ESCITALOPRAM 10 mg Film-Coated Tablets

Зміст інструкції

1. Escitalopram Accord 10 mg film-coated tablets
   1. What is escitalopram Accord and what it is used for
   2. What you need to know before taking Escitalopram Accord
   3. How to take Escitalopram Accord
   4. Possible side effects
   5. How to store Escitalopram Accord
   6. Package Contents and Other Information

Escitalopram Accord 10 mg film-coated tablets

Escitalopram Accord 20 mg film-coated tablets
escitalopram

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful. If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Escitalopram Accord is and what it is used for
• 2. What you need to know before you take Escitalopram Accord
• 3. How to take Escitalopram Accord
• 4. Possible side effects
• 5. How to store Escitalopram Accord
• 6. Contents of the pack and other information

1. What is escitalopram Accord and what it is used for

Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing the level of serotonin.
Escitalopram Accord 10/20 mg film-coated tablets contain escitalopram and are used for the treatment of depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder and obsessive-compulsive disorder).
It may take a couple of weeks before you begin to feel better. Continue to take Escitalopram film-coated tablets, even if it may take time before you can perceive an improvement in your condition.
Contact a doctor if you do not feel better or if you should worsen.

2. What you need to know before taking Escitalopram Accord

Do not take Escitalopram Accord

• If you are allergic to escitalopram or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines that belong to a group called MAO inhibitors, including selegiline (used for the treatment of Parkinson's disease), moclobemide (used for the treatment of depression) and linezolid (an antibiotic).
• If you were born with or have had an episode of abnormal heart rhythm (visible on an electrocardiogram (ECG), a test to assess how your heart is working).
• If you are taking medicines for heart rhythm problems or that can affect the heart rhythm (see section 2 “Other medicines and Escitalopram Accord”).

Warnings and precautions
Tell your doctor if you suffer from any other condition or illness, as the doctor may
need to take this into account. In particular, tell your doctor:

• If you suffer from epilepsy. Treatment with Escitalopram Accord must be stopped if you experience seizures for the first time or if the frequency of epileptic seizures increases (see also section 4 “Possible side effects").
• If your liver or kidney function is impaired. The doctor may adjust the dosage of the medicine.
• If you suffer from diabetes. Treatment with Escitalopram Accord may alter blood glucose control. It may be necessary to revise the dosage of insulin and/or oral hypoglycemic agents.
• If your sodium level in the blood is low.
• If you have a predisposition to bleeding or easy bruising or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• If you are undergoing electroconvulsive therapy.
• If you suffer from coronary heart disease.
• If you suffer from or have suffered from heart problems or have recently had a heart attack.
• If you have a low resting heart rate and/or if you think your body may have experienced significant salt loss following severe and prolonged diarrhea and vomiting or through the use of diuretics (water pills).
• If you experience a fast or irregular heartbeat, fainting, collapse or dizziness when standing up, which may indicate an irregularity of the heart rate.
• If you suffer from eye problems, such as certain types of glaucoma (increased pressure in the eye)

Warning
Some patients with manic-depressive illness may enter a manic phase, which is
characterized by unusual and rapid changes in ideas, unjustified happiness and excessive physical
activity. If you should experience such symptoms, contact your doctor.
Symptoms such as restlessness or difficulty staying seated or standing still may also occur
during the first weeks of treatment. Tell your doctor immediately if you notice these symptoms.
Medicines such as Escitalopram (so-called SSRIs/SNRIs) can cause symptoms of sexual
dysfunction (see section 4). In some cases, these symptoms have continued even after
stopping treatment.

Thoughts of suicide and worsening of depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes experience the urge to harm yourself or
even to commit suicide. These thoughts may increase at the beginning of treatment with
antidepressants, as these medicines take time to work, usually about two
weeks but sometimes even longer.
You may be more likely to have these thoughts if:

• You have already expressed an intention to commit suicide or harm yourself in the past.
• If you are a young adult. Information from clinical studies has shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with an antidepressant.

If you should haveat any time thoughts of self-harm or suicide, contact your doctor immediately
or go to the nearest hospital.
It may be helpful to tell a relativeor close friendabout your state of depression or
asking them to notify you if they think your depression or anxiety is worsening, or if
they are concerned about any changes in your behavior.

Use in children and adolescents
Escitalopram Accord is not normally used in children and adolescents under the age of 18 years. Also, you should know that patients under the age of 18 have an
increased risk of side effects such as suicide attempts, suicidal thoughts and hostility
(mainly aggression, oppositional behavior and anger) when taking
this class of medicines. However, the doctor may still prescribe Escitalopram
Accord to patients under the age of 18 if they believe it is the best solution in that case. If the
doctor has prescribed Escitalopram Accord to a patient under the age of 18 and you want to
discuss it, consult your doctor again. You should tell your doctor if any of the symptoms
described above occur or worsen while the patient under the age of 18 is taking
Escitalopram Accord. In addition, the long-term safety of Escitalopram Accord regarding
growth, maturation and cognitive and behavioral development in this age group has not
yet been demonstrated.

Other medicines and Escitalopram Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
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 must wait 14 days before starting to take Escitalopram Accord. After stopping taking Escitalopram Accord you must wait 7 days before taking any of these medicines.
• “Selective reversible MAO-A inhibitors”, containing moclobemide (used for the treatment of depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.
• Buprenorphine (a type of opioid medicine). Concomitant use increases the risk of serotonin syndrome, a potentially life-threatening condition. Symptoms may include involuntary and rhythmic muscle contractions, including muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased muscle contraction, fever above 38 °C. Contact your doctor if you experience these symptoms.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used for the treatment of depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol and similar drugs (opioids, used for severe pain). These medicines increase the risk of side effects.
• Cimetidine, lansoprazole and omeprazole used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These medicines can cause an increase in the levels of Escitalopram Accord.
• St John's Wort ( hypericum perforatum) - a herbal remedy used for depression.
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used to relieve pain or to thin the blood, so-called anticoagulants). These medicines can increase the tendency to bleed.
• Warfarin, dipyridamole and acenocoumarol, phenprocoumon (medicines used to thin the blood, so-called anticoagulants). The doctor will probably check your blood clotting time at the beginning and end of therapy with Escitalopram Accord, to verify whether your anticoagulant dose is still adequate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used for severe pain), due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone and metoprolol (used in cardiovascular diseases) clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). The dosage of Escitalopram Accord may need to be adjusted.

DO NOT TAKE Escitalopram Accordif you are taking medicines for heart rhythm problems or
that can affect the heart rhythm such as, for example, Class IA and III antiarrhythmics,
antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants,
some antimicrobial agents (such as sparfloxacin, moxifloxacin, IV erythromycin, pentamidine,
antimalarials, in particular halofantrine), some antihistamines (astemizole, hydroxyzine,
mizolastine). If you have any doubts, contact your doctor.

Escitalopram Accord with food, drinks and alcohol
Escitalopram Accord can be taken independently of meals (see section 3 “How
to take Escitalopram Accord”).
As with many medicines, it is not advisable to combine Escitalopram Accord with alcohol, although
no interactions between escitalopram and alcohol are expected.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this
medicine. Do not take Escitalopram Accord if you are pregnant, or if you are breastfeeding, unless you have already discussed the relevant risks and benefits with your doctor. If you take
Escitalopram Accord during the last 3 months of pregnancy, you should consider that the newborn
may experience the following effects: difficulty breathing, bluish skin discoloration,
convulsions, variations in body temperature, difficulty feeding, vomiting, low blood sugar, rigid or
flaccid muscles, excessive liveliness of reflexes, tremor,
nervousness, irritability, lethargy, difficulty falling asleep and difficulty falling asleep. If
your baby experiences any of these symptoms, contact your doctor immediately.
Make sure your midwife and/or doctor know that you are taking Escitalopram
Accord. When taken during pregnancy, especially in the last trimester of gestation,
medicines such as Escitalopram Accord can increase the risk of a serious
illness in the baby, called persistent pulmonary hypertension of the newborn (PPHN),
which
causes the baby to breathe faster than normal and a bluish skin discoloration. These
symptoms usually appear within the first 24 hours after the baby's birth. If this should
occur in your baby, contact your midwife and/or doctor immediately.
If you take Escitalopram Accord near the end of pregnancy, there may be an increased risk
of heavy vaginal bleeding shortly after delivery, especially if you suffer from
bleeding disorders (easy bleeding). Inform your doctor or midwife about the fact that you are taking Escitalopram Accord, so that they can advise you on what to do.
If used during pregnancy, Escitalopram Accord should never be stopped
abruptly.
It is expected that escitalopram Accord will be excreted in breast milk.
In animal studies, citalopram, a medicine like Escitalopram
Accord, has been shown to reduce sperm quality. Theoretically this could have effects on fertility, but
to date no impact on human fertility has been observed.

Driving and using machines
It is recommended not to drive vehicles or operate machinery until you know
the effects of Escitalopram Accord on your body.

Escitalopram Accord contains sodium
This medicine contains less than 1mmol (23mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take Escitalopram Accord

Always take this medicine exactly as your doctor has told you. If you have doubts
consult your doctor or pharmacist.
Adults

Depression
The normally recommended dose of Escitalopram Accord is 10 mg in a single dose
daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Panic disorder
The initial dose of Escitalopram Accord is 5 mg in a single daily dose for the first
week, then moving to 10 mg per day. The dose may be further increased by the
doctor up to a maximum of 20 mg per day.

Social anxiety disorder
The normally recommended dose of Escitalopram Accord is 10 mg in a single dose
daily. Your doctor may either decrease the dose to 5 mg per day or increase it up to a
maximum of 20 mg per day, based on your response to the medicine.

Generalized anxiety disorder
The normally recommended dose of Escitalopram Accord is 10 mg in a single dose
daily. The dose may be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder
The recommended dose of Escitalopram Accord is 10 mg in a single daily dose. The dose may
be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram Accord is 5 mg in a single daily dose. The
dose may be increased by your doctor to 10 mg per day.

Use in children and adolescents
Escitalopram Accord is not normally used in children and adolescents.
For further information see section 2 “Warnings and precautions”.
Reduced kidney function
Caution is advised in patients with severely impaired kidney function. Take as
prescribed by your doctor.
Reduced liver function
Patients with liver disorders should not receive more than 10 mg per day. Take as
prescribed by your doctor.
Patients known to be poor metabolizers of the CYP2C19 enzyme
Patients with this known genotype should not receive more than 10 mg per day. Take as
prescribed by your doctor.

How to take the tablets
Escitalopram Accord can be taken with or without food. Swallow the
tablet with a little water. Do not chew the tablets because they taste bitter.
If necessary, you can divide the tablet by first placing it on a flat surface
with the score line facing upwards. The tablet can then be broken by pressing
down on both sides of the tablet, using your index fingers as shown in the
drawing below.
Only the 10 mg and 20 mg tablets can be divided into equal doses.

Duration of treatment
It may take a couple of weeks before you start to feel better. Continue to take
Escitalopram Accord even if you have to wait some time before noticing an improvement in
your condition.
Do not change the dose of the medicine without discussing it first with your doctor.
Continue to take Escitalopram Accord for the entire period of time that your doctor has recommended to you. If you stop treatment too early, your symptoms may return. It is
recommended to continue treatment for at least another 6 months after you have recovered.

If you take more Escitalopram Accord than you should
If you have taken a dose of Escitalopram Accord higher than that prescribed, contact
your doctor or the emergency room of the nearest hospital immediately, even if you do not experience
any symptoms or discomfort. Some signs of overdose may be dizziness, tremor,
agitation, convulsions, coma, nausea, vomiting, altered heartbeat, decreased
blood pressure and changes in the balance of fluids and salts in the body. Bring with you the
box/container of Escitalopram Accord when you go to the doctor or to the hospital.

If you forget to take Escitalopram Accord
Do not take a double dose to make up for the missed dose. If you have forgotten
to take a dose and remember before going to bed, take the dose immediately and continue
as usual the next day. If you only remember during the night or the next day,
skip the missed dose and continue with your usual schedule.

If you stop taking Escitalopram Accord
Do not stop taking Escitalopram Accord until your doctor tells you that you can do so.
Once the course of treatment is completed, it is generally recommended to gradually
reduce the dose of Escitalopram Accord over several weeks.
When you stop taking Escitalopram Accord, especially if abruptly, you may
experience withdrawal symptoms. These symptoms are common when stopping
treatment with Escitalopram Accord. The risk is greater if Escitalopram Accord has been used
for a long time or at high doses or when the dose is reduced too quickly. Most people find these symptoms mild and able to disappear on their own
within two weeks. However, in some patients the symptoms may be severe or
prolonged (2-3 months or more). If you experience severe withdrawal symptoms
when you stop taking Escitalopram Accord, consult your doctor. Your doctor may advise you
to restart the tablets and then discontinue treatment more slowly.
Withdrawal symptoms include: feeling dizzy (unsteady and unstable balance), sensations of tingling, sensations of burning and (less commonly) electric shock,
even in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep),
feeling anxious, headache, malaise (nausea), sweating (including night sweats),
feeling restless or agitated, tremor, feeling confused or disoriented,
feeling emotional or irritable, diarrhea (loose stools), visual disturbances, heartbeat
palpitations or pounding (palpitations).
If you have any questions about 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 everyone will experience them.
Side effects generally disappear after a few weeks of treatment. However, consider that many of these effects may also be symptoms of your illness, and therefore will improve as soon as the treatment brings its benefits and you feel better.

If you experience any of the following symptoms, contact your doctor or go to
hospital immediately:
Uncommon(may affect up to 1 in 100 people)

• Unusual bleeding, including gastrointestinal bleeding

Rare(may affect up to 1 in 1000)

• Swelling of the skin, tongue, lips, throat or face, hives or difficulty breathing or swallowing (severe allergic reaction). High fever, agitation, confusion, tremor and sudden muscle contractions may be signs of a rare condition called serotonin syndrome.

Not known(frequency cannot be estimated from the available data):

• Difficulty urinating
• Fast and irregular heartbeat and fainting, which may be symptoms of a life-threatening condition, known as Torsades de Pointes.
• Seizures (convulsions), see also section 2 “Warnings and precautions”
• Yellowing of the skin and whites of the eyes may be signs of impaired liver function/hepatitis.
• Self-harming or suicidal thoughts, see also section 2 “Warnings and precautions”
• Sudden swelling of the skin or mucous membranes (angioedema)

The following side effects have been reported in addition to those mentioned above:
Very common(may affect more than 1 in 10 people)

• Feeling unwell (nausea)
• Headache

Common(may affect up to 1 in 10 people)

• Stuffy or runny nose (sinusitis)
• Decreased or increased appetite
• Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremor, tingling of the skin
• Diarrhoea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain (arthralgia and myalgia)
• Sexual dysfunction (delayed ejaculation, problems with erection, decreased sexual desire, while women may experience difficulty reaching orgasm)
• Fatigue, fever
• Weight gain

Uncommon(may affect up to 1 in 100 people)

• Hives, rash, itching
• Teeth grinding, agitation, nervousness, panic attack, confused state
• Disturbed sleep, altered taste, fainting (syncope)
• Enlarged pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus)
• Hair loss
• Heavy menstrual bleeding
• Irregular menstrual cycle
• Vaginal bleeding
• Weight loss
• Fast heartbeat
• Swelling of the arms or legs
• Nosebleeds

Rare(may affect up to 1 in 1000)

• Aggression, depersonalization, hallucinations
• Slow heartbeat

Not known(frequency cannot be estimated from the available data)

• Reduced levels of sodium in the blood (symptoms are malaise, muscle weakness or confusion)
• Abnormal heart rhythm (defined as “prolongation of the QT interval”, visible on ECG, heart electrical activity).
• Dizziness when getting up due to low blood pressure (orthostatic hypotension)
• Abnormal liver function tests (increased liver enzyme levels in the blood)
• Movement disorders (involuntary muscle movements)
• Painful erection (priapism)
• Signs of abnormal bleeding, for example from the skin and mucous membranes (ecchymosis)
• Increased secretion of a hormone called ADH, which causes the body to retain water and dilute the blood, reducing the amount of sodium (inappropriate secretion of ADH)
• Milk flow in men and women who are not breastfeeding
• Mania
• An increased risk of bone fractures has been observed in patients taking this type of medicine.
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see section 2, Pregnancy, breastfeeding and fertility, for further information

In addition, there are side effects that occur with medicines that work in a similar way to escitalopram (the active substance of Escitalopram Accord film-coated tablets), such as the following:

• Restlessness (akathisia)
• Loss of appetite

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to
reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Escitalopram Accord

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, on the label or
on the packaging after EXP.
The expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Escitalopram Accord contains
The active ingredient is escitalopram.
Each film-coated tablet of Escitalopram Accord 10mg/20mg contains 10mg/20mg of
escitalopram (as oxalate).
The excipients are:
Core: microcrystalline cellulose (PH 101) (E460), sodium croscarmellose (E468), hypromellose
E5 (E464), talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E470b)
Coating: hypromellose E-15 (E464), titanium dioxide (E171), macrogol 400

Description of the appearance of Escitalopram Accord and contents of the pack
Escitalopram Accord is presented in film-coated tablets of 10 mg and 20 mg. The tablets
are described below.
10 mg: Film-coated tablets of colour from white to off-white, oval in shape, approximately

• 8.10 mm in length and 5.60 mm in width, biconvex, with inscription ‘1’ and ‘0’ on either side of the fracture line on one side of the tablet and smooth on the other side. 20 mg: Film-coated tablets of colour from white to off-white, oval in shape, approximately
• 11.60 mm in length and 7.10 mm in width, biconvex, with a fracture line on one side of the tablet and smooth on the other side.

The 10 mg and 20 mg tablets can be divided into equal doses.
Escitalopram Accord 10 / 20 mg is available in the following pack sizes:
Blisters in the outer box:
10mg and 20 mg: 14, 28, 56 and 98 tablets
Packs with HDPE bottle containing 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, Schimatari, 32009, Greece

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
NameofMember
State
Name of the medicinal product
Austria Escitalopram Accord 5 mg/10mg/20mg filmtabletten
Czech Republic Escitalopram Accord 5 mg /10mg/20mg potahovanй tablety
Denmark Escitalopram Accord Healthcare
Estonia Escitalopram Accord 10mg/20mg
Ireland Escitalopram 5 mg/10mg/20mg film-coated tablets
Latvia Escitalopram Accord 10mg/20mg apvalkotās tabletes
Portugal Escitalopram Accord
Spain Escitalopram Accord 5 mg /10mg/20mg comprimidos recubiertos
con pelicula
Bulgaria Escitalopram Accord 10 mg филмирани таблетки
Finland Escitalopram Accord 10/20 mg Tabletti, kalvopäällysteinen
Italy Escitalopram Accord
Netherlands Escitalopram Accord 5 mg/10 mg /20 mg Filmomhulde tabletten
Sweden Escitalopram Accord 5 mg /10 mg /20 mg Filmdragerade tabletter
Slovak Republic Escitalopram Accord 10 mg /20 mg filmom obalené tablety
United Kingdom Escitalopram 5 mg/10 mg /20 mg Film-coated tablets