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PATIENT INFORMATION LEAFLET

Citalopram 20mg and 40mg Film-Coated Tablets

Each film-coated tablet contains 20mg or 40mg of Citalopram (as Citalopram hydrobromide)

Important things you need to know about Citalopram:

■    Citalopram treats major depression. 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 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:

What Citalopram is and what it is used for    |4 Possible side effects

■ 2 What you need to know before you take Citalopram Q How to store Citalopram

■ 3 How to take Citalopram    Q Contents of the pack and other information

What Citalopram is and what it is used for

Citalopram belongs to a group of antidepressants called SSRIs (Selective Serotonin Reuptake Inhibitors).

Citalopram is used to treat major depression.

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")

■    You are taking the medicine pimozide, used to treat mental disorders (see "Other medicines and Citalopram" section)

■    You are taking or have recently taken medicines used to treat depression called Monoamine Oxidase Inhibitors (MAOIs) e.g. moclobemide (see "Other medicines and Citalopram" section), Before starting treatment with Citalopram, you may have to wait for up to 14 days after stopping the use of a MAOI. The MAOI selegiline (used to treat Parkinson's disease) may be used, but not in doses exceeding 10mg per day. When changing from Citalopram, you have to wait for at least 7 days before you start taking MAOIs.

■    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)

■    You take medicines for heart rhythm problems or that may affect the heart's rhythm (see "Other medicines and Citalopram" section)

Warnings and precautions

Talk to your doctor before taking Citalopram if:

■    You have liver problems as your dose may need to be reduced and you should be closely monitored

■    You suffer from severe kidney problems as the use of Citalopram is not recommended

■    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 have a history of bleeding disorders or are taking anticoagulant medicines (for thinning the blood) (see 'Other medicines and Citalopram" section)

■    You have diabetes as your dose of your diabetic medicine may need to be adjusted (see 'Other medicines and Citalopram" section)

■    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 are receiving ECT (Electro-Convulsive Treatment)

■    You or the patient is under 18 years of age (see "Use in children and adolescents under the age of 18 years" section below)

■    You are older (above 65 years of age)

■    You suffer from a panic disorder as you may need to start treatment with a low dose

■    You have abnormally low levels of salt (sodium) in your 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 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

■    You have or are at risk of increased pressure in the eye (glaucoma) as Citalopram can cause dilation of the pupils (mydriasis)

■    You are taking serotonergic medicines (antidepressants) such as sumatriptan or other triptans, tramadol, oxitriptan or 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

■    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)

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You may be more likely to think like this:

■    if you have previously had thoughts about killing or harming yourself.

■    if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in 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 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 anti-arrhythmics

■    Anti-psychotics, medicines used to treat mental health problems (phenothiazine derivatives, pimozide, haloperidol)

■    Tricyclic antidepressants such as clomipramine, nortriptyline, imipramine and desipramine

■    Certain anti-microbial 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

■    Medicines for thinning your blood such as warfarin,

■    Non-Steroidal Anti-Inflammatory Drugs (NSAID's) (aspirin)

■    Dipyridamol (used to treat thrombosis)

■    Ticlopidine (used to reduce the risk of stroke)

■    SSRI antidepressants (fluvoxamine)

■    Cimetidine, omeprazole, esomeprazole and lansoprazole (used to treat indigestion, stomach ulcers and heartburn)

■    Lithium, a medicine used to treat mood disorders

■    Mefloquin (used to treat malaria)

■    Bupropion (used to help you stop smoking)

■    Butyrophenones, phenothiazines such as chlorpromazine, thioxanthenes, risperidone

and thioridazine (used to treat mental and emotional conditions)

■    Medicines that decrease blood levels of potassium or magnesium

■    Flecainide, propafenone and metoprolol (when used for heart failure)

■    Medicines used to treat diabetes, as the dose may need to be adjusted

Taking Citalopram with food and drink and 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 your doctor considers it absolutely necessary. You should not discontinue treatment with Citalopram abruptly.

If you take Citalopram, particularly in the last 3 months of pregnancy, the following symptoms may occur in your baby: not being able to sleep or feed well, having trouble breathing, blue coloured skin, being too hot or cold, being sick, low blood sugar levels, crying a lot, irritability, stiff or floppy muscles, abnormally increased reflexes, lacking energy, drowsiness, shaking, jitters or fits. Any effects usually begin on the first day after birth. If your baby has any of these symptoms when it is born, contact your midwife and/or doctor who will be able to advise you.

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.

Breast-feeding

Citalopram passes into breast milk in small amounts and may affect your 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.

Driving and using machines

Citalopram may affect your ability to drive and use machines since it can reduce the ability to make judgements and to react to emergencies. If this occurs, you should not drive or operate any machinery.

continued....

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

When stopping Citalopram, your doctor will help you to gradually take less of the medicine. This will be over a period of at least one to two weeks. As you take less Citalopram you may notice some side effects. If you notice any effects when you are reducing Citalopram, your doctor may decide that you should come off it more slowly. If you notice any severe effects, talk to your doctor. Your doctor may ask you to start taking Citalopram again and reduce your dose more slowly.

Withdrawal symptoms are common, particularly if treatment is stopped suddenly e.g. feeling dizzy, feelings like pins and needles (paraesthesia), finding it difficult to sleep (insomnia) or having intense dreams, feeling anxious or agitated, headaches, 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 (may affect more than 1 in 10 people)

■    Headache

■    Feeling sick (nausea)

■    Dry mouth

■    Constipation

■    Increased sweating

■    Feeling your heartbeat (palpitations)

■    Feeling of weakness (asthenia)

■    Eyes unable to focus properly

■    Sleep disorders including feeling sleepy (somnolence/lethargy) or difficulty sleeping (insomnia)

Common side effects (may affect up to 1 in 10 people)

■    Abnormal dreams

■    Memory loss (amnesia)

■    Feeling agitated, anxious or nervous

■    Reduced sex drive (libido)

■    Loss of appetite

■    Lack of feeling or emotion (apathy)

■    Confusion

■    Migraine

■    Faster heartbeat (tachycardia)

■    Low blood pressure (hypotension)

■    High blood pressure (hypertension)

■    Indigestion (dyspepsia)

■    Being sick (vomiting)

■    Abdominal pain

■    Excessive wind

■    Unable to ejaculate

■    Runny nose (rhinitis)

■    Painful periods (dysmenorrhoea)

■    Skin rashes

■    Severe itching (pruritus)

■    Visual disturbances

■    Tiredness (fatigue) and yawning

■    Problems with concentration

■    Weight decrease

■    Increased production of saliva

■    Unable to have a female orgasm

■    Unable to maintain an erection (impotence)

■    Need to pass urine more frequently (polyuria) and a larger amount (micturition disorder)

■    Tingling or numbness in the hands or feet (paraesthesia)

■    Dizziness

■    Light headedness or fainting on standing up due to a fall in blood pressure (orthostatic hypotension)

■    Inflammation of the sinuses (sinusitis)

■    Shakiness (tremor)

■    Ringing in the ears (tinnitus)

■    Diarrhoea

■    Muscle pain (myalgia)

■    Joint pain (athralgia)

■    Fever (pyrexia)

Uncommon side effects (may affect up to 1 in 100

people)

■    Increased appetite

■    Weight increase

■    Aggression

■    Feeling detached from yourself (depersonalisation)

■    Seeing or hearing things that are not real (hallucinations)

■    Coughing

■    Feeling unwell (malaise)

■    Slower heartbeat (bradycardia)

■    Fainting

■    Cramps

■    Increased sex drive (libido)

■    Increased sensitivity to light (photosensitivity)

■    Medicine-induced changes in muscular movement (extrapyramidal disorders)

■    Dilation of the pupil of the eye (mydriasis)

■    Sudden eye pain, red eyes and reduced vision caused by pressure inside the eye rising quickly (acute narrow angle glaucoma)

■    Skin rashes with the formation of wheals (urticaria)

■    Skin rash caused by small blood vessels bleeding into the skin (purpura)

■    Hair loss (alopecia)

■    Difficulty in passing urine

■    Abnormally heavy and prolonged menstrual period at regular intervals (menorrhagia)

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 abnormalities

■    Extreme restlessness accompanied by an increase in muscle spasms, tremors and twitching (psychomotor restlessness/akathisia)

■    Severe bleeding (haemorrhage)

■    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 abnormally low levels of potassium in blood (hypokalaemia)

■    Feeling of panic

■    Excessive grinding of the teeth and/or clenching of the jaw (bruxism)

■    Restlessness

■    Movement disorders

■    Nose bleeds (epistaxis)

■    Abnormal liver function tests

■    Bruising (ecchymosis)

■    Bleeding from the uterus between menstrual periods (metrorrhagia)

■    Persistent and often painful erection that lasts for several hours (priapism)

■    An increased risk of bone fractures has been observed in patients (particularly aged 50 years and older) taking this type of medicine

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.

15 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 20mg or 40mg 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 20mg are white, oblong, biconvex, film-coated tablets with a one sided notch and the embossment C20.

■    Citalopram 40mg are white, oblong, biconvex, film-coated tablets with a one sided notch and the embossment C40.

Citalopram is available in:

■    Citalopram 20mg are available in blisters packs of 12, 14, 20, 28, 30, 50, 50 x 1,56, 98, 100 or 250 tablets and bottles containing 250 tablets.

■    Citalopram 40mg are available in blisters packs of 10, 14, 20, 28, 30, 50, 56, 98 or 100 tablets and bottles containing 250 tablets.

Not all pack sizes or pack types may be marketed.

Product Licence Numbers:

Citalopram 20mg Film-Coated Tablets: PL 11311/0416 Citalopram 40mg Film-Coated Tablets: PL 11311/0418

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 last revised in March 2016

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