Escitalopram 5 Mg Film-Coated Tablets
Out of date information, search anotherPackage leaflet: Information for the user Escitalopram 5 mg Film-Coated Tablets Escitalopram 10 mg Film-Coated Tablets Escitalopram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 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What this medicine is and what it is used for.
2. Before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. What this medicine is and what it is used for
This medicine belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). 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.
This medicine contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder).
2. What you need to know before you take this medicine
• If you are allergic (hypersensitive) to escitalopram or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”).
• If you take other medicines that 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 “Taking other medicines”).
Take special care with this medicine
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 this medicine should be stopped if seizures occur for the first time, or if there is an increase in the seizure frequency (see also section 4 “Possible side effects”).
• If you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage.
• If you have diabetes. Treatment with this medicine may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
• If you have a decreased level of sodium in the blood.
• If you have a tendency to easily develop bleedings or bruises.
• If you are receiving electroconvulsive treatment.
• 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.
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 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 yourselves. 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.
Use in children and adolescents under 18 years of age
This medicine 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 this medicine for patients under 18 because he/she decides that this is in their best interest. If your doctor has prescribed this medicine 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 this medicine. Also, the long term safety effects concerning growth, maturation and cognitive and behavioural development of this medicine in this age group have not yet been demonstrated.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
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 Film-Coated Tablets. After stopping Escitalopram Film-Coated Tablets 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.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used against severe pain). These
Page 1
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 Film-Coated Tablets.
• St. John's Wort (hypericum perforatum) - a herbal remedy used for depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to thin the blood, so called anti-coagulant). These may increase bleeding-tendency.
• 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 Film-Coated Tablets in order to verify that your dose of anti-coagulant is still adequate.
• Mefloquin (used to treat Malaria), bupropion (used to treat depression) 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 cardiovascular diseases) clomipramine, and nortriptyline (antidepressants) and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Escitalopram Film-Coated Tablets may need to be adjusted.
Do not take this medicine 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.
This medicine with food and drink and alcohol
This medicine can be taken with or without food (see section 3 “How to take this medicine”).
As with many medicines, combining this medicine with alcohol is not advisable, although this medicine is not expected to interact with alcohol.
Pregnancy and breast-feeding and fertility
Inform your doctor if you are pregnant or planning to become pregnant. Do not take this medicine if you are pregnant or breast-feeding, unless you and your doctor have discussed the risks and benefits involved.
If you take this medicine 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, bluish 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.
Make sure your midwife and/or doctor know you are on this medicine. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Escitalopram Film-Coated Tablets 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 used during pregnancy this medicine should never be stopped abruptly.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You are advised not to drive a car or operate machinery until you know how this medicine affects you.
3. How to take this medicine
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
Depression
The normally recommended dose of this medicine is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.
Panic disorder
The starting dose of this medicine is 5 mg as one daily dose for the first week before increasing the dose to 10 mg per day. The dose may be further increased by your doctor to a maximum of 20 mg per day.
Social anxiety disorder
The normally recommended dose of this medicine is 10 mg taken as one daily dose. Your doctor can either decrease your dose to 5 mg per day or increase the dose to a maximum of 20 mg per day, depending on how you respond to the medicine.
Generalised anxiety disorder
The normally recommended dose of this medicine is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The normally recommended dose of this medicine is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.
Elderly patients (above 65 years of age)
The recommended starting dose of this medicine 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)
This medicine should not normally be given to children and adolescents. For further information please see section 2 “Before you take this medicine”.
You can take this medicine with or without food. Swallow the tablet with some water. Do not chew them, as the taste is bitter.
The 10 mg and 20 mg tablets can be divided into equal halves. You can divide the tablets 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.
It may take a couple of weeks before you start to feel better. Continue to take this medicine 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 this medicine 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 medicine than you should
If you take more than the prescribed dose of this medicine, contact your doctor or nearest hospital emergency department immediately. Do this even if there are no signs of discomfort. Some of the signs of an overdose could be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and change in body fluid/salt balance. Take the Escitalopram Film-Coated Tablets box/container with you when you go to the doctor or hospital.
If you forget to take this medicine
Do not take a double dose to make up for forgotten doses. 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.
Page 2
H H H
50 86
If you stop taking this medicine
Do not stop taking this medicine until your doctor tells you to do so. When you have completed your course of treatment, it is generally advised that the dose of this medicine is gradually reduced over a number of weeks.
When you stop taking this medicine, especially if it is abruptly, you may feel discontinuation symptoms. These are common when treatment with this medicine is stopped. The risk is higher, when this medicine 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 this medicine, 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, fluttering or pounding heartbeat (palpitations).
If you have any further questions on the use of this product, 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:
Uncommon (affects 1 to 10 users in 1000):
• Unusual bleeds, including gastrointestinal bleeds Rare (affects 1 to 10 users in 10000):
• 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 section “Take special care with this medicine”.
• 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 torsade de pointes
In addition to above the following side effects have been reported:
Very common (affects more than 1 user in 10):
• Feeling sick (nausea)
Common (affects 1 to 10 users in 100):
• Blocked or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulties falling asleep, feeling sleepy, dizziness, yawning, tremors, prickling of the skin
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Pain in muscle and joints (arthralgia and myalgia)
• Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)
• Fatigue, fever
• Increased weight
Uncommon (affects 1 to 10 users in 1000):
• Nettle rash (urticaria), rash, itching (pruritus)
• Grinding one’s teeth, agitation, nervousness, panic attack, confusion state
• Disturbed sleep, taste disturbance, fainting (syncope)
• Enlarged pupils (mydriasis), visual disturbance, ringing in the ears (tinnitus)
• Loss of hair
• Vaginal bleeding
• Decreased weight
• Fast heart beat
• Swelling of the arms or legs
• Nosebleeds
Rare (affects 1 to 10 users in 10000):
• Aggression, depersonalisation, hallucination
• Slow heart beat
Some patients have reported (frequency can not be estimated from the available data):
• Thoughts of harming yourself or thoughts of killing yourself, see also section “Take special care with this medicine”
• Decreased levels of sodium in the blood (the symptoms are feeling sick and unwell with weak muscles or confused)
• Dizziness when you stand up due to low blood pressure (orthostatic hypotension)
• Abnormal liver function test (increased amounts of liver enzymes in the blood)
• Movement disorders (involuntary movements of the muscles)
• Painful erections (priapism)
• Bleeding disorders including skin and mucous bleeding (ecchymosis) and low level of blood platelets (thrombycytopenia)
• Sudden swelling of skin or mucosa (angioedemas)
• Increase in the amount of urine excreted (inappropriate ADH secretion)
• Flow of milk in women that are not nursing
• Mania
• 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, measuring electrical activity of the heart)
In addition, a number of side effects are known to occur with drugs that work in a similar way to escitalopram (the active ingredient of this medicine). These are:
• Motor restlessness (akathisia)
• Anorexia
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
6. Contents of the pack and other information
What this medicine contains
- The active substance is escitalopram. Each Escitalopram Film-Coated Tablets tablet contains 5 mg, 10 mg or 20 mg escitalopram (as oxalate).
- The other ingredients are:
Core: Mannitol, Microcrystalline Cellulose (Avicel PH101), Croscarmellose Sodium, Maize Starch, Magnesium Stearate
Coating: Hypromellose 15 cp (E464), Titanium dioxide (E171), Macrogol 6000 What this medicine looks like and contents of the pack
This medicine is presented as 5 mg, 10 mg and 20 mg film-coated tablets. The tablets are described below
5 mg- White to off white, round, biconvex film coated tablets with “E5” debossed on one side and plain on the other
side.
10 mg- White to off white, round, biconvex film coated tablets with “E10” debossed on one side and break line on the other side
20 mg- White to off white, round, biconvex film coated tablets with “E20” debossed on one side and break line on the other side.
This medicine is available in the following pack sizes
Blister pack with an outer carton
14, 20, 28, 50, 56, 98, 100 and 200 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Cipla (EU) Limited.
Hillbrow House, Hillbrow Road,
Esher, Surrey, KT10 9NW,
United Kingdom.
Manufacturer
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola, PLA 3000,
Malta
S&D Pharma CZ, spol. s r.o.
Theodor 28, 273 08 Pchery (Pharmos a.s. facility)
Czech republic
Cipla (EU) Limited,
4th Floor, 1 Kingdom Street,
London, W2 6BY,
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
UK Escitalopram 5/10/20 mg Film-Coated Tablets IE Escitalopram 5/10/20 mg Film-Coated Tablets CY Escitalopram 5/10/20 mg smKaZuppsva ps Xsmo upsvio Siaria MT Escitalopram 5/10/20 mg Film-Coated Tablets
This leaflet was last revised in 12/2013.
5. How to store this medicine
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the label or carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Cipla |
PACKAGING DEVELOPMENT
Product Name : Escitalopram 5mg 10mg 20mg
Coordinator : Shweta
Item Code : KS75 A Item : PIL Date : 06-12-13
Artist : Atul
Software : Illustrator CS5
Fonts : Convert to curve
Colours :
BLUE WOOL TEST VALUE 5-8 (LIGHT FASTENING DATA)
Pantone Black C
Spectro-Densitometer Delta-E reading (AE) for colour: NOT MORE THAN dE2.5
Glossmeter reading
(for white surface): NOT LESS THAN 80 %
Supersedes / Reference :
Screen : # 150
Unwinding Direction :
Tuck flap:
Side / Collar flap overlap:
Caliper (Thickness) for Board:
Links :
Pharmacode : 567_mini
Design : Folded
Material : 42 GSM ITC Paper with plain perforated tear here tape.
Varnish
Actual Size : 340 x 460mm
Size after Folding : 43 x 58mm
Print repeat length :
Grain Direction : Perpendicular to Crease / Perpendicular to Pasting Flap / Parallel to length
Reference / Instructions / Remark / Braille Text Embossing:
Artwork Print Size: | | actual | | scaled
Path : F:atul/Cipla (EU)/Own Launch/KS75 A Escitalopram 5mg 10mg 20mg Cipla (EU) PIL.ai
|
Checked by |
Artist |
Cordinator |
Section Head |
File Copied by: |
file loaded in BCT HO |
|
Pharma Code |
□ |
□ | |||
|
2D Code |
□ |
□ | |||
|
Barcode Code |
□ |
□ | |||
|
Artwork |
□ |
□ | |||
|
Spell check |
□ |
□ |
Date: |
NOTE TO THE PRINTER :
• Return approved artwork alongwith the proof.
• The proof must be verified against the approved hardcopy, should be certified and signed by an authorised QA person. The unsigned proof will not be accepted.
• Colour scheme must be as approved by packaging development co-ordinator.
• Any deviation must be brought to the notice of packaging development co-ordinator immediately.
• For any clarification, please contact packaging development co-ordinator immediately.