Document: document 26 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6
• document 7
• document 8
• document 9
• document 10
• document 11
• document 12
• document 13
• document 14
• document 15
• document 16
• document 17
• document 18
• document 19
• document 20
• document 21
• document 22
• document 23
• document 24
• document 25
• document 26
• document 27
• document 28
• document 29
• document 30

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

ESCITALOPRAM 5 mg FILM-COATED TABLETS ESCITALOPRAM 10 mg FILM-COATED TABLETS ESCITALOPRAM 20 mg FILM-COATED TABLETS

escitalopram

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 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.

What is in this leaflet:

1.    What Escitalopram is and what it is used for

2.    What you need to know before you take Escitalopram

3.    How to take Escitalopram

4.    Possible side effects

5.    How to store Escitalopram

6.    Contents of the pack and other information.

1. What Escitalopram is and what it is used for Escitalopram belongs to a group of medicines called Selective Serotonin Re-uptake Inhibitor (SSRI) antidepressants. These medicines act on the serotonin-system in the brain by increasing the serotonin level. Disturbances in the serotonin-system are considered an important factor in the development of depression and related diseases.

Escitalopram can be given to treat the following conditions:

•    depression (major depressive episodes)

•    panic disorder which may or may not be associated with agoraphobia (fear of open spaces)

2. What you need to know before you take Escitalopram

Do not take Escitalopram:

•    if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of this medicine (listed in section 6 "Further information”)

•    if you take other medicines that belong to a group called MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic)

•    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 (see section 2 "Other medicines and escitalopram”)

Warnings and precautions

Talk to your doctor or pharmacist before taking

Escitalopram:

•    if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage

•    if you are elderly

•    if you have epilepsy or have a history of fits (seizures). Treatment with Escitalopram should be stopped if seizures occur for the first time, or if there is an increase of seizure frequency (see also section 4 "Possible side effects”)

•    if you have a history of mania (overactive behaviour or thoughts)

•    if you are receiving electro-convulsive therapy (ECT)

•    if you have a tendency to easily develop bleeding or bruises

•    if you suffer from diabetes. Treatment with Escitalopram may alter glycaemic control (control of blood sugar levels). Your dosage of Insulin and/ or oral hypoglycaemic medicine may need to be adjusted.

•    if you have a decreased level of sodium in the blood.

•    if you have coronary heart disease

•    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 heart beat, fainting, collapse or dizziness on standing up, which may indicate abnormal functioning of the heart rate

•    if you suffer glaucoma (increased pressure in the eye) Please note

Some patients with manic-depressive illness may enter into a manic phase. This is characterised by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty in sitting or standing still can also occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms.

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 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 18 years of age Escitalopram 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 attempts, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Escitalopram for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed Escitalopram for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any symptoms listed above develop or get worse when patients under 18 are taking Escitalopram. Also, the long term safety effects of Escitalopram concerning growth, maturation and cognitive and behavioural development in this age group have not yet been demonstrated.

Other medicines and Escitalopram

Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines.

It is especially important to tell your doctor if you are using some of the following medicines:

•    'Non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, isocarboxazid, nialamide and tranylcypromine as active ingredients. If you have taken any of these medicines you will need to wait 14 days before you start taking Escitalopram. After stopping Escitalopram you must allow 7 days before taking any of these medicines.

•    Reversible, selective MAO-A inhibitors, containing moclobemide (used to treat depression)

•    Irreversible MAO-B inhibitors, containing selegiline (used to treat Parkinson's disease). These increase the risk of side effects.

•    Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These increase the risk of side effects.

•    The antibiotic linezolid

•    Cimetidine, omeprazole and lansoprazole (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These may cause increased blood levels of Escitalopram.

•    St. John's Wort (Hypericum perforatum) - a herbal remedy used for depression.

•    Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (NSAIDS) (medicines used for pain relief or to thin the blood, so called anticoagulant). These may increase bleeding-tendency.

•    Warfarin, dipyridamole and phenprocoumon or other anticoagulants (medicines used to thin the blood). Your doctor will probably check the coagulation time of your blood when starting and discontinuing Escitalopram to make sure that your dose of anti-coagulant is still adequate.

•    Mefloquin (used to treat malaria), bupropion (used when trying to stop smoking or treat depression) and tramadol (used to treat severe pain) due to a possible risk of a lowered threshold for seizures (fits).

•    Neuroleptics (medicines to treat schizophrenia, psychosis) and antidepressants and other SSRI's, due to a possible risk of a lowered threshold for seizures.

•    Flecainide, propafenone and metoprolol (used in cardio-vascular diseases) and desipramine, clomipramine and nortriptyline (used to treat depression) and risperidone, thioridazine and haloperidol (antipsychotics). Your dosage of Escitalopram may need to be adjusted.

•    Lithium (used in the treatment of manic-depressive disorder) and tryptophan.

•    Imipramine and desipramine (both used to treat depression).

•    Medicines that induce low potassium levels in the blood (hypokalaemia) or low magnesium levels in the blood (hypomagnesaemia).

Do not take Escitalopram if you take medicines for heart rhythm problems or medicines that may affect the heart's rhythm, such as Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (e.g. astemizole, mizolastine). If you have any further questions about this you should speak to your doctor. Escitalopram with food, drink and alcohol Escitalopram can be taken with or without food (see section 3 "How to take Escitalopram”)

You should avoid alcohol while you are taking this medicine.

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.

Pregnancy

Tell your doctor if you are pregnant or planning to get pregnant. Do not take Escitalopram if you are pregnant unless you and your doctor have discussed the risks and benefits involved. You should not discontinue treatment with Escitalopram abruptly. Make sure your midwife and/or doctor know you are on Escitalopram. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram 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.

Other symptoms that may occur when Escitalopram is used in the late stages of pregnancy might include trouble with breathing, blue-ish skin, fits, body temperature changes, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleeping difficulties. If your baby has any of these symptoms when it is born, talk to your doctor immediately who will be able to advise you. Breast-feeding

Tell your doctor if you are breast-feeding. Escitalopram is likely to pass into breast milk.

Do not breast-feed if you are taking Escitalopram. Your doctor will decide whether you should continue/discontinue breast-feeding or continue/ discontinue the therapy with Escitalopram.

Fertility

Citalopram, a medicine like Escitalopram, 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

Do not drive or use machines until you know how

Escitalopram affects you.

Escitalopram 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.

				Date: 25 OCT 2013		Time: 08:5<	8
Description	Escitalopram 5/10/20 mg 28			No. of colours	1	Page Count	1/2
Component Type	Leaflet	Vendor Job No.	215103	Colours	Black
Affiliate Item Code	10005317	Proof No.	3		■■
TrackWise PR No.	N/A	Client Market	UK	Non-Print
MA No.	04569/0776 0777 0778	Keyline/DrawingNioj	NA	Colours
Packing Site/Printer	GE Pharma	Barcode Info	N/A	Main Font	Myriad Pro	Body Text Size	9 pt
Supplier Code	N/A	Dimensions	160 x 480mm	This proof represents how this job will image on plate. Please check thoroughly to ensure it meets your requirements as NO liability will be accepted for consequential loss.
Pharma Code	TBC
Sign-offs

3. How to take Escitalopram Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Remember that you may need to take Escitalopram tablets for 2 or more weeks before you begin to feel better.

ADULTS

Depression - The recommended dose is 10 mg of escitalopram a day. Your doctor may increase this dose to a maximum of 20 mg a day. It may take 2 to

4    weeks before you start to feel better. Treatment should last for at least 6 months after you feel better. Panic disorder - The recommended starting dose is

5    mg of escitalopram a day. After the first week, this dose may be increased by your doctor to 10 mg a day, and if necessary up to a maximum dose of 20 mg a day. The maximum effect is reached after 3 months. ELDERLY PATIENTS (above 65 years of age)

Your doctor will give you a lower dose to that stated above, as elderly patients may be more sensitive to the effects of escitalopram. The recommended starting dose of escitalopram is 5 mg taken as one daily dose. The dose may be increased by your doctor to 10 mg per day.

USE IN CHILDREN AND ADOLESCENTS (below 18 years of age)

Escitalopram should not normally be given to children and adolescents under the age of 18. For further information please see section 2 "What you need to know before you take Escitalopram".

If you have liver or severe kidney problems, your doctor will give you a lower dose than stated above. You can take Escitalopram with or without food. Swallow the tablet with some water. Do not chew them, as the taste is bitter.

Keep on taking your tablets for as long as your doctor recommends, even after you start to feel better. This should be for at least six months after you recover to stop your symptoms coming back.

If you take more Escitalopram than you should Contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort. Some symptoms of the signs of overdose could be dizziness, shaking, agitation, convulsion, coma, feeling and being sick, change in heart rhythm (slower or faster heartbeat), decreased blood pressure and change in body fluid/salt balance. Take the container and any remaining tablets with you when you go to the doctor or hospital.

If you forget to take Escitalopram Do not take a double dose to make up for a forgotten dose. If you do forget to take a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day. If you only remember during the night, or the next day, leave out the missed dose and carry on as usual.

If you stop taking Escitalopram Do not stop taking Escitalopram until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of Escitalopram is gradually reduced over a number of weeks.

When you stop taking Escitalopram, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with Escitalopram is stopped. The risk is higher, when Escitalopram has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more). If you get severe discontinuation symptoms when you stop taking Escitalopram, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.

Discontinuation symptoms include: feeling dizzy (unsteady or off-balance), feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headaches, feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances and fluttering or pounding heartbeat (palpitations).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects may also be symptoms of your illness and therefore will improve when you start to get better. See your doctor if you get any of the following side effects during treatment:

Unusual bleeds, including gastrointestinal bleeds If you experience swelling of skin, tongue, lips, or face, or have difficulties breathing or swallowing (allergic reaction), contact your doctor or go to a hospital straight away.

If you have a high fever, agitation, confusion, trembling and abrupt contractions of muscles these may be signs of a rare condition called serotonin syndrome. If you feel like this contact your doctor.

If you experience the following side effects you should contact your doctor or go to the hospital straight away:

•    difficulties urinating

•    seizures (fits), see also "Warnings and precautions"

•    yellowing of the skin and the white in the eyes are signs of liver function impairment/hepatitis

•    fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsades de Pointes

In addition to above the following side effects have been reported:

Very common may affect more than 1 in 10 people

•    headache

•    feeling sick (nausea)

Common may affect up to 1 in 10 people

•    lack of appetite

•    increased appetite

•    weight increase

•    feeling anxious or restless

•    difficulty falling asleep

•    feeling sleepy

•    abnormal dreams

•    tingling or numbness of the hands and feet

•    shaking (tremors)

•    feeling dizzy

•    yawning

•    inflamed swollen sinuses causing pain, high temperature, tenderness (known as sinusitis)

•    diarrhoea

•    constipation

•    vomiting

•    dry mouth

•    increased sweating

•    fever

•    muscle or joint pain

•    feeling unusually tired

•    sexual problems (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)

Uncommon may affect up to 1 in 100 people

•    feeling confused

•    agitated

•    nervous

•    grinding teeth while asleep

•    panic attack

•    taste disturbance

•    change in your sleep pattern

•    fainting

•    enlarged pupils (mydriasis), visual disturbance

•    ringing in the ears (tinnitus)

•    fast heart beat

•    nose bleed

•    decreased weight

•    bleeding from the gut including the rectum seen as blood in the stools

•    hair loss

•    nettle rash or hives

•    rash

•    itchy skin

•    heavy periods or bleeding between periods

•    swelling of the arms or legs

Rare may affect up to 1 in 1,000 people

•    feeling aggressive or detached from yourself

•    hallucinations

•    slow heart beat

Some patients have reported (frequency cannot be estimated from the available data):

•    thrombocytopenia (reduction in blood platelets which increases risk of bleeding and bruising)

•    sudden swelling of skin or mucosa (angioedemas)

•    increase in the amount of urine excreted (inappropriate ADH secretion)

•    a lower than normal level of sodium in the blood making you feel weak and confused with aching

•    mania (feeling elated or over-excited, which causes unusual behaviour)

•    thoughts of harming yourself or thoughts of killing yourself, see also section "Warnings and precautions"

•    abnormal muscle movements

•    convulsions

•    dizziness when you stand up due to low blood pressure (orthostatic hypotension)

•    changes to the results of liver enzyme tests

•    persistent painful erection of the penis

•    flow of milk in women that are not nursing

•    an increased risk of bone fractures has been observed in patients taking this type of medicine

•    alteration of the heart rhythm (called "prolongation of QT interval') seen on ECG, electrical activity of the heart)

In addition, other side effects are known to occur with drugs that work in a similar way as escitalopram. These are:

•    restlessness or difficulty sitting still (psychomotor restlessness/akathisia)

•    anorexia

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 this medicine.

5. How to store Escitalopram Tablets

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 tablet container /blister and the carton after 'EXP mm/yyyy' used for the expiry date. The expiry date refers to the last day of that month. Store below 25 °C.

Do not use this medicine if you notice visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask you pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Further information What Escitalopram contains

The active substance is escitalopram.

One tablet contains 5 mg, 10 mg or 20 mg of escitalopram (as oxalate). The other ingredients are: Tablet core:

microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium and magnesium stearate. The coating contains lactose monohydrate, macrogol 4000, titanium dioxide (E171) and hypromellose.

What Escitalopram Tablets look like and contents of the pack

Escitalopram is a film-coated tablet.

The 5 mg film-coated tablets are white, round and marked 'EC 5' on one side and 'G' on the other side. The 10 mg film-coated tablets are white, oblong, scored and marked with "EC|10" on one side and "G" on the other. The tablet can be divided into equal halves. The 20 mg film-coated tablets are white, oblong, scored and marked with "EC|20" on one side and "G" on the other. The tablet can be divided into equal halves. Escitalopram is available in blisters of 28 film-coated tablets.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL,

United Kingdom.

Manufacturer

Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.

This leaflet was last revised in 10/2013    10005317

				Date: 25 OCT 2013		Time: 08:5<	8
Description	Escitalopram 5/10/20 mg 28			No. of colours	1	Page Count	2/2
Component Type	Leaflet	Vendor Job No.	215103	Colours	Black
Affiliate Item Code	10005317	Proof No.	3		■■
TrackWise PR No.	N/A	Client Market	UK	Non-Print
MA No.	04569/0776 0777 0778	Keyline/DrawingNoj	NA	Colours
Packing Site/Printer	GE Pharma	Barcode Info	N/A	Main Font	Myriad Pro	Body Text Size	9 pt
Supplier Code	N/A	Dimensions	160 x 480mm	This proof represents how this job will image on plate. Please check thoroughly to ensure it meets your requirements as NO liability will be accepted for consequential loss.
Pharma Code	TBC
Sign-offs