Citalopram 10mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET
Citalopram 10mg Film-Coated Tablets
Each film-coated tablet contains 10mg of Citalopram (as citalopram hydrobromide)
Important things you need to know about Citalopram:
■ Citalopram treats major depression and anxiety disorders. Like all medicines, it can have unwanted effects. It is important that you and your doctor talk about the benefits of treatment against the possible unwanted effects of the medicine before you start taking it.
■ Citalopram must not be taken by children or teenagers under 18 years of age. (See section 3 "Use in children").
■ Citalopram will not work straight away. You may feel worse before feeling better after starting the medicine. Your doctor should see you regularly during the course of treatment. Tell your doctor if you do not feel better.
■ Some people with depression or anxiety think of harming or killing themselves. If you start to feel worse or have any of these thoughts, see your doctor or go to a hospital straight away.
■ Do not stop taking Citalopram without talking to your doctor. If you stop taking it suddenly you may get unwanted effects.
■ Taking some other medicines with Citalopram can cause problems. You may need to talk to your doctor first. (See section 2 "Other medicines and Citalopram").
■ If you are pregnant or planning to get pregnant, talk to your doctor before taking Citalopram. (See section 2 "Pregnancy and breast-feeding and fertility").
■ If you feel restless and feel like you can't sit or stand still, tell your doctor. Increasing the dose of Citalopram
may make these feelings worse. (See section 4 "Possible side effects").
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 your 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.
What is in this leaflet:
D What Citalopram is and what it is used for 0 Possible side effects
UL What you need to know before you take Citalopram Q How to store Citalopram
rnL How to take Citalopram Q Contents of the pack and other information
r7 What Citalopram is and what it is used for
Citalopram belongs to a group of antidepressants known as Selective Serotonin Reuptake Inhibitors (SSRIs).
Citalopram is used for the treatment of :
■ Depressive illnesses (major depressive episodes)
■ Panic disorders with or without agoraphobia (e.g.strong fear of leaving the house, entering shops, or
fear of public places)
BWhat you need to know before you take Citalopram
Do not take Citalopram
■ If you are allergic (hypersensitive) to Citalopram, other SSRI antidepressants or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information")
■ If you are taking or have recently taken medicines used to treat depression called Monoamine Oxidase Inhibitors (MAOIs): e.g moclobemide or you are being treated with the non-selective MAOI linezolid (an antibiotic medicine), unless you are being closely monitored (see "Other medicines and Citalopram" section). The irreversible MAOI selegiline (used to treat Parkinson's disease) may be used in combination with Citalopram in doses not exceeding 10mg selegiline per day. Before starting treatment with Citalopram, you may have to wait for up to 14 days after stopping the use of a MAOI.
When changing from Citalopram, you may have to wait for at least 7 days before you start taking MAOIs
■ If you are taking the medicine pimozide, used to treat mental disorders (see "Other medicines and Citalopram" section)
■ 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
Warnings and precautions
Talk to your doctor before taking Citalopram if:
■ You are older (above 65 years of age)
■ You suffer from kidney and liver problems
■ You suffer from a panic disorder as you may need to start treatment with a low dose
■ You are at risk of a decreased salt (sodium) level in the blood (hyponatraemia)
■ You start to feel restless and cannot sit or stand still (akathisia). This is most likely to occur within the first few weeks of treatment. Increasing your dose of Citalopram may make this condition worse
■ You have a history of feeling/being elated/over-excited which causes unusual behaviour (mania). If you have a manic episode, your treatment with Citalopram should be discontinued
■ You have diabetes as the dose of your diabetic medicine may need to be adjusted (see "Other medicines and Citalopram" section)
■ You have or are at risk of increased pressure in the eye (glaucoma) as Citalopram can cause dilation of the pupils (mydriasis)
■ You have unstable epilepsy, Citalopram should be avoided. If you have controlled epilepsy, you should be carefully monitored. Citalopram should be discontinued if you develop fits (seizures) or there is an increase in the frequency
■ You are receiving ECT (Electro-Convulsive Treatment)
■ You have a history of bleeding disorders or are taking anticoagulant medicines (for thinning the blood) (see "Other medicines and Citalopram section")
■ You are taking serotonergic medicines (antidepressants) such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan (see "Other medicines and Citalopram" section) as on rare occasions, development of serotonin syndrome have occurred. Treatment with Citalopram should be discontinued if symptoms such as agitation, shakiness (tremor), involuntary muscle twitching (myoclonus) and fever (hyperthermia) should occur
■ You are taking St. John's Wort, a herbal remedy used to treat depression as it may result in an increase in undesirable effects (see "Other medicines and Citalopram" section)
■ You have suspected congenital long qt- syndrome or suffer from low blood levels of potassium or magnesium (hypokalaemia/hypomagnesaemia)
■ You suffer from or have a history of heart problems or have recently had a heart attack. If signs of irregular heartbeat (cardiac arrhythmia) occur during treatment with Citalopram, treatment should be withdrawn and an ECG should be performed
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 an adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults aged less than 25 years old 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 disorder is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents under the age of 18 years:
Citalopram should not be used in the treatment of children and adolescents under the age of 18 years. Patients under the age of 18 years have an increased risk of suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) when treated with antidepressants. 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. Studies of people under 18 taking Citalopram have not shown for certain whether or not the medicine affects growth, or development of the brain or body.
Other medicines and Citalopram
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Medicines which must not be taken with Citalopram
■ Monoamine Oxidase Inhibitors (MAOIs), medicines used to treat depression e.g. moclobemide, selegiline, linezolid (see "Do not take" section)
■ Buspirone, used to treat anxiety disorders
Do not take Citalopram if you take medicines that may affect the heart's rhythm such as:
■ Class IA and III antiarrhythmics
■ Anti-psychotics, medicines used to treat mental health problems (phenothiazine derivatives, pimozide, haloperidol)
■ Tricyclic antidepressants such as clomipramine, nortriptyline, imipramine, desipramine
■ Certain anti-microbioal agents (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment - particularly halofantrine)
■ Certain anti-histamines, medicines used to treat allergic conditions (astemizole, mizolastine)
Other medicines which should not be taken with Citalopram
■ Sumatriptan and other triptans (used to treat headaches and migraines)
■ Tramadol (used to treat severe pain)
■ Oxitriptan, tryptophan (used to treat depression)
■ Herbal products containing St. John's Wort (hypericum perforatum)
Medicines which may influence the effect of or be influenced by Citalopram
■ Metoprolol, flecainide and propafenone (to treat heart problems)
■ Medicines that decrease blood levels of potassium or magnesium
■ Butyrophenones, phenothiazines such as chlorpromazine, thioxanthenes, risperidone and thioridazine (used to treat mental and emotional conditions)
■ Mefloquin (used to treat malaria)
■ Bupropion (used to help you stop smoking)
■ Lithium, a medicine used to treat mood disorders
■ Cimetidine, omeprazole, esomeprazole, lansoprazole (used to treat indigestion, stomach ulcers and heartburn)
■ SSRI antidepressants (fluvoxamine)
■ Medicines for thinning your blood such as warfarin
■ Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (aspirin)
■ Dipyridamol (used to treat thrombosis)
■ Ticlopidine (used to reduce the risk of stroke)
■ Medicines used to treat diabetes, as the dose may need to be adjusted
Taking Citalopram with food and drink alcohol:
■ You are advised not to drink alcohol whilst taking Citalopram.
■ These tablets may be taken with or without food but should be taken with a glass of water.
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 for advice before taking this medicine.
Pregnancy
Do not take Citalopram if you are pregnant or think you may be pregnant, unless you and your doctor have discussed the risks and benefits involved. You should not stop treatment with Citalopram abruptly during pregnancy. Contact your doctor if you wish to pause or stop the treatment.
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.
If you take Citalopram, particularly during the last 3 months of pregnancy, your newborn child may experience serious side effects such as breathing difficulties, bluish skin/lips (cyanosis), irregular breathing with breathing pauses (apnoea), temperature fluctuations, fits (seizures), lack energy (lethargy), sleeping difficulties, difficulty in feeding, being sick (vomiting), low level of sugar in the blood (hypoglycaemia), stiff or floppy muscles, abnormally increased reflexes, shaking (tremor), extreme nervousness or nervous shaking, irritability, constant crying and drowsiness (somnolence). If your baby has any of these symptoms when it is born, contact your midwife/and or doctor immediately.
Breast-feeding
Citalopram passes into breast milk in small amounts and there is a risk of an effect on the baby. If treatment with Citalopram is considered necessary, discontinuation of breast-feeding should be considered.
Fertility
Citalopram has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
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Driving and using machines
Citalopram has minor to moderate influence on the ability to drive and use machines as it can reduce the ability to make judgements and react to emergencies. If this occurs, you should not drive or use machines.
Citalopram contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Citalopram
Always take Citalopram exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
■ It may take 2-4 weeks before you notice an improvement.
■ Treatment should continue until you have been free of symptoms for 4-6 months.
■ When the treatment with Citalopram is to cease, the dose should be reduced gradually over a period of at least 1-2 weeks.
■ These tablets are to be taken orally as a single dose either in the morning or the evening
■ Swallow with a glass of water
■ These tablets may be taken with or without food
Adults:
Depression:
The recommended dose is 20mg per day. This may be increased up 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 20mg per day. The dose may be increased to a maximum of 40mg per day.
■ Full therapeutic response may take up to 3 months to develop.
Older people (above 65 years of age)
■ The starting dose should be decreased to half of the recommended dose, e.g. 10-20mg per day.
■ The maximum recommended dose for older people is 20mg per day.
Children and adolescents under the age of 18 years:
Citalopram should not be used in children and adolescents under the age of 18 years.
Patients with liver problems:
The usual dose is 10mg once daily. Patients with liver complaints should not receive more than 20mg per day.
Patients with kidney problems:
Dose adjustment is not necessary if you have mild to moderate kidney problems. The use of Citalopram is not recommended if you suffer from severe kidney problems,
If you take more Citalopram than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.
Symptoms of overdose include: irregular heartbeat, changes in heart rhythm (faster or slower heartbeat [tachycardia/bradycardia]), feeling sick (nausea), being sick (vomiting), sweating, drowsiness (somnolence), unconsciousness (stupor), shakiness (tremor), fits (convulsions), changes in blood pressure (may be increased [hypertension] or decreased [hypotension]), serotonin syndrome, agitation, dizziness, enlarged eye pupils (mydriasis), bluish skin (cyanosis), breathing too quickly (hyperventilation), heart attack (cardiac arrest), coma.
If you forget to take Citalopram
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Citalopram
It is important that you keep taking Citalopram for as long as your doctor has told you to.
Abrupt discontinuation should be avoided. When you stop treatment with Citalopram the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions. If side effects should occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, your doctor may continue decreasing the dose, but at a more gradual rate.
Withdrawal symptoms are common, particularly if treatment is stopped suddenly e.g. feeling dizzy, tingling or numbness in the hands or feet (paraesthesia), finding it difficult to sleep (insomnia) or having intense dreams, agitation, anxiety, feeling (nausea) or being sick (vomiting), shaking (tremor), confusion, sweating, headache, diarrhoea, feeling your heartbeat (palpitations), feeling emotional, irritability, visual disturbances. Most people find that any effects are mild to moderate and go away within two weeks. Some people find they are more severe and last longer (2-3 months or more).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
[4 Possible side effects
Like all medicines, citalopram can cause side effects, although not everybody gets them.
Stop taking and seek medical advice immediately if you
develop the following symptoms:
■ If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight
away. (See section 2 "Thoughts of suicide and worsening of your depression or anxiety disorder”)
■ Allergic reactions: swelling of the face, throat or tongue, difficulty breathing, dizziness (anaphylaxis)
■ Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)
■ Swelling of parts of the body (oedema)
■ A group of symptoms together e.g. abnormally high body temperature, rigidity, muscle spasms, confusion, irritability, agitation (serotonin syndrome)
■ Irregular heartbeat (could be symptom of life-threatening condition Torsades de Pointes)
■ Bloody vomit and/or black stools due to bleeding from the stomach, gums or bottom (gastrointestinal haemorrhage)
Tell your doctor immediately if you develop:
■ Feeling elated (euphoria) or emotionally "high” (mania)
■ Nausea (feeling sick), muscle weakness, confusion, tiredness and muscle twitching due to abnormally low levels of salt (sodium) in blood (hyponatraemia)
■ A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
■ Fits (convulsions)
Very common side effects (may affect more than 1 in 10 people)
■ Feeling your heartbeat (palpitations)
■ Increased sweating
■ Sleeping disorders, drowsiness (somnolence), lethargy (urge to sleep), difficulty sleeping (insomnia)
■ Eyes unable to focus properly
■ General weakness (asthenia)
■ Dry mouth
■ Feeling sick (nausea)
■ Constipation
■ Headache
■ Being sick (vomiting)
■ Gastric discomfort (e.g. indigestion, heartburn), stomach pain, wind (flatulence)
■ Faster heartbeat (tachycardia)
■ Low or high blood pressure (hypotension, hypertension)
■ Dizziness and possibly fainting (possibly only when you stand up) due to low blood pressure (orthostatic hypotension)
■ Fever (pyrexia)
■ Shakiness (tremor)
■ Tingling or numbness in the hands or feet (paraesthesia)
■ Tiredness (fatigue), abnormal dreams
■ Dizziness
■ Migraine
■ Ringing in the ears (tinnitus)
■ Visual disturbances
■ Runny nose (rhinitis), swelling of the lining of the sinuses (sinusitis)
■ Yawning
■ Difficulties urinating (micturition disorder)
■ Severe itching (pruritus), rash
■ Muscle pain (myalgia), joint pain (arthralgia)
■ Ejaculation problems, inability to maintain an erection (impotence)
■ Menstrual pain (dysmenorrhoea)
■ Orgasm difficulties (female)
■ Reduced libido
■ Confusion
■ Indifference (apathy)
■ Concentration disturbances, memory loss (amnesia)
■ Increased salivation
■ Excessive secretion of urine (polyuria)
Uncommon side effects (may affect up to 1 in 100
people):
■ Seeing or hearing things that are not real (hallucinations)
■ Fainting
■ Cramps
■ Movement disorders (medicine-induced)
■ Enlarged pupils (mydriasis), which may lead to glaucoma
■ Slower heartbeat (bradycardia)
■ Coughing
■ Difficulties urinating, possibly urinary retention.
■ Skin rashes with the formation of wheals (urticaria)
■ Hair loss (alopecia)
■ Increased sensitivity of the skin to light (photosensitivity)
■ Skin rash caused by small blood vessels bleeding into the skin (purpura)
■ Unusually heavy menstrual bleeding (menorrhagia)
■ Aggression
■ Feeling detached from yourself (depersonalisation)
■ Increased libido
■ Increased weight, increased appetite
■ Feeling unwell (malaise)
Rare side effects (may affect up to 1 in 1000 people)
■ Anti-Diuretic Hormone (ADH) is produced by the brain and is stored in and released by the pituitary gland. ADH controls how your body releases and conserves water. SIADH occurs when ADH is produced somewhere other than the brain, which makes it difficult for your body to get rid of excess water. This causes a build-up of fluids as well as abnormally low sodium levels
■ Loss of consciousness and violent muscle contractions (grand mal seizure)
■ Involuntary movements or movement disorders (dyskinesia)
■ Taste disturbances
■ Severe bleeding (haemorrhage)
■ Extreme restlessness accompanied by an increase in muscle spasms, tremors and twitching (psychomotor restlessness/akathisia)
■ Inflammation of the liver (hepatitis)
Very rare side effects (may affect up to 1 in 10,000
people)
■ Abnormal production of breast milk in men and women (galactorrhoea)
Other side effects (frequency not known)
■ Weakness, reduced muscle power, quivering and abnormal heart rhythm due to low potassium levels in the blood (hypokalaemia)
■ Nose bleeds (epistaxis)
■ Bruising (ecchymosis)
■ Irregular, heavy menstrual bleeding (metrorrhagia)
■ Persistent, painful erection (priapism)
■ Panic attacks
■ Teeth grinding (bruxism)
■ Restlessness
■ Movement disorders
■ An increased risk of bone fractures has been observed in patients (particularly aged 50 years and older) taking this type of medicine
■ Changes in certain laboratory test results, such as liver counts
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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Citalopram
■ Keep this medicine out of the sight and reach of children.
■ Do not use this medicine after the expiry date which is stated on the carton/blister/container after EXP. The expiry date refers to the last day of that month.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
□ Contents of the pack and other information
What Citalopram contains:
Each film-coated tablet contains 10mg citalopram (as Citalopram Hydrobromide).
The other ingredients are: microcrystalline cellulose, glycerol 85%, magnesium stearate, maize starch, lactose monohydrate, copovidone, sodium starch glycollate (type A), macrogol 6000, hypromellose, talc and titanium dioxide (colouring agent E 171).
What Citalopram looks like and contents of the pack:
Citalopram 10mg are white, round, film- coated tablets without a score line.
Citalopram is available in:
Citalopram 10mg are available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98 or 100 tablets and bottles containing 100 or 250 tablets.
Not all pack sizes or pack types may be marketed.
Product Licence Number:
PL 11311/0415
Marketing Authorisation Holder
Tillomed Laboratories Ltd.,
3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 8ET, United Kingdom
Manufacturer
Salutas Pharma GmbH Otto-von-Guericke-Allee 1,
D-39179 Barleben,Germany
This leaflet was revised in March 2016
Common side effects (may effect up to 1 in 10 people):
■ Decreased appetite, weight loss
■ Agitation, anxiety, nervousness
■ Diarrhoea
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