
♦ 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)
♦ Experience a fast or irregular heartbeat, fainting, collapse or dizziness on standing up which may indicate abnormal functioning of the heart rate
♦ Have problems with your eyes, such as certain kinds of glaucoma
♦ During thefirstfew weeks oftreatment symptoms such as restlessness, and an inability to sit or stand still may develop in patients taking anti-depressants. In patients who develop these symptoms, increasing the dose could be harmful.
♦ Citalopram should be discontinued in any patients who developfits (epilepsy) or iftheirfrequency of fits increase. Citalopram should be avoided in patientswith unstable (uncontrolled) epilepsy.
Patients with controlled epilepsy should be carefully
♦ Citalopram should not be used atthe same time as medicines which have a serotonergic effect including pain killers and medicines used totreat migraines (see "Other medicines and Citalopram")
♦ Citalopram should be used with caution in patients with low sodium levels.
You should notdiscontinuetreatmentwith Citalopram abruptly due to the withdrawal effects that might occur (see section 3).
Thoughts of suicide and worsening of your depression
Ifyou are depressed 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 maybe more likely to think like this:
♦ Ifyou have previously had thoughts about killing or harming yourself
♦ Ifyou are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25years with psychiatricconditions who were treated with an antidepressant.
Ifyou 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, and askthem to read this leaflet.You might askthem to tell you if they thinkyour depression is getting worse, or if they are worried aboutchanges in your behaviour.
Children and adolescents
Citalopram should normally not be used forchildren 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 takethis class of medicines. Despite this, your doctor may prescribe Citalopram for patients under 18 because he/she decides thatthis is in their best interests. Ifyour doctor has prescribed Citalopram for a patient under 18 and you wantto discuss this, please go backto your doctor. You should inform your doctor if any ofthe symptoms listed above develop orworsen when patients under 18 are taking Citalopram. Also, the long-term safetyeffects concerning growth, maturation and cognitive and behavioural development of Citalopram in this age group have notyet been demonstrated.
Other medicines and Citalopram
Tell your doctor or pharmacist ifyou are taking, have
recently taken or might take any other medicines.
DO NOT TAKE Citalopram
♦ Ifyou 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 speaktoyourdoctor.
♦ Ifyou take monoamine oxidase inhibitors (MAOIs), e g. phenelzine, isocarboxazid ortranylcypromine do nottake Citalopram for 14 days after discontinuation of treatment with a so called irreversible MAOI. Do nottake Citalopram forthe time specified after discontinuation of treatment with a reversible MAOI (e.g. moclobemide), as stated in the patient information leaflet of the reversible MAOI. Do nottake MAOIs for 7 days after discontinuation of treatment with Citalopram. Do not use Citalopram ifyou are taking morethan
10 mg/day ofthe MAO selegiline.
♦ Ifyou take pimozide (an antipsychotic medicine). Citalopram must not be taken togetherwith pimozide due to the influence ofthis combination to the heart function.
♦ Ifyou take medicines containing selegiline (used to treat Parkinson's disease).
Talkto your doctor or pharmacist ifyou aretaking, or have previouslytaken any ofthe following:
♦ Other medicinal products with serotonergic effects such as sumatriptan, othertriptans or tryptophan (see Take special care with Citalopram')
♦ An anticoagulant (to prevent blood clotting), e g. warfarin, aspirin (acetylsalicylic acid), dipyridamole orticlopidine
♦ Medicines that lowerthe seizure threshold i.e. neuroleptics, mefloquine or bupropion
♦ Herbal preparations containing StJohn's wort (Hypericum perforatum)
♦ Pain-relief and inflammation medicines called non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, ketoprofen or diclofenac
♦ Medicines used totreat pain, such as tramadol (see "Warnings and precautions")
♦ Medicines used totreat depression, e g. fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine
♦ Medicines used totreat migraine, e g. sumatriptan and othertriptans (see "Warnings and precautions")
♦ Medicines used totreat heartfailure, e g. metoprolol
♦ Medicines for psychiatric illness, e g. lithium, risperidone or dilorpromazine
♦ Medicines for stomach ulcers, e g. omeprazole, esomeprazole, lansoprazole or cimetidine
♦ Medicines that decrease blood levels of potassium or magnesium asthese conditions increase the risk of life-threatening heart rhythm disorder (QT prolongation,Torsades de Pointes)
♦ Linezolid (an antibioticmedicine).
Citalopram with food, drink and alcohol
You are advised not to drink alcohol whilst taking Citalopram.
Citalopram can betaken with orwithout food. Pregnancy, breast-feeding and fertility
Ifyou are pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, askyour doctorfor advice before taking this medicine. Pregnancy
There isonly limited experience concerning the use of Citalopram during pregnancy. Do not take Citalopram if you arepregnantorplanningto become pregnant, unless your doctor considers it absolutely necessary. Make sure your midwife and/or doctor know you areon 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 babyyou should contactyour midwife and/or doctor immediately.
You should not discontinue treatmentwith Citalopram abruptly. If you are taking Citalopram in the last 3 months of pregnancy, letyour doctor know as your baby might have some symptomswhen it is born.These symptoms usuallybeginduring 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 skinor being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, litters or fits. Ifyour baby has any of these symptoms when it is born, contactyour doctorwho will be able to advise you.
Ask your doctor or pharmacist for advice before taking
Breast-feeding
Citalopram passes into breast milk in small amounts. There is a risk ofan effect on the baby. Ifyou are taking Citalopram, talkto your doctor before you start breast-feeding.
Askyour doctor or phar
a
20 mg p
stfor advice before taking
Fertility
Citalopram has been shown to reduce the quality of sperm in animal studies.Theoretically,thiscould affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Citalopram may affectyour ability to drive acar or use machines. Do not drive or use machines until you know how Citalopram affectsyou. Please askyour doctor or pharmacist if you are unsure about anything. Citalopram contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take Citalopram
Citalopram should betaken as a single dose, either in the morning orthe evening.The tablets can be taken with orwithoutfood.The tablets should be swallowed with a drink ofwater or other fluid. Citalopram does notwork immediately. An antidepressant effect should not be expected for at least 2 weeks.Treatment should continue until you are free of symptoms for 4-6 months. Citalopram should bewithdrawn slowly. It is advised thatthe dose is gradually reduced over a 1-2 week period. Do not stop taking Citalopram even ifyou begin to feel better, unless you are told to do so by the doctor. Neverchange the dose ofyour medicine without talking toyour doctorfirst.
Adults
The usual dose is 20 mg per day.This may be increased by your doctorto a maximum of 40 mg per day. Elderly patients (>65 years of age)
The starting dose should be decreased to half ofthe recommended dose, e g. 10-20 mg per day.
Elderly patients should not usually receive more than
Use in children and adolescents
Citalopram should not be used in the treatment of children and adolescents under 18 years of age.
(see "Warnings and precautions").
Liver problems
Patients with mild to moderate liver problems should receive a starting dose of 10 mg per day. Patients with livercomplaints should not receive more than 20mg per day. Such patients should be clinically monitored. Caution and extra careful dosing is advised in patients with severe liver problems.
Kidney problems
Inpatientswith mild tomoderate kidneyproblems no dosage adiustment is required.The use of Citalopram in patents with severe kidney problem is not recommended as no information is available in these patients. Withdrawal symptoms seen on discontinuation Abrupt discontinuation should be avoided. When stopping treatmentwith Citalopram the dose should be gradually reduced over a 1-2 weekperiod in orderto reducethe risk of withdrawal reactions (see section 'If you stop taking Citalopram' and 'Possible side effects'). If intolerable symptoms occurfollowing a decrease in the dose upon discontinuation oftreatment, then resuming the previously prescribed dose may be considered. Subsequently, your doctor may continue decreasing the dose, but at a more gradual rate.
If you take more Citalopram than you should If you have taken more Citalopram than you should, talkto a doctor or pharmacist immediately.
Symptoms of an overdose include: sleepiness, a condition ofnearunconsciousnesswith apparent mental inactivity, reduced ability to respond to stimulation orcoma, seizures, ECG changes (e g. prolonged QT interval), irregular heart beat,feeling sick,vomiting, discolouration of the skin, sweating, hyperventilation. Features of serotonin syndrome may occur (see 'Possible side effects'), particularly when other substances are co-ingested.
If you forget to take Citalopram
If you miss a dose, do nottake a double dose to make up for a forgotten dose.
If you stop taking Citalopram
Do not stop taking Citalopram unless you are told to ' sobyyourdoctor.
ce withdrawal reactions may occurwhen the treatment is stopped, it is advised to reduce the dose gradually at intervals of 1-2 weeks.
Withdrawal reactions include: dizziness, pins and needles, electric shock sensations, numbness, sleeplessness, intense dreams, agitation, anxiety, feeling sick or being sick, shaking, confusion, sweating, headadie, diarrhoea,faster heartbeat (palpitations), emotional instability, irritability and visual disturbances. Most ofthe withdrawal reactions are mild and self-limiting in nature but may be severe in some patients.
If you have any further questions on the use of this
medicine, askyour doctor or pharmacist.
^ Possible side effects
Like all medicines,this medicine can cause side effects, although not everybody gets them.
A few people may develop a severe allergic reaction. This is avery rare but serious side effect. If you experience any of the following symptoms stop taking citalopram and tell your doctor immediately or go to your nearest casualty department:
♦ Swelling of the lips,face and neck (allergic reaction) leading to severe difficulty in swallowing or breathing
♦ Shock (strong decrease of blood pressure, paleness, agitation, weak and fast pulse, clammy skin, decreased consciousness) caused by a sudden strong vascular dilatation as a result of severe allergy to certain substances (anaphylactic reactions)
♦ Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes.
Serotonin syndrome has been reported in patients treated with this type of antidepressant (SSRI). Tell your doctor if you experience high fever, trembling, muscle twitches and anxiety because these symptoms may indicate the development of this condition. Treatment with Citalopram should be discontinued immediately.
2 Cases ofthoughts/behaviours of harming or killing J yourself have been reported during Citalopram therapy or early after treatment has been stopped (see section 2 Warnings and precautions). If you have thoughts of harming or killing yourself at anytime, contactyour doctor or go to a hospital.
An increased risk of bone fractures has been observed in patients taking this type of medicines.
The following side effects have been reported atthe approximate frequencies shown:
Very common: may affect more than 1 in 10 people
♦ sleepiness,difficultysleeping
♦ headache
♦ feeling your heart beat
♦ feeling sick, dry mouth
♦ increased sweating
♦ feeling ofweakness (asthenia).
Common: may affect uptol in 10 people
♦ reduction in weight, loss of appetite
♦ agitation, problems with concentration, abnormal dreaming (unusual and intense dreams), memory
loss, anxiety, decreased sex drive, absence of emotion or enthusiasm, confusion, nervousness
♦ pins and needles or numbness
♦ dilatation ofthe eye pupil
♦ tremor, dizziness, ringing in the ears (tinnitus), pain in muscles and joints
♦ runny and itchy nose, inflammation ofthe sinuses (pain and pressure in yourface,which is worse when you lean forwards, blocked nose, sore throat and cough, headache,fever, earadie, toothache or pain in your upper jaw)
♦ indigestion/heart burn, being sick, stomach pain, wind, increased saliva, diarrhoea, constipation
♦ problems with urination (e g. controlling urination)
♦ inability to achieve orgasm in women, impotence (inability to get or maintain an erection), ejaculation
♦ itching
♦ fatigue,yawning.
Uncommon: may affect up to 1 in 100 people
♦ increase in weight, increase in appetite, absence of appetite
♦ a state of optimism, cheerfulness and well-being (euphoria), aggression, reduced emotions, indifference, hallucinations, mania, general feeling of discomfort or uneasiness
♦ fainting
♦ slowing ofthe heart beat,fast heart beat
♦ nettle rash, hair loss, rash, bruising easily, sensitivity to sunlight, dilatation of the pupil
♦ problems passing urine
♦ swelling of the arms and legs
♦ abnormally heavy and prolonged menstrual period.
Rare: may affect up to 1 in 1,000 people
♦ bleeding, e g. from the vagina, stomach, skin and mucous membranes (the lubricated inner lining of the mouth, nasal passages, vagina and urethra)
♦ convulsions, involuntary movements, taste abnormalities
♦ unintentional and purposeless motion
♦ inflammation of the liver (hepatitis)
♦ lower amount of blood sodium, predominantly in the elderly (which causes hallucinations, confusion, fits, lack of energy and muscle cramps orweakness)
Not known (cannot be estimated from the available data)
♦ low levels of platelets in your blood (thrombocytopenia) which can increase bleeding or bruising
♦ panic attacks, grinding teeth, restlessness
♦ inappropriate ADH secretion (characterised by an excessive production of urine)
♦ fits, impairment ofvoluntary movement, i.e. tremor, tics, changes in muscle tone, slowness of movement, involuntary and/or irregular muscle movements that occur in the facial area, restlessness ofthe arms and legs (akathisia)
♦ visual disturbance
♦ dizziness when suddenly standing up
♦ changes in electric recording heart (ECG QT interval prolonged)
♦ bleeding in your stomach or intestine
♦ bleeding disorder including skin and mucosal bleeding (ecchymosis)
♦ sudden swelling of skin and mucosa
♦ abnormal liver function tests
♦ abnormal milk secretion from the breast (galactorrhoea)
♦ irregularmenstrual bleeding
♦ painful erections in men
♦ low potassium levels in the blood.
Since withdrawal reactions may occurwhen the treatment is stopped, it is advised to reduce the dose gradually at intervals of 1-2 weeks.
Withdrawal reactions include: dizziness, pins and needles, electricshock sensations,numbness_, sleeplessness, intense dreams, agitation, anxiety, feeling sick or being sick, shaking, confusion, sweating, headache, diarrhoea,faster heartbeat (palpitations), emotional instability, irritability and visual disturbances. Most of the withdrawal reactions are mild and self limiting in nature.
Any side effects thatdo occurwill usually disappear after a few days.
Reporting of side effects
If you get any side effects,talkto your doctor,
pharmacist or nurse.This includes any possible side
effects not listed in this leaflet.You can also report side
effects directly via theYellow Card Scheme at:
By reporting side effectsyou 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 this medicine afterthe expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month.
Do not store above 25°C.
Do notthrow away any medicines via waste water or householdwaste. Askyour pharmacist how to throw
will help protectthe environment.
Contents of the pack and other information
What Citalopram contains:
♦ The active substance is citalopram hydrobromide
♦ Citalopram 10 mg Film-coatedTablets: Each film-coated tablet contains 12.49 mg citalopram hydrobromide equivalent to 10 mg citalopram
♦ Citalopram 20 mg Film-coatedTablets: Each film-coated tablet contains 24.98 mg citalopram hydrobromide equivalent to 20 mg citalopram
♦ Citalopram 40 mg Film-coatedTablets: Each film-coated tablet contains 49.96 mg citalopram hydrobromide equivalent to 40 mg citalopram
♦ The other ingredients are:
♦ Core: copovidone, croscarmellose sodium (E466), glycerol (E422), lactose monohydrate, magnesium stearate (E470b), maize starch, microcrystalline cellulose (E460i)
♦ Coating: hypromellose (E464), microcrystalline cellulose (E460i), macrogol stearate 40 (E431) and titanium dioxide (El71).
What Citalopram looks like and contents of the pack:
♦ Citalopram 10 mg Film-coatedTablets are round, white tabletswith a diameter of 6 mm
♦ Citalopram 20 mg Film-coatedTablets are oval, white tablets with a break-line on one side and diameter of
11 mm
♦ Citalopram 10 mg Film-coatedTablets are available in pack sizes of 10,14, 20,28,30,50,56,98 and 100 tablets per box, 50x1 unit dose blister.
♦ Citalopram 20 mg Film-coatedTablets are available in packsizes of 10,14, 20,28,30,50,56, 60,98, 100 and 120tablets per box,50x1 unitdoseblister.
♦ Citalopram 40 mg Film-coatedTablets are available in packsizes of 10,14, 20,28,30,50,56, 60,98, 100 and 120tablets per box,50x1 unitdoseblister.
♦ Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder isTEVA UK
Limited, Eastbourne, BN22 9AG and the company
responsible for manufacture isTEVA Pharmaceutical
Works Company Limited, Hungary.
This leaflet was last revised: 07/2014.