Escitalopram 5mg Film Coated Tablets
Out of date information, search anotherPackage leaflet: Information for the user
Escitalopram 5mg, 10mg and 20mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet J What Escitalopram is and what it is used for
What you need to know before you take Escitalopram How to take Escitalopram ^ Possible side effects How to store Escitalopram Contents of the pack and other information
J What Escitalopram is and what it is used for
Escitalopram is an antidepressant which belongs to the 'SSRI' group (selective serotonin reuptake inhibitors). 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 is used to treat:
• Depressive disorders (episodes of a major depression)
• Panic disorder with or without agoraphobia (e.g. fear of leaving the house, entering shops, being in crowds and in public places)
• Social anxiety disorder (social phobia)
• Obsessive-compulsive disorder
What you need to know before you take Escitalopram Do not take Escitalopram
• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6)
• if you take other medicines which belongs 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, pharmacist or nurse before taking Escitalopram.
Please tell your doctor if you have any other condition or illness, as your doctor may need to take this into consideration. In particular, tell your doctor if you:
• have epilepsy. Treatment with Escitalopram should be stopped if seizures occur or if there is an increase in the seizure frequency (see also section 4 "Possible side effects”)
• suffer from impaired liver or kidney
function. Your doctor may need to adjust your dosage
• have diabetes. Treatment with Escitalopram may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted
• have a decreased level of sodium in the blood
• have low levels of potassium or magnesium in your blood (hypookalemia/ hypomagnesaemia).
• have a tendency to easily develop bleedings or bruises
• are receiving electroconvulsive treatment
• have coronary heart disease
• suffer or have suffered from heart problems or have recently had a heart attack
• suffer from a heart condition called 'QT-prolongation' or if the condition runs in your family
Continued top of next column AAAG7572
• 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 or have a history of glaucoma.
Please note
Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty to sit or stand 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 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.
Children and adolescents
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 (predominately 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 worsen when patients under 18 are taking Escitalopram. Also, the long term safety effects concerning growth, maturation and cognitive and behavioural development of Escitalopram 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.
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-malarian treatment particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions about this you should speak to your doctor.
Tell your doctor if you are taking any 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
• The antibiotic linezolid
Continued top of next column
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain) These increase the risk of side effects
• Cimetidine and omeprazole (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 and non-steroidal antiinflammatory drugs (medicines used for pain relief or to thin the blood, so called anti-coagulant)
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anti-coagulant). Your doctor will probably check the coagulation time of your blood when starting and discontinuing Escitalopram in order to verify that your dose of anti-coagulant is still adequate
• Mefloquin (used to treat Malaria), bupropion (used to treat depression and to help you quit smoking) and tramadol (used to treat severe pain) due to a possible risk of a lowered threshold for seizures
• Neuroleptics (medicines to treat schizophrenia, psychosis) due to a possible risk of a lowered threshold for seizures, and antidepressants
• Flecainide, propafenone, and metoprolol (used in cardio-vascular diseases) desipramine, clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Escitalopram may need to be adjusted
• Medicines that prolong the so-called 'QT interval' or medicines which lower potassium or magnesium levels in the blood. Ask your doctor for advice on these medicines.
Escitalopram with food, drink and alcohol
Escitalopram can be taken with or without food (see section 3 "How to take Escitalopram”).
As with many medicines, combining Escitalopram with alcohol is not advisable, although Escitalopram is not expected to interact with alcohol.
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.
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 new born (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 Escitalopram during the last 3 months of your pregnancy you should be aware that the following effects may be seen in your newborn baby: 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 newborn baby has any of these symptoms, please contact your doctor immediately.
If used during pregnancy Escitalopram should never be stopped abruptly.
Do not take Escitalopram if you are breastfeeding unless you and your doctor have discussed the risks and benefits involved.
Ask your doctor or pharmacist for advice before taking any medicine.
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
This medicine can alter reaction times severely enough, even when used as indicated, to impair the ability to drive or use machinery. Do not drive a car or operate machinery until you know how Escitalopram affects you.
Continued over page
_3| How to take Escitalopram
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
To treat depression
The recommended dose of Escitalopram is 10mg taken as one daily dose. The dose can be increased by your doctor to a maximum of 20 mg per day.
To treat panic disorders, with or without agoraphobia
The starting dose of Escitalopram is 5 mg as one daily dose for the first week before increasing the dose to 10mg per day. The dose may be further increased by your doctor to a maximum of 20 mg per day.
To treat social anxiety disorder (social phobia)
The recommended dose of Escitalopram is 10 mg taken as one daily dose. Depending on your response to the treatment, your doctor can either decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg daily.
To treat Obsessive-Compulsive Disorder (OCD)
The recommended dose of Escitalopram is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg daily. For long-term treatment, the benefits of treatment should be regularly checked.
Elderly patients (above 65 years of age)
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.
The efficacy of Escitalopram in social anxiety disorder (social phobia) in elderly patients has not been studied.
Patients with impaired liver function
The recommended starting dose of Escitalopram for patients with impaired liver function should not exceed 5 mg daily in the first 14 days. Your doctor can then raise the daily dose, depending on your response, up to 10 mg daily. Caution and an especially careful dose titration are indicated in patients with severely impaired liver function.
Patients with impaired kidney function
With mild to moderate impairment of kidney function, no dose adjustment is required. Caution is indicated for patients with severely impaired kidney function.
Use in children and adolescents (below 18 years of age)
Escitalopram should not normally be given to children and adolescents. For further information please see section 2 "What you need to know before you take Escitalopram”
Escitalopram 5mg Film-coated Tablets:
Please take the film-coated tablets once daily, swallowed whole with sufficient fluid (preferably a glass of water). Escitalopram may be taken with or without food.
Escitalopram 10mg and 20mg Film-coated Tablets:
Please take the film-coated tablets once daily, swallowed whole with sufficient fluid (preferably a glass of water). Escitalopram may be taken with or without food.
If necessary, tablets may be broken by firstly placing the tablet on a flat surface with the score facing upwards. The tablets may then be broken by pressing down on each end of the tablet, using both forefingers as shown in the drawing.
Duration of treatment
It may take a couple of weeks before you start to feel better. Continue to take Escitalopram even if it takes some time before you feel any improvement in your condition. Do not change the dose of your medicine without talking to your doctor first. Continue to take Escitalopram for as long as your doctor recommends. If you stop your treatment too soon, your symptoms may return. It is recommended that treatment should be continued for at least 6 months after you feel well again.
If you take more Escitalopram than you should.
If you have taken more Escitalopram than you should, or if someone else has taken your medicine by mistake, inform your doctor or go to a hospital straight away. Do this even if you still feel well. Take any remaining tablets as well as the box/container with you, even if this is empty.
Symptoms of overdose might include dizziness, shaking, restlessness, feeling sleepy, falling unconscious, change in heart rhythm, fits, hypoventilation, muscle weakness, tenderness or pain and feeling unwell or have a high temperature (rhabdomyolysis), change in body fluid/salt balance, vomiting and being sick.
If you forget to take Escitalopram.
Do not take a double dose to make up for forgotten doses. If you should forget to take a dose of Escitalopram, just take Escitalopram as usual the next time.
If you stop taking Escitalopram.
If you want to interrupt the treatment, please discuss this with your doctor beforehand. He might need to take appropriate measures.
Do not stop taking the medicine on your own initiative without discussing this with your doctor. When stopping treatment with Escitalopram, your doctor will gradually reduce your dose over a number of weeks or months. This should help reduce the possibility of withdrawal effects.
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) and vomiting, sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling emotional or irritable, diarrhoea (loose stools), visual disturbances, fluttering or pounding heartbeat (palpitations).
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
^ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects most commonly occur in the first or second week of treatment, and normally become less severe and less frequent as treatment continues.
See your doctor if you get any of the following side effects during treatment: Uncommon (more than 1 out of 1000 persons and less than 1 out of 100 persons):
• Unusual bleeds, including gastrointestinal bleeds
Rare (more than 1 out of 10000 and less than 1 out of 1000 persons):
• 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 experience the following side affects you should contact your doctor or go to the hospital straight away:
• Difficulties urinating
• Seizures (fits)
• 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 (more than 1 out of 10 persons):
• Feeling sick (nausea)
• Headache
Common (more than 1 out of 100 persons and less than 1 out of 10 persons):
• Generalised fear, restlessness, abnormal dreams, difficulty in sleeping, sleepiness, dizziness, a skin sensation, such as burning, prickling, itching, or tingling, with no apparent physical cause, tremor, yawning
• Sexual disturbances (delayed ejaculation, problem with erection, decreased sexual drive and women may experience difficulties achieving orgasm)
• Diarrhoea, constipation, vomiting, dry mouth
• Blocked or runny nose (sinusitis)
• Increased sweating
• Fatigue, fever
• Joint and muscle pain
• Increased weight
• Decreased or increased appetite
Uncommon (more than 1 out of 1000 persons and less than 1 out of 100 persons):
• Involuntary grinding or clenching of the teeth, agitation, nervousness, panic attack, confusion state
• Taste disturbance, sleep disorder, fainting
• Nosebleed
• Bleeding from the uterus that is not associated with menstruation, abnormally heavy or extended menstrual flow
• Nettle rash (urticaria), rash, itching (pruritus)
• Hair loss
• Swelling of the arms or legs
• Enlarged pupils (mydriasis), blurred vision, ringing in the ears (tinnitus)
• Fast heart beat
• Decreased weight
Rare (more than 1 out of 10000 and less than 1 out of 1000 persons):
• Aggression, depersonalisation, hallucination
• Slow heart beat
Some patients have reported (frequency cannot be estimated from the available data):
• Thoughts of harming yourself or thoughts of killing yourself, see also section "Warnings and precautions”
• Mania
• Movement disorders (involuntary movements of the muscles)
• Flow of milk in women that are not nursing
• Painful erection of the penis
• Bleeding disorders including skin and mucous bleeding (ecchymosis) and low level of blood platelets (thrombycytopenia)
• Dizziness when you stand up due to low blood pressure (orthostatic hypotension)
• Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused)
• Increase in the amount of urine excreted (inappropriate ADH secretion)
• Abnormal liver function test (increased amounts of liver enzymes in the blood)
• Sudden swelling of the skin and mucosa (angioedemas)
• Suicide-related events
• Inability to sit still or remain motionless, feeling of restlessness associated with increased movement*
• Anorexia*
• 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)
• These side effects have been reported with drugs that work in a similar way to escitalopram (the active ingredient of Escitalopram).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
How to store Escitalopram
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 blister strips, tablet container and carton after EXP. The expiry date refers to the last day of that month.
Blister packs: Do not store above 25oC Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other
information
What Escitalopram contains:
The active substance is escitalopram. Each film-coated tablet contains 5mg, 10mg or 20mg escitalopram (as oxalate).
The other ingredients are:
Tablet coremicrocrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate
Coating: hypromellose 6cP, titanium dioxide (E 171), macrogol 6000.
What Escitalopram looks like and contents of the pack:
Escitalopram 5mg: Round, biconvex, white film-coated tablets (diameter 6 mm), marked with 'E' on one side.
Escitalopram 10mg: Oval, biconvex, white film coated tablets, (6.4mm x 9.25mm), with score on one side, sidescores and marked with 'E' on the other side. The tablet can be divided into equal halves. Escitalopram 20mg: Oval, biconvex, white film coated tablets, (8mm x 11.7mm), with score on one side, sidescores and marked with 'E' on the other side. The tablet can be divided into equal halves.
Escitalopram are available in blister packs of 28 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavfkurvegi 76-78,
220 Hafnarfjordur, Iceland
Manufacturer
Actavis Ltd, B16 Bulebel Industrial Estate,
Zejtun ZTN 08, Malta This leaflet was last revised in March 2014
Continued top of next column
Continued top of next column
AAAG7572
Actavis, Barnstaple, EX32 8NS, UK